GE ECHOPAC MODEL BT10 by GE VINGMED ULTRASOUND AS

The GE EchoPAC BT10 workstation is indicated for diagnostic review and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalio; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative skeletal (abdominal, thoracic, & vascular).

Device Description

GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family of ultrasound scanners, primarily for cardiology ultrasound applications but also for general imaging. The EchoPAC software is an integral component of each Vivid system, providing the post acquisition image management and reporting functions of the scanner. Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS. EchoPAC is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations. The modified or added software features for GE EchoPAC BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6.

AI/ML Overview

This document, K101324, describes a 510(k) Premarket Notification for the GE EchoPAC BT10 Review station. It's important to note that this is a submission for a review station software and not a diagnostic AI device in the modern sense. Therefore, many of the performance metrics and study designs typically associated with AI/ML diagnostic tools (like sensitivity, specificity, MRMC studies, training set details) are not applicable here. The submission focuses on demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing and verification of design specifications.

Here's an analysis based on the provided text, addressing your questions to the extent possible:

Acceptance Criteria and Device Performance:

Since this is not a diagnostic AI device, the "acceptance criteria" are not framed in terms of clinical performance metrics like sensitivity or specificity. Instead, they are focused on design specifications, compliance with standards, and functional equivalence to predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to design specifications	The device has been evaluated for conformance to its design specifications.
Conformance to applicable industry standards for software development	The device has been evaluated for conformance to applicable industry standards for software development.
System compatibility with communicating devices	It is further verified for system compatibility with the devices with which it communicates.
Conformance to DICOM standard	Conformance to DICOM standard is verified.
Substantial equivalence to predicate devices (GE Vivid E9, GE Vivid S5/S6, GE EchoPAC K072952)	The modified or added software features for GE EchoPAC BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6. The EchoPAC BT10 employs the same fundamental scientific technology as its predicate devices. GE Healthcare considers the EchoPAC BT10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

2. Sample size used for the test set and the data provenance:

Not applicable / Not explicitly stated. This submission focuses on non-clinical testing and verification. There is no mention of a "test set" in the context of clinical data or patient samples being analyzed for performance metrics. The testing would have involved software validation and verification against functional requirements, not clinical diagnostic accuracy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. As there was no clinical "test set" in the diagnostic sense, there was no need for experts to establish ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. No clinical test set requiring adjudication was used.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. An MRMC study was not conducted. This device is a review station, not an AI-powered diagnostic tool, and its purpose is not to assist human readers in a diagnostic capacity that would be measured by an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. The GE EchoPAC BT10 is workstation software for image review, analysis, and reporting, which by its nature is a human-in-the-loop system. It is not an algorithm that operates standalone to produce diagnostic outputs.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable / System Functionality, Compliance, and Equivalence. For this type of device, "ground truth" would relate to the correct functioning of the software, its adherence to design specifications, and its ability to process and display images as intended, consistent with DICOM standards and the functionality of predicate devices. There wouldn't be a clinical "ground truth" in the sense of a disease state.

8. The sample size for the training set:

Not applicable. As the GE EchoPAC BT10 is not an AI/ML device that requires a "training set" in the machine learning context, this information is not relevant.

9. How the ground truth for the training set was established:

Not applicable. There was no training set for a machine learning model.

Summary

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K101324
GE Health

GE Healthcare Special 510(k) Premarket Notification GE EchoPAC BT10 Review station May 10, 2010

510(k) Summary

OCT 5 2010

In accordance with 21 CFR 807.92 the following summary of information is provided:

Date: May 10, 2010

GE Healthcare, GE Medical Systems Ultrasound and Primary Care Submitter: Diagnostics. LLC. 9900 Innovation Drive Wauwatosa, WI, USA 53226

Primary Contact Person:

Bryan Behn Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics. LLC. Phone: (414) 721-42 14 Fax: (414) 918-8275

Secondary Contact Person:

Jim Turner Regulatory Affairs Manager GE Healthcare Phone: (262) 544-33 59 Fax: (414) 908-9225

GE EchoPAC BT10 Device: Trade Name:

Workstation Software for ultrasound image review, analysis and Common/Usual Name: reporting

Classification Names:

21 CFR 892.2050

Product Code: LLZ

Predicate Device(s):

K081921 - GE Vivid E9 K092079 - GE Vivid S5/S6

K072952 - GE EchoPAC

Device Description:

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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a circular design. The logo is black and white and has a vintage look.

GE Healthcare Special 510(k) Premarket Notification GE EchoPAC BT10 Review station May 10, 2010

The GE EchoPAC workstation is indicated for diagnostic review Intended Use: and analysis of ultrasound images acquired under various modes of operation including B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D. Clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal. thoracic, & vascular).

The EchoPAC BT10 employs the same fundamental scientific Technology: technology as its predicate devices.

Determination of Substantial Equivalence:

Summary of Non-Clinical Tests:

The device has been evaluated for conformance to its design specifications and applicable industry standards for software development. It is further verified for system compatibility with the devices with which it communicates, including conformance to DICOM standard.

Summary of Clinical Tests:

The subject of this premarket submission, EchoPAC BT10, did not require clinical studies to support substantial equivalence.

Conclusion:

GE Healthcare considers the EchoPAC BT10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

GE Vingmed Ultrasound AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Dr., RP-2138 WAUWATOSA WI 53226

DCT 5 2010

Re: K101324

Trade/Device Name: GE EchoPAC BT10 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 27, 2010 Received: August 30, 2010

Dear Mr. Behn:

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) 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 the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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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" intertwined in a circular shape. The letters are stylized and have a vintage look. The logo is black and white.

GE Healthcare Special 510(k) Premarket Notification GE EchoPAC BT10 Review station May 10, 2010

510(k) Number:

Device Name: GE EchoPAC BT10

Indications for Use:

Prescription Use: YES (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: NO (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE )

hal D.D.H.m. for David G.L. Brown
(Division Sign-Off)

Division of Radiological De

510K K101324

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).