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K Number
K213341
Device Name
Fibrillar Collagen Wound Dressing
Manufacturer
Collagen Matrix, Inc.
Date Cleared
2022-05-31

(236 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K030921
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Fibrillar Collagen Wound Dressing is indicated for the management of moderately to heavily exudating wounds and to control minor bleeding.

Fibrillar Collagen Wound Dressing may be used for the management of exudating wounds such as:

  • Pressure ulcers
  • Venous stasis ulcers
  • Diabetic ulcers
  • Acute wounds, for example trauma and surgical wounds
  • Partial-thickness burns
Device Description

The Fibrillar Collagen Wound Dressing is an absorbent microfibrillar collagen matrix intended for the management of moderately to heavily exudating wounds and the control of minor bleeding. When interacting with the wound fluid, the product immediately begins to absorb the exudates. The Fibrillar Collagen Wound Dressing is applied directly to the secreting wound and protects the wound bed and delicate new tissue. In addition, the product, being comprised of microfibrillar collagen, has intrinsic hemostatic properties, which can be used to control minor bleeding.

The product is available in various sizes and is provided sterile, non-pyrogenic, and for single use only.

AI/ML Overview

This document does not contain an AI/ML device, and therefore does not have acceptance criteria or study information relevant to AI/ML performance. Instead, it is a 510(k) premarket notification for a Fibrillar Collagen Wound Dressing, claiming substantial equivalence to a predicate device.

The document discusses:

  • Regulatory information: FDA approval, regulatory class, product code, general controls, and compliance with various parts of the Code of Federal Regulations.
  • Indications for Use: For the management of moderately to heavily exudating wounds and control of minor bleeding, applicable to pressure ulcers, venous stasis ulcers, diabetic ulcers, acute wounds (trauma, surgical), and partial-thickness burns.
  • Device Description: An absorbent microfibrillar collagen matrix that absorbs exudates, protects the wound bed, and has intrinsic hemostatic properties.
  • Comparison to Predicate Device (K030921): Shows identical indications for use, material (collagen), biocompatibility, sterility, pyrogenicity, and single-use/reuse characteristics.
  • Nonclinical Tests: The submission included summary-level information demonstrating compliance with design controls and risk analysis. Specific tests mentioned are:
    • Cytotoxicity (L929 MEM Elution, ISO 10993-5)
    • Sensitization (Guinea Pig Maximization, ISO 10993-10)
    • Intracutaneous Reactivity (Rabbits, ISO 10993-10)
    • Acute Systemic Toxicity (Mice, ISO 10993-11)
    • Pyrogenicity (Rabbit Pyrogen Study, USP )
    • Additional in-vivo implantation and subchronic toxicity testing of the predicate device was leveraged.
  • Conclusion: The device is substantially equivalent to its legally marketed predicate based on the design control process and non-clinical studies.

N/A