ACCELL TBM-R

{0}------------------------------------------------ SECTION 5 ## 5.0 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS SFP 2 4 2000 This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. | APPLICANT: | IsoTis OrthoBiologics, Inc. | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------| | TRADE NAME: | ACCELL TBM-R | | COMMON NAME: | Bone Void Filler | | CLASSIFICATION<br>NAME: | Resorbable calcium salt bone void filler | | DEVICE<br>CLASSIFICATION: | Class II | | PRODUCT CODE | MQV, MBP | | PREDICATE DEVICES: | Accell Family of Products K061880 (Accell DBM100, Accell<br>TBM, Accell A2i and Accell Connexus), and Grafton DBM-<br>Flex K051195 | #### 5.1 Substantially Equivalence: The Accell TBM-R is substantially equivalent in intended use, principal of operation and technological characteristics to the current Accell Family of Products (Accell DBM100, Accell TBM, Accell A2i and Accell Connexus); 510(K) - K061880. #### Description of the Device Subject to Premarket Notification: 5.2 The Accell TBM-R is an extension to the Accell Family of Products 510(K) K061880. The Accell Family of Products, including Accell TBM-R, contain human demineralized bone matrix (ground, demineralized cortical bone). The Accell TBM-R is an addition to the Accell product family which has improved ease of use in handling characteristics and manual manipulation of the device. #### 5.3 Indication for Use: The Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. #### Technical Characteristics: 5.4 The Accell TBM-R and Accell Family of Products (K061880) utilize ground and demineralized, {1}------------------------------------------------ human cortical bone (DBM) in the formulation of the product. The DBM component exhibits osteoinductive potential in validated animal and/or in vitro models. It is unknown how the osteoinductive potential, measured in these validated models, will correlate with clinical performance in human subjects. #### ર્સ્ડ Performance Data: All necessary verification testing has been performed for the Accell TBM-R product to assure substantial equivalence to the predicate device as well as safety and efficacy. #### 5.6 Osteoinductive Potential Each lot of DBM used to manufacture the Accell TBM-R and the Accell Family of Products is tested for osteoinductive potential using an in vitro test. The in vitro assay has been validated to correlate to an athymic mouse osteoinductive potential assay. It is unknown how osteoinductive potential measured via the in viro or athymic mouse assays will correlate with human clinical performance. #### 5.7 Viral Inactivation Validation The methods for processing of the DBM contained in Accell TBM-R and the Accell Family of Products were evaluated for their viral inactivation potential. A selected panel of viruses representing various virus types, sizes, shapes and genomes were evaluated. The viral inactivation testing demonstrated suitable inactivation potential of the processing methods for a wide range of potential viruses. #### Basis for Determination of Substantial Equivalence: 5.8 Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics, the Accell TBM-R, has been determined by IsoTis OrthoBiologics to be substantially equivalent to an existing legally marketed device. {2}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The text is in all caps and appears to be in a sans-serif font. The logo is black and white. ### Public Health Service SEP 2 4 2008 Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850 Iso Tis Orthobiologics, Inc. % Integra Lifesciences Corporation Ms. Judith E. O'Grady Senior VP, Regulatory Affairs 311 Enterprise Drive Plainsboro, New Jersey 08536 Rc: K081817 Trade/Device Name: Accell TBM-Regulation Number: 21 CFR 888.3045 Regulation Names: Resorbable calcium salt bonc void filler device. Regulatory Class: II Product Code: MBP, MOV Dated: June 25, 2008 Received: June 26, 2008 Dear Ms. O'Grady: 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. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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. {3}------------------------------------------------ Page 2 - Ms. Judith E. O'Grady This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html. Sincerely yours, Mark H. Wilkerson Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {4}------------------------------------------------ # Indications for Use 510(k) Number (if known): K081817 Device Name: Accell TBM-R Indications For Use: Accell TBM-R is intended for filling voids and gaps in the skeletal system that are not intrinsic to the stability of the bony structure. The products are indicated for use as bone graft extenders, bone void fillers or bone graft substitutes in the extremities, pelvis and spine (i.e. posterolateral spine fusion). The voids or gaps may be surgically created defects or the result of traumatic injury to the bone. Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) R.D. 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