(15 days)
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.
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.
This document is a 510(k) summary for a medical device called "Collagen Dental Membrane - Conformable II". This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving effectiveness through clinical studies with specific performance criteria in the way a new drug or novel medical device might. Therefore, the information typically requested regarding acceptance criteria, study design parameters like sample size, expert involvement, and ground truth establishment, is not present in this document.
The provided text focuses on demonstrating the new device's similarity to a previously cleared predicate device ("Collagen Dental Membrane, K011695") in terms of materials, intended use, and various physical characteristics, along with biocompatibility testing. It explicitly states: "The results of the in vitro product characterization studies show that the device... is safe and substantially equivalent to the original device."
Based on the provided text, the following information cannot be extracted:
- A table of acceptance criteria and reported device performance (in the context of clinical efficacy/accuracy)
- Sample size used for a test set or data provenance related to clinical performance
- Number of experts used to establish ground truth or their qualifications
- Adjudication method for a test set
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size
- Whether a standalone algorithm performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set (as this is not an AI/algorithm-driven device)
- How the ground truth for the training set was established.
However, here's what can be gathered, re-framing the "acceptance criteria" based on the nature of a 510(k) for a material device:
1. Table of Acceptance Criteria and Reported Device Performance (Re-framed for a 510(k) of a material device):
| Acceptance Criteria Category (Demonstrating Substantial Equivalence) | Reported Device Performance / Evidence Provided |
|---|---|
| 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." (Identical to predicate's stated use, though not explicitly detailed in the provided text for the predicate) |
| Material Composition | "engineered from highly purified type I collagen derived from bovine Achilles tendon." (Similar to predicate) |
| Form, Sizes & Thickness | "It is flexible and conforms to the contours of the defect site." "supplied sterile, non-pyrogenic, in various sizes". (Similar to predicate) |
| Physical Integrity | Not explicitly detailed, but implied by "similar technological characteristics" and "nonfriable." (Similar to predicate) |
| Permeability | "similar technological characteristics." (Similar to predicate) |
| Conformability | "flexible and conforms to the contours of the defect site." "similar technological characteristics." (Similar to predicate) |
| Biocompatibility/Safety | "The device passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing for the biological evaluation of medical devices." |
| Sterility & Pyrogenicity | "supplied sterile, non-pyrogenic." (Standard for implantable devices) |
| Single Use Only | "for single use only." (Standard for implantable devices) |
2. Sample size used for the test set and the data provenance:
- Not applicable in the context of clinical performance data for this 510(k). The evaluation was primarily via in vitro testing for biocompatibility and characterization studies to demonstrate equivalence in physical properties. No clinical "test set" from patients is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. Ground truth for clinical performance was not established as there was no clinical study described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the in vitro characterization and biocompatibility testing, the "ground truth" would be established by reference standards in analytical chemistry, mechanical engineering, and specific biological assays as per FDA Blue Book Memorandum G95-1 and ISO 10993-1. These are standardized, objective measures, not clinical "ground truth" derived from patient outcomes or expert consensus.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device that uses a "training set."
9. How the ground truth for the training set was established:
- Not applicable.
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510(k) Summary of Safety and Effectiveness
OCT 1 1 2006
| Applicant Name and Address: Collagen Matrix, Inc. | 509 Commerce StreetFranklin Lakes, New Jersey 07417 |
|---|---|
| Contact Person: | Peggy Hansen, RACSr. Director, Clinical, Regulatory, and Quality AssuranceTel: (201) 405-1477Fax: (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 MaterialClass II872.3930LYC |
| 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.
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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.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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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
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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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§ 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.