BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES

K120828 · Coloplast A/S · FRO · Apr 5, 2012 · SU

Device Facts

• Record ID: K120828
• Device Name: BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES
• Applicant: Coloplast A/S
• Product Code: FRO · SU
• Decision Date: Apr 5, 2012
• Decision: SESE
• Submission Type: Special
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

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 Story

Biatain Silicone Ag Foam Dressing is a sterile, single-use topical wound dressing for exuding wounds with delayed healing or infection risk. It consists of a moisture-permeable polyurethane top film, an antimicrobial polyurethane foam center containing silver, and a border with silicone adhesive for skin attachment. The silver is released upon contact with wound exudate. The device is applied by clinicians to manage exudate and provide a bacterial barrier. It functions as a passive dressing to absorb fluid and deliver antimicrobial silver to the wound site, aiding in wound management and potentially reducing infection risk.

Clinical Evidence

Bench testing only; no clinical data provided. Substantial equivalence supported by bench testing compared to the predicate device and biocompatibility testing.

Technological Characteristics

Materials: Polyurethane (PU) film, PU antimicrobial foam, hot melt acrylic adhesive, silicone adhesive. Form factor: Square-shaped with rounded corners, 3mm foam thickness. Features: Semi-permeable film backing, waterproof, bacterial barrier. Sterilization: Sterile, single-use.

Indications for Use

Indicated for management of moderately to highly exuding leg ulcers, pressure sores, 2nd degree burns, donor sites, post-operative wounds, and skin abrasions.

Predicate Devices

• Biatain Ag Adhesive Dressings (K100218)

Submission Summary (Full Text)

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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

[phone] Telephone: Facsimile: [phone] Email: [e-mail]

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

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.

#### 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

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.

#### 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 [phone] or [phone] 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:

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.

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