EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088

K011941 · The Kendall Company · FRO · Aug 22, 2001 · SU

Device Facts

• Record ID: K011941
• Device Name: EXCILON AMD ANTIMICROBIAL SPONGE MODEL #7088
• Applicant: The Kendall Company
• Product Code: FRO · SU
• Decision Date: Aug 22, 2001
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Excilon® A.M.D. Antimicrobial Sponges are intended for use as primary dressings for IV sites, Tracheostomy tube sites, chest tube sites, catheter sites and drain sites. The antimicrobial activity of the PHMB in Excilon® A.M.D. helps to resist bacterial colonization of the dressing and inhibit bacterial penetration through the dressing. The barrier function of the dressing may help reduce infections in partial and full thickness wounds.

Device Story

Sterile, single-use nonwoven wound dressing; treated with Polyhexamethylene Biguanide Hydrochloride (PHMB) via Cosmocil®CQ. Features slit and T-cut design for site accommodation. Used in clinical settings as primary dressing for IV, tracheostomy, chest tube, catheter, and drain sites. Antimicrobial agent resists bacterial colonization and inhibits penetration through dressing; acts as barrier to reduce infection risk in partial and full-thickness wounds. Applied by healthcare professionals.

Clinical Evidence

Bench testing only. Biocompatibility testing performed in accordance with ISO 10993 Standard, Part 1, and FDA modified matrix G95-1.

Technological Characteristics

Nonwoven material treated with Polyhexamethylene Biguanide Hydrochloride (PHMB). Sterile, single-use. Available in 2" x 2" and 4" x 4" sizes. Slit and T-cut configuration.

Indications for Use

Indicated for use as a primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter sites, and drain sites in patients requiring wound management.

Predicate Devices

• Kendall Kerlix AMD Antimicrobial Gauze (K990530)
• Acticoat® Primary Antimicrobial Dressing (K992221)

Submission Summary (Full Text)

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# AUG 2 2 2001

# EXHIBIT # 12

## 510(k) Summary

## Kendall Excilon® A.M.D. Antimicrobial Sponges

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 / Division of Tyco Healthcare 15 Hampshire Street Mansfield, MA 02048 June 20, 2001 Date Prepared:

- Contact Person 1.
Michael P. Spears Regulatory Affairs Specialist Phone - [phone] -[phone] Fax

- 2. Name of Medical Device
Proprietary Name: Common Name: Classification Name:

Excilon® A.M.D. Antimicrobial Sponges wound dressing dressing

- 3. Identification of Legally Marketed Device
The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is substantially equivalent in intended use, function and composition to the Kendall Kerlix AMD Antimicrobial Gauze, 510(k) No. K990530 and the Acticoat® Primary Antimicrobial Dressing, 510(k) No. K992221.

- 4. Device Description
1 - 1 - 1 - 1 -

The proposed Kendall Excilon® A.M.D. Antimicrobial Sponge is a sterile, single use wound dressing consisting of nonwoven material treated with Cosmocil®CQ. Polyhexamethylene Biguanide Hydrochloride (PHMB) is the active ingredient in Cosmocil ®CQ. The sponges have a slit cut in them from the center of one side up through the midpoint wher a T-cut is formed. The dressing is packaged in a paper paper pouch and will be available in 2" x 2" and 4" x 4" sponge form.

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0 11941

### 5. Device Intended Use

Excilon® A.M.D. Antimicrobial Sponges are intended for use as primary dressings for IV sites, Tracheostomy tube sites, chest tube sites, catheter sites and drain sites. The antimicrobial activity of the PHMB in Excilon® A.M.D. helps to resist bacterial colonization of the dressing and inhibit bacterial penetration through the dressing. The barrier function of the dressing may help reduce infections in partial and full thickness wounds.

### റ്. Product Comparison

The Kendall Excilon® A.M.D. Antimicrobial Sponge is equivalent to the referenced predicate devices in that they are intended to be used as wound dressings. They each contain an ingredient that enhances the bacterial barrier function of the dressings and each has a broad spectrum of antimicrobial activity.

#### 7. Nonclinical Testing

Biocompatibility testing of the proposed 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

9200 Corp
Rockville

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Michael P. Spears Regulatory Affairs Specialist The Kendall Company Division of Tyco Healthcare Group 15 Hampshire Street Mansfield, Massachusetts 02048

Re: K011941

Trade/Device Name: Excilon A.M.D. Antimicrobial Sponge Regulatory Class: Unclassified Product Code: EFQ Dated: June 20, 2001 Received: June 21, 2001

Dear Mr. Spears:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have teviewed your becall be (x) =e is substantially equivalent (for the indications for use above and we nave acteriired predicate devices marketed in interstate commerce Stated in the encreate, to regary inte Medical Device Amendments, or to devices that pror to may 20, 1978, and and with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosmone Act (ree). Tot may) and controls provisions of the Act include requirements for annual provisions of the Fee. "The general smanufacturing practice, labeling, and prohibitions against misbranding and adulteration.

AUG 2 2 2001

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 (1 remarter ripped any in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspotions, the Four and Lation 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.

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Page 2 - Mr. Michael P. Spears

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis lotter will and it your ding 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" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mountactor on your respons and Consumer Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrb/dsma/dsmamain.html".

Sincerely vours.

for Mark N. Millerson

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1_of_1

K011941 510(k) Number (if Known):

Device Name: Excilon A.M.D. Antimicrobial Sponge

Indications For Use:

Primary dressing for IV sites, tracheostomy tube sites, chest tube sites, catheter and drain sites.

(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 |

| 510(k) Number | K011941 |
|---------------|---------|
|---------------|---------|

| Prescription Use | X (Per 21 CFR 801.109) |
|----------------------|--------------------------|
| | OR |
| Over-The-Counter Use | (Optional Format 1-2-96) |