Altapore Shape

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. Baxter Healthcare Corporation Phillip Romei Specialist, Global Regulatory Affairs 32650 N. Wilson Road Round Lake, Illinois 60073 Re: K191513 Trade/Device Name: Altapore Shape Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable calcium salt bone void filler device Regulatory Class: Class II Product Code: MQV Dated: September 16, 2019 Received: September 18, 2019 Dear Mr. Romei: 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. 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You must comply with all the Act's {1}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Laurence D. Coyne, Ph.D. Acting Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191513 Device Name Altapore Shape Indications for Use (Describe) ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine). ALTAPORE SHAPE must be used in combination with autograft as a bone graft extender in posterolateral spinal fusion procedures. 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. ALTAPORE resorbs and is replaced with bone during the healing process. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------------------------|--| | <span style="display:inline-block;"><input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</span> | | | <span style="display:inline-block;"><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</span> | | 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. 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The font is sans-serif and the letters are closely spaced together. ## Section 5. 510(k) Summary October 17, 2019 #### OWNER: Baxter Healthcare Corporation One Baxter Parkway Deerfield, Illinois 60015 ## CONTACT PERSON: Phillip Romei Specialist, Regulatory Affairs 32650 N Wilson Road Round Lake, IL 60073 Telephone: (224) 948-2652 Fax: (224) 270-4119 #### IDENTIFICATION OF THE DEVICE: Common Name: Bone Void Filler Trade/Device Name: ALTAPORE SHAPE Classification Panel: 87 Orthopedic Regulation Number: 21 CFR 888.3045 Regulation Name: Resorbable Calcium Salt Bone Void Filler Device Regulatory Class: Class II Product Code: MQV | Model Number | Name | |--------------|----------------------------------------| | 1508043 | ALTAPORE SHAPE, 1.6 ml small cylinder | | 1508044 | ALTAPORE SHAPE, 2.6 ml medium cylinder | | 1508045 | ALTAPORE SHAPE, 8 ml large cylinder | | 1508046 | ALTAPORE SHAPE, 15.8 ml large strip | #### Table 1. Model Numbers for ALTAPORE {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "Baxter" in a bold, italicized, sans-serif font. The color of the text is a dark blue. The word is the logo for the company Baxter International, a global medical technology company. ## PREDICATE AND REFERENCE DEVICES: ALTAPORE SHAPE is substantially equivalent to the following predicate and reference devices (Table 2): | Device | Company | 510(k) | Clearance Date | |------------------------------------------|--------------------------------------|---------|-------------------| | ALTAPORE<br>(Predicate Device) | Baxter Healthcare<br>Corporation | K181225 | August 31, 2018 | | ACTIFUSE SHAPE<br>(Reference Device) | Baxter Healthcare<br>Corporation | K082575 | November 25, 2018 | | MASTERGRAFT® Putty<br>(Predicate Device) | Medtronic Sofamor Danek<br>USA, Inc. | K140375 | April 18, 2014 | Table 2. Predicate and Reference Devices ## DESCRIPTION OF THE DEVICE: ALTAPORE SHAPE is a bioactive and osteoconductive silicate-substituted calcium phosphate bone void filler. The interconnected and open porous structure of the silicatesubstituted calcium phosphate phase of ALTAPORE SHAPE is similar to human cancellous bone and is intended to support bone growth with macro and micro-porosity. The microgranule phase ALTAPORE SHAPE is composed solely of elements that exist naturally in normal bone (Ca, P, O, H, Si). ALTAPORE SHAPE is supplied as a shaped wax-like putty in a sterile pouch containing ALTAPORE microgranules, sized 1-2 mm, 80-85% total porosity, suspended in an absorbable Alkylene Oxide co-polymer carrier. ALTAPORE does not set in-situ following implantation. ALTAPORE is available as a 1.6 ml small cylinder, 2.6 ml medium cylinder, 8 ml large cylinder, and 15.8 ml large strip. ALTAPORE SHAPE is designed for use as a standalone bone graft substitute or as an autograft extender. While not necessary, the product can be mixed with autologous blood or autologous bone at the discretion of the surgeon. ALTAPORE SHAPE is bioactive based on in vitro studies that show it forms a surface apatite-layer when submerged in simulated body fluid that contains the same ion concentrations as human blood plasma. This apatite layer provides scaffolding onto which the patient's new bone will grow, allowing complete repair of the defect. ALTAPORE SHAPE is osteoconductive based on in vivo animal studies that show it achieves bone healing in a critical defect model as confirmed with radiographic, {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the word "Baxter" in a stylized, bold, blue font. The word is slightly slanted to the right, giving it a dynamic appearance. The font is sans-serif, and the letters are closely spaced together. histolopathological, histomorphometric, and mechanical analyses. ALTAPORE SHAPE undergoes cell-mediated remodeling and is replaced by natural bone. #### INDICATIONS FOR USE ALTAPORE SHAPE is an implant intended to fill bony voids or gaps of the skeletal system (i.e., extremities, pelvis and posterolateral spine). ALTAPORE SHAPE must be used in combination with autograft as a bone graft extender in posterolateral spinal fusion procedures. 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. ALTAPORE resorbs and is replaced with bone during the healing process. ## PURPOSE OF SUBMISSION The purpose of this submission is to introduce the ALTAPORE SHAPE bone void filler to the market. The proposed device is a suspension of ALTAPORE microgranules currently used in Baxter's ALTAPORE Bone Graft substitute product lines, previously cleared under 510(k) premarket notifications K181225, in the alkylene oxide copolymer carrier currently used in Baxter's ACTIFUSE SHAPE bone graft substitute, previously cleared under 510(k) premarket notification K082575. The hydroxyapatite granules used in ALTAPORE SHAPE, ALTAPORE, and ACTIFUSE SHAPE are all chemically identical. The intended use of the proposed product is the same as the predicate and reference device, and the fundamental technology of the device is the same across all three devices. ## TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE ALTAPORE SHAPE is substantially equivalent to the predicate device previously cleared under 510(k) premarket notification, K181225 and the reference devices cleared under 510(k) premarket notifications K082575 and K140375. The function and intended use of the proposed device are equivalent to the predicate and reference devices. Table 3 provides a comparison of the technological characteristics of the proposed and predicate devices. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font is sans-serif and appears to be slightly italicized. The word is horizontally oriented and takes up most of the image space. | | Predicate Device<br>(K140375): | Reference Device<br>(K082575): | Predicate Device<br>(K181225): | Proposed Device: | |--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| | Features | MASTERGRAFT® Putty | ACTIFUSE<br>SHAPE | ALTAPORE | ALTAPORE<br>SHAPE | | Composition | Calcium Phosphate<br>Salt:<br>Purified collagen<br>of bovine origin and<br>biphasic calcium<br>phosphate ceramic.<br>Type I bovine<br>collagen.<br>15 percent<br>hydroxyapatite and<br>85 percent β-<br>tricalcium<br>phosphate<br>formulation. | Calcium Phosphate<br>Salt:<br>Silicate-substituted<br>calcium phosphate<br>composed solely of<br>elements that exist<br>naturally in normal<br>bone (Ca, P, O, H,<br>Si). | Calcium Phosphate<br>Salt:<br>Silicate-substituted<br>calcium phosphate<br>composed solely of<br>elements that exist<br>naturally in normal<br>bone (Ca, P, O, H,<br>Si). | Identical to<br>Altapore predicate<br>device and<br>ACTIFUSE<br>SHAPE refrence<br>device. | | Physical<br>Structure | Granules with a<br>natural,<br>interconnected,<br>porous structure<br>which mimics the<br>natural structure of<br>bone. | Granules with a<br>natural,<br>interconnected,<br>porous structure<br>which mimics the<br>natural structure of<br>bone. | Granules with a<br>porosity similar to<br>cancellous bone. | Identical to<br>Altapore (predicate)<br>and Actifuse Shape<br>(reference device). | | Nominal<br>(Total)<br>Porosity | 80%<br>(interconnected<br>porosity) | 80 ± 2.5% | 82.5 ± 2.5% | Identical to<br>Altapore (predicate)<br>and Actifuse Shape<br>(reference device). | | Strut<br>Porosity | Information not<br>publicly available. | Microporous | 31-47% | Identical to<br>Altapore<br>(predicate). | | Sterility | Irradiation | Irradiation | Irradiation | Identical to<br>Altapore (predicate)<br>and Actifuse Shape<br>(reference device). | # Table 3. Technological Characteristics # DISCUSSION OF NONCLINICAL TESTS Baxter Healthcare Corporation conducts risk analyses and design verification tests based on the result of these analyses. All test results met the acceptance criteria, and support that the proposed devices are appropriately designed for their intended use. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the word "Baxter" in a bold, blue font. The font appears to be sans-serif. The word is slightly slanted to the right, giving it a dynamic appearance. #### Sterility The ALTAPORE SHAPE device is sterilized with radiation. The minimum sterilizing dose (MSD) required to provide a 10-6 Sterility Assurance Level (SAL) for this (sub) category was established and validated at the manufacturing facility as described in ANSI/AAMI/ISO ISO 11137-2, "Sterilization of health care products- Radiation-Part 2: Establishing the Sterilization Dose." These products are labeled "Sterile". Package Verification testing is based on Visual Inspection, Seal Strength, and Bubble Leak testing. #### Shelf Life Stability indicating parameters are identical between the reference device ACTIFUSE SHAPE and ALTAPORE SHAPE. as both are composed of the same materials and have identical packaging materials. A shelf life claim of 5 years is substantiated by stability results of the reference device ACTIFUSE SHAPE, (cleared under K082575). #### Performance Testing- Bench The microgranule phase of the proposed device and predicate device has identical chemical composition, physical structure, and manufacturing process and the carrier phase of the proposed device is identical to the chemical composition, packaging and sterilization methods . As such, no additional bench testing was conducted. All previous verification and validation testing performed for the predicate device, cleared under K181225, and testing performed for the ACTIFUSE SHAPE reference device, cleared under K082575, are applicable to the proposed product. The following in vitro studies were conducted as part of the predicate submission to evaluate the performance characteristics of ALTAPORE SHAPE: - Bioactive properties #### Performance Testing- Animal A preclinical animal study was conducted to evaluate the following performance characteristics of ALTAPORE SHAPE for use in the spine: - Effectiveness for use in posterolateral fusion (with autogenous iliac crest bone graft (ICBG)) {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the word "Baxter" in a bold, blue, sans-serif font. The word is slightly italicized, giving it a sense of forward motion. The color of the text is a vibrant blue, which stands out against the white background. The overall impression is one of a clean and professional logo. A preclinical animal study was carried out to assess the following performance characteristics of ALTAPORE SHAPE in extremities: - Effectiveness for use in extremities (with and without autologous blood)) #### Biocompatibility The hydroxyapatite microgranule phase in the proposed device has been used in the predicate device, ALTAPORE, with the same intended use and with the same type and duration of contact. ALTAPORE has been previously cleared under 510(k) submission, K181225. The alkylene oxide copolymer carrier phase in the proposed device has previously been used in the reference device. ACTIFUSE SHAPE, with the same intended use and with the same type and duration of contact. ACTIFUSE SHAPE has been previously cleared under 510(k) submission, K082575. Biocompatibility assessments were conducted based on ISO-10993-1 and FDA guidance Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process," as recommended in the FDA guidance document, Guidance for Industry and FDA Staff- Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device. The battery of testing included the following tests: - Cytotoxicity - Sensitization - Irritation - System Toxicity - Pyrogen - Genotoxicity - Implantation #### CONCLUSION The non-clinical data demonstrate that the subject device is substantially equivalent and performs comparably to the predicate device and reference devices that are currently marketed for the same intended use.