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K Number
K131286
Device Name
PRIMATRIX DERMAL REPAIR SCAFFOLD
Manufacturer
TEI BIOSCIENCES INC.
Date Cleared
2013-08-05

(91 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K083440,K023778
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

PriMatrix is intended for the management of wounds that include:

  • Partial and full thickness wounds
  • Pressure, diabetic, and venous ulcers
  • Second-degree burns
  • Surgical wounds-donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence
  • Trauma wounds-abrasions, lacerations, and skin tears
  • Tunneled/undermined wounds
  • Draining wounds
Device Description

PriMatrix is an acellular dermal tissue matrix. The device is supplied sterile and is provided in sheet form in a variety of sizes to be trimmed by the surgeon to meet the individual patient's needs.

AI/ML Overview

The provided text is a 510(k) premarket notification for a medical device called "PriMatrix Dermal Repair Scaffold." This document describes the device, its intended use, and claims substantial equivalence to previously marketed devices. However, it does not contain information about acceptance criteria, a specific study proving the device meets these criteria, or any details related to AI/algorithm performance. Therefore, I cannot extract the requested information regarding AI device evaluation.

The relevant sections of the input text for medical device regulation are highlighted below, but they do not pertain to the performance evaluation of an AI-powered device.

Device Information:

  • Proprietary name: PriMatrix Dermal Repair Scaffold
  • Common name: Animal-derived, dermal extracellular matrix wound care product
  • Classification: Unclassified
  • Intended Use: Management of various types of wounds (partial and full thickness, pressure, diabetic, and venous ulcers, second-degree burns, surgical wounds, trauma wounds, tunneled/undermined wounds, draining wounds).

Substantial Equivalence:

The device claims substantial equivalence to:

  • PriMatrix (TEI Biosciences, K083440)
  • DressSkin (TEI Biosciences, K023778)

Summary of Technological Characteristics and Biocompatibility:

  • PriMatrix is an acellular dermal tissue matrix.
  • It is described as substantially equivalent to other wound care products in design and application.
  • Biocompatibility was assessed through tests including cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, genotoxicity, hemolysis, and pyrogenicity.
  • Manufacturing methods were tested for viral inactivation.

The document focuses on regulatory approval based on substantial equivalence to existing devices and biocompatibility, not on the performance evaluation of a new AI algorithm.

N/A