GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC June 11, 2020
GE Healthcare
℅ Ms. Tracey Ortiz
Regulatory Affairs Director
9900 W. Innovation Drive
WAUWATOSA WI 53226
Re: K200998
Trade/Device Name: Versana Active
Regulation Number: 21 CFR 892.1550
Regulation Name: Ultrasonic pulsed doppler imaging system
Regulatory Class: Class II
Product Code: IYN, IYO, ITX
Dated: April 14, 2020
Received: April 16, 2020
Dear Ms. Ortiz:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced
above and have determined the device is substantially equivalent (for the indications for use stated in the
enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the
enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance
with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a
premarket approval application (PMA). You may, therefore, market the device, subject to the general
controls provisions of the Act. Although this letter refers to your product as a device, please be aware that
some cleared products may instead be combination products. The 510(k) Premarket Notification Database
located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination
product submissions. The general controls provisions of the Act include requirements for annual registration,
listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and
adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We
remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be
subject to additional controls. Existing major regulations affecting your device can be found in the Code of
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements
concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA
has made a determination that your device complies with other requirements of the Act or any Federal
statutes and regulations administered by other Federal agencies. You must comply with all the Act's
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.04.16
Silver Spring, MD 20993
www.fda.gov
K200998 – Ms. Tracey Ortiz Page 2
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-
combination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for
combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-
542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part
807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part
803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-
mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including
information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-
devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn
(https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the
Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See
the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-
assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE
by email ([email protected]) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D.
Director
Division of Radiological Health
OHT7: Office of In Vitro Diagnostics
and Radiological Health
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
DEPARTMENT OF HEALTH AND HUMAN SERVICES Form Approved: OMB No. 0910-0120
Food and Drug Administration Expiration Date: 06/30/2020
Indications for Use See PRA Statement below.
510(k) Number (if known)
K200998
Device Name
Versana Active
Indications for Use (Describe)
The Versana Active is a general-purpose diagnostic ultrasound system intended for use by qualified and trained healthcare
professionals for ultrasound imaging, measurement, display and analysis of the human body and fluid.
Versana Active clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Organ
(includes breast, testes, thyroid), Neonatal Cephalic, Adult Cephalic, Cardiac (includes Adult and Pediatric), Vascular/
Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/ Pleural, Transcranial,
Transrectal, Transvaginal, Interventional guidance (includes tissue biopsy, fluid drainage, vascular and non-vascular
access).
Modes of operation include: B, M, PW Doppler, CW Doppler, Color Doppler, Color M Doppler, Power Doppler,
Harmonic Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/ Color M, B/PWD or CWD, B/Color/PWD or
CWD, B/Power/PWD or CWD.
The device is intended for use in an indoor hospital environment, in medical offices/clinics and other Healthcare facilities.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
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Office of Chief Information Officer
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FORM FDA 3881 (7/17) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary K200998
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: April 14, 2020
Submitter: GE Medical Systems Ultrasound and Primary Care Diagnostics
9900 Innovation Drive
Wauwatosa, WI 53226
Primary Contact Person: Tracey Ortiz
Regulatory Affairs Director
GE Healthcare
T:(262)676-6120
Secondary Contact Person: Gao Ju
Regulatory Affairs
GE Healthcare
Device Trade Name: Versana Active
Common/Usual Name: Diagnostic Ultrasound System
Classification Names: Class II
IYN (primary), IYO, ITX (secondary)
Product Code:
Ultrasonic Pulsed Doppler Imaging System. 21CFR 892.1550 90-
IYN; Ultrasonic Pulsed Echo Imaging System, 21CFR 892.1560,
90-IYO; Diagnostic Ultrasound Transducer, 21 CFR 892.1570,
90-ITX
Primary Predicate Device: Versana Active (K191798)
Secondary Predicate Versana Balance (K191792)
Device(s):
Device Description: The Versana Active is a general purpose, Track 3, diagnostic
ultrasound system for use by qualified and trained healthcare
professionals. The Versana Active is a compact, portable system,
the device includes operator control panel, display monitor and
transducers.
The system provides digital acquisition, processing and display
capability.
The system can be powered through an electrical wall outlet for
long term use or from internal battery for a short time use.
The operator control panel includes function keys, trackball and
an alfa-numeric keyboard as input sources of the device.
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GE Healthcare
510(k) Premarket Notification Submission
The Versana Active design enables the system to be attached to
three kinds of optional mobile carts.
The variety of transducers include convex, linear, sector and
mechanical 4D. The access types include trans- body surface,
transrectal, transvaginal and transcranial.
Data can be imported or exported by DVD, USB, LAN or WiFi if
the USB wireless adapter is connected to the system. An external
ECG module has been verified to use as input for
gating/triggering during scanning.
The system has a HDMI port connection and with the use of
optional Video Output Adapter, the system can have a Composite
Out port connection and a S-Video Out port connection. An
optional spare battery charger allows the system battery to be
charged externally. The system has an option for an external
Printer USB Isolator for printers to connect. The system supports
one way, Bluetooth communication capability from the system to
a personal device to allow for sharing of the patient’s data/images
when the Bluetooth USB adapter is connected to the system.
Intended Use: The Versana Active is a general-purpose diagnostic ultrasound
system intended for use by qualified and trained healthcare
professionals for ultrasound imaging, measurement, display and
analysis of the human body and fluid.
Versana Active clinical applications include: Fetal/Obstetrics,
Abdominal, Gynecology, Urology, Pediatric, Small Organ
(includes breast, testes, thyroid), Neonatal Cephalic, Adult
Cephalic, Cardiac (includes Adult and Pediatric),
Vascular/Peripheral Vascular, Musculoskeletal Conventional,
Musculoskeletal Superficial, Thoracic/ Pleural, Transcranial,
Transrectal, Transvaginal, Interventional guidance (includes
tissue biopsy, fluid drainage, vascular and non-vascular access).
Modes of operation include: B, M, PW Doppler, CW Doppler,
Color Doppler, Color M Doppler, Power Doppler, Harmonic
Imaging, Coded Pulse, 3D, 4D and Combined modes: B/M, B/
Color M, B/PWD or CWD, B/Color/PWD or CWD,
B/Power/PWD or CWD.
The device is intended for use in an indoor hospital environment,
in medical offices/clinics and other Healthcare facilities.
Technology: The Versana Active employs the same fundamental scientific
technology as its predicate devices.
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GE Healthcare
510(k) Premarket Notification Submission
Determination of Comparison to Predicate Devices
Substantial Equivalence: The proposed Versana Active system is substantially equivalent to the
predicate Versana Active device (K191798) with regard to intended
use, imaging capabilities, technological characteristics and safety
effectiveness.
The proposed Versana Active and predicate Versana Active
(K191798) have similar clinical indications for use.
RAB2-6-RS transducer, which was cleared in predicate
Versana Balance (K191792), is being added to the proposed
Versana Active. The RAB2-6-RS transducer supports the same
applications and modes as the RAB2-6-RS that was cleared in
predicate Versana Balance (K191792).
The proposed Versana Active and predicate Versana Active
(K191798) have similar imaging modes. 3D and 4D Imaging
modes are being added for the use with RAB2-6-RS transducer,
which were cleared in predicate Versana Balance (K191792).
The biopsy guide is being added for RAB2-6-RS transducer.
The biopsy guide is the same as the biopsy guide used with
RAB2-6-RS transducer in predicate Versana Balance
(K191792).
TUI (Tomographic Ultrasound Imaging) feature is being added,
which has already been cleared in predicate Versana Balance
(K191792).
Adding new hardware options:
- Two addition mobile cart options.
- Video Output Adapter, which allows HDMI signal to be
transferred to S-video and CVBS video signal.
- Spare Battery Charger, which allows battery to be charged
out from system.
Summary of Non-Clinical Tests:
Versana Active has been evaluated for acoustic output, biocompatibility,
cleaning and disinfection effectiveness as well as thermal, electrical,
electromagnetic, and mechanical safety, and has been found to comply
with applicable medical device safety standards. The Versana Active
complies with voluntary standards:
ANSI/AAMI ES60601-1, Medical Electrical Equipment – Part
1: General requirements for basic safety and essential
performance - 2005/(R)2012 and A1:2012, C1:2009/(R)2012
and A2:2010/(R)2012
IEC 60601-1-2, Medical electrical equipment - Part 1-2:
General requirements for basic safety and essential
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GE Healthcare
510(k) Premarket Notification Submission
performance - Collateral Standard: Electromagnetic
disturbances - Requirements and tests - Edition 4.0, 2014
IEC 60601-2-37, Medical electrical equipment - Part 2-37:
Particular requirements for the basic safety and essential
performance of ultrasonic medical diagnostic and monitoring
equipment - Edition 2.1, 2015
ISO 10993-1, Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process -
Fourth edition, 2009
ISO 14971, Application of risk management to medical devices
- 2007
IEC 62359, Ultrasonics - Field characterization - Test methods
for the determination of thermal and mechanical indices related
to medical diagnostic ultrasonic fields - Edition 2.1, 2017
NEMA PS 3.1 - 3.20, Digital Imaging and Communications in
Medicine (DICOM) Set, 2016
The following quality assurance measures are applied to the
development of the system:
Risk Analysis
Requirements Reviews
Design Reviews
Testing on unit level (Module verification)
Integration testing (System verification)
Performance testing (Verification)
Safety testing (Verification)
Transducer material and other patient contact materials are
biocompatible.
Summary of Clinical Tests:
The subject of this premarket submission, Versana Active, did not
require clinical studies to support substantial equivalence.
Conclusion: GE Healthcare considers the Versana Active to be as safe, as effective,
and performance is substantially equivalent to the predicate devices.
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