MEPILEX BORDER AG DRESSING

K100029 · Molnlycke Health Care · FRO · Sep 15, 2010 · SU

Device Facts

• Record ID: K100029
• Device Name: MEPILEX BORDER AG DRESSING
• Applicant: Molnlycke Health Care
• Product Code: FRO · SU
• Decision Date: Sep 15, 2010
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Mepilex Border Ag dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Mepilex Border Ag can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.

Device Story

Mepilex Border Ag is a soft silicone foam dressing for exuding wounds. Construction includes Safetac soft silicone wound contact layer; absorbent polyurethane foam pad containing silver sulfate and activated carbon; super absorbent polyacrylate fiber layer; non-woven layer; vapor-permeable waterproof film. Device functions by absorbing wound exudate to maintain moist healing environment while releasing silver ions to inactivate wound-related pathogens (bacteria and fungi) on the dressing. Used in clinical or home settings; applied by healthcare providers or patients. Silver sulfate provides antimicrobial barrier properties for up to 7-8 days. Output is physical wound management and microbial colonization reduction on the dressing. Benefits include exudate management and antimicrobial protection.

Clinical Evidence

Bench testing only. No clinical trials. In vitro testing per ASTM E2149-01 demonstrated antimicrobial activity against representative bacteria and fungi for up to 8 days and sustained silver release. Biocompatibility testing confirmed non-cytotoxic, non-irritating, and non-sensitizing properties.

Technological Characteristics

Materials: Safetac soft silicone, polyurethane foam, silver sulfate, activated carbon, polyacrylate fibers, non-woven fabric, vapor-permeable waterproof film. Antimicrobial mechanism: silver ion release. Form factor: Bordered foam dressing. Testing standards: ASTM E2149-01 for antimicrobial activity.

Indications for Use

Indicated for management of exuding wounds including leg/foot ulcers, pressure ulcers, traumatic/surgical wounds, and superficial/partial thickness burns. Suitable for use under compression bandaging.

Predicate Devices

• Mepilex Ag Foam Dressing

Submission Summary (Full Text)

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#### Section 12: 510(k) Summary

### 510(k) SUMMARY

Applicant:

-

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

Contact Person:

Steven Dowdley Director of Regulatory Affairs 678-250-7930 Tel.: Fax: [phone]

Proprietary Name:

Device Name:

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

Predicate Device Mepilex Ag Foam Dressing

## Description:

Mepilex Border Ag consists of a Safetac soft silicone wound contact layer, an absorbent polyurethane foam pad containing a silver compound and activated carbon, a layer with super absorbent polyacrylate fibres, a non woven and activeled canvaled candon, a fayer w
absorbent polyacrylate fibres, a non woven and a vapour permeable waterproof film.

Mepilex Border Ag is a soft silicone foam dressing that absorbs exudate, maintains a moist wound healing environment and has antimicrobial properties.

Mepilex Border Ag contains silver sulfate that when in contact with fluid releases silver ions to inactivate a wide range of wound related pathogens (bacteria and fungi), shown in vitro. By reducing the number of wound related putnogens (bacteria and lung), shown in the

Mepilex Border Ag has been shown to inactivate wound related pathogens up to 7 days in vitro.

## Intended Use:

Mepilex Border Ag dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, to the management of extunity wounds, such as legal burns. Mepilex Border Ag can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.

## Summary of Biocompatibility Testing:

Mepilex Border 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

Mepilex Border Ag has been shown to provide a barrier against microbial contamination and inactivates a broad range of bacteria and function and function of the blank on and final and ASTM E2149-01: "Determining antimicrobial activity of invol penod as delivolistian in

Premarket Notification: Mepilex®Ag

Mölnlycke Health Care 2

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K100029
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Mepilex Border Ag has also been shown to inactivate representative bacteria and fungi for up to 8 days, as demonstrated by ASTM E2149-01.

Mepilex Border Ag also shows a sustained release of silver over this time period. Mepilex Ag has also been shown to inactivate bacteria within 30 hours, as in demonstrated by ASTM E2149-01 "Determining antimicrobial activity of immobilized antimicrobial agents".

## Conclusion:

The date provided in this 510(k) summary concludes that Mepilex Border Ag is substantially equivalent to the currently marketed Mary of need inder in the producting to oubstantial

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized design featuring three abstract shapes that resemble waves or flowing lines.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mölnlycke Health Care % Mr. Steven Dowdley Global Director of Regulatory Affairs 5550 Peachtree Parkway60 Middleton Avenue North Haven, Connecticut 06473

SEP 1 5 2010

Re: K100029

Trade/Device Name: Mepilex® Border Ag Regulatory Class: Unclassified Product Code: FRO Dated: August 18, 2010 Received: August 25, 2010

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Steven Dowdley

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

erely yours,

N. Melkerson

Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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#### Section 3: Indications for Use Statement

## PREMARKET NOTIFICATION

## Indications for Use

510(k) Number K1000029: Device Name: Mepilex® Border Ag

Indications for Use:

Mepilex Border Ag dressing is indicated for the management of exuding wounds such as leg and foot ulcers, pressure ulcers, traumatic and surgical wounds, superficial and partial thickness burns. Mepilex Border Ag can also be used under compression bandaging. Silver sulfate present in the dressing helps reduce microbial colonization on the dressing.

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR

(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)

David KroskeillKM

(Division Sign-C Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100029

Premarket Notification: Mepilex®Ag

Mölnlycke Health Care