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K Number
K093231
Device Name
ALBOGRAFT VASCULAR PROSTHESIS
Manufacturer
LEMAITRE VASCULAR, INC.
Date Cleared
2010-01-14

(92 days)

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

The AlboGraft Double Velour Knitted and Woven Grafts are indicated for use in the replacement or repair of Abdominal and Thoracic affected with aneurysmal or occlusive disease.

Device Description

Not Found

AI/ML Overview

I am sorry, but based on the provided document, there is no information available regarding acceptance criteria and a study that proves a device meets those criteria. The document is a 510(k) premarket notification letter from the FDA to LeMaitre Vascular, Inc. for the AlboGraft™ Double Velour Woven and Knitted Vascular Prostheses.

This letter primarily focuses on:

  • Acknowledging the 510(k) submission (K093231).
  • Stating that the device has been determined substantially equivalent to legally marketed predicate devices.
  • Outlining the regulatory class (Class II) and product code (MAL).
  • Listing general controls provisions of the Act that apply to the device.
  • Providing information on how to obtain further regulatory advice.
  • Presenting the Indications for Use for the AlboGraft Vascular Prosthesis.

The document does not contain details about:

  1. A table of acceptance criteria or reported device performance.
  2. Sample sizes, data provenance, or study types (retrospective/prospective).
  3. Number or qualifications of experts for ground truth establishment.
  4. Adjudication methods.
  5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
  6. Standalone algorithm performance.
  7. Type of ground truth used.
  8. Training set sample size or how its ground truth was established.

Therefore, I cannot fulfill your request for this specific information using the provided text.

§ 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.”