MEPILEX TRANSFER AG

K123892 · Molnlycke Health Care · FRO · Apr 5, 2013 · SU

Device Facts

• Record ID: K123892
• Device Name: MEPILEX TRANSFER AG
• Applicant: Molnlycke Health Care
• Product Code: FRO · SU
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds. Mepilex® Transfer Ag can be used under compression bandaging.

Device Story

Mepilex® Transfer Ag is a soft silicone wound contact layer dressing designed to manage exuding wounds. It absorbs and transfers exudate while maintaining a moist wound environment to facilitate healing. The dressing incorporates silver sulphate, which acts as a preservative to minimize microorganism growth within the dressing, and activated carbon. It is effective at inactivating microorganisms for up to 14 days in vitro. The device is applied topically to the wound site by healthcare professionals. It can be used in conjunction with compression bandaging. By managing exudate and providing an antimicrobial environment, the dressing supports wound healing and reduces the risk of infection.

Clinical Evidence

No clinical data was required. Bench testing included in vitro antimicrobial efficacy testing against 16 strains and antimicrobial effect inside the dressing against P. aeruginosa, S. aureus, and C. albicans, demonstrating performance as expected.

Technological Characteristics

Wound dressing consisting of a Safetac® silicone adhesive layer and a compressed polyurethane foam containing silver sulphate and activated carbon. No backing film. Antimicrobial properties provided by silver sulphate.

Indications for Use

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

Predicate Devices

• Mepilex® Border Ag (K100029)

Submission Summary (Full Text)

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K123892

APR 0 5 2013

### 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92(c).

| Date Prepared: | March 20, 2013 |
|-------------------------|----------------------------------------------|
| Submitter: | Mölnlycke Health Care US, LLC |
| | 5550 Peachtree Parkway, Suite 500 |
| | Norcross, GA 30092 |
| Official Correspondent: | Angela L. Bunn, RAC |
| | Director, Regulatory Affairs of the Americas |
| | Tel: [phone] |
| | Fax: [phone] |
| | e-mail: [e-mail] |
| Trade/Proprietary Name: | Mepilex® Transfer Ag |
| Common Name: | Wound and Burn Dressing |

und and Burn Dressing Classification Name: Dressing, Wound, Drug Device Class: Unclassified Product Code: FRO Mepilex® Border Ag Predicate Device Name(s):

## Description of Device:

Mepilex® Transfer Ag is a soft silicone wound contact layer that absorbs and transfers exudate, maintains a moist wound environment and has antimicrobial properties. A moist wound environment is shown to be beneficial for wound healing.

Mepilex® Transfer Ag contains silver sulphate which acts as a preservative to reduce or minimize growth of microorganisms within the dressing.

Mepilex® Transfer Ag has been shown to inactivate microorganisms for up to 14 days in vitro.

Mepilex® Transfer Ag consists of:

- a Safetac® adhesive layer . o which is a unique and a patented adhesive technology
- a compressed polyurethane foam containing silver sulphate and activated carbon .

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#### Intended Use/Indication for Use:

Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds. Mepilex® Transfer Ag can be used under compression bandaging.

## In vitro Data:

The following performance testing was completed on the proposed device:

- Antimicrobial effect against 16 stains .
- Antimicrobial effect inside the dressing against P.a, S.a and C.a .

All areas performed as expected to provide a level of efficacy deemed necessary for the intended use of this device.

# Clinical Testing:

No clinical data was required.

#### Conclusion:

Based on the information presented in this submission, it can be concluded that the Mepilex Transfer Ag is equivalent to the Mepilex® Border Ag (K100029) predicate with respect to intended use, materials, design, and technological characteristics. The only difference in the two materials is the removal of the backing film from the predicate device to the proposed device.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

MöInlycke Health Care US, LLC % Angela L. Bunn. RAC Director, Regulatory Affairs of the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K123892

Trade/Device Name: Mepilex® Transfer Ag Regulatory Class: Unclassified Product Code: FRO Dated: February 20, 2013 Received: February 25, 2013

Dear Ms. Bunn:

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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Letter dated: April 5, 2013

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Page 2 - Angela L. Bunn, RAC

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.htm 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/ResourcesforYou/Industrv/default.htm.

Sincerely yours,

# Mark Nighterson -S

Mark N. Melkerson Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### INDICATIONS FOR USE

510(k) Number (if known): _ _ _ _ _ _ K 123892

Device Name: Mepilex® Transfer Ag

Indications For Use:

Mepilex® Transfer Ag dressing is indicated for the management of a wide range of exuding wounds such as leg and foot ulcers, pressure ulcers, partial thickness burns, traumatic and surgical wounds.

Mepilex® Transfer Ag can also be used under compression bandaging.

Prescription Use X X (Part 21 CFR 801 Subpart D)

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)

# Jiyoung Dang -S

(Division Sign-Off) Division of Surgical Devices 510(k) Number: K123892