(60 days)
Not Found
No
The document describes standard ultrasound imaging technology and processing, with no mention of AI or ML capabilities.
No
The device is described as an ultrasound system for imaging, measurement, and analysis, which are diagnostic functions, not therapeutic ones. It does not mention any form of treatment or therapy being delivered to the patient.
Yes
The device is intended for "ultrasound imaging, measurement and analysis of the human body for multiple clinical applications," which are activities performed to diagnose conditions.
No
The device description explicitly states it is a "compact and extremely portable ultrasound system consisting of a hand-carried console" and utilizes "interchangeable electronic-array transducers," indicating it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, the Venue 40 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "ultrasound imaging, measurement and analysis of the human body". This describes a device used for in vivo (within the living body) imaging and diagnosis, not in vitro (outside the living body) testing of samples like blood, urine, or tissue.
- Device Description: The description details an ultrasound system with transducers, a console, and display capabilities. This aligns with the components of an ultrasound machine used for imaging the body.
- Anatomical Site: The listed anatomical sites are all parts of the human body that are imaged directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, the Venue 40 is an ultrasound imaging device, which is a type of medical device used for diagnosis, but it does not fall under the category of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Venue 40 is intended for ultrasound imaging, measurement and analysis of the human body for multiple clinical applications including: Fetal/OB: Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial: Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
Product codes
IYN, IYO, ITX
Device Description
The Venue 40 device is a compact and extremely portable ultrasound system consisting of a hand-carried console with the ability to dock it with a Docking station or mobile Docking cart. The primary means of control is a small number of dedicated push buttons and graphical user interface implemented by a touch sensitive screen over the color LCD display providing additional command input and keyboard entry. It utilizes interchangeable electronic-array transducers operating B, Color and Power Doppler, M modes with digital acquisition, processing and display capability operating under a Linux OS. Powered by an integrated battery or from a separate power supply/charger in the docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The subject of this premarket submission, Venue 40, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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.
0
Image /page/0/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. The letters are enclosed within a circle, and there are decorative swirls or flourishes around the outer edge of the circle.
SEP 2 3 2011
510(k) Premarket Notification Submission
510(k) Summary
.
| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|---|---|
| Date: | July 21, 2011 |
| Submitter: | GE Healthcare |
| 9900 Innovation Dr | |
| Wauwatosa, WI 53226 | |
| Primary Contact Person: | Bryan Behn |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| T:(414)721-4214 | |
| F:(414)918-8275 | |
| Secondary Contact Person: | Yalan Wu |
| Regulatory Affairs Manager | |
| GE Healthcare | |
| T: +86 510 8527 8652 | |
| F: +86 510 8522 7347 | |
| Device: | |
| Trade Name: | Venue 40 |
| Common/Usual Name: | Venue 40 |
| Classification Names: | |
| Product Code: | Class II |
| 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 | |
| Predicate Device(s): | Venue 40 - K102113 |
| LOGIQ i/e & Vivide e - K102256 | |
| Logiq P5 - K060993 | |
| Device Description: | The Venue 40 device is a compact and extremely portable |
| ultrasound system consisting of a hand-carried console with the | |
| ability to dock it with a Docking station or mobile Docking cart. | |
| The primary means of control is a small number of dedicated | |
| push buttons and graphical user interface implemented by a touch | |
| sensitive screen over the color LCD display providing additional | |
| command input and keyboard entry. It utilizes interchangeable | |
| electronic-array transducers operating B, Color and Power | |
| Doppler, M modes with digital acquisition, processing and | |
| display capability operating under a Linux OS. Powered by an | |
| integrated battery or from a separate power supply/charger in the |
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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" in a stylized font, enclosed within a circular frame. The letters and the frame are solid black, creating a strong contrast against the white background. The logo is a well-known symbol associated with the General Electric company.
GE Healthcare 510(k) Premarket Notification Submission
docking station or docking cart, the Venue 40 is used primarily where portability, size and convenience are essential.
Fetal/OB; Abdominal (GYN & Urology); Pediatric; Small Organ Intended Use: (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult & pediatric); Peripheral Vascular; Musculoskeletal Conventional & Superficial; Transvaginal; Intraoperative (abdominal, thoracic and peripheral); Thoracic/Pleural for motion and fluid detection and imaging guidance of interventional procedures.
The Venue 40 employs the same fundamental scientific Technology: technology as its predicate devices.
Determination of Summary of Non-Clinical Tests: Substantial Equivalence: The Venue 40 and its applications comply with voluntary standards as detailed in Section 9, 11 and 17 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analvsis
- Requirements Reviews .
- Design Reviews .
- Testing on unit level (Module verification) .
- Integration testing (System verification)
- . Performance testing (Verification)
- . Safety testing (Verification)
- Simulated use testing (Validation) .
Transducer material and other patient contact materials such as needle guidance kits are biocompatible.
Summary of Clinical Tests:
.
The subject of this premarket submission, Venue 40, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the Venue 40 to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device(s).
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Image /page/2/Picture/1 description: The image shows a circular seal with text around the perimeter and a stylized bird in the center. The text around the perimeter is in all capital letters, but it is difficult to read due to the image quality. The bird in the center is black and appears to be in flight, with its wings spread. The seal is likely a symbol of an organization or government agency.
Food and Drug Aciministration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Brvan Behn Regulatory Aflairs Manager GE Healtheare 9900 Innovation Dr. WAUWATOSA WI 53226
grp 2 3 2011
Re: K112122
Trade/Device Name: Venue 40 Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN Dated: July 21, 2011 Received: August 2, 2011
Dear Mr. Behn:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. 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.
This determination of substantial equivalence applies to the following transducers intended for use with the Venue 40, as described in your premarket notification:
| 12L-SC |
|---|
| 3S-SC |
| 4C-SC |
| L8-18i-SC |
| E8CS-SC |
Transducer Model Number
3
Page 2 - Mr. Behn
If vour device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations. Title 21, Parts 800 to 895. In addition. FDA mav 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 fisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus permits your device to proceed to market.
If you desire specific advice for vour device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/uem115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
If you have any questions regarding the content of this letter. please contact Lauren Hefner at (301) 796-6881.
Sincerely Yours.
Mary Slater
Mary S. Pastel. Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure(s)
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "G" and "E" intertwined within a circle. The letters are stylized and appear to be handwritten or calligraphic. The logo is black and white.
GE Healthcare 510(k) Premarket Notification Submission
510(k) Number (if known): |