(26 days)
Not Found
No
The summary describes a system for communication, storage, viewing, and geometric measurement of medical images. There is no mention of AI, ML, or any related concepts like deep learning, training sets for algorithms, or performance metrics typically associated with AI/ML models (like AUC, sensitivity, specificity). The performance study focuses on comparing geometric measurements, not the output of an AI/ML algorithm.
No
The device is intended for the communication, storage, and viewing of medical images, and for making geometric measurements on those images. It does not provide any treatment or therapy.
No
The device is intended for communication, storage, viewing, and geometric measurement of medical images, but it does not produce original medical images nor does it contain features that perform diagnosis or assist in diagnosis. It facilitates the management and review of diagnostic images, but is not a diagnostic device itself.
No
The device description explicitly states that WebPAX is an "integrated software and hardware package."
Based on the provided information, WebPAX is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use of WebPAX is for the communication, storage, and viewing of medical images, and making geometric measurements on those images. This is related to medical imaging and image analysis, not the examination of specimens derived from the human body (which is the core of IVD).
- Device Description: The description focuses on software and hardware for handling medical images from scanners and workstations. It doesn't mention any components or processes related to analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, urine, or any other biological specimen. The device interacts with medical images, not biological samples.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for diagnosis, monitoring, or screening. WebPAX's function is entirely within the realm of medical imaging and image management.
N/A
Intended Use / 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.
Product codes
LLZ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Medical images based on a plurality of imaging modalities
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
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. No statistically significant differences were detected when comparing geometric measurements made using the WebPAX system with those of the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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).
0
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, LLC
327 West Main St.
Durham, NC 27701 |
|----------------------|------------------------------------------------------------------------------------|
| Registration Number: | 3005107869 |
| Contact Person: | Robert M. Judd, Ph.D.
President
Telephone: 919-384-5044
FAX: 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
1
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.
2
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
3
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