OCS-B COLLAGEN

K142040 · Nibec Co., Ltd. · NPM · Jul 31, 2015 · Dental

Device Facts

• Record ID: K142040
• Device Name: OCS-B COLLAGEN
• Applicant: Nibec Co., Ltd.
• Product Code: NPM · Dental
• Decision Date: Jul 31, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3930
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K142040 · Jul 31, 2015	OCS-B COLLAGEN	Nibec Co., Ltd.	Clinical case series	A clinical case series was used to demonstrate defect healing and new bone formation of sufficient quality for dental implant placement, supporting the device's biocompatibility and performance.	Clinical case series; Bone graft; Dental implant

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Clinical case series; Clinical case series	Patients requiring dental bone grafting/implant placement	Not applicable for this study	Defect healing and formation of new bone of sufficient quality to obtain dental implant placement

Indications for Use

OCS-B Collagen® is recommended for: 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 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)

Device Story

OCS-B Collagen is a bone grafting material composed of purified bovine cancellous bone mineral granules and 10% porcine-derived collagen. It is provided in block or cylindrical forms. Used by dental professionals in oral and maxillofacial surgery to fill intra-osseous cavities and defects. The device acts as an osteoconductive scaffold, facilitating new bone formation and mineralization by osteoblasts. It is intended to be used in conjunction with GTR or GBR membranes where applicable. The device is sterilized via gamma irradiation. Clinical benefit includes successful defect healing and preparation of bone quality sufficient for dental implant placement.

Clinical Evidence

Evidence includes chemical/physical characterization, animal studies demonstrating new bone growth and resorption rates comparable to the predicate, and a clinical case series showing successful defect healing and bone quality sufficient for dental implant placement. Biocompatibility testing performed per ISO 10993, including cytotoxicity, hemolysis, sensitization, genotoxicity, and implantation studies.

Technological Characteristics

Material: Anorganic bovine bone mineral granules and porcine-derived type I collagen. Morphology: Trabecular, interconnecting macro/micro pores. Dimensions: 0.2-1.0mm or 1.0-2.0mm granules; various block/cylinder sizes. Sterilization: Gamma irradiation (SAL 10^-6). Standards: ASTM F1581-99, ISO 10993, ISO 11137, ASTM F1980-99. Non-pyrogenic.

Indications for Use

Indicated for human oral and periodontal bone grafting, including alveolar ridge augmentation, filling of infrabony periodontal defects, defects post-root resection/apicoectomy/cystectomy, extraction sockets, maxillary sinus floor elevation, and peri-implant defects, often 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

• Bio-Oss Collagen® (K092428)
• OCS-B® (K113246)

Submission Summary (Full Text)

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

July 31, 2015

NIBEC CO., LTD c/o Mr. Daniel Nam PATS CORP 904 E. Windsor Road #102 Glendale, CA 91203

Re: K142040

Trade/Device Name: OCS-B Collagen® Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: NPM Dated: June 30, 2015 Received: July 2, 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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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) K142040

Device Name

OCS-B Collagen®

#### Indications for Use (Describe)

OCS-B Collagen ® is recommended for:

- 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 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)

| 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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# K142040 510(k) Summary

#### Sponsor/Applicant

NIBEC Co., Ltd. Iwol electricity-electronic Agro-industrial Complex, 116, Bamdi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do, Korea Phone: [phone] Fax: [phone] Contact: Dr. Park, Yoon-Jeong

Date Prepared : July 29, 2015

## Device Name and Identification

Proprietary Name: OCS-B Collagen® Bone Grafting Material Plus Collagen Common/Usual Name: Anorganic Bovine Bone Grafting Material Classification Name: Bone Filling Material Bone grafting material, animal source (NPM)

### Predicate devices

Bio-Oss Collagen® (K092428) (Primary Predicate) Manufactured by: Geistlich Pharma AG Bahnhofstrasse 40 CH-6110 Wolhusen Switzerland

OCS-B® (K113246) (Reference Predicate) Manufactured by: NIBEC Co., Ltd. lwol electricity-electronic Agro-industrial Complex, 116, Bamdi-gil, Iwol-myeon, Jincheon-gun, Chungcheongbuk-do, Korea

### Device Category/Class

Device Class: Regulation Number: Product Code:

Class II 21 C.F.R. 872.3930 NPM

### Intended use

OCS-B Collagen®is recommended for: Filling of large oral and maxillofacial intra-osseous cavities

### Indications for use

OCS-B Collagen® is recommended for:

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- 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 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)

### Device Description

OCS-B Collagen® is a combination of purified cancellous bone mineral granules (OCS-B") and 10% collagen in a block form in a blister and cylinderic form in a syringe and blister. It is sterilized by yirradiation.

### Basis for Substantial Equivalence

OCS-B Collagen® and Bio-Oss® Collagen 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. Both products have same component ratio of bone mineral granules and collagen. Both products have same source of bone (bovine bone), and collagen (porcine skin). The bone granules were treated through a specific process for removal of organic compound. The collagen was purified through specific process for removal of other proteins and organic compounds. Therefore, OCS-B Collagen® is substantially equivalent to Bio-Oss® Collagen.

The following is a table comparing OCS-B Collagen® and OCS-B® a Bone graft cleared for GBR.

#### Table 1: Substantial Equivalence Comparison

| | OCS-B Collagen® | Primary Predicate<br>Bio-Oss® Collagen*<br>(K092428) | | Reference Predicate<br>OCS-B®**<br>(K113246) | | Cylinderic<br>5.6X45 | 500mg | | | | |
|----------------------|----------------------------------------------------------------------------|--------------------------------------------------------------|---------------|--------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|
| ITEM | | | | | Material | Anorganic derived<br>osteoconductive hydroxyapatite<br>(pre-sterilized product of OCS-<br>B® (K113246), Collagen | Anorganic derived<br>osteoconductive<br>hydroxyapatite,<br>Collagen | Anorganic derived<br>osteoconductive<br>hydroxyapatite bone<br>mineral | | | |
| Intended<br>Use | Used as an adjective therapy in<br>restoring bony defects | Used as an adjective<br>therapy in restoring<br>bony defects | | Used as an adjective<br>therapy in restoring<br>bony defects | Source<br>of bone | Bovine bone | Bovine bone | Bovine bone | | | |
| Target<br>population | Human oral, periodontal | Human oral, periodontal | | Human oral,<br>periodontal | Source<br>of collagen | Porcine skin | Porcine skin | - | | | |
| Dosage<br>form | a block form in a blister<br>a cylinderic form in a syringe<br>and blister | a block form in a blister | | Granules contained in<br>single use container | Physical<br>Morphology | Trabecular, interconnecting<br>macro and micro pores | Trabecular, interconnecting<br>macro and micro pores | Trabecular,<br>interconnecting macro<br>and micro pores | | | |
| | 0.2mm to 1.0mm or 1.0mm to<br>2.0mm granules | 0.25mm to 1.0mm or<br>1.0mm to 2.0mm granules | | 0.2mm to 1.0mm or<br>1.0mm to 2.0mm<br>granules | Biocompatible | Biocompatible, as demonstrated<br>by :<br>- Cytotoxicity testing<br>- Hemolysis testing<br>- Acute systemic injection testing<br>- Intracutaneous reactivity<br>testing<br>- Skin sensitization testing<br>(LLNA)<br>- Genotoxicity testing<br>(Micronucleus test)<br>- Oral Mucosa Irritation<br>- Genotoxicity testing (AMES<br>test)<br>- Implantation testing<br>- Genotoxicity<br>testing(Chromosome aberration<br>test)<br>- Preclinical quality testing<br>- Clinical case series | Biocompatible<br>(as demonstrated<br>in published literature) | Biocompatible (as<br>demonstrated in<br>published literature) | | | |
| Dimension | Shape | Dimension<br>(mm) | Weight<br>(g) | Shape | Dimension<br>(mm) | Weight<br>(g) | | Performance | Bone formation | Bone formation | Bone formation |
| | Block | 6X6X3 | 50mg | | | | | Compatibility<br>with other<br>devices | Can be used with GTR<br>membrane | Can be used with GTR<br>membrane | Can be used with<br>GTR membrane |
| | Block | 6X6X6 | 100mg | Block | 6X6X6 | 100mg | | | | | |
| | Block | 7X8X9 | 250mg | Block | 7X8X9 | 250mg | | | | | |
| | Block | 9X10X11 | 500mg | Block | 9X10X11 | 500mg | | | | | |
| | Cylinderic | 4.6X40 | 250mg | | | | | | | | |

*= Primary Predicate (K092428)

**=Reference Predicate(K113246)

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| Sterilization<br>Process | Sterile by Gamma Irradiation | Sterile by Gamma<br>Irradiation | Sterile by Gamma<br>Irradiation |
|--------------------------|------------------------------|---------------------------------|---------------------------------|
| Biocom-<br>patibility | Biocompatible | Biocompatible | Biocompatible |
| Anatomical<br>sites | Oral, Periodontal | Oral, Periodontal | Oral, Periodontal |
| Non-<br>Pyrogenic | Yes | Yes | Yes |
| Shelf-Life | 36 Months | 36 Months | 36 Months |

## Brief Summary of Data Submitted

The Sponsor evaluated the performance characteristics of OCS-B Collagen® and Bio-Oss® Collagen with a thorough chemical and physical characterization. The physical and chemical characteristics of the products were found to be comparable. Further, in several animal studies, both products were found to grow new bone and be subsequently resorbed at similar rates. Finally, in a clinical case series, use of OCS-B Collagen resulted in defect healing and formation of new bone of sufficient quality to obtain dental implant placement.

OCS-B Collagen was 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. Test results confirmed equivalence to predicates. OCS-B® (K113246) was manufactured to remove organic impurities 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. In addition, the TSE inactivation as well as virus inactivation study result confirmed product suitability. Collagen is purified from porcine skin by a standardized controlled manufacturing process. The type I collagen has been purified from veterinary certified porcine skin. OCS-B Collagen® is composed of cancellous bone mineral granules (pre-sterilized OCS-B®) and 10% collagen. The dosage form is a blister or a cylinderic form in a syringe and blister. Further, the product is sterilized to achieve a sterility assurance level SAL 1 x 10 °. Further, OCS-B Collagen® is sterilized to achieve a sterility assurance level SAL 1 x 10 °.

Specifically, OCS-B Collagen® was evaluated and tested in accordance with the following performance standards:

- · ISO 10993 "Biological Evaluation of Medical Devices"
- · ASTM F 1581-99 "Standard Specification for Composition of Anorganic Bone for Surgical Implants" (1999)
- · FDA's "Medical Device Materials Derived from Animal Sources" (1998)
- · ISO 11137 "Sterilization of Healthcare Products Radiation"
- · ASTM F 1980-99 "Standard Guide for Accelerated Aging of Sterile Medical device Packages"

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Based on the information presented herein, it has been demonstrated that OCS-B Collagen® is substantially equivalent to Bio-Oss® Collagen, and suitable for the proposed indications for use.

## Conclusion

OCS-B Collagen® has the same indications for use, same intended use, same sterilization process, same shelf-life, biocompatibility and similar technologies as its primary predicate, Bio-Oss® Collagen. The subject device and predicate device encompass the same range of physical dimensions. They share similar physical and chemical structure. Both are porous, biocompatible bone grafts that facilitate the formation and mineralization of new bone by the osteoblast. Both products have same component ratio of bone mineral granules and collagen.

Both products have same source of bone (bovine bone), and collagen (porcine skin). The bone granules were treated through specific process for removal of organic compound. The collagen was purified through specific process for removal of other proteins and organic compounds.

OCS-B Collagen® presents the same types of potential risks to consumers as the predicate device Bio-Oss Collagen, and has controlled these risks in a similar manner. Accordingly, OCS-B Collagen® is deemed suitable for its intended uses. Biocompatibility tests and additional performance testing demonstrate that OCS-B Collagen® meets the requirements of those standards.

The nonclinical, animal and clinical data included in this submission support the substantial equivalence of OCS-B Collagen® to the predicate devices listed in this submission. Literature and post market experience show that the device is substantially equivalent. Comparison with the predicate device shows that the device has similar specifications and performance. Therefore, it is concluded that OCS-B Collagen® is substantially equivalent to the predicate device.