KENDALL CURITY NON-ADHERING DRESSING

K973619 · Kendall Healthcare Products Co. Div.Of Tyco Health · KMF · Dec 10, 1997 · General Hospital

Device Facts

• Record ID: K973619
• Device Name: KENDALL CURITY NON-ADHERING DRESSING
• Applicant: Kendall Healthcare Products Co. Div.Of Tyco Health
• Product Code: KMF · General Hospital
• Decision Date: Dec 10, 1997
• Decision: SN
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Kendall Curity Non-Adhering Dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the supervision of a health care professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

Device Story

Kendall Curity Non-Adhering Dressing is a sterile, single-use primary wound dressing; composed of cellulose acetate fabric impregnated with petrolatum emulsion. Used in clinical settings or home care for management of medium to heavy draining wounds; applied by healthcare professionals or patients. Dressing provides non-adherent interface to protect wound bed; facilitates exudate management. Does not accelerate healing; not for use on third-degree burns or as permanent skin substitute.

Clinical Evidence

No clinical data. Biocompatibility testing performed per ISO 10993 Part 1 and FDA memorandum G95-1 demonstrated no bioactive components.

Technological Characteristics

Cellulose acetate fabric impregnated with petrolatum emulsion. Sterile, single-use. Available in various dimensions (3"x3" to 14"x4 yds). Non-bioactive. Complies with ISO 10993 biocompatibility standards.

Indications for Use

Indicated for management of medium to heavy draining wounds including minor burns, abrasions, lacerations, surgical incisions, skin grafts, and dermal ulcers. Contraindicated 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

• Adaptic Non-Adhering Dressing

Submission Summary (Full Text)

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K973619

DEC I O 1997

### EXHIBIT #6

### 510(k) Summary

# Kendall Curity Non-Adhering Dressing

In accordance with section 513(I) of the SMDA and as defined in 21 CFR Part 807.3 final rule dated December 14, 1994, this summary is submitted by

Kendall Healthcare Products Company 15 Hampshire Street Mansfield, MA 02048 September 17, 1997 Date Prepared:

- Contact Person 1.
David A. Olson Manager Regulatory Affairs [phone]

- Name of Medical Device 2.
Classification Name: Unclassified Common or Usual Name: Non-Adhering Dressing

- Identification of Legally Marketed Device ਤੇ.
The proposed Kendall Curity Non-Adhering Dressing is substantially equivalent in intended use and composition to the Johnson & Johnson Medical, Inc., Adaptic® Non-Adhering Dressing which was in commercial distribution before May 28, 1976.

#### Device Description 4.

The proposed Kendall Curity Non-Adhering Dressing is a sterile, single-use, dressing consisting of cellulose acetate fabric impregnated with a specially formulated petrolatum emulsion. It is packaged in clear polyester pouches and is available in 3" x 3", 3" x 8", 3" x 16" and 14" x 4 yds sizes.

- Device Intended Use 5.
The Kendall Curity Non-Adhering Dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burns, abrasions and lacerations. These dressings may also be used under the supervision of a health care professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

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#### 6. Product Comparison

The Kendall Curity Non-Adhering Dressing is equivalent to the referenced predicate device in that they are fabricated from similar materials, have a similar function and equivalent indications for use.

#### 7. Nonclinical Testing

Biocompatibility testing of the Kendall Curity Non-Adhering Dressing has demonstrated that it contains no bioactive components. Testing performed on the product was based upon guidelines presented in the 10993 ISO Standard, Part 1. with the FDA modified matrix presented in memorandum G95-1.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 0 1997

Mr. David A. Olson "Manger, Regulatory Affairs The Kendall Healthcare Products Company 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K973619 Kendall Curity Non-Adhering Dressing Regulatory Class: Unclassified Product Code: KMF Dated: September 18, 1997 Received: September 23, 1997

Dear Mr. Olson:

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.
- 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

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Page 2 - Mr. David A. Olson

registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

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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## 510(k) Number (if known): K973619

Device Name: Kendall Curity Non-Adhering Dressing

Indications For Use:

Theae dressings are intended for use as a primary dressing in the management of medium to heavy draining wounds such as minor burne, abrasions and lacerations. These dressings may also be used under the care of a health tare professional for wounds such as surgical incisions, skin grafts, and dermal ulcers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973619 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use <span></span> |
|------------------------------------------|----|------------------------------------|
| | | (Optional Format 1-2-96) |