LogoFDA 510(k) Search
K Number
K053095
Device Name
HONEY ALGINATE DRESSING
Manufacturer
DERMA SCIENCES CANADA, INC.
Date Cleared
2007-07-12

(616 days)

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

Under the supervision of a healthcare professional, API-MED™ ACTIVE MANUKA HONEY ABSORBENT Dressing provides a moist environment conducive to wound healing and is indicated for moderate to heavily exuding wounds such as:

  • diabetic foot ulcers .
  • leg ulcers (venous stasis ulcers, arterial ulcers and leg ulcers of mixed . etiology)
  • pressure ulcers / sores (partial and full thickness) .
  • 1st and 2nd degree partial thickness burns .
  • donor sites, and traumatic and surgical wounds. .
Device Description

Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing

AI/ML Overview

The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "Derma Sciences API-MED™ Active Manuka Honey Absorbent Dressing." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement as requested in the prompt.

The letter primarily:

  • Confirms the FDA's review of the 510(k) submission (K053095).
  • States that the device is substantially equivalent to legally marketed predicate devices.
  • Grants permission to market the device, subject to general controls provisions.
  • Outlines general regulatory responsibilities.
  • Includes an "Indications for Use" statement for the device.

Therefore, I cannot provide the requested table or answer the specific questions about acceptance criteria and study details based on the given input. The document is solely a regulatory approval letter, not a technical report or study summary.

N/A