The GE EchoPAC 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 Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).

The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

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 postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. 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 are substantially equivalent to the predicate devices.

AI/ML Overview

This GE EchoPAC Review station K123894 510(k) summary states that no clinical studies were required to support substantial equivalence, thus no specific acceptance criteria or performance studies as typically described for a new diagnostic device are provided. The submission focuses on non-clinical tests and conformance to design specifications and industry standards.

Therefore, many of the requested fields cannot be filled as they pertain to clinical performance studies that were not conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Conformance to design specifications	The device has been evaluated for conformance to its design specifications.
Conformance with 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	The device is verified for system compatibility with the devices with which it communicates.
Conformance to DICOM standard	The device complies with DICOM standard (PS 3.2).
Compliance with IEC 60601-1-4 (Programmable electrical medical systems)	The device complies with IEC 60601-1-4.
Compliance with IEC 60601-1-6 (Usability)	The device complies with IEC 60601-1-6.
Compliance with IEC 62304 (Medical device software life cycle process)	The device complies with IEC 62304.
Compliance with ISO 14971 (Risk management)	The device complies with ISO 14971.
Substantially equivalent to predicate devices (K120221, K121063) in safety and effectiveness	GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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

Not applicable. No clinical test set or patient data was used as part of this 510(k) submission.

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

Not applicable. No clinical test set requiring expert ground truth was used.

4. Adjudication method 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

Not applicable. No MRMC comparative effectiveness study was done. The device (EchoPAC) is a workstation software for image review, analysis, and reporting, and the submission does not describe it as an AI-assisted diagnostic tool for human readers.

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

Not applicable. The device is software for a workstation, intended for human review and analysis of ultrasound images. It is not a standalone algorithm performing automated diagnoses without human intervention.

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

Not applicable. No clinical ground truth was established as no clinical studies were performed.

8. The sample size for the training set

Not applicable. No clinical training set was described or used for this submission.

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

Not applicable. No clinical training set was described or used, and therefore no ground truth for a training set was established.

Summary

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K123894

GE Healthcare Traditional510(k) Premarket Notification

GE EchoPAC Review station

510(k) Summarv

JAN 2 9 2013

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: December 11, 2012 Submitter: GE Healthcare 9900 Innovation Drive · Wauwatosa, WI, USA 53226 Primary Contact Person: Bryan Behn Requlatory Affairs Manager GE Healthcare Phone: (414) 721-4214 Fax: (414) 918-8275 Secondary Contact Jan Tore Thollefsen Person: Requlatory Affairs Manager GE Healthcare, GE Vingmed Ultrasound AS Phone: +47 33 02 12 69 Fax: +47 33 02 13 50 Device: Trade Name: GE EchoPAC Workstation Software for ultrasound image review, analysis and Common/Usual Name: reporting Classification Names: 21 CFR 892.2050 Product Code: LLZ ……… Predicate Device(s): K120221 - GE EchoPAC K121063 - GE Vivid S5/S6 Diagnostic Ultrasound System including EchoPilot Software

GE EchoPAC provides image processing, annotation, analysis, Device Description: 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 postacquisition image management and reporting functions of the scanner. EchoPAC will be offered as SW-only to be installed directly on customer PC hardware, or as an accessory to selected 3rd party image management workstations. 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 are substantially equivalent to the predicate devices.

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GE Healthcare Traditional510(k) Premarket Notification GE EchoPAC Review station

Intended Use:

Technology:

Determination of

Substantial Equivalence:

: The device may include EchoPilot reporting software which provides guidance to support the quality of the echocardiography examination and report. It compares patient data, user entered clinical data and measurements to generally accepted guidelines and studies, and helps to identify mismatches, inconsistencies and unusual or missing data. It can generate a preliminary data analysis that can be used as basis for the examination report.

The EchoPAC employs the same fundamental scientific technology as its predicate device.

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. The device complies to the following standards:

IEC60601-1-4: Medical Electrical Equipment - Part 1-4: General Requirements for Safety - Collateral Standard: Programmable electrical medical systems, consolidated with amendment 1

IEC60601-1-6: Medical Electrical Equipment - Part 1-6: General Requirements For Safety - Collateral Standard: Usability

IEC 62304: Medical device software Software life cycle process
DICOM PS 3.2, Digital Imaging and Communications in Medicine - Conformance Standard

ISO14971: Medical Devices - Application of risk management to medical devices

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GE Healthcare

Traditional510(k) Premarket Notification GE EchoPAC Review station

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

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Conclusion: ... GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized eagle or bird-like symbol with three curved lines representing its wings or body. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

January 29, 2013

GE Healthcare C/O Mr. Bryan Behn Regulatory Affairs Manager 9900 W. Innovation Drive, RP-2138 WAUWATOSA WI 53226

Re: K123894

Trade/Device Name: GE EchoPAC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System Regulatory Class: II Product Code: LLZ Dated: December 11, 2012 Received: December 18, 2012

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. 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); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.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.

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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Sean M. Boyd -S

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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GE Healthcare Traditional510(k) Premarket Notification GE EchoPAC Review station

510(k) Number:

Device Name: GE EchoPAC

Indications for Use:

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

X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use N/A (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Sean M. Boyd -S

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123894 510(k)

Page 1 of 1

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).