MEPILEX AG ABSORBENT SILICONE-COATED DRESSING

K061554 · Molnlycke Health Care · FRO · Jan 25, 2007 · SU

Device Facts

• Record ID: K061554
• Device Name: MEPILEX AG ABSORBENT SILICONE-COATED DRESSING
• Applicant: Molnlycke Health Care
• Product Code: FRO · SU
• Decision Date: Jan 25, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

Mepilex Ag is an antimicrobial, absorbent soft silicone dressing. Construction includes a flexible polyurethane foam pad containing silver and activated charcoal, coated with a silicone wound contact layer and a water vapor permeable polyurethane film backing. The device is applied to the wound surface to manage exudate and reduce microbial colonization on the dressing. It provides a barrier against microbial contamination and inactivates bacteria and fungi. The dressing releases silver ions for up to 7 days. It is intended for use on breached or compromised skin surfaces.

Clinical Evidence

Bench testing only. Biocompatibility testing per FDA-modified matrix confirmed non-cytotoxic, non-irritating, and non-sensitizing properties. Antimicrobial efficacy demonstrated in vitro via Corrected Zone of Inhibition (CZOI) and Shake flask method (ASTM E2141-01), showing inactivation of bacteria and fungi over 24 hours and up to 7 days.

Technological Characteristics

Materials: Polyurethane foam, silver, activated charcoal, silicone wound contact layer, polyethylene release film, polyurethane film backing. Principle: Passive exudate absorption and sustained silver ion release for antimicrobial effect. Form factor: Flexible dressing. Testing: ASTM E2141-01 (Shake flask method).

Indications for Use

Indicated for management of low to moderately exuding wounds, including leg ulcers, foot ulcers, pressure ulcers, and partial thickness burns.

Predicate Devices

• Contreet Foam Dressings
• 3M Tegaderm Silver Nonwoven Dressing
• Mepilex Absorbent Silicone-Coated Dressing

Submission Summary (Full Text)

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# 510(k) SUMMARY

K061554
Page 1 of 2

| Applicant: | Mölnlycke Health Care<br>5550 Peachtree Parkway<br>Suite 500<br>Norcross, GA 30092 | |
|-----------------|---------------------------------------------------------------------------------------------|--------------------------------------------------|
| Contact Person: | Steven Dowdley<br>Director of Regulatory Affairs<br>Tel.: [phone]<br>Fax: [phone] | |
| Device Name: | Proprietary Name: | Mepilex Ag Absorbent<br>Silicone-Coated Dressing |
| | Common/Usual Name:<br>Device Classification: | Silver Dressing<br>Unclassified |

### 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:

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.

# 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.

#### 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 [phone]. 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 [phone] or [phone] 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:

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.

× 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