AQUACEL HYDROFIBER WOUND DRESSING

K982116 · Convatec, A Bristol-Myers Squibb Co. · KMF · Sep 8, 1998 · General Hospital

Device Facts

• Record ID: K982116
• Device Name: AQUACEL HYDROFIBER WOUND DRESSING
• Applicant: Convatec, A Bristol-Myers Squibb Co.
• Product Code: KMF · General Hospital
• Decision Date: Sep 8, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

Device Story

Aquacel Hydrofiber Wound Dressing is a non-absorbable wound dressing designed to provide a moist wound healing environment. It aids in autolytic debridement and allows for non-traumatic removal without damaging newly formed tissue. The dressing is used for the local management of various wounds, including ulcers, surgical sites, and traumatic wounds, and can assist in the control of minor bleeding. It is intended for both over-the-counter use for minor injuries and professional use for more complex wounds under the supervision of a healthcare provider.

Clinical Evidence

No clinical data provided. Safety information was referenced from Premarket Notification K943258.

Technological Characteristics

Non-absorbable wound dressing. Hydrofiber technology. Provides moist wound healing environment. No specific materials or standards listed.

Indications for Use

Indicated for OTC use on abrasions, minor cuts, minor scalds/burns. Professional use indicated for leg/pressure/diabetic ulcers, surgical/traumatic wounds, donor sites, and first/second-degree burns. Contraindicated for individuals with known sensitivity to dressing or components.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Kaltostat® Wound Dressing

Submission Summary (Full Text)

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K982116

# ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant: | ConvaTec, A Division of E.R. Squibb & Sons, Inc.<br>100 Headquarters Park Drive, Skillman, NJ 08558 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------|
| Contact: | Adrienne McNally, Director, Regulatory Affairs<br>[phone] |
| Device: | AQUACEL ™ Hydrofiber™ Wound Dressing |
| Substantially<br>Equivalent Device: | Kaltostat® Wound Dressing |

Aquacel Hydrofiber Wound Dressing is a non-absorbable wound dressing. For Over The Counter use, Aquacel may be used for abrasions, lacerations, minor cuts, minor scalds and burns. Under the supervision of a healthcare professional, Aquacel may also be used for wounds such as leg ulcers, pressure ulcers (Stages I-IV), diabetic ulcers, surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree), and the management of surgical or traumatic wounds which have been left to heal by secondary intention. Aquacel may also be used for the local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds. Aquacel may be used in the control of minor bleeding.

Aquacel Hydrofiber Wound Dressing is contraindicated for use on individuals with a known sensitivity to the dressing or its components.

Aquacel Hydrofiber Wound Dressing is substantially equivalent to ConvaTec's Kaltostat® Wound Dressing. Both products are equivalent in intended use and dressing characteristics. Both products provide a moist wound healing environment that is supportive of the healing process by aiding autolytic debridement and allowing non-traumatic removal of the dressing without damaging newly formed tissue.

Data/information supporting the safety of Aquacel Hydrofiber Wound Dressing was presented in Premarket Notification K943258. All testing was performed in accordance with Good Laboratory Practice Regulations.

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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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 8 1998

Mr. Ameer Ally Director, Regulatory Affairs ConvaTec 100 Headquarters Park Drive Skillman, New Jersey 08558

Re: K982116

Trade Name: Aquacel Hydrofiber Wound Dressing Regulatory Class: Unclassified Product Code: KMF Dated: May 28, 1998 Received: June 16, 1998

Dear Mr. Ally

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 - Mr. Ameer Ally

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,

to coellatz

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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## ITEM 1J: INDICATIONS FOR USE STATEMENT:

#### 510(k) Number (if known): K982116

## Device Name: AQUACEL™ Hydrofiber™ Wound Dressing

#### Indications for Use:

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For Over The Counter use, Aquacel Hydrofiber Wound Dressing may be used for: abrasions, minor cuts and minor scalds and burns. Under the supervision of a health care professional, Aquacel may be used for wounds such as: leg ulcers, pressure ulcers (Stages I-IV), and diabetic ulcers; surgical wounds (post-operative, donor sites, dermatological), burns (first and second degree); management of surgical or traumatic wounds that have been left to heal by secondary intention; local management of wounds that are prone to bleeding such as wounds that have been mechanically or surgically debrided, donor sites, and traumatic wounds.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K982116 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-the-Counter Use X<br>(Optimal Format 1-2-96) |
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