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K Number
K990042
Device Name
SILON DUAL-DRESS
Manufacturer
BIO MED SCIENCES, INC.
Date Cleared
1999-03-19

(72 days)

Product Code
FRO,MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K912032,K923150,K971337
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

For the management of partial and full thickness wounds including the following:

  • Second Degree Burns
  • Skin Graft Donor Sites
  • Autograft Sites
  • Abrasions
  • Lacerations
  • Stage II III Chronic Wounds (Venous Stasis, Decubitus & Diabetic)
  • Skin Tears
Device Description

Silon® Dual-Dress™ is a single dressing with two different sides. One side consists of an open-celled hydrophilic foam. The other side consists of a non-adherent semi-occlusive film. The semi-occlusive film is perforated to allow wound exude to wick away from the wound.

With the foam side of the dressing down against the wound, the product provides an adhesive surface for difficult fixation conditions. With the film side down, the dressing provides a non-adherent covering for fragile and sensitive wounds. One side of the dressing is clearly marked with the product name and the words "Foam on Other Side" printed with a biocompatible ink.

AI/ML Overview

This document does not contain information about the acceptance criteria or a study that proves the device meets acceptance criteria.

The provided text is a 510(k) summary for the Silon® Dual-Dress™ wound dressing. It includes a product description, indications for use, contraindications, and claims of substantial equivalence to predicate devices. The subsequent pages are the FDA's response letter indicating that the device has been found substantially equivalent to predicate devices and can be marketed under certain limitations.

This type of submission (510(k)) focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove device performance against specific acceptance criteria.

Therefore, I cannot provide the requested table or answer the specific questions about sample sizes, ground truth, expert qualifications, adjudication methods, or MRMC studies, as this information is not present in the provided document.

N/A