(162 days)
No
The document describes a standard diagnostic ultrasound system with various imaging modes and connectivity options, but there is no mention of AI or ML technology in the intended use, device description, or any other section.
No
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 rather than therapeutic functions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Versana Premier is a "general purpose diagnostic ultrasound system."
No
The device description clearly outlines a physical console, display monitor, transducers, and various ports and connections, indicating it is a hardware-based ultrasound system with integrated software, not a software-only device.
Based on the provided information, the Versana Premier is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Definition of IVD: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. These tests are performed outside of the living body (in vitro).
- Versana Premier's Function: The Versana Premier is a diagnostic ultrasound system. It uses sound waves to create images of internal structures of the human body. This is an in vivo (within the living body) imaging technique.
- Intended Use: The intended use clearly states it's for "ultrasound imaging, measurement, display and analysis of the human body and fluid." This describes an imaging modality, not a test performed on a sample outside the body.
Therefore, the Versana Premier falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Versana Premier 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 Premier clinical applications include : Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, 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 Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier is intended to be used in a hospital or medical clinic.
Product codes
IYN, IYO, ITX
Device Description
The Versana Premier is a general purpose, 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. The operator control panel includes function keys, trackball, an alfa-numeric keyboard and a touch panel as input sources of the device. The variety of transducers include convex, linear, sector, dual 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, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, 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 Premier, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Versana Premier (K182277)
Reference Device(s)
LOGIQ P6 (K073297), Versana Active (K191798)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Tracey Ortiz Regulatory Affairs Director 9900 W. Innovation Drive WAUWATOSA WI 53226
Re: K200138
Trade/Device Name: Versana Premier Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: Class II Product Code: IYN, IYO, ITX Dated: June 1, 2020 Received: June 2, 2020
Dear Tracey 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/cfpmp/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.
July 1, 2020
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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/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,
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
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Indications for Use
510(k) Number (if known) K200138
Device Name
Versana Premier
Indications for Use (Describe)
The Versana Premier 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 Premier clinical applications include : Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vasculoskeletal Conventional, Musculosketal Superficial, 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, Harmonic Imaging, Coded Pulse, 3D/4D Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier 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) |
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Image /page/3/Picture/0 description: The image shows the logo for GE (General Electric). The logo is a blue circle with the letters "GE" in a stylized script in the center. There are three curved lines emanating from the top, left, and right sides of the circle, resembling water droplets or stylized flames. The blue color is consistent throughout the logo.
GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | May 28, 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: | Karim Amrouche |
| Regulatory Affairs | |
| GE Healthcare | |
| Device Trade Name: | Versana Premier |
| Common/Usual Name: | Diagnostic Ultrasound System |
| Classification Names: | Class II |
| IYN (primary), IYO, ITX (secondary) | |
| 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 Premier (K182277) |
| Reference Device(s): | LOGIQ P6 (K073297) |
| Versana Active (K191798) | |
| Device Description: | The Versana Premier is a general purpose, 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.
The operator control panel includes function keys, trackball, an
alfa-numeric keyboard and a touch panel as input sources of the
device |
4
Image /page/4/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 is surrounded by three curved, teardrop-shaped elements, also in blue, which give the impression of motion or energy emanating from the central letters. The overall design is clean and recognizable, representing the brand identity of GE.
GE Healthcare 510(k) Premarket Notification Submission
The variety of transducers include convex, linear, sector, dual 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, VGA connection port, Audio out port, S-Video port, and a Composite Out port connection. The system has an external AC outlet to allow connection of a printer and sit in the printer box of the console and an option for external Printer USB Isolator for other 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 Premier 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 Premier clinical applications include : Fetal/Obstetrics, Abdominal (includes GYN, Urology), Pediatric, Small Organ (includes breast, testes, thyroid), Cardiac (includes Adult and Pediatric), Vascular/Peripheral Vascular, Musculoskeletal Conventional, Musculoskeletal Superficial, 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 Imaging mode and Combined modes: B/M, B/Color, B/PWD, B/Color/PWD, B/Power/PWD. Versana Premier is intended to be used in a hospital or medical clinic.
Technology: The Versana Premier employs the same fundamental scientific technology as its predicate device and reference devices.
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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a stylized script, enclosed within a blue circle. There are decorative swirls or water droplet-like shapes surrounding the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the brand identity of General Electric.
GE Healthcare
510(k) Premarket Notification Submission
Comparison to Predicate Devices Determination of The proposed Versana Premier system is substantially equivalent Substantial Equivalence:
to the predicate Versana Premier device with regard to intended use, imaging capabilities, technological characteristics and safety effectiveness.
- The proposed Versana Premier and predicate . Versana Premier (K182277) have similar clinical indications for use exept for the following changes:
- . Vascular has been added with peripheral vascular, this clarifies vessels and is not a change in imaging or product. No impact to safe or effective use.
- . Applications that were listed in the notes of the probe IFU tables have been added in the written statement, so this is really not a change from the predicate.
- Modes of operation & use environment are added to ● the written statement as per the 2019 ultrasound guidance. There was no change in the modes or the use environment from the predicate.
- . A new transducer, E7C8L-RS, is being added to the Versana Premier. The E7C8L-RS transducer has similar applications as the reference device ERB transducer on LOGIQ P6, cleared in K073297. Interventional needle guidance use is expanding to include non-vascular access but does not include brachytherapy.
- E7C8L-RS transducer materials are similar to the ● E8Cs-RS cleared on predicate Versana Premier (K182277).
- Adding M-mode to L6-12-RS, 12L-RS and LK760-● RS already cleared on Versana Active (K191798);
- Adding Transcranial clinical application to the 8C-RS transducer.
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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 script inside. There are also some curved lines around the letters, which give the impression of movement or energy. The logo is simple and recognizable, and it is often used to represent the company's products and services.
GE Healthcare 510(k) Premarket Notification Submission
Summary of Non-Clinical Tests:
Versana Premier 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 Premier 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 4.0, 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
- 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, Application of risk management to medical devices, 2007
- NEMA PS 3.1 3.20. Digital Imaging and . Communications in Medicine (DICOM) Set , 2016
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Image /page/7/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized font, enclosed within a circle. The circle is surrounded by what appear to be stylized water droplets or flourishes, giving the logo a dynamic and fluid appearance. The color of the logo is a bright, solid blue.
GE Healthcare
510(k) Premarket Notification Submission
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 Premier, did not require clinical studies to support substantial equivalence.
- Conclusion: GE Healthcare considers the Versana Premier to be as safe, as effective, and performance is substantially equivalent to the predicate devices.