MODIFICATION TO WOUN'DRES

K991202 · Coloplast Corp. · MGQ · Jun 4, 1999 · SU

Device Facts

• Record ID: K991202
• Device Name: MODIFICATION TO WOUN'DRES
• Applicant: Coloplast Corp.
• Product Code: MGQ · SU
• Decision Date: Jun 4, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U

Intended Use

May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.

Device Story

Woun'Dres® is a collagen hydrogel wound dressing used for local management of various wound types. Applied topically by healthcare professionals or patients (for minor wounds), the hydrogel provides a moist wound environment. It is a non-sterile or sterile (implied by bioburden testing) topical application. It does not accelerate healing, treat/cure wounds, or serve as artificial skin. Benefits include moisture maintenance for wound management. No complex electronics or software involved.

Clinical Evidence

Bench testing only. Evidence includes acute dermal toxicity, primary skin irritation, delayed contact sensitization, cytotoxicity (agarose overlay), hemolysis, and USP 23 <51> antimicrobial preservative effectiveness testing. All tests passed, indicating the device is non-toxic, non-irritating, non-sensitizing, and non-hemolytic.

Technological Characteristics

Collagen-based hydrogel wound dressing. Formulated with antimicrobial preservatives meeting USP 23 <51> standards. Biocompatibility verified via ISO/USP-related testing protocols (sensitization, toxicity, irritation, hemolysis). No electronic components, software, or energy sources.

Indications for Use

Indicated for superficial wounds, abrasions, minor burns, partial- and full-thickness wounds (pressure, diabetic, venous, arterial, mixed etiology ulcers), surgical wounds, and first- and second-degree burns (including dermabrasion/laser resurfacing).

Predicate Devices

• Carrasyn Hydrogel Wound Dressing (K894541)
• DuoDerm Hydroactive Gel (K925993)

Submission Summary (Full Text)

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4 1999

2.

3.

JUN

Coloplast 510(k) -Woun'Dres® Collagen Hydrogel Wound Dressing

510(k) SUMMARY

- 1. DATE PREPARED June 4, 1999
- SUBMITTER Coloplast Corporation Skin Care Division 1940 Commerce Drive North Mankato, MN 56003
- CONTACT PERSON Harvey M. Arbit, Pharm.D., M.B.A. Vice President Research and Development
- 4. NAME OF THE MEDICAL DEVICE Classification Name: Dressing, Wound and Burn, Hydrogel Common/Usual Name: Collagen Hydrogel Wound Dressing

Proprietary Name: Woun'Dres®

- 5. DEVICE CLASSIFICATION Regulatory Class: Not Classified Product Code: MGQ SU (80)
#### STATEMENT OF SUBSTANTIAL EQUIVALENCE દ.

Woun'Dres® is substantially equivalent to Carrasyn Hydrogel Wound Dressing which obtained marketing approval under 510(k) K894541 and DuoDerm Hydroactive Gel which obtained marketing approval under 510(k) K925993. Carrasyn Hydrogel Wound Dressing was found to be substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976.

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## Coloplast 510(k) —Woun'Dres® Collagen Hydrogel Wound Dressing

#### INDICATIONS FOR USE 7.

May be used for superficial wounds and abrasions and minor burns. Use under the supervision of health care professionals for the local management of partial- and full-thickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.

### PHYSICAL DESCRIPTION 8. Hydrogel

#### BIOCOMPATIBILITY 9.

The safety and preservative effectiveness of Woun'Dres® are substantiated by the sensitization, biotoxicological and challenge tests conducted on this device as listed below:

| Test | Results |
|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Acute Dermal Toxicity Study | Not Considered Toxic |
| Primary Skin Irritation Test | Is not considered a primary Irritant |
| Delayed Contact Sensitization Study | No evidence of causing delayed<br>contact sensitization. |
| Cytotoxicity Agarose overlay | Nontoxic |
| Hemolysis Test (In Vitro) | Nonhemolytic |
| USP 23 <51> Anti-microbial<br>Preservatives-Effectiveness | Meets USP 23 <51> Requirements |
| Bioburden | Pass |
| Drop Ship Test | No leakage or damage to tubes<br>occurred. |
| Latex Gloves Product Compatibility | No changes imparted to Woun'Dres<br>from the gloves and no change in<br>strength of the gloves was observed. |

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Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three wavy lines, resembling a caduceus or a symbol of health and medicine.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1999

Harvey M. Arbit, PharmD, MBA Vice President, Research and Development Coloplast Corporation 1940 Commerce Drive P.O. Box 8300 North Mankato, Minnesota 56003

Re: K991202 Trade Name: Woun'Dres Regulatory Class: Unclassifed Product Code: MGQ Dated: March 19, 1999 Received: March 22, 1999

Dear Dr. Arbit:

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:

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

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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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 your 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.

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 991202

## Device Name: Woun'Dres® Collagen Hydrogel Wound Dressing

## Indications for Use:

May be used for superficial wounds and abrasions and ● minor burns. Use under the supervision of health care professionals for the local management of partial- and fullthickness wounds including pressure, and diabetic ulcers; lower extremity ulcers including those of venous, arterial and mixed etiology; surgical wounds; first- and second-degree burns including management of abrasions and burns associated with dermabrasion and laser resurfacing.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X (Per 21 CFR 801.109) Or Over-The-Counter Use

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K991202