(241 days)
Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.
Porcine Mineral Collagen Composite 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 (GBR).
Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.
The product is available in the following shape and sizes:
| Product Shape | Dimensions |
|---|---|
| Plug | 10mm (5mm dry) x 17mm (diameter x length) |
| Umbrella | 17mm (13mm dry) x 10mm (diameter x height) |
| Umbrella | 22mm (17mm dry) x 12mm (diameter x height) |
This document describes the performance data for a medical device called "Porcine Mineral Collagen Composite" in the context of its 510(k) premarket notification to the FDA. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily focuses on demonstrating substantial equivalence through various performance tests rather than against explicit numerical "acceptance criteria" in the way one might see for an AI algorithm's sensitivity/specificity. However, the outcomes of these tests effectively serve as the criteria for acceptance to demonstrate equivalence to the predicate device.
| Test Category | Specific Test (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Sensitization (ISO 10993-10) | No evidence of causing delayed dermal contact sensitization in the guinea pig | |
| Irritation Intracutaneous Reactivity (ISO 10993-10) | No evidence of irritation or toxicity | |
| Acute Systemic Toxicity (ISO 10993-3) | No mortality or evidence of systemic toxicity | |
| Pyrogenicity (USP 151, USP 85) | Non-pyrogenic | |
| Genotoxicity (Mouse Lymphoma Assay, ISO 10993-3) | No evidence of causing increase in the mean mutant frequency of the L5178Y/TK+/- cell line; not mutagenic | |
| Genotoxicity (Ames Assay) | Non-mutagenic to Salmonella typhimurium and to Escherichia coli strain WP2uvra | |
| Implantation (Canine Intrabony Defect Model, ISO 10993-6) | Minimum tissue reaction at 4, 8, and 13 weeks of implantation and no adverse tissue reaction to the host | |
| Subacute / Subchronic / Chronic Toxicity (Canine Intrabony Defect Model, ISO 10993-11) | Minimum tissue reaction at 4, 8, and 13 weeks of implantation and no adverse tissue reaction to the host | |
| Formaldehyde Residuals (Toxicology Risk Assessment) | Amount of formaldehyde residual for single product use has been addressed. No long-term toxicological effects are anticipated for single use. (Note: Risk of exposure to formaldehyde has not been addressed when multiple products are used.) | |
| Bench Testing | Mineral Content | Similar to predicate devices |
| Size | Similar to predicate devices | |
| Calcium to Phosphate Ratio (mineral only) | Similar to predicate device | |
| Scanning Electron Micrograph (SEM) - Morphologies | Similar to reference device | |
| X-Ray Diffraction - Diffraction Patterns | Similar to reference device | |
| IR Spectroscopy - Functional Groups | Similar to reference device | |
| Porosity | Similar to predicate | |
| pH | Similar to predicate device | |
| Absorbency | ≥ 5ml/g | |
| Pyrogenicity | Non-pyrogenic | |
| Animal Testing | Canine One-Wall Intrabony Defect Model (Radiographic, Micro CT, Histology, Histomorphometry analyses) | Performance substantially equivalent to the predicate device Bio-Oss® Collagen when used as intended. |
| Sterilization | Validation (ISO 11137-1, 11137-2, 11737) | Performed in accordance with standards |
| Pyrogenicity | Finished product release test (LAL endotoxin test, USP 85) | Non-pyrogenic (Each batch tested) |
| Shelf Life/Stability | Product and Packaging Stability (ASTM D4169, ISO 11607) | Determined using data; performance testing of packaging system performed in accordance with ASTM D4169; selection, qualification, and validation of packaging performed in accordance with ISO 11607. |
| Viral Inactivation | Studies (ISO 22442-3) | Performed to ensure viral safety of the product. |
2. Sample Size Used for the Test Set and the Data Provenance:
- Biocompatibility Testing: The specific sample sizes for each biocompatibility test (e.g., number of guinea pigs for sensitization, number of mice for acute systemic toxicity) are not explicitly stated in the summary. The tests were performed in vitro (e.g., L929 MEM Elution) and in vivo (e.g., Guinea Pig Maximization, Rabbit Intracutaneous Reactivity, mice for systemic toxicity, canine for implantation).
- Bench Testing: Sample sizes for each bench test are not specified. These tests are inherently in vitro.
- Animal Testing (Canine Study): The sample size (number of canines) for the intrabony defect model is not specified. The study was in vivo, involving implantation at 4, 8, and 13 weeks. Its provenance is not stated (e.g., specific country or institution), but it's an animal study conducted to demonstrate performance.
- Data Provenance: The document does not explicitly state the country of origin for the data for any of the studies, nor does it explicitly classify them as "retrospective" or "prospective" as one would for human clinical trials. However, given the nature of the studies (biocompatibility, bench, animal), they would generally be considered prospective studies designed to evaluate the device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This level of detail is not provided for most tests.
- Animal Testing (Canine Study): Radiographic, Micro CT, Histology, and Histomorphometry analyses were conducted. While these analyses require expert interpretation (e.g., veterinary pathologists, radiologists), the number of experts and their specific qualifications are not specified in this summary. The "ground truth" here is derived from the scientific measurements and observations from these analyses compared to a predicate device and sham control.
- For in vitro and other standardized tests (e.g., cytotoxicity, pyrogenicity), the "ground truth" is typically the result of the standardized test itself, not expert consensus on interpretations.
4. Adjudication Method for the Test Set:
Not applicable or specified for the types of tests conducted. These are not studies requiring human expert adjudication of ambiguous cases, as would be common for AI in medical imaging. The studies focus on objective measurements and established biological responses.
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:
No. This type of study (MRMC for AI assistance) was not performed because:
- The device is a medical implant (bone graft material), not a software or AI-driven diagnostic tool.
- "Clinical performance data was not required to determine substantial equivalence" (Page 8), meaning human clinical trials comparing device performance or AI assistance were not deemed necessary for this 510(k) submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
No. This question is also specifically relevant for AI algorithms. The "Porcine Mineral Collagen Composite" is a physical device, so the concept of an "algorithm only" or "human-in-the-loop" performance study does not apply.
7. The Type of Ground Truth Used:
The ground truth for the performance evaluation of this device is established through a combination of:
- Standardized Test Results/Reference Values: For biocompatibility tests (e.g., non-cytotoxic, non-mutagenic), specific thresholds or qualitative outcomes defined by recognized standards (ISO, USP) serve as the ground truth.
- Predicate Device Equivalence: For many bench tests (e.g., mineral content, calcium to phosphate ratio, porosity, pH), the "ground truth" is similarity to the legally marketed predicate devices, as the goal is to demonstrate substantial equivalence.
- Pathological/Histological Findings: In the canine intrabony defect model, ground truth is derived from objective measurements (e.g., radiographic density, Micro CT analyses) and expert evaluation of tissue samples (histology, histomorphometry) for parameters like tissue reaction, new bone formation, etc.
8. The Sample Size for the Training Set:
This device does not involve a "training set" in the context of machine learning or AI models. Therefore, this question is not applicable.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for an AI model, this question is not applicable. The device's characteristics are inherent to its manufacturing process and tested through established laboratory and animal study protocols.
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Image /page/0/Picture/0 description: The image shows 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 in blue. Below the FDA logo is the word ADMINISTRATION.
4/2/2021
Collagen Matrix, Inc. Gloria Zuclich Director, Regulatory Affairs 15 Thornton Road Oakland, New Jersey 07436
Re: K202183
Trade/Device Name: Porcine Mineral Collagen Composite Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: February 28, 2021 Received: March 2, 2021
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 53 1 -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/cdrl-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-ind-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,
Sherrill Lathrop Blitzer
for Andrew Steen Assistant 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)
Device Name
Porcine Mineral Collagen Composite
Indications for Use (Describe)
Porcine Mineral Collagen Composite 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 Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- · Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR),
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☑ Production, Post-ATF MRA Import/Export | ☐ Own-Use, Post-ATF MRA Import/Export |
|---|---|
| ------------------------------------------------------------------------------ | --------------------------------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
__ Over-The-Counter Use (21 CFR 801 Subpart C)
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Collagen Matrix, Inc.
510(k) Summary 510(k) Submission No.: K202183 Porcine Mineral Collagen Composite
Page 1 of 6
510(k) SUMMARY
| 1. Applicant Information |
|---|
| Applicant Name: Collagen Matrix, Inc. |
| Address: 15 Thornton RoadOakland, New Jersey 07436 |
| Telephone: (201) 405-1477 |
| Fax: (201) 405-1355 |
| Contact Person: Gloria ZuclichDirector of Regulatory Affairsgzuclich@collagenmatrix.com |
| Date Prepared: April 2, 2021 |
| 2. Name of the Device |
| Device Trade Name: Porcine Mineral Collagen Composite |
| 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: Bio-Oss® CollagenGeistlich-Pharma AGK033815 |
| Reference Device(s): Anorganic Bone Mineral with Collagen in DeliveryApplicatorCollagen Matrix, Inc.K171008 |
| Collagen Dental Membrane – Porcine Type ICollagenCollagen Matrix, Inc.K110600 |
| Collagen Dental Wound DressingsCollagen Matrix, Inc.K122115 |
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4. Description of the Device
Porcine Mineral Collagen Composite is an osteoconductive bone mineral with collagen composite for bone grafting in periodontal. oral and maxillofacial surgery. The device is composed of anorganic bone mineral granules derived from porcine cancellous bone and collagen from porcine Achilles tendon in compressed, formaldehyde-crosslinked, preformed sponge matrices designed to fit the size of the defect upon hydration. The product is supplied sterile, non-pvrogenic and for single use only.
The product is available in the following shape and sizes:
| Product Shape | Dimensions |
|---|---|
| Plug | 10mm (5mm dry) x 17mm (diameter x length) |
| Umbrella | 17mm (13mm dry) x 10mm (diameter x height) |
| Umbrella | 22mm (17mm dry) x 12mm (diameter x height) |
5. Intended Use
Porcine Mineral Collagen Composite is intended to be used for bone grafting in periodontal, oral and maxillofacial surgeries.
Porcine Mineral Collagen Composite 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 (GBR).
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, product size range and/or product weight range. Differences in the physical form and product size range have been determined to be minor and are substantiated when compared to that of the cited reference device. The difference in product weight range offered for the subject device falls within the range supplied for the primary predicate device.
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| Feature | Porcine Mineral CollagenComposite(This Submission) | Bio-Oss® Collagen(K033815) | Anorganic Bone Mineralwith Collagen in DeliveryApplicator (K171008) |
|---|---|---|---|
| Indications forUse | Augmentation orreconstructive treatmentof alveolar ridge• Filling of infrabonyperiodontal defects• Filling of defects afterroot resection,apicoectomy, andcystectomy• Filling of extractionsockets to enhancepreservation of the• Elevation of maxillarysinus floor• Filling of periodontaldefects in conjunctionwith products intendedfor Guided TissueRegeneration (GTR) andGuided BoneRegeneration (GBR)• Filling of peri-implantdefects in conjunctionwith products intendedfor Guided BoneRegeneration (GBR) | 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 periodontaldefects in conjunctionwith products intendedfor Guided TissueRegeneration (GTR) andGuided BoneRegeneration (GBR)• Filling of peri-implantdefects in conjunctionwith products intendedfor Guided BoneRegeneration (GBR) | Augmentation orreconstructive treatmentof alveolar ridge• Filling of infrabonyperiodontal defects• Filing of defects afterroot resection,apicoectomy, andcystectomy• Filing of extractionsockets to enhancepreservation of thealveolar ridge• Elevation of maxillarysinus floor• Filling of periodontaldefects in conjunctionwith products intendedfor Guided TissueRegeneration (GTR) andGuided BoneRegeneration (GBR)• Filing of peri-implantdefects in conjunctionwith products intendedfor Guided BoneRegeneration (GBR) |
| Physical Form | Preformed sponge matrix | Block Shaped | Preformed sponge matrix |
| Color | White to off-white | White to off-white | White to off-white |
| MaterialComposition | • Anorganic bone mineral(calcium phosphate)• Type I collagen | • Anorganic bone mineral(calcium phosphate)• Type I collagen | • Anorganic bone mineral(calcium phosphate)• Type I collagen |
| Size (Dimension) | 10mm x 17mm17mm x 10mm22mm x 12mm | N/A | 4.8mm x 12.5mm4.8mm x 25.0mm4.8mm x 37.5mm |
| Weight | 80mg175mg350mg | 50mg100mg250mg500mg | N/A |
| Cross-linking | Crosslinked withformaldehyde | Unknown | Crosslinked withformaldehyde |
| Biocompatibility | BiocompatibleISO 10993 | BiocompatibleISO 10993 | BiocompatibleISO 10993 |
| Sterility | Sterile, SAL 10-6Gamma irradiationISO 11137 | Sterile, SAL 10-6Gamma irradiation | Sterile, SAL 10-6Gamma irradiationISO 11137 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic | Non-pyrogenic |
| Single Use/Reuse | Single use only | Single use only | Single use only |
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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 |
| Sensitization | Guinea Pig Maximization,ISO 10993-10 | No evidence of causing delayeddermal contact sensitization inthe guinea pig |
| Irritation IntracutaneousReactivity | ISO Intracutaneous Reactivity inRabbits, ISO 10993-10 | No evidence of irritation ortoxicity |
| Acute SystemicToxicity | Acute Systemic Toxicity in Mice,ISO 10993-3 | No mortality or evidence ofsystemic toxicity |
| Pyrogenicity | USP (151) Rabbit PyrogenStudyUSP <85> Bacterial EndotoxinTest | Non-pyrogenic |
| Genotoxicity | Mouse Lymphoma Assay, ISO10993-3 | No evidence of causing increasein the mean mutant frequency ofthe L5178Y/TK+/- cell line eitherin the presence or absence ofmetabolic inactivation. The testarticle was not mutagenic |
| Genotoxicity | Ames Assay | Non-mutagenic to Salmonellatyphimurium and to Escherichiacoli strain WP2uvra |
| Implantation | Implantation in Canine IntrabonyDefect Model, ISO 10993-6 | Minimum tissue reaction at 4, 8and 13 weeks of implantationand no adverse tissue reactionto the host |
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| Test | Test Method | Results |
|---|---|---|
| Subacute / Subchronic /Chronic Toxicity | Implantation in Canine IntrabonyDefect Model, ISO 10993-11 | Minimum tissue reaction at 4, 8,and 13 weeks of implantationand no adverse tissue reactionto the host |
A Toxicology Risk Assessment was performed to evaluate formaldehyde residuals. The assessment included an evaluation of information presented in scientific literature and biocompatibility testing conduct on the subject device as well as similar devices. The results of the assessment concluded that the amount of formaldehyde residual for single product use has been addressed. No long-term toxicological effects are anticipated. Risk of exposure to formaldehyde has not been addressed when multiple products are used in a single patient procedure.
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 bon 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 devices |
| Size | Sizes similar to predicate devices |
| 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 |
| Porosity | Porosity similar to predicate |
| pH | pH similar to predicate device |
| Absorbency | ≥ 5ml/g |
| Pyrogenicity | Non-pyrogenic |
Animal Testing
The performance of the device in a canine one-wall intrabony defect model was compared to the performance of the predicate device. Bio-Oss Collagen. Radiographic, Micro CT. Histology and Histomorphometry analyses were conducted following implantation at 4, 8, and 13 weeks for the subject device, reference device and sham negative control. The results demonstrate performance substantially equivalent to the predicate device Bio-Oss Collagen when used as intended.
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Animal Tissue Management
Animal tissues are managed in accordance with the following standards and guidance 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 Part 1 Requirements for development, validation and routine control of a sterilization process for medical devices. ISO 11137-2 Sterilization of health care products – Radiation Part 2 Establishing the sterilization dose, and ISO 11737 Sterilization of Medical Devices - Microbiological Method - Determination of the Population of Microorganisms on Products.
Pyrogenicity
Porcine Mineral Collagen Composite products are non-pyrogenic. Each batch of product manufactured is tested for endotoxin per the Limulus Amebocyte Lysate (LAL) endotoxin test. USP <85>. as a finished product release test.
Shelf Life and Stability
Product and packaging stability was determined using data. Performance testing of packaging system was tested in accordance with ASTM D4169 Standard Practice for Performance Testing of Shipping Containers and Systems. Selection, qualification, and validation of packaging were conducted in accordance with ISO 11607 Packaging for Terminally Sterilized Medical Devices - Requirements for Materials, Sterile Barrier Systems, and Packaging 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.