(42 days)
No
The document describes image processing, analysis, and reporting features, but does not mention AI, ML, or related terms like deep learning or neural networks. The EchoPilot software provides guidance based on guidelines and studies, which is not indicative of AI/ML.
No
The device is a workstation indicated for diagnostic review and analysis of ultrasound images, not for therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for diagnostic review and analysis of ultrasound images."
Yes
The device description explicitly states that "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." This indicates a software-only configuration is available and intended for use.
Based on the provided information, the GE EchoPAC workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The GE EchoPAC workstation is used for the review and analysis of ultrasound images acquired directly from the patient's body. It processes and manages imaging data, not biological samples.
- The intended use and device description clearly focus on image processing, analysis, and management. There is no mention of analyzing blood, tissue, or other bodily fluids or substances.
- The device description explicitly states it works with ultrasound images acquired via GE Vivid family of ultrasound scanners. This confirms its role in post-acquisition image handling, not laboratory testing of specimens.
Therefore, the GE EchoPAC workstation falls under the category of medical imaging software/workstations, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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.
Anatomical Site
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).
Indicated Patient Age Range
Fetal; Pediatric; Neonatal and Adult.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K120221 - GE EchoPAC
Reference Device(s)
K121063 - GE Vivid S5/S6 Diagnostic Ultrasound System including EchoPilot Software
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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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Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined and surrounded by a circular shape. The logo is black and white, with the letters and the surrounding shape in black and the background in white. The logo is simple and recognizable.
GE Healthcare Traditional510(k) Premarket Notification GE EchoPAC Review station
Intended Use:
Technology:
Determination of
Substantial Equivalence:
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.
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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Image /page/5/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The border has a decorative, swirling pattern around the letters.
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).
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.
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)
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