PRECLUDE MVP DURA SUBSTITUTE

• K Number: K021477
• Device Name: PRECLUDE MVP DURA SUBSTITUTE
• Manufacturer: W. L. GORE & ASSOCIATES, INC.
• Date Cleared: 2002-11-08 ( 184 days)
• Product Code: GXQ
• Regulation Number: 882.5910
• Type: Traditional
• Panel: NE
• Reference & Predicate Devices: K984534 , K953969 , K010936 , K982180

Intended Use

The PRECLUDE® MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.

Device Description

The applicant PRECLUDE® MVP Dura Substitute includes substantially equivalent materials and designs as the predicate PRECLUDE® Dura Substitute devices. The microstructure on the dural side of the applicant device is slightly altered to permit enhanced biological fixation and sealing. The neural side of the material is unchanged from the predicate PRECLUDE® Dura Substitutes. Side orientation is rendered apparent to the surgeon by means of texturing the open microstructure side with a visually and tactilely distinct "ridges and valleys" or "corduroy" pattern.

AI/ML Overview

This document describes the PRECLUDE® MVP Dura Substitute, a device intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery.

However, based on the provided text, there is no information available regarding acceptance criteria or a specific study that proves the device meets such criteria. The document is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than presenting a detailed study with specific performance metrics and acceptance criteria.

The information provided covers:

• Applicant and Contact Information
• Date Prepared
• Trade/Proprietary Name, Common Name, and Classification Name
• Device Predicates:
  • PRECLUDE® ACUSEAL Dura Substitute (K984534)
  • PRECLUDE® Dura Substitute (K953969)
  • SEAMGUARD Staple Line Reinforcement Material (K010936)
  • DuraGen Dural Graft Matrix (K982180)
• Device Description: The PRECLUDE® MVP Dura Substitute has "substantially equivalent materials and designs as the predicate PRECLUDE® Dura Substitute devices." Key features include a slightly altered microstructure on the dural side for enhanced biological fixation and sealing, an unchanged neural side, and a textured open microstructure side ("ridges and valleys" or "corduroy" pattern) for side orientation.
• Statement of Intended Use: "The PRECLUDE® MVP Dura Substitute is intended for use as a temporary or permanent prosthesis for repair of dura mater during neurosurgery."
• Statement of Substantial Equivalence: "A variety of tests, assessments, and comparisons demonstrate that the PRECLUDE® MVP Dura Substitute is substantially equivalent to the cited predicate devices in terms of composition, design, intended use, and performance attributes." The FDA letter confirms the substantial equivalence determination.

Therefore, I cannot provide the requested table or answer the other questions as the necessary data is not present in the provided text. The document describes the regulatory pathway (510(k)) and the basis for market clearance (substantial equivalence), which does not typically include a detailed performance study with explicit acceptance criteria as would be found for novel devices requiring clinical trials.

The emphasis here is on demonstrating that the new device is as safe and effective as existing legally marketed devices, rather than establishing de novo performance benchmarks.

Regulation Number and Section

§ 882.5910 Dura substitute.

(a)
Identification. A dura substitute is a sheet or material that is used to repair the dura mater (the membrane surrounding the brain).(b)
Classification. Class II (performance standards).