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K Number
K130719
Device Name
TVC IMAGING SYSTEM, TVC INSIGHT CATHETER
Manufacturer
Infraredx, Inc.
Date Cleared
2013-10-17

(213 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.
    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 text is a 510(k) premarket notification decision letter from the FDA for the Infraredx TVC Imaging System. It does not contain the detailed information necessary to answer all the questions about acceptance criteria and study particulars. The letter primarily focuses on regulatory approval based on substantial equivalence to predicate devices and outlines general regulatory obligations.

However, based on the limited information provided in the "Indications for Use" section (Section 8 of the original submission, which is referenced in the letter), we can infer the primary performance goals for the device. The "Indications for Use" state:

  • 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.
  • The System is intended for ultrasound examination of coronary intravascular pathology.
    • Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.

Given this, the acceptance criteria would revolve around the ability of the device to accurately detect lipid-core-containing plaques and assess coronary artery lipid core burden using near-infrared, and to perform ultrasound examination of coronary intravascular pathology.

Based on the provided document, I cannot complete most of the requested information because the 510(k) decision letter does not include the detailed study design and results. The information below reflects what could be inferred as acceptance criteria and explicitly states where the document is insufficient to answer the question.

Inferred Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from Indications for Use)Reported Device Performance (Not Available in this Document)
Accurate detection of lipid-core-containing plaques of interest via Near-Infrared (NIR)Not Available in this document
Accurate assessment of coronary artery lipid core burden via NIRNot Available in this document
Effective ultrasound examination of coronary intravascular pathologyNot Available in this document

Detailed Study Information

  1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

    • Not available in this document. The 510(k) decision letter does not include details on the test set, its size, or provenance.

  2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

    • Not available in this document.

  3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

    • Not available in this document.

  4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

    • Not applicable based on available information. The device described (TVC Imaging System) is an imaging system (hardware and associated software for image acquisition and analysis), not explicitly stated to be an AI-assisted diagnostic tool for human readers in the context of an MRMC study. While it provides "assessment of coronary artery lipid core burden" and "detection of lipid-core-containing plaques," the document does not describe its interaction with human readers for improved diagnostic accuracy in an MRMC setting.

  5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

    • Not available in this document. The document does not specify if a standalone performance study was conducted.

  6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

    • Not available in this document.

  7. The sample size for the training set

    • Not available in this document. The 510(k) decision letter does not provide details about training data, as it primarily focuses on the regulatory decision rather than detailed technical study methodologies.

  8. How the ground truth for the training set was established

    • Not available in this document.

§ 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).