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K Number
K040890
Device Name
3M TEGADERM SILVER
Manufacturer
3M COMPANY
Date Cleared
2004-11-02

(223 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
General & Plastic Surgery
Reference & Predicate Devices
N/A
Predicate For
K053256
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

3M™ Tegaderm™ Silver Nonwoven Dressing is indicated for use as a primary wound dressing over:

  • abrasions
  • ulcers
  • trauma wounds
  • surgical wounds
  • first and second degree burns
  • donor sites
Device Description

3M™ Tegaderm™ Silver Nonwoven Dressing is a cotton nonwoven mesh dressing which contains silver oxide. It is available as rectangle or square dressings of various sizes.

AI/ML Overview

The provided text describes a 510(k) submission for the 3M™ Tegaderm™ Silver Dressing, focusing on demonstrating its substantial equivalence to a predicate device, the Acticoat™ Silver Coated Dressing. The study conducted is a comparative effectiveness study, but it is not related to an AI/ML powered device. Therefore, many of the requested fields are not applicable to the information provided.

However, I can extract the relevant information regarding the device's performance, acceptance criteria, and the nature of the study.

1. Table of Acceptance Criteria and Reported Device Performance

Criterion TypeAcceptance CriteriaReported Device Performance
Safety (Biocompatibility)No deleterious effects observed. Results comparable to or better than those reported for the predicate device (Acticoat Silver Coated Dressing). Based on standard battery tests: Cytotoxicity, Intracutaneous Irritation (rabbits), Skin Sensitization (guinea pigs).No deleterious effects were observed with Tegaderm Silver Dressing. Results were comparable to or better than those reported for Acticoat Silver Coated Dressing across all biocompatibility tests (Cytotoxicity, Intracutaneous Irritation in rabbits, and Skin Sensitization in guinea pigs).
Effectiveness (Antimicrobial)Equivalent antimicrobial reduction in vitro against known gram-negative and gram-positive bacteria, and Candida albicans, compared to the predicate device (Acticoat Silver Coated Dressing).3M Tegaderm Silver Dressing was found to be equivalent to Acticoat Silver Coated Dressing in in vitro reduction studies against a known number of gram-negative and gram-positive bacteria and against Candida albicans.

2. Sample Size and Data Provenance for the Test Set

  • Sample Size for Test Set:
    • Biocompatibility: Not explicitly stated as a number of samples/patients. Standard tests were conducted using animal models (rabbits for intracutaneous irritation, guinea pigs for skin sensitization).
    • Effectiveness: Not explicitly stated as a number of samples. "Known number of gram-negative and gram-positive bacteria" and "Candida albicans" were used in in vitro reduction studies. This implies laboratory cultures, not patient data.
  • Data Provenance: In vitro laboratory studies and animal model studies. No human patient data is referenced.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

  • Not applicable. This study is not evaluating an AI/ML device where expert ground truth is typically established for image or data interpretation. The ground truth for biocompatibility is based on biological assays and observations, and for effectiveness, it's based on microbial growth reduction in a laboratory setting. No, human experts were not used in this context to establish a "ground truth" as it would be for an AI diagnostic device.

4. Adjudication Method for the Test Set

  • Not applicable. There was no adjudication method described as this was not a human expert-based evaluation or a clinical trial requiring such.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

  • No. This was not an MRMC study. The comparison was device-to-predicate in in vitro and animal model settings for safety and effectiveness. It does not involve human readers using or not using AI.

6. Standalone (Algorithm Only) Performance

  • Not applicable. This device is a wound dressing, not an algorithm or AI system.

7. Type of Ground Truth Used

  • Biocompatibility: Biological assay results and observations in animal models (e.g., presence/absence of irritation, cytotoxicity).
  • Effectiveness: Quantitative reduction of microbial growth in in vitro cultures.

8. Sample Size for the Training Set

  • Not applicable. This is not an AI/ML device that requires a training set. The descriptions are for preclinical studies of a medical device.

9. How the Ground Truth for the Training Set Was Established

  • Not applicable. No training set was used or described.

N/A