Mepitel® 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.

Device Description

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. 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.

AI/ML Overview

The provided text describes the regulatory submission for a wound dressing, Mepitel® Ag, and its performance testing. However, it does not include information about AI/ML device performance, multi-reader multi-case (MRMC) studies, or complex ground truth establishment as often seen in diagnostic imaging or AI applications. The "device" in this context is a wound dressing, not a software algorithm.

Therefore, the following information is extracted and presented as per the request, but many sections will be marked as "Not Applicable" because the provided document is for a medical device (a wound dressing) that does not employ AI or require those types of studies.

K130040: Mepitel® Ag Wound Dressing Acceptance Criteria and Performance

This summary is based on the provided 510(k) submission for the Mepitel® Ag wound dressing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Antimicrobial Effect (In vitro)	≥4 log reduction of specified bacteria and yeast on the dressing	Mepitel Ag gives a ≥4 log reduction, on the dressing, of the following Gram positive bacteria, Gram negative bacteria and yeast; Enterococcus faecalis (VRE), Staphylococcus aureus (MRSA), Staphylococcus epidermidis, Acinetobacter baumanii, Enterobacter cloacae, Pseudomonas aeruginosa, Candida albicans, Candida guillermondi, Candida lusitiane.
Antimicrobial Duration (In vitro)	Sustained antimicrobial activity for up to eight (8) days	The dressing sustains antimicrobial activity for up to eight (8) days in in vitro studies.
Antimicrobial Effect with Secondary Dressing (In vitro)	4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing	Mepitel Ag has shown to have a 4 log microbial reduction up to eight (8) days when tested in vitro with a secondary dressing.
Moist Wound Environment	Maintains a moist wound environment in combination with a secondary dressing	Mepitel Ag maintains a moist wound environment in combination with a secondary dressing.
Compatibility with Compression	Usable under compression bandaging	Mepitel Ag can be used under compression bandaging.

2. Sample Size for Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated as a "test set" in the context of an algorithm. The testing described is in vitro (laboratory) against microbial strains, not human data.
Data Provenance: In vitro laboratory testing. Not applicable for country of origin or retrospective/prospective human data.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

Not applicable. The "ground truth" for this device's performance is determined by microbiological and physical in vitro testing, not by expert consensus on clinical data.

4. Adjudication Method (Test Set)

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human expert review of clinical cases. This device underwent in vitro performance testing.

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

Was it done? No. This is a wound dressing, not an AI performance study with human readers.
Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only) Performance Study

Was it done? No. This is a physical wound dressing, not a software algorithm.

7. Type of Ground Truth Used

Ground Truth: In vitro microbiological data (specific bacterial and yeast strains and their reduction rates) and physical performance characteristics of the dressing (e.g., maintaining moist environment, structural integrity, compatibility with compression).

8. Sample Size for Training Set

Not applicable. This is a conventional medical device (wound dressing), not an AI/ML algorithm that requires a training set.

9. How Ground Truth for Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

Summary

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K130040

Page 1 of 2

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: 678-250-7930
	Fax: 678-250-7981
	e-mail: angela.bunn@molnlycke.com
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

Page 2 of 2

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.
1. 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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Page 1 of ____________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

N/A