NONWOVEN PAD

K980720 · Convatec, A Division of E.R. Squibb & Sons · KMF · Apr 15, 1998 · General Hospital

Device Facts

• Record ID: K980720
• Device Name: NONWOVEN PAD
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: KMF · General Hospital
• Decision Date: Apr 15, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.

Device Story

Nonwoven Pad is a sterile, absorbent wound dressing; manages moderately to heavily exudating acute and chronic wounds. Features hydrophobic layer to minimize strike-through and distribute fluid. Used in clinical settings under healthcare professional guidance for various ulcer types and surgical wounds. Absorbs exudate to facilitate wound management. Benefits patient by providing protective, absorbent barrier for wound healing.

Clinical Evidence

Bench testing only. Comparative bench testing performed against predicate device showed equivalent performance. Biocompatibility testing conducted per ISO 10993 Part I with FDA modified matrix confirmed non-toxic status.

Technological Characteristics

Sterile, absorbent nonwoven pad dressing. Features hydrophobic layer for exudate management. Biocompatible per ISO 10993.

Indications for Use

Indicated for management of moderately to heavily exudating acute and chronic wounds, including minor lacerations, minor burns, biopsies, surgical incisions/excisions, pressure ulcers, diabetic ulcers, and leg ulcers (venous, arterial, mixed). Contraindicated for individuals with sensitivity or allergic reaction to dressing 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

• TENDERSORB® WET PRUF® Abd Pad (Kendall Healthcare Products Company)

Submission Summary (Full Text)

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APR 1 5 1998

## ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS

| Applicant: | ConvaTec, A Division of E.R. Squibb and Sons, Inc<br>100 Headquarters Park Drive, Skillman, NJ 08558 |
|-------------------------------------|------------------------------------------------------------------------------------------------------|
| Contact: | Ameer Ally, Director,Regulatory Affairs<br>[phone] |
| Device: | Nonwoven Pad |
| Substantially<br>Equivalent Device: | TENDERSORB® WET PRUF® Abd Pad<br>(Kendall Healthcare Products Company) |

Nonwoven Pad is a sterile, absorbent pad dressing intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor abrasions, minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers of mixed aetiology. Nonwoven Pad absorbs wound exudate. The hydrophobic layer minimizes strike through of exudate and ensures distribution of the fluid throughout the dressing.

Nonwoven Pad is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.

Nonwoven Pad is substantially equivalent to Kendall's TENDERSORB® WET PRUF® Abd Pad . Both products are equivalent in intended use, design and function. They are considered general use wound care dressings which can be used in the management of acute and chronic wounds.

Comparative bench testing was conducted on Nonwoven Pad versus TENDERSORB® WET PRUF® Abd Pad. Test results show the two products to be equivalent.

Nonwoven Pad has been subjected to biocompatibility testing utilizing the ISO 10993 Part I "Biological Evaluation of Medical Devices" with FDA modified matrix (Guidance effective July 1, 1995). The results of this testing demonstrate that Nonwoven Pad is considered to be non-toxic. All tests were conducted in accordance with Good Laboratory Practices.

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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 an abstract symbol that resembles a stylized human figure or a bird in flight, composed of several curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 5 1998

Mr. Ameer Ally Director, Regulatory Affairs ConvaTec P.O. Box 5254 Princeton, New Jersey 08558

K980720 Re: Trade Name: ConvaTec Nonwoven Pad Regulatory Class: Unclassified Product Code: KMF Dated: February 23, 1998 Received: February 24, 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.
- 2. This device may not be labeled as having any accelerating effect on the rate of 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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## Page 2 - Mr. 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,

Mark n Mullein

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): Not Known

Device Name: Nonwoven Pad

Indications for Use:

The ConvaTec Nonwoven Pad is intended for use in the management of moderately to heavily exudating acute and chronic wounds. The dressing is indicated for minor lacerations and minor burns. Under the guidance of a healthcare professional, the dressing is also indicated for biopsies, open and closed surgical incisions and excisions, pressure ulcers, diabetic ulcers and leg ulcers such as venous stasis ulcers, arterial ulcers and leg ulcers of mixed aetiology.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use _ (Per 21 CFR 801.109) OR

Over-the-Counter Use
(Optimal Format 1-2-96)

Mark N-Milke

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(Division Sign-Off)
- Division of General Restorative Devices
510(k) Number. K980720