(98 days)
Not Found
No
The document describes a standard diagnostic ultrasound system with various imaging modes and data handling capabilities, but there is no mention of AI or ML features in the intended use, device description, or any other section.
No
Explanation: The device is described as a "general-purpose diagnostic ultrasound system" and its intended uses are for "ultrasound imaging, measurement, display and analysis", which are diagnostic functions, not therapeutic.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Versana Essential 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." This directly identifies it as a diagnostic device.
No
The device description clearly states it is a "mobile console that includes an operator control panel, display monitor and transducers," indicating it is a hardware system with integrated software, not a software-only device.
Based on the provided text, the Versana Essential is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Definition of IVD: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Intended Use of Versana Essential: The Versana Essential is described as 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." It directly images the human body.
- Lack of Specimen Analysis: The description focuses on imaging the body directly, not on analyzing samples taken from the body.
Therefore, the Versana Essential falls under the category of medical imaging devices, not IVD devices.
N/A
Intended Use / Indications for Use
The Versana Essential 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 Essential clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, 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 M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color.
Versana Essential is intended to be used in a hospital or medical clinic.
Product codes (comma separated list FDA assigned to the subject device)
IYN, IYO, ITX
Device Description
The Versana Essential is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.
The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.
The operator control panel includes function keys, trackball, an alfa-numeric keyboard.
The variety of transducers include convex, linear, sector, and mechanical 4D transducers. 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. The Video adapter is optional part which used to extend the S-Video/Composite Out interface by connecting with HDMI port. The system has a DC outlet to allow connection of a DC printer which sits in the printer box of the console and an option for external Printer USB Isolator for other commercial printers to connect.
The system allows for electronic instructions for use and software updates to be download from a GE Healthcare website.
Mentions image processing
digital acquisition, processing and display capability
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleura, Transcranial, Transrectal, Transvaginal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified and trained healthcare professionals / hospital or medical clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, Versana Essential, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Versana Balance (K220446)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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February 15, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Lee Bush Regulatory Affairs Director GE Healthcare 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K223407
Trade/Device Name: Versana Essential Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: January 19, 2023 Received: January 19, 2023
Dear Lee Bush:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Yanna S. Kang -S
Yanna Kang, Ph.D. Assistant Director Mammography and Ultrasound Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Image /page/2/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white water droplets around the edge of the circle. The logo is simple and recognizable.
Expiration Date: 06/30/2023
See PRA Statement below.
Form Approved: OMB No. 0910-0120
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K223407
Device Name
Versana Essential
Indications for Use (Describe)
The Versana Essential 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 Essential clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, VascularPeripheral Vascular, Musculoskeletal Conventional, Musculosketal Superficial, Thoracic/Pleural, 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 M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color.
Versana Essential is intended to be used in a hospital or medical clinic.
| 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.
3
Image /page/3/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are small white water droplet shapes around the inside of the circle.
K223407
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
| Date: | Jan. 19, 2022 |
|---|---|
| Submitter: | GE Medical Systems Ultrasound and Primary Care Diagnostics |
| 9900 Innovation Drive | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Lee Bush |
| Regulatory Affairs Director | |
| GE Healthcare | |
| T:(262)309-9429 | |
| Secondary Contact Person: | Jian Xie |
| Regulatory Affairs Leader | |
| GE Healthcare | |
| Device Trade Name: | Versana Essential |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | 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 Balance (K220446), Diagnostic Ultrasound System |
| Classification Names: | Class II |
| Product Code(s): | 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 |
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' written in a stylized, cursive font, enclosed within a circular border. The border has four droplet-like shapes extending outwards at the cardinal directions, giving it a dynamic and fluid appearance. The logo is presented in a blue color.
Device Description:
The Versana Essential is a general purpose, Track 3, diagnostic ultrasound system for use by qualified and trained healthcare professionals. The system is a mobile console that includes an operator control panel, display monitor and transducers.
The console provides digital acquisition, processing and display capability. The system has an internal battery to allow for acquisition while the system is not plugged into a power source. Acquisition can also be done while the system is connected to an AC power source.
The operator control panel includes function keys, trackball, an alfa-numeric keyboard.
The variety of transducers include convex, linear, sector, and mechanical 4D transducers. 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. The Video adapter is optional part which used to extend the S-Video/Composite Out interface by connecting with HDMI port. The system has a DC outlet to allow connection of a DC printer which sits in the printer box of the console and an option for external Printer USB Isolator for other commercial printers to connect.
The system allows for electronic instructions for use and software updates to be download from a GE Healthcare website.
Intended Use/Indication for Use:
Versana Essential and predicate device Versana Balance (K220446) have the same intended use:
The Versana Essential 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 Essential clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Urology, Pediatric, Small Parts (includes breast, testes, thyroid), Cardiac Pediatric, Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, Thoracic/Pleura, 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 M Doppler, Power Doppler, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode, Elastography, and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD, B Flow/B Flow Color.
Versana Essential is intended to be used in a hospital or medical clinic.
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Image /page/5/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" written in a stylized script, enclosed within a blue circle. The circle is surrounded by three white, curved shapes that resemble water droplets or stylized flames.
GE Healthcare
510(k) Premarket Notification Submission
Technology:
The Versana Essential employs the same fundamental scientific technology as its predicate device Versana Balance device (K220446).
Determination of Substantial Equivalence:
The proposed Versana Essential system is substantially equivalent to the predicate device Versana Balance with regard to intended use, imaging capabilities, technological characteristics, imaging modes, hardware, and safety effectiveness.
Transducers and Modes:
- The proposed Versana Essential transducers are same as predicate Versana Balance (K220446) systems . transducers
- l 4C-RS
- E8C-RS
- 35c-RS
- L6-12-RS
- ર્દ-૪૮
- 8C-KS
- I E8CS-RS
- RAB2-6-RS I
- LK760-RS
- Versana Essential and predicate device Versana Balance (K220446) have the same imaging modes ●
Software:
The proposed Versana Essential has the same features and functionality as the predicate device Versana Balance (K220446). The design of all features is same as predicate device Versana Balance, the workflow is same as predicate device Versana Balance non-touchscreen version.
The key feature list as below:
- LI-RADS:
- Probe Check (transducer element check) ●
- Whizz Color Flow ●
- Lateral Gain Compensation (LGC) ●
- VOCAL ●
- V-Live
- Standby mode (Fast boot up)
- Follow up Tool
- Breast Productivity (BI-RADS) ●
- Thyroid productivity (TI-RADS)
- Auto Bladder
- . B-Flow&B-Flow Color
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Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three water droplet shapes around the circle. The logo is simple and recognizable.
- Breast Care ●
- . Needle recognition
- Auto EF
- TUI ●
- Stress Echo ●
- . Advance 3D
- Tricefy
- . Elastography imaging
- e-Delivery
Note: The predicate device Versana Balance (K220446) has two additional features, whizz label and multi-touch, that are not available in the proposed Versana Essential.
Hardware:
The proposed Versana Essential and predicate Versana Balance (K2220446) non-touchscreen version have the same power input/output and similar design of internal circuits. Both of them have been designed in compliance with approved electrical and physical safety standards.
The proposed Versana Essential and predicate Versana Balance (K2220446) support the same accessories such printers, DVD, USB disk and barcode reader.
| Characteristic | Proposed Device
Versana Essential | Predicate Device
Versana Balance
(K220446) | Comment on comparison |
|-----------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Scan channels | 48 Channels | 64 Channels | The number of channels on Versana
Essential is less than on predicate
Versana Balance, however all safety and
performance requirements are met
according to the device evaluation and
verification. No impact to safety or
effectiveness |
| Touch panel | Not available | Option
(Configuration
dependent) | Identical with predicate device Versana
Balance non-touchscreen version. |
| Network /
Archive: | USB, thermal b&w
image printer,
memory stick and
Encrypt patient
information store to
a removable | USB, thermal b&w
image printer,
memory stick and
Encrypt patient
information store to a
removable memory | The proposed device accessories for
network/archive were previously
available in predicate Versana Balance.
An additional Bluetooth adapter was
available in the predicate device but not
Versana Essential. However, there is no |
Comparison of technological characteristics with Predicate device:
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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. There are also some water droplet shapes around the circle. The logo is simple and recognizable, representing the company's brand identity.
| Characteristic | Proposed Device
Versana Essential | Predicate Device
Versana Balance
(K220446) | Comment on comparison |
|----------------|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| | memory device,
Ethernet/DICOM/LAN via hardware,
wireless adapter, Tricefy Uplink | device,
Ethernet/DICOM/LAN via hardware, wireless
adapter, Bluetooth USB adaptor, Tricefy
Uplink | impact to safety or effectiveness because
the memory stick, LAN, or wireless
adapter are alternative means to share
patient images/data. |
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Image /page/8/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized script inside. The circle is surrounded by a series of curved lines that resemble water droplets or stylized flames. The logo is simple and recognizable, and it is often used to represent the company's brand.
Summary of Non-Clinical Tests:
Versana Essential 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 Essential complies with voluntary standards:
- AAMI/ANSI 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 performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - Edition 4.1, 2020
- . 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
- 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
- ISO 14971, Medical devices - Application of risk management to medical devices, 2019
- NEMA PS 3.1 - 3.20, Digital Imaging and Communications in Medicine (DICOM) Set, 2020e
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 Essential, did not require clinical studies to support substantial equivalence.
Conclusion:
Based on the equipment design similarities, conformance to recognized performance
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Image /page/9/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized script, enclosed within a blue circle. The circle has decorative flourishes resembling water droplets or stylized leaves around the perimeter, giving it a distinctive and recognizable appearance.
standards, and performance testing, GE Healthcare considers the Versana Essential to be as safe, effective, and performs in a substantially equivalent manner as the predicate device Versana Balance (K220446).