KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662

K070685 · Tyco Healthcare · FRO · Sep 14, 2007 · SU

Device Facts

• Record ID: K070685
• Device Name: KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
• Applicant: Tyco Healthcare
• Product Code: FRO · SU
• Decision Date: Sep 14, 2007
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Kendall Antimicrobial Drain Dressing is intended for OTC use. It is used as a primary dressing around drains, IV sites, and tracheotomies.

Device Story

Kendall Antimicrobial Drain Dressing is a sterile, single-use wound dressing; composed of rayon/polyester nonwoven material treated with 0.2% polyhexamethylene biguanide hydrochloride (PHMB). Device functions as a primary dressing to provide a bacterial barrier around drains, IV sites, and tracheotomies. Intended for over-the-counter (OTC) retail use by patients or caregivers. PHMB treatment provides broad-spectrum antimicrobial activity. Dressing is applied topically to the wound site; acts as a physical and antimicrobial barrier to protect the site from contamination.

Clinical Evidence

No clinical data. Substantial equivalence is based on identical composition and material characteristics to the predicate device, supported by existing biocompatibility testing.

Technological Characteristics

Rayon/polyester nonwoven material; treated with 0.2% polyhexamethylene biguanide hydrochloride (PHMB). Sterile, single-use sponge form factor. Antimicrobial barrier function. Biocompatibility meets ISO 10993 standards.

Indications for Use

Indicated for over-the-counter use as a primary dressing around drains, IV sites, and tracheotomies.

Predicate Devices

• Kendall Excilon AMD Antimicrobial Sponge (K011941)

Submission Summary (Full Text)

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**SEP 14 2007**

K070685

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510(k) Summary

In accordance with section 513(1) of the SMDA and as defined in 21 CFR Part 807,3 final rule dated December 14, 1994, this summary is submitted by:

Tyco Healthcare 15 Hampshire St. Mansfield, MA 02048 Date Prepared:

- l. Contact Person:
Paul W. Evans Director, Regulatory Affairs [phone]

- 2. Name of Medical Device:

| Classification Name: | Dressing |
|-----------------------|--------------------------------------------|
| Common or Usual Name: | Kendall Antimicrobial Drain Dressing (OTC) |

- 3. Identification of Legally Marketed Device:
The Kendall Antimicrobial Drain Dressing for OTC use is substantially equivalent in intended use, function, and composition to Kendall's Excilon AMD Antimicrobial Sponge (Rx) cleared by FDA under 510(k) No. K011941. The primary purpose of this 510(k) is to allow OTC retail marketing of this dressing. Labeling of the OTC product has been augmented to include added directions for use and other information for a non-professional retail population.

- 4. Device Description:
The Kendall Antimicrobial Drain Dressing for OTC use is a sterile, single use wound dressing consisting of a rayon/polyester nonwoven material treated with polyhexamethylene biguanide hydrochloride (0.2%), and is available in sponge form.

- న. Device Intended Use:
The Kendall Antimicrobial Drain Dressing is intended for OTC use. It is used as a primary dressing around drains, IV sites, and tracheotomies.

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КО706ГГ
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## 6. Product Comparison

The Kendall Antimicrobial Drain Dressing is equivalent to the referenced predicate device in that it is composed of similar materials and concentration of PHMB (0.2%) that enhances the bacterial barrier function of the dressing, and it has a broad spectrum of antimicrobial activity.

## 7. Nonclinical Testing

Biocompatibility testing of the predicate Kendall Excilon AMD Antimicrobial Drain Sponge, (predicate device), has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1. The dressing subject to this submission is identical to the predicate device with the exception of OTC labeling.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of a human figure with three lines representing the body, head, and arms.

Public Health Service

SEP 1 4 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tyco Healthcarc % The Kendall Company Mr. Paul W. Evans Director, Regulatory Affairs 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K070685

Trade/Device Name: Kendall Antimicrobial Drain Dressing Regulatory Class: Unclassified Product Code: FRO Dated: June 14, 2007 Received: June 18, 2007

Dear Mr. Evans:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Paul W. Evans

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO7068(

## Indications for Use

510(k) Number (if known): K070685

Device Name: Kendall Antimicrobial Drain Dressing

Indications For Use: Over the counter use as a primary dressing around drains, IV sites, and tracheotomies.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(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, and Neurological Devices | Page 1 of ______ |
| 510(k) Number | 14070688 |