KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON

K974205 · Convatec, A Division of E.R. Squibb & Sons · KMF · Feb 6, 1998 · General Hospital

Device Facts

• Record ID: K974205
• Device Name: KNITTED WOUND DRESSING-STANDARD, WCL AND RIBBON
• Applicant: Convatec, A Division of E.R. Squibb & Sons
• Product Code: KMF · General Hospital
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

Knitted Wound Dressing Standard, WCL and Ribbon can be used in the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon as a packing strip for cavity wounds, fistulae and sinuses.

Device Story

Knitted Wound Dressing is a sterile gelling gauze for wound management. Warp fibers consist of viscose yarn; wefts consist of co-spun alginate and viscose. Available in Standard, WCL, and Ribbon presentations. Used in clinical or home settings for acute and chronic wounds; applied by clinicians or patients. Gelling fibers absorb exudate to manage wound environment. Output is physical dressing application; aids in wound protection and exudate management. Does not accelerate healing or act as artificial skin.

Clinical Evidence

Bench testing only. Comparative bench testing performed against predicate devices demonstrated equivalence. Biocompatibility testing conducted per ISO 10993 Part I (FDA modified matrix) confirmed device is non-sensitizing, non-toxic, non-hemolytic, and a negligible irritant.

Technological Characteristics

Sterile gelling gauze; warp: viscose yarn; weft: co-spun alginate and viscose. Biocompatibility per ISO 10993. No electronic components or software.

Indications for Use

Indicated for management of acute and chronic wounds, including diabetic ulcers, in patients requiring wound dressings. Standard version for shallow or cavity wounds; Ribbon version for packing cavity wounds, fistulae, and sinuses. Not for third-degree burns.

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

• KERLIX Super Sponges (The Kendall Company)
• Profore Wound Contact Layer (Smith & Nephew Medical Limited)
• NU GAUZE (Johnson & Johnson Medical Inc.)

Submission Summary (Full Text)

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K974205

FEB 6 1000

510(k) Premarket Notification Knitted Wound Dressing

# ITEM 8: SUMMARY OF SAFETY AND EFFECTIVENESS

The purpose of this 510(k) Premarket Notification is to request clearance to market Knitted Wound Dressing, which be available in three presentations -Standard, WCL and Ribbon and will be labeled as an OTC product.

Knitted Wound Dressing is a sterile gelling gauze. The warp (fibers running top to bottom) consist of viscose yarn, while the wefts (fibers running left right) are a co-spun alginate and viscose.

Knitted Wound Dressing Standard, WCL and Ribbon are comprised of absorbent gelling yarns for the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon, as a packing strip for cavity wounds, fistulae and sinuses.

Knitted Wound Dressing Standard, WCL and Ribbon are substantially equivalent to KERLIX* Super Sponges manufactured by The Kendall Company. Profore*Wound Contact Laver manufactured by Smith & Nephew Medical Limited and NU GAUZE* manufactured by Johnson & Johnson Medical Inc., respectively.

The products are equivalent in intended use and design. They all are considered general use wound care dressings which can be used in the management of acute and chronic wounds. Knitted Wound Dressing has the added feature of gelling fibers.

Comparative bench testing was conducted on the Knitted Wound Dressing versus its substantially equivalent products. Test results show the products to be equivalent.

Knitted Wound Dressing 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 Knitted Wound Dressing is considered to be non-sensitizing, non-toxic, non-hemolytic and a negligible irritant.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 6 1998

Ms. Adrienne McNally Senior Manager. Regulatory Affairs ConvaTec PO Box 5254 Princeton, New Jersey 08543-5254

Re: K974205

> Knitted Wound Dressing (Standard, WCL, and Ribbon) Regulatory Class: Unclassified Product Code: KMF Dated: November 3, 1997 ...... Received: November 10, 1997

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:

- l. This device may not be labeled for use on third degree burns.
- 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 - Ms. Adrienne 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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K974205

510(k) Premarket Notification Knitted Wound Dressing

## ITEM 1J: INDICATIONS FOR USE STATEMENT

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

### Device Name: Knitted Wound Dressing

Indications for Use:

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Knitted Wound Dressing Standard, WCL and Ribbon can be used in the management of acute and chronic wounds, including diabetic ulcers. The design of Standard makes it suitable for shallow or cavity wounds and Ribbon as a packing strip for cavity wounds, fistulae and sinuses. . .........................................................................................................

(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 Devices | |
| 510(k) Number | K974205 |

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

11 ConvaTec, A Division of E.R.Squibb and Sons, Inc.