(83 days)
No
The summary describes a collagen wound dressing and does not mention any AI or ML components or functionalities.
Yes
The device is indicated for the management of oral wounds and sores, which aligns with the definition of a therapeutic device as it is used to treat or alleviate a medical condition.
No
The device is a wound dressing used for managing oral wounds and sores; it does not diagnose conditions.
No
The device description clearly states it is a "microfibrillar collagen matrix," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "management of oral wounds and sores." This is a therapeutic application, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description of a "collagen matrix" for wound dressing aligns with a therapeutic device, not a diagnostic one.
- Lack of Diagnostic Elements: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
- Predicate Devices: The listed predicate devices (hyCure® Oral and Collagen Topical Wound Dressing) are also wound dressings, which are therapeutic devices.
Therefore, this device falls under the category of a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / 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 .
Product codes
KGN
Device Description
Collagen Wound Dressing - Oral is a white to off-white, absorbent, microfibrillar collagen matrix. The product is supplied sterile and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral wounds and sores
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
hyCure® Oral, The Hymed Group Corp, K994339, Collagen Topical Wound Dressing, Collagen Matrix, Inc., K030921
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
N/A
0
MAY 1 0 2004
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 .
1
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.
2
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
3
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.
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)