Mepilex Ag Dressing is indicated for the management of low to moderately exuding wounds such as leg and foot ulcers, pressure ulcers and partial thickness burns. Silver sulphate present in the dressing helps reduce microbial colonization on the dressing.

Device Description

Mepilex Ag is an anti-microbial, absorbent soft silicone dressing consisting of a flexible, absorbent polvurethane foam pad with added silver and activated charcoal, which is coated with a silicone wound contact layer and a wrinkled water vapor permeable polyurethane film backing. The silicone layer is covered with a polyethylene release film.

AI/ML Overview

The provided 510(k) summary for the Mepilex Ag Dressing indicates that no clinical data was submitted as part of this specific submission. The submission is a "Special 510(k)," which often signifies that no changes were made to the currently marketed device or its indications for use. Instead, the submission focuses on demonstrating substantial equivalence to a previously marketed device (K061554) based on a comparison of technological characteristics and non-clinical data (shelf life).

Therefore, I cannot provide a detailed answer to your request regarding acceptance criteria and studies that prove the device meets them, as the relevant information is explicitly stated as "Not applicable" for clinical data in this document.

Here's what can be extracted from the document regarding the information you requested, based on the absence of clinical data:

A table of acceptance criteria and the reported device performance:
- No acceptance criteria for device performance in clinical settings are mentioned, as no clinical studies were performed for this submission.
- The "performance" documented relates to non-clinical data: "The data provided in this submission substantiate a 24 month shelf life." No specific acceptance criteria for shelf-life are given.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable, as no clinical test set was used for this submission.
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, as no clinical test set requiring expert ground truth was used.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable, as no clinical test set requiring adjudication was used.
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, as this device is a medical dressing, not an AI-assisted diagnostic tool, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a medical dressing, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable, as no clinical studies requiring ground truth for device performance were conducted for this submission.
The sample size for the training set:
- Not applicable, as no machine learning algorithm was developed for this device in this submission.
How the ground truth for the training set was established:
- Not applicable, as no machine learning algorithm was developed for this device in this submission.

In summary: This 510(k) submission is specifically a "Special 510(k)" relying on demonstrating substantial equivalence to a predicate device without new clinical data. The information you're requesting primarily relates to clinical performance studies, which were not part of this specific regulatory filing for the Mepilex Ag Dressing.

Summary

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Page 1 of 1

JUL 1 3 2007

510(k) Summary Section 13:

510(k) SUMMARY

Applicant:

Mölnlycke Health Care 5550 Peachtree Parkway Suite 500 Norcross, GA 30092

Contact Person:

Steven Dowdley Director of Requlatory Affairs Tel.: 678-250-7930 Fax: 678-250-7981

Proprietary Name: Mepilex Ag Dressing Device Name: Silver Dressing Common/Usual Name: Device Classification: Unclassified Mepilex Ag Dressing Predicate Device

Description:

Intended Use:

Substantial Equivalence

Comparison of Technological Characteristics No changes have been made to the currently 를 marketed device or device indication for use.
Non-clinical Data The data provided in this submission substantiate a 24 month shelf life. No 】 additional studies were performed.
Clinical Data Not applicable

Conclusion:

The date provided in this 510(k) summary concludes that Mepilex Ag Absorbent Silicone-Coated Dressing is substantially equivalent to the currently marketed Mepilex Ag Absorbent Silicone-Coated Dressing marketed under K061554.

Special 510(k)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black, set against a white background.

Public Health Service

JUL 1 3 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Molnlycke Heath Care Inc. % Mr. Steven Dowdley, RAC Director, Regulatory Affairs 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K071354

Trade/Device Name: Mepilex Ag Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 10, 2007 Received: May 15, 2007

Dear Mr. Dowdley:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, 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 may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with 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.

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Page 2 - Mr. Steven Dowdley, RAC

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson OM
Director
JIRSLR
7/12/07
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

510(k) Number (if known): K071354

Device Name: Mepilex Ag Dressing

Indications For Use:

Prescription Use × (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)

(Division -Off)

Division of General, Restorative,

and Neurological Devices Page 1 of 1

Number	1071354
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stimber

Regulation Number and Section

N/A