(65 days)
No
The document describes standard image processing, analysis, and management features without mentioning AI, ML, or related concepts.
No.
The device is indicated for diagnostic review and analysis of ultrasound images, and for image processing, analysis, measurement, and report generation, not for treating a condition or disease.
Yes
The "Intended Use / Indications for Use" section 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 a primary offering.
Based on the provided information, the GE EchoPAC workstation is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- GE EchoPAC Function: The GE EchoPAC workstation is described as a device for the review and analysis of ultrasound images. Ultrasound is an in vivo imaging modality, meaning it creates images of structures within the living body, not from specimens taken from the body.
- Intended Use: The intended use clearly states it's for diagnostic review and analysis of ultrasound images.
- Device Description: The description focuses on image processing, management, and reporting of ultrasound images.
Therefore, the GE EchoPAC workstation falls under the category of medical imaging devices, not in vitro diagnostic devices.
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).
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 ultrasound scanners, primarily for cardiology ultrasound of 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 K101324.
Mentions image processing
GE EchoPAC provides image processing, annotation, analysis, measurement, report generation, communication, storage and retrieval of ultrasound images that are acquired via GE Vivid family ultrasound scanners, primarily for cardiology ultrasound of applications but also for general imaging.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
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
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 subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
K101324 - GE EchoPAC
Reference Device(s)
Not Found
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).
0
MAR 3 0 2012
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station January 20, 2012
510(k) Summary
In accordance with 21 CFR 807.92 the follow ing summary of information is provided:
January 20, 2012
Date: Submitter:
Primary Contact Person:
GE Healthcare 9900 Innovation Drive Wauwatosa, WI, USA 53226 Bryan Behn Requlatory Affairs Manager GE Healthcare Phone: (414) 721-4214 Fax: (414) 918-8275
Secondary Contact Person:
Charlotte Kaas Munthe Jørgensen Requlatory Affairs Specialist GE Healthcare, GE Vingmed Ultrasound AS Phone: +47 33 02 12 80 Fax: +47 33 02 13 50 GE EchoPAC
Device: Trade Name: Common/Usual Name:
Workstation Software for ultrasound i mage review, analysis and reporting
Classification Names:
21 CFR 892.2050 LLZ
Predicate Device(s):
Product Code:
K101324 - GE EchoPAC
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 ultrasound scanners, primarily for cardiology ultrasound of 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 K101324.
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 &
Image /page/0/Picture/18 description: The image contains the letters 'SU' with a line underneath. The letters are in a simple, sans-serif font and appear to be part of a larger text or label. The line beneath the letters suggests emphasis or that they are part of a title or heading.
1
K120221
Page 2 of 2
Image /page/1/Picture/1 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined within a circular border. The design is stylized and recognizable as the brand symbol for the company.
GE Healthcare
Special 510(k) Premarket Notification GE EchoPAC Review station January 20, 2012
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).
Technology:
Determination of Substantial Equivalence:
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.
Summary of Clinical Tests:
The subject of this premarket submission, EchoPAC, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the EchoPAC to be as safe, as effective, and performance is substantially equivalent to the predicate device.
18
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 Innovation Drive, RP-2138 WAUWATOSA WI 53226
Re: K120221
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: March 21, 2012 Received: March 22, 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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
MAR 3 0 2012
3
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/0 description: The image shows a logo with the letters 'GE' intertwined within a circular border. The letters are stylized and appear to be in a sans-serif font. The logo is black and white, with the letters and border being black against a white background. The image quality is somewhat grainy, suggesting it may be a scan or a low-resolution image.
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC Review station January 20, 2012
510(k) Number: K120221
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); Musculo-Conventional; Transrectal (TR); Transvaginal (TV); and Intraoperative skeletal (abdominal, thoracic, & vascular).
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 Diagnostic Devices (OIVD)
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
Klaaza
510K