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K Number
K141682
Device Name
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Manufacturer
Infraredx, Inc.
Date Cleared
2014-11-24

(154 days)

Product Code
OGZ,IYO
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.
    1. 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 document, a 510(k) premarket notification letter for the Infraredx, Inc. TVC Imaging System™, does not contain the acceptance criteria or a study proving its performance. The letter is an FDA response stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed.

Key information missing from this document includes:

  • Acceptance criteria the manufacturer set for the device's performance.
  • The actual study results that demonstrate the device meets those criteria.
  • Details about the test set, training set, ground truth establishment, or expert involvement.

To answer your request thoroughly, the corresponding 510(k) summary or the full 510(k) submission would be required. The provided text only confirms the device's regulatory clearance.

§ 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).