NON-WOVEN COMPRESS

K980382 · Convatec, A Division of E.R. Squibb & Sons · KMF · Mar 9, 1998 · General Hospital

Device Facts

• Record ID: K980382
• Device Name: NON-WOVEN COMPRESS
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: KMF · General Hospital
• Decision Date: Mar 9, 1998
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1

Intended Use

Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.

Device Story

Non-woven Compress is a sterile, absorbent wound dressing for acute and chronic wound management. Upon contact with wound exudate, the material hydrates to form a gel, immobilizing fluid and preventing migration. The contact layer is designed for easy removal from both wet and dry wounds. Used in clinical or home settings for wound care. The device functions as a passive dressing to manage exudate levels. It does not treat or cure wounds, nor is it indicated for third-degree burns or as a permanent skin substitute.

Clinical Evidence

No clinical data. Evidence consists of comparative bench testing against the predicate device and biocompatibility testing conducted per ISO 10993 Part I (FDA modified matrix). Biocompatibility results indicate the device is non-sensitizing, non-cytotoxic, non-hemolytic, and a negligible irritant.

Technological Characteristics

Sterile, non-woven absorbent wound dressing. Material hydrates to form a gel for exudate immobilization. Biocompatibility verified per ISO 10993. No electronic components or software.

Indications for Use

Indicated for management of light to moderately exuding acute wounds (minor burns, superficial cuts, skin tears, lacerations, abrasions, minor skin irritations) and chronic wounds (diabetic, leg, and pressure ulcers). Contraindicated for individuals with sensitivity or allergic reaction to the dressing or its 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

• Mirasorb Sponges

Submission Summary (Full Text)

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K980382

510(k) Premarket Notification Non-woven Compress

MAR 97
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## ITEM 10: SUMMARY OF SAFETY AND EFFECTIVENESS

ConvaTec, A Division of E.R. Squibb and Sons, Inc Applicant: 100 Headquarters Park Drive, Skillman, NJ 08558 Adrienne McNally, Senior Manager, Regulatory Affairs Contact: [phone]

Device:

Nonwoven Compress

Substantially Mirasorb Sponges Equivalent Device:

Non-woven Compress is a sterile wound dressing indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and abrasions and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers. Non-woven Compress absorbs wound exudate. The absorbent material, on hydration, forms a gel which immobilizes absorbed fluid exudate and helps prevent migration. The wound contact layer is designed to facilitate easy removal from both wet and dry wounds.

Non-woven Compress is contraindicated for use on individuals who are sensitive to or who have had an allergic reaction to the dressing or its components.

Non-woven Compress is substantially equivalent to Johnson and Johnson's Mirasorb Sponges. 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. The absorbent material in the Non-woven Compress forms a gel which helps retain fluid and exudate.

Comparative bench testing was conducted on Non-woven Compress and Mirasorb Sponges. Test results show the two products to be equivalent.

Non-woven Compress 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 Non-woven Compress is considered to be nonsensitizing, non-cytotoxic, non-hemolytic and a negligible irritant. 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 stylized eagle with three heads, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 1998

Ms. Adrienne McNally Senior Manager, Regulatory Affairs Convatec Division of E. R. Squibb & Son 100 Headquarters Park Drive Skillman, New Jersey 08558

Re: K980382 Trade Name: Non Woven Compress Regulatory Class: Unclassified Product Code: KMF Dated: January 28,1998 Received: February 2, 1998

Dear Ms. McNally:

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.
- This device may not be labeled as a long-term, permanent, or no-change dressing, or 3. as an artificial (synthetic)-sking-anders ....................................................................................................................................
- 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 - Ms. McNally

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,

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 3.10: INDICATIONS FOR USE STATEMENT

k980382 510(k) Number (if known): Not Known

Device Name: Non-woven Compress

Indications for Use:

Non-woven Compress is indicated for use in the management of light to moderately exuding acute wounds such as minor burns, superficial cuts, skin tears, lacerations and minor irritations of the skin; and light to moderately exuding chronic wounds such as diabetic ulcers, leg ulcers and pressure ulcers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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| Division of General Restorative Devices |
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| 510(k) Number | K980382 |
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Prescription Use (Per 21 CFR 801.109) OR

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

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