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K Number
K090823
Device Name
THERAFORM BILAYER
Manufacturer
SEWON CELLONTECH CO., LTD.
Date Cleared
2009-10-22

(210 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K021792
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

TheraForm™ Bilayer is intended for the management of wounds including:

  • Partial and full-thickness wounds .
  • Pressure ulcers .
  • . Venous ulcers
  • Diabetic ulcers .
  • Chronic ulcers .
  • Surgical wounds (donor sites / grafts, post-moh's surgery, post-laser surgery, podiatric, wound . dehiscence)
  • Trauma wounds (abrasions, lacerations, second-degree burns, and skin tears) .
  • . Draining wounds
Device Description

TheraForm™ Bilayer Absorbable Collagen Membrane is a sterile, pliable surgical porous scaffold agent made of highly purified collagen derived from porcine skin. TheraForm™ Bilayer is completely absorbable (with the exclusion of silicone layer) and highly biocompatible. The semi-permeable silicone layer helps maintaining moist environment, increases tear strength and provides a flexible adherent covering for the wound surface.

AI/ML Overview

This document describes a wound dressing, not an AI/ML medical device. Therefore, the requested information about acceptance criteria, study details, and ground truth for an AI/ML device is not applicable and cannot be extracted from the provided text. The document focuses on the substantial equivalence of the "TheraForm™ Bilayer" wound dressing to predicate devices based on design, materials, indications, packaging, labeling, and performance (specifically biocompatibility tests).

N/A