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K Number
K982282
Device Name
DURA-GUARD - DURAL REPAIR PATCH
Manufacturer
BIO-VASCULAR, INC.
Date Cleared
1998-07-30

(30 days)

Product Code
GXQ
Regulation Number
882.5910
Type
Special
Panel
NE
Reference & Predicate Devices
K973706
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For use as a dural substitute for the closure of dura mater during neurosurgery.

Device Description

Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.

AI/ML Overview

The provided text describes a 510(k) submission for a dural repair patch, Dura-Guard, and its substantial equivalence to a previously marketed device. However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/medical device performance study with specific metrics like accuracy, sensitivity, specificity, etc.

The document focuses on:

  • Device Description: Dura-Guard is a dural repair patch manufactured from bovine pericardium cross-linked with glutaraldehyde.
  • Technological Characteristics Comparison: The submission primarily compares a new version of Dura-Guard (treated with 1M NaOH) to an older version (not treated with 1M NaOH). The comparison is based on physical properties (shrink, suture, thickness), bioburden, sterility, pH, pyrogen, chemical residuals, biocompatibility, and animal testing.
  • Conclusion: The manufacturer believes the NaOH-treated product performs similarly to the non-NaOH-treated product and poses no additional safety or effectiveness concerns.
  • FDA Clearance: The FDA found the device substantially equivalent to pre-amendments devices.

Therefore, I cannot populate the requested table and sections. The information needed to address your prompt (e.g., acceptance criteria for diagnostic performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth for AI model evaluation) is not present in the provided text, as this is a traditional medical device submission, not an AI/ML-based diagnostic device.

§ 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).