CONTREET FOAM ADHESIVE/NON-ADHESIVE

K022416 · Coloplast Corp. · FRO · Feb 3, 2003 · SU

Device Facts

• Record ID: K022416
• Device Name: CONTREET FOAM ADHESIVE/NON-ADHESIVE
• Applicant: Coloplast Corp.
• Product Code: FRO · SU
• Decision Date: Feb 3, 2003
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Contreet Foam is 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. Contreet Foam Nonadhesive is additionally indicated for diabetic foot ulcers.

Device Story

Contreet Foam Dressing is a topical wound dressing containing silver as an active antimicrobial component. It consists of an absorbent foam pad, with or without a hydrocolloid adhesive border, and a waterproof, semi-permeable film backing. The device manages wound exudate while providing a barrier to bacterial penetration. It is intended for use by healthcare professionals in clinical settings for the management of various wound types. The silver component provides in-vitro antibacterial activity against a broad spectrum of microorganisms, potentially reducing wound odor and supporting the healing environment. The device is suitable for use under compression bandaging.

Clinical Evidence

Bench testing only. In-vitro antibacterial activity demonstrated for up to 7 days against various strains including Pseudomonas aeruginosa, Staphylococcus aureus, MRSA, and VRE.

Technological Characteristics

Polyurethane (PU) foam dressing with incorporated silver. Features a waterproof, semi-permeable film backing. Adhesive version includes a hydrocolloid border. Antimicrobial barrier function via silver. Non-sterile/sterile status not explicitly detailed, but standard wound dressing form factor.

Indications for Use

Indicated for patients with moderately to highly exuding wounds, including leg ulcers, pressure sores, 2nd degree burns, donor sites, postoperative wounds, and skin abrasions. Contreet Foam Non-adhesive is also indicated for diabetic foot ulcers.

Predicate Devices

• Biatain Foam Adhesive Dressing (K983173)
• Biatain Foam Non-adhesive Dressing (K983163)
• Acticoat Moisture Control Dressing (K010447)

Submission Summary (Full Text)

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Contreet Foam Dressing K022416 January 21, 2003

# 510(k) Summary

# Contreet Foam Dressing

FEB 0 3 2003

Submitters name, address, phone and fax numbers

Coloplast Corporation 1955 West Oak Circle Marietta, GA 30062-2249 USA Phone: [phone] Fax: [phone]

Contact person at Coloplast Corp

Elizabeth Boots Vice President Quality Assurance 1940 Commerce Drive PO Box 8300 North Mankato, MN 56002-8300 USA Phone: [phone] Fax: [phone]

Date 510(k) prepared

June 14, 2002

Name of the medical device

Trade name Contreet Foam Dressing, Adhesive and non-adhesive Common name Topical wound dressing Classification name Dressing, wound and burn, occlusive (21CFR878.4020)

Legally marketed device to which substantial equivalence is claimed

Biatain Foam Adhesive Dressing (K983173) Biatain Foam Non-adhesive Dressing (K983163) Acticoat Moisture Control Dressing (K010447)

### Description of the device

Contreet Foam Dressing is a wound dressing with silver as the active component. The dressing provides an optimal moist wound healing environment, combining an effective antibacterial barrier activity with exudates management.

Contreet Foam Non-adhesive is suitable for use on fragile skin due to the absence of adhesive. The film backing is waterproof and semi permeable.

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Contreet Foam Dressing K022416 January 21, 2003

Contreet Foam Adhesive has a hydrocolloid adhesive border and a central absorbent foam pad containing silver. The film backing is waterproof and semi permeable.

The dressing demonstrates in-vitro antibacterial activity for up to 7 days in certain strains known to be detrimental to wound healing such as Pseudomonas aeruginosa, Staphylococcus aureus, B-haemolytic Streptococcus, MRSA and VRE.*

*The list of bacteria that Contreet Foam has demonstrated in-vitro antibacterial activity towards is as follows: Acinetobacter, C. albicans, C. perfringens, E. cloacae, E. faecalis, E. faecium, E. coli, hemolytic Streptococcus Gr.A, MRSA (Methicillin resistant S. aureus), anaerobic Peptostreptococcus , P. mirabilis, P. vulgaris, P. aeruginosa, S. aureus. Coaqulase negative Staphylococcus, S. epidermidis. VREF (Vancomvcin resistant E. faecium).

#### Intended use of the device

Contreet Foam is an effective barrier to bacterial penetration in wounds.

Contreet Foam is indicated for exuding wounds, preferably for the management of wounds with moderately to high amounts of exudates.

Contreet Foam is indicated for partial and full thickness wounds, leg ulcers and pressure sores. The dressing can also be used for 20d degree burns, donor sites, postoperative wounds and skin abrasions.

Contreet Foam Non-Adhesive dressing is additionally indicated for diabetic foot ulcers.

Contreet Foam can also support reduction of the odor caused by microorganisms from the wound.

Contreet Foam can be used on patients with wound infection at the discretion of the physician.

Contreet Foam is suitable for use where compression bandaging is indicated.

#### Summary of technological characteristics of subject device compared to predicate

Contreet Foam compared to Biatain Foam Dressings: Biatain Foam Dressings are PUfoam dressings and are the products that Contreet Foam is based on. The only difference is that Contreet Foam has silver incorporated into it. The indications for use that apply to Biatain also apply to Contreet Foam.

Contreet Foam compared to Acticoat Moisture Control Dressing: Both dressings contain silver, which acts as an antimicrobial barrier.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 0 3 2003

Coloplast Corporation Elizabeth Boots Vice President, Ouality Assurance 1940 Commerce Drive P. O. Box 8300 North Mankato, Minnesota 56002-8300

Re: K022416

Trade/Device Name: Contreet Foam Adhesive/Non-Adhesive Regulation Number: Unclassified Regulation Name: Dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 11, 2002 Received: November 18, 2002

Dear Ms. Boots:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Ms. Elizabeth Boots

(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 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 your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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.qov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

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

Enclosure

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### Statement of indications for use

510(k) Number (if known):

K022416

Device Name:

Contreet Foam Adhesive Contreet Foam Non-Adhesive

Indications for Use:

The Contreet Foam is 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. Contreet Foam Nonadhesive is additionally indicated for diabetic foot ulcers.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

OR

Prescription Use_ (Per 21 CFR 801.109

Over-The-Counter Use

(Optional Format 1-2-96)

Muriam C. Provost

al, Restorative

K622416

Contreet Foam