FIBERGRAFT BG MORSELS

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of a human face in profile, with three overlapping profiles creating a sense of depth. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 August 13, 2014 Prosidyan, Inc. % Ms. Janice Hogan Regulatory Counsel Hogan Lovells US LLP 1835 Market Street, 29th Floor Philadelphia, Pennsylvania 19103 Re: K141956 Trade/Device Name: FIBERGRAFT™ BG Morsels Bone Graft Substitute Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV Dated: July 18, 2014 Received: July 18, 2014 Dear Ms. Hogan: 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 comply with all the Act's requirements, including, but not limited to: registration and listing {1}------------------------------------------------ (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 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, Lori A. Wiggins -S for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Statement ## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k)Number (if known) K141956 Device Name FIBERGRAFT™ BG Morsels Bone Graft Substitute Indications for Use (Describe) FIBERGRAFT™ BG Morsels Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone . The product provides a bone void filler that resorbs and is replaced with the healing process. FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------------------------| | <span style="text-decoration: underline;"> Prescription Use (Part21 CFR 801 Subpart D) </span> | | Over-The-Counter Use (21 CFR 801 Subpart C) | ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) #### This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) #### Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." Form Approved: OMB No. 0910-0120 Expiration Date: January31. 2017 See PRA Statement on last page {3}------------------------------------------------ ### 510(k) SUMMARY ## Prosidyan, Inc.'s FIBERGRAFT™ BG Morsels Bone Graft Substitute ## Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared Prosidyan, Inc. 30 Technology Drive Warren. NJ 07059 Tel. 908-517-3666 Fax 908-396-1151 Contact Person: Charanpreet S. Bagga Date Prepared: July 17, 2014 #### Name of Device and Name/Address of Sponsor FIBERGRAFT™ BG Morsels Bone Graft Substitute #### Common or Usual Name Bone Void Filler ### Classification Name/CFR Requlation/Product Code Resorbable Calcium Salt Bone Void Filler, 21 CFR 888.3045, product code MQV, Class II #### Predicate Devices Prosidyan's BG Morsels Bone Graft Substitute ## Purpose of the Special 510(k) notice. The FIBERGRAFT™ BG Morsels Bone Graft Substitute is a modification to the previously cleared BG Morsels. There have been no changes to the intended use of the device or its fundamental scientific technology. #### Intended Use The FIBERGRAFT™ BG Morsels Bone Graft Substitute is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. FIBERGRAFT™ BG Morsels is indicated to be gently packed into bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. The product provides a bone void filler that resorbs and is replaced with bone during the healing process. FIBERGRAFT™ BG Morsels is not indicated for use in load-bearing applications; therefore, standard internal or external stabilization techniques must be followed to obtain rigid stabilization. {4}------------------------------------------------ ## Technological Characteristics FIBERGRAFT™ BG Morsels provides an osteoconductive, resorbable, biocompatible bone graft substitute made from crystalline 45S5 bioactive glass. Each granule of FIBERGRAFT™ BG Morsels is created from a matrix of bioactive glass fibers and microspheres. Bioactive glass is defined as a group of glasses which has a compositional range that allows the formation of hydroxyapatite (HA) as a surface layer when exposed to an aqueous phosphate-containing solution such as simulated body fluid. The HA layer that forms in an aqueous phosphate-containing solution plays a significant role in forming a strong bond with natural bone. The granules provide an ultra-porous scaffold for desired biological response and improved handling characteristics, while optimizing radiopacity and resorption. FIBERGRAFT™ BG Morsels are generally spherical in appearance and provided in granular form. The matrix is flash sintered to form a porous shell at its surface, which creates the generally spherical structure of the granules, while maintaining a level of porosity within each granule. The primary purpose of this submission is to add the option to use blood to mix with the product prior to implantation. Changes were also made to the product trade name and the labeled volume sizes. ## Performance Data In support of this submission, testing was conducted to compare the fluid absorbability of the product when mixed with blood compared to saline. Device packability and handling characteristics were also observed during testing. Testing was conducted at time zero and after aging. All test results were passing, supporting substantial equivalence of the modified device compared to the predicate device. No changes were made to the product composition, packaging, sterility, or biocompatibility as compared to the predicate device. The performance testing results demonstrated that the FIBERGRAFT ™ BG Morsels is substantially equivalent to the predicate device. ## Substantial Equivalence The indications for use and the fundamental scientific technology of the proposed FIBERGRAFT™ BG Morsels product has not changed relative to the predicate. The FIBERGRAFT™ BG Morsels has the same intended use, indications, and technological characteristics as the previously cleared BG Morsels, and similar principles of operation. The FIBERGRAFT™ BG Morsels is manufactured using the same material, has the same shelf life, and is packaged and sterilized using the same materials and processes as the predicate, demonstrating substantial equivalence to the predicate device. Performance testing of the modified FIBERGRAFT™ BG Morsels demonstrated that the device functions as intended without raising new safety or effectiveness questions compared to the previously cleared BG Morsels. ## Conclusion The FIBERGRAFT™ BG Morsels is an osteoconductive, resorbable, biocompatible bone graft substitute composed of crystalline bioactive glass. The purpose of this Special 510(k) is to add the option to use blood as a mixing agent to the labeling. In addition, the labeled {5}------------------------------------------------ volume sizes and the product name of the subject device have been modified since the previously cleared predicate. The verification and process qualification testing confirms that these changes meet the acceptance criteria in testing. Thus, the proposed FIBERGRAFT™ BG Morsels is substantially equivalent to its predicate.