KYPHON VuE Bone Cement

{0}------------------------------------------------ April 18, 2022 Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Tecres S.p.A. % Christine L. Brauer, PhD Regulatory Affairs Consultant Brauer Device Consultants, LLC 7 Trail House Court Rockville, Maryland 20850 Re: K220131 Trade/Device Name: KYPHONTM VuE™ Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN Dated: January 14, 2022 Received: January 18, 2022 Dear Christine Brauer: 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 {1}------------------------------------------------ 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 (QS) 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, For: Laura C. Rose, Ph.D. Assistant 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) K220131 Device Name KYPHONTM VuE™ Bone Cement #### Indications for Use (Describe) The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesing a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | |-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) | --- ### 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}------------------------------------------------ ### 510(k) SUMMARY #### GENERAL INFORMATION 1 ### 1.1 Submitter and Owner of the 510(k) Tecres S.p.A. Via A. Doria 6 37066 Sommacampagna Verona – Italy ### 1.2 Official Correspondent Christine L. Brauer, PhD Regulatory Affairs Consultant 7 Trail House Court Rockville, Maryland 20850 Telephone: (301) 545-1990 E-mail: chris.brauer@comcast.net #### Devices Subject of this 510(k) 1.3 KYPHON™ VuE™ Bone Cement #### 1.4 Date of Preparation March 16, 2022 ### 1.5 510(k) Number K220131 ### 2 NAME OF THE DEVICE AND CLASSIFICATION INFORMATION #### 2.1 Trade/Proprietary Name KYPHON™ VuE™ Bone Cement #### 2.2 Common/Usual Name Acrylic resin for vertebroplasty/kyphoplasty #### 2.3 Classification Information | Classification Name: | Polymethylmethacrylate (PMMA) bone cement | |----------------------------|-------------------------------------------| | Classification Regulation: | 21 CFR 888.3027 | | Class: | II | | Product Code(s): | NDN – Cement, Bone, Vertebroplasty | {4}------------------------------------------------ | Panel: | Orthopaedic | |--------|-------------| |--------|-------------| ### 3 PREDICATE DEVICE The predicate devices are identified as follows: - KYPHON® Xpede™ Bone Cement which was cleared originally through 510(k) . application K102397 and subsequently cleared in K151227, K163032, K171938 and K191148. - Spineplex™ Bone Cement by Stryker which was originally cleared through 510(k) ● notification K032945. #### DEVICE DESCRIPTION ব KYPHON™ VuE™ Bone Cement is a polymethylmethacrylate (PMMA) acrylic resin intended for use for vertebroplasty or kyphoplasty procedures, and sacroplasty procedures. K YPHON™ VuE™ Bone Cement is a modification of the KYPHON® Xpede™ Bone Cement. Like the predicate, KYPHON™ VuE™ Bone Cement contains approximately 30% barium sulfate. However, KYPHON™ VuE™ Bone Cement contains barium sulfate in two forms (powder and granules) whereas the predicate has only the powder form of barium sulfate. The larger radio-opaque granules of barium sulfate increase visualization of the acrylic resin during delivery using fluoroscopy. KYPHON™ VuE™ Bone Cement is provided sterile in two components: 20 grams of powder and 9 grams of liquid. The powder contains methylmethacrylate-styrene copolymer, barium sulfate and benzoyl peroxide. The The liquid contains methylmethacrylate (monomer), hydroquinone and N,N-dimethyl-p-toluidine. The components are manually mixed immediately prior to use. #### ഗ INDICATIONS FOR USE Below is the indication for use. The KYPHON™ VuE™ Bone Cement is indicated for the treatment of pathological fractures of the vertebral body due to osteoporosis, cancer, or benign lesions using a cementoplasty (i.e. kyphoplasty or vertebroplasty) procedure. It is also indicated for the fixation of pathological fractures of the sacral vertebral body or ala using sacral vertebroplasty or sacroplasty. Cancer includes multiple myeloma and metastatic lesions, including those arising from breast or lung cancer, or lymphoma. Benign lesions include hemangioma and giant cell tumor. Pathological fracture may include a symptomatic microfracture (as documented by appropriate imaging and/or presence of a lytic lesion) without obvious loss of vertebral body height. {5}------------------------------------------------ ### 6 COMPARISON OF THE INTENDED USE WITH THE PREDICATE DEVICE The KYPHON™ VuE™ Bone Cement and the predicate devices, the KYPHON® Xpede™ Bone Cement and the Spineplex™ Bone Cement, are intended to be used in the same surgical procedure (kyphoplasty, vertebroplasty or sacroplasty procedure) in the same target patient population and have the same primary function of treatment of pathological fractures of the vertebral body. Thus, the KYPHON™ VuE™ Bone Cement has the same intended use as the predicate devices. #### 7 COMPARISON OF THE TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VuE™ -KYPHON™ Bone Cement shares many of the same technological characteristics compared to the predicate KYPHON® Xpede" Bone Cement (see Table 1) and to the predicate Spineplex™ Bone Cement (see Table 2). | Characteristics | KYPHON™ VuE™<br>Bone Cement<br>(Subject Device) | KYPHON® Xpede™ Bone<br>Cement<br>(Predicate Device,<br>K102397, K151227,<br>K163032, K171938 and<br>K191148) | Comparison | |---------------------------------------------|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|------------| | Main Components | Polymethylmethacrylate<br>(PMMA)<br>Methylmethacrylate<br>(MMA) | Polymethylmethacrylate<br>(PMMA)<br>Methylmethacrylate<br>(MMA) | Same | | Main Components | Barium Sulfate<br>(powder and granules) | Barium Sulfate<br>(powder only) | Different | | Other Significant<br>Components | Benzoyl peroxide<br>N,N-Dimethyl-p-toluidine<br>Hydroquinone | Benzoyl peroxide<br>N,N-Dimethyl-p-toluidine<br>Hydroquinone | Same | | Mixing/Application | Manual | Manual | Same | | Powder Sterilization<br>Method | Gamma-ray irradiation | Gamma-ray irradiation | Same | | Sterility Assurance Level<br>(SAL) - Powder | 10-6 | 10-6 | Same | | Liquid Sterilization<br>Method | Filtration | Filtration | Same | | SAL - Liquid | 10-3 | 10-3 | Same | Table 1: Summary of Technological Characteristics between the KYPHON VuE™ Bone Cement and the Predicate Device, the KYPHON® Xpede™ Bone Cement {6}------------------------------------------------ | Characteristics | KYPHON™ VuE™<br>Bone Cement<br>(Subject Device) | Spineplex Bone Cement<br>(Predicate Device,<br>K032945) | Comparison | |---------------------------------------------|------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-------------------| | Main Components | Polymethylmethacrylate<br>(PMMA)<br>Methylmethacrylate<br>(MMA)<br>Barium Sulfate<br>(powder and granules) | Polymethylmethacrylate<br>(PMMA)<br>Methylmethacrylate<br>(MMA)<br>Barium Sulfate<br>(powder only) | Same<br>Different | | Other Significant<br>Components | Benzoyl peroxide<br>N,N-Dimethyl-p-toluidine<br>Hydroquinone | Benzoyl peroxide<br>N,N-Dimethyl-p-toluidine<br>Hydroquinone | Same | | Mixing/Application | Manual | Manual | Same | | Powder Sterilization<br>Method | Gamma-ray irradiation | Irradiation | Same | | Sterility Assurance<br>Level (SAL) – Powder | 10-6 | 10-6 | Same | | Liquid Sterilization<br>Method | Filtration | Filtration | Same | | SAL - Liquid | 10-3 | 10-3 | Same | Table 2: Summary of Technological Characteristics between the KYPHON™ VuE™ Bone Cement and the Predicate Device, the Spineplex™ Bone Cement ## 8 PERFORMANCE DATA This 510(k) notification provided performance data to establish the substantial equivalence of the KYPHON™ VuE™ Bone Cement to the predicate device. Performance testing was conducted in accordance with the "FDA Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement: Guidance for Industry and FDA " dated July 17, 2002. The following is a summary of the performance data. Sterilization and Shelf Life: The device is sterilized using standard methods and the sterilization cycles have been validated following international standards. The shelf life of 2 years has been established in stability studies in that evaluated both device functionality and sterility. Bacterial endotoxin testing was performed using the LAL test (gel clot) method, following the current edition of the European Pharmacopoeia (EP) Standard 2.6.14. Bacterial Endotoxins and met the limits (<20 EU/device). The analytical procedures described in the official pharmacopoeial texts, European Pharmacopoeia (Ph. Eur.): 2.6.14. Bacterial Endotoxins, Japanese Pharmacopoeia (JP): 4.01 Bacterial Endotoxins Test, and United States Pharmacopeia (USP) General Chapter Bacterial Endotoxins Test, can be used as interchangeable in the ICH regions (Guidance for Industry O4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions Annex 14 Bacterial Endotoxins Test General Chapter, October 2013). {7}------------------------------------------------ Biocompatibility: Biocompatibility evaluation has been performed to show the device materials are safe, biocompatible, and suitable for their intended use. FDA Guidance "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" was taken into account to evaluate the biocompatibility of the device materials and the following biocompatibility studies were completed. | Biocompatibility Test | Test Method | Results | |----------------------------------|--------------------------------|---------------------------------------| | Cytotoxicity | ISO 10993-5 | Not cytotoxic | | Sensitization | ISO 10993-10 | Not sensitizing | | Intracutaneous reactivity | ISO 10993-10 | No signs of erythema, eschar or edema | | Systemic toxicity (acute) | ISO 10993-11 | Non-toxic | | Material-mediated pyrogenicity | USP 42 <151><br>ISO 10993-11 | Absence of pyrogens | | Genotoxicity (Ames test) | ISO 10993-3 | Non-mutagenic | | Genotoxicity (Mouse<br>Lymphoma) | ISO 10993-3<br>ISO/TR 10993-33 | Non-mutagenic | | Implantation 13W | ISO 10993-6 | No local and systemic effects- | Performance Testing: Performance testing was performed to characterize the bone cement in accordance with special controls guidance document. This testing included the following: - Mixing and application characteristics (e.g., dough time, setting time) - Chemical composition (e.g., residuals, molecular weight and polymer structure, glass ● transition temperature) - Thermal properties (e.g., polymerization temperature) ● - Mechanical properties (e.g., modulus and flexural properties, static compression and . bending, fatigue testing, fracture toughness and viscoelasticity) - . Sacroplasty testing (extravasation rate) Results show comparable performances to the predicate devices and are in compliance with ASTM F451-16, ISO 5833:2002, ISO 527:1/2, ASTM F2118-14, ASTM D2990-17, ASTM D732-17 and ASTM E399-20. The performance data demonstrate that the new devices are substantially equivalent to the predicate device and meet the requirements of the Special Controls Guidance document.