(332 days)
-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, and cystectomy.
-Filling of extraction sockets to enhance preservation of the alveolar ridge.
-Elevation of the 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).
Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula. Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.
The provided text describes the 510(k) submission for Cytrans Granules, a bone grafting material. While it discusses performance testing, it does not explicitly state acceptance criteria in a quantitative table or directly link numerical performance results to specific criteria. The document focuses on demonstrating substantial equivalence to a predicate device rather than meeting predefined acceptance criteria for a novel performance claim.
However, based on the information provided, we can infer the aspects of performance that were evaluated and deemed acceptable for the device to be considered substantially equivalent.
Here's an attempt to structure the information according to your request, acknowledging the limitations of the provided text:
Acceptance Criteria and Device Performance for Cytrans Granules
1. Table of Acceptance Criteria and Reported Device Performance
As specific quantitative "acceptance criteria" for the device's clinical performance are not explicitly stated in the document (which is common for 510(k) submissions focusing on substantial equivalence), the table below infers the performance aspects that were evaluated and found acceptable relative to the predicate devices and general expectations for bone grafting materials. The "Reported Device Performance" column reflects the findings from the non-clinical and clinical studies.
| Performance Aspect (Inferred Acceptance Criterion) | Reported Device Performance |
|---|---|
| Biocompatibility | - Non-cytotoxic |
| (Materials must be safe for biological systems, | - Non-irritating |
| non-toxic, and non-sensitizing) | - Non-systemically toxic |
| - Negative test results with no tissue damage observed in Cytotoxicity, Sensitization, Genotoxicity (reverse mutation and chromosomal aberration), Intracutaneous Reactivity, Acute Toxicity, and Sub-chronic Toxicity tests (in accordance with ISO 10993). | |
| Bone Formation / Regeneration | - Animal Studies: Bone formation occurred faster with Cytrans Granules compared to some commercially available bone substitutes in a beagle dog model for alveolar bone defects with simultaneous dental implant installation (evaluated at 12 weeks). New bone formation occurred faster and demonstrated a higher bone-to-implant contact ratio after 4 and 12 weeks in a beagle mandible model. |
| (Device must promote or facilitate new bone | - Clinical Study (Sinus Floor Augmentation): All major evaluation items exceeded the level deemed to be effective for the combined single-phase and two-phase treatment groups. |
| growth and integration) | - Clinical Study (Sinus Floor Augmentation): Opacity due to the product or new bone formation confirmed by panoramic X-ray in the single-stage group (7±2 months post-implantation). Average 10.5 mm vertical residual bone confirmed by CT imaging in the two-stage group. Tissue biopsy confirmed new bone formation in all cases of the two-stage group. |
| Mechanical Stability / Implant Integration | - Clinical Study (Sinus Floor Augmentation): No rotation or movement occurred in any of the cases due to torque loading (single-stage treatment group). Implant placement torque of 26.9 N average (two-stage treatment group). |
| (Device must provide adequate support and allow | |
| for implant placement/integration) | |
| Resorption Properties | - Resorption time: 6-24 months. Resorption slows down after being covered with newly formed bone. (Comparable to predicate device) |
| (Device should resorb over time and be replaced | |
| by natural bone) | |
| Physical and Chemical Specifications | - Meets specifications for: chemical composition (100% Carbonate Apatite, ~12% Carbonate content, Ca/P ratio 1.67/1), particle size (0.3-0.6 mm S size, 0.6-1.0 mm M size), shape, porosity (28%), resorption properties, phase purity (85% crystalline), crushing strength (2.75 N), pH (7.8), and water solubility (in vitro dissolution @ 25°C in pH 5.5 after 30 min: 14.8 mg/L (S), 10.7 mg/L (M); in vitro dissolution @ 25°C in pH 7.3 after 30 min: 0.81 mg/L (S), 0.52 mg/L (M)). |
| (Device must conform to defined material | |
| characteristics) | |
| Sterility | - Sterilized to a Sterility Assurance Level (SAL) of 1 x 10^-6. |
| (Device must be sterile) | - Sterilization cycle validated in accordance with FDA's Quality Systems Regulation and ISO 11137-1:2006, compliance with ISO 11137-2. |
2. Sample Size Used for the Test Set and Data Provenance
-
Test Set (Clinical Study):
- Sample Size: 22 cases (patients) for sinus floor augmentation (excluding 6 cases due to exclusion criteria).
- Data Provenance: Japan (stated as "three institutions in Japan"). The study was prospective clinical testing.
-
Test Set (Animal Studies):
- Sample Size: Not explicitly stated beyond "a beagle dog model" where "three commercially available bone substitutes" were compared. It implies multiple animals were used, but the exact number is not provided.
- Data Provenance: Not specified, but generally animal studies typically involve institutional animal care and use committee approval from the research facility.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not explicitly state the number of experts used or their detailed qualifications for establishing ground truth in the clinical study.
- For a clinical study involving sinus floor augmentation and dental implants, it is implicitly understood that the "ground truth" (e.g., successful implant placement, bone formation assessment, complication rates) would be established by qualified dental surgeons and potentially radiologists/pathologists involved in patient follow-up and evaluation (panoramic X-ray, CT imaging, tissue biopsy).
- The study was conducted across "three institutions in Japan," suggesting that multiple clinical professionals were involved in the evaluations.
4. Adjudication Method for the Test Set
- The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1).
- Clinical trials typically involve standardized protocols for evaluation and data collection, and any discrepancies might be resolved by consensus or a senior investigator, but a formal adjudication process beyond standard clinical practice is not mentioned. Outcomes like "success rate...exceeded the level deemed to be effective" suggest a predefined standard, but not a specific adjudication protocol.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done in the context of comparing human readers' performance with and without AI assistance. This document describes a medical device (bone grafting material), not an AI-powered diagnostic or assistive tool.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Not applicable. This device is a bone grafting material, not an algorithm or AI system. Its performance is evaluated through its biological interaction within the patient's body, not as a standalone software algorithm.
7. Type of Ground Truth Used
- Clinical Study (Sinus Floor Augmentation):
- Clinical Outcomes Data: Successful implant placement, lack of rotation/movement, implant placement torque, absence of complications.
- Imaging Data: Opacity on panoramic X-ray and vertical residual bone on CT imaging confirming new bone formation.
- Pathology/Histology: Tissue biopsy confirming new bone formation in all cases of the two-stage group.
- Animal Studies: New bone formation, bone-to-implant contact ratio (likely assessed histologically and/or with imaging).
- Biocompatibility Testing: Lab-based tests (Cytotoxicity, Sensitization, Genotoxicity, etc.) with established assay endpoints and interpretations.
8. Sample Size for the Training Set
- Not applicable. This is a medical device, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The device's development involved material science, preclinical, and clinical testing, but not an ML training paradigm.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set (for AI/ML), there is no ground truth established for it. The "ground truth" equivalent in medical device development would be the scientific and clinical validation of its material properties, biological interactions, and clinical efficacy through established testing methods and clinical trials.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
August 17, 2020
GC America, Inc. % H. Jenkins Official Correspondent Wood Burditt Group 10 E. Scranton Ave., Ste. 201 Lake Bluff, Illinois 60045
Re: K192597
Trade/Device Name: Cytrans Granules Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: Class II Product Code: LYC Dated: August 13, 2020 Received: August 14, 2020
Dear H. Jenkins:
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 (OS) 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 medical devices and radiation-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 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) K192597
Device Name Cytrans Granules
Indications for Use (Describe)
-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, and cystectomy.
-Filling of extraction sockets to enhance preservation of the alveolar ridge.
-Elevation of the 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K192597 510(k) Summary
Date prepared: August 17, 2020
| Submitter / Contact Person | H. Carl JenkinsThe Wood Burditt Group10 E. Scranton Ave, Suite 201Lake Bluff, IL 60044 |
|---|---|
| (ph.) 847-234-7500 x 205(fax) 847-578-0728(email) hcjenkins@woodburditt.com |
| Applicant | GC America Inc. |
|---|---|
| (Device Distributor) | 3737 W. 127th Street |
| Alsip, IL 60803 USA |
Device Name
| Trade / Proprietary Name | Cytrans Granules |
|---|---|
| Common Name | Bone Grafting Material, Synthetic |
| Classification Name | Bone Grafting Material |
| Classification Panel | Dental |
| Regulation | 21 CFR 872.3930 |
| Product Code | LYC |
| Classification | 2 |
Reason for 510(k) Submission
The applicant device is a new device.
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Predicate Device Summary Table
Substantial equivalence for the indications for use, safety, efficacy, and technological characteristics is based on Cytrans Granules being substantially equivalent to the following Predicate Device and Reference Device:
- Predicate Device: SynOss Granules (Collagen Matrix) K072397 -
- -Reference Device: Cerasorb M (Curasan) - K113282
| Subject Device | Predicate Device | Reference Device |
|---|---|---|
| Cytrans Granules | SynOss Granules(Collagen Matrix) | Cerasorb M(Curasan) |
| Subject Device | K072397 | K113282 |
Device Description
Cytrans Granules is composed of carbonate apatite. The material of Cytrans Granules has been formulated in terms of carbonate apatite content to the mineral content of natural bone. As Cytrans Granules is completely synthetic, there are no animal derived ingredients in the formula.
Cytrans Granules is gradually resorbed and eventually replaced with new bone. Resorption is by osteoclasts under acidic conditions. Cytrans Granules is manufactured by a validated manufacturing process which guarantees batch to batch conformity and reproducibility. It is sterilized via gamma irradiation and will be marketed/sold in sterile vials for single use.
Intended use:
Cytrans Granules is bone graft substitute material for dental use (oral surgery, periodontal surgery, etc.), intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
It is used for filling bone defects in the upper and lower jawbones and alveolar bones. It is used to fill a site where the implant is exposed during implant placement, to fill the bone defect during the implant placement procedure.
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Indications for Use:
-Augmentation or reconstructive treatment of the alveolar ridge.
-Filling of periodontal defects.
-Filling of defects after root resection, apicocetomy, and cystectomy.
-Filling of extraction sockets to enhance preservation of the alveolar ridge.
-Elevation of the 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).
| DescriptiveInformation | Subject DeviceCytrans Granules (GC)K192597 | Primary Predicate SynOssGranules (Collagen Matrix)K072397 | Reference Device Cerasorb M(Curasan) K113282 |
|---|---|---|---|
| Intended Use | A synthetic bone graftingmaterial intended to fill,augment, or reconstructperiodontal and or bony defectsof the upper or lower jaw. | Synthetic calcium-phosphate-based bone grafting material thatis intended for filling of defectsand extraction sockets, foraugmentation of the alveolarridge, and for elevation of themaxillary sinus floor. | Resorbable, pure-phase P-TCPmatrix with interconnectingporosity for bone regenerationesp. for use in periodontaltherapy. |
| Indications forUse | -Augmentation orreconstructive treatment of thealveolar ridge.-Filling of periodontal defects.-Filling of defects after rootresection, apicocetomy, andcystectomy.-Filling of extraction sockets toenhance preservation of thealveolar ridge.-Elevation of the maxillarysinus floor.-Filling of periodontal defectsin conjunction with productsintended for Guided TissueRegeneration (GTR) andGuided Bone Regeneration(GBR).-Filling of periimplant defectsin conjunction with productsintended for Guided BoneRegeneration (GBR). | -Augmentation or reconstructivetreatment of the alveolar ridge.-Filling of periodontal defects.-Filling of defects after rootresection, apicocetomy, andcystectomy.-Filling of extraction sockets toenhance preservation of thealveolar ridge.-Elevation of the maxillary sinusfloor.-Filling of periodontal defects inconjunction with productsintended for Guided TissueRegeneration (GTR) and GuidedBone Regeneration (GBR).-Filling of periimplant defects inconjunction with productsintended for Guided BoneRegeneration (GBR). | -Augmentation or reconstructivetreatment of the alveolar ridge.-Filling of infrabony periodontaldefects.-Filling of defects after rootresection, apicoectomy, andcystectomy.-Filling of extraction sockets toenhance preservation of thealveolar ridge.-Elevation of the maxillary sinusfloor.-Filling of periodontal defects inconjunction with productsintended for Guided TissueRegeneration (GTR) and GuidedBone Regeneration (GBR)-Filling of perio-implant defectsin conjunction with productsintended for Guided BoneRegeneration (GBR) |
| Device Design | GranuleParticle size0.3-0.6 mm (S size),0.6-1.0 mm (M size) | GranuleParticle size0.35-1.0 mm | GranuleParticle size0.15-0.5 mm, 0.5-1.0 mm,1.0-2.0 mm |
| Composition ofMaterials | Carbonate Apatite, 100%(Carbonate content: ~12%) | Carbonate Apatite, 100%(Carbonate content: ~5% ) | β-Tricalcium Phosphate, 100% |
| ResorptionTime | 6-24 monthsResorption will slow down aftercovered with newly formedbone. | 6-24 months | 6-24 months> 99%(150-2000 μm)65vol% |
| Phase Purity*(i.e. relativemasspercentagescrystalline vs.amorphous) | 85% (Crystalline) | Crystalline | Crystalline |
| Ca/P Ratio | 1.67/1 | 1.43/1 | 1.5/1 |
| Particle SizeRange(µg/mm3) | 0.3-0.6 mm (S size),0.6-1.0 mm (M size) | 0.250-1.0mm (250-1000μm) | 0.150-2.0 mm (150-2000 μm)(150-500/ 500-1000/ 1000-2000μm, provided in cc) |
| VolumericPorosity(%) | 28% | 81 | 65% |
| pH | 7.8 | 7.8 | 7.8 |
| SinteringTemperature | Not Applicable* (*device isfabricated in aqueous solution). | 650°C | 1000°C |
| in vitrodissolution@ 25°C in pH5.5 after 30minutes | 14.8 mg/L (S size)10.7 mg/L (M size) | 15.9 mg/L | 7.3 mg/L |
| in vitrodissolution@ 25°C in pH7.3 after 30minutes | 0.81 mg/L (S size)0.52 mg/L (M size) | 0.52 mg/L | 0.42 mg/L |
| ChemicalComposition | Carbonate apatite: 100% | Carbonate apatite: 100% | β-tricalcium phosphate: 100%Ca1O(PO4 C0 3)6(OH) 2 |
| Carbonate orCO3 Content(%) | 12% | 5 | Not Applicable |
| Product Code | LYC | LYC | LYC |
| Crushingstrength (N) | 2.75 N | 0.42 N | 1.97 N |
| CitedStandards | -ISO 14971:2007-ISO 13779-3:2008-ISO 13485:2003-ISO 11137-1:2006-JIS Z 8841:1993 (TBC)-JIS K 0061:2001 (TBC)-JIS T 0330-3:2012(ISO 13175-3:2012)-ISO 10993-5:2009-ISO 10993-6:2007-ISO 10993-10:2010-ISO 10993-11:2006-ISO 10993-12:2007 | -ANSI/AAMI/ISO 11137:2003-ISO 10993, 3rd edition | ASTM F1088 ISO 10993;ASTM F756ISO 11137, 11737-1 and 2ISO 14971 |
Technological Characteristics
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The Wood Burditt Group LLC
Total L. Scranton Ave., Suite 2014
10 E. Scranton Ave., Suite 2014
10 E. Scranton Ave., 2017 144
847. 233. 233. 2234. 27. 23. Jerl.)
847. 57. 847. www.woodburditt.com
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Image /page/7/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The words "the", "Wood", and "Burditt" are stacked on top of each other on the left side of the image. To the right of the words is a teal-colored graphic that resembles a crescent shape. The word "group" is located to the right of the crescent shape.
Performance Testing:
Nonclinical and clinical testing of Cytrans Granules was conducted to support the performance of the subject device for its intended use. In addition to shelf- life determination and pyrogenicity sampling plan, biocompatibility testing, animal studies and clinical testing were conducted to establish the performance of the subject device.
Biocompatibility testing conducted on the subject device demonstrates that the materials used in the design and manufacture of the subject device are non-toxic and non-sensitizing to biological bone and tissues with intended use. Calcium phosphate bone grafting materials of this composition are known to be biocompatible for this intended use. In order to further confirm the biocompatibility of Cytans Granules, the following tests in accordance with ISO 10993 were performed: Cytotoxicity, Sensitization, Genotoxicity (reverse mutation), Genotoxicity (Chromosomal aberration), Intracutaneous Reactivity, Acute Toxicity and Sub-chronic Toxicity. According the specified test conditions, Cytans Granules was found to be non-cytotoxic, nonirritating, and non-systemically toxic. Test results were negative with no tissue damage observed.
Animal studies conducted in a beagle dog model, comparing three commercially available bone substitutes at 12 weeks for the reconstruction of alveolar bone defects with simultaneous dental implant installation demonstrated that bone formation occurred faster with Cytrans Granules. Further, when comparing three commercially available bone substitutes in a beagle dog model, new bone formation occurred faster and demonstrated a higher bone-to-implant contact ratio
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Image /page/8/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The words "The Wood" are stacked on top of each other on the left side of the image. The word "Burditt" is on the right side of the image, and the word "group" is stacked below it. A teal-colored curved line connects the two sides of the logo.
after 4 weeks and 12 weeks for the reconstruction of alveolar bone defects of a beagle mandible with simultaneous dental implant installation.
A clinical trial involving three institutions in Japan and a total of 22 cases (ages: 37-77) of patients (not including excluded cases) with indications for sinus floor augmentation during placement of an implant for a maxillary molar (maximum quantity used was 2.5 g) was conducted. The exclusions were: mucosal hypertrophy with suspicion of inflammation, oro-nasal communication from past otolaryngology treatment, use of prohibited concomitant drugs (one case each), and three cases of perforated mucous membrane of the maxillary sinus. Sinus floor augmentation: single-stage treatment group (pre-operative bone thickness: 3.7 mm (minimum) -6.0 mm (maximum): average 5.2 mm, evaluation period: 6 months (minimum) - 8.5 months (maximum): average 7.5 months. No rotation or movement occurred in any of the cases due to torque loading. Sinus floor augmentation: two-stage treatment group (pre-operative bone thickness: 1.0 mm (minimum) - 5.0 mm (maximum): average 3.4 mm, evaluation period: 6 months (minimum) - 9.5 months (maximum): average 8 months. The implant placement torque was evaluated, with the result of 26.9 N average. Success rate for the treatment was calculated for the combined single-phase and two two-phase treatment groups, and it was confirmed that all major evaluation items exceeded the level deemed to be effective. Furthermore, 7±2 months after the implantation, opacity due to the product or new bone formation was confirmed in the single single-stage group by panoramic X-ray, and the average of 10.5 mm vertical residual bone was confirmed in the two two-stage group by CT imaging. In addition, tissue biopsy confirmed new bone formation in all cases of the two-stage group.
Performance testing demonstrates that (a) the Cytrans Granules product meets specifications in the following categories: chemical composition, particle size, shape, porosity, resorption properties, phase purity, crushing strength, pH, and water solubility; and (b) Cytrans Granules is substantially equivalent to the legally marketed primary predicate, meeting requisite characteristics.
Sterilization:
The device is sterilized to a sterility assurance level (SAL) of 1 x 106 using a sterilization cycle that has been validated in accordance with FDA's Quality Systems Regulation.
| ISO 11137-1:2006 | Sterilization of health care products -- Radiation -- Part1: Requirements for development, validation and routinecontrol of a sterilization process for medical devices | 14-428 |
|---|---|---|
| ------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------- |
Method Used to Validate the Sterilization Cycle: compliance with ISO 11137-2
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Image /page/9/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The logo consists of the words "the Wood" stacked on top of each other on the left side of the image. To the right of the words is the word "Burditt" stacked on top of the word "group". A teal-colored curved line connects the two parts of the logo.
Substantial Equivalence
Cytrans Granules is comparable to other calcium phosphate bone grafting materials on the market such as primary predicate SynOss (Collagen Matrix) K072397 and reference device Cerasorb M (Curasan) K113282. The devices feature the similar formulation and indications, with similar particle size distributions, morphology, volumetric porosity, and resorption characteristics. The subject device, Cytrans Granules, and its primary predicate share identical Indications for Use statements, namely to serve as a bone grafting material intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region, as well as peri-implant bony defects. They also share similar material composition and similar resorption profiles.
The primary difference between the subject device and its primary predicate is related to slight mechanical and physical characteristics, such as small differences in pore and particle sizes. The subject device features a slight difference in granule particle size from its primary predicate. ranging from 0.3 - 1.0 mm for Cytrans Granules (GC) K192597 and 0.35 - 1.0 mm for primary predicate SynOss Granules (Collagen Matrix) K072397. To address this difference in the larger granule particle sizes featured in Cytrans Granules, a reference device Cerasorb M (Curasan) K113282 is provided which features a range of pore sizes capturing those of the subject device. However, additional nonclinical testing results demonstrate that the any differences noted between Cytrans Granules and its primary predicate do not raise new concerns. An additional difference noted between the subject device and its primary predicate is volumetric porosity, which is much lower in the subject device when compared to its predicate and reference devices. However, the differences in volumetric porosity do not affect the intended use for demonstrating substantially equivalent bone formation, based on the provided animal and clinical testing.
Conclusion
The applicant device is substantially equivalent in its intended use, technology / principle of operation, ingredients, and performance to the primary predicate device identified in this 510(k) submission. There is no significant difference that raises any new concerns.
§ 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.