SpineKure Kyphoplasty System

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the words "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line. May 29, 2018 HANCHANG Co., Ltd. % GeumHyeon Kim Lead Consultant DT&S Co., Ltd. #1206, Mario Tower, 28, Digital-ro 30-gil Guro-gu, Seoul 08389 Republic of Korea Re: K172871 Trade/Device Name: SpineKure Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN. HRX Dated: March 7, 2018 Received: April 18, 2018 Dear GeumHyeon Kim: 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 {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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); 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, Katherine D. Kavlock -S for 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) K172871 Device Name SpineKure Kyphoplasty System ### Indications for Use (Describe) The SpineKure Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylme (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. | Type of Use (Select one or both, as applicable) | | |-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> | 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 features a logo with the letters "HME" in bold, red font. The letters are enclosed within a red oval shape. The logo has a simple and clean design, with the focus on the company's initials. #301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501, Republic of Korea > K172871 Page 1/5 # 510(k) Summary [As required by 21 CFR 807.92] ## 1. Date Prepared [21 CFR 807.92(a)(a)] March. 23. 2018 ### 2. Submitter's Information [21 CFR 807.92(c)(1)] | ● | Name of Manufacturer: | HANCHANG Co., Ltd | |---|-----------------------|------------------------------------------------------------------------------------------------------| | ● | Address: | #301-204 Bucheon Techno-park, 345, Seokcheon-ro<br>Bucheon-si, Gyeonggi-do, 14501, Republic of Korea | | ● | Telephone No.: | +82-32-234-0033 | | ● | Fax No.: | +82-32-234-0040 | ### 3. Submission Correspondent | ● | Name of company: | DT&S Co., Ltd. | |---|------------------|----------------------------------------------------------------------------------------| | ● | Address: | #1206, Mario Tower, 28, Digital-ro 30-gil, Guro-gu, Seoul,<br>08389, Republic of Korea | | ● | Contact Name: | GeumHyeon Kim | | ● | Contact Title | Lead Consultant | | ● | E-mail Address | gh.kim@dtns.co.kr | | ● | Telephone No.: | +82-2-357-8401 | | ● | Fax No.: | +82-2-357-8027 | ### Trade Name, Regulation Name, Classification [21 CFR 807.92(c)(2)[ 4. | Trade/Device Name | SpineKure Kyphoplasty System | |-------------------|-------------------------------------------| | Common Name | Inflatable Bone Tamp | | Regulation Number | 21 CFR 888. 3027 | | Regulation Name | Polymethylmethacrylate (PMMA) bone cement | | Regulation Class | Class II | | Product Code | NDN, HRX | | Product Code Name | Cement, Bone, Vertebroplasty | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows a red logo with the letters "HME" inside of a red oval. The letters "HME" are in a bold, sans-serif font. The logo is simple and clean, and the red color is eye-catching. The logo is likely for a company or organization with the initials "HME". #301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501, Republic of Korea > K172871 Page 2/5 ### 5. Identification of Predicate Device(s) [21 CFR 807.92(c)(3)[ ### Predicate device #1 | • 510(k) Number: | K153296 | |------------------|--------------------| | • Manufacturer: | IMEDICOM Co., Ltd. | - Device Name: MEDINAUT Kyphoplasty System ### Predicate device #2 - K150322 • 510(k) Number: - · Manufacturer: Pan Medical Ltd. - Device Name: InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini) ### Predicate device #3 - 510(k) Number: K131824 - Manufacturer: CareFusion - Device Name: AVAflex Vertebral Balloon System ### 6. Description of the Device [21 CFR 807.92(c)(4)] The SpineKure Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment by creating a space in the vertebral body to facilitate the insertion of bone cement. The SpineKure Kyphoplasty System is comprised of a Balloon Catheter, Balloon Inflator and Cement Delivery System (Accessories kit). The Balloon Catheter's main components are the shaft, hub and the inflatable balloon located at the distal tip. The surface of balloon is covered with a silicone lubricant to enhance the insertion and withdrawal of catheter. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. The Balloon Inflator (SBI) is a disposable device with an integral pressure gauge. The Cement Delivery System (SCDS) are consist of Bone Access Needle (SBN), Cement Filler & Pusher (SFP), Cannula & Expander (SCE), Drill Bit (SDB), Wire-pin (SWP-T, SWP-R). ### 7. Indications for use [21 CFR 807.92(c)(5)] The SpineKure Kyphoplasty System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. This system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. {5}------------------------------------------------ Image /page/5/Picture/6 description: The image shows a red logo with the letters "HME" stacked vertically. The letters are stylized and appear to be stenciled. To the right of the logo, there is some text that is oriented vertically, but it is too blurry to read. -204 Bucheon Techno-park, 345, Seokcheon-r neon-si, Gyeonggi-do, 14501, Republic of Kore K172871 Page 3/5 # etermination of Substantial Equivaler 8 The Spine Kyphalaty System ar substantine sevice with respect nintespect nintrespect nincitors or use and technic | | oposed Devi | edicate Device | redicate Device | edicate Device | |-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------| | evice Nam | pineKure Kyphoplasty | DINAUT Kyphoplas | -V Kyphoplasty Cather V Kyphoplash Cather V Kyphoplash Catheter (Ministration) | Aflex Vertebral Ballo | | 10(k) Numbe | K172871 | | | K131824 | | anufacture | | | | CareFusio | | roduct Code | ANCHANG Co. Ltd. | K153296 EDICOM Co., Ltd., Ltd., Ltd., Ltd., Ltd., Ltd., Ltd., Ltd., Ltd., HRX, NDN | RX, NDI | HRX, NDN | | evice Class | | | | | | cations for | olymethylmethacrylate 'MMA) bone cements 'MMA) bone cements idicated for use arrively ercutameous versions in al ugmentation, succh as<br>yphoplasty.<br>spinal | lymethylmethacrylacryla.cryla.cryla.com MMA) bone cemential.com dicated for used for used by in the propriation rementation, words butter butter butter thematication,<br>phoplasty.<br>oina | | onded for reduction af frances tion of francisco and the may | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows a red logo with the letters HME stacked vertically. The logo is enclosed in a red oval shape with dashed lines. The text is oriented vertically on the left side of the image. 301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501, Republic of Korea K172871 Page 4/5 | Components | Proposed Device | Predicate Device #1 | Predicate Device #2 | Page 4/5<br>Predicate Device #3 | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------| | | 1) Balloon Bone Catheter<br>2) Balloon Inflator<br>3) Cement Delivery System<br>- Bone Access Needle,<br>Cement Filler & Pusher,<br>Cannula & Expander, Drill<br>Bit, Wire-pin Trocar, Wire-<br>pin Round | 1) Bone Catheter<br>2) Expander Syringe<br>3) Kit<br>- Needle Pipe, Needle Pin,<br>Expander, Cannula, Spacer,<br>Guide Wire, Wire Pin,<br>Cement Pusher, Cement<br>Filler, and Guide wire | 1) Balloon Bone Catheter<br>2) Bone access tools<br>- Bone access needle,<br>Kirschner wire, Bone<br>access drill, Curette, Bone<br>access cannula<br>3) Cement delivery tools<br>- Cement delivery cannula,<br>Cement dispenser<br>4) Inflation device | 1) Balloon Bone Catheter<br>2) Accessory Kit | | Specifications | | | | | | Balloon Size | 10mm, 15mm, 20mm | 10mm, 15mm, 20mm | 10mm, 15mm, 20mm | 15mm, 20mm, 30mm | | Balloon Material | Thermoplastic Polyurethane | Thermoplastic Polyurethane | Polyurethane | Polyurethane | | Max. Inflation Pressure | 400 Psi | 350 Psi | 750 Psi | 400 Psi | | Max. Recommended<br>Inflation Volume | 10 mm balloon: 3 ml<br>15 mm balloon: 5 ml<br>20 mm balloon: 7 ml | 10 mm balloon: 3 ml<br>15 mm balloon: 5 ml<br>20 mm balloon: 7 ml | 10 mm balloon: 4 ml<br>15 mm balloon: 4 ml<br>20 mm balloon: 6 ml | 15 mm balloon: 4 ml<br>20 mm balloon: 6 ml<br>30 mm balloon: 8 ml | | Balloon Shape | Cylindrical | Cylindrical | Cylindrical | Cylindrical | | Radiopaque Marker | Yes | Yes | Yes | Yes | | Packaging information | Pouch (Medical grade paper),<br>PE Film, Blister Pack,<br>Cardboard Box | Pouch, Tyvek Blister Tray,<br>Cardboard Box | Not known | Not known | | Sterilization | EtO Sterilization | Gamma Sterilization | EtO Sterilization | Not known | | Biocompatibility | Meets ISO 10993 | Meets ISO 10993 | Not known | Not known | {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows a red logo with the letters "HME" inside of a red oval. The letters are in a bold, sans-serif font and are stacked on top of each other. The oval is slightly tilted to the right. The logo is simple and eye-catching. #301-204 Bucheon Techno-park, 345, Seokcheon-ro, Bucheon-si, Gyeonggi-do, 14501, Republic of Korea > K172871 Page 5/5 ### 9. Non-Clinical Test Summary - 1) Biocompatibility tests were performed in accordance with ISO 10993- 5, 10, 11 as well as the FDA's Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The subject devices have been evaluated through the following tests: - ISO 10993-5:2009, Biological evaluation of medical devices Part 5: tests for in vitro cytotoxicity - ISO 10993-10:2010, Biological evaluation of medical devices Part 10: tests for irritation and skin sensitization - · ISO 10993-11:2006 Biological evaluation of medical devices Part 11: Tests for systemic toxicity including the pyrogen test - 2) Verification activities including mechanical and functional testing as required by the risk analysis were performed to evaluate the performance and the safety of the subject devices and the test results met the preset criteria and it does not raise any new issues of safety or effectiveness. - · Balloon deflation time - · Burst pressure (constrained, unconstrained) - · Fatigue strength - · Balloon dimension before and after inflation, - Insertion and withdrawal force - · Tensile bond strength - 3) The shelf life test of the device were conducted in accordance with ASTM F1980-07. - The sterilization validation confirmed that the sterilization cycle maintained a sterility 4) assurance level (SAL) of 10-6 in accordance with the following standard: - · ISO 11135-1:2007, Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - 5) The packaging integrity testing were conducted with visual inspection, seal strength and dye penetration test per ISTA-2A, ASTM F1929 and ASTM F88 ### 10. Clinical Test Summary N/A- No clinical tests were conducted for this submission ### 11. Conclusion [21 CFR 807.92(b)(3)] Based on those information, we conclude that the SpineKure Kyphoplasty System is substantially equivalent to the predicate devices