(332 days)
No
The device description and performance studies focus on the material properties and clinical outcomes of a bone graft substitute, with no mention of AI or ML technology.
Yes
The device is a bone void filler used for the augmentation or reconstructive treatment of the alveolar ridge, filling of bone defects, and elevation of the maxillary sinus floor, which are therapeutic medical procedures.
No
The device description and intended use indicate that Cytrans Granules is a material used for augmentation or reconstructive treatment of the alveolar ridge and filling defects, which are therapeutic and restorative actions, not diagnostic.
No
The device description clearly states that the device is "Cytrans Granules," a physical material composed of carbonate apatite, intended for surgical implantation. This is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Description and Intended Use: The description and intended use of Cytrans Granules clearly indicate it is a bone graft substitute material used for surgical procedures to augment or reconstruct bone in the oral and maxillofacial region. It is implanted directly into the body to facilitate bone regeneration.
- Lack of Specimen Analysis: The device does not involve the analysis of specimens taken from the body. Its function is to act as a scaffold for bone growth within the body.
Therefore, Cytrans Granules falls under the category of a medical device used for surgical intervention, not an in vitro diagnostic device.
N/A
Intended Use / 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 Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR).
-Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration (GBR).
Product codes (comma separated list FDA assigned to the subject device)
LYC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral and maxillofacial region, upper and lower jawbones and alveolar bones, maxillary sinus
Indicated Patient Age Range
The clinical trial included patients aged 37-77.
Intended User / Care Setting
dental use (oral surgery, periodontal surgery, etc.)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical and clinical testing was conducted.
Biocompatibility testing: Cytotoxicity, Sensitization, Genotoxicity (reverse mutation), Genotoxicity (Chromosomal aberration), Intracutaneous Reactivity, Acute Toxicity and Sub-chronic Toxicity. Results found the device to be non-cytotoxic, nonirritating, and non-systemically toxic, with negative test results and no tissue damage observed.
Animal Studies: Beagle dog model, comparing three commercially available bone substitutes, for reconstruction of alveolar bone defects with simultaneous dental implant installation. The studies demonstrated that bone formation occurred faster with Cytrans Granules and showed a higher bone-to-implant contact ratio after 4 weeks and 12 weeks.
Clinical Trial: Conducted in Japan across three institutions, involving 22 patients (ages 37-77) with indications for sinus floor augmentation during placement of an implant for a maxillary molar.
Key results:
- 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 due to torque loading.
- 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). Implant placement torque average was 26.9 N.
- Success rate for the treatment was confirmed for the combined groups, exceeding the level deemed to be effective.
- 7±2 months after implantation, opacity due to the product or new bone formation was confirmed in the single-stage group by panoramic X-ray, and an average of 10.5 mm vertical residual bone was confirmed in the two-stage group by CT imaging.
- Tissue biopsy confirmed new bone formation in all cases of the two-stage group.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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 Jenkins
The Wood Burditt Group
10 E. Scranton Ave, Suite 201
Lake 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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Image /page/5/Picture/0 description: The image shows the logo for "The Wood Burditt Group". The text is arranged in three lines on the left side of the image, with the words "the" and "group" being smaller than the words "Wood" and "Burditt". A teal-colored, curved line is on the right side of the text, which appears to be a stylized letter C.
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).
| Descriptive
Information | Subject Device
Cytrans Granules (GC)
K192597 | Primary Predicate SynOss
Granules (Collagen Matrix)
K072397 | Reference Device Cerasorb M
(Curasan) K113282 |
|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | A synthetic bone grafting
material intended to fill,
augment, or reconstruct
periodontal and or bony defects
of the upper or lower jaw. | Synthetic calcium-phosphate-
based bone grafting material that
is intended for filling of defects
and extraction sockets, for
augmentation of the alveolar
ridge, and for elevation of the
maxillary sinus floor. | Resorbable, pure-phase P-TCP
matrix with interconnecting
porosity for bone regeneration
esp. for use in periodontal
therapy. |
| 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 periimplant defects
in conjunction with products
intended for Guided Bone
Regeneration (GBR). | -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 periimplant defects in
conjunction with products
intended for Guided Bone
Regeneration (GBR). | -Augmentation or reconstructive
treatment of the 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 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 perio-implant defects
in conjunction with products
intended for Guided Bone
Regeneration (GBR) |
| Device Design | Granule
Particle size
0.3-0.6 mm (S size),
0.6-1.0 mm (M size) | Granule
Particle size
0.35-1.0 mm | Granule
Particle size
0.15-0.5 mm, 0.5-1.0 mm,
1.0-2.0 mm |
| Composition of
Materials | Carbonate Apatite, 100%
(Carbonate content: ~12%) | Carbonate Apatite, 100%
(Carbonate content: ~5% ) | β-Tricalcium Phosphate, 100% |
| Resorption
Time | 6-24 months
Resorption will slow down after
covered with newly formed
bone. | 6-24 months | 6-24 months
99%
(150-2000 μm)
65vol% |
| Phase Purity*
(i.e. relative
mass
percentages
crystalline vs.
amorphous) | 85% (Crystalline) | Crystalline | Crystalline |
| Ca/P Ratio | 1.67/1 | 1.43/1 | 1.5/1 |
| Particle Size
Range
(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) |
| Volumeric
Porosity
(%) | 28% | 81 | 65% |
| pH | 7.8 | 7.8 | 7.8 |
| Sintering
Temperature | Not Applicable* (*device is
fabricated in aqueous solution). | 650°C | 1000°C |
| in vitro
dissolution
@ 25°C in pH
5.5 after 30
minutes | 14.8 mg/L (S size)
10.7 mg/L (M size) | 15.9 mg/L | 7.3 mg/L |
| in vitro
dissolution
@ 25°C in pH
7.3 after 30
minutes | 0.81 mg/L (S size)
0.52 mg/L (M size) | 0.52 mg/L | 0.42 mg/L |
| Chemical
Composition | Carbonate apatite: 100% | Carbonate apatite: 100% | β-tricalcium phosphate: 100%
Ca1O(PO4 C0 3)6(OH) 2 |
| Carbonate or
CO3 Content
(%) | 12% | 5 | Not Applicable |
| Product Code | LYC | LYC | LYC |
| Crushing
strength (N) | 2.75 N | 0.42 N | 1.97 N |
| Cited
Standards | -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 F756
ISO 11137, 11737-1 and 2
ISO 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 -- Part
1: Requirements for development, validation and routine
control 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.