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The Integris H 5000 / BH 5000 systems are subject to Federal Performance Standards, defined in 21CFR - part 1000; The Integris H5000 / BH 5000 systems will be manufactured in accordance with voluntary safety standards, such as UL 187 and UL 2601; The information for Users contains comprehensive information to insure safe and effective use; Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.
The provided document is a 510(k) summary for Philips Integris H 5000 and BH 5000 Cardio/Vascular Systems, dated February 25, 1997. It is a pre-market notification to the FDA for medical devices.
This document describes a medical imaging system (Cardio/Vascular Systems), not an AI-powered device or an algorithm. Therefore, it does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, ground truth, or AI-specific performance metrics. These types of details were not typically part of 510(k) submissions in 1997 for non-AI hardware.
The summary focuses on:
- Compliance with Federal Performance Standards (21CFR - part 1000).
- Manufacturing in accordance with voluntary safety standards (UL 187 and UL 2601).
- Comprehensive user information for safe and effective use.
- Past experience with predicate devices for safety and effectiveness.
Therefore, I cannot provide the requested information based on the provided text, as it pertains to a different type of medical device submission and predates the common application of AI in medical imaging at a level requiring such detailed performance evaluation.
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Image /page/0/Picture/0 description: The image shows the Philips logo, which consists of the word "PHILIPS" in a bold, sans-serif font above a shield-like emblem. The emblem features a circle with two wavy lines across the middle, resembling water or sound waves. Above and below the wavy lines are four-pointed stars, adding a celestial or technological element to the design.
MAY 1 4 1997
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are large and black, contrasting with the white background. The text appears to be a logo or brand name.
Philips Medical Systems
P.O. Box 10000, 5680 DA Best, The Netherlands Department of Health and Human Services Center for Devices and Radiological Health Office of Device Evaluation Pre-Market Notification section.
TOM XRD Best XDB087-970107/RR/TT
1997.02.25
SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
for
PHILIPS INTEGRIS H 5000 and BH 5000 CARDIO / VASCULAR SYSTEMS
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
The undersigned certifies that the 510(k) Pre-Market notification for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence.
This information and data is summarized as follows:
-
- The Integris H 5000 / BH 5000 systems are subject to Federal Performance Standards, defined in 21CFR - part 1000;
-
- The Integris H5000 / BH 5000 systems will be manufactured in accordance with voluntary safety standards, such as UL 187 and UL 2601;
-
- The information for Users contains comprehensive information to insure safe and effective use;
-
- Past experience with substantially equivalent predicate devices has shown our device to be safe and effective when used as directed in the Information for Users.
Ing. R.W.Rijntjes
Approbation manager
Approbation manager Quality Assurance dept. XSB / XCB Philips Medical Systems Nederland BV Best, The Netherlands.
522 104 2893
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.