X uy i C areyou M edica l P rodu ct C o.

, L td

C E T ec h n i cal D ocum ent o f N eb u lizer W ith M ask

ID No KEY-QS-TF-3 Version 4 Issue date 2018-06-22

Clinical Evaluation
Nebulizer With Mask
（Aerosal Mask with Connecting Tube)

Xianou Gong Xianhe Gong Sumei Duan

Compiled by Audited by Approved by

Controlled
Status Distribution No. Holder
Document
 Clinical evaluations
1 clinical evaluation plan
1.1The purpose of evaluation of Nebulizer with Mask is to meet the requirement of Annex IX of MDD
93/42/EEC. The evaluation also proves that the use value and benefit of product is much greater than its risks,
which means that the product can be used safe and effective as medical devices.
1.2. Means of clinical assessment
This product does not belong to class III , invasive or innovative products. The intended use, use methods,
materials of our products are the same as those products already wildly used in the markets. In addition, the
production technique, process of Nebulizer W ith Mask are mature and reliable, the products are widely used in
hospitals and clinical fields, no complaint on performance or other nonconformity received, no one case of user or
patient death or depravation of health. We choose literature route as clinical evaluation method. And we also
implement risk management analysis as a supplement.
1.3. Scope of the clinical evaluation
1.3.1 Product information
Product name: Nebulizer with Mask
Spec: S, M, L, XL
1.3.2 Name and address of the manufacturer
Name: Xuyi Careyou Medical Product Co., Ltd
Address : No. 2, Keyuan Third Road, Xuyi Industrial Park, 211700 Xuyi, Jiangsu, P.R.China
1.4.Product description
1.4.1 Product introduction :
The product is made of high-quality non-toxic polymer materials PVC for single use, replacing the traditional
atomizer. It is made of face mask, spray cup (bottle), connecting tube, suction-tip and oxygen humidifier. Oxygen
is the driving source of the product in order to decompose medication liquid into 0.2 micron -5μm particle fog
form of which would result in immediate effect on patient inhalation by distributing these particles around
respiratory tract lesion sites. These amounts of atomization can be freely adjusted, and the face masks are
consistent with human facial appearance with several vents. The nose clip is also adjustable with a 2m connection
tube and a 6MM plum-shaped aperture with anti-extrusion capabilities. The product has three models including S,
M, L and XL. It is colorless and transparent, and sterilized by ethylene oxide. The other attributes including small
atomized particles, large atomization volume, comfortable in use, enhanced efficacy, safe and reliable. The product
does not have any notable negative stimulus on human skin and mucous membranes, nor any known allergic
reactions, other harm, or precipitation of toxic substances. In order to ensure that the product is used only one time,
it should be destroyed immediately after using.
Including: Nebulizer with Mouth Piece, Full Nebulizer Kits, Oxygen Connection Tubings
1.4.2 Intended use: This product is intended for connecting with active respiration equipment, and
intended for rhinitis, pharyngitis, laryngitis, tracheitis, bronchitis and other respiratory diseases
treated by inhalation.
1.4.3 Classification: MDD93/42/EEC Class IIa (Rule 2)
1.4.4 Indications
Cold, flu, allergic rhinitis, nasal congestion, nasal polyps, acute or chronic pharyngitis, laryngitis,
bronchitis, emphysema, upper respiratory tract infectious diseases.
1.4.5 Contraindications:
Medicine excitant strong on respiratory, oily agentia, acute pulmonary edema, and bronchus asthma.
 X uy i C areyou M edica l P rodu ct C o., L td

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ID No KEY-QS-TF-3 Version 4 Issue date 2018-06-22

1.4.6 Caution：
a) For single use. Discard after use.
b) Do not ifpackage is open or damaged.
c) Do not store at extreme temperature and humidity.
Store in cool and dry place.

d) Ensure that all connections are secure and air circulates freely through the tubing.
1.4.7 Single use or reusable: Single use
1.4.8 Validity period:5 years
1.5. Information needed for evaluation of equivalence
1 .5. 1Information of equivalent product
Instrument used for comparison must be equivalent instrument and with CE mark.
1.5.2 Characteristics comparison:
Characteristics comparison should include: Component, intend use , component supplier, classification, quality
inspection item, life time.
1.6 Risk management:
The risk management documents of the device, e.g. the hazard identification list, clinical risks identified from the risk
analysis. The scope of the clinical evaluation will need data from and cross references to risk management
documents. The risk management documents are expected to identify the risks associated with the device and how
such risks have been addressed. The clinical evaluation is expected to address the significance of any clinical risk that
remain after design risk mitigation strategies.
1.7. Applicable standards and guidance documents
MEDDEV 2.7/ 1 revision 3 June 2016 CLINICAL EVALUATION:A GUIDE FOR MANUFACTURERS AND
NOTIFIED BODIES UNDER DIRECTIVES 93/42/EEC and 90/385/EEC
1.8 Literature search
The production technique, process of Nebulizer With Mask are mature and reliable, the products are widely used in
hospitals and clinical fields, no complaint on performance or other nonconformity received, no one case of user or
patient death or depravation of health. Here we choose literature route for clinical evaluation.
1.8.1Methods
Period covered by research: Clinical evaluation
Literature source: Pubmed (website: http://www.ncbi.nlm.nih.gov/pubmed/)
http://www.wanfangdata.com.cn/
PubMed is a free database accessing primarily the MEDLINE database of citations and abstracts on life sciences and
biomedical topics. The United States National Library of Medicine (NLM) at the National Institutes of Health (NIH)
maintains PubMed as part of the Entrez information retrieval system.
In addition to MEDLINE, PubMed also provides access to: OLDMEDLINE, In-process citations,
publisher-supplied citations and some life science journals that submit full text to the PubMed Central digital library and
may not have been recommended for the inclusion in MEDLINE.
Wangfang Data provide access to mainland China science and technology journals, ten thousand data. Establish
professional academic knowledge service website. Belongs to Wanfang data resources system, service data
provided by the data resources system unified deployment of ten thousand

Database search details: Nebulizer with Mask, Nebulizer With Mask for single use
X uy i C areyou M edica l P rodu ct C o., L td

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ID No KEY-QS-TF-3 Version 4 Issue date 2018-06-22

Medium used: internet

Selection criteria used to choose articles:
a) English language
b) Chinese language
c) Clinical studies
d) Human studies
e) Date limit:2010 to 2016
In addition, the following exclusion criteria were identified:
a) Outcomes beyond the scope of review
b) Data not pertaining to the review of interest
c) Pre-clinical articles
d) Case reports
e) Abstract only
f) Foreign language(except English)
g) Comment on an article
h) Duplicate articles
i) Articles published beyond the selected time frame
j) Criteria of Suitability(According to MEDDEV2.7. 1)

Suitability Criteria Description Grading System

Appropriate device Were the data generated from the device in question? D1 Actual device
D2 Equivalent device
D3 Other device

Appropriate device Was the device used for the same intended use (e.g., A1 Same use
application methods of deployment, application, etc.)? A2 Minor deviation
A3 Major deviation

Appropriate patient Where the data generated from a patient group that is P1 Applicable
group representative of the intended treatment population P2 Limited
e.g., age, sex, etc.) and clinical condition (i.e., P3 Different population
disease, including state and severity)?
Acceptable report/data Do the reports or collations of data contain sufficient R1 High quality
collation information to be able to undertake a rational and R2 Minor deficiencies
objective assessment? R3 Insufficient
information

1.8.2 Clinical data from literature

Brief summary and justification of the literature search strategy applied for retrieval of clinical data, including
objectives, sources used, search questions, search questions, search terms, selection criteria applied to the output of
the search, quality control measures, results, number and type of literature found to be pertinent.
1.8.3 Summary and appraisal
Summaries of clinical data generated and held by the manufacturer and of scientific literature found to be pertinent.
Including brief summary of the studies or reference (methods, results, conclusion of the authors), evaluation of their
methodological quality, scientific validity of contents, relevance to the clinical evaluation, weighting attributed to
the data, contents used (performance data, safety data, both) reasons for rejecting a study or document, reasons for
rejecting some of its contents.
1.8.4 Analysis of the clinical data

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The goal of the analysis stage is to determine if the appraised data sets available for a medical device collectively
demonstrate compliance with each of the Essential Requirements pertaining to the clinical performance and clinical
safety of the device, when the device is used according to its intended purpose.
1.9. Updating the clinical evaluation
1.9.1 When the manufacturer receives new information from Post Market Surveillance that has the potential to
change the current evaluation.

1.9.2 If no such information is received, then

a) At least annually if the device carries significant risk or is not yet well established; or
b) Every 2 to 5 years if the device is not expected to carry significant risks and is well established. A justification
should be provided.

When involvement of notified bodies is required, updates are usually coordinated with the notified body. Typically,
they are aligned with the timetable for surveillance audits and the renewal of the certificates.
1. 10. Qualification of the responsible evaluators
1.10.1 Evaluators should possess knowledge of the following:
a) Research methodology( including clinical investigation design and biostatistics)
b) Information management( e.g. scientific background or librarianship qualification)
c) Experience with relevant databases such as Embase and Medline.
d) Regulatory requirements; and
e) Medical writing (e.g. post-graduate experience in a relevant science or in medicine;
f) Training and experience in medical writing, systematic review and clinical data appraisal.
1.10.2 With respect to the particular device under evaluation, the evaluators should in addition have knowledge of
the device technology and its application;

Diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of
medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical
specialty)
1.10.3 The evaluators should have at least the following training and experience in the relevant field;
a) A degree from higher education in the respective field and 5 year of documented professional experience; or
b) 10 years of documented professional experience if a degree is not a prerequisite for a given task.
2Clinical Evaluation Report
2. 1Clinical evaluation purposes
The purpose of evaluation of Nebulizer With Mask is to meet the requirement of Annex IX
of MDD 93/42/EEC. The evaluation also proves that the use value and benefit of product is
much greater than its risks, which means that the product can be used safe and effective
as medical devices.
2.2Means of clinical assessment
This product does not belong to class III , invasive or innovative products. The intended
use, use methods, materials of our products are the same as those products already
wildly used in the markets. In addition, the production technique, process of Nebulizer
With Mask are mature and reliable, the products are widely used in hospitals and clinical
fields, no complaint on performance or other nonconformity received, no one case of user
or patient death or depravation of health. We choose literature route as clinical evaluation
method. And we also implement risk management analysis as a supplement.
2.3. Scope of the clinical evaluation
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ID No KEY-QS-TF-3 Version 4 Issue date 2018-06-22

2.3.1 Product information

Product name: Nebulizer With Mask
Spec: XL, L, M, S
2.3.2 Name and address of the manufacturer
Name: Xuyi Careyou Medical Product Co., Ltd
Address : No. 2, Keyuan Third Road, Xuyi Industrial Park, 211700 Xuyi, Jiangsu, P.R.China
2.4Product description
2.4.1 Product introduction:
The product is made of high-quality non-toxic polymer materials PVC for single use, replacing the traditional
atomizer. It is made of face mask, spray cup (bottle), connecting tube, suction-tip and oxygen humidifier. Oxygen
is the driving source of the product in order to decompose medication liquid into 0.2 micron -5μm particle fog
form of which would result in immediate effect on patient inhalation by distributing these particles around
respiratory tract lesion sites. These amounts of atomization can be freely adjusted, and the face masks are
consistent with human facial appearance with several vents. The nose clip is also adjustable with a 2m connection
tube and a 6MM plum-shaped aperture with anti-extrusion capabilities. The product has three models including S,
M, L and XL. It is colorless and transparent, and sterilized by ethylene oxide. The other attributes including small
atomized particles, large atomization volume, comfortable in use, enhanced efficacy, safe and reliable. The product
does not have any notable negative stimulus on human skin and mucous membranes, nor any known allergic
reactions, other harm, or precipitation of toxic substances. In order to ensure that the product is used only one time,
it should be destroyed immediately after using.
Including: Nebulizer with Mouth Piece, Full Nebulizer Kits, Oxygen Connection Tubings
2.4.2 Intended use: This product is intended for connecting with active respiration equipment,
and intended for rhinitis, pharyngitis, laryngitis, tracheitis, bronchitis and other respiratory
diseases treated by inhalation.
2.4.3 Classification: MDD93/42/EEC Class IIa (Rule 2)
2.4.4 Indications
Cold, flu, allergic rhinitis, nasal congestion, nasal polyps, acute or chronic pharyngitis, laryngitis,
bronchitis, emphysema, upper respiratory tract infectious diseases.
2.4.5 Contraindications:
Medicine excitant strong on respiratory, oily agentia, acute pulmonary edema, and bronchus asthma.
2.4.6 Caution：
1)For single use. Discard after use.
2)Do not ifpackage is open or damaged.
3)Do not store at extreme temperature and humidity.
Store in cool and dry place.
4)Ensure that all connections are secure and air circulates freely through the tubing.
2.4.7 Single use or reusable: Single use
2.4.8 Validity period: 5 years

2.5. Product Changes and Summary of Sales

The process of Nebulizer With Mask are no changes as others. Since we decided to
produce this product there are no products with CE market saled.
2.6. Equivalent product
2.6.1 Information of equivalent product
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Product name Disposable nebulizer oxygen mask

Model S, M, L, XL
Manufacturer name Yuhuan County Shengbo Mould Manufacturing Co., Ltd
CE mark CE0123
CE Certificate No. G2 16 01 94018 003
Start Date of CE
Not yet
Certificate

2.6.2 There are many similar devices available with different features and claimed
benefits; the following table shows the commonly seen competitor devices and their
characteristics.
model Summary
Item Equivalent Product Our Product of Conclu
supporting sion
data
Compo
Including: Nebulizer with
nent is
Mouth Piece, Full Nebulizer
Including: Nebulizer with Mouth same
Piece, Full Nebulizer Kits,
Kits, Oxygen Connection Product
and
Component Oxygen Connection Tubings
Tubings Introductio
key
n
materia
l is
same
This product is
intended for connecting
with active respiration
Used for helping patient equipment, and
breathing liquid mist, used intended for rhinitis, Product
Intend use with the nebulizer pharyngitis, laryngitis, Introductio Same
Short-term use, Body tracheitis, bronchitis n
orifice invasive device. and other respiratory
diseases treated by
inhalation.

Product
Held the ISO13485 QMS Held the ISO13485
Component supplier Introductio Same
certificate QMS certificate
n
Product
Classification of product
IIa. IIa. Introductio Same
n
Manufact
100000 cleanning
Work environment 100000 cleanning room ure Same
room
process
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model Summary
Item Equivalent Product Our Product of Conclu
supporting sion
data
descriptio
n

LIST OF
APPLICA
BLE
REGULA
Main material MedicalPVC PVC TIONS same
AND
STANDA
RDS

Composed of a large
aperture mask, an
atomizing interface, an
elastic strip, an aluminum Including connector of
tube, tube connector of Product
sheet, an atomization
Structure mask, Mask, Nebulizer Introducti same
upper cover,an atomizing
Jar , Ribbon , M etal C lip on
liner, an atomization base, etc.
an oxygen input joint, an
oxygen delivery tube and
an oxygen output joint etc.

Dimensions, Tensile
properties Sterility test, Appearances, Dimension,
Symbols & Labeling, Connection fastness, Tube
Performa
Cytotoxicity test, Skin pass and leak aging,
Performance test nce test same
allergy test, Test of nebulization, Skin irritation
report
subcutaneous stimulation test, Cytotoxicity test, Skin
etc. sensitivity test

Product
Life time of Component 5years 5years Introductio Same
n

2.6.3 Conclusion
The N ebulizer Mask manufactured by our company share the same intended use,
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structure, materials and ttechnical parameters with Yuhuan County Shengbo Mould
Manufacturing Co., Ltd. The performance of Yuhuan County Shengbo Mould
Manufacturing Co., Ltd has a very similar reference on the performance of the device
manufactured by our company.
2.7. Literature search
Beacause the production technique, process of Nebulizer With Mask are mature and
reliable, the products are widely used in hospitals and clinical fields, no complaint on
performance or other nonconformity received, no one case of user or patient death or
depravation of health. Here we choose literature route for clinical evaluation.

2.7.1 Medical device: Nebulizer With Mask

2.7.2 Methods: internet
Date of search: 2016-8-20
Searched by: gongxianhe
Period covered by search: 2010. 1-2016.8
Literature source: PubMed (website: http://www.ncbi.nlm.nih.gov/pubmed/)
PubMed is a free database accessing primarily the MEDLINE database of citations and
abstracts on life sciences and biomedical topics. The U
f
ry
b
lL
o
N
s
a
S
d
ite
n
Medicine (NLM) at the National Institutes of Health (NIH) maintains PubMed as part of the
Entrez information retrieval system .
In addition to MEDLINE, PubMed also provides access to: OLDMEDLINE, In-process
citations, publisher-supplied citations and some life science journals that submit full text to
the PubMed Central digital library and may not have been recommended for inclusion in
MEDLINE.
Database search details:
Search terms:
Nebulizer With Mask, Nebulizer With Mask for single use, Disposable nebulizer oxygen
mask
Medium used: Internet.
Selection criteria used to choose articles:
a) English language
b) Chinese language
c) Clinical studies
d) Human studies
e) Date limit: 2010 to 2016
In addition, the following exclusion criteria were identified:
a) Outcomes beyond the scope of review
b) Data not pertaining to the review of interest
c) Pre-clinical articles
d) Case reports
e) Abstract only
f) Foreign language (except English)
g) Comment on an article
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h) Duplicate articles
i) Articles published beyond the selected time frame (Jan 01, 1991 to June. 30, 2016)

Criteria of Suitability (According to MEDDEV2.7. 1):

Suitability Criteria Description Grading System

Appropriate Were the data generated from the device D1 Actual device
device in question? D2 Equivalent
D3 device
Other device
Appropriate Was the device used for the same A1 Same use
device application intended use (e.g., methods of A2 Minor deviation
deployment, application, etc.)? A3 Major deviation

Appropriate Where the data generated from a patient P1 Applicable

patient group group that is representative of the P2 Limited
intended treatment population e.g., age, P3 Different
sex, etc.) and clinical condition (i.e., population
disease, including state and severity)?
Acceptable Do the reports or collations of data R1 High quality
report/data contain sufficient information to be able to R2 Minor
collation undertake a rational and objective R3 deficiencies
assessment? Insufficient
information

2.7.3 Output
2.7.3. 1 Literature 1
Radioaerosol Pulmonary Deposition Using Mesh and Jet Nebulizers During Noninvasive
Ventilation in Healthy Subjects
Valdecir C Galindo-Filho PhD, Maria Eveline Ramos PT, Catarina SF Rattes MSc,
Antoˆ nio K Barbosa MSc, Daniella C Branda˜o PhD, Simone Cristina S Branda˜o PhD,
James B Fink PhD FAARC, and Arme`le Dornelas de Andrade PhD
RESPIRATORY CARE • SEPTEMBER 2015 VOL 60 NO 9
2.7.3.2 Literature 2
No objective benefit from steroids inhaled via a spacer in infants recovering from
bronchiolitis
J.Y.W. Wong, S. Moon, C. Beardsmore, C. O'Callaghan, H. Simpson
Dept of Child Health, University of Leicester, Leicester Royal Infirmary, Leicester, UK.
Eur Respir J 2000; 15: 388–394
2.7.3.3 Literature 3
Nebulizer hood compared to mask in wheezy infants: aerosol therapy without tears!
I Amirav, I Balanov, M Gorenberg, D Groshar, A S Luder
Department, Sieff Hospital, Safed, PO Box 1079, Rosh Pina 12000, Israel;
Arch Dis Child 2003;88:719–723
2.7.3.4 Literature 4
Evaluation of lung function and deposition of aerosolized bronchodilators carried by heliox
associated with positive expiratory pressure in stable asthmatics:A randomized clinical
trial
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Luciana Alcoforado a, Simone Branda˜o b, Catarina Rattes a, Daniella Branda˜o a,

Vito´ ria Lima a, Gildo Ferreira Lima c, James B. Fink d, Armele Dornelas de Andrade a,*
a Department of Physiotherapy, Universidade Federal de Pernambuco, Recife, Brazil
b Department of Nuclear Medicine, Hospital das Clinicas da UFPE, Recife, Brazil
c Department of Pulmonology, Hospital das Clı´ nicas da UFPE, Recife, Brazil
d Georgia State University, Atlanta, GA, USA
Respiratory Medicine (2013) 107, 1178e1185
2.7.3.5Literature 5
Nebulizers versus pressurized metered-dose inhalers in preschool children with wheezing
Christine Smith MB BS Ran D. Goldman MD FRCPC
Canadian Family Physician • Le Médecin de famille canadien | Vol 58: may • mai 2012
2.7.3.6Literature 6
Influence of Nebulizer Type With Different Pediatric Aerosol Masks on Drug Deposition in
a Model of a Spontaneously Breathing Small Child
Hui-Ling Lin MSc RRT RN FAARC, Gwo-Hwa Wan PhD, Yuan-Huey Chen MSc PT,
James B Fink PhD RRT FAARC, Wen-Qie Liu RRT, and Kai-Ying Liu RRT
Ms Lin, Dr Wan, and Ms Chen are affiliated with the Department of Respiratory Therapy,
Chang Gung University, Taoyuan, Taiwan. Dr Fink is affiliated with the Division of
Respiratory Therapy, Georgia State University, Atlanta, Georgia. Wen-Qie Liu is affiliated
with the Department of Respiratory Therapy, Keelung Branch, Chang Gung Memorial
Hospital, Keeling, Taiwan. Kai-Ying Liu is affiliated with the Department of Respiratory
Therapy, Chang Gung Memorial Hospital, LinKou Branch, Linkou, Taiwan.
RESPIRATORY CARE • NOVEMBER 2012 VOL 57 NO 11
2.7.3.7Literature 7
Nebulizers in cystic fibrosis: a source of bacterial contamination in cystic fibrosis patients?
Lorena Xavier Costa Brzezinski, Carlos Antônio Riedi, Paulo Kussek, Helena Homem de
Melo de Souza, Nelson Rosário
J Bras Pneumol. 2011;37(3):341-347
2.7.3.8Literature 8
Testing of Nebulizers for Delivering Magnesium Sulfate to Pediatric Asthma Patients in the
Emergency Department
Allan L Coates MDCM, Kitty Leung, Laurent Vecellio PhD, and Suzanne Schuh MD
Allan L Coates MDCM and Kitty Leung are affiliated with the Department of Physiology
and Experimental Medicine; and Suzanne Schuh MD is affiliated with the Department of
Population Health, Hospital for Sick Children Research Institute, University of Toronto,
Toronto, Ontario, Canada. Laurent Vecellio PhD is affiliated with Aerodrug, and with
Institut National de la Sante´ et de la Recherche Me ´dicale (INSERM), Universite´
Franc¸ois Rableais, Tours, France.
RESPIRATORY CARE, MARCH 2011 VOL 56 NO 3
2.7.4 Explanation:
These literatures are about Nebulizer With Mask. The intended use, work principle,
materials of our products are the same or similar as the products selected in last literature.
So these literatures also prove that our product is effective and safe.
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Appropriate Acceptable
Appropriate Appropriate
Device device report/data
device patient group
application collation
Our company D1 / / /
Literature 1 D2 A1 P1 R1
Literature 2 D2 A1 P1 R2
Literature 3 D2 A1 P1 R1
Literature 4 D2 A1 P1 R1
Literature 5 D2 A1 P1 R1
Literature 6 D2 A1 P1 R1
Literature 7 D2 A1 P1 R2
Literature 8 D2 A1 P1 R1

2.8. In <Product Risk Management Report> which compiled by our company, we

determined the potential hazards related products. We listed the causes of each hazard in
details. In the meantime, we also evaluated these risks and adopted relevant risk control
measures. We believed that all the risks were under control and acceptable which show
that our device is safety. Compared to use value of our product, all the risks were deemed
acceptable.

2.9. Conclusions
2.9.1 In general, the benefits of Nebulizer With Mask Use of our company is over than
residual risk which is meet the requirements of MDD Annex I. The products are safe and
can be used as medical device.
2.9.2 Our Nebulizer With Mask uses the same technologies of products which have
already wildly used in the markets. In addition, various aspects of the product have been
mature the total performance test is ok. We also have done the various aspects of clinical
assess completely before sale the product, we also implement risk management analysis
as a supplement. We herewith declare that the product clinical performance and clinical
safety are foreseen by us.
2. 10 Post market clinical follow-up (PMCF)
This product does not belong to class III, implanted or innovative products. The intended
use, use methods, materials of our products are the same as those products already wildly
used in the markets. In addition, various aspects of the product have been mature. We also
have done the various aspects of clinical assess completely before sale the product, so
PMCF is not applicable for this product.
2. 11. Date of the next clinical evaluation
2.11.1 When the manufacturer receives new information from Post Market Surveillance
that has the potential to change the current evaluation;
2.11.2 If no such information is received, then
- at least annually if the device carries significant risks or is not yet well established;
- every 2 to 5 years if the device is not expected to carry significant risks and is well
established, a justification should be provided.
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When involvement of notified bodies is required, updates are usually coordinated with the
notified body. Typically, they are aligned with the timetable for surveillance audits and the
renewal of the certificates.
2. 12. Signature

Mr.Gongxianhe Evaluator &Editor 2016-6- 12

Signature Name Position Date

2. 13. Qualification of the responsible evaluators

2.13.1 Evaluators should possess knowledge of the following:
research methodology (including clinical investigation design and biostatistics);
Information management (e.g. scientific background or librarianship qualification;
experience with relevant databases such as Embase and Medline);
regulatory requirements; and
medical writing (e.g. post-graduate experience in a relevant science or in medicine;
training and experience in medical writing, systematic review and clinical data appraisal).
2.13.2 With respect to the particular device under evaluation, the evaluators should in
addition have knowledge of:
the device technology and its application;
diagnosis and management of the conditions intended to be diagnosed or managed by the
device, knowledge of medical alternatives, treatment standards and technology (e.g.
specialist clinical expertise in the relevant medical specialty).
2.13.3 The evaluators should have at least the following training and experience in the
relevant field:
a degree from higher education in the respective field and 5 years of documented
professional experience; or
10 years of documented professional experience if a degree is not a prerequisite for a
given task.
5.2. 14.Annex
5.2.14.1 Annex 1: Literature 1
5.2.14.2 Annex 2: Literature 2
5.2.14.3 Annex 3: Literature 3
5.2.14.4 Annex 4: Literature 4
5.2.14.5 Annex 5: Literature 5
5.2.14.6 Annex 6: Literature 6
5.2.14.7 Annex 7: Literature 7
5.2.14.8 Annex 8: Literature 8
5.2.14.9 Annex 9: Editor Resume
 X uy i C areyou M edica l P rodu ct C o., L td

C E T ec h n i cal D ocum ent o f N eb u lizer W ith M ask

ID No KEY-QS-TF-3 Version 4 Issue date 2018-06-22