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K Number
K011941
Device Name
EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
Manufacturer
THE KENDALL COMPANY
Date Cleared
2001-08-22

(62 days)

Product Code
FRO,EFQ
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K990530,K992221
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.

Device Description

The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.

AI/ML Overview

This document is a 510(k) summary for the Kendall Excilon® A.M.D. Antimicrobial Sponges. It focuses on demonstrating substantial equivalence to previously marketed devices and does not contain information about specific acceptance criteria, device performance, or human subject studies as typically described for software or AI-based devices.

Therefore, I cannot provide the requested information for the following reasons:

  • No Acceptance Criteria or Reported Device Performance: This submission is for a physical wound dressing, not a software or AI device. The document states that "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." This is the extent of performance "criteria" discussed, and it's for biocompatibility, not for a functional or diagnostic performance as would be expected for a device where a table of acceptance criteria and reported performance would be relevant.
  • No Study Data for Software/AI Performance: The submission does not describe a study that proves device performance in the context of AI or software. There are no mentions of test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This is not applicable to a non-digital, physical medical device like an antimicrobial sponge.
  • No AI or Software Component: The device described is an antimicrobial wound dressing. It does not incorporate any AI, machine learning, or software components that would require the types of studies and criteria outlined in your request.

N/A