COPA AMD ANTIMICROBIAL WOUND DRESSING

K071371 · Tyco Healthcare Group LP · FRO · Nov 19, 2007 · SU

Device Facts

• Record ID: K071371
• Device Name: COPA AMD ANTIMICROBIAL WOUND DRESSING
• Applicant: Tyco Healthcare Group LP
• Product Code: FRO · SU
• Decision Date: Nov 19, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

Device Story

Hydrophilic polyurethane foam dressing impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB); antimicrobial agent protects dressing from bacterial penetration and colonization. Used in clinical or home settings for wound management. PHMB provides broad-spectrum antimicrobial activity against gram-positive, gram-negative, and fungal organisms. Dressing acts as physical barrier and antimicrobial agent to reduce bacterial colonization within the dressing, potentially aiding wound healing and reducing infection risk.

Clinical Evidence

Bench testing only. In-vitro testing demonstrated broad-spectrum activity against 6 organisms (P. aeruginosa, E. coli, C. albicans, S. epidermidis, S. aureus, E. faecalis). Achieved total kill for 7 consecutive days with daily challenge of >6 log of each organism.

Technological Characteristics

Hydrophilic polyurethane foam impregnated with PHMB antimicrobial agent. Antimicrobial mechanism via PHMB. Form factor: foam dressing.

Indications for Use

Indicated for management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 2nd degree burns, dermatologic disorders, traumatic wounds, and as secondary/cover dressing for packed wounds.

Predicate Devices

• COPA (Curafoam) polyurethane foam wound dressings
• Kerlix AMD
• Excilon AMD

Submission Summary (Full Text)

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15 HAMPSHIRE STREET, MANSFIELD, MASSACHUSETTS 02048 ・ [phone]

510(k) Premarket Notification COPA AMD Antimicrobial Wound Dressing

K071371
page 1 of 2

# Section B - 510(K) Summary

| Date Summary<br>Was Prepared: | May 11, 2007 | |
|-------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Submitter's<br>Information: | Kendall<br>a Division of Tyco Healthcare Group LP<br>15 Hampshire Street<br>Mansfield, MA 02048<br>Phone: [phone]<br>Fax: [phone] | |
| Contact: | James Welsh<br>VP, Regulatory Affairs<br>Kendall<br>a Division of Tyco Healthcare Group LP<br>Telephone: [phone]<br>Fax: [phone] | NOV 1 9 2007 |
| Device Trade<br>Name: | COPA AMD Antimicrobial Wound Dressing | |
| Device Common<br>Name: | Wound Dressing, Antimicrobial | |

Classification Panel: General and Plastic Surgery

# Legally Marketed Devices To Which Substantial Equivalence Is Claimed:

The COPA AMD antimicrobial wound dressing is substantially equivalent to the existing COPA (Curafoam) polyurethane foam wound dressings in intended use, materials, physical characteristics, and performance characteristics. The modification attribut, the predicate device is the addition of PHMB antimicrobial agent to prevent bacterial penetration and colonization of the dressing.

Substantial equivalence is also claimed to Kerlix AMD and Excilon AMD, absorbent wound dressings which contain PHBM antimicrobial agent to prevent bacrial penetration and colonization of the dressing.

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510(k) Premarket Notification COPA AMD Antimicrobial Wound Dressing

# Section B - 510(K) Summary

## Device Description:

COPA AMD is a hydrophilic polyurethane foam that is impregnated with Polyhexamethylene Biguanide Hydrochloride (PHMB), an antimicrobial agent that protects the dressing from bacterial penetration and colonization.

## Intended Use:

COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, lacerations, 18 and 200 degree burns, dermatologic disorders, other wounds, inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

Performance Data: Performance data submitted in support of this 510k included in-vitro and animal testing.

Broad spectrum activity was demonstrated against 6 organisms including gram positive, gram negative, and fungal types. Total kill was achieved for 7 consecutive days, with a daily challenge of >6 log of each organism:

- . P. aeruginosa
- . E. coli
- C. albicans .
- � S. epidermidis
- S. aureus .
- . E. faecalis

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 9 2007

Tyco Healthcare LLP % Mr. James Welsh VP. Regulatory Affairs 15 Hampshire Street Mansfield. Massachusetts 02048

Re: K071371

Trade/Device Name: COPA AMD antimicrobial wound dressing Regulatory Class: Unclassified Product Code: FRO Dated: November 2, 2007 Received: November 7, 2007

Dear Mr. Welsh:

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 (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.

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Page 2 - Mr. James Welsh

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). 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/cdrh/industry/support/index.html.

Sincerely v

for
Mark N. Melkerson
Dep D.R
1965

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

## 510(k) number: K071371

### Device Name:

COPA AMD antimicrobial wound dressing

#### Indications for Use:

COPA AMD dressings are indicated for use in management of post-surgical incisions, pressure sores, venous stasis ulcers, diabetic ulcers, donor sites, abrasions, 1st and 200 degree burns, dermatologic disorders, other wounds inflicted by trauma and, as a secondary dressing or cover dressing for packed wounds.

Prescription Use (Part 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 If Needed

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|------------------------------------------------------------|--------|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| 510(k) Number | 407137 |
| Page | |

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