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K Number
K972261
Device Name
RIVETTI-LEVINSON INSTRALUMINAL SHUNT
Manufacturer
INTEGRA NEUROCARE LLC.
Date Cleared
1997-09-15

(90 days)

Product Code
DWF,74D
Regulation Number
870.4210
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Rivetti-Levinson Intraluminal Shunt is indicated for use in preventing ischemia during the construction of coronary artery bypass grafts (either saphenous vein or of mammary artery) in the non-arrested heart.

Intraluminal shunting is indicated for temporary perfusion of the distal coronary lumen as an adjunct to the surgical technique and as a mechanism to prevent myocardial ischemia while the target coronary artery is opened and surgically grafted to a donor vessel.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided text, there is no information about the acceptance criteria and the study that proves the device meets the acceptance criteria. The document is a 510(k) clearance letter from the FDA for a medical device called the "Rivetti-Levinson Intraluminal Shunt". It states that the device is substantially equivalent to legally marketed predicate devices.

The document discusses:

  • The trade name of the device.
  • Regulatory class and product code.
  • The FDA's determination of substantial equivalence.
  • General controls provisions and other regulations the device is subject to.
  • Indications for use of the device.

However, it does not include details about:

  1. A table of acceptance criteria and reported device performance.
  2. Sample size used for a test set or its provenance.
  3. Number and qualifications of experts for ground truth establishment.
  4. Adjudication method for a test set.
  5. Multi reader multi case (MRMC) comparative effectiveness study or its effect size.
  6. Standalone performance study.
  7. Type of ground truth used.
  8. Sample size for a training set.
  9. How ground truth for the training set was established.

This document is a regulatory approval notice, not a clinical study report or a technical performance evaluation.

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).