Biatain Silicone Ag Foam Dressings are indicated for use in the management of moderately to highly exuding leg ulcers and pressure sores. The dressing can also be used for 2nd degree burns, donor sites, post operative wounds and skin abrasions.

Device Description

Biatain Silicone Ag Foam Dressings are wound dressings for exuding wounds with delayed healing due to bacteria or where there is a risk of infection. Biatain Ag Foam Dressings consist of a Top film (Printed high moisture-permeable barrier polyurethane (PU) film); a Center part (Soft, absorbing polyurethane (PU) antimicrobial foam (same Biatain Ag foam from Coloplast cleared via K100218) pads adhered to the top film with hot melt acrylic adhesive to avoid delamination when wet); a Border part (Perforated laminate of acrylic adhesive/melt blown polyurethane film/silicone adhesive, where the acrylic adhesive adheres to the top film, and the silicone adhesive is for skin adherence); and a Release liner: 3-part release liner that covers both center and border part. The foam contains silver, which is released upon contact with wound exudate. The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers. The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.

AI/ML Overview

This 510(k) summary describes a medical device, the Biatain Silicone Ag Foam Dressing, which is a topical wound dressing. The submission aims to demonstrate substantial equivalence to a predicate device rather than providing a study on novel performance claims. As such, the information you've requested regarding acceptance criteria and a study proving those criteria (which are typically associated with AI/ML device performance or new functional claims) is not directly applicable to this type of submission.

Specifically:

No new performance claims: The document states that "Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device." There are no explicit acceptance criteria for diagnostic accuracy, sensitivity, specificity, or other performance metrics typically associated with AI/ML systems or novel diagnostic/therapeutic functions.
Focus on substantial equivalence: The core of this 510(k) is to demonstrate that the new device (Biatain Silicone Ag Foam Dressings) is "substantially equivalent in performance, indications, design and materials" to a legally marketed predicate device (Coloplast's Biatain Ag Adhesive Dressings, cleared under K100218). This means the focus is on showing the new device is as safe and effective as the existing one, not on proving new levels of performance against specific clinical benchmarks.

Therefore, many of the requested categories are not relevant to this specific premarket notification:

Table of acceptance criteria and reported device performance: Not applicable. The document does not define specific performance acceptance criteria or report performance metrics in the way an AI/ML device or a device with new functional claims would. The "performance" being assessed here is largely about equivalence in material properties and physical characteristics demonstrated through bench testing.
Sample size for test set and data provenance: No "test set" in the context of clinical performance evaluation (e.g., patient data for diagnostic accuracy) is mentioned. Bench testing data is used.
Number of experts used to establish ground truth & qualifications: Not applicable. There is no ground truth establishment in the diagnostic sense.
Adjudication method: Not applicable.
MRMC comparative effectiveness study: Not applicable. This is a wound dressing, not an AI-assisted diagnostic tool.
Standalone performance: Not applicable.
Type of ground truth used: Not applicable.
Sample size for training set: Not applicable. This is not an AI/ML device requiring a training set.
How ground truth for training set was established: Not applicable.

Summary of relevant information from the provided text:

Device: Biatain Silicone Ag Foam Dressings
Claim: Substantial Equivalence to predicate device (Biatain Ag Adhesive Dressings, K100218).
Support for claim: Bench testing (comparing material properties, design, and performance characteristics to the predicate) and biocompatibility testing.
Indications for Use: Management of moderately to highly exuding leg ulcers and pressure sores. Also for 2nd degree burns, donor sites, post-operative wounds, and skin abrasions.

To answer your request based on the provided text, the response must reflect that these specific questions are not addressed in this type of 510(k) submission which focuses on substantial equivalence rather than novel performance claims against specific clinical outcomes or diagnostic accuracy.

Summary

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K120828
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510(k) Summary

APR - 5 2012

Biatain Silicone Ag Foam Dressings

The assigned 510(k) number is:

510(k) Owner's Name:

Coloplast A/S

Contact Person:

Rebeka A. Stoltman Manager, Regulatory Affairs Coloplast Corp. 1601 West River Road North Minneapolis, MN 55411

(612) 302-4997 Telephone: Facsimile: (612) 287-4138 Email: usrst@coloplast.com

Date Prepared:

March 16, 2012

Device Name and Classification

Trade Name: Common Name: Classification: Classification Name: Product Code:

Biatain Silicone Ag Foam Dressings Topical Wound Dressing Unclassified; 21 CFR § 878.4020 Dressing, Wound, Drug FRO

Manufacturer

Coloplast A/S Holtedam 1 3050 Humlebaek, Denmark

Establishment Registration: 9610694 Owner/Operator: 8010144

Biatain Silicone Ag Foam Dressing

-Confidential-

Page 322 of 324

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· Device Description

The foam contains silver, which is released upon contact with wound exudate.

The dressings are available in different sizes. The dressing is square-shaped with rounded corners. Foam thickness is 3 mm. Biatain Silicone Ag foam dressing is protected with semi-permeable film backings that are waterproof and provide bacterial barriers.

The dressings are individually-packed in a pouch: All dressings are sterile and are for single use only.

Substantial Equivalence Claim

The modified Coloplast Biatain Silicone Ag Foam Dressings are substantially equivalent in performance, indications, design and materials to Coloplast's currently marketed Biatain Ag Adhesive Dressings, which were cleared under 510(k) K100218.

Indications for Use

Summary & Conclusions of the Nonclinical Tests Submitted

Substantial equivalency is supported by bench testing compared to the predicate device and biocompatibility testing performed on the subject device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird-like figure, with its wings spread and head turned to the right. The image is in black and white.

Public Health Service

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

Coloplast A/S % Coloplast Corporation Ms. Rebeka Stoltman 1601 West River Road North Minneapolis, Minnesota 55411

Re: K120828

Trade/Device Name: Biatain Silicone Ag Foam Dressing Regulatory Class: Unclassified Product Code: FRO Dated: March 16, 2012 Received: March 19, 2012

Dear Ms. Stoltman:

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

APR - 5 2012

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Page 2 - Ms. Rebeka Stoltman

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/CDRH0ffices/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Erine D. Keith
C. Mark N. Malkerson

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

Enclosure

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Indications for Use

510(k) Number (if known): K120828

Device Name: Biatain Silicone Ag Foam Dressing

Indications for Use:

Prescription Use X (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)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K120928

Regulation Number and Section

N/A