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K Number
K071552
Device Name
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2008-04-25

(324 days)

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

Puracol® Plus Ag MicroScaffold™ Wound Dressing is indicated for the management of:

  • Full thickness and partial thickness wounds
  • Pressure ulcers
  • Venous ulcers
  • Ulcers caused by mixed vascular etiologies
  • Diabetic ulcers
  • First and second degree burns
  • Donor sites and other bleeding surface wounds
  • Abrasions
  • Trauma wounds healing by secondary intention
  • Dehisced wounds
  • Surgical wounds
  • Dehisced surgical wounds

These dressings may be cut to size and may be layered for the management of deep wounds.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a wound dressing, which grants market approval by deeming the device substantially equivalent to a predicate device. It specifies indications for use, precautions, and contraindications.

However, it does not provide any details about:

  • Acceptance criteria and reported device performance (in terms of specific metrics like sensitivity, specificity, accuracy, etc.)
  • Details of a study proving the device meets acceptance criteria.
  • Sample sizes for test or training sets.
  • Data provenance, number or qualifications of experts, or adjudication methods for ground truth.
  • Whether MRMC or standalone comparative effectiveness studies were performed, or any associated effect sizes.
  • How ground truth was established for training or test sets.

Essentially, this document is a regulatory approval notice, not a detailed scientific study report on device performance.

N/A