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K Number
K041528
Device Name
MODIFICATION TO EPTFE GRAFT
Manufacturer
VASCUTEK LTD.
Date Cleared
2004-09-14

(98 days)

Product Code
DSY
Regulation Number
870.3450
Type
Traditional
Panel
CV
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

SUBCUTANEOUS OF CREATION CONDUITS FOR BLOOD ARTERIOVENOUS ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.

Device Description

VASCUTEK ePTFE WRAPPED ePTFE VASCULAR PROSTHESES

AI/ML Overview

I apologize, but the provided text from the FDA 510(k) K041528 document does not contain the information required to answer your request.

The document is a letter from the FDA to Vascutek Ltd. acknowledging the review of their 510(k) premarket notification for the "Vascutek ePTFE Wrapped ePTFE Vascular Prosthesis." It states that the device is substantially equivalent to legally marketed predicate devices.

Specifically, the document does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes for test sets, data provenance, or training sets.
  3. Information on the number or qualifications of experts used to establish ground truth.
  4. Adjudication methods.
  5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes.
  6. Results of a standalone algorithm performance study.
  7. The type of ground truth used.
  8. How ground truth for a training set was established.

This document is primarily an approval letter and an "Indications for Use" statement, not a detailed study report. To find the information you're looking for, you would typically need to consult the actual 510(k) submission summary or associated clinical/technical reports, which are not provided in this excerpt.

§ 870.3450 Vascular graft prosthesis.

(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”