3M™ Tegaderm™ Silver Nonwoven Dressing is a nonwoven dressing that contains (8 mg/gm of dressing) of silver sulfate. Silver ions released from the silver sulfate create an effective barrier. The soft, absorbent dressing is supplied sterile and may be custom cut to fit the wound. The porous, non-occlusive dressing conforms to the wound base and wicks drainage into the dressing where in vitro studies show that the silver ions may reduce the number of microorganisms, including bacteria and yeast.

AI/ML Overview

The provided text describes a medical device called "3M™ Tegaderm™ Silver Nonwoven Dressing" and its clearance through a 510(k) premarket notification. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials to prove effectiveness. Therefore, the information requested in the prompt, which pertains to clinical studies, acceptance criteria, expert ground truth, and AI performance, is largely not applicable to this document.

Here's a breakdown of why and what can be inferred from the provided text:

1. A table of acceptance criteria and the reported device performance

Not Applicable. This document does not establish specific acceptance criteria for a new device's performance in a clinical setting in the way an AI/ML device would. Instead, it demonstrates substantial equivalence to existing predicate devices.
What's reported:
- Safety: Biocompatibility studies (Cytotoxicity, Intracutaneous Irritation, Skin Sensitization) were conducted and showed "No deleterious effects" and "results were comparable to or better than those reported for Acticoat™ Silver Coated Dressing."
- Effectiveness: "in vitro reduction studies against a known number of microorganisms, such as gram-negative and gram-positive bacteria and yeast (Candida albicans)" were performed. The results "demonstrated that 3M™ Tegaderm™ Silver Nonwoven Dressing was substantially equivalent to Acticoat™ Silver Coated Dressing effectiveness."

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not Applicable directly for clinical efficacy. The "studies" mentioned are laboratory-based (biocompatibility and in vitro antimicrobial reduction), not human clinical trials.
For biocompatibility: Standard battery of tests in rabbits (for Intracutaneous Irritation) and guinea pigs (for Skin Sensitization). The specific number of animals is not detailed.
For in vitro effectiveness: Microorganisms (gram-negative, gram-positive bacteria, and Candida albicans) were used, but specific sample sizes (e.g., number of replicates or strains) are not provided.
Data Provenance: Not specified, but generally, regulatory studies follow international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not Applicable. No human experts were used to establish "ground truth" for clinical performance in this context. The evaluation was based on laboratory testing.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for human expert review in clinical studies, which were not conducted for this 510(k) cleared device.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. MRMC studies are specific to evaluating AI performance in diagnostic imaging or similar fields where human readers interpret cases. This device is a wound dressing.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a physical wound dressing, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For safety studies: Biocompatibility was assessed against established toxicological endpoints (e.g., irritation, sensitization) in animal models. The "ground truth" is the absence of adverse biological reactions.
For effectiveness studies: The "ground truth" was the quantitative reduction of microorganisms in an in vitro setting, measured against controls and the predicate device.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

Not Applicable. As above, no training set.

Summary of Device Acceptance (from the document):

The device was "accepted" or cleared by the FDA because it demonstrated Substantial Equivalence to legally marketed predicate devices (3M™ Tegaderm™ Silver Nonwoven Dressing (K040890) and Acticoat™ Silver Coated Dressing).

The study that proves the device meets the acceptance criteria (i.e., Substantial Equivalence):

The submission relies on:

Biocompatibility Studies: "A standard battery of biocompatibility studies was conducted: Cytotoxicity, Intracutaneous Irritation in rabbits, and Skin Sensitization in guinea pigs. No deleterious effects were observed with 3M™ Tegaderm™ Silver Nonwoven Dressing : results were comparable to or better than those reported for Acticoat™ Silver Coated Dressing." These results were also presented for the previously cleared 3M™ Tegaderm™ Silver Nonwoven Dressing (K040890).
In Vitro Effectiveness Studies: "3M™ Tegaderm™ Silver Nonwoven Dressing was compared with Acticoat™ Silver Coated Dressing in in vitro reduction studies against a known number of microorganisms, such as gram-negative and gram-positive bacteria and yeast (Candida albicans). The results of this study demonstrated that 3M™ Tegaderm™ Silver Nonwoven Dressing was substantially equivalent to Acticoat™ Silver Coated Dressing effectiveness." These results were also presented for the previously cleared 3M™ Tegaderm™ Silver Nonwoven Dressing (K040890).

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms that the presented studies and comparisons adequately met the FDA's criteria for substantial equivalence.

Summary

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Premarket Notification Summary

Sponsor Information: .

3M Health Care 3M Center, Bldg. 275-5W-06 St. Paul, MN 55144-1000

Contact Person: Amv E. Short Regulatory Manager Phone Number: (651) 737-6707 FAX Number: (651) 737-5320

Device Name:

Common or Usual Name: Silver Dressing 3M™ Tegaderm™ Silver Nonwoven Dressing Proprietary Name: Also called 3M™ Tegaderm™ Ag Mesh Dressing with Silver Classification Name: Unclassified

Predicate Device:

3MTM Tegaderm™ Silver Nonwoven Dressing has predicates 3M™ Tegaderm™ Silver Nonwoven Dressing (K040890) and Acticoat™ Silver Coated Dressing, aka Acticoat TM Burn Antimicrobial Dressing, manufactured by Smith & Nephew (originally cleared under K955453).

Description of Device: .

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Indications for Use:

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

K 053256

abrasions
ulcers
trauma wounds
surgical wounds
first and second degree burns
donor sites,

Description of Safety and Substantial Equivalence:

Safety Studies – A standard battery of biocompatibility studies was conducted: Cytotoxicity, Intracutaneous Irritation in rabbits, and Skin Sensitization in guinea pigs. No deleterious effects were observed with 3M™ Tegaderm™ Silver Nonwoven Dressing : results were comparable to or better than those reported for Acticoat ™ Silver Coated Dressing. The results are those presented for the previously cleared device, 3MTM Tegaderm™ Silver Nonwoven Dressing, (K040890).

Effectiveness -- 3M™ Tegaderm™ Silver Nonwoven Dressing was compared with Acticoat ™ Silver Coated Dressing in in vitro reduction studies aqainst a known number of microorganisms, such as gramnegative and gram-positive bacteria and yeast (Candida albicans). The results of this study demonstrated that 3MTM Tegaderm™ Silver Nonwoven Dressing was substantially equivalent to Acticoat ™ Silver Coated Dressing effectiveness. The results are those presented for 3MTM Tegaderm™ Silver Nonwoven Dressing (K040890)

Substantial Equivalence – 3M ™ Tegaderm™ Silver Nonwoven Dressing with modified label, the previously cleared device (K040890) and Acticoat Silver Coated Dressing (aka, Acticoat TM Burn Antimicrobial Dressing) provide the same function and have the same indications for use. These characteristics, as well as the results of safety studies and effectiveness show the two products to be substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name in a circular arrangement around a stylized caduceus symbol. The caduceus is composed of four wavy lines that converge at the bottom, resembling a staff with intertwined snakes, a symbol often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2005

Amy E. Short Regulatory Manager 3M Health Care 3M Center, Building 275-5W-06 St. Paul, Minnesota 55144-1000

Re: K053256

Trade/Device Name: 3M™ Tegadrem™ Silver Nonwoven Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 21, 2005 Received: November 22, 2005

Dear Ms. Short:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becasil 310(t) premained is substantially equivalent (for the indications felerenced above and nave determined ly marketed predicate devices marketed in interstate for use statuu in the choosure) to regars comment date of the Medical Device American so to commerce provision of May 20, 1976, the encordance with the provisions of the Federal Food, Drug, devices mat have been recuire approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration, listing of general controls provisions of the tice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it rryour device is classified (600 a00 10) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD may be subject to such additional controller Life. Barts 800 to 898. In addition, FDA may be found in the Oous an ents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease of advised that i DTF 3185aanse or our device complies with other requirements of the Act that 1 177 has made a determinations administered by other Federal agencies. You must of any I cuch statutes and regulations and and limited to: registration and listing (21 comply with an the Not orequire Bart 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic (200 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter will anow you to begin management of your device of your device to a legally

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Page 2-Amy E. Short

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r loase be actised and termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Cbaubaua Buchund
for

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K053256 510(k) Number (if known):

Device Name: 3M™ Tegaderm™ Silver Nonwoven Dressing, also called 3M™ Tegaderm™ Ag Mesh Dressing with Silver

Indications for Use:

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

abrasions -
ulcers ﮯ
trauma wounds
surgical wounds
first and second degree burns
donor sites

Prescription Use XX (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Brigham Johnson

(Division Sign-Division of General, Restorative, and Neurological Devices

510(k) Number K053256

Page vi

Regulation Number and Section

N/A