COLLAGEN WOUND DRESSING - ORAL

K040403 · Collagen Matrix, Inc. · KGN · May 10, 2004 · SU

Device Facts

• Record ID: K040403
• Device Name: COLLAGEN WOUND DRESSING - ORAL
• Applicant: Collagen Matrix, Inc.
• Product Code: KGN · SU
• Decision Date: May 10, 2004
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Collayen Wound Dressing - Oral is indicated for the management of oral wounds and sores, including: Denture sores . Oral ulcers (non-infected or viral) . Periodontal surgical wounds . . Suture sites . . Burns . Extraction sites ● . Surgical wounds . . Traumatic wounds .

Device Story

Collagen Wound Dressing - Oral is an absorbent, microfibrillar collagen matrix; supplied sterile for single use. Intended for management of various oral wounds including denture sores, ulcers, surgical sites, and burns. Device acts as a topical dressing to support wound management. Used in clinical or dental settings; applied by healthcare professionals. Provides a physical matrix for wound coverage.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological characteristics and intended use similarities to predicate devices.

Technological Characteristics

Absorbent, microfibrillar collagen matrix. Supplied sterile for single use. Form factor is a topical dressing.

Indications for Use

Indicated for management of oral wounds and sores in patients with denture sores, non-infected or viral oral ulcers, periodontal surgical wounds, suture sites, burns, extraction sites, surgical wounds, and traumatic wounds.

Predicate Devices

• hyCure® Oral, The Hymed Group Corp (K994339)
• Collagen Topical Wound Dressing, Collagen Matrix, Inc. (K030921)

Submission Summary (Full Text)

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# MAY 1 0 2004

K040403

## 510(k) Summary of Safety and Effectiveness

| Applicant Name and Address: | Collagen Matrix, Inc. 509 Commerce Street Franklin Lakes, New Jersey 07417 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC Director, Clinical, Regulatory, and Quality Assurance Tel: [phone] Fax: [phone] |
| Date of Summary: | February 13, 2004 |
| Device Common Name: | Collagen Topical Wound Dressing - Oral |
| Device Trade Name: | To be determined |
| Device Classification Name: | Bandage, Liquid Unclassified 880.5090 KMF |
| Predicate Device(s): | hyCure® Oral, The Hymed Group Corp, K994339 Collagen Topical Wound Dressing, Collagen Matrix, Inc., K030921 |

#### Description of the Device

Collagen Wound Dressing - Oral is a white to off-white, absorbent, microfibrillar collagen matrix. The product is supplied sterile and for single use only.

#### Indications for Use

Collayen Wound Dressing - Oral is indicated for the management of oral wounds and sores, including:

- Denture sores .
- Oral ulcers (non-infected or viral) .
- Periodontal surgical wounds .

. :

- Suture sites .
- . Burns
- Extraction sites ●
- Surgical wounds .
- Traumatic wounds .

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol often associated with healthcare and medicine.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### MAY 1 0 2004

Ms. Peggy Hansen Director, Clinical, Regulatory and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417

Re: K040403

Trade/Device Name: Collagen Wound Dressing-Oral Regulation Number: Unclassified Regulation Name: Collagen Wound Dressing Regulatory Class: None Product Code: KGN Dated: February 13, 2004 Received: February 17, 2004

Dear Ms. Hansen:

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.

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#### Page 2 -Ms. Hansen

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.

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/dsma/dsmamain.html

Sincerely yours.

Chiu Lin, Ph.D.

Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KO40 403

: 10(k) Number (if known):

Collagen Wound Dressing - Oral Device Name:

!ndications for Use:

Collagen Wound Dressing - Oral is indicated for the management of oral wounds and Sores, including:

- Denture sores ●
- . Oral ulcers (non-infected or viral)
- Periodontal surgical wounds ●
- . Suture sites
- Burns .
- Extraction sites .
- Surgical wounds ●
- Traumatic wounds

Suas Rummell
Division Sign-Off)

on of Anesthesiology, General Hospital, Infection Control, Dental Devices

510(k) Number: K041402

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Image /page/3/Picture/18 description: The image shows the words "Prescription Use" in bold font, followed by the text "(Per 21 CFR 801.109)" in a smaller font. There is a large X over the words "Prescription Use". The text indicates that the product is for prescription use only, according to the Code of Federal Regulations.

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

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