(368 days)
No
The summary describes a bone graft material and does not mention any computational or algorithmic components.
Yes
The device is described for use in reconstructive treatment and filling defects, which are therapeutic interventions.
No
The device, OCS-B Collagen®, is described as a material for reconstructive treatment and filling of defects, not for identifying or diagnosing diseases or conditions.
No
The device description explicitly states it is a combination of bone mineral granules and collagen in a block or cylindrical form, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses listed are all related to surgical procedures for bone grafting and regeneration in the oral and periodontal areas. These are therapeutic and reconstructive applications, not diagnostic tests performed on samples taken from the body.
- Device Description: The device is described as a combination of bone mineral granules and collagen in a block or syringe form. This is a material intended to be implanted or placed within the body to facilitate healing and regeneration.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing information for diagnosis. The device itself is the treatment material.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.
N/A
Intended Use / 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)
Product codes (comma separated list FDA assigned to the subject device)
NPM
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 y-irradiation.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral, Periodontal
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
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.
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the basic outline of the face visible.
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.
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 (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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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3
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: 82-10-2889-8590 Fax: 82-2-744-8732 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:
4
- 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
Bio-Oss® Collagen*
(K092428) | | Reference Predicate
OCS-B®**
(K113246) | | Cylinderic
5.6X45 | 500mg | | | | |
|----------------------|----------------------------------------------------------------------------|--------------------------------------------------------------|---------------|--------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|
| ITEM | | | | | Material | Anorganic derived
osteoconductive hydroxyapatite
(pre-sterilized product of OCS-
B® (K113246), Collagen | Anorganic derived
osteoconductive
hydroxyapatite,
Collagen | Anorganic derived
osteoconductive
hydroxyapatite bone
mineral | | | |
| Intended
Use | Used as an adjective therapy in
restoring bony defects | Used as an adjective
therapy in restoring
bony defects | | Used as an adjective
therapy in restoring
bony defects | Source
of bone | Bovine bone | Bovine bone | Bovine bone | | | |
| Target
population | Human oral, periodontal | Human oral, periodontal | | Human oral,
periodontal | Source
of collagen | Porcine skin | Porcine skin | - | | | |
| Dosage
form | a block form in a blister
a cylinderic form in a syringe
and blister | a block form in a blister | | Granules contained in
single use container | Physical
Morphology | Trabecular, interconnecting
macro and micro pores | Trabecular, interconnecting
macro and micro pores | Trabecular,
interconnecting macro
and micro pores | | | |
| | 0.2mm to 1.0mm or 1.0mm to
2.0mm granules | 0.25mm to 1.0mm or
1.0mm to 2.0mm granules | | 0.2mm to 1.0mm or
1.0mm to 2.0mm
granules | Biocompatible | Biocompatible, as demonstrated
by :
- Cytotoxicity testing
- Hemolysis testing
- Acute systemic injection testing
- Intracutaneous reactivity
testing - Skin sensitization testing
(LLNA) - Genotoxicity testing
(Micronucleus test) - Oral Mucosa Irritation
- Genotoxicity testing (AMES
test) - Implantation testing
- Genotoxicity
testing(Chromosome aberration
test) - Preclinical quality testing
- Clinical case series | Biocompatible
(as demonstrated
in published literature) | Biocompatible (as
demonstrated in
published literature) | | | |
| Dimension | Shape | Dimension
(mm) | Weight
(g) | Shape | Dimension
(mm) | Weight
(g) | | Performance | Bone formation | Bone formation | Bone formation |
| | Block | 6X6X3 | 50mg | | | | | Compatibility
with other
devices | Can be used with GTR
membrane | Can be used with GTR
membrane | Can be used with
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
Process | Sterile by Gamma Irradiation | Sterile by Gamma
Irradiation | Sterile by Gamma
Irradiation |
|--------------------------|------------------------------|---------------------------------|---------------------------------|
| Biocom-
patibility | Biocompatible | Biocompatible | Biocompatible |
| Anatomical
sites | Oral, Periodontal | Oral, Periodontal | Oral, Periodontal |
| Non-
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.