(15 days)
Not Found
No
The device description and intended use describe a passive, resorbable collagen membrane with no mention of computational or analytical capabilities, let alone AI/ML. The "Not Found" entries for AI/ML mentions and training/test sets further support this.
Yes
This device aids in wound healing in oral surgical procedures, which is a therapeutic function.
No
Explanation: The device is a resorbable membrane for wound healing in oral surgery, not for diagnosing conditions. Its intended use is to aid in healing rather than to identify or characterize a disease or condition.
No
The device description clearly states it is a physical membrane made from collagen, 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 it's for use in oral surgical procedures to aid in wound healing in areas like dental implants, bone defects, or ridge augmentation. This is a therapeutic and structural function within the body.
- Device Description: The description details a resorbable membrane matrix made from collagen, designed to be placed in vivo (within the body).
- Lack of Diagnostic Function: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic purposes. IVDs are typically used to test blood, urine, tissue samples, etc., to detect diseases, conditions, or markers.
This device is a medical device used for surgical and regenerative purposes, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
Collagen Dental Membrane-Conformable II is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.
Product codes (comma separated list FDA assigned to the subject device)
NPL
Device Description
Collagen Dental Membrane-Conformable II is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Conformable II is supplied sterile, non-pyrogenic, in various sizes, 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 surgical
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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510(k) Summary of Safety and Effectiveness
OCT 1 1 2006
| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce Street
Franklin Lakes, New Jersey 07417 |
|---------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Peggy Hansen, RAC
Sr. Director, Clinical, Regulatory, and Quality Assurance
Tel: (201) 405-1477
Fax: (201) 405-1355 |
| Date of Summary: | September 25, 2006 |
| Device Common Name: | Collagen Dental Membrane |
| Device Trade Name: | Collagen Dental Membrane - Conformable II |
| Device Classification Name: | Bone Grafting Material
Class II
872.3930
LYC |
| Predicate Device(s): | Collagen Dental Membrane, K011695 |
Description of the Device
Collagen Dental Membrane-Conformable II is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from bovine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Conformable II is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
Intended Use
Collagen Dental Membrane-Conformable II is intended for use in dental surgery procedures as a material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing post dental surgery.
Summary/Comparison of Technical Characteristics
Collagen Dental Membrane-Conformable II and its predicate have similar technological characteristics. In particular, the Collagen Dental Membrane-Conformable II and its predicate are similar with respect to intended use, material, form, sizes, thickness, physical integrity, permeability and conformability.
1
Safety
A Collagen Dental Membrane-Conformable II equivalent has been evaluated by a I Contagen Domar Messa its safety/biocompatibility. The device passed all applicable FDA Blue Book Memorandum G95-1and ISO 10993-1 testing for the biological evaluation of medical devices.
Conclusion
The results of the in vitro product characterization studies show that the device Firstitution of the Collagen Dental Membrane-Conformable II is safe and substantially equivalent to the original device.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing to the right, stacked on top of each other, creating a sense of depth and unity.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850
OCT 1 0 2007
Ms. Peggy Hansen Senior Director, Clinical, Regulatory and Quality Assurance Collagen Matrix, Incorporated 509 Commerce Street Franklin Lakes, New Jersey 07417
Re: K062881
Trade Name: Collagen Dental Membrane-Conformable II Regulation Number: 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: 2 Product Code: NPL Dated: September 25, 2006 Received: September 27, 2006
Dear Ms. Hansen:
This letter corrects our substantially equivalent letter of October 11, 2006.
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 (PMA). You may, therefore, market the require apple 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 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 -
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 continue 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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address 1 http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Syrite Y. Michieoms.
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
Image /page/3/Picture/7 description: The image is a circular logo or emblem. The text "1906 - 2006" is at the top of the circle. The letters "FDA" are in the center of the circle in a bold, stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are below the word "Centennial".
Protecting and Promoting Public Health
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Indications for Use
510(k) Number (if known):
Collagen Dental Membrane - Conformable II Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications for Use:
Collagen Dental Membrane – Conformable 11 is intended for use in oral surgical Collegon Donal resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.
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)
Susan Byrne
on Sign-Off) of Anesthesiology, General Hospital, . Non Control, Dental Devis
Number:
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