(110 days)
Not Found
No
The summary describes a collagen sponge for wound healing and does not mention any computational or analytical capabilities that would suggest AI/ML.
Yes
The device is intended to aid in wound healing post periodontal surgery, indicating a therapeutic purpose.
No
The device, Collagen Dental Sponge Membranes, is intended for placement in periodontal defects to aid in wound healing after surgery. Its purpose is therapeutic (healing), not diagnostic (identifying or characterizing a disease).
No
The device description clearly states it is a physical product ("manufactured from crosslinked type I collagen derived from bovine Achilles tendon") and is supplied as a sterile, non-pyrogenic material. There is no mention of software as the primary component or function.
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 placement in periodontal defects to aid in wound healing post periodontal surgery. This is a therapeutic and structural function within the body, not a diagnostic test performed on samples outside the body.
- Device Description: The description details a resorbable material made from collagen for surgical use. This aligns with a medical device used in a surgical procedure, not a diagnostic test.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
Therefore, the Collagen Dental Sponge Membrane is a medical device used for surgical intervention and wound healing, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Collagen Dental Sponge Membranes are intended for use in patients with moderate to Sollagen Bontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.
Product codes
LYC
Device Description
Description of the Dore." Conagen Domar Sponge recemsnufactured from crosslinked type I collagen derived from bovine Achilles tendon. The product is supplied sterile, non-pyrogenic, and for single use only.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
periodontal defects
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3930 Bone grafting material.
(a)
Identification. Bone grafting material is a material such as hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen, that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.(b)
Classification. (1) Class II (special controls) for bone grafting materials that do not contain a drug that is a therapeutic biologic. The special control is FDA's “Class II Special Controls Guidance Document: Dental Bone Grafting Material Devices.” (See § 872.1(e) for the availability of this guidance document.)(2) Class III (premarket approval) for bone grafting materials that contain a drug that is a therapeutic biologic. Bone grafting materials that contain a drug that is a therapeutic biologic, such as biological response modifiers, require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.
0
MAR 1 7 2004
Image /page/0/Picture/1 description: The image shows the text string "K033729" in a handwritten style. The text is oriented diagonally, with the "K" at the bottom left and the "9" at the top right. The handwriting appears to be in black ink on a white background, and the numbers are slightly distorted.
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: | March 11, 2004 |
| Device Common Name: | Collagen Dental Sponge Membranes |
| Device Trade Name: | To be determined |
| Device Classification Name: | Bone filling augmentation material
Unclassified
LYC |
| Predicate Device(s): | Collagen Dental Membrane, K011695
Collagen Periodontal Membrane, K003339 |
Description of the Device
Description of the Dore." Conagen Domar Sponge recemsnufactured from crosslinked type I collagen derived from bovine Achilles tendon. The product is supplied sterile, non-pyrogenic, and for single use only.
Indications for Use
Thurculous for 'Co Conagen Donal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.
Summary/Comparison of Technical Characteristics
Sullagen Dental Sponge Membranes and its predicates have similar technological characteristics. In particular, the Collagen Dental Sponge Membranes and their enaracteristics. In particles pect to intended use, material, source, sterilization, etc.
Safety
Collagen Dental Sponge Membranes have been evaluated by a number of tests to assess Conagen Doman oponge .ye. The device passed all applicable ISO 10993-1 testing for the biological evaluation of medical devices.
Conclusion
Conclusion The results of the will of the Sponge Membranes are safe and substantially equivalent to its predicate devices.
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Ms. Peggy Hansen Director, Clinical, Regulatory, and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K033729
Trade/Device Name: Collagen Dental Sponge Membrane Regulation Number: Unclassified Regulation Name: None Regulatory Class: None Product Code: LYC Dated: January 26, 2004 Received: January 27, 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,
foc
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
Indications for Use
510(k) Number (if known): ____K033729
Collagen Dental Sponge Membranes Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Collagen Dental Sponge Membranes are intended for use in patients with moderate to Sollagen Bontal disease as a resorbable material for placement in periodontal defects to aid in wound healing post periodontal surgery.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
follwutrhh
sion Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
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510(k) Number: K033729