(86 days)
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).
EchoPAC Software Only / EchoPAC Plug-in provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval functionality to ultrasound images that are acquired via the Vivid family of ultrasound scanners by GE Healthcare. The EchoPAC Software Only / EchoPAC Plug-in software is an integral component of each Vivid system, providing the post-acquisition image management and reporting functions of the scanner. EchoPAC Software Only will be offered as SW-only to be installed directly on customer PC hardware, and EchoPAC Plug-in will be offered as an accessory to selected 3rd party image management workstations. EchoPAC Software Only / EchoPAC Plug-in is DICOM compliant, transferring images and data via LAN between scanners, hard copy devices, file servers and other workstations.
Here's an analysis of the provided text regarding the acceptance criteria and study for the EchoPAC Software Only / EchoPAC Plug-in:
Important Note: The provided document is a 510(k) Premarket Notification Summary. This type of submission often focuses on demonstrating substantial equivalence to a predicate device rather than conducting extensive new clinical studies to prove the device meets specific, novel acceptance criteria defined by the manufacturer. Therefore, "acceptance criteria" in this context refers more to the demonstration of meeting the established performance of the predicate device and relevant standards.
Acceptance Criteria and Study Overview for EchoPAC Software Only / EchoPAC Plug-in
Based on the provided 510(k) summary, the device EchoPAC Software Only / EchoPAC Plug-in did not undergo a clinical study to establish new acceptance criteria or prove device performance through a clinical trial. Instead, the submission relies on demonstrating substantial equivalence to predicate devices and adherence to relevant non-clinical standards and software development processes.
Therefore, the table below will reflect the comparative approach taken in a 510(k) summary. The "Reported Device Performance" for the new features is described in relation to existing functionalities or predicate devices.
Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied from Substantial Equivalence and Standards) | Reported Device Performance (as described in 510(k) for new features/changes) |
|---|---|
| Functional Equivalence: Device performs diagnostic review, analysis, patient record management, and reporting of ultrasound images. | The device maintains the same intended use for diagnostic review, analysis, patient record management, and reporting of ultrasound images. |
| Imaging Capabilities Equivalence: Supports current ultrasound imaging modes (B, M, Color M, Color, Power, Pulsed, CW Doppler, Coded Pulse, Harmonic, Real time 3D). | The device uses ultrasound images acquired via the same imaging modes as the predicate device. |
| Processing and Display Features Equivalence: Maintains similar processing and display features. | The device has the same processing and display features as the predicate device. |
| Clinical Applications Equivalence: Covers specified clinical applications (Fetal, Abdominal, Urology, etc.). | The device has the same indications and clinical applications as the predicate, with the addition of Musculo-skeletal Superficial (which was cleared with predicate K161706 – Vivid iq). |
| "Myocardial Work" Functionality: Builds on existing "2D-Strain" functionality. | The new "Myocardial Work" feature builds on the functionality of the existing "2D-Strain" functionality available with the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies it performs similarly or as an enhancement to the established 2D-Strain). |
| "4D Auto RVQ" and "4D Auto MVQ" Functionality: Alternative implementation of features offered by predicate K150122 (TomTec Arena TTA2). | The new features "4D Auto RVQ" and "4D Auto MVQ" are both alternative implementations of functionality offered with TomTec Arena (K150122) as available on the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies performing equivalent functions to a cleared predicate's features). |
| "Cardiac AutoDoppler" Functionality: Represents workflow improvements for existing functionality. | "Cardiac AutoDoppler" is a workflow improvement of functionality already available on the predicate EchoPAC Software Only / EchoPAC Plug-in (K150085). (Implies it delivers the same core functionality with enhanced efficiency). |
| "3rd party DICOM SR Read" Functionality: Builds on existing DICOM SR support. | "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). (Implies enhancement or expansion of existing DICOM capabilities). |
| Compliance with Voluntary Standards: (IEC 62366, IEC 62304, NEMA PS 3.1-3.20, ISO 14971) | The device and its applications comply with these voluntary standards. |
| Quality Assurance Measures Adherence: Risk Analysis, Requirements Reviews, Design Reviews, Unit Testing, Integration Testing, Performance Testing, Safety Testing. | These quality assurance measures were and are applied to the development of the system. (Ensures software development process rigor, intending to produce a safe and effective product without adverse events or significant performance issues). |
| Safety and Effectiveness: As safe and effective as predicate devices. | GE Healthcare considers the EchoPAC Software Only / EchoPAC Plug-in to be as safe, as effective, and performance is substantially equivalent to the predicate devices. (This is the overarching conclusion of the 510(k) submission based on the comparisons and non-clinical tests). |
Detailed Study Information (Based on the Provided Text):
-
Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated. The document indicates that no clinical studies were required to support substantial equivalence. The "tests" mentioned are primarily non-clinical software verification and validation activities (unit testing, integration testing, performance testing, safety testing). The size of the test sets for these software verification activities is not provided in this summary.
- Data Provenance: Not applicable for a clinical test set, as no clinical studies were performed. The "data" being tested in non-clinical scenarios would be simulated or internal developmental data.
-
Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. Since no clinical studies were conducted to generate a new test set requiring expert ground truth, this information is not provided. The performance comparison is against the established functionality of predicate devices.
-
Adjudication Method for the Test Set:
- Not applicable. No clinical test set requiring expert adjudication was described.
-
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not performed or referenced. The document explicitly states: "The subject of this premarket submission, EchoPAC Software Only / EchoPAC Plug-in, did not require clinical studies to support substantial equivalence."
- Effect Size of Human Reader Improvement: Not applicable, as no MRMC study was conducted.
-
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable in the context of a separate "standalone" study for novel algorithm performance. The device itself is software that provides image processing, annotation, analysis, and measurement tools for diagnostic review by a physician. Its performance is inherent to its functionality and how it supports a human user in interpreting specific ultrasound findings. The performance of its new features (Myocardial Work, 4D Auto RVQ/MVQ, Cardiac AutoDoppler, 3rd party DICOM SR Read) is assessed through comparison to existing or predicate functionalities and non-clinical testing.
-
Type of Ground Truth Used:
- Not applicable for a clinical ground truth in the context of a new efficacy study. For the non-clinical software testing, the "ground truth" would be defined by explicit software requirements and expected outputs based on the predicate device's behavior or industry standards. The new features ("Myocardial Work", "4D Auto RVQ/MVQ") are described as building on or being alternative implementations of existing functionalities, implying their performance aligns with the established behavior of those predicate features.
-
Sample Size for the Training Set:
- Not applicable / Not provided. The document describes software that provides analysis, measurement, and reporting functions. It is not an AI/ML algorithm that typically requires a distinct "training set" in the sense of supervised learning from labeled clinical data. Its development would involve software engineering best practices and testing against defined specifications.
-
How Ground Truth for the Training Set Was Established:
- Not applicable. As indicated above, this device description does not align with a typical AI/ML device requiring a training set with established ground truth.
In summary, the 510(k) submission for the EchoPAC Software Only / EchoPAC Plug-in demonstrates substantial equivalence primarily through non-clinical testing, adherence to software development lifecycle standards, and direct comparisons of its features and intended use to legally marketed predicate devices. It does not involve new clinical studies to establish and meet novel performance criteria or to conduct head-to-head comparisons of human reader performance with and without AI assistance.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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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 Healthcare9900 Innovation DriveWauwatosa, WI 53226 |
| Primary Contact Person: | Renee WebbRegulatory Affairs ManagerGE HealthcareT:847-277-6078F:847-277-4506 |
| Secondary Contact Person: | Charlotte Kaas Munthe JørgensenRegulatory Affairs LeaderGE Vingmed Ultrasound AS |
| Device: Trade name: | EchoPAC Software Only / EchoPAC Plug-in |
| Common/Usual Name: | Workstation Software for ultrasound image review, analysis andreporting |
| Classification Names: | Class II |
| Product Code: | LLZ |
| Primary Predicate Device: | K150085 - EchoPAC |
| Secondary Predicate Device(s): | K150122 - TomTec Arena TTA2K161706 – Vivid iq |
| Device Description: | EchoPAC Software Only / EchoPAC Plug-in provides imageprocessing, annotation, analysis, measurement, report generation,communication, storage and retrieval functionality to ultrasoundimages that are acquired via the Vivid family of ultrasoundscanners by GE Healthcare. The EchoPAC Software Only /EchoPAC Plug-in software is an integral component of each Vividsystem, providing the post-acquisition image management andreporting functions of the scanner. EchoPAC Software Only willbe offered as SW-only to be installed directly on customer PChardware, and EchoPAC Plug-in will be offered as an accessory toselected 3rd party image management workstations. EchoPACSoftware Only / EchoPAC Plug-in is DICOM compliant,transferring images and data via LAN between scanners, hardcopy 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:
-
- IEC 62366:2007 + A1:2014. Medical devices -Application of usability engineering to medical devices
-
- IEC 62304:2006, Medical device software Software life cycle process.
-
- NEMA PS 3.1 3.20 (2011), Digital Imaging and Communications in Medicine (DICOM) Set. (Radiology)
-
- 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.
§ 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).