(26 days)
WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use in viewing medical images and making geometric measurements on medical images over the world wide web.
WebPAX is an integrated software and hardware package capable of communicating and storing medical images. WebPAX provides users with capabilities relating to the transfer, display, and storage of medical images as well as the ability to make geometric measurement of features within the medical images. WebPAX is designed to be deployed over conventional TCP/IP networks and interacts with standard commercially-available computer platforms. WebPAX does not produce any original medical images have been received from DICOM compliant scanners and workstations.
Heart Imaging Technologies, LLC - 510(k) for WebPAX
Acceptance Criteria and Study Details:
This 510(k) pertains to WebPAX, a Picture Archiving and Communications System (PACS). The core functionality tested was its ability to perform geometric measurements on medical images, comparing it to a predicate device, the Siemens LEONARDO syngo Cardiology Workstation.
The acceptance criteria for the WebPAX device were based on demonstrating substantial equivalence to the predicate device in geometric measurements. The study aimed to show that there were no statistically significant differences between measurements made using WebPAX and those made using the predicate device.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No statistically significant differences in geometric measurements compared to the predicate device. | "No statistically significant differences were detected when comparing geometric measurements made using the WebPAX system with those of the predicate device." This directly indicates that the device met the established acceptance criteria by demonstrating performance comparable to the predicate device for geometric measurements. |
2. Sample Size and Data Provenance for the Test Set:
- Sample Size: The document states that "geometric measurements were made on the plurality of medical images in a plurality of identical locations within each of the images." While "plurality" indicates more than one, a specific number for the images or locations is not provided in this summary.
- Data Provenance: Medical images based on a plurality of imaging modalities were used. The document does not specify the country of origin of the data or whether the data was retrospective or prospective. It only states that the images were "received from DICOM compliant scanners and workstations."
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set):
The study described is a non-clinical, comparative performance study between two devices, not an evaluation of human performance or diagnostic accuracy that would typically require expert-established ground truth.
- No information is provided regarding experts or their qualifications for establishing ground truth as the study focused on device-to-device measurement comparison, not human interpretability or diagnosis.
4. Adjudication Method for the Test Set:
As the study compares geometric measurements between two systems and does not involve human interpretation or subjective assessments that would require adjudication for discrepancies, no adjudication method is mentioned or appears to be applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical test comparing the geometric measurement capabilities of WebPAX to a predicate device. It does not involve human readers evaluating images with and without AI assistance (as WebPAX is a PACS, not an AI for image interpretation).
6. Standalone Performance Study:
- Yes, a standalone performance was done in the context of comparing its geometric measurement capabilities to a predicate device. The study directly evaluated the WebPAX system's ability to perform geometric measurements independently, then compared these measurements to those from the predicate device. The performance was "algorithm only" in the sense that the device's measurement function was tested, rather than its impact on human diagnostic accuracy.
7. Type of Ground Truth Used:
- The "ground truth" for the test was established by the measurements made by the predicate device. The study's objective was to demonstrate that WebPAX produced measurements that were not statistically significantly different from those of the legally marketed predicate device. This is a form of comparative ground truth against an established device.
8. Sample Size for the Training Set:
- This device is not described as involving machine learning or AI that would require a separate training set. The WebPAX system is a PACS for image communication, storage, viewing, and geometric measurement. Therefore, a training set is not applicable or mentioned.
9. How Ground Truth for the Training Set Was Established:
- As there is no mention of a training set for machine learning, this question is not applicable to the information provided.
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Heart Imaging Technologies, LLC - 510(k) for WebPAX
APPENDIX B -- 510(k) Summary of Safety and Effectiveness
JUN 1 5 2005
Image /page/0/Picture/4 description: The image shows a logo for Heart Imaging Technologies. On the left is a stylized image of a computer monitor with a heart design on the screen. To the right of the monitor are the words "HEART IMAGING TECHNOLOGIES" stacked vertically. The words are in a sans-serif font and are all capitalized.
Heart Imaging Technologies, LLC
This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of 21 CFR Part 807.92.
PART (a) - 510(k) Summary
(1) Identification of Submitter
| Address: | Heart Imaging Technologies, LLC327 West Main St.Durham, NC 27701 |
|---|---|
| Registration Number: | 3005107869 |
| Contact Person: | Robert M. Judd, Ph.D.PresidentTelephone: 919-384-5044FAX: 866-457-3694 |
| Date of Preparation: | May 9, 2005 |
(2) Identification of Device
| Trade Name: | WebPAX |
|---|---|
| Common Name: | Picture archiving and communications system (PACS) |
| Regulation Number: | 892.2050 |
| Device Class: | II |
| Product Code: | LLZ |
(3) Predicate Device
| Manufacturer: | Siemens Medical Solutions, Inc. |
|---|---|
| Trade Name: | LEONARDO syngo Cardiology Workstation |
| Common Name: | Picture archiving and communications system (PACS) |
| Regulation Number: | 892.2050 |
| Device Class: | II |
| Product Code: | LLZ |
| 510k Number: | K042203 |
(4) Description of Device
WebPAX is an integrated software and hardware package capable of communicating and storing medical images. WebPAX provides users with capabilities relating to the transfer, display, and storage of medical images as well as the ability to make geometric measurement of
CONFIDENTIAL
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Heart Imaging Technologies, LLC - 510(k) for WebPAX
features within the medical images. WebPAX is designed to be deployed over conventional TCP/IP networks and interacts with standard commercially-available computer platforms. WebPAX does not produce any original medical images have been received from DICOM compliant scanners and workstations.
(5) Intended Use
WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use in viewing medical images and making geometric measurements on medical images over the world wide web.
(6) Technological Characteristics
Like the predicate device, WebPAX does not contact the patient nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention, interprets the images and information being displayed. The communication and storage components of the WebPAX system are essentially identical to those of the predicate device (eg. DICOM communication over TCP/IP networks, digital image storage on computer hard disk drives). Substantial equivalence of the geometric measurement component was determined based on non-clinical testing (see next section).
PART (b) - Performance Data
(1) Non-Clinical Tests
Medical images based on a plurality of imaging modalities were pushed to the predicate device using a standard DICOM network transfer. The identical mages were pushed to the WebPAX system using the same standard DICOM network transfer. On both systems, geometric measurements were made on the plurality of medical images in a plurality of identical locations within each of the images and the results recorded for statistical comparison.
(2) Clinical Tests
Not applicable.
(3) Conclusions Drawn From Tests
No statistically significant differences were detected when comparing geometric measurements made using the WebPAX system with those of the predicate device. We conclude that the WebPAX system is substantially equivalent.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or a bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Robert M. Judd, Ph.D. President Heart Imaging Technologies, LLC 108 Barton Lane CHAPEL HILL NC 27516
Re: K051325 Trade/Device Name: WebPAX Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 15, 2005 Received: May 20, 2005
Dear Dr. Judd:
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 (Premarket Approval), 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.
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.
JUN 1 5 2005
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This letter will allow you to begin marketing your device as described in your Section $10(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematice notification: - The stilication 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 In you atte 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" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Heart Imaging Technologies, LLC - 510(k) for WebPAX
APPENDIX C – FDA Indications for Use Form
INDICATION FOR USE FORM
510(k) Number (if known):
K05 1325
Device Name:
WebPAX
Indications for Use:
WebPAX is intended for use in the communication and storage of medical images. WebPAX is also intended for use in viewing medical images and making geometric measurements on medical images over the world wide web.
(Please do not write below this line - continue on another page if needed) Concurrence of the CDRH, Office of Device Evaluation (ODE)
ﺎ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR Prescription Use (Per 21 CFR 801.109)
Daniel G. Lyman
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K051325
CONFIDENTIAL
§ 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).