(147 days)
No
The document describes standard image processing, analysis, and management functions typical of a PACS or workstation for ultrasound images, without mentioning any AI or ML capabilities.
No
The device is described as a workstation for diagnostic review and analysis of ultrasound images, and its functions include image processing, annotation, analysis, measurement, report generation, communication, storage, and retrieval of images. These functions are for diagnostic purposes, not therapeutic intervention.
Yes
The device is indicated for "diagnostic review and analysis of ultrasound images".
Yes
The device description explicitly states it is "Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS." This indicates it is a software application intended to run on existing hardware, not a dedicated hardware device.
Based on the provided information, the GE EchoPAC BT10 workstation is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The GE EchoPAC BT10 workstation processes and analyzes ultrasound images acquired directly from the patient's body. It does not analyze biological samples like blood, urine, or tissue.
- The intended use and device description focus on image processing, analysis, and management. The device's function is to work with ultrasound data, not to perform tests on biological specimens.
Therefore, the GE EchoPAC BT10 workstation falls under the category of a medical imaging device or software, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The GE EchoPAC BT10 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 Cephalio; 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 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. Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS. 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 BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6.
Mentions image processing
Yes
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
Neonatal and Adult, Pediatric, Fetal
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 subject of this premarket submission, EchoPAC BT10, did not require clinical studies to support substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
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).
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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 circular border. The logo is in black and white, with the letters and border appearing in black against a white background.
K101324
GE Health
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC BT10 Review station May 10, 2010
510(k) Summary
OCT 5 2010
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: May 10, 2010
GE Healthcare, GE Medical Systems Ultrasound and Primary Care Submitter: Diagnostics. LLC. 9900 Innovation Drive Wauwatosa, WI, USA 53226
Primary Contact Person:
Bryan Behn Regulatory Affairs Manager GE Healthcare, GE Medical Systems Ultrasound and Primary Care Diagnostics. LLC. Phone: (414) 721-42 14 Fax: (414) 918-8275
Secondary Contact Person:
Jim Turner Regulatory Affairs Manager GE Healthcare Phone: (262) 544-33 59 Fax: (414) 908-9225
GE EchoPAC BT10 Device: Trade Name:
Workstation Software for ultrasound image review, analysis and Common/Usual Name: reporting
Classification Names:
21 CFR 892.2050
Product Code: LLZ
Predicate Device(s):
K081921 - GE Vivid E9 K092079 - GE Vivid S5/S6
K072952 - 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 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. Sold as a stand-alone software only product it can be installation on the customer's PC hardware, or as a plug-in to third party PACS. 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 BT10 are substantially equivalent to the unmodified device and functionality cleared on GE Vivid E9 and GE Vivid S5/S6.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined in a circular design. The logo is black and white and has a vintage look.
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC BT10 Review station May 10, 2010
The GE EchoPAC workstation is indicated for diagnostic review Intended Use: 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 EchoPAC BT10 employs the same fundamental scientific Technology: technology as its predicate devices.
Determination of Substantial Equivalence:
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 BT10, did not require clinical studies to support substantial equivalence.
Conclusion:
GE Healthcare considers the EchoPAC BT10 to be as safe, as effective, and performance is substantially equivalent to the predicate device(s).
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
GE Vingmed Ultrasound AS % Mr. Bryan Behn Regulatory Affairs Manager GE Healthcare 9900 W Innovation Dr., RP-2138 WAUWATOSA WI 53226
DCT 5 2010
Re: K101324
Trade/Device Name: GE EchoPAC BT10 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 27, 2010 Received: August 30, 2010
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
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/ReportalProblem/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,
signature
David G. Brown, Ph.D. Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined in a circular shape. The letters are stylized and have a vintage look. The logo is black and white.
GE Healthcare Special 510(k) Premarket Notification GE EchoPAC BT10 Review station May 10, 2010
510(k) Number:
Device Name: GE EchoPAC BT10
Indications for Use:
The GE EchoPAC BT10 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 Cephalio; 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 Device Evaluation (ODE )
hal D.D.H.m. for David G.L. Brown
(Division Sign-Off)
Division of Radiological De
510K K101324