(149 days)
Collagen Dental Membrane – Porcine Type I Collagen is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect, or ridge augmentation to aid in wound healing.
Collagen Dental Membrane-Porcine Type I Collagen is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from porcine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Porcine Type I Collagen is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
The provided text is a 510(k) summary for the Collagen Dental Membrane - Porcine Type I Collagen. This device is a resorbable membrane for use in oral surgical procedures. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than a standalone performance study with specific acceptance criteria in the context of AI/software device evaluation.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance measures like AUC, sensitivity, specificity, FROC curves) are not applicable to this type of device and submission.
Here's an analysis based on the information available in the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of device (resorbable collagen membrane), acceptance criteria and performance are typically related to material properties, biocompatibility, and substantial equivalence to legally marketed devices. The document does not explicitly present a table of quantitative acceptance criteria as would be seen for a diagnostic or AI-driven device. Instead, it states that the device was evaluated against various standards and compared to predicate devices for similar characteristics.
| Criterion | Reported Device Performance (as per submission) |
|---|---|
| Substantial Equivalence to Predicates | Device found substantially equivalent in intended use, purified starting material (type I collagen), form, sizes, thickness, physical integrity, permeability, and conformability to K062881 (Collagen Dental Membrane-Conformable II) and K053260 (Ossix Plus). |
| Material Properties | Evaluated through in vitro characterization studies; results support substantial equivalence. (Specific metrics not provided) |
| Biological Properties | Evaluated through in vitro characterization studies; results support substantial equivalence. (Specific metrics not provided) |
| Chemical and Physical Properties | Evaluated through in vitro characterization studies; results support substantial equivalence. (Specific metrics not provided) |
| Safety/Biocompatibility | Passed all applicable FDA Blue Book Memorandum G95-1 and ISO 10993-1 testing. |
| Viral Inactivation | Viral inactivation studies were performed to ensure viral safety. (Specific metrics not provided, just successful completion) |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission relies on in-vitro characterization, biocompatibility testing, and comparison to the clinical history of predicate devices, not a 'test set' of patient data in the typical sense of an AI/diagnostic device study.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth, in the context of this device, refers to the scientific validation of material properties and biocompatibility, not expert interpretation of diagnostic images or patient outcomes for a specific clinical condition using the device.
4. Adjudication Method for the Test Set
Not applicable. No "test set" requiring adjudication by experts was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. This is not an AI/software device and therefore an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device requiring standalone algorithm performance evaluation.
7. The Type of Ground Truth Used
The 'ground truth' in this submission is established through:
- In vitro characterization studies: Demonstrating material, chemical, and physical properties.
- Biocompatibility studies (in vitro and in vivo): Conforming to FDA Blue Book Memorandum G95-1 and ISO 10993-1 standards.
- Viral inactivation studies: Demonstrating viral safety.
- Clinical history of predicate devices: Used to infer expected performance and safety in a clinical setting by demonstrating substantial equivalence.
8. The Sample Size for the Training Set
Not applicable. There is no 'training set' as this is not an AI/machine learning device. The design and validation are based on established engineering principles, material science, and regulatory standards.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no 'training set' for this medical device. The 'ground truth' for the device's design and fundamental properties is based on scientific and regulatory standards for collagen-based resorbable membranes, as evaluated in the in vitro and in vivo (biocompatibility) studies.
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510(k) SUMMARY
JUL 2 9 2011
1. Applicant Information
ﺍﻟﻤﺴﺎﺣﺔ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘ
| Applicant Name: | Collagen Matrix, Inc. |
|---|---|
| Address: | 15 Thornton Road |
| Oakland, New Jersey 07436 | |
| Telephone: | (201) 405-1477 |
| Fax: | (201) 405-1355 |
| Contact Person: | Peggy Hansen, RAC |
| VP, Clinical, Regulatory, QA, and Marketing | |
| Date Prepared: | February 28, 2011 |
2. Name of the Device
Device Common Name: Resorbable Collagen Membrane Collagen Dental Membrane - Porcine Type | Collagen Device Trade Name: Device Classification Name: Barrier, animal source, intraoral 872.3930 NPL Class II
3. Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s):
Collagen Dental Membrane-Conformable II K062881
Ossix Plus K053260
Description of the Device 4.
Collagen Dental Membrane-Porcine Type I Collagen is a white, nonfriable, conformable, resorbable, membrane matrix engineered from highly purified type I collagen derived from porcine Achilles tendon. It is flexible and conforms to the contours of the defect site. Collagen Dental Membrane-Porcine Type I Collagen is supplied sterile, non-pyrogenic, in various sizes, and for single use only.
5. Intended Use
Collagen Dental Membrane-Porcine Type I Collagen is intended for use in oral surgical procedures as a resorbable material for placement in the area of dental implant, bone defect or ridge reconstruction to aid in wound healing.
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Summary/Comparison of Technical Characteristics 6.
Collagen Dental Membrane-Porcine Type I Collagen and its predicates have similar technological characteristics. In particular, the Collagen Dental Membrane-Porcine Type I Collagen and its predicates are similar with respect to intended use, purified starting material (type I collagen), form, sizes, thickness, physical integrity, permeability and conformability. The substantial equivalence of Collagen Dental Membrane-Porcine Type I Collagen and its predicates was demonstrated based on in vitro characterization studies, biocompatibility studies, and clinical history of the predicate devices.
In vitro characterization studies included evaluation of material properties, biological properties, chemical and physical properties.
Collagen Dental Membrane-Porcine Type I Collagen has been evaluated in a number of in vitro and in vivo tests to assess 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. No clinical tests were performed on the product, however clinical history of the predicate device was referenced in the submission.
Viral inactivation studies were performed to ensure the viral safety of the product.
Conclusion of Non-clinical Studies
The results of the in vitro product characterization studies as well as in vitro and in vivo biocompatibility studies show that Collagen Dental Membrane-Porcine Type I Collagen is safe and substantially equivalent to the predicate devices.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Collagen Matrix, Incorporated Ms. Peggy Hansen Vice President, Clinical. Regulatory, OA, and Marketing 15 Thornton Road Oakland, New Jersey 07436
JUL 2 9 2011
Re: K110600
Trade/Device Name: Collagen Dental Membrane - Porcine Type I Collagen Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPL Dated: July 22, 2011 Received: July 25, 2011
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however. that device labeling must be truthful and not misleading.
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 - 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm 115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Susan Runser
Anthony D. Watson, B.S., M.S., M.B.A.
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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Indications for Use
510(k) Number (if known): _ K \ 0 6 00
Collagen Dental Membrane – Porcine Type I Collagen Device Name: ________
Indications for Use:
Collagen Dental Membrane – Porcine Type I Collagen is intended for use in oral surgical procedures as a 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 CBRH, Office of Device Evaluation (ODE)
Swart-Kaser
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K110600
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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.