COLACTIVE COLLAGEN WOUND DRESSING

K050177 · Covalontechnologies, Inc. · KGN · Apr 27, 2005 · SU

Device Facts

• Record ID: K050177
• Device Name: COLACTIVE COLLAGEN WOUND DRESSING
• Applicant: Covalontechnologies, Inc.
• Product Code: KGN · SU
• Decision Date: Apr 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

ColActive™ Collagen Wound 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 Second degree burns Donor and graft sites Abrasions Dehisced surgical wounds Traumatic wounds healing by secondary intention.

Device Story

ColActive™ Collagen Wound Dressing is a sterile, pliable, absorbent wound dressing composed of collagen and sodium alginate. Available in sheet or rope form; cut to fit or layered for deep wounds. Functions by absorbing wound fluid to form a gel, maintaining a moist wound environment to facilitate granulation tissue formation and epithelialization. Used in clinical settings for management of various full and partial thickness wounds. Biocompatibility verified per ISO 10993-1.

Clinical Evidence

No clinical data provided. Safety supported by biocompatibility testing conducted in accordance with ISO 10993 Part 1.

Technological Characteristics

Composed of collagen and sodium alginate. Provided in sterile sheet or rope form. Pliable, absorbent material. Biocompatibility tested per ISO 10993-1.

Indications for Use

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

Predicate Devices

• FIBRACOL PLUS Collagen Wound Dressing with Alginate (K050177)
• SkinTemp Kollagen Wound Management Material (K050177)

Submission Summary (Full Text)

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510 (k) Notification, ColActive™ Collagen Wound Dressing Covalon Technologies, Inc.

K050177 1/2

# 510 (k) Summary

- January 24, 2005 1. Date Prepared:
- Covalon Technologies Inc. 2. Submitter 405 Britannia Road East, Suite 106 Mississauga, L4Z 3E6 Ontario, CANADA Tel: [phone] Fax: [phone]

Paul L. Guilbaud Submission Vice President and Director Wound & Tissue Correspondent: Repair

> 14510 Kandi Court Largo, Florida 33774 Tel: [phone] Fax: [phone] Email: [e-mail]

- Proprietary Name: ColActive™ Collagen Wound Dressing 4.
Common Name: Wound Dressing

- ક. Requiatory Class: FRO
### Statement of Substantial Equivalence: 6.

ColActive™ Collagen Wound 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 and SkinTemp Kollagen Wound Management Material manufactured by Biocore Medical Technologies.

### 7. Indications For Use:

ColActive™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:

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510 (k) Notification, ColActive™ Collagen Wound Dressing Covalon Technologies, Inc.

KOTO17

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

#### 8. Description:

ColActive™ Collagen Wound Dressing is an advanced wound care dressing composed of collagen and sodium alginate provided in a sterile sheet or rope form. Collagen Wound 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 can be cut to fit specific wounds and are able to be layered for the management of deep wounds.

#### 9. Biocompatibility:

ColActive™ Collagen Wound 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™ Collagen Wound Dressings are taken into consideration as a whole, ColActive™ Collagen Wound 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 logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, arranged in a row. The profiles are connected and appear to be emerging from a single form. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 9 2007

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

K050177 Re:

Trade Name: ColActive™ Collagen Wound Dressing Regulatory Class: Unclassified Product Code: KGN Dated: March 29, 2005 Received: March 31, 2005

Dear Mr. Guilbaud:

This letter corrects our substantially equivalent letter of April 27, 2005.

We have reviewed your Section 510(k) premarket notification of intent to market the We have reviewed your Section > Po(t); prematic come is substantially equivalent to May 28 device relefenced above and have decemined use assures on or to May 28, 1976, legally marketed predicate device managements or to devices that have been the enactment date of the Medical Device Thirefections of the Federal Food, Drug, and Cosmetic Act
reclassified in accordance with the provisions of the Federal (DMA) - You m reclassified in accordance with the provisions of a proval (PMA). You may, therefore,
(Act) that do not require approval of a premarket approval (PMA). Ast The general (Act) that do not require approval or a provisions of the Act. The general market the device, subject to the general on programments for annual registration, listing of controls provisions of the Act metading requirement.
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 If your device is classified (see above) into cation (spior regulations affecting your
(PMA), it may be subject to additional controls . Time . The 21, 2017 . In (PMA), it may be subject to additional connects of the 21, Parts 800 to 898. In the Federal device can be louind in the Code of Pederal Hegations).
addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 – Mr. Paul L. Guilbaud

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 mean that I Dr Hab made a well Federal statutes and regulations administered by other requirements of the Free and on anyone with all the Act's requirements, including, but not I coderal agonolos: You may some (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 manufacturing practice require, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section This leter will anow you to comment DA finding of substantial equivalence of your device 510(K) premarket nothreation "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), If you dobile specific at the Office of Compliance at [phone]. Also, please note the presse contact the other by reference to premarket notification" (21CFR Part 16 guildion onlines, which other general information on your responsibilities under the Act 807.27). Tourinal of Small Manufacturers, International and Consumer Assistance at its troll the Driber [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Millican

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

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KOK0177

510 (k) Notification, ColActive™ Collagen Wound Dressing Covalon Technologies, Inc.

Page 1 of 1

# PREMARKET NOTIFICATION INDICATIONS FOR USE STATEMENT

| 510 (k) Number: | k 050177 |
|-----------------|----------------------------|
| | Covalon Technologies, Inc. |

ColActive™ Collagen Wound Dressing Device Name:

## Indications for Use:

ColActive™ Collagen Wound 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 .
- Second degree burns .
- Donor and graft sites .
- Abrasions ●
- Dehisced surgical wounds .
- Traumatic wounds healing by secondary intention .

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

Use

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