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K Number
K083440
Device Name
PRIMATRIX DERMAL REPAIR SCAFFOLD
Manufacturer
TEI BIOSCIENCES INC.
Date Cleared
2008-12-12

(22 days)

Product Code
KGN
Regulation Number
N/A
Type
Special
Panel
SU
Reference & Predicate Devices
K061407,K061711
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 the PriMatrix Dermal Repair Scaffold. This type of regulatory submission in the US is for devices that are demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with specific performance criteria against a disease state or condition.

Therefore, the document does not contain the kind of information requested in your prompt regarding acceptance criteria, device performance metrics, study designs (test sets, training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance), or statistical results like effect sizes.

Instead, the submission focuses on:

  • Device Description: What the device is (acellular dermal tissue matrix).
  • Intended Use: The types of wounds it's meant to manage.
  • Substantial Equivalence: Claiming similarity in function and intended use to existing devices (PriMatrix K061407 and Oasis K061711).
  • Biocompatibility Assessment: Mentioning tests performed (cytotoxicity, sensitization, etc.) to demonstrate safety.
  • Manufacturing Methods: Stating that viral inactivation levels were assured.

Consequently, I cannot fill out the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth, or expert qualifications based on the information provided in this 510(k) summary.

N/A