TI-OSS

K140021 · Chiyewon · NPM · Jun 5, 2015 · Dental

Device Facts

• Record ID: K140021
• Device Name: TI-OSS
• Applicant: Chiyewon
• Product Code: NPM · Dental
• Decision Date: Jun 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Ti-oss® is intended for use in dental surgery. The product is recommended for the following surgeries : Augmentation or reconstructive treatment of alveolar ridge Filling of periodontal defects Filling of defects after root resection, apicoectorny, and cystectorny 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

Device Story

Ti-oss is a sterile, porous, bovine-derived bone mineral matrix (anorganic hydroxyapatite). Supplied as cancellous or cortical granules in vials or syringe applicators. Used by dentists/oral surgeons in clinical settings for bone grafting procedures; facilitates osteoconduction and new bone formation. Applied to surgical sites (alveolar ridge, periodontal defects, extraction sockets, maxillary sinus) to support bone regeneration; often used with GTR/GBR membranes. Provides structural scaffold for osteoblasts; promotes mineralization. Benefits patients by restoring bone volume for dental implant placement or periodontal health.

Clinical Evidence

Clinical evidence provided via a case series of 6 patients (ages 47-61) with various bone defects (alveolar ridge resorption, extraction defects, periodontal disease). Outcomes evaluated via baseline/follow-up radiographs and histological evaluation of core biopsies. Results demonstrated new bone growth and sufficient bone quality for subsequent dental implant placement. Additional evidence includes extensive bench testing: chemical/physical characterization (SEM, FT-IR, ICP, XRD), biocompatibility per ISO 10993, viral inactivation studies, and shelf-life testing per ASTM standards.

Technological Characteristics

Material: Anorganic bovine-derived hydroxyapatite bone mineral. Structure: Trabecular, interconnecting macro/micro pores. Form: Granules (0.2-1.7mm) in vials or syringe applicators. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ISO 3310-1 (particle size), ISO 11885 (ICP), USP 29 (FT-IR, pH, heavy metals), ASTM F88/F1140/F2096/F1929/F1608 (shelf life/packaging).

Indications for Use

Indicated for dental surgery patients requiring alveolar ridge augmentation, periodontal defect filling, root resection/apicoectomy/cystectomy defect filling, extraction socket preservation, maxillary sinus floor elevation, or peri-implant defect filling in conjunction with GTR/GBR products.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OCS-B™ (K113246)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 5, 2015

Chiyewon c/o Mr. Daniel Nam Pats Corp 4568 W. 1st St. Suite 104 Los Angeles. California 90004

Re: K140021 Trade/Device Name: Ti-oss® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: May 4, 2015 Received: May 5, 2015

Dear Mr. Nam:

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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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) Number (if known)

K140021

Device Name

Ti-oss®

Indications for Use (Describe)

Ti-oss® is intended for use in dental surgery.

The product is recommended for the following surgeries :

* Augmentation or reconstructive treatment of alveolar ridge

* Filling of periodontal defects

* Filling of defects after root resection, apicoectorny, and cystectorny

* 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

Type of Use (Select one or both, as applicable)

[ Prescription Use (Part 21 CFR 801 Subpart D)

[ ] Over-The-Counter Use (21 CFR 801 Subpart C)

## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

IN CONTROLLER CONSTITUTION FOR FOR FOR FOR FOR FOR FOR FOR FOR FOR Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

FORM FDA 3881 (1/14)

337 Produktion Services (30) 1443 6749

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

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# 510(k) Summary

[as required by 807.92(c)]

## 1. Applicant

CHIYEWON Co., Ltd. 6F., 192, Gyeongchun-ro, Guri-si, Gyeonggi-do, Republic of Korea Phone : [phone] Fax : [phone] Contact : Kim, Sung-O

2. Date Prepared : June 4, 2014

## 3. Device Name and Identification

Proprietary Name : Ti-oss® Device Class : Class II Regulation Number :21 C.F.R. 872.3930 Product Code : NPM Common / Usual Name : Animal Source Dental Bone Grafting Material Classification Name : Bone Grafting Material

# 4. Predicate Device

SE Number: K113246 Product name: OCS-B™ Company: NIBEC Co., Ltd.

#### 5. Indication for use

Intended for use in dental surgery.

The product is recommended for the following surgeries:

- Augmentation or reconstructive treatment of alveolar ridge
- Filling of periodontal defects
- Filling of defects after root resection, apicoectomy, and cystectomy

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- Filling of extraction sockets to enhance preservation of the alveolar ridge
- Elevation of maxillary sinus floor
- Filling of periodontal defects in conjunction with products intended for Guided Tissue Regeneration (GTR) and Guided Bone Regeneration (GBR)
- Filling of peri-implant defects in conjunction with products intended for Guided Bone Regeneration

# 6. Device Description

Ti-oss is a sterile, porous bone mineral matrix produced by the removal of organic compounds from bovine bone. It is supplied as cancellous (spongiosa) or cortical granules in a single use container, packaged in a secondary thermoform blister, and sterilized by yirradiation.

| Name as per Device Label | Model No. | Brief Description of Item |
|---------------------------|-----------|---------------------------------------------------------|
| Ti-oss®, 0.25g, 0.2-1.0mm | 25-0210 | 0.25g, 0.2-1.0mm particle size, granules in the<br>vial |
| Ti-oss®, 0.5g, 0.2-1.0mm | 05-0210 | 0.5g, 0.2-1.0mm particle size, granules in the vial |
| Ti-oss®, 1g, 0.2-1.0mm | 10-0210 | 1g, 0.2-1.0mm particle size, granules in the vial |
| Ti-oss®, 2g, 0.2-1.0mm | 20-0210 | 2g, 0.2-1.0mm particle size, granules in the vial |
| Ti-oss®, 0.1g, 0.5-1.2mm | 01-0512 | 0.1g, 0.5-1.2 mm particle size, granules in the<br>vial |
| Ti-oss®, 0.25g, 0.5-1.2mm | 25-0512 | 0.25g, 0.5-1.2mm particle size, granules in the<br>vial |
| Ti-oss®, 0.5g, 0.5-1.2mm | 05-0512 | 0.5g, 0.5-1.2mm particle size, granules in the vial |
| Ti-oss®, 1g, 0.5-1.2mm | 10-0512 | 1g, 0.5-1.2mm particle size, granules in the vial |
| Ti-oss®, 2g, 0.5-1.2mm | 20-0512 | 2g, 0.5-1.2mm particle size, granules in the vial |
| Ti-oss®, 0.1g, 1.2-1.7mm | 01-1217 | 0.1g, 1.2-1.7mm particle size, granules in the vial |
| Ti-oss®, 0.25g, 1.2-1.7mm | 25-1217 | 0.25g, 1.2-1.7mm particle size, granules in the<br>vial |

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| Ti-oss®, 0.5g, 1.2-1.7mm | 05-1217 | 0.5g, 1.2-1.7mm particle size, granules in the vial |
|-----------------------------------|----------|-----------------------------------------------------------------------|
| Ti-oss®, 1g, 1.2-1.7mm | 10-1217 | 1g, 1.2-1.7mm particle size, granules in the vial |
| Ti-oss®, 2g, 1.2-1.7mm | 20-1217 | 2g, 1.2-1.7mm particle size, granules in the vial |
| Ti-oss® Syringe, 0.25g, 0.5-1.2mm | S25-0512 | 0.25g, 0.5-1.2mm particle size, granules in the<br>Syringe applicator |
| Ti-oss® Syringe, 0.5g, 0.5-1.2mm | S05-0512 | 0.5-1.2mm particle size, , granules in<br>0.5g.<br>Syringe applicator |
| Ti-oss® Syringe, 0.25g, 1.2-1.7mm | S25-1217 | 0.25g, 1.2-1.7mm particle size, granules in the<br>Syringe applicator |
| Ti-oss® Syringe, 0.5g, 1.2-1.7mm | S05-1217 | 0.5g, 1.2-1.7mm particle size, granules in the<br>Syringe applicator |

# 7. Basis for Substantial Equivalence

Ti-oss® and OCS-B™ have a similar physical and chemical structure. Both are porous, biocompatible bone grafts that facilitate the formation and mineralization of new bone by the osteoblast. As both products have same source of bone (bovine source) and similar process for removal of organic compounds, the product is substantially equivalent to OCS-BTM

The following table summarizes the basis for the Sponsor's substantial equivalence determination:

#### Substantial Equivalence Comparison

| ITEM | Ti-oss® | OCS-B™ | Compatibility<br>w/other devices | Can be used with GTR membrane | Can be used with GTR membrane |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Intended Use | Intended for use in dental surgery.<br>The product is recommended for the<br>following surgeries:<br>- Augmentation or reconstructive<br>treatment of alveolar ridge<br>- Filling of periodontal defects<br>- Filling of defects after root resection,<br>apicoectomy, and cystectomy<br>- Filling of extraction sockets to | OCS-B™ cancellous and cortical<br>granules are recommended for:<br>- Augmentation or reconstructive<br>treatment of alveolar ridge<br>- Filling of infrabony periodontal<br>defects.<br>- Filling of defects after root<br>resection, apicoectomy, and<br>cystectomy | Sterilization<br>Process | Sterile by Gamma irradiation | Sterile by Gamma irradiation |
| - enhance preservation of the alveolar<br>ridge<br>- Elevation of maxillary sinus floor<br>- Filling of periodontal defects in<br>conjunction with products intended for<br>Guided Tissue Regeneration (GTR)<br>and Guided Bone Regeneration<br>(GBR)<br>- Filling of peri-implant defects in<br>conjunction with products intended for<br>Guided Bone Regeneration | - Filling of extraction sockets to<br>enhance preservation of the alveolar<br>ridge<br>- Elevation of maxillary sinus floor<br>- Filling of periodontal defects in<br>conjunction with products intended<br>for Guided Tissue Regeneration<br>(GTR) and Guided Bone<br>Regeneration (GBR)<br>- Filling of peri-implant defects in<br>conjunction with products intended<br>for Guided Bone Regeneration | Chemical<br>Composition | Similar to predicate based on chemical analysis, XRD, FT-IR and ICP analysis | Similar to based on chemical analysis, XRD, FT-IR and ICP analysis | |
| Target population | Human Oral, Periodontal | Human Oral, Periodontal | Anatomical sites | Oral, Periodontal | Oral, Periodontal |
| Dosage form | Granules contained in single use<br>container | Granules contained in single use<br>container | Non-pyrogenic | Yes | Yes |
| Granule sizes | 0,2mm to 1,0mm, 0.5mm to 1.2mm,<br>1.2mm to 1.7mm | 0.2mm to 1.0mm or 1.0mm to 2.0<br>mm granules | Shelf life | 2 years | Determined by Manufacturer |
| Material | Anorganic derived osteoconductive<br>hydroxyapatite bone mineral | Anorganic derived osteoconductive<br>hydroxyapatite bone mineral | Risk | Non-risk, as demonstrated by :<br>- Virus Clearance study<br>- Analysis of residual solvent<br>- Risk analysis<br>- Cleaning Validation | - |
| Source bone | Bovine bone | Bovine bone | | | |
| Physical<br>Morphology | Trabecular, interconnecting macro<br>and micro pores | Trabecular, interconnecting macro<br>and micro pores | | | |
| Biocompatibility | □ Appearance Test<br>□ Packaging test<br>□ Packaging (Dye infiltration test)<br>□ Demension (Particle size Test)<br>□ Weight Test<br>□ Ca/P ratio<br>□ Crystallinity<br>□ Heavy metal<br>□ Porosity<br>□ Solubility<br>□ Extraction<br>□ Sterility | Biocompatible (as demonstrated in<br>published literature) | | | |
| Performance | Bone formation | Bone formation | | | |

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# Brief Summary of Data Submitted

The Sponsor evaluated the performance characteristics of Ti-oss® and OCS-B™ with a thorough chemical and physical characterization. The physical and chemical characteristics of the products were found to be comparable as shown in the following:

- Appearance Test by visual inspection ●
- Particle Size test by ISO 3310-1 and particle size distribution ●
- Porosity, Pore size distribution, and level of interconnectivity .
- Weight Test by gravimetric ●
- Structure comparison by SEM ●
- FT-IR Analysis by USP 29 ●
- ICP Analysis by ISO 11885
- XRD Analysis .
- Loss on drying test ●
- pH test by USP 29 ●
- . KMnO4 Volume for Reduction Test
- UV(Ultraviolet) Absorbance Analysis ●
- Heavy metal test by USP 29 ●
- Residue on Ignition Test ●
- Pyrogenicity LAL testing ●
- . Sterility test by USP 29

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In a clinical case series, use of Ti-oss® resulted in defect healing and formation of new bone of sufficient quality to obtain dental implant placement. The patients were treated for intrabony periodontal defects. For each case study, the report includes baseline radiographs, radiographs at various time point, and core biopsy for histological evaluation. Histological and radiographic images demonstrate new bone growth and shown in the table as below.

| Case | Subject | Location | Bone defect type |
|--------|---------------|-------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Case 1 | 61-Y-O-Female | Left Maxillary First, Second<br>Molar area<br>(operation site : #26,27) | Insufficient alveolar ridge<br>height due to significant bone<br>resorption vertically and<br>laterally |
| Case 2 | 58-Y-O-Female | Right Maxillary First Molar<br>area<br>(operation site : #16) | Insufficient alveolar ridge<br>height due to pneumatization<br>and bone resorption |
| Case 3 | 53-Y-O-Male | Right Maxillary First Molar<br>area<br>(operation site : #16) | Big extraction defect with<br>vertical alveolar bone<br>resorption and insufficient<br>alveolar ridge height |
| Case 4 | 47-Y-O-Female | Right Maxillary First Molar<br>area<br>(operation site : #16) | Significant vertical and lateral<br>bone resorption with no<br>buccal and lingual wall |
| Case 5 | 57-Y-O-Female | Left Mandibular central<br>incisor area<br>(operation site : #31) | Significant bone loss on the<br>lingual side of central incisor |
| Case 6 | 47-Y-O-Male | Left Mandibular Second<br>Molar defect<br>(operation site : #37) | Big extraction defect caused<br>by advance periodontal<br>disease |

Ti-oss® granules and the application syringe were the subject of the full range of biocompatibility tests recommended in the FDA's "Class II. Special Controls Guidance Document : Dental Bone Grafting Devices" and in accordance with ISO 10993. Organic material has been removed from the product, and product specifications have been established to limit protein content. Throughout the risk analysis for each production step, for example, cleaning validation, the removal of organic solvent, the risk control was conducted during the manufacturing process. A viral inactivation study was conducted for BHV, BVDV, BPIV, and CPV viri. Further, the product is sterilized to achieve a sterility assurance level

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SAL 1 x 10°. Finally, accelerated and real-time shelf life testing was conducted according to ASTM F88, ASTM F1140, ASTM F2096, ASTM F1929, and ASTM F1608.

Based on the information presented herein, it has been demonstrated that Ti-oss is substantially equivalent to OCS-B'M.

# Conclusion

The Ti-oss® presents the same types of potential risks to consumers as the predicate device OCS-B™, and has controlled these risks in a similar manner. And biocompatibility tests and compatibility test show that the device meets the requirements of those standards.

Literatures, in vitro chemical and physical characterization tests, and clinical data show that the device is substantially equivalent. Comparison with the predicate device shows that the device has similar specification and performance.

Therefore, it is concluded that Ti-oss® is substantially equivalent to the predicate device.