BICERA (TM) RESORBABLE BONE SUBSTITUTE

{0}------------------------------------------------ # 110949 AGE I OF 4 SEP 1 8 2012 ### 510(K) Summary ## 1. Submitter's Identification Address: No.221, Sec.1, Chung Hsing Rd., Chutung, Hsinchu, Taiwian 31053, R.O.C. TEL: (886) 3-582-8999 FAX: (886) 3-582-6859 Contact: Yung-Chih Wu US Representative: Address: 5025 Collwood Way, Unit 19 San Diego, CA 92115, USA TEL: 1-808-277-1579 Email: mhanb20012001@gmail.com Contact: Yi-An Lai - 2. Proprietary Name Bicera™ Resorbable Bone Substitute #### 3. Common Name Bone Void Filler ## 4. Classification Name 21 CFR 888.3045 – Resorbable Calcium Salt Bone Void Filler Device – Class II # 5. Device Code/Panel Code Orthopedics/MQV - 6. Predicate Device {1}------------------------------------------------ MBCPTM Bone Graft Substitute, K032268 ### 7. Mandatory Performance Standard Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA (Document # 855) #### 8. Voluntary Performance Standards ISO 11137-2:2006 ISO 9001:2000 ISO 10993-1,3,5,6,10,11,12,14 ISO/IEC 17025:2005 21 CFR 58 ASTM F2150-02 ASTM D695-02a ASTM D1621-04a ASTM D3576-4 ASTM F1185-03 ASTM F1185-87. ASTM D4332 ASTM F1140-07 ASTM F88-07a ASTM F1929-98 ASTM F1608-00 ASTM F895 ASTM F1408-97 ASTM F1980-07 ### 9. Device Description Bicera™ Resorbable Bone Substitute is a bioceramic medical device that its composition of crystalline phase contains 60% hydroxyapatite (HAP) and 40% beta-tricalcium (B-TCP). Bicera™ is a bone void filler for orthopedic surgery. It is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. This composite material is acretts resumity in vivo and is replaced by new bone. Bicera™ Resorbable Bone Substitute is supplied sterile in various shapes and sizes. See Table 1 below for {2}------------------------------------------------ available shapes and sizes. | Table 1. Product Form | | |-------------------------------------------------|------------------------------| | Form | Size | | Stick, ≤ 5 mm width or height<br>≤ 20 mm length | 2.0 to 10.0 cm3 total volume | | Granule, ≤ 3 mm diameter | 0.25, 0.5, and 1 gram | #### 10. Intended Use Bicera™ Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera™ Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera™ Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process. #### 11. Comparison to Predicate Device Bicera™ is substantially equivalent in design, function, and intended use to MBCPTM Bone Graft Substitute cleared as K032268 on December 11, 2003. | | Bicera™ | MBCP™ | |------------------------------|-----------------------|-----------------------| | Composition (wt%) | 60% HAP and 40% β-TCP | 60% HAP and 40% β-TCP | | Porosity (%) | 79.22 ± 1.04 | 70 | | Pore size (µm) | 442.65 ± 80.31 | 450 ± 49 | | Ca/P | 1.61 | 1.60 ± 0.02 | | Density (g/cm³) | 0.64 ± 0.03 | 0.87 ± 0.04 | | Pore structure | Interconnected pores | Interconnected pores | | Specific surface area (m²/g) | 1.57 | 1.8 ± 0.1 | | Compressive strength (MPa) | 1.80 ± 0.24 | 3.04 ± 0.79 | Comparison of Technological Characteristics between Bicera™ and MBCPTM # 12. Discussions of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows Assessments for biocompatibility evaluation are based on the final, to-be-implanted version of Bicera™. These assessments were conducted in accordance with the International Standard ISO 10993 part 4, 5, 6, 10, 11, ASTM F-1408-97, USP <85> version 34, <161> version 34 and the guideline provided by the FDA of the United {3}------------------------------------------------ K110949 PAGE 4 OF 4 States. The test results for cytotoxicity, sensitization, irritation, acute systemic toxicity, and pyrogen assessments were considered acceptable. The result of the subcutaneous implantation study shows that Bicera™ has a good affinity with the surrounding tissue with no observations of inflammatory or adverse reaction. It can be concluded that Bicera™ has a substantially equivalent biocompatibility to that of MBCP™. Bicera™ is mainly composed of 60% of hydroxyapatite and 40% of ß-tri-calcium phosphate which is an osteoconductive material and has been widely applied in clinical application for years. In addition to these biocompatibility assessments, Bicera™ was compared to the predicate device in a long bone animal critical sized defect model. The results over time at multiple post-op evaluations demonstrate that Bicera™ was substantially equivalent to the predicate device with respect to resorption profile and new bone formation. ## 13. Discussion of Clinical Tests Performed N/A #### 14. Conclusion We have demonstrated that the Bicera™ is substantially equivalent to the predicate device,MBCP™ (K032268), based on physical and chemical characteristics as well as biocompatibility and animal implantation testing. {4}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the bird symbol. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Wiltrom Corporation Limited % Mr. Yung-Chih Wu Plant Manager No. 221, Section 1, Chung Hsing Road Chutung Township, Hsinchu China (Taiwan) 31053 SEP 1 8 2012 Re: K110949 Trade/Device Name: Bicera™ Resorbable Bone Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: August 27, 2012 Received: August 28, 2012 Dear Mr. Wu: 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. 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 : ﻟﻢ - {5}------------------------------------------------ Page 2 - Mr. Yung-Chih Wu 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, Erin Keith Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {6}------------------------------------------------ ## INDICATIONS FOR USE #### 510(k) Number (if known): K110949 Device Name: Bicera™ Resorbable Bone Substitute #### Indications For Use: Bicera™ Resorbable Bone Substitute is intended for use as a bone void filler for voids or gaps that are not intrinsic to the stability of the bony structure. Bicera™ Resorbable Bone Substitute is indicated for use in the treatment of surgically created osseous defects or osseous defects resulting from traumatic injury to the bone. Bicera™ Resorbable Bone Substitute is intended to be packed into bony voids or gaps of the skeletal system as a bone void filler (i.e., extremities and pelvis). This product provides a bone void filler that resorbs and is replaced by bone during the healing process. Prescription Use__X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use_ NO (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) Yariv N. Eliazy (Division Sign-Off) (Division Sign-On), Online Divisionative Devices 510(k) Number K110949