ACTICOAT PRIMARY ANTIMICROBIAL DRESSING

K992221 · Westaim Biomedical, Inc. · FRO · Jun 7, 2000 · SU

Device Facts

• Record ID: K992221
• Device Name: ACTICOAT PRIMARY ANTIMICROBIAL DRESSING
• Applicant: Westaim Biomedical, Inc.
• Product Code: FRO · SU
• Decision Date: Jun 7, 2000
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and fungal penetration. The barrier of the dressing may help reduce infections in ulcers, venous stasis ulcers, partial and full thickness wounds including decubitus ulcers, neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor sites and surgical wounds. It may be used over debrided and grafted partial thickness wounds.

Device Story

ACTICOAT® is a non-adherent, silver-coated HDPE primary wound dressing. It functions as a barrier to bacterial and fungal penetration via sustained release of silver. Used in clinical settings for management of various wounds (ulcers, burns, surgical sites); applied directly to wound bed. The dressing is non-absorbent, requiring a secondary dressing chosen by the clinician. Benefits include infection reduction and protection of the wound bed during dressing changes. Device is supplied in multiple sizes.

Clinical Evidence

Bench testing only. In vitro testing was conducted to demonstrate the antimicrobial barrier function of the silver coating. Biocompatibility was established through in vivo and in vitro testing of the device and its individual components.

Technological Characteristics

Material: High-density polyethylene (HDPE) skin contact layer with antimicrobial silver coating. Form factor: Non-adherent, single-coated dressing available in various sizes (e.g., 2"x2" to 4"x48"). Principle: Sustained release of silver for antimicrobial barrier protection. Non-absorbent.

Indications for Use

Indicated for use as a barrier to bacterial and fungal penetration in partial and full thickness wounds, including decubitus, venous stasis, neuropathic, and diabetic ulcers, first- and second-degree burns, donor sites, and surgical wounds. May be used over debrided and grafted partial thickness wounds. Contraindicated for third-degree burns.

Predicate Devices

• Acticoat® Composite dressing (K983883)
• N'Terface dressing (K820198)
• N'Terface dressing (K973538)

Submission Summary (Full Text)

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## 510K Summary of Safety and Efficacy ACTICOAT® Primary Antimicrobial Dressing

May 17, 2000

Westaim Biomedical, Inc Submitter 1. One Hampton Rd. Suite 302 Exeter, NH 03833

> Steve Chartier Manager, Regulatory and Clinical Affairs [phone]

#### Device Name 2.

| Proprietary Name: | ACTICOAT® Primary Antimicrobial Dressing |
|----------------------|------------------------------------------|
| Common Name: | Dressing |
| Classification Name: | Dressing |
| Regulatory Class: | Unclassified |

#### Intended Use 3.

The Acticoat® Primary Antimicrobial Dressing is an effective barrier to bacterial and The Acticoat® Frimary Antimiorobial Broomy 10 the dressing may help reduce infections in fungal perfetration. The battler of the areasing ulcers, venous stasis ulcers, partial and Tull Thickness wounds informating "accuration" sites and surgical wounds. It may be used over grafted and partial thickness wounds.

#### Device Description 4.

Acticoat® primary antimicrobial dressings consists of single-coated, non-adherent, high-Acticulate phinaly antimisrobial droosings of the sustained release of silver actively protects the wound site from bacterial and fungal1 contamination.

The dressing will be sold in a variety of sizes the size used will depend on the size of the size of the The dressing will be sold in a valiety in alle the largest will be a 4" x 48" roll.

### How Supplied

| 2" x 2" | (5cm x 5 cm) |
|-----------|------------------|
| 4" x 4" | (10 cm x 10 cm) |
| 4" x 8" | (10 cm x 20 cm) |
| 8" x 16" | (20 cm x 40 cm) |
| 16" x 16" | (40 cm x 40 cm) |
| 4" x 48" | (10 cm x 120 cm) |

1 based on in vitro testing. Data on file.

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#### 5. Predicate Device Comparison

Acticoat® Primary Antimicrobial Dressing is the identical skin contact layer that is used in the Acticoat® Composite dressing (K983883). The absorbent outer laver has been This configuration allows the user to choose an appropriate secondary omitted. dressing.

This product is also similar to N'Terface dressing distributed by Winfield Laboratories. (K820298 and K973538). Both products are manufactured from HDPE and intended for use as a primary dressing to minimize damage to the wound bed during dressing changes. The only difference between these two products is that the Acticoat® dressing has an antimicrobial coating.

The table below compares the features and characteristics of the ACTICOAT® Primary antimicrobial dressing to the predicate products.

### Comparison of the ACTICOAT® Contact Layer Dressing to Predicate Products

| | Acticoat<br>Antimicrobial<br>Contact Layer<br>Dressing | Acticoat®<br>Composite<br>Dressing<br>(K983883) | Winfield Labs<br>N'Terface<br>(K820198 &<br>K973538) |
|---------------------------------|--------------------------------------------------------|------------------------------------------------------------|------------------------------------------------------|
| INTENDED USE | | | |
| Wound Dressing | Yes | Yes | Yes |
| DESIGN | | | |
| HDPE Skin Contact<br>Layer | Yes | Yes | Yes |
| Absorbable | No | Yes | No |
| Antimicrobial silver<br>coating | YES | Yes | NO |
| MATERIALS | | | |
| | HDPE | HDPE &<br>Polyurethane<br>backing<br>Absorbent<br>material | HDPE |

#### 6. Biocompatibilitv

biocompatibility of Acticoat® Primary Antimicrobial Dressing has been The demonstrated through appropriate in vivo and in vitro tests as well as previous tests on individual components.

> Premarket Notification ACTICOAT® Primary Antimicrobial Dressing Westaim Biomedical Inc.

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Public Health Service

# JUN - 7 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Steve Chartier Manager, Regulatory and Clinical Affairs Westaim Biomedical, Inc. One Hampton Road, Suite 302 Exeter, New Hampshire 03833

Re: K992221

Trade Name: ACTICOAT® Primary Antimicrobial Dressing Regulatory Class: Unclassified Product Code: MGP Dated: April 13, 2000 Received: April 14, 2000

Dear Mr. Chartier:

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 (Act). 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 (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, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 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.

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Page 2 - Mr. Steve Chartier

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 [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Dmna R. Lochner

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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## Indications For Use Device Name: ACTICOAT® Primary Antimicrobial Dressing K 992221

The Acticoat® silver coated contact layer dressing is an effective barrier to bacterial and fungal penetration. The barner function of the dressing may help reduce infections in partial and full thickness wounds including decubitus ulcers, venous stasio unes, Neuropathic ulcers, diabetic ulcers, first- and second-degree burns, donor siten and surgical wounds. It may be used over debrided and grafted partial thickness wounds.

It has not been evaluated in third degree burns.

'based on invitro testing. Data on file.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

Dona R. Lochner.

of General Restorative Devices 510(k) Number_K

Prescription Use (Per 21 CFR §801.109)

OR

Over-the-Counter Use

(Optional Format 1-2-96)