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K Number
K042164
Device Name
SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE)
Manufacturer
MEDLINE INDUSTRIES, INC.
Date Cleared
2005-06-09

(302 days)

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

Silver Antimicrobial Gauze Sponge/Bandage devices are indicated for external use only. These devices are intended for use in the management of Pressure ulcers, Stasis ulcers, Diabetic foot ulcers, First and second degree burns, Lacerations, Abrasions, Skin tears, Surgical incision sites, Graft sites, and Donor sites.

Device Description

The new product is a non-X-ray detectable, non-absorbable gauze sponge/bandage consisting of cotton, rayon/polyester formed material that has been treated with proprietary silver saccharinate which can give rise to ionic silver when put into contact with aqueous moisture such as that in wound fluid. Sterile gauze sponges and bandages of various sizes and formats in individual single use packaging are for use as primary or secondary wound dressings.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device and its clearance by the FDA. However, it does not contain specific acceptance criteria, performance metrics, or study details that would allow for the completion of the requested table and information.

The document primarily focuses on:

  • Device Description: What the Silver Antimicrobial Wound Gauze is made of and how it works.
  • Intended Use: The types of wounds it's designed to treat.
  • Technological Characteristics: The mechanism of action (ionic silver antimicrobial activity).
  • Pre-Clinical Testing: In vitro antimicrobial activity against various strains and duration of activity (up to 5 days), along with biocompatibility assurance (ISO standard).
  • Regulatory Information: Comparison to legally marketed predicate devices, substantial equivalence determination, and FDA clearance.

Missing Information:

The document explicitly states: "No performance standards are prescribed for the new product." This means that detailed acceptance criteria and a study proving the device meets those criteria, as typically seen in a rigorous clinical trial, are not present in this 510(k) summary. The submission relies on establishing substantial equivalence to predicate devices and demonstrating in vitro antimicrobial activity and biocompatibility rather than presenting a comparative clinical performance study with acceptance criteria.

Therefore, I cannot fill out the requested table or provide the detailed study information because it is not present in the provided text.

N/A