DSM Biomedical Calcium Phosphate Cement with Microspheres

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Kensey Nash Corporation dba DSM Biomedical Susan Pileggi Senior Regulatory Specialist 735 Pennsylvania Drive Exton, Pennsylvania 19431 May 9, 2018 ## Re: K173572 Trade/Device Name: DSM Biomedical Calcium Phosphate Cement with Microspheres Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MOV, OIS Dated: April 6, 2018 Received: April 9, 2018 Dear Ms. Pileggi: 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); {1}------------------------------------------------ and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Mark N. Melkerson -S Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below. #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K173572 #### Device Name DSM Biomedical Calcium Phosphate Cement with Microspheres #### Indications for Use (Describe) DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the sketal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microsheres resorbs and is replaced by bone during the healing process. Type of Use (Select one or both, as applicable) > Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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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}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping, translucent shapes in various colors, including blue, green, orange, and purple, creating a sense of dynamism and innovation. ### 510(k) Summary | Submitted By: | DSM Biomedical<br>735 Pennsylvania Drive<br>Exton, PA 19341 | |-----------------|--------------------------------------------------------------------------------| | Contact Person: | Susan Pileggi<br>susan.pileggi@dsm.com<br>(P) 484-713-2100<br>(F) 484-713-2903 | Date Prepared: April 6, 2018 #### Device: | Trade Name: | DSM Biomedical Calcium Phosphate Cement with Microspheres | |----------------------------|-------------------------------------------------------------------------------------------------------------------| | Common/Usual Name: | Bone Void Filler | | Classification Name: | Resorbable Calcium Salt Bone Void Filler Device | | Classification Regulation: | 21 CFR 888.3045 | | Device Class: | II | | Device Code: | MQV: Filler, Bone Void, Calcium Compound<br>OIS: Calcium Salt Bone Void Filler, Drillable, Non-screw Augmentation | | Advisory Panel: | Orthopedic | Predicate Device: Stryker® Injectable Cement (K060061) [Stryker® CMF] #### Device Description DSM Biomedical Calcium Phosphate Cement with Microspheres is an injectable, fast self-setting bone substitute. DSM Biomedical Calcium Phosphate Cement with Microspheres is composed of calcium phosphate which converts to hydroxyapatite in vivo, bovine collagen powder, and PLGA microspheres. The device can also be used to augment provisional hardware to help support bone fragments during the surgical procedure. The cement is provided in a powder form packaged in a mixing syringe. The mixing syringe allows for the combination of saline, the patient's blood, or the patient's bone marrow at the required powder-to-liquid ratio. DSM Biomedical Calcium Phosphate Cement with Microspheres is supplied sterile by gamma irradiation and is non-pyrogenic. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo consists of a colorful abstract graphic on the left and the letters "DSM" in bold blue font on the right. The graphic is composed of overlapping curved shapes in shades of blue, green, orange, and purple, forming a circular design with a hexagonal space in the center. #### Indications For Use: DSM Biomedical Calcium Phosphate Cement with Microspheres is indicated to fill bony voids or gaps of the skeletal system (i.e. extremities and pelvis). These defects may be surgically created or osseous defects created from traumatic injury to the bone. The Calcium Phosphate Cement with Microspheres is indicated only for bony voids or gaps that are not intrinsic to the stability of the bony structure. The Calcium Phosphate Cement with Microspheres cured in situ provides an open void/gap filler that can augment provisional hardware (e.g. K-Wires, plates, screws) to help support bone fragments during the surgical procedure. The cured cement acts only as a temporary support media and is not intended to provide structural support during the healing process. The Calcium Phosphate Cement with Microspheres resorbs and is replaced by bone during the healing process. #### Basis for Substantial Equivalence: The DSM Biomedical Calcium Phosphate Cement with Microspheres is substantially equivalent in terms of indications for use, material composition, technological characteristics and performance characteristics to that of the predicate device, Stryker® Injectable Cement (K060061). DSM Biomedical Calcium Phosphate Cement with Microspheres and the predicate device have comparable indications for use. Both are calcium phosphate powders that when mixing liquid form a fast setting cement. The addition of the collagen and PLGA to the subject device does not raise questions of substantial equivalence as the safety of the materials has been shown through biocompatibility, bench top testing, an animal study, and a viral inactivation study. The subject and predicate devices are both injectable, sculptable, and fast setting calcium phosphate cement that converts to hydroxyapatite over time. Both the subject and predicate devices are packaged with accessories to aid in the mixing and delivery of the cement. The subject and predicate devices are provided sterile and are for single use only. The subject and predicate devices are biocompatible and non-pyrogenic. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for DSM, a global science-based company active in health, nutrition, and materials. The logo features a colorful abstract graphic on the left, resembling a stylized flower or a multi-layered shape with overlapping petals in shades of blue, purple, and yellow. To the right of the graphic is the company name "DSM" in bold, blue capital letters. | Charactestic | DSM Biomedical Calcium Phosphate<br>Cement with Microspheres (Proposed) | Stryker® Injectable Cement<br>(K060061) | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications For<br>Use | DSM Biomedical Calcium Phosphate<br>Cement with Microspheres is indicated<br>to fill bony voids or gaps of the skeletal<br>system (i.e. extremities and pelvis).<br>These defects may be surgically created<br>or osseous defects created from<br>traumatic injury to the bone. The<br>Calcium Phosphate Cement with<br>Microspheres is indicated only for bony<br>voids or gaps that are not intrinsic to<br>the stability of the bony structure. The<br>Calcium Phosphate Cement with<br>Microspheres cured in situ provides an<br>open void/gap filler that can augment<br>provisional hardware (e.g. K-Wires,<br>plates, screws) to help support bone<br>fragments during the surgical<br>procedure. The cured cement acts only<br>as a temporary support media and is not<br>intended to provide structural support<br>during the healing process. The<br>Calcium Phosphate Cement with<br>Microspheres resorbs and is replaced by<br>bone during the healing process. | Stryker Injectable Cement is a self-setting<br>calcium phosphate cement indicated to fill<br>bony voids or gaps of the skeletal system<br>(i.e. extremities, craniofacial, spine, and<br>pelvis.) These defects may be surgically<br>created or osseous defects created from<br>traumatic injury to the bone. The Stryker<br>Injectable Cement is indicated only for<br>bony voids or gaps that are not intrinsic to<br>the stability of the bony structure. Stryker<br>Injectable Cement Stryker Injectable<br>Cement cured in situ provides an open<br>void/gap filler that can augment<br>provisional hardware (e.g. K-Wires,plates,<br>screws) to help support bone fragments<br>during the surgical procedure. The cured<br>cement acts only as a temporary support<br>media and is not intended to provide<br>structural support during the healing<br>process. | | Material | Calcium phosphate powder with bovine<br>collagen and PLGA microspheres mixed<br>with saline, patient's blood, or<br>patient's bone marrow to form<br>hydroxyapatite | Calcium phosphate powder mixed with<br>mixing liquid to form hydroxyapatite | | Form | Injectable, sculptable, and fast setting<br>calcium phosphate cement that<br>converts to hydroxyapatite | Injectable, sculptable, and fast setting<br>calcium phosphate cement that converts to<br>hydroxyapatite | | Packaging | Powder prepackaged in a mixing and<br>delivery syringe, packaged with<br>accessories to aid in the mixing and<br>delivery of cement | Calcium phosphate powder in a bowl,<br>packaged with accessories to aid in the<br>mixing and delivery of the cement | | Sterilization | Sterile, SAL 10-6 | Sterile, SAL 10-6 | | Reusable | Single Use Device | Single Use Device | | Biocompatible | Yes | Yes | ## Performance Data: Material characterization, including chemical and material characterization, bench testing, biocompatibility testing, viral inactivation, and an animal study have been conducted to evaluate the {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the DSM company logo. The logo consists of a colorful abstract design on the left and the letters "DSM" in bold blue font on the right. The abstract design features overlapping shapes in various colors, including blue, orange, and purple, creating a sense of dynamism and innovation. The overall design is clean and modern, reflecting the company's brand identity. performance characteristics and biological safety of DSM Biomedical Calcium Phosphate Cement with Microspheres. Material characterization and performance testing of the DSM Biomedical Calcium Phosphate Cement with Microspheres was completed in accordance with the FDA Guidance Document, Resorbable Calcium Salt Bone Void Filler Device and ASTM F1185 Standard Specification of Hydroxylapatite for Surgical Implants. An ovine bilateral femoral defect animal study was performed to evaluate bone healing following treatment with the DSM Biomedical Calcium Phosphate Cement with Microspheres compared to the predicate device. Biocompatibility testing was completed in accordance with the requirements of ISO 10993-1: 2009, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing within a Risk Management Process for a permanent implant device with tissue/bone contact. Testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, genotoxicity, hemocompatibility, subacute toxicity, and implantation. Other safety testing included a viral inactivation study and residual chemical assessment. Results indicate that the device's biocompatibility profile is acceptable. #### Substantial Equivalence: DSM Biomedical Calcium Phosphate Cement with Microspheres has the same intended use and similar indications, technological characteristics, and principles of operation as the predicate device. The minor technological differences that exist between the DSM Biomedical Calcium Phosphate Cement with Microspheres do not raise any new issues of safety and effectiveness. The bench, animal, and biocompatibility testing demonstrates that DSM Biomedical Calcium Phosphate Cement with Microspheres is substantially equivalent to the predicate device. ## Conclusion: The DSM Biomedical Calcium Phosphate Cement with Microspheres is substantially equivalent in terms of indications for use, material composition, technological characteristics, and performance characteristics to the predicate device, Stryker® Injectable Cement (K060061) [Stryker® CMF].