COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING

K043296 · Covalontechnologies, Inc. · FRO · Jun 6, 2005 · SU

Device Facts

• Record ID: K043296
• Device Name: COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING
• Applicant: Covalontechnologies, Inc.
• Product Code: FRO · SU
• Decision Date: Jun 6, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including: Pressure ulcers. Diabetic ulcers. Ulcers caused by mixed vascular etiologies. Venous ulcers. First and Second degree burns. Donor and graft sites. Abrasions. Dehisced surgical wounds. Traumatic wounds healing by secondary intention.

Device Story

ColActive Ag™ is a sterile, pliable, absorbent wound dressing composed of collagen, sodium alginate, and silver chloride. Provided in sheet or rope form, it is applied topically to wounds by healthcare providers. The dressing absorbs wound fluid to form a gel, maintaining a moist environment that promotes granulation tissue formation and epithelialization. The silver chloride component acts as a barrier to bacterial and fungal penetration, preventing colonization of the dressing. The dressing can be cut to size or layered for deep wounds. It benefits patients by managing wound exudate and protecting the wound bed from microbial contamination.

Clinical Evidence

Bench testing only. Biocompatibility was demonstrated through safety testing in accordance with ISO 10993 Part 1.

Technological Characteristics

Composition: collagen, sodium alginate, silver chloride. Form: sterile sheet or rope. Function: absorbent, gel-forming, antimicrobial barrier. Biocompatibility: ISO 10993-1 compliant.

Indications for Use

Indicated for management of full and partial thickness wounds in patients with pressure ulcers, diabetic ulcers, mixed vascular ulcers, venous ulcers, first/second degree burns, donor/graft sites, abrasions, lacerations, dehisced surgical wounds, and traumatic wounds healing by secondary intention.

Predicate Devices

• FIBRACOL PLUS Collagen Wound Dressing with Alginate (Johnson & Johnson Medical)
• Vitaphore Silver Foam Wound Dressing (Vitaphore Corporation)
• Acticoat Silver Coated Dressing (Westaim Biomedical, Inc.)

Submission Summary (Full Text)

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JUN 6 - 2005 510 (k) Notification ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Covalon Technologies, Inc.

K043296

## 510 (k) Summary

- November 15, 2004 1. Date Prepared:
ﻛﺮﺓ ﺍﻟﻘﺮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

- Covalon Technologies Inc. 2. Submitter 586 Spadina Avenue Toronto M5S 2H2 Ontario, CANADA Tel: [phone] Fax: [phone]

| Submission<br>Correspondent: | Paul L. Guilbaud<br>Vice President and Director Wound & Tissue<br>Repair<br>Covalon Technologies Inc.<br>14510 Kandi Court<br>Largo, Florida 33774<br>Tel: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
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- Proprietary Name: ColActive Ag™ Collagen with Silver, Antimicrobial 4. Dressing
Common Name: Wound Dressing

- 5. Requiatory Class: MPG
#### 6. Statement of Substantial Equivalence:

ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are substantially equivalent in materials of construction and intended use and identical in function to FIBRACOL PLUS Collagen Wound Dressing with Alginate manufactured by Johnson & Johnson Medical, Vitaphore Silver Foam Wound Dressing manufactured by Vitaphore Corporation and Acticoat Silver Coated Dressing manufactured by Westaim Biomedical, Inc.

#### 7. Indications For Use:

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness wounds including:

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510 (k) Notification 910 (K) Notinoddon'
ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Covalon Technologies, Inc.

- Pressure ulcers ●
- Diabetic ulcers ●
- Ulcers caused by mixed vascular etiologies ●
- Venous ulcers ●
- First and Second degree burns .
- Donor and graft sites .
- Abrasions .
- Dehisced surgical wounds .
- Traumatic wounds healing by secondary intention .

#### Description: 8.

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is an advanced wound care dressing composed of collagen, sodium alginate and silver chloride provided in a sterile sheet or rope form. ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings act as an effective barrier to bacterial and fungal penetration. The silver content is intended to prevent colonization of the dressing. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds."

#### Biocompatibility: 9.

ColActive Ag™ Collagen with Silver, Antimicrobial Dressings have been demonstrated to be safe wound dressings. To support the biocompatibility of these products, safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices.

When all test results from tests conducted on ColActive Ag™ Collagen with Silver, Antimicrobial Dressings are taken into consideration as a whole, ColActive Ag™ Collagen with Silver, Antimicrobial Dressings have been demonstrated to be safe topical wound dressings in accordance with ISO 10993-1.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is written around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN € - 2005

Mr. Paul L. Guilbaud Vice President and Director of Wound and Tissue Repair Covalon Technologies Incorporated 14510 Kandi Court Largo, Florida 33774

Re: K043296

Trade/Device Name: ColActive Ag™ Collagen with Silver, Antimicrobial Dressing Regulatory Class: Unclassified Product Code: FRO Dated: May 20, 2005 Received: May 23, 2005

Dear Mr. Guilbaud:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed four becaller by (a) } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } } for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to trgans) in the Medical Device Amendments, or to conninered phorts to May 20, 1978, as eccordance with the provisions of the Federal Food, DNA A de rices mat nave been require approval of a premarket approval application (PMA). and Costiete Her (110. (110.) that be novice, subject to the general controls provisions of the Act. The r ou may, merelore, mains of the Act include requirements for annual registration, listing of general controls provider ing 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 n may be subject to stan as Execural 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 I lease be devilsed that i Drivisantes vour device complies with other requirements of the Act that I Drederal statutes and regulations administered by other Federal agencies. You must or any I edetar station and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Of It in the quality systems (QS) regulation (21 CFR Part 820): and if applicable, the electronic form in the quiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Paul L. Guilbaud

This letter will allow you to begin marketing your device as described in your Section 510(k) I ms letter water notification. The FDA finding of substantial equivalence of your device to a legally premative nedicate 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 If you desire specific arrivaliance 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 other general international and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Signature

Miriam C. Provost, Ph.D. Acting 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

# PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

510 (k) Number:

KO43796 Covalon Technologies, Inc.

Device Name: ColActive Ag™ Collagen with Silver, Antimicrobial Dressing

### Indications for Use:

ColActive Ag™ Collagen with Silver, Antimicrobial Dressing is indicated for the management of full and partial thickness including:

- Pressure ulcers .
- Diabetic ulcers .
- Ulcers caused by mixed vascular etiologies ◆
- Venous ulcers ●
- First and Second degree burns ●
- Donor and graft sites .
- Abrasions & lacerations ●
- Dehisced surgical wounds .
- . Traumatic wounds healing by secondary intention

Prescription Use
(Per 21 CFR 801.109) √

OR Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

| Concurrence of CDRH, Office of Device Evaluation (ODE) |
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| | K043296 |