MEPITEL AG

K130040 · Molnlycke Health Care · FRO · Feb 12, 2014 · SU

Device Facts

• Record ID: K130040
• Device Name: MEPITEL AG
• Applicant: Molnlycke Health Care
• Product Code: FRO · SU
• Decision Date: Feb 12, 2014
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Mepitel® Ag is intended for the management of a wide range of exuding wounds such as skin tears, skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, lacerations, diabetic ulcers, venous ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.

Device Story

Mepitel Ag is a soft silicone wound contact layer; functions as a primary dressing allowing exudate to pass vertically into a secondary absorbent dressing. Composed of a polyamide net coated with Safetac adhesive containing silver sulphate and cellulose. Applied by clinicians to wound sites; remains in place for up to eight days. Silver sulphate acts as a preservative to inhibit microbial growth on the dressing, potentially reducing odor. Maintains a moist wound environment; compatible with compression bandaging. Benefits include reduced dressing change frequency and protection of the wound bed during secondary dressing changes.

Clinical Evidence

No clinical data was required. Evidence consists of in vitro bench testing demonstrating a ≥4 log reduction of various bacteria (e.g., MRSA, VRE, P. aeruginosa) and yeast (e.g., C. albicans) on the dressing for up to eight days.

Technological Characteristics

Soft silicone wound contact layer; materials: Polydimethylsiloxane, Polyamide, Sodium carboxymethylcellulose, and silver sulphate. Features Safetac adhesive technology. Non-latex. Standalone dressing; non-powered.

Indications for Use

Indicated for management of exuding wounds including skin tears, abrasions, surgical wounds, partial thickness burns, partial/full thickness grafts, lacerations, and diabetic, venous, or arterial ulcers.

Predicate Devices

• Mepitel (K984371)
• Urgotul Ag (K100430)

Submission Summary (Full Text)

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### K130040

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#### 510(k) SUMMARY

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

| Date Prepared: | November 19, 2013 | |
|---------------------------|----------------------------------------------|------------|
| Applicant: | Mölnlycke Health Care US, LLC | |
| | 5550 Peachtree Parkway, Suite 500 | |
| | Norcross, GA 30092 | |
| | Registration number: | 3004763499 |
| | Owner/Operator Number: | 9067000 |
| Official Correspondent: | Angela L. Bunn, RAC | |
| | Director, Regulatory Affairs of the Americas | |
| | Tel: [phone] | |
| | Fax: [phone] | |
| | e-mail: [e-mail] | |
| Trade/Proprietary Name: | Mepitel® Ag | |
| Common Name: | Wound and Burn Dressing | |
| Classification Name: | Dressing, Wound, Drug | |
| Device Class: | Unclassified | |
| Product Code: | FRO | |
| Predicate Device Name(s): | Mepitel® and Urgotul® Ag | |

Description of Device:

Mepitel Ag is a soft silicone wound contact layer that allows exudate to pass vertically into a secondary dressing.

Mepitel Ag makes it possible to change only the secondary absorbent dressing. It maintains its structural integrity and can be left in place for up to eight (8) days depending on the wound condition and surrounding skin (or as indicated by accepted clinical practice).

In vitro testing demonstrates that Mepitel Ag gives a ≥4 log reduction, on the dressing, of the following Gram positive bacteria, Gram negative bacteria and yeast; Enterococcus feacalis (VRE), Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, Candida guillermondi, Candida lusitiane. The dressing sustains antimicrobial activity for up to eight (8) days in in vitro studies. By reducing the number of micro-organisms, Mepitel Ag may also reduce odour.

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## K130040

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Mepitel Ag has shown to have a 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing.

Mepitel Ag maintains a moist wound environment in combination with a secondary dressing.

Mepitel Ag can be used under compression bandaging.

Mepitel Ag consists of:

- a Safetac adhesive layer containing silver sulphate and cellulose compound. Safetac is a unique and a 1. patented adhesive technology.
- 2. a polyamide net

Contents of the dressing: Polydimethylsiloxane, Polyamide, Sodium carboxymethylcellulose.

The product and its packaging are not made with natural rubber latex.

#### Intended Use/Indication for Use:

Mepite!® Ag is intended for the management of a wide range of exuding wounds such as skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, lacerations, diabetic ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth on the dressing.

#### Performance Data:

The following in vitro performance testing was completed on the proposed device:

- Antimicrobial effect against 9 strains ●
- . Antimicrobial effect on the dressing against P.a, S.a and C.a

All areas performed as expected to provide a level of effectiveness deemed necessary for the intended us 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 Mepitel® Ag is equivalent to the Mepitel® (K984371) and the Urgoture Ag (K 100430) predicate devices with respect to intended use, materials, design, and technological characteristics.

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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 stylized emblem with three curved lines, resembling a stylized caduceus or a symbol of health and medicine. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Public Health Service

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

February 12, 2014

Mölnlycke Health Care US, LLC Ms. Angela L. Bunn, RAC Director, Regulatory Affairs for the Americas 5550 Peachtree Parkway, Suite 500 Norcross, Georgia 30092

Re: K130040

Trade/Device Name: Mepitel® Ag Regulatory Class: Unclassified Product Code: FRO Dated: January 10, 2014 Received: January 10, 2014

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 or any I outh 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 - Ms. 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 conact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part the regulation untiled, "Missilling 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 I ou may obtain bate. generational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# David Krause -S

- Binita S. Ashar, M.D., M.B.A., F.A.C.S. for 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): ____________________________________________________________________________________________________________________________________________________

Mepitel® Ag Device Name:

Indications For Use:

Mepiter® Ag is intended for the management of a wide range of exuding wounds such as skin tears, skin abrasions, sutured/surgical wounds, partial thickness burns, partial and full thickness grafts, laccrations, disbectc ulcers, venous ulcers, and arterial ulcers. Silver Sulphate is added to the dressing as a preservative to inhibit or reduce microbial growth 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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