XeliteMed VertehighFix High Viscosity Spinal Bone Cement

{0}------------------------------------------------ September 18, 2024 Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable. Xelite Biomed Ltd. Mandy Lin Regulatory Affairs Specialist 2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist New Taipei City, 231022 Taiwan Re: K241775 Trade/Device Name: XeliteMed VertehighFix High Viscosity Spinal Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN Dated: June 19, 2024 Received: June 20, 2024 Dear Mandy Lin: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" {1}------------------------------------------------ (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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). {2}------------------------------------------------ Sincerely, | JESSE | Digitally signed by<br>JESSE MUIR -S | |---------|--------------------------------------| | MUIR -S | Date: 2024.09.18<br>12:06:17 -04'00' | Jesse Muir, 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 {3}------------------------------------------------ # Indications for Use 510(k) Number (if known) K241775 #### Device Name XeliteMed VertehighFix High Viscosity Spinal Bone Cement Indications for Use (Describe) XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty procedure. Painful vertebral compression fractures may be caused by osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma). | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div> <input checked="true" type="checkbox"/> Transaction Involving OFF-Highway Diesel </div> | <div> <input type="checkbox"/> Transaction Involving OFF-Highway Kerosene </div> | |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| |-------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) | 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." {4}------------------------------------------------ # 510(k) SUMMARY #### 1. Submission Information | Submitter: | XELITE BIOMED LTD.<br>2F., No. 9, Aly. 2, Siwei Ln., Zhongzheng Rd., Xindian Dist.,<br>New Taipei City 231, Taiwan (R.O.C.) New Taipei City<br>231022 Taiwan | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submitter contact: | Mr. Wei Chun Chang<br>Tel: +886-912111529<br>E-mail: raychang@xelitemd.com | | Prepared date: | 2024-08-06 | #### 2. Device Name and Classification | Product Name: | XeliteMed VertehighFix High Viscosity Spinal<br>Bone Cement (HSA0125/HSA0200/HSA0250) | |-----------------------|---------------------------------------------------------------------------------------| | Classification Name: | Cement, Bone, Vertebroplasty | | Common or Usual Name: | Polymethylmethacrylate (PMMA) bone cement | | Regulation Number: | 888.3027 | | Product Code: | NDN | #### 3. Predicate Device(s) | Product Name: | Mendec Spine (K042415) | | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------| | Common or Usual Name: | Polymethylmethacrylate (PMMA) bone cement | | | Regulation Number: | 888.3027 | | | Product Code: | NDN | | | Items | Predicate Device | Proposed Device | | Device Name<br>(Common name) | Mendec Spine<br>(TECRES S.p.A) | XeliteMed VertehighFix<br>High Viscosity Spinal<br>Bone Cement | | K. number | K042415 | / | | Regulation Number | 21 CFR 888.3027 | Substantially identical | | Product code | NDN | Substantially identical | | Intended Use | Mendec Spine is indicated for<br>the treatment of pathological<br>fractures of the vertebrae using a<br>vertebroplasty or kyphoplasty<br>procedure. Painful vertebral<br>compression fractures may<br>result from osteoporosis, benign<br>lesions (hemangioma), and<br>malignant lesions (metastatic<br>cancers, myeloma). | Substantially identical | | Main Components | Polymethylmethacrylate<br>(PMMA)<br>Methylmethacrylate (MMA) | Substantially identical | | | Barium sulphate | Substantially identical | | Other Significant<br>Components | Benzoyl peroxide<br>N,N-Dimethyl-p-toluidine<br>Hydroquinone | Substantially identical | | Mixing/Application | Manual | Substantially identical | | Powder Sterilization<br>Method | EtO gas | Substantially identical | | Sterility Assurance<br>Level (SAL) – Powder | 10-6 | Substantially identical | | Items | Predicate Device | Proposed Device | | Liquid Sterilization<br>Method | Filtration | Substantially identical | | SAL - Liquid | 10-3 | Substantially identical | | Biocompatibility | Biocompatible | Substantially identical | | Performance | Compliance with Special<br>Controls Guidance document | Substantially identical | #### 4. Device Description XeliteMed VertehighFix High Viscosity Spinal Bone Cement is provided as a twocomponent system. The powder component consists of a PMMA-styrene copolymer with barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methyl methacrylate monomer with the addition of hydroquinone as a stabilizer and N,N-dimethyl-p-toluidine as promoter. The powder and liquid components are mixed prior to use. ## 5. Indications for Use XeliteMed VertehighFix High Viscosity Spinal Bone Cement is indicated for the treatment of pathological fracture of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may be caused by {5}------------------------------------------------ osteoporosis, benign tumors (e.g., hemangioma), or malignancy (e.g., metastatic cancer, myeloma). # 6. Comparison to the Predicate Device {6}------------------------------------------------ XeliteMed VertehighFix High Viscosity Spinal Bone Cement has similar technological characteristics as the predicate devices including overall design, intended use, material composition, function, and range of sizes. Even though the manufacturing methods are different, this does not affect the same acceptability attributes between the product and the predicates and does not cause new issue relating to the safety or performance. 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. #### 7. Performance Data ### Non-clinical tests were performed on the proposed device. The following tests were conducted: - Setting time and Max temperature . - Dough time . - Intrusion . - BPO content ● - Barium Sulfate Content ● - Trace elements . - Residual monomer ● - Leachables ● - Molecular weights ● - NMR ● - Glass transition temperature . - Powder morphology ● - Porosity, Dimension change . - % Water Absorption ● - Stability ● - Compressive Strength & Compressive Modulus ● {7}------------------------------------------------ - Bending Strength & Bending Modulus . - . Tensile Strength & Tensile Modulus. - Bacterial endotoxin testing was performed using the LAL test method, following . the USP <85> Bacterial Endotoxins Test, and met the limits (<20 EU/device). ## Conclusion Test data indicate that the final properties of XeliteMed VertehighFix High Viscosity Spinal Bone Cement are in compliance with the standard reference for bone cement: ISO 5833 "implants for surgery - acrylic resin cements" and are substantially equivalent to the predicate device.