CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING

K022584 · Cardiotech Intl. · MGQ · Dec 30, 2002 · SU

Device Facts

• Record ID: K022584
• Device Name: CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING
• Applicant: Cardiotech Intl.
• Product Code: MGQ · SU
• Decision Date: Dec 30, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and full-thickness wounds. They may be used on the following wounds: Venous stasis ulcers Diabetic ulcers Pressure sores Blisters Superficial burns Abrasions and lacerations Donor sites

Device Story

CardioTech Antibiotic Hydrogel Wound Dressing is a semi-occlusive, absorptive wound dressing. It features a wound-contact hydrogel layer containing an antibiotic mixture (Neomycin Sulfate, Bacitracin Zinc, Polymyxin B Sulfate) to prevent bacterial contamination, and an outer polymeric film layer. The dressing is applied topically to wounds to manage exudate and protect the wound site. It is intended for use by clinicians or patients in the management of various wound types.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Semi-occlusive, absorptive hydrogel dressing. Components: Neomycin Sulfate (3.5mg), Bacitracin Zinc (500 Units), Polymyxin B Sulfate (10,000 Units) in hydrogel; outer polymeric film layer.

Indications for Use

Indicated for management of partial and full-thickness wounds, including venous stasis ulcers, diabetic ulcers, pressure sores, blisters, superficial burns, abrasions, lacerations, and donor sites.

Predicate Devices

• MEDIMAC Bandages (K930457)
• Adhesive Bandage with Antibiotic (K943314)

Submission Summary (Full Text)

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K022584

510(k) CardioTech Antibiotic Hydrogel Wound Dressing CardioTech International, Inc.

DEC 3 0 2002

### 510(k) Summary

# CardioTech Antibiotic Hydrogel Wound Dressing

| Submitters Details: | CardioTech International, Inc.<br>78-E, Olympia Avenue,<br>Woburn, MA 01801-2057<br>Tel: [phone]<br>Fax: [phone] | |
|--------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|
| Contact Person: | Michael Szycher, Ph.D.<br>Chairman and CEO<br>CardioTech International, Inc.<br>Tel: [phone]<br>Fax: [phone] | |
| Name of Device: | Classification Name: Dressing, Wound<br>Common Name: Dressing<br>Proprietary Name: CardioTech Antibiotic Hydrogel Wound Dressing<br>Device Classification: Unclassified. | |
| Substantial Equivalence: | CardioTech Antibiotic Hydrogel Wound Dressings are substantially equivalent<br>to MEDIMAC Bandages (Enquay Pharmaceutical Associates, K930457) and<br>Adhesive Bandage with Antibiotic (Johnson & Johnson, K943314). | |
| Description: | CardioTech Antibiotic Hydrogel Wound Dressings are semi-occlusive,<br>and absorptive. The wound contact surface is composed of an antibiotic<br>containing hydrogel. The OTC antibiotic mixture used consists of the<br>following components: Neomycin Sulfate, 3.5mg, Bacitracin Zinc 500 Units<br>and Polymyxin B Sulfate, 10,000 Units. The antibiotic mixture is present to<br>help prevent bacterial contamination of the dressing. A second outer layer<br>consists of a polymeric film. | |
| Indications for Use: | CardioTech Antibiotic Hydrogel Wound Dressings are intended for use in the<br>management of partial and full- thickness wounds. They may be used on the<br>following wounds: | |
| | Venous stasis ulcers<br>Diabetic ulcers<br>Pressure sores<br>Blisters | Superficial burns<br>Abrasions and lacerations<br>Donor sites |

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight.

Public Health Service .

DEC 30 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CardioTech International, Inc Andrew M. Reed. Ph.D. 12106 West 75" Lane Arvada, Colorado 80005-5306

Re: K022584

Trade/Device Name: CardioTech Antibiotic Hydrogel Wound Dressing Regulatory Class: Unclassified Product Code: MGQ Dated: October 31. 2002 Received: November. 7, 2002

Dear Dr. Reed:

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 mav 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); good manufacturing practice requirements as set forth in the

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Dr. Andrew M. Reed

quality systems (OS) 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]. 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" (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 vours.

Miriam C. Provost

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

Enclosure

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#### 510(k) CardioTech Antibiotic Hydrogel Wound Dressing CardioTech International, Inc.

Page 1 of 1

#### PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

510(k) Number:

K022584 CardioTech International, Inc.

Device Name:

CardioTech Antibiotic Hydrogel Wound Dressing

Indications for Use:

Cardio Tech Antibiotic Hydrogel Wound Dressings are intended for use in the management of partial and fullthickness wounds. They may be used on the following wounds:

> Venous stasis ulcers Diabetic ulcers Pressure sores Blisters

Superficial burns Abrasions and lacerations Donor sites

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109)

OR
Miriam C. Provost

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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