(67 days)
Porcine Mineral Collagen Composite Moldable is indicated for:
- · Augmentation or reconstructive treatment of alveolar ridge
- · Filling of infrabony periodontal defects
- · Filling of defects after root resection, apicoectomy, and cystectomy
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of maxillary sinus floor
- · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:
Device Name: Porcine Mineral Collagen Composite Moldable (K201859)
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria here are based on demonstrating substantial equivalence to predicate devices (K140714 and K033815, K110600, K122115) through a series of non-clinical tests. The criteria used are the standards and expected outcomes for these tests.
| Test Category | Acceptance Criteria (e.g., standard, expected outcome for equivalence) | Reported Device Performance (Results) |
|---|---|---|
| Biocompatibility | In accordance with ISO 10993-1 and FDA Guidance | |
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Genotoxicity (Mouse Lymphoma Assay) | No increase in mutant frequency / not mutagenic | No evidence of causing increase in the mean mutant frequency; not mutagenic |
| Genotoxicity (Ames Assay) | Non-mutagenic | Non-mutagenic to Salmonella typhimurium and Escherichia coli strain WP2uvra |
| Sensitization | No evidence of dermal contact sensitization | No evidence of causing delayed dermal contact sensitization in the guinea pig |
| Irritation Intracutaneous Reactivity | No evidence of irritation or toxicity | No evidence of irritation or toxicity |
| Acute Systemic Toxicity | No mortality or systemic toxicity | No mortality or evidence of systemic toxicity |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Implantation | Minimum tissue reaction, no adverse tissue reaction | Minimum tissue reaction up to 13 weeks of implantation and no adverse tissue reaction to the host |
| Subacute / Subchronic / Chronic Toxicity | Minimum tissue reaction, no adverse tissue reaction | Minimum tissue reaction up to 13 weeks of implantation and no adverse tissue reaction to the host |
| Bench Testing | Similar to predicate device, appropriate characteristics | |
| Mineral Content | Similar to predicate device | Mineral content similar to predicate device |
| Size | Volumes similar to predicate device | Volumes similar to predicate device |
| Calcium to Phosphate Ratio (mineral only) | Similar to predicate device | Ratio similar to predicate device |
| Scanning Electron Micrograph (SEM) | Morphologies similar to reference device | Morphologies similar to reference device |
| X-Ray Diffraction | Similar diffraction patterns to reference device | Similar diffraction patterns to reference device |
| IR Spectroscopy | Similar functional groups to reference device | Similar functional groups to reference device |
| Density | Appropriate density for sufficient porosity | Appropriate density for sufficient porosity |
| pH | Similar to predicate device | pH similar to predicate device |
| Absorbency | Similar to predicate device | Absorbency similar to predicate device |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Animal Testing | Performance substantially equivalent to reference device | Performance substantially equivalent to the reference device Bio-Oss Collagen when used as intended (Radiographic, Micro CT, Histology and Histomorphometry analyses at 4, 8, and 13 weeks) |
| Sterilization | In accordance with ISO 11137-1 | Sterilization validation performed in accordance with ISO 11137-1 |
| Shelf Life & Stability | Determined using real-time aging data, performance testing of packaging | Product and packaging stability determined using real-time aging data. Packaging system tested per ASTM D4169. |
| Viral Inactivation | Performed in accordance with ISO 22442-3 | Viral inactivation studies performed in accordance with ISO 22442-3 |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state numeric "sample sizes" in terms of "test sets" for many of the individual tests beyond the animal study.
- Animal Study (Implantation/Toxicity/Performance): The text mentions "Implantation in Canine Intrabony Defect Model" and "performance of the device in a canine one-wall intrabony defect model." It refers to "the subject device, reference device and sham negative control." While it doesn't give an exact number of dogs or defects, it implies experimental groups were used for comparison.
- Biocompatibility Tests: These tests typically use standardized biological samples (e.g., L929 cells for cytotoxicity, guinea pigs for sensitization, rabbits for irritation, mice for acute systemic toxicity). The specific sample numbers for each of these tests are not provided but are generally dictated by the referenced ISO standards.
- Bench Testing: These tests assess material properties and are performed on samples of the device and predicate/reference devices. Specific sample numbers (e.g., how many units were tested for mineral content, density, pH) are not specified.
- Data Provenance: The studies are described as non-clinical (in vitro, bench, and animal testing). The country of origin for the data is not specified, but the use of international standards (ISO, ASTM, USP) suggests these are likely standardized laboratory tests. The nature of these tests is prospective within the context of the study design for each specific test, as the device was manufactured and then subjected to these evaluations according to pre-defined protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Not applicable in the conventional sense. This is a non-clinical device submission for a bone grafting material. The "ground truth" for these tests refers to the established scientific principles, standardized test methods (like ISO, ASTM, USP), and documented performance of predicate devices. There wouldn't be "experts" establishing a "ground truth" for a test set in the same way clinical image interpretation requires expert radiologists. The "truth" is determined by the objective measurements and observations defined by the test protocols and standards.
- For the Animal Testing, the "ground truth" for efficacy (performance) would be established by objective measurements (Radiographic, Micro CT, Histology, Histomorphometry analyses) performed by trained scientists/pathologists in accordance with the study protocol. Their qualifications are not specified but would typically involve veterinary expertise, histology pathology, and imaging interpretation.
4. Adjudication Method for the Test Set
- Not applicable. As this is a non-clinical submission relying on objective measurement and comparison to predicate devices and standards, there is no "adjudication" in the sense of resolving conflicting interpretations by multiple human readers. The results of the tests (e.g., non-cytotoxic, similar mineral content, substantially equivalent performance in canines) are based on pre-defined criteria within the test protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a submission for a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No. As explained above, this device is a physical bone grafting material, not a software algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is primarily based on:
- Standardized Test Outcomes: Adherence to established international standards (ISO, ASTM, USP) for biocompatibility, material properties, sterility, etc. The results are compared against the pass/fail criteria or expected values defined by these standards.
- Comparison to Predicate Device Performance: Demonstrating that the subject device's performance (e.g., physical, chemical, biological characteristics, and performance in animal models) is "substantially equivalent" to legally marketed predicate devices. This is achieved by showing similar results across various tests.
- Histopathology/Imaging (for Animal Study): For the animal study, the ground truth for biological response and bone regeneration comes from objective analyses like radiography, Micro CT, histology, and histomorphometry of tissue samples, interpreted by experts in these fields.
8. The Sample Size for the Training Set
- Not applicable. This submission describes the evaluation of a manufactured medical device. There is no concept of a "training set" in the context of machine learning for this type of product. The device itself is the product being tested, not an algorithm that learns from data.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. Since there is no "training set," the establishment of its ground truth is not relevant.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 11, 2020,
Collagen Matrix, Inc. Gloria Zuclich Director, Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K201859
Trade/Device Name: Porcine Mineral Collagen Composite Moldable Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: July 1, 2020 Received: July 6, 2020
Dear Gloria Zuclich:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201859
Device Name
Porcine Mineral Collagen Composite Moldable
Indications for Use (Describe)
Porcine Mineral Collagen Composite Moldable is indicated for:
- · Augmentation or reconstructive treatment of alveolar ridge
- · Filling of infrabony periodontal defects
- · Filling of defects after root resection, apicoectomy, and cystectomy
- · Filling of extraction sockets to enhance preservation of the alveolar ridge
- · Elevation of maxillary sinus floor
- · Filling of periodontal defects in conjuncts intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
| Type of Use (Select one or both, as applicable) |
|---|
| Reproduction Use (Part 31 CFR 301, Subpart C) One-Time Screening Use (31 CFR 301, Subpart C) |
X Prescription Use (Part 21 CFR 801 Subpart D)
| | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) SUMMARY
| 1. | Applicant Information | |
|---|---|---|
| Applicant Name:Address:Telephone:Fax: | Collagen Matrix, Inc.15 Thornton RoadOakland, New Jersey 07436(201) 405-1477(201) 405-1355 | |
| Contact Person: | Gloria ZuclichDirector of Regulatory Affairsgzuclich@collagenmatrix.com | |
| Date Prepared: | September 08, 2020 | |
| 2. | Name of the Device | |
| Device Trade Name: | Porcine Mineral Collagen Composite Moldable | |
| Device Common Name(s): | Bone Grafting Material | |
| Device Classification Name: | Bone Grafting Material, Animal Source872.3930NPMClass II | |
| 3. | Legally Marketed Devices to Which Substantial Equivalence is Claimed | |
| Primary Predicate Device: | Porcine Anorganic Bone MineralCollagen Matrix, Inc.K140714 | |
| Reference Device(s): | Bio-Oss® CollagenGeistlich-Pharma AGK033815 | |
| Collagen Dental Membrane - Porcine Type ICollagenCollagen Matrix, Inc.K110600 | ||
| Collagen Dental Wound DressingsCollagen Matrix, Inc.K122115 |
4. Description of the Device
Porcine Mineral Collagen Composite Moldable is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal, oral and maxillofacial surgery. The device is
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composed of 90% anorqanic bone mineral granules derived from porcine cancellous bone and 10% collagen from porcine Achilles tendon in a composite matrix. The product is supplied sterile, non-pyrogenic and for single use only.
Porcine Mineral Collagen Composite Moldable is provided in a block form and is available in three sizes, 0.5cc, 1.0cc, and 2.0cc.
5. Intended Use
Porcine Mineral Collagen Composite Moldable is indicated for:
- . Augmentation or reconstructive treatment of alveolar ridge
- Filling of infrabony periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy
- . Filling of extraction sockets to enhance preservation of the alveolar ridge
- . Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- . Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration.
6. Summary/Comparison of Technical Characteristics
The subject device and the predicate device have the same indications for use.
The subject device has substantially equivalent technological characteristics as the cited legally marketed predicate device. Differences include the physical form, material composition and product range volumes. Differences in the physical form and material composition have been determined to be minor and are substantiated when compared to that of the cited reference devices. The difference in product range volume offered for the subject device falls within the range supplied for the primary predicate device.
| Feature | Porcine Mineral CollagenComposite Moldable(This Submission) | Porcine Anorganic BoneMineral(K140714) | Bio-Oss® Collagen(K033815) |
|---|---|---|---|
| Indications forUse | Augmentation orreconstructive treatmentof alveolar ridge Filling of infrabonyperiodontal defects Filling of defects afterroot resection,apicoectomy, andcystectomy Filling of extractionsockets to enhancepreservation of thealveolar ridge Elevation of maxillarysinus floor Filling of periodontal | Augmentation orreconstructive treatmentof alveolar ridge Filling of infrabonyperiodontal defects Filling of defects afterroot resection,apicoectomy, andcystectomy Filling of extractionsockets to enhancepreservation of thealveolar ridge Elevation of maxillarysinus floor Filling of periodontal | Augmentation orreconstructive treatmentof alveolar ridge Filling of periodontaldefects Filling of defects afterroot resection,apicoectomy, andcystectomy Filling of extractionsockets to enhancepreservation of thealveolar ridge Elevation of maxillarysinus floor Filling of periodontal |
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| defects in conjunction | defects in conjunction | defects in conjunction | |
|---|---|---|---|
| with products intended | with products intended | with products intended | |
| for Guided Tissue | for Guided Tissue | for Guided Tissue | |
| Regeneration (GTR) and | Regeneration (GTR) and | Regeneration (GTR) and | |
| Guided Bone | Guided Bone | Guided Bone | |
| Regeneration (GBR) | Regeneration (GBR) | Regeneration (GBR). | |
| Filling of peri-implant defectsin conjunction with productsintended for Guided BoneRegeneration (GBR) | Filling of peri-implant defectsin conjunction with productsintended for Guided BoneRegeneration (GBR) | Filing of peri-implant defectsin conjunction with productsintended for Guided BoneRegeneration (GBR) | |
| Physical Form | Block Shaped | Granules | Block Shaped |
| Color | White to off-white | White to off-white | White to off-white |
| MaterialComposition | • Anorganic (porcine) bonemineral | • Anorganic (porcine) bonemineral | • Anorganic (bovine) bonemineral |
| • Purified (porcine) collagen | • Purified (porcine) collagen | ||
| Product Range(volume) | 0.5 cc to 2.0 cc | 0.5 cc to 4.0 cc | 0.2 cc to 1.2 cc |
| Biocompatible | Biocompatible | Biocompatible | |
| Biocompatibility | ISO 10993 | ISO 10993 | ISO 10993 |
| Sterile, SAL 10-6 | Sterile, SAL 10-6 | Sterile, SAL 10-6 | |
| Sterility | Gamma irradiation | Gamma irradiation | Gamma irradiation |
| ISO 11137 | ISO 11137 | ||
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single Use/Reuse | Single use only | Single use only | Single use only |
7. Performance Data
In vivo and in vitro testing of the subject device was conducted to demonstrate substantial equivalence of the subject device to its predicate devices. The following performance data are provided in support of the substantial equivalence determination.
Biocompatibility Testing
A series of in vitro and in vivo biocompatibility testing was performed to assess the safety of the subject device. Testing was determined in accordance with ISO 10993-1 and FDA Guidance on Use of International Standard ISO 10993-1 for the biological evaluation of medical devices within a risk management process. The biocompatibility testing performed is summarized in the table below.
| Test | Test Method | Results |
|---|---|---|
| Cytotoxicity | L929 MEM Elution Test, ISO10993-5 | Non-cytotoxic |
| Genotoxicity | Mouse Lymphoma Assay, ISO10993-3 | No evidence of causing increasein the mean mutant frequency ofthe L5178Y/TK+/- cell line either inthe presence or absence ofmetabolic inactivation. The testarticle was not mutagenic |
| Ames Assay | Non-mutagenic to Salmonellatyphimurium and to Escherichia |
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| Test | Test Method | Results |
|---|---|---|
| coli strain WP2uvra | ||
| Sensitization | Guinea Pig Maximization,ISO 10993-10 | No evidence of causing delayeddermal contact sensitization in theguinea pig |
| Irritation IntracutaneousReactivity | ISO Intracutaneous Reactivityin Rabbits, ISO 10993-10 | No evidence of irritation or toxicity |
| Acute SystemicToxicity | Acute Systemic Toxicity inMice, ISO 10993-3 | No mortality or evidence ofsystemic toxicity |
| Pyrogenicity | USP (151) Rabbit PyrogenStudyUSP <85> Bacterial EndotoxinTest | Non-pyrogenic |
| Implantation | Implantation in CanineIntrabony Defect Model, ISO10993-6 | Minimum tissue reaction up to 13weeks of implantation and noadverse tissue reaction to the host |
| Subacute / Subchronic /Chronic Toxicity | Implantation in CanineIntrabony Defect Model, ISO10993-11 | Minimum tissue reaction up to 13weeks of implantation and noadverse tissue reaction to the host |
Bench Testing
In vitro product characterization testing was performed to demonstrate substantial equivalence of the subject device to its predicate devices. A series of bench tests were conducted to evaluate material properties, biological properties, chemical and physical properties as indicated. Testing of the anorganic bone mineral component was conducted in accordance with ASTM F1581 Standard Specifications for Composition of Anorganic Bone for Surgical Implants.
| Test | Results |
|---|---|
| Mineral Content | Mineral content similar to predicate device |
| Size | Volumes similar to predicate device |
| Calcium to PhosphateRatio (mineral only) | Ratio similar to predicate device |
| Scanning ElectronMicrograph (SEM) | Morphologies similar to reference device |
| X-Ray Diffraction | Similar diffraction patterns to reference device |
| IR Spectroscopy | Similar functional groups to reference device |
| Density | Appropriate density for sufficient porosity |
| pH | pH similar to predicate device |
| Absorbency | Absorbency similar to predicate device |
| Pyrogenicity | Non-pyrogenic |
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Animal Testing
The performance of the device in a canine one-wall intrabony defect model was compared to the performance of the reference device. Bio-Oss Collagen. Radiographic, Micro CT, Histology and Histomorphometry analyses were conducted following implantation at 4, 8, and 13 weeks for the subiect device, reference device and sham negative control. The results demonstrate performance substantially equivalent to the reference device Bio-Oss Collagen when used as intended.
Animal Tissue Management
Animal tissues are managed in accordance with the following standards and quidance documents:
- ISO 22442-1 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical . Devices - Part 1: Analysis and Risk Management
- . ISO 22442-2 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical Devices - Part 2: Controls on Sourcing, Collection, and Handling
- ISO 22442-3 Animal Tissues and Their Derivatives Utilized in the Manufacture of Medical . Devices – Part 3: Validation of the Elimination and/or Inactivation of Viruses and Transmissible Agents
- Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro . Diagnostic Devices) Guidance for Industry and Food and Drug Administration Staff, CDRH, FDA, March 15, 2019
- FDA Guidance for Industry Q5A Viral Safety Evaluation of Biotechnology Products . Derived from Cell Lines of Human or Animal Origin, CDER, September 1998
Sterilization
Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of health care products - Radiation.
Shelf Life and Stability
Product and packaging stability was determined using real-time aging data. Performance testing of packaging system was tested in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems.
Viral Inactivation
Viral inactivation studies were performed in accordance with ISO 22442-3 to ensure the viral safety of the product.
Clinical Studies
Clinical performance data was not required to determine substantial equivalence.
8. Conclusions Drawn from Non-clinical Studies
The conclusions drawn from the nonclinical tests demonstrate that the device is substantially equivalent to its predicate devices.
§ 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.