(25 days)
Bone Plus ™ BCP Eagle Eye is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, 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
Bone Plus™ BCP Eagle Eye is an osteocondective, synthetic bone graft material. Bone Plus™ BCP Eagle Eye is biphasic calcium phosphate (BCP) bioceramics that is composed of bioactive HA and bioresorbable beta-TCP. The ratio of HA to beta-TCP is 60:40. Bone Plus has interconnected porous structure that is made of macro-pores and/or micro-pores. Bone Plus™ BCP Eagle Eye is supplied in granules of different sizes and shapes.
Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) submission for Bone Plus™ BCP Eagle Eye:
I. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance (Bone Plus™ BCP Eagle Eye) |
|---|---|---|---|
| Material Composition | HA to Beta-TCP Ratio | Not explicitly stated as acceptance criteria, but described as a key characteristic of the predicate device (60:40). | 60% Hydroxyapatite (HA) and 40% Beta Tricalcium Phosphate (ß-TCP) |
| Physicochemical Properties | Call Ratio | Performed according to ISO 13779-1 and ISO 13779-3. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) |
| Crystallinity | Performed according to ISO 13779-1 and ISO 13779-3. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) | |
| Phase Analysis | Performed according to ISO 13779-3. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) | |
| Phase Purity | Performed according to ISO 13779-3. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) | |
| Porosity | Performed according to ISO 13779-3. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) | |
| pH | Performed according to ISO 10993-14. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) | |
| Water Solubility | Performed according to ISO 10993-14. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) | |
| Biocompatibility | Implantation Test | Performed according to ISO 10993-6. Specific numerical criteria not detailed. | Performed. (Specific results not provided in this document) |
II. Sample Size and Data Provenance for Test Set
- Sample Size: Not applicable. This submission describes non-clinical testing of material properties and biocompatibility, not performance in a human clinical "test set" in the context of AI/diagnostic devices. The testing is on the device material itself.
- Data Provenance: The document does not specify the country of origin for the non-clinical tests. It lists ISO standards, which are international standards. The tests are retrospective in the sense that they are conducted on manufactured samples of the device.
III. Number and Qualifications of Experts for Ground Truth
- Not applicable. The ground truth for the non-clinical tests is established by adherence to international standards (ISO) and laboratory measurements of material properties, not through expert consensus on cases.
IV. Adjudication Method
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used for assessing visual data (e.g., medical images) by multiple human readers, not for objective material property tests.
V. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No such study was performed or is relevant to this 510(k) submission. This device is a bone grafting material, not an AI or diagnostic tool designed to assist human readers in interpreting data.
VI. Standalone (Algorithm Only) Performance Study
- No such study was performed or is relevant. This device is a physical bone grafting material, not an algorithm.
VII. Type of Ground Truth Used
- The ground truth used for this device is based on objective material property measurements and biocompatibility assessments performed according to established international standards (ISO 13779-1, ISO 13779-3, ISO 10993-14, ISO 10993-6).
VIII. Sample Size for Training Set
- Not applicable. There is no "training set" in the context of this traditional medical device submission. The device is manufactured according to a specified composition and process, and its properties are then tested.
IX. How Ground Truth for Training Set Was Established
- Not applicable. See VIII.
Summary of the Study:
The provided 510(k) summary for Bone Plus™ BCP Eagle Eye describes a series of non-clinical bench and in-vitro/in-vivo tests designed to demonstrate the device's material properties and biocompatibility. The primary method of demonstrating substantial equivalence to the predicate device (Bone Plus™ BCP, K090950) is through direct comparison of design, materials, indications, and performance, supported by these non-clinical tests.
The study did not involve human readers, clinical cases, AI algorithms, or the establishment of ground truth through expert consensus on medical images. Instead, the "study" comprises laboratory testing against defined ISO standards to characterize the synthetic bone graft material. The specific numerical results of these tests are not provided in this summary, but the submission states that they were performed according to the listed standards. The equivalence argument relies on the subject device being "identical and equivalent in design, materials, indications and intended use, and performance" to the predicate device, with the non-clinical tests serving as evidence for the performance aspect.
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Bone Plus™ BCP Eagle Eye 510(K) Submission
MegaGen Implant Co., Ltd.
AUG 2 1 2012
510(K) Summary
Submitter Kwang Bum Park MegaGen Implant Co., Ltd. 472, Hanjanggun-ro, Jain-myeon, Gyeongsan-si Gyeongbuk, South Korea Phone: 82-53-857-5770 Fax: 82-53-857-5432
Official Correspondent/ US agent April Lee KoDent, Inc. 325 N. Puente St. Unit B Brea, CA 92821 Phone: 714-525-0114 Fax: 714-525-0116
Device Information
Trade name: Bone Plus ™ BCP Eagle Eye
Common name: Bone grafting material
Classification name: Bone Grafting Material, Synthetic
Classification product code: LYC
Regulation number: 872.3930
Device class: Class II
Date prepared: 7/13/2012
Device Description
Bone Plus™ BCP Eagle Eye is an osteocondective, synthetic bone graft material. Bone Plus™ BCP Eagle Eye is biphasic calcium phosphate (BCP) bioceramics that is composed of bioactive HA and bioresorbable beta-TCP. The ratio of HA to beta-TCP is 60:40. Bone Plus has interconnected porous structure that is made of macro-pores and/or micro-pores. Bone Plus™ BCP Eagle Eye is supplied in granules of different sizes and shapes.
Device Type
- Bone Plus™ BCP Eagle Eye o
40
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Indication for Use
Bone Plus ™ BCP Eagle Eye is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, 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
Materials
Bone Plus ™ BCP Eagle Eye is comprised of 60% Hydroxyapatite (HA) and 40% Beta Tricalcium Phosphate (ß-TCP)
Non Clinical Test Report
Call Ratio, Crystallinity was performed according to ISO 13779-1 and ISO 13779-3 Standard.
Phase Analysis and Phase purity was performed according to ISO 13779-3 Standard.
Porosity was performed according to ISO 13779-3 Standard.
pH and water solubility Analysis was performed according to ISO 10993-14 Standard.
Implantation test was performed according to ISO 10993-6 Standard.
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Predicate Devices
The subject device is substantially equivalent to the following predicate devices:
- Bone PlusTM BCP (K090950) manufactured by Megagen Implant Co., Ltd. .
Comparison to Predicate Devices
Testing and other comparisons have established that the subject of Bone Plus™ BCP Eagle Eye I corning and equivalent in design, materials, indications and intended use, and performance to the predicate of the type currently marketed in the U.S.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an abstract image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle. The seal is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
AUG 2 1 2012
Megagen Implant Company., LTD C/O Ms. April Lee Kodent, Incorporated 325 N. Puente St. Unit B Brea, California 92821
Re: K122240
Trade/Device Name: Bone Plus™ BCP Eagle eye Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: July 26, 2012 Received: July 27, 2012
Dear Ms. Lee:
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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Page 2 - Ms. Lee
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely yours.
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(K) Number (if known): K122240
Device Name: Bone Plus™ BCP Eagle Eye
Indication for Use:
Bone Plus™ BCP Eagle Eye is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.
- Augmentation or reconstructive treatment of alveolar ridge .
- Filling of periodontal defects .
- Filling of defects after root resection, apicocectomy, 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
Prescription Use AND/OR Over-The-Counter
(Part 21 CFR 801 Subpart D)
(Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
Susan Ruar
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
§ 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.