(29 days)
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, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
The GE EchoPAC is an Ultrasound image Analysis and Review Workstation optimized for ultrasound images that are acquired primarily via the GE Vivid family of diagnostic ultrasound systems. It is sold either with computer hardware only with hardware specifications.
This document, K072952, describes the GE EchoPAC Ultrasound Workstation, a medical image management device. It's important to note that this is a Special 510(k) Premarket Notification, meaning it leverages a previously cleared device (K060542) and likely involves minor changes. Therefore, the depth of performance data might differ from a standard 510(k).
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Conformance to design specifications | "The device has been evaluated for conformance to its design specifications..." |
| Conformance to applicable industry standards for software development | "...and applicable industry standards for software development." |
| System compatibility with communicating devices | "It is further verified for system compatibility with the devices with which it communicates." |
| Computer hardware certified to applicable safety standards | "Computer hardware is certified to applicable safety standards." |
| Reliability within the intended network environment | "evaluation in a clinical setting is performed to help assure reliability within the intended network environment." |
| Consistency with traditional clinical practice, FDA guidelines, and established methods for handling patient examination images and data | "Intended uses and other key features of the device are consistent with traditional clinical practice. FDA quidelines and established methods of handling patient examination images and data." |
| Conformance to 21 CFR 820, ISO 9001:2000, and ISO 13485:2000 quality systems | "The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems." |
| Conformance to applicable medical device safety standards | "The device conforms to applicable medical device safety standards..." |
| Compliance verified through internal and independent quality system audit | "...and compliance is verified through internal and independent quality system audit." |
| Substantial equivalence to predicate device (K060542) | "it is the opinion of GE Healthcare that the GE EchoPAC™ is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The document refers to "evaluation in a clinical setting" but does not provide details on the number of cases or patients used for this evaluation.
- Data Provenance: Not explicitly stated. The "clinical setting" implies real-world data, but the country of origin and whether it was retrospective or prospective data are not mentioned. Given the nature of a Special 510(k) for an updated workstation for existing ultrasound systems, it's possible this involved internal testing or smaller-scale evaluations rather than a large clinical trial.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not specified. The document does not describe the methodology for establishing ground truth for any test set or the involvement of experts for this purpose.
4. Adjudication Method for the Test Set:
- Not specified. No information about expert adjudication or consensus is provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests: None required to confirm safety and effectiveness." The evaluation mentioned is for "reliability within the intended network environment," which is not an MRMC study.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- No standalone study was conducted or described in the provided text. The device is an "Image Analysis and Review Workstation," implying interaction with a human user. The performance claims focus on its design, software, compatibility, and safety standards, rather than the standalone diagnostic accuracy of an algorithm.
7. Type of Ground Truth Used:
- Not specified. Since no clinical tests for confirming safety and effectiveness were "required" and no details of an evaluation test set (beyond "reliability within the intended network environment") are provided, the type of ground truth used is not described.
8. Sample Size for the Training Set:
- Not applicable/Not specified. The GE EchoPAC is described as an "Ultrasound image Analysis and Review Workstation." It does not appear to employ AI in the sense of a machine learning algorithm that requires a "training set" to learn to perform a diagnostic task. Its function is image management, processing, and review, not automated diagnosis. Therefore, there's no mention of a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not specified, as there is no mention of a training set for an AI algorithm.
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Special 510(k) Premarket Notification GE EchoPAC Ultrasound Workstation - Medical Image Management Device October 17, 2007
Attachment B:
NOV 1 2005
Summary of Safety and Effectiveness
Prepared in accordance with 21 CFR Part 807.92(c).
GE Healthcare
General Electric Company P.O. Box 414, Milwaukee, WI 53201
Section a):
| Submitter: | GE Medical Systems, Ultrasound and Primary Care DiagnosticsPO Box 414Milwaukee, WI 53201 |
|---|---|
| Contact Person: | Allen Schuh,Manager, Ultrasound Regulatory AffairsTelephone: 414-721-3992; Fax: 414-721-3899 |
| Date Prepared: | October 17, 2007 |
-
Device Name: GE EchoPAC™ Ultrasound Image Workstation System, Image Processing, Radiological , 21 CFR 892.2050, 90-LLZ
-
Marketed Device: GE Vivid 7 Diagnostic Ultrasound with EchoPAC - K060542 Ultrasonic Pulsed Doppler Imaging System, 21 CFR 892.1550, 90-IYN4. Device Description: The GE EchoPAC is an Ultrasound image Analysis and Review Workstation optimized for ultrasound images that are acquired primarily via the GE Vivid family of diagnostic ultrasound systems. It is sold either with computer hardware only with hardware specifications.
-
Indications for Use: 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. Specific clinical applications include: Fetal; Abdominal; Urology (including prostate); Pediatric; Small Organ (breast, testes, thyroid); Neonatal and Adult Cephalic; Cardiac (adult and pediatric); Peripheral Vascular; Musculo-skeletal Conventional; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular)
-
Comparison with Predicate Device: The GE EchoPAC™ is the same device previously cleared as an accessory to the Vivid 7 ultrasound system under K060542. It has the technological characteristics, key safety and effectiveness features, physical design, construction, and materials, and has essentially the same intended uses and post acquisition characteristics as the Vivid 7 ultrasound system.
Section b):
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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. Computer hardware is certified to applicable safety standards.
-
Clinical Tests: None required to confirm safety and effectiveness. However, evaluation in a clinical setting is performed to help assure reliability within the intended network environment.
-
Conclusion: Intended uses and other key features of the device are consistent with traditional clinical practice. FDA quidelines and established methods of handling patient examination images and data. The design and development process of the manufacturer conforms with 21 CFR 820, ISO 9001:2000 and ISO 13485:2000 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through internal and independent quality system audit. PACS devices and medical information management systems in general have accumulated a long history of safe and effective performance. Therefore, it is the opinion of GE Healthcare that the GE EchoPAC™ is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird with three wing-like shapes above a wavy line.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 6 2007
Mr. Allen Schuh Manager, Ultrasound Regulatory Affairs General Electric Company GE Medical Systems, Ultrasound and Primary Care Diagnostics, LLC 9900 Innovation Drive WAUWATOSA WI 53226
Re: K072952
Trade/Device Name: GE EchoPACTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 17, 2007 Received: October 18, 2007
Dear Mr. Schuh:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancy C. B rogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Page 2
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Special 510(k) Premarket Notification Special 310(K) Promance Netical Image Management Device October 17, 2007
Attachment E
Indications for Use
510(k) Number (if known):
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, Code Pulse, Harmonic and Realtime 3D. Specific clinical applications Fetal; Abdominal; Urology (including prostate); include: Pediatric; Small Organ (breast, testes, thyroid); Neonatal Cephalic; Adult Cephalic; Cardiac (adult and pediatric); Musculo-skeletal Conventional; Peripheral Vascular; Transesophageal (TEE); Transrectal (TR); Transvaginal (TV); and Intraoperative (abdominal, thoracic, & vascular).
Prescription Use XXX (Part 21 CFR 801 Subpart D) AND/OR
Over The Counter Use (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)
logu h'Whing
(Division Division of Reproductive. Abdominal ar Radiological Devices 510(k) Number
E-1
§ 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).