GE EchoPAC

K150085 · Ge Vingmed Ultrasound AS · LLZ · Mar 2, 2015 · Radiology

Device Facts

• Record ID: K150085
• Device Name: GE EchoPAC
• Applicant: Ge Vingmed Ultrasound AS
• Product Code: LLZ · Radiology
• Decision Date: Mar 2, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

The GE EchoPAC Software Only is indicated for diagnostic review and analysis of ultrasound images 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; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

Device Story

EchoPAC is a software-only workstation application for post-acquisition review, analysis, and reporting of ultrasound images; inputs include B-mode, M-mode, Doppler, and 3D/4D ultrasound data acquired via GE Vivid scanners. Software functions include image processing, annotation, measurement, and report generation. Used in clinical settings by healthcare providers to facilitate diagnostic decision-making in cardiology and general imaging. Operates on customer PC hardware or as an accessory to third-party workstations; DICOM-compliant for data transfer via LAN. Benefits include streamlined workflow for quantitative analysis and clinical reporting.

Clinical Evidence

No clinical studies were required to support substantial equivalence. Evidence is based on non-clinical bench testing, including software verification and validation, risk management, and usability engineering.

Technological Characteristics

Software-only workstation application; DICOM-compliant; supports B-mode, M-mode, Doppler, and 3D/4D imaging. Complies with IEC 62304 (software life cycle), IEC 62366 (usability), ISO 14971 (risk management), and NEMA PS 3.1-3.20 (DICOM).

Indications for Use

Indicated for diagnostic review and analysis of ultrasound images in fetal, abdominal, urological, pediatric, small organ, neonatal, cephalic, cardiac, peripheral vascular, TEE, musculoskeletal, and intraoperative applications.

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

• GE EchoPAC (K131685)
• Vivid S60/S70 (K142323)

Submission Summary (Full Text)

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

March 2, 2015

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

Re: K150085

Trade/Device Name: EchoPAC Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: January 14, 2015 Received: January 15, 2015

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 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/Resourcesfor You/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 yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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)

### K150085

Device Name EchoPAC

#### Indications for Use (Describe)

The GE EchoPAC is indicated for diagnostic review and analysis of ultrasound images 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; Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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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 within a circular frame. The frame has a swirling design, giving it a dynamic and recognizable appearance. The logo is presented in a light blue color.

Section 5: 510(k) Summary

GE EchoPAC

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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 within a circular frame. The frame has a swirling design, giving it a dynamic and recognizable appearance. The logo is presented in a light blue color.

## 510(k) Summary

| In accordance with 21 CFR 807.92 the following summary of information is provided: | |
|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Date: | January 14, 2015 |
| Submitter: | GE Healthcare |
| | 9900 Innovation Dr |
| | Wauwatosa, WI 53226 |
| Primary Contact Person: | Bryan Behn |
| | Regulatory Affairs Manager |
| | GE Healthcare |
| | T:[phone] |
| | F:[phone] |
| Secondary Contact Person: | Charlotte Kaas Munthe Jørgensen |
| | Regulatory Affairs Specialist |
| | GE Vingmed Ultrasound AS |
| | T: [phone] |
| | F: [phone] |
| Device: Trade Name: | GE EchoPAC Workstation Software for ultrasound image review, |
| | analysis and reporting |
| Common/Usual Name: | EchoPAC |
| Classification Names: | Class II |
| Product Code: | 21 CFR 892.2050 |
| Predicate Device(s): | K131685 GE EchoPAC |
| | K142323 Vivid S60/S70 |
| Device Description: | GE EchoPAC provides image processing, annotation, analysis, |
| | measurement, report generation, communication, storage and<br>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. 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 device and functionality cleared on GE EchoPAC |
| | K131685 |
| Intended Use: | The GE EchoPAC Software Only is indicated for diagnostic |
| | review and analysis of ultrasound images acquired via B (2D), M, |
| | Color M modes, Color, Power, Pulsed and CW Doppler modes. |

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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' written in a stylized script, enclosed within a blue circular frame. The frame has decorative swirls or flourishes extending outward from the circle, giving it a distinctive and recognizable appearance.

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; Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic and vascular).

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

Determination of Substantial Equivalence: The GE EchoPAC systems are substantially equivalent to the predicate devices with regard to intended use, imaging capabilities, technological characteristics and safety and effectiveness.

| | Proposed Device<br>GE EchoPAC | Predicate Device<br>GE EchoPAC<br>(K131685 ) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------|
| Indications and Clinical Applications: | | |
| • Fetal; | ✓ | ✓ |
| • Abdominal (Including<br>Renal & Gyn) | ✓ | ✓ |
| • Urology (including<br>prostate); | ✓ | ✓ |
| • Pediatric | ✓ | ✓ |
| • Small Organ (breast, testes,<br>thyroid); | ✓ | ✓ |
| • Neonatal and Adult<br>Cephalic; | ✓ | ✓ |
| • Cardiac (adult and<br>pediatrics); | ✓ | ✓ |
| • Peripheral Vascular; | ✓ | ✓ |
| • Transesophageal (TEE); | ✓ | ✓ |
| • Musculo-skeletal<br>Conventional | ✓ | ✓ |
| • Transrectal (TR); | ✓ | ✓ |
| • Transvaginal (TV); | ✓ | ✓ |
| • Intraoperative (abdominal,<br>thoracic, & vascular). | ✓ | ✓ |
| Image modes: | | |
| B (2D), M, Color M modes, Color,<br>Power, Pulsed and CW Doppler<br>modes, Coded Pulse, Harmonic and<br>Real time 3D | ✓ | ✓ |
| Processing &Display features: | | |
| Image mapping (color &<br>gray), Time/ spatial filtering<br>and enhancement, TGC, TVI,<br>SI/SRI, TSI, Harmonic<br>Imaging, Pulsatile-Flow, B-<br>Flow, Extended FOV, Tissue<br>Tracking, Realtime 3D and<br>Multi-plane processing, 2D<br>Stress and Multiplane Stress,<br>4D Stress, TSI w/ surface<br>rendering, Blood Flow<br>Imaging (BFI), Spatial<br>Compounding / Speckle<br>Reduction imaging, LCD<br>display, Realtime 3D Color<br>Flow, Automated Functional<br>Imaging (AFI), Triplane AFI,<br>Auto EF (2D), Depth Color<br>Rendering/map, Depth<br>Illumination map, Stereo<br>Vision (Anaglyph Stereo<br>Vision and Polarized Stereo<br>Vision), 2 Click Crop,<br>FlexiSlice, LaserLines, Auto<br>ROI, | ✓ | ✓ |
| HD live, | | ✓<br>(Improvement to<br>Depth<br>Illumination<br>Map) |
| AFI Stress. | | ✓<br>(same features as<br>on the predicate<br>Vivid S60/S70<br>K142323) |
| Measurement & Analysis<br>Length, Area, Time, Circumference,<br>Volume, Heart rate, Slope, Velocity,<br>Angle, Thickness Measurement Tool<br>(IMT), OB Tables, Vascular and<br>Cardiac calcs. including Strain (2D<br>and 4D) and Strain rate, 4D LV<br>Function by TomTec, 4D RV Function<br>by TomTec, 4D LV Mass, Mitral<br>Valve (MV) Quantification tool by<br>TomTec, Z-score, LA Volume by<br>Biplane Simpson, 4D Auto LVQ,<br>Multilayered 2D Strain , ROI width<br>adjustment, Time Caliper, Export of<br>4D Strain trace and mesh data, | ✓ | ✓ |
| 4D Auto AVQ. | ✓<br>(modification of<br>area<br>measurements<br>used in predicate<br>EchoPAC) | |

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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' in a stylized, cursive font, enclosed within a blue circle. There are also some white swirls around the letters. The logo is simple and recognizable, representing the multinational conglomerate corporation.

GE Healthcare 510(k) Premarket Notification Submission

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Image /page/7/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. Three white swirls surround the circle, adding a dynamic element to the design. The logo is simple, recognizable, and represents the multinational conglomerate corporation.

GE Healthcare 510(k) Premarket Notification Submission

Summary of Non-Clinical Tests:

The GE EchoPAC and its applications comply with voluntary standards. The following quality assurance measures were applied to the development of the system:

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

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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)
- Final Acceptance Testing (Validation)
- Performance testing (Verification)
- Safety testing (Verification) .

Summary of Clinical Tests:

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

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