EP Granules™ BVF

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Elute, Inc. Ashok Khandkar, PhD CEO 417 Wakara Way Suite 3510 Salt Lake City, Utah 84108 Re: K180853 Trade/Device Name: EP Granules™ BVF Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV Dated: June 29, 2018 Received: July 5, 2018 Dear Dr. Khandkar: 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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device 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); U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov August 6, 2018 {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 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Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. 510(k) Number (if known) K180853 Device Name EP Granules™ BVF Indications for Use (Describe) EP Granules™ BVF is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. EP Granules™ BVF resorbs and is replaced with bone during the healing process. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ #### K180853 510(k) Summary | Submitter: | Elute, Inc. | |----------------------|-----------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | AK Khandkar, PhD - CEO<br>417 Wakara Way. Suite 3510<br>Salt Lake City, UT 84108<br>801-696-4716 | | Date Prepared: | March 29, 2018 | | Trade Name: | EP Granules™ BVF | | Classification Name: | Resorbable calcium salt bone void filler device<br>21 CFR §888.3045, Product Code MQV, Class II | | Predicate Device(s): | K990131, ProOsteon 500R bone graft substitute (1º predicate);<br>K082073, Actifuse Flow bone graft substitute (additional<br>predicate) | #### Device Description: EP Granules™ BVF is an osteoconductive device comprising hydroxyapatite (HA) and calcium carbonate (CaCO3) and calcium chloride (CaCl2) particles bound together with a degradable polymer-based binding matrix of poly(caprolactone) (PCL), poly(ethylene glycol) (PEG), and poly(lactide-co-glycolide) (PLGA). The hydroxyapatite and calcium carbonate particles are dispersed throughout the entire structure of the device. Upon implantation, the ceramic hydroxyapatite and calcium carbonate particles resorb over time. The polymer-based binding matrix also resorbs over time. It is supplied sterile in a granulated form of various sizes. When EP Granules™ BVF is placed in direct contact with viable non-infected bone, porous regions form in the device and are infiltrated with bone tissue. Bone formation occurs in apposition to the hydroxyapatite and calcium carbonate surface and within the pores of the device. As the device resorbs, bone and soft tissue grow into the space previously occupied by the device. ## Indications For Use: EP Granules™ BVF is an implant intended to fill bony voids or gaps of the skeletal system (i.e., the extremities and pelvis). These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. EP Granules™ BVF resorbs and is replaced with bone during the healing process. {4}------------------------------------------------ #### Comparative Analysis: lt has been demonstrated that the EP Granules™ BVF device is comparable to the predicate devices in intended use, fundamental scientific technology, design, principles of operation and functional performance evaluations. The EP Granules™ BVF device has been fully assessed within Elute's Risk Management and Design Controls systems. All necessary verification steps met pre-determined acceptance criteria to confirm safety and effectiveness. | Technology Comparison of EP Granules™ BVF with Predicate Device: | | | | |------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Subject Device – | 1° Predicate<br>(K990131) | Additional Predicate<br>(K082073) | | Device Name | EP Granules™ BVF | Pro Osteon 500 R Bone<br>Graft Substitute | Actifuse Flow Bone<br>Graft Substitute | | Intended Use | Bone Graft Substitute | Bone Graft Substitute | Bone Graft Substitute | | Indications<br>for use | EP Granules™ BVF is an<br>implant intended to fill<br>bony voids or gaps of the<br>skeletal system (i.e., the<br>extremities and pelvis).<br>These osseous defects<br>are surgically created or<br>the result of traumatic<br>injury to the bone and are<br>not intrinsic to the stability<br>of the bony structure. EP<br>Granules™ BVF resorbs<br>and is replaced with bone<br>during the healing<br>process. | Pro Osteon 500 R<br>Resorbable Bone Graft<br>Substitute is indicated only<br>for bony voids or gaps that<br>are not intrinsic to the<br>stability of the bony<br>structure. Pro Osteon 500<br>R is indicated to be gently<br>packed into bony voids or<br>gaps of the skeletal<br>system (i.e., the<br>extremities and pelvis).<br>These defects may be<br>surgically created osseous<br>defects or osseous<br>defects created from<br>traumatic injury to the<br>bone. The product<br>provides a bone graft<br>substitute that resorbs and<br>is replaced with bone<br>during the healing<br>process. | Actifuse Flow is intended<br>only for orthopaedic<br>applications as filler for<br>gaps and voids that are<br>not intrinsic to the stability<br>of the bony structure.<br>Actifuse Flow Bone Graft<br>Substitute can be injected<br>into bony voids or gaps of<br>the skeletal system, i.e.,<br>extremities and pelvis with<br>appropriate stabilizing<br>hardware. These defects<br>may be surgically created<br>osseous defects or<br>osseous defects created<br>from traumatic injury to the<br>bone. The product<br>provides bone void filler<br>that resorbs and is<br>replaced by bone during<br>the healing process. | | Prescription<br>(Rx Only) | Yes | Yes | Yes | | Classification | Orthopedic Devices-<br>Resorbable Calcium Salt<br>Bone Void Filler<br>21 CFR §888.3045,<br>Product code: MQV<br>Class II | Orthopedic Devices-<br>Resorbable Calcium Salt<br>Bone Void Filler<br>21 CFR §888.3045,<br>Product code: MQV<br>Class II | Orthopedic Devices-<br>Resorbable Calcium Salt<br>Bone Void Filler<br>21 CFR §888.3045,<br>Product code: MQV<br>Class II | | Anatomical<br>site | Within voids or gaps that<br>are not intrinsic to the<br>stability of the bony<br>structure. | Within voids or gaps that<br>are not intrinsic to the<br>stability of the bony<br>structure. | Within voids or gaps that<br>are not intrinsic to the<br>stability of the bony<br>structure. | | Where Used | Operating Room or<br>Surgical Suite | Operating Room or<br>Surgical Suite | Operating Room or<br>Surgical Suite | | Morphology | Granules and croutons of<br>calcium salts with<br>resorbable polymer binder | Particles, granules &<br>blocks of calcium salts | Hydrated putty of calcium<br>salt granules with<br>resorbable polymer binder | | Fundamental<br>Scientific<br>Technology | Once implantation, the<br>ceramic hydroxyapatite<br>and calcium carbonate<br>particles slowly resorb<br>over time, allowing for new<br>bone growth. | Once implanted, the<br>calcium phosphate outer<br>layer will slowly resorb,<br>delaying exposure of the<br>underlying and faster<br>resorbing calcium<br>carbonate | Once implanted<br>resorbable polymers bind<br>and deliver osteo-<br>conductive calcium salt<br>particles to be used as a<br>bone void filler | | Sterilization | Gamma irradiation | Gamma irradiation | Provided Sterile, Method<br>Unknown | | Bioactivity | Osteo-conductive | Osteo-conductive | Osteo-conductive &<br>Osteo-stimulatory | {5}------------------------------------------------ #### Functional/Safety Testing: The following functional tests were performed. All data met pre-determined acceptance criteria. ## · Bench-top Testing: - In-Vitro degradation and surface characterizations of EP Granules™ BVF O formulation - o X-ray diffraction (XRD) and compressive mechanical testing of EP Granules™ BVF formulation from an Accelerated Shelf-Life Study - In-vitro pH exposure study of EP Granules™ BVF o - Pre-Clinical Testing –Large animal models, i.e. as critical size defect model, under an IACUC approved protocol - · Biocompatibility Per ISO 10993-1 for Implant Devices, Tissue/bone Contact, Permanent contact (> 30 days) including: - Cytotoxicity ● - Sensitization - Irritation/ Intracutaneous Toxicity ● - Systemic Toxicity (Material ● Mediated pyrogenicity) - Sub-Acute Toxicity ● - Genotoxicity - Implant Study ● - Bacterial Endotoxin (LAL -Pyrogenicity) ● ## Conclusion: The EP Granules BVF device is substantially equivalent to the cited predicate devices. Additionally, the EP Granules BVF device met all acceptance criteria to confirm safety and effectiveness.