(106 days)
No
The document describes image processing, analysis, and reporting features, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The reporting software uses "generally accepted guidelines and studies" for comparison, which does not indicate AI/ML.
No
The device is indicated for diagnostic review and analysis of ultrasound images, and for post-acquisition image management and reporting functions. It does not provide any direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is indicated for diagnostic review and analysis of ultrasound images." It also mentions "EchoPliot reporting software which provides guidance to support the quality of the echocardiography examination and report" and helps "generate a preliminary data analysis that can be used as basis for the examination report."
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 text, the GE EchoPAC workstation is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- GE EchoPAC Function: The GE EchoPAC workstation is described as a device for the review and analysis of ultrasound images. It processes, annotates, measures, and manages images acquired directly from ultrasound scanners. It also includes reporting software that analyzes patient data and measurements based on these images.
- No Specimen Analysis: The text explicitly states that the device works with "ultrasound images acquired via GE Vivid family of ultrasound scanners." There is no mention of analyzing biological 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 (including renal and GYN); Urology (including 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.
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 device and functionality cleared on GE EchoPAC K123894.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound (B, M, Color M modes, Color, Power, Pulsed & CW Doppler modes, Coded Pulse, Harmonic and Realtime 3D)
Anatomical Site
Fetal; Abdominal (including renal and GYN); Urology (including 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).
Indicated Patient Age Range
Fetal, Pediatric, Neonatal, 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)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/0 description: The image shows a logo of General Electric (GE). The logo consists of the letters "GE" intertwined within a circle. The letters are stylized and have a vintage look. The logo is black and white.
KB1685
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tion
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station June 7, 2013
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
June 7, 2013 Date:
GE Healthcare Submitter: 9900 Innovation Drive Wauwatosa, WI, USA 53226
| Primary Contact Person: | Bryan Behn
Regulatory Affairs Manager
GE Healthcare
Phone: (414) 721-4214
Fax: (414) 918-8275 | | | | SEP |
| ------------------------- | ----------------------------------------------------------------------------------------------------------- | -- | -- | -- | ----- |
|---|
Charlotte Kaas Munthe Jørgensen Secondary Contact Regulatory Affairs Specialist Person: GE Healthcare, GE Vingmed Ultrasound AS Phone: +47 33 02 12 80 Fax: +47 33 02 13 50
- Device: Trade Name: GE EchoPAC
- Common/Usual Name: Workstation Software for ultrasound image review, analysis and reporting
- Classification Names: 21 CFR 892.2050
Product Code: LLZ
K123894 - GE EchoPAC Predicate Device(s):
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
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Image /page/1/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 logo is black and white.
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station June 7, 2013
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 K123894.
Intended 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 (including renal and GYN); Urology (including 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.
Device Modification The following is a brief overview of the differences between the Overview: proposed EchoPAC and the predicate EchoPAC (K123894).
The following modifications of existing features available on the predicate EchoPAC will be introduced with the modified EchoPAC:
-
- 4D Strain: Export of 4D strain trace and mesh data.
-
- 2D Strain: -Multilayered 2D strain
- Variable width ROI -
- Add Caliper
-
- Alternative automated ROI tracing for Auto EF and AFI features
-
- Depth Illumination map
The subject modified EchoPAC will introduce one new plug-in feature originally cleared in its own right by their OEM
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GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station June 7, 2013
K131685
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manufacturer, Sony Electronics.
-
- Polarized Stereo Vision, visualization of 3D data on Sony LMD-2451MT LCD monitor, K113203, intended for 3D and 2D color video displays of clinical images.
The Intended Use and Indications for Use of the device have not changed by this modification.
- Polarized Stereo Vision, visualization of 3D data on Sony LMD-2451MT LCD monitor, K113203, intended for 3D and 2D color video displays of clinical images.
These modifications all lead to ease of use of the EchoPAC
- Technology: The EchoPAC employs the same fundamental scientific technology as its predicate device.
Determination of Summary of Non-Clinical Tests:
Substantial Equivalence: 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.
Summary of Clinical Tests:
The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence.
GE Healthcare considers the EchoPAC to be as safe, as effective, Conclusion: and performance is substantially equivalent to the predicate device.
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Comrol Center - W(266-G609 Silver Spring, MD 20093-0002
September 24, 2013
GE VINGMED ULTRASOUND AS % Mr. Bryan Behn Regulatory Affairs Manager GE HealthCare 9900 Innovation Drive, RP-2138 WAUWATOSA WI 53226
Re: K131685
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: August 22, 2013 Received: August 23, 2013
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: CDRII 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.
4
Page 2-Mr. Behn
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Safetv/ReportaProblem/dcfault.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/ResourcesforYou/Industry/default.htm.
Sincerely yours.
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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GE Healthcare 510(k) Premarket Notification GE EchoPAC Review station June 7, 2013
510(k) Number: K131685
Device Name: GE EchoPAC
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 (including renal and GYN); 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 EchoPliot 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.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use: NO (Part 21 CFR 801 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)
Smh.7)
(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
210(k) R131685
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