NANOFUSE DBM

{0}------------------------------------------------ ## (120279 SE 1 OF 3 # anotherapeutics - 6 2019 #### 510(k) SUMMARY OF SAFETY & EFFECTIVENESS #### NanoFUSE® DBM Date: January 27, 2012 Submitted by: Nanotherapeutics, Inc. 13859 Progress Blvd., Suite 300 Alachua, FL 32615 Representative: Gregg Ritter, MS, RAC, CTBS Regulatory Affairs Manager Phone: (386) 462-9663 FAX: (386) 462-2087 NanoFUSE® DBM Proprietary Name: Common Name: Bone Void Filler, Bone Graft Substitute Classification Name: Filler, Calcium Sulfate Preformed Pellets, 21 CFR § 888.3045 Classification Codes: MQV, MBP - Class II Predicate Devices: | Trade/Proprietary Name | Manufacturer | 510(k) Number | |----------------------------------|------------------|------------------| | Origen™ DBM with Bioactive Glass | Nanotherapeutics | K062459, K110976 | | (NanoFUSE® DBM) | | | Description: NanoFUSE® DBM is a malleable, putty-like, bone-void filler. The product is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. These coated particles are packaged dry in a single use, polypropylene syringe (20 cc or 3 cc), double-wrapped in peel-back pouches, and final packaged in a dust cover paperboard carton. The 20 cc syringe will be filled with either of two different fill quantities of dry powder, identified as 10 cc or 5 cc final product volume. The 3 cc syringe will be filled with dry powder, identified as 2 cc final product volume. NanoFUSE® DBM is intended for single patient use only. At point of use, the surgeon will reconstitute the product with an appropriate sterile solution of his/her choice (sterile saline, water for injection). The coated particles rehydrate in less than 30 seconds and do not require mixing to form a uniform paste or putty. The material is then gently extruded by the surgeon into the appropriate bone voids. NanoFUSE® DBM is progressively resorbed and replaced by host bone during the osteo-remodeling process. Indications for Use: NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of {1}------------------------------------------------ K120279 PAGE 2 OF 3 the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal svstem. #### Technological Characteristics: The applicant version of NanoFUSE® DBM is identical to the currently legally marketed medical device NanoFUSE® DBM, also manufactured by Nanotherapeutics, Inc. with respect to materials. design, and intended use. The applicant version is comprised of human demineralized bone matrix (DBM) and synthetic calcium phosphor-silicate particulate material particles (45s5 bioactive glass), both coated with gelatin derived from porcine skin. It is provided dry and is reconstituted at the point of use into a paste-like, malleable form that can be molded or manipulated into bony defects. NanoFUSE® DBM is reconstituted by the addition of fluid and waiting 30 seconds before expelling the contents from the syringe. At 30 seconds, the product extrudes as a very fluid paste and, with time, the gelatin carrier absorbs the fluid, becomes progressively thicker, and eventually sets in a rubbery mass. Currently, each lot of DBM used in manufacturing the predicate Origen DBM® with Bioactive Glass (NanoFUSE® DBM) is screened for osteoinductivity in an in vitro bioassay. Each lot of DBM used in manufacturing the applicant version of NanoFUSE® DBM will be screened for osteoinductivity with either the in vitro bioassay originally submitted or the in vivo athymic rat model herein submitted. The scientific technology of NanoFUSE® DBM applicant product. using in vivo testing for osteoinductivity, is identical to the technology used in the FDA cleared predicates. (K062459, K110976) | Comparison<br>Feature | NanoFUSE® DBM -<br>Predicate | NanoFUSE® DBM<br>- Applicant | |------------------------------|----------------------------------|----------------------------------------------------| | Form | Syringe | Same | | Materials of<br>Construction | DBM, bioactive glass,<br>gelatin | Same | | Comparable<br>Sizes | Yes | Yes | | Osteoinductivity<br>Assay | Cell bioassay | in vivo athymic rat<br>implant or cell<br>bioassay | | Sterility | Yes - Radiation | Same | {2}------------------------------------------------ ## K120279 PAGE 3 OF 3 #### Osteoinductivity Potential: athymic rat model. Results from this bioassay were correlated to the athymic rat model. Testing each lot of DBM with this cell bioassay or athymic rat model assures that only DBM with osteoinductive potential is used in NanoFUSE® DBM. The combination of DBM. bioactive glass, and porcine gelatin has not been evaluated for osteoinductivity; therefore, it is unknown to what extent the formulation components may alter the osteoinductive character of the DBM. It is unknown how the OI of the DBM component, measured via the in vitro bioassay or athymic rat model, will correlate with human clinical performance of NanoFUSE® DBM. The change in osteoinductivity potential testing for the DBM does not alter the fundamental scientific technology of the device and it does not have an effect on the viral clearance and inactivation of the device. A panel of model potential human viruses representing various virus types, sizes, shapes and genomes has previously been evaluated. The viral inactivation testing demonstrated that suitable viral inactivation potential was obtained by the processing method for a wide spectrum of potential human viruses. according to ISO 10993. (NanoFUSE® DBM). Each lot of DBM incorporated into NanoFUSE® DBM is evaluated for osteoinductive (OI) potential using an in vitro bioassay or in vivo Viral Clearance and Inactivation: Safety and Effectiveness: The change in osteoinductivity potential testing for the DBM does not alter the fundamental scientific technology of the device and it does not have an effect on the biocompatibility of the device. Biocompatibility testing, pre-clinical animal testing and in vitro bench testing has previously been conducted to evaluate the biological safety and performance characteristics of NanoFUSE® DBM The change in osteoinductivity potential testing for the DBM does not alter the fundamental scientific technology of the device. Based on the testing provided, the submitted change does not have an effect on the safety or effectiveness of the device. Therefore, the applicant version of NanoFUSE® DBM is substantially equivalent to the currently cleared version of Origen DBM® with Bioactive Glass Substantial Equivalence: ર-3 {3}------------------------------------------------ ### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of an eagle or bird-like figure. Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Nanotherapeutics, Incorporated % Mr. Gregg Ritter, MS, RAC, CTBS Regulatory Affairs Manager 13859 Progress Boulevard, Suite 300 Alachua, Florida 32615 APR - 6 2012 Re: K120279 Trade/Device Name: NanoFUSE® DBM Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV, MBP Dated: January 27, 2012 Received: January 30, 2012 Dear Mr. Ritter: 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 of any I cated butter and registements, 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. {4}------------------------------------------------ ### Page 2 - Mr. Gregg Ritter, MS, RAC, CTBS 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, Mark N. Melkerso Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ # nanotherapeutics #### INDICATIONS FOR USE 510(k) Number (if known): K120279 Device Name: NanoFUSE® DBM Indications for Use: NanoFUSE® DBM is indicated to be gently placed into bony voids or gaps of the skeletal system that are not intrinsic to the stability of the bony structure. It is indicated to be placed into bony voids or gaps of the skeletal structure (e.g., the extremities and pelvis). These defects may be surgically created osseous defects or osseous defects created by traumatic injury to the bone. The product provides a bone graft substitute that remodels into the recipient's skeletal system. × Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE) Signature (Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices 510(k) Number K120279 4-1