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K Number
K133897
Device Name
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Manufacturer
Infraredx, Inc.
Date Cleared
2014-04-23

(124 days)

Product Code
OGZ,OBJ
Regulation Number
870.1200
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  1. The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
    a. The System is intended for the detection of lipid-core-containing plaques of interest.
    b. The System is intended for the assessment of coronary artery lipid core burden.
  2. The System is intended for ultrasound examination of coronary intravascular pathology.
    a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) summary from the FDA for a medical device called the TVC Imaging System. It states the indications for use but does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

Therefore, I cannot fulfill your request for:

  1. A table of acceptance criteria and reported device performance.
  2. Sample sizes or data provenance for a test set.
  3. Number and qualifications of experts for ground truth.
  4. Adjudication method for the test set.
  5. MRMC comparative effectiveness study results.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Sample size for the training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval, not a clinical study report or a detailed technical specification about performance benchmarks. To find the information you're looking for, you would typically need to consult the device's clinical study reports, scientific publications, or its design verification and validation documentation, which are not included in this FDA letter.

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).