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K Number
K973482
Device Name
PHILIPS INTEGRIS V5000 AND BV5000
Manufacturer
PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC.
Date Cleared
1997-11-10

(56 days)

Product Code
IZI
Regulation Number
892.1600
Type
Traditional
Panel
RA
Reference & Predicate Devices
K910370
Predicate For
K092713
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Philips INTEGRIS V5000 and BV5000 system family is intended for use in dedicated vascular and neurovascular applications, including diagnostic and interventional procedures. This includes, e.g., peripheral, cerebral, thoracic and abdominal angiography as well as PTA's stent placements, embolisations, and thrombolysis. The systems are also intended for use in mixed cardiac/vascular/neuro applications and also non vascular interventions.

Device Description

The family of Philips INTEGRIS V5000 and BV5000 systems are angiographic X ray systems for vascular, neurovascular and cardiovascular procedures, as well as nonvascular procedures. The monoplane Philips INTEGRIS V5000 system features a ceiling suspended CESAR C-arm stand that can be configured with a 12" or 15" Image Intensifier. In the biplane system, Philips INTEGRIS BV5000, a floor mounted CESAR C-arm stand is combined with a ceiling suspended double C-Arc (LARC). The Floormounted CESAR C-arm stand can be configured with a 12" or 15" Image Intensifier, the LARC always features a 12" Image Intensifier.

AI/ML Overview

This document, a 510(k) summary for the Philips INTEGRIS V5000 and BV5000 family, does not contain information regarding acceptance criteria or the study details to prove the device meets those criteria.

The provided text focuses on:

  • Identification of the device: Philips INTEGRIS V5000 and BV5000 family, an angiographic X-ray system.
  • Company information: Philips Medical Systems North America Company.
  • Intended Use: Dedicated vascular and neurovascular applications, including diagnostic and interventional procedures (e.g., angiography, PTA, stent placements, embolizations, thrombolysis, mixed cardiac/vascular/neuro applications, and non-vascular interventions).
  • System Description: Monoplane (V5000) and biplane (BV5000) configurations with different C-arm stands and Image Intensifier sizes.
  • FDA approval letter: Confirming substantial equivalence to a predicate device (Philips Integris V3000, K910370).

Therefore, based solely on the provided text, I cannot answer the questions about:

  1. A table of acceptance criteria and the reported device performance
  2. Sample sized used for the test set and the data provenance
  3. Number of experts used to establish the ground truth for the test set and their qualifications
  4. Adjudication method for the test set
  5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done and its effect size
  6. If a standalone performance study was done
  7. The type of ground truth used
  8. The sample size for the training set
  9. How the ground truth for the training set was established

§ 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.