EchoPAC Software Only, EchoPAC Plug-in

K170847 · GE Medical Systems Ultrasound and Primary Care Diagnostics · LLZ · Jun 14, 2017 · Radiology

Device Facts

• Record ID: K170847
• Device Name: EchoPAC Software Only, EchoPAC Plug-in
• Applicant: GE Medical Systems Ultrasound and Primary Care Diagnostics
• Product Code: LLZ · Radiology
• Decision Date: Jun 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

Device Story

EchoPAC Software Only / EchoPAC Plug-in provides post-acquisition image processing, analysis, measurement, and reporting for ultrasound data. Input consists of raw data from GE ultrasound scanners or standard DICOM ultrasound images. Software functions as an integral component of Vivid ultrasound systems or as a standalone application on customer PC hardware/third-party workstations. Physicians use the software to review images, perform measurements, and generate clinical reports. Features include Myocardial Work (based on 2D-Strain), 4D Auto RVQ/MVQ (automated quantification), and Cardiac AutoDoppler. The device facilitates clinical decision-making by providing quantitative analysis of ultrasound data across various clinical applications, including cardiac and vascular assessments. It is DICOM compliant for data transfer via LAN.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, including module verification, system integration testing, performance testing, and safety verification.

Technological Characteristics

Software-only workstation application for ultrasound image processing. DICOM compliant. Standards: IEC 62366:2007+A1:2014 (usability), IEC 62304:2006 (software lifecycle), NEMA PS 3.1-3.20 (DICOM), ISO 14971:2007 (risk management). Connectivity via LAN. Operates on customer PC hardware or third-party workstations.

Indications for Use

Indicated for diagnostic review, analysis, and reporting of ultrasound images for fetal, abdominal, urological, pediatric, small organ, neonatal, adult cephalic, cardiac, peripheral vascular, TEE, musculoskeletal, transrectal, transvaginal, and intraoperative applications. For use by or on the order of a licensed physician.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• EchoPAC (K150085)
• TomTec Arena TTA2 (K150122)
• Vivid iq (K161706)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus, with three human profiles facing right, stacked on top of each other.

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

GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC % Ms. Renee Webb Regulatory Affairs Manager 9900 W. Innovation Drive WAUWATOSA WI 53226

June 14, 2017

Re: K170847

Trade/Device Name: EchoPAC Software Only / EchoPAC Plug-in Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: May 15, 2017 Received: May 16, 2017

Dear Ms. Webb:

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Michael D'Hara
For

Robert A. Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

## K170847

Device Name EchoPAC Software Only / EchoPAC Plug-in

#### Indications for Use (Describe)

EchoPAC Software Only / EchoPAC Plug-in is intended for diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images.

Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D.

Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-sketal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
| | |

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

## CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The logo is colored in a shade of blue, and the background is white.

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: | March 16, 2017 |
| Submitter: | GE Healthcare<br>9900 Innovation Drive<br>Wauwatosa, WI 53226 |
| Primary Contact Person: | Renee Webb<br>Regulatory Affairs Manager<br>GE Healthcare<br>T:847-277-6078<br>F:847-277-4506 |
| Secondary Contact Person: | Charlotte Kaas Munthe Jørgensen<br>Regulatory Affairs Leader<br>GE Vingmed Ultrasound AS |
| Device: Trade name: | EchoPAC Software Only / EchoPAC Plug-in |
| Common/Usual Name: | Workstation Software for ultrasound image review, analysis and<br>reporting |
| Classification Names: | Class II |
| Product Code: | LLZ |
| Primary Predicate Device: | K150085 - EchoPAC |
| Secondary Predicate Device(s): | K150122 - TomTec Arena TTA2<br>K161706 – Vivid iq |
| Device Description: | EchoPAC Software Only / EchoPAC Plug-in provides image<br>processing, annotation, analysis, measurement, report generation,<br>communication, storage and retrieval functionality to ultrasound<br>images that are acquired via the Vivid family of ultrasound<br>scanners by GE Healthcare. The EchoPAC Software Only /<br>EchoPAC Plug-in software is an integral component of each Vivid<br>system, providing the post-acquisition image management and<br>reporting functions of the scanner. EchoPAC Software Only will<br>be offered as SW-only to be installed directly on customer PC<br>hardware, and EchoPAC Plug-in will be offered as an accessory to<br>selected 3rd party image management workstations. EchoPAC<br>Software Only / EchoPAC Plug-in is DICOM compliant,<br>transferring images and data via LAN between scanners, hard<br>copy devices, file servers and other workstations. |

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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 in a stylized script, enclosed within a circular frame. The frame is adorned with decorative swirls or flourishes, giving it a classic and recognizable appearance. The logo is presented in a blue color.

GE Healthcare

510(k) Premarket Notification Submission

EchoPAC Software Only / EchoPAC Plug-in is intended for Intended Use: diagnostic review and analysis of ultrasound images, patient record management and reporting, for use by, or on the order of a licensed physician. EchoPAC Software Only / EchoPAC Plug-in allows post-processing of raw data images from GE ultrasound scanners and DICOM ultrasound images. Ultrasound images are acquired via B (2D), M, Color M modes, Color, Power, Pulsed and CW Doppler modes, Coded Pulse, Harmonic and Real time 3D. Clinical applications include: Fetal; Abdominal (including renal and GYN); Urology (including prostate); Pediatric; Small organs (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Transesophageal (TEE); Musculo-skeletal Conventional; Musculo-skeletal Superficial; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular). Technology: EchoPAC Software Only / EchoPAC Plug-in employ the same fundamental scientific technology as its predicate devices. Determination of Comparison to Predicate Devices Substantial Equivalence: EchoPAC Software Only / EchoPAC Plug-in is substantially

equivalent to the predicate device with regards to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

- The proposed EchoPAC Software Only / EchoPAC Plugin and the predicate EchoPAC Software Only / EchoPAC Plug-in are all intended for diagnostic review and analysis of ultrasound images, patient record management and reporting.
- The proposed EchoPAC Software Only / EchoPAC Plug-● in and the predicate EchoPAC Software Only / EchoPAC Plug-in have the same capabilities in term of performing measurements and analysis/reviewing the images, except:.
- The new feature "Myocardial Work" builds on the functionality of the existing "2D-Strain" functionality available with the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085).
- The new features "4D Auto RVQ" and "4D Auto MVQ" are both alternative implementation of functionality offered with TomTec Arena (K150122) as available on the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085).

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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular frame. The color of the logo is a light blue.

# GE Healthcare

510(k) Premarket Notification Submission

- "Cardiac AutoDoppler" is workflow improvements of 0 functionality already available on the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085)
- 3rd party DICOM SR Read builds on the capability of the ● existing DICOM SR support available with the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085).
- The proposed EchoPAC Software Only / EchoPAC Plug-● in and the predicate EchoPAC Software Only / EchoPAC Plug-in use ultrasound images acquired via the same imaging modes.
- The proposed EchoPAC Software Only / EchoPAC Plug-● in and the predicate EchoPAC Software Only / EchoPAC Plug-in have the same processing and display features.
- . The proposed EchoPAC Software Only / EchoPAC Plugin and the predicate EchoPAC Software Only / EchoPAC Plug-in have the same indications and clinical.applications, except Musculo-skeletal Superficial which was cleared with Vivid iq (K161706).

## Summary of Non-Clinical Tests:

EchoPAC Software Only / EchoPAC Plug-in and its applications comply with voluntary standards. The following quality assurance measures were applied to the development of the system:

- 1. IEC 62366:2007 + A1:2014. Medical devices -Application of usability engineering to medical devices
- 2. IEC 62304:2006, Medical device software Software life cycle process.
- 3. NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
- 4. ISO 14971:2007 Medical Devices Application of risk management to medical devices

The following quality assurance measures are 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)

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Image /page/6/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle is surrounded by decorative flourishes, giving the logo a classic and recognizable appearance.

GE Healthcare 510(k) Premarket Notification Submission

Summary of Clinical Tests:

The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence.

GE Healthcare considers the EchoPAC Software Only / Conclusion: EchoPAC Plug-in to be as safe, as effective, and performance is substantially equivalent to the predicate devices.