PERIOPHIL B-TCP

{0}------------------------------------------------ K093871 APR 2 2 2010 # 4.0 510K (k) Summary of Safety and Effectiveness | Trade Name: | Periophil β -TCP | |------------------------|-------------------------------------------------------------------------| | Common Name: | Synthetic Bone Graft Material | | Classification Name: | Bone Filling and Augmentation Materia | | Official Contact Name: | Victor M. Bowers<br>VP Medical Affairs | | Address: | Cytophil, Inc.<br>2485 Corporate Circle, Suite 2<br>East Troy, WI 53120 | | Phone: | 262-642-2765 | | Fax: | 262-642-2745 | | E-mail: | vbowers@cytophil.com | | Date Prepared: | 12/14/2009 | ## 4.1 Indication for Use Periophil B -TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil 3 - TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities. ### 4.2 Product Description Periophil 8 -TCP is a bone graft substitute. Periophil 3 -TCP is a microporous and macroporous calcium phosphate ceramic consisting of beta tricalcium phosphate (6-TCP). Periophil ß -TCP is available as granules and is provided sterile for single patient use. Periophil B -TCP is a multidirectional interconnected porosity structure, similar to that of human cancellous bone. Periophil ß -TCP slowly resorbs during the remodeling and bone defect repair process and is progressively replaced with bone and soft tissues. There is progressive resorption for 4 to 12 months (may vary patient to patient) of Periophil B -TCP resorbable bone filler. #### 4.3 Substantial Equivalence {1}------------------------------------------------ The following are the predicate devices that are substantially equivalent to Periophil ß -TCP: K063634 - RTR Syringe Septodont C/O Mr. Wayne H. Matelski Arent Fox, PLLC 1050 Connecticut Avenue, NW Washington, District of Columbia 20036-5339 K051885 - MBCP™ BIOMATLANTE ZA DES IV NATIONS 5. rue Edouard Belin -F- 44360 VIGNEUX DE BRETAGNE France K082917 - Mastergraft Resorbable Ceramic Granules Medtronic Sofamor Danek 1800 Pyramid Place Memphis, TN 38132 #### 4.4 Biocompatibility Evaluations The biocompatibility of B-TCP is well documented. This biomaterial has consistently proven to be non-toxic, non-allergenic, biocompatible, and elicit no inflammation. No adverse effects or foreign body reactions have been reported. Periophil 3 -TCP utilizes identical materials to K063634 - RTR Syringe, and has the same type and duration of patient contact. #### 4.5 Sterilization Periophil 3 -TCP is sterilized using gamma radiation. Processing is performed by Steris Isomedix Services, a contract sterilization company, cycle parameters were validated using an overkill methodology to 10 SAL. Sterilization by the user is not required. #### 4.6 Pre-Clinical Tests Performed Chemical safety of Periophil 3 - TCP is based on the recognized consensus standard specification ASTM F1088 "Standard Specification for Beta-Tricalcium Phosphate for Surgical Implantation". Periophil ß -TCP conforms to the required specifications for heavy metal trace element levels. {2}------------------------------------------------ ### 4.7 Risk Assessment The primary risks with Periophil ß -TCP have been identified through a risk assessment procedure in accordance with ISO 14971. ### 4.8 Summary In summary, Periophil ß -TCP is substantially equivalent to the cited predicate devices. All have the same indication for use. Periophil ß-TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil ß -TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities. The components used in Periophil 3 -TCP and the predicate devices are biocompatible, based on the history and use in many medical devices, peer reviewed literature, and from preclinical testing. Periophil 3 -TCP is substantially equivalent in indication for use, technical characteristics, and is as safe as the predicate device K063634 - RTR Syringe, Septodont, C/O Mr. Wayne H. Matelski, Arent Fox, PLLC, 1050 Connecticut Avenue, NW, Washington, District of Columbia 20036-5339. {3}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the perimeter. Inside the circle is an image of an eagle with its wings spread, which is a common symbol of the United States. APR 2 2 2010 Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Mr. Victor M. Bowers Vice President Medical Affairs Cytophil, Incorporated 2485 Corporate Circle, Unit 2 East Troy, Wisconsin 53120 Re: K093871 Trade/Device Name: Periophil B-TCP Regulation Number: 21 CFR 872.3930 Regulation Name: Bone Grafting Material Regulatory Class: II Product Code: LYC Dated: April 13, 2010 Received: April 15, 2010 Dear Mr. Bowers: 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. {4}------------------------------------------------ #### Page 2- Mr. Bowers 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 (OS) 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. h for Anthony 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 {5}------------------------------------------------ ## SECTION 2 ## 2.0 Indications for Use 510(k) Number: K093871 Device Name: Periophil ß -TCP Indications for Use: Periophil ß -TCP is indicated for use as a bone grafting material to fill, augment, or reconstruct periodontal or oral/maxillofacial defects. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. Periophil ß -TCP can be used with autogenous bone grafting materials. Typical uses include: periodontal/infrabony defects, ridge augmentation, extraction sites (implant preparation/placement), sinus lifts, and cystic cavities. (PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED) ...................................................................................................................................................................... Concurrence of CDRH, Office of Device Evaluation (ODE) Prescription Use **X** or Over-the-Counter Use __ (Per 21 CFR 801.109) (Division Sign-Off) Division of Anesthesiology, General Hospital Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K093871 Cytophil, Inc. 2-1