Mepelix 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 polyurethane 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

This document describes the Mepilex Ag Absorbent Silicone-Coated Dressing, a wound dressing with antimicrobial properties. The key information is extracted and presented below regarding its acceptance criteria and the studies performed.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state quantitative acceptance criteria in a dedicated section. However, the "Summary of Testing for Anti-microbial Properties" describes the demonstrated performance, which implicitly serves as the criteria for substantial equivalence.

Performance Characteristic	Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility	Non-cytotoxic, non-irritating, non-sensitizing for a surface device used on breached or compromised surfaces for up to several days.	Mepilex Ag was tested for cytotoxicity, sensitization and irritation and was found to be non-cytotoxic, non-irritating and non-sensitizing.
Microbial Barrier	Provide a barrier against microbial contamination.	The Mepilex Ag has been shown to provide a barrier against microbial contamination.
Inactivation of Bacteria & Fungi (24 hr)	Inactivate a wide range of bacteria and fungi during a 24-hour period (in-vitro).	The Mepilex Ag has been shown to inactivate a wide range of bacteria and fungi during a 24 hour period as shown in-vitro in the Corrected Zone of Inhibition (CZOI) test method.
Sustained Inactivation of Bacteria (7 days)	Inactivate representative bacteria up to 7 days (in-vitro).	Mepilex Ag has also been shown to inactivate representative bacteria up to 7 days, as shown in vitro in CZOI.
Rapid Inactivation of Bacteria	Inactivate bacteria within 30 hours (in-vitro).	Mepilex Ag has also been shown to inactivate bacteria within 30 hours, as shown in vitro in Shake flask method ASTM E2141-01.
Sustained Silver Ion Release	Demonstrate a sustained release of silver ions.	The Mepilex Ag has demonstrated a sustained release of silver Ions for up to 7 days.

2. Sample Size Used for the Test Set and Data Provenance

The provided document does not specify the exact sample sizes used for the in-vitro antimicrobial tests (CZOI and Shake Flask). It only states that the tests were conducted in-vitro.

Test set sample size: Not explicitly stated for each test.
Data provenance: In-vitro laboratory tests. No country of origin is mentioned for the data, but the applicant is Mölnlycke Health Care from Norcross, GA, USA. The nature of the studies is experimental, not retrospective or prospective clinical studies.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This submission pertains to in-vitro laboratory testing and biocompatibility testing, not clinical studies involving interpretation of medical images or patient outcomes by experts. Therefore, the concept of "experts establishing ground truth for a test set" with qualifications like "radiologist with 10 years of experience" is not applicable here. The ground truth for these types of tests is established by adhering to standardized laboratory protocols and measurement techniques.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies where human readers interpret data or images. This is not applicable to the in-vitro performance and biocompatibility tests described in this 510(k) summary. The results of the laboratory tests are objective measurements based on established protocols.

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

No MRMC comparative effectiveness study was mentioned or conducted, as this device submission relies on in-vitro performance and biocompatibility rather than clinical efficacy involving human readers. The document states that the device is "substantially equivalent in composition, function and 'indications for use' to the Contreet Foam Dressings and the 3M Tegaderm Silver Nonwoven Dressing," and "substantially equivalent in design to the currently marketed Mepilex Absorbent Silicone-Coated Dressing." This is a comparison to predicate devices, not a study involving human readers with and without AI assistance.

6. Standalone Performance Study

Yes, standalone (i.e., algorithm only without human-in-the-loop performance) studies were done. The antimicrobial properties and biocompatibility were evaluated through in-vitro laboratory tests (CZOI, Shake Flask method, and standard biocompatibility assessments) without human intervention in the performance of the device's core function. The device's performance in reducing microbial colonization is inherent to its design and material properties, tested independently.

7. Type of Ground Truth Used

The ground truth for the performance tests is based on:

Biocompatibility: Standardized in-vitro tests for cytotoxicity, sensitization, and irritation as recommended by FDA guidance (using the "FDA-modified matrix"). The "ground truth" is the objective biological response observed in these controlled experiments.
Antimicrobial Properties: Established in-vitro laboratory methods, specifically the Corrected Zone of Inhibition (CZOI) test method and the Shake Flask method ASTM E2141-01. The "ground truth" is the quantitative measurement of bacterial/fungal reduction or inhibition zone size according to these validated protocols.

8. Sample Size for the Training Set

This submission does not discuss any "training set" in the context of machine learning or AI. The tests performed are laboratory-based experimental validations of device properties, not data-driven model training.

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

As there is no mention of a "training set" or AI/machine learning model in this 510(k) summary, the concept of establishing ground truth for a training set is not applicable. The product is a physical wound dressing, and its performance is evaluated through direct in-vitro and biocompatibility testing.

Summary

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510(k) SUMMARY

K061554
Page 1 of 2

Applicant:	Mölnlycke Health Care5550 Peachtree ParkwaySuite 500Norcross, GA 30092
Contact Person:	Steven DowdleyDirector of Regulatory AffairsTel.: 678-250-7930Fax: 678-250-7992
Device Name:	Proprietary Name:	Mepilex Ag AbsorbentSilicone-Coated Dressing
	Common/Usual Name:Device Classification:	Silver DressingUnclassified

Substantial Equivalence:

The Mepilex Ag is substantially equivalent in composition, function and "indications for use" to the Contreet Foam Dressings and the 3M Tegaderm Silver Nonwoven Dressing. In addition, Mepilex Ag is substantially equivalent in design to the currently marketed Mepilex Absorbent Silicone-Coated Dressing.

Intended Use:

Description:

Summary of Biocompatibility Testing:

Using the FDA-modified matrix, Mepilex Ag is a surface device which is used on breached or compromised surfaces and may be used for up to several days depending on the condition of the wound. Therefore, the Mepilex Ag was tested for cytotoxicity, sensitization and irritation and was found to be non-cytotoxic, non-irritating and non-sensitizing.

Summary of Testing for Anti-microbial Properties

. The Mepilex Ag has been shown to provide a barrier against microbial contamination and inactivates a wide range of bacteria and fungi during a 24 hour period as shown in-vitro in the Corrected Zone of Inhibition (CZOI) test method.
. Mepilex Ag has also been shown to inactivate representative bacteria up to 7 days, as shown in vitro in CZOI.
. Mepilex Ag has also been shown to inactivate bacteria within 30 hours, as shown in vitro in Shake flask method ASTM E2141-01.

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K 061554
page 2 of 2

Based on the test results, Mepilex Ag has demonstrated effective anti-microbial properties by providing an anti-microbial barrier and an anti-microbial effect within and under the dressing. The Mepilex Ag has demonstrated a sustained release of silver lons for up to 7 days.

Conclusion:

The date provided in this 510(k) summary concludes that Mepilex Ag Absorbent Silicone-Coated Dressing is substantially equivalent to Mepilex Absorbent Silicone-Coated Dressing, Contreet Foam Dressing and the 3M Tegaderm Silver Non-woven Dressing.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mölnlycke Health Care % Mr. Steven Dowdleyt 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

JAN 2 5 2007

Re: K061554

Trade/Device Name: Mepilex® Ag Dressing Regulatory Class: Unclassified Product Code: FRO Dated: December 20, 2006 Received: December 21, 2006

Dear Mr. Dowdlevt:

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 Dowdleyt

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

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

Enclosure

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PREMARKET NOTIFICATION

Indications for Use

510(k) Number (if known): K 06

Mepilex® Ag Dressing Device Name:

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page _ of _

Division G General, Restorative, and Neurological Devices

510(k) Number K061554

Regulation Number and Section

N/A