(368 days)
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)
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.
The provided text describes the OCS-B Collagen® device, a bone grafting material, and its substantial equivalence to predicate devices, primarily Bio-Oss Collagen®. The information requested falls under the category of performance testing for medical devices, which typically includes detailed studies to prove efficacy and safety. However, this document is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to existing legally marketed devices rather than performing extensive novel clinical trials as would be required for a novel device or a PMA.
Therefore, the study described here is primarily a comparative study against predicate devices, supported by biocompatibility testing and animal studies, rather than a standalone clinical efficacy study with specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or improvement with AI assistance.
Here's the breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in terms of quantitative performance metrics (e.g., specific percentages for success rates, bone growth, etc.). Instead, the acceptance criteria are implicitly that the OCS-B Collagen® device is "substantially equivalent" to its predicate devices (Bio-Oss® Collagen and OCS-B®) in terms of:
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Same Indications for Use | OCS-B Collagen® has the same indications for use as Bio-Oss® Collagen, including augmentation/reconstructive treatment of alveolar ridge, filling of infrabony periodontal defects, defects after root resection/apicoectomy/cystectomy, extraction sockets, elevation of maxillary sinus floor, and filling of periodontal/peri-implant defects in conjunction with GTR/GBR. |
| Same Intended Use | OCS-B Collagen® has the same intended use as Bio-Oss® Collagen and OCS-B® (adjective therapy in restoring bony defects). |
| Similar Physical and Chemical Structure | Both OCS-B Collagen® and Bio-Oss® Collagen are porous, biocompatible bone grafts facilitating new bone formation. They have the same component ratio of bone mineral granules and collagen, same source of bone (bovine bone), and collagen (porcine skin). Physical and chemical characteristics were found to be comparable. |
| Comparable Biocompatibility | OCS-B Collagen® was subjected to a full range of biocompatibility tests (ISO 10993, cytotoxicity, hemolysis, acute systemic injection, intracutaneous reactivity, skin sensitization, genotoxicity, oral mucosa irritation, implantation) and confirmed equivalence to predicates. |
| Similar Performance in Animal Studies (Bone Growth and Resorption) | In several animal studies, both OCS-B Collagen® and predicate devices were found to grow new bone and be subsequently resorbed at similar rates. |
| Successful Clinical Outcomes (Case Series) | A clinical case series using OCS-B Collagen® resulted in defect healing and formation of new bone of sufficient quality to allow dental implant placement. |
| Same Sterilization Process | Sterile by Gamma Irradiation (SAL 1 x 10⁻⁶). |
| Same Shelf-Life | 36 Months. |
| Compliance with Relevant Standards (ASTM F1581-99, FDA "Medical Device Materials Derived from Animal Sources", ISO 11137, ASTM F1980-99) | OCS-B Collagen® was tested in accordance with these standards. (Compliance implies meeting the requirements set forth in these standards, but specific results against numerical criteria are not detailed in this summary). |
| Controlled Risks | OCS-B Collagen® presents the same types of potential risks as the predicate and controls these risks in a similar manner (e.g., manufacturing processes for removal of organic impurities, protein content limits, TSE/virus inactivation studies). |
2. Sample Size Used for the Test Set and Data Provenance
- Animal Studies: "several animal studies" are mentioned, but no specific sample sizes or species are provided in this summary document.
- Clinical Case Series: "a clinical case series" is mentioned, but no specific number of patients (sample size) is provided.
- Data Provenance: Not explicitly stated for animal studies or the clinical case series (e.g., country of origin, retrospective/prospective). However, the sponsor is NIBEC Co., Ltd. from Korea. Given the K-number, the submission is to the U.S. FDA, so the data would have been submitted to the U.S. regulatory body. The document does not specify if these studies are retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This type of information is generally not applicable to the studies described for this device. The "ground truth" here is the biological and clinical outcome (bone formation, resorption, defect healing, suitability for implant placement), which would be assessed by standard histological, imaging, and clinical follow-up methods by trained professionals (e.g., veterinarians for animal studies, dentists/oral surgeons for clinical case series). The document does not specify an "expert panel" for establishing ground truth in the context of, for example, image interpretation.
4. Adjudication Method for the Test Set
Not applicable in the context of this 510(k) summary. Adjudication methods (like 2+1, 3+1) are typically used for studies where multiple human readers interpret data (e.g., images) and consensus is needed, often in AI comparative effectiveness studies. The studies mentioned here focus on biological outcomes rather than interpretive tasks.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not conducted as described in this summary. The comparison is between the device and predicate devices based on physical/chemical properties, biocompatibility, and general performance in animal studies and a clinical case series, not a comparative study of human reader performance with and without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to an AI algorithm's performance, which is not relevant for this bone graft material. The device itself is a physical implant, not a diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth used in the animal studies and clinical case series would be based on:
- Histology: Direct examination of tissue to confirm new bone formation and resorption.
- Imaging: X-rays, CT scans, or other imaging modalities to assess defect healing and bone density/volume.
- Clinical Outcomes: Assessment of defect healing, absence of adverse events, and functional outcomes, such as successful dental implant placement.
8. The Sample Size for the Training Set
Not applicable. This device is a physical bone graft, not a machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set for a machine learning algorithm.
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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 (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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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:
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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 PredicateBio-Oss® Collagen*(K092428) | Reference PredicateOCS-B®**(K113246) | Cylinderic5.6X45 | 500mg | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
| ITEM | Material | Anorganic derivedosteoconductive hydroxyapatite(pre-sterilized product of OCS-B® (K113246), Collagen | Anorganic derivedosteoconductivehydroxyapatite,Collagen | Anorganic derivedosteoconductivehydroxyapatite bonemineral | |||||||
| IntendedUse | Used as an adjective therapy inrestoring bony defects | Used as an adjectivetherapy in restoringbony defects | Used as an adjectivetherapy in restoringbony defects | Sourceof bone | Bovine bone | Bovine bone | Bovine bone | ||||
| Targetpopulation | Human oral, periodontal | Human oral, periodontal | Human oral,periodontal | Sourceof collagen | Porcine skin | Porcine skin | - | ||||
| Dosageform | a block form in a blistera cylinderic form in a syringeand blister | a block form in a blister | Granules contained insingle use container | PhysicalMorphology | Trabecular, interconnectingmacro and micro pores | Trabecular, interconnectingmacro and micro pores | Trabecular,interconnecting macroand micro pores | ||||
| 0.2mm to 1.0mm or 1.0mm to2.0mm granules | 0.25mm to 1.0mm or1.0mm to 2.0mm granules | 0.2mm to 1.0mm or1.0mm to 2.0mmgranules | Biocompatible | Biocompatible, as demonstratedby :- Cytotoxicity testing- Hemolysis testing- Acute systemic injection testing- Intracutaneous reactivitytesting- Skin sensitization testing(LLNA)- Genotoxicity testing(Micronucleus test)- Oral Mucosa Irritation- Genotoxicity testing (AMEStest)- Implantation testing- Genotoxicitytesting(Chromosome aberrationtest)- Preclinical quality testing- Clinical case series | Biocompatible(as demonstratedin published literature) | Biocompatible (asdemonstrated inpublished literature) | |||||
| Dimension | Shape | Dimension(mm) | Weight(g) | Shape | Dimension(mm) | Weight(g) | Performance | Bone formation | Bone formation | Bone formation | |
| Block | 6X6X3 | 50mg | Compatibilitywith otherdevices | Can be used with GTRmembrane | Can be used with GTRmembrane | Can be used withGTR 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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| SterilizationProcess | Sterile by Gamma Irradiation | Sterile by GammaIrradiation | Sterile by GammaIrradiation |
|---|---|---|---|
| Biocom-patibility | Biocompatible | Biocompatible | Biocompatible |
| Anatomicalsites | 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.
§ 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.