BIATAIN FOAM ADHESIVE DRESSING

K983173 · Coloplast Corp. · FRO · Dec 16, 1998 · SU

Device Facts

• Record ID: K983173
• Device Name: BIATAIN FOAM ADHESIVE DRESSING
• Applicant: Coloplast Corp.
• Product Code: FRO · SU
• Decision Date: Dec 16, 1998
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Biatain Foam Adhesive Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

Device Story

Biatain Foam Adhesive Dressing is a sterile, single-use, highly absorbent 3-D polymer wound dressing. It consists of a polyurethane foam pad, a polyurethane film backing, and a hydrocolloid-containing adhesive. The device manages wound exudate by absorbing fluid into the 3-D polymer structure while maintaining a moist wound environment. It is applied topically to the wound site by a healthcare professional or patient. The dressing is suitable for use under compression bandaging. It provides a physical barrier and exudate management for various wound types, potentially aiding the healing process by maintaining an optimal moisture balance.

Clinical Evidence

Bench testing only. Biocompatibility studies included USP Elution Test (non-cytotoxic, grade ≤2), intracutaneous rabbit test (primary irritation index 0.0), and guinea pig maximization test for delayed contact hypersensitivity (no evidence of hypersensitivity).

Technological Characteristics

Materials: Polyurethane foam, polyurethane film, hydrocolloid-containing adhesive. Form factor: 3-D polymer absorbent pad with semi-permeable film backing. Sterilization: Beta-irradiation. Connectivity: None.

Indications for Use

Indicated for management of low to highly exudating leg ulcers, skin tears, pressure sores, 2nd degree burns, 2nd degree partial thickness burns, donor sites, post-operative wounds, and skin abrasions.

Predicate Devices

• Tielle Hydropolymer Dressing (K946245)

Reference Devices

• Comfeel Plus Transparent Dressing (K942283)

Submission Summary (Full Text)

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DFC 6 1009

## 510(k) SUMMARY Biatain Foam Adhesive Dressing Page 1 of 3

Coloplast Corporation Submitter: 1. 1955 West Oak Circle Marietta, Georgia 30062-2249

> Contact Person: Ms. Syd Lilly

> Date of Preparation: July 30, 1998

- 2. DEVICE NAME:
Proprietary Name: Biatain Foam Adhesive Dressing Topical Wound Dressing Common name: Classification Name: Wound Dressing

#### DEVICE CLASSIFICATION: 3. Unclassified

### PRODUCT CLASSIFICATION NUMBER: 79FRO 4.

### 5. PREDICATE DEVICE:

Tielle Hydropolymer Dressing (J&J Ltd. UK); 946245.

### DEVICE DESCRIPTION: 6.

The Biatain Foam Adhesive Dressing is a highly absorbent 3-D polymer dressing consisting of a Polyurethane foam with a Polyurethane film printed with inks and a hydrocolloid containing adhesive.

The dressing is supplied in two size:120x120 cm (3420) and 180x180cm (3423). The dressings are packaged in individual peel pouches and sterilized by ß-irradiation.

The topical safety of Biatain Foam Adhesive Dressing has been established in the following studies:

### The foam formulation:

In the USP Elution Test, diluted and undiluted solutions of the Biatain Foam Dressing were shown to be non-cytotoxic (cytotoxicity grad ≤2).

In the intracutanous test in the rabbit of the Biatain Foam Adhesive Dressing the primary irritation index was 0.0.

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## K983173

## 510(k) SUMMARY Biatain Foam Adhesive Dressing Page 2 of 3

In the test for delayed contact hypersensitivity test using the guinea pig maxi mation test, the Biatain Foam Adhesive Dressing showed no evidence of delayed contact hypersensitivity.

### The Adhesive

The adhesive consists of the same components as Comfeel Plus Transparent Dressing K942283, and no further toxicological studies have been performed.

### 7. INTENDED USE:

For use in the management of low to medium exudating leg ulcers, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

### COMPARISON TO PREDICATE DEVICE 8.

Biatain Foam Adhesive Dressing is similar in composition, function, and inten ded use to other foam wound dressings, such as Tielle Hydropolymer Dressing (J&J Ltd. UK); K946245. A comparison is presented in the following Table.

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# |6983173

## 510(k) SUMMARY Biatain Foam Adhesive Dressing

| | Biatain Foam Adhesive<br>Dressing | Tielle Hydropolymer Dressing |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description | Biatain Foam Adhesive<br>Dressing provides an exudate<br>handling system for low to<br>medium exudating wounds. It<br>is a highly absorbent 3-D<br>polymer dressing. It has a<br>hydrocolloid<br>adhesive and a central 3-D<br>polymer absorbent pad with a<br>waterproof semi-permeable<br>film backing | Tielle Hydropolymer Dressing<br>provides an exudate handling<br>system for low to moderate<br>exudating wounds. It is a highly<br>absorbent dressing. The<br>absorbent material is a synthetic<br>polymer. The island dressng<br>provides a moist wound<br>environment that aids in the<br>wound healing process. During<br>use the absorbent island gently<br>expands as it takes up exudate. |
| Sizes | 120x120 cm, 180x180 cm | 7x9 cm, 11x11 cm, 15x15 cm,<br>15x20 cm, 18x18 cm, 18x18 cm<br>sacrum |
| Use (single,<br>reusable<br>disposable) | Single | Single |
| Intended use | For use in the management of<br>low to medium exudating leg<br>ulcers, and pressure sores.<br>Can also be used for<br>management of 2nd degree<br>burns, 2nd degree partial<br>thickness burns, donor sites,<br>post operative wounds and<br>skin abraisons.<br>It can be used for diabetic or<br>infected wounds under the | For use in the management of<br>both chronic and superficial, low<br>to moderate exudating wounds,<br>including the following: Pressure<br>sores (all stages) and venous<br>ulcers.<br>It is suitable for use under<br>compression bandaging |
| | supervision of a health care<br>professional.<br>Is suitable for use under | |
| | compression bandaging | |
| Sterility | Sterile | Sterile |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC I 6 1998

Ms. M. Sydney Lilly Quality Assurance and Regulatory Affairs Manager Coloplast Corporation 1955 West Oak Circle Marietta, Georgia 30062-2249

Re: K983173

Trade Name: Biatain Foam Adhesive Dressing Regulatory Class: Unclassified Product Code: MGP Dated: November 4, 1998 Received: November 17, 1998

Dear Ms. Lilly:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 (the Act). You may, therefore, market your device subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- This device may not be labeled for use on third degree burns. 1.
- This device may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic) skin.
- This device may not be labeled as a treatment or a cure for any type of wound. 4.

The labeling claims listed above would be considered a major modification in the intended use of the device and would require a premarket notification submission (21 CFR 807.81).

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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Page 2 - Ms. M. Sydney Lilly

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits vour device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Biatain Foam Adhesive Dressing

Indications for Use:

The Biatain Foam Adhesive Dressing is indicated for use in the management of low to highly exudating leg ulcers, skin tears, and pressure sores. The dressing can also be used for 2nd degree burns, 2nd degree partial thickness burns, donor sites, post operative wounds and skin abrasions.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Restorative Devices

Prescription Use (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1-2-96)