(134 days)
Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- 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.
Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.
The document describes a 510(k) premarket notification for a medical device called "Anorganic Bone Mineral in Delivery Applicator". It does not describe a study involving an algorithm or AI.
Therefore, many of the requested categories (sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth type for test set, training set sample size, ground truth for training set) are not applicable to this document.
However, I can provide the acceptance criteria and demonstrated performance based on the non-clinical testing described.
1. Table of acceptance criteria and the reported device performance
| Feature | Acceptance Criteria / Standard | Reported Device Performance |
|---|---|---|
| Material/Source | Bovine Bone, Anorganic Bone Mineral | Bovine Bone (anorganic bone mineral) |
| Composition | 100% Anorganic Bone Mineral Granules | 100% Anorganic Bone Mineral Granules |
| Particle Size | 0.25 - 1.0 mm | 0.25 - 1.0 mm |
| Biocompatibility | Biocompatible (based on ISO standards) | Biocompatible (demonstrated by testing) |
| Sterility | Gamma irradiation, SAL 10^-6 | Gamma irradiation, SAL 10^-6 (validated based on ISO 11137-1) |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use | Single Use Only | Single Use Only |
| Plunger Force | Not explicitly defined as "acceptance criteria", but a performance measure for the delivery applicator | 8.18 ± 3.8 N (measured for the subject device) |
Additional Non-Clinical Performance Testing:
- Biocompatibility of Sterile Finished Device: Cytotoxicity, irritation, and sensitization tests were performed and demonstrated biocompatibility. (Specific acceptance criteria for these individual tests are not detailed, but the conclusion states they were met.)
- Biocompatibility of Delivery Applicator: Cytotoxicity, physicochemical attributes of a polymeric material, and USP <661> physicochemical tests were performed. (Specific acceptance criteria not detailed, but the conclusion states they were met.)
- Biocompatibility of Anorganic Bone Mineral: Cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, and subacute/subchronic toxicity tests were performed. (Previously submitted and deemed applicable, conclusion states they were met.)
- Sterilization Validation: Performed in accordance with ISO 11137-1. (Implies meeting the SAL 10^-6 requirement.)
- Bench Testing of Delivery Applicator Functionality and Customer Assessment: Performed. (Implies proper functioning of the applicator.)
- Animal Performance Testing:
- Anorganic Bone Mineral (derived from porcine bone tissue): Tested in an intraoral defect in a canine model.
- Anorganic Bone Mineral with and without Collagen: Tested in a rabbit femoral condyle defect model.
(These studies supported the performance of the bone mineral component, which is part of the subject device.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study. The relevant "tests" involved laboratory-based biocompatibility, sterilization validation, and bench testing, as well as animal studies. The sample sizes for these specific non-clinical tests (e.g., number of animals, number of test samples for material characterization) are not detailed in this summary.
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, as this document describes non-clinical performance testing for a medical device (bone graft material and applicator), not an AI/algorithm study requiring expert-established ground truth.
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.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as this document describes non-clinical performance testing not requiring a clinical "ground truth" as typically defined for diagnostic AI. The "ground truth" for these tests would be the established scientific standards and methods for assessing material properties, biocompatibility, and sterility.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2017
Collagen Matrix, Inc. Danielle Lindner Senior Regulatory Affairs Associate II 15 Thornton Road Oakland, New Jersey 07436
Re: K170541
Trade/Device Name: Anorganic Bone Mineral In Delivery Applicator Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: NPM Dated: February 21, 2017 Received: February 23, 2017
Dear Danielle Lindner:
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 mav publish further announcements concerning your device in the Federal Register.
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Mary S. Runner -A
Lori Wiggins Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K170541
Device Name
Anorganic Bone Mineral in Delivery Applicator
Indications for Use (Describe)
Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- · 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) |
|---|
| Experimental Use (Applicable to STEs Only) - Project or Pilot |
| Routine Use (Applicable to STEs Only) - Production |
|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 K170541
Applicant Information
| Applicant Name: | Collagen Matrix, Inc. |
|---|---|
| Owner Operator No.: | 9043463 |
| Address: | 15 Thornton RoadOakland, New Jersey 07436 |
| Telephone: | (201) 405-1477 |
| Fax: | (201) 405-1355 |
| Contact Person: | Danielle LindnerSenior Regulatory Affairs Associate II(201) 405 -1477dlindner@collagenmatrix.com |
| cc: | Peggy HansenSenior VP, Quality and Regulatory Affairs(201) 405 -1477phansen@collagenmatrix.com |
| Date Prepared: | February 21, 2017 |
Name of Device
| Trade Name: | Anorganic Bone Mineral in Delivery Applicator |
|---|---|
| Common Name: | Bone Grafting Material |
| Classification Name: | Bone Grafting Material, Animal Source21 CFR 872.3930NPMClass IIDental |
Legally Marketed Devices to Which Substantial Equivalence is Claimed
Predicate Device(s) Anorganic Bone Mineral (K043034) Anorganic Bone Mineral with Collagen (K043034) Anorganic Bone Mineral with Collagen Blocks (K043034)
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| Reference Predicates: | Porcine Anorganic Bone Mineral in Delivery ApplicatorK16215821 CFR 872.3930Bone Grafting MaterialClass IINPM |
|---|---|
| Geistlich Bio-Oss Pen®K12060121 CFR 872.3930Bone Grafting MaterialClass IINPM |
Description of the Device
Anorganic Bone Mineral in Delivery Applicator are porous bone mineral matrices consisting of calcium phosphate derived from bovine bone without the addition of bovine type I collagen, preloaded into a delivery applicator for ease of placement in the defect site. The anorganic bone mineral component is produced by removal of the organic components from bovine bone. Anorganic Bone Mineral in Delivery Applicator is sterilized by gamma irradiation. The products are non-pyrogenic and for single use only.
Indications for Use
Anorganic Bone Mineral in Delivery Applicator is intended for use in dental surgery. The products may be used in surgical procedures such as:
- . 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.
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Page 3 of 3
Summary/Comparison of Technical Characteristics
The delivery applicator has been designed to deliver the anorganic bone mineral products to the intended treatment area that may be more difficult to reach. The significant modifications that were made are (i) additional sizes offered to the user in a pre-loaded applicator and (ii) new packaging configuration. The key device characteristics, environment for use, performance specifications, principals of operation, mechanism of action and technological characteristics remain unchanged.
The addition of the delivery applicator does not affect the product performance of the bone grafting material, and therefore does not affect substantial equivalence when comparing the subject device to its predicate device. The table below summarizes the comparison of technical characteristics.
| Feature | Anorganic Bone Mineral in DeliveryApplicator (Subject Device) | Anorganic Bone Mineral with orwithout Collagen (K043034) |
|---|---|---|
| Indications for Use | - Augmentation or reconstructivetreatment of alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection,apicoectomy, and cystectomy- Filling of extraction sockets- Elevation of maxillary sinus floor- Filling of periodontal and peri-implantdefects in conjunction with productsintended for GTR and GBR | - Augmentation or reconstructivetreatment of alveolar ridge- Filling of infrabony periodontal defects- Filling of defects after root resection,apicoectomy, and cystectomy- Filling of extraction sockets- Elevation of maxillary sinus floor- Filling of periodontal and peri-implantdefects in conjunction with productsintended for GTR and GBR |
| Material | Anorganic Bone Mineral | Anorganic Bone Mineral with or withoutPurified Type I Collagen |
| Source | Bovine bone (anorganic bone mineral) | Bovine bone (anorganic bone mineral)with or without bovine tendon (collagen) |
| Composition | Granules: 100% anorganic bone mineral | Granules: 100% anorganic bone mineralGranules with Collagen:90% anorganic bone mineral & 10%collagen |
| Sizes | 0.25 cc, 0.5 cc, 0.75 cc, 1.0 cc | 0.25 g, 0.5 g, 1.0 g, 2.0 g |
| Particle Size Range | 0.25 - 1.0 mm | 0.25 - 1.0 mm (small particle size)1.0 - 2.0 mm (large particle size) |
| Biocompatibility | Biocompatible | Biocompatible |
| Packaging | Plastic delivery applicator in a singleblister tray with Tyvek lid | Glass vial with plastic screw cap in asingle blister with Tyvek lid |
| Plunger Force | 8.18 ± 3.8 N | Not applicable |
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| Feature | Anorganic Bone Mineral in DeliveryApplicator (Subject Device) | Anorganic Bone Mineral with orwithout Collagen (K043034) |
|---|---|---|
| Sterility | Gamma irradiationSAL 10-6 | Gamma irradiationSAL 10-6 |
| Pyrogenicity | Non-pyrogenic | Non-pyrogenic |
| Single Use | Single Use Only | Single Use Only |
Non-Clinical Performance Testing
To demonstrate substantial equivalence, the following non-clinical performance testing on the subject device was performed:
- . Biocompatibility of Sterile Finished Device: cytotoxicity, irritation, and sensitization
- Biocompatibility of Delivery Applicator: cytotoxicity, physicochemical attributes of a polymeric material, containers - plastics, physicochemical tests USP <661>
- Biocompatibility of Anorganic Bone Mineral (previously submitted in the company's own predicate device premarket notification and applicable to the subject device): cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, pyrogenicity, implantation, subacute/subchronic toxicity
- Sterilization validation was performed in accordance with ISO 11137-1 Sterilization of ● health care products - Radiation
- Bench testing of delivery applicator functionality and customer assessment. ●
- Animal performance testing of the Anorganic Bone Mineral derived from porcine bone . tissue (K140714) in an intraoral defect in a canine model and the Anorganic Bone Mineral with and without Collagen (K043034) in a rabbit femoral condyle defect model.
Conclusion
The results of the in vitro product characterization studies, functionality testing, animal performance testing, and biocompatibility studies show that the Anorganic Bone Mineral in Delivery Applicator is substantially equivalent to its predicate device.
§ 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.