(252 days)
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.
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 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.
The provided documents describe the Mepilex Border Ag dressing, which is a silver-containing foam dressing. The 510(k) summary focuses primarily on the device's antimicrobial and biocompatibility properties. It details performance tests related to these aspects.
Here's an analysis based on the provided text, addressing your specific questions:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity | Non-cytotoxic |
| Sensitization | Non-sensitizing |
| Irritation | Non-irritating |
| Antimicrobial Properties: | |
| Barrier against microbial contamination | Shown to provide a barrier against microbial contamination |
| Inactivation of broad range of bacteria and fungi | Shown to inactivate a broad range of bacteria and fungi (in vitro, as per ASTM E2149-01) and wound-related pathogens |
| Sustained antimicrobial activity | Shown to inactivate representative bacteria and fungi for up to 8 days (as per ASTM E2149-01) |
| Sustained silver release | Shows a sustained release of silver over this time period (up to 8 days) |
| Rapid antimicrobial activity | Shown to inactivate bacteria within 30 hours (as in demonstrated by ASTM E2149-01 "Determining antimicrobial activity of immobilized antimicrobial agents") |
2. Sample Size Used for the Test Set and Data Provenance
The documents do not provide details on the sample size used for the test set in terms of number of dressings or bacterial/fungal strains specifically. The methods refer to "representative bacteria and fungi" and "broad range of bacteria and fungi" but do not quantify them.
The provenance of the data is in vitro (laboratory testing) as explicitly stated for the antimicrobial properties. There is no information regarding country of origin or whether clinical (prospective/retrospective) data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided in the given text. The tests described (biocompatibility and antimicrobial) are laboratory-based and generally follow standardized protocols (e.g., ASTM E2149-01) rather than relying on expert consensus for establishing ground truth.
4. Adjudication Method for the Test Set
This information is not applicable/provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human interpretation of data, where discrepancies need to be resolved. The described tests are laboratory analyses with objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done according to the provided text. This type of study is relevant for evaluating diagnostic or interpretive devices where human readers are involved. The Mepilex Border Ag is a therapeutic dressing, and its performance evaluation focuses on its inherent material properties and biological effects.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable to the Mepilex Border Ag dressing. This type of performance evaluation is typically for AI/software-as-a-medical-device (SaMD) products. The device in question is a physical wound dressing; therefore, there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The ground truth for the biocompatibility tests (cytotoxicity, sensitization, irritation) would be established by standard biological assays and observation of biological responses (e.g., cell viability, skin reactions) against predefined thresholds for acceptable limits.
The ground truth for the antimicrobial properties was established by in vitro laboratory results using standardized test methods (specifically listed as ASTM E2149-01). This standard dictates how to "Determine antimicrobial activity of immobilized antimicrobial agents," providing objective measurements of bacterial/fungal reduction or inactivation.
8. The Sample Size for the Training Set
This information is not provided and is not applicable in the context of this device. A "training set" refers to data used to train machine learning models. The Mepilex Border Ag is a physical medical device, not an AI/ML-based diagnostic or therapeutic algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is not applicable for the reasons stated above (no training set for a physical device).
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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: 678-250-7986
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
page 2 of 2
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 (800) 638-2041 or (301) 796-7100 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
N/A