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

AI/ML Overview

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that a device meets those criteria. The document is a 510(k) summary for a Collagen Wound Dressing-Oral, which is a regulatory document from the FDA. It discusses the device's classification, indications for use, and substantial equivalence to predicate devices, but it does not include details on performance studies with acceptance criteria, sample sizes, expert qualifications, or ground truth methodologies.

Summary

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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: (201) 405-1477 Fax: (201) 405-1355
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 (301) 594-4613. 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 (800) 638-2041 or (301) 443-6597 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

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

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.

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Regulation Number and Section

N/A