KERLIX MD ANTIMICROBIAL GAUZE DRESSING

K990530 · The Kendall Company, L.P. · NAD · Jan 31, 2000 · General, Plastic Surgery

Device Facts

• Record ID: K990530
• Device Name: KERLIX MD ANTIMICROBIAL GAUZE DRESSING
• Applicant: The Kendall Company, L.P.
• Product Code: NAD · General, Plastic Surgery
• Decision Date: Jan 31, 2000
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4020
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing

Device Story

Kendall Kerlix MD Antimicrobial Gauze Dressing is a sterile, single-use wound dressing composed of gauze treated with Polyhexamethylene Biguanide Hydrochloride (PHMB). The dressing functions as a primary wound covering to manage exuding wounds, first and second degree burns, and surgical wounds; it also serves to secure primary dressings or act as wound packing. The antimicrobial agent provides a bacterial barrier. The device is intended for clinical or home use as a wound management tool. It does not accelerate healing, nor is it a permanent dressing or synthetic skin. Healthcare providers apply the dressing directly to the wound site to provide a barrier against bacterial contamination, aiding in the management of the wound environment.

Clinical Evidence

No clinical data. Biocompatibility testing was performed in accordance with ISO 10993, Part 1, and FDA memorandum G95-1.

Technological Characteristics

Sterile, single-use gauze dressing treated with Polyhexamethylene Biguanide Hydrochloride (PHMB). Available in sponge and roll forms. Packaged in Tyvek/Poly pouches or Tyvek/Styrene trays. Biocompatibility meets ISO 10993 standards.

Indications for Use

Indicated for patients with exuding wounds, first and second degree burns, and surgical wounds requiring a primary dressing, securement of primary dressings, or wound packing. Not indicated for third degree burns.

Regulatory Classification

Identification

An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.

Predicate Devices

• Vitapatch (K895993)
• Arglaes Antimicrobial Barrier Film Dressing (K973657)

Submission Summary (Full Text)

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JAN 3 1 2000

EXHIBIT #12

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## 510(k) Summary

Kendall Kerlix MD Antimicrobial Gauze 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:

The Kendall Company LP 15 Hampshire Street Mansfield, MA 02048 Date Prepared: February 12, 1999

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

- 2. Name of Medical Device
Classification Name; Common or Usual Name: Unclassified Kerlix MD Antimicrobial Gauze Dressing

#### 3. Identification of Legally Marketed Device

The proposed Kendall Kerlix MD Antimicrobial Gauze Dressing is substantially equivalent in intended use, function and composition to Vitaphore Corporations Vitapatch, 510(k) No. K895993 and Maersk Medical Ltd. Arglaes Antimicrobial Barrier Film Dressing, 510(k) No. K973657.

#### 4. Device Description

The proposed Kerlix MD Antimicrobial Gauze Dressing is a sterile, single use, wound dressing consisting of gauze treated with Polyhexamethylene Biguanide Hydrochloride. The dressing is packaged in Tyvek/Poly pouches as well as Tyvek/Styrene trays and is available in both sponge and roll form.

- นว่ Device Intended Use
The Kendall Kerlix MD Antimicrobial Gauze Dressing is intended for use as a primary dressing for exuding wounds, first and second degree burns, as a cover for surgical wounds, to secure and prevent movement of primary dressings and as a wound packing.

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### Product Comparison 6.

The Kendall Kerlix MD Antimicrobial Gauze Dressing is equivalent to the referenced predicate devices in that they are intended to be used as wound coverings, they each contain an ingredient that enhances the bacterial barrier function of the dressing and each has a broad spectrum of antimicrobial activity.

### 7. Nonclinical Testing

Biocompatibility testing of the Kendall Kerlix MD Antimicrobial Gauze Dressing has demonstrated that it meets the requirements of quidelines 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

JAN 31 2000

Mr. Frank J. Fucile, Esq. Vice President, Regulatory Affairs The Kendall Company, L.P. 15 Hampshire Street Mansfield. Massachusetts 02048

> K990530 Trade Name: Kendall Kerlix™ Antimicrobial Gauze Regulatory Class: I Product Code: NAD Dated: October 11, 1999 Received: November 3, 1999

Dear Mr. Fucile:

Re:

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.
- 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. Frank J. Fucile, Esq.

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,

sincerely yours,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

510K Number: K990530

Kendall KERLIX™ Antimicrobial Gauze Device Name:

Indications for Use:

KERUX Antimicrobial Gauze is intended for use as a primary dressing for exuding wounds, first and second degree burns, and surgical wounds, to secure and prevent movement of a primary dressing, and as a wound packing

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(per 21 CFR 801.109) OR Over-the-Counter Use

(Division Sign-Off)
Division of General Restorative Devices K990530

510(k) Number