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).

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. 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

AI/ML Overview

The provided document is a 510(k) premarket notification for the GE EchoPAC, a software-only device for diagnostic review and analysis of ultrasound images. Based on the document, here's a breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" in the format of a table with numerical targets, nor does it present specific "reported device performance" metrics for individual features. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" is implicitly deemed acceptable if the device performs as safely and effectively as the predicate and exhibits similar technological characteristics.

The comparison table provided in the document focuses on features and capabilities rather than quantifiable performance metrics.

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

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "The subject of this premarket submission. GE EchoPAC, did not require clinical studies to support substantial equivalence."

Therefore, there is no information provided regarding a "test set" in the context of clinical performance evaluation (i.e., patient data, images, etc.). The "testing" referred to in the "Summary of Non-Clinical Tests" section pertains to software development and validation processes, not clinical outcome testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

As clinical studies were not required, there is no mention of experts establishing ground truth for a clinical test set.

4. Adjudication Method for the Test Set

Not applicable, as 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 MRMC comparative effectiveness study was conducted or reported in this submission for the GE EchoPAC. The device is for "diagnostic review and analysis" of ultrasound images, and the submission focuses on software functionality and equivalence to predicates, not AI-assisted reader performance improvement.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document does not describe standalone algorithm performance without human-in-the-loop. The device, EchoPAC workstation software, is inherently designed to be used by human operators for review and analysis. The "performance testing" described in the non-clinical tests refers to software verification and validation, not clinical standalone performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

Given the lack of clinical studies, there is no information about the type of clinical ground truth used for performance evaluation. The "ground truth" for the software's functionality would have been defined by the software requirements and design specifications, verified through internal testing against those specifications.

8. The Sample Size for the Training Set

No training set information is provided, as clinical studies involving machine learning or AI model training are not discussed in this 510(k) submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as no training set information is provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" presented here is a non-clinical software verification and validation effort to demonstrate the device's adherence to voluntary standards and internal quality assurance measures, as well as a comparison to legally marketed predicate devices to establish substantial equivalence.

The proof the device meets acceptance criteria (which are largely defined by demonstrating substantial equivalence and compliance with engineering standards) comes from:

Non-Clinical Tests:
- Compliance with voluntary standards: IEC 62366 (usability), IEC 62304 (software life cycle), NEMA PS 3.1 3.20 (DICOM), ISO 14971 (risk management).
- Internal quality assurance measures: Risk analysis, requirements reviews, design reviews, unit testing, integration testing, final acceptance testing (validation), performance testing (verification), and safety testing (verification).
Substantial Equivalence Argument: The core of the submission is the detailed comparison of the proposed GE EchoPAC's indications for use, imaging capabilities, technological characteristics, and safety and effectiveness to those of the predicate devices (K131685 GE EchoPAC and K142323 Vivid S60/S70). The document concludes that the proposed device employs the "same fundamental scientific technology" and is "substantially equivalent" to the predicates.

In essence, for this 510(k), the "acceptance criteria" are implicitly met by demonstrating that the new GE EchoPAC, with its modified/added software features, is as safe, as effective, and performs substantially equivalently to the previously cleared predicate devices, supported by robust software development and testing processes, rather than new clinical performance data.

Summary

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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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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

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Section 5: 510(k) Summary

GE EchoPAC

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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:(414)721-4214
	F:(414)918-8275
Secondary Contact Person:	Charlotte Kaas Munthe Jørgensen
	Regulatory Affairs Specialist
	GE Vingmed Ultrasound AS
	T: +47 97 06 26 46
	F: +47 33 02 12 80
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 andretrieval 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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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 DeviceGE EchoPAC	Predicate DeviceGE EchoPAC(K131685 )
Indications and Clinical Applications:
• Fetal;	✓	✓
• Abdominal (IncludingRenal & Gyn)	✓	✓
• Urology (includingprostate);	✓	✓
• Pediatric	✓	✓
• Small Organ (breast, testes,thyroid);	✓	✓
• Neonatal and AdultCephalic;	✓	✓
• Cardiac (adult andpediatrics);	✓	✓
• Peripheral Vascular;	✓	✓
• Transesophageal (TEE);	✓	✓
• Musculo-skeletalConventional	✓	✓
• Transrectal (TR);	✓	✓
• Transvaginal (TV);	✓	✓
• Intraoperative (abdominal,thoracic, & vascular).	✓	✓
Image modes:
B (2D), M, Color M modes, Color,Power, Pulsed and CW Dopplermodes, Coded Pulse, Harmonic andReal time 3D	✓	✓
Processing &Display features:
Image mapping (color &gray), Time/ spatial filteringand enhancement, TGC, TVI,SI/SRI, TSI, HarmonicImaging, Pulsatile-Flow, B-Flow, Extended FOV, TissueTracking, Realtime 3D andMulti-plane processing, 2DStress and Multiplane Stress,4D Stress, TSI w/ surfacerendering, Blood FlowImaging (BFI), SpatialCompounding / SpeckleReduction imaging, LCDdisplay, Realtime 3D ColorFlow, Automated FunctionalImaging (AFI), Triplane AFI,Auto EF (2D), Depth ColorRendering/map, DepthIllumination map, StereoVision (Anaglyph StereoVision and Polarized StereoVision), 2 Click Crop,FlexiSlice, LaserLines, AutoROI,	✓	✓
HD live,		✓(Improvement toDepthIlluminationMap)
AFI Stress.		✓(same features ason the predicateVivid S60/S70K142323)
Measurement & AnalysisLength, Area, Time, Circumference,Volume, Heart rate, Slope, Velocity,Angle, Thickness Measurement Tool(IMT), OB Tables, Vascular andCardiac calcs. including Strain (2Dand 4D) and Strain rate, 4D LVFunction by TomTec, 4D RV Functionby TomTec, 4D LV Mass, MitralValve (MV) Quantification tool byTomTec, Z-score, LA Volume byBiplane Simpson, 4D Auto LVQ,Multilayered 2D Strain , ROI widthadjustment, Time Caliper, Export of4D Strain trace and mesh data,	✓	✓
4D Auto AVQ.	✓(modification ofareameasurementsused in predicateEchoPAC)

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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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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
1. IEC 62304, Medical device software Software life cycle process, 2006.
1. NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
1. 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.

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).