DCM Kyphoplasty System

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads, representing the department's commitment to health, human services, and well-being. The eagle is positioned above the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA," which are arranged in a circular fashion around the eagle. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 6, 2017 Dragon Crown Medical Co., Ltd. Mr. Zhi Yong Song Supervisor of Product Regulation 6F, Kehui Building, No. 109, Shunhua Road, High-Tech Development Zone Jinan, Shandong Province 250101 China Re: K162283 Trade/Device Name: DCM Kyphoplasty System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: January 3, 2017 Received: January 9, 2017 Dear Mr. Song: 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in {1}------------------------------------------------ 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. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K162283 Device Name The DCM Kyphoplasty System #### Indications for Use (Describe) The DCM Kyphoplasty System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate(PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) #### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ # 山东冠龙医疗用品有限公司 Section 5 of Traditional 510(K) Submission: #### 510 (K) Summary # This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92 - 1. Date of Submission: Feb. 2, 2017 - 2. Submitter / 510(K) Holder Dragon Crown Medical Co., Ltd. 6F, Kehui Building, No.109, Shunhua Road, High-Tech Development Zone Jinan, Shandong Province, China250101 Contact Person: Mr. Zhi Yong Song Tel: (86) 531-81217228 Fax: (86) 531-82959557 E-mail: guanfda2016@hotmail.com ## 3. Proposed Device Name Trade name: DCM Kyphoplasty System Common name:Kyphoplasty System Classification Name: Polymethylmethacrylate (PMMA) Bone Cement Cement, bone, vertebroplasty Device Class: Class II Classification Panel: Orthopedic Panel Product Code: PFP ."HRX Regulation Number: 21 CFR 888.3027, 21 CFR 888.1100 #### 4. Predicate Devices Predicate Devices: 510 (k) Number: K143006 Product Name: GUARDIAN-SG Inflatable Bone Expander System Submitter: BM KOREA CO., LTD. #### 5. Indication for Use DCM Kyphoplasty System is intended to be used for the reduction of fractures and/or creation {4}------------------------------------------------ of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. #### 6. Device Description The DCMKyphoplasty System is designed to reduce compression fracture and create a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty. DCM Kyphoplasty System contains balloon catheter, balloon inflator, puncture needle and tool kit. The balloon catheter is used to position inside of the vertebral body where it is inflated to make a cavity. The balloon inflator is used to inflate the balloon catheter that is filled with a contrast agent. The puncture needle is used to percutaneous puncture during the surgery and have two types: locking and rotating. The tool kit is used to support to perform the surgery and fill the bone cement. All parts of DCM Kyphoplasty System are supplied sterile and are single use only. The balloon catheter has four specifications: Φ9×15, Φ12×19, Φ14×17 and Φ17×22. Balloon Inflator has two specifications: 20ml/30atm, 25ml/30atm. Puncture Needle has seven specifications: Φ2.5×100, Ф2.5×130, Ф3.0×100, Ф3.2×100, Ф3.2×130, Ф3.5×126, Ф4.0×126. The tool kit is consisting of bone expander, spiral propeller, guide needle, expansion tube, working cannula, solid vertebral drill, hollow vertebral drill, push rod, bone cement injector and locator. They are supplied sterile and are single use only. #### 7. Sterilization DCM Kyphoplasty System is provided sterile and is for single use only. The ETOgas sterilization process isvalidated with a resulting sterility assurance level (SAL) of 106.1t meets requirements of ISO 11135, sterilization of health-care products for ethylene oxide - requirements for the development, validation and routine control of a sterilization process for medical devices. ETOresidual testing was also performed and the test result meets specification. #### 8. Packaging The package of partsof DCM Kyphoplasty System has four levels. Firstlyeach parts is placed in the sterilization package and heat sealed. Secondly each sterilization package is placed in inner box. Thirdly four inner boxes are packaged in middle box. Finally, this middlebox isplaced in a shipping box. Expiration dating testing was conducted using methodof the industry standard AAMI/ANSV/ISO 11607Packaging for Terminally Sterilized Medical Devicesfor accelerated aging and real-time aging was also performed. {5}------------------------------------------------ #### 9. Materials All materials used in the manufacture of the DCM Kyphoplasty System can meet the requirements of AAMI/ANSI/ISO 10993, biological evaluation of medical devices -- part 1: evaluation and testing within a risk management process. Typical material hasPolyurethane, Platinum, Polycarbonate(PC), Stainless Steel S30408, S51740, ABS etc. #### 10. Non-Clinical Testing Product testing of DCM Kyphoplasty System was performed on final sterilized devices. Testing was completed, including:dimensional, inflation, balloon size, insertion/withdraw force, fatigue testing and tensile strength. All testing met theacceptance criteria. Biocompatibility testing was performed per AAMI/ANSI/ISO 10993 as required for a temporary bone/tissuecontacting device. All materials were found to be biocompatible and suitable for this use. | N | Compare | Proposed Device: | Predicate Device | Comparis<br>on Result | |----|------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | 0 | Items | DCM Kyphoplasty System | 510(K) No.K143006 | | | 1 | Class | Class II | Class II | Same | | 2 | Product Code | HRX, NDN | HRX, NDN | Same | | 3 | Intended Use | DCM Kyphoplasty System is intended<br>to be used for the reduction and<br>fixation of fractures and/or creation of<br>a void in cancellous bone in the spine.<br>This includes use during percutaneous<br>vertebral augmentation. The system is<br>to be used with cleared spinal<br>polymethylmethacrylate (PMMA)<br>bone cements indicated for use during<br>percutaneous vertebral augmentation,<br>such as kyphoplasty. | GUARDIAN-SG Inflatable Bone<br>Expander System is intended to be<br>used for the reduction and fixation of<br>fractures and/or creation of a void in<br>cancellous bone in the spine. This<br>includes use during percutaneous<br>vertebral augmentation. The system is<br>to be used with cleared spinal<br>polymethylmethacrylate (PMMA)<br>bone cements indicated for use during<br>percutaneous vertebral augmentation,<br>such as kyphoplasty. | Same | | 4 | Design | DCM Kyphoplasty System consists of<br>four components:<br>* Balloon Catheter<br>* Balloon Inflator<br>* Puncture Needle<br>* Tool Kit<br><br>The balloon catheter has four<br>specifications: Φ9×15, Φ12×19, | The GUARDIAN-SG IBES<br>components are Inflatable Bone<br>Tamp (balloon catheter,<br>compressor) and accessory kit.<br>and balloon catheter' main<br>components are the shaft, Yhub<br>and the inflatable balloon located<br>at the distal tip | Similar | | | | | | | | | | $Φ14×17$ and $Φ17×22$ | The balloon catheter has three | | | | | Balloon Inflator: 20ml/30atm<br>25ml/30atm | specifications: BMK10, BMK15,<br>BMK20 | | | | | Puncture Needle: $Φ2.5×100$ , $Φ

lt;br>$2.5×130$ , $Φ3.0×100$ , $Φ3.2×100$ , $Φ3.2×130$ , $Φ3.5×126$ , $Φ4.0×126$ | | | | 5 | Material | Balloon Catheter is made of<br>Polyurethane, Platinum,<br>Polycarbonate(PC), Stainless Steel<br>S30408 | All materials used in the<br>GUARDIAN-SG Inflatable Bone<br>Expander System are Plastic and<br>Stainless Steel etc. | Similar | | | | Balloon Inflator is made of<br>Polycarbonate(PC), Nylon reinforced<br>polyurethane, Brass, Stainless Steel<br>S30408, Nylon(PA6), ethylene<br>propylene diene monomer | | | | | | Puncture Needle is made of Stainless<br>Steel S30408, S51740, ABS,<br>Polycarbonate(PC) | | | | | | Other parts are made of Plastic and<br>Stainless Steel etc. | | | | 6 | Biocompatibility | All materials are made of stainless<br>steel & plastic material etc. and used<br>in the DCM Kyphoplasty System can<br>meet the requirements of<br>AAMI/ANSI/ISO 10993, biological<br>evaluation of medical devices -- part 1:<br>evaluation and testing within a risk<br>management process. | All materials used in<br>the GUARDIAN-SG Inflatable Bone<br>Expander System can meet the<br>requirements of FDA requirement<br>related to biocompatibility. | | | 7 | Properties | Product testing of DCM Kyphoplasty<br>System was performed on final<br>sterilized devices. Testing was<br>completed, including: dimensional,<br>inflation/deflation, balloon size,<br>insertion/withdraw force, fatigue<br>testing and tensile strength. All testing<br>met the acceptance criteria.<br><br>Biocompatibility testing was<br>performed per AAMI/ANSI/ISO<br>10993 | The testing of the GUARDIAN-SG<br>Inflatable Bone Expander System<br>included functional, such as balloon<br>compliance, deflation time, insertion /<br>withdraw force and fatigue testing as<br>well as mechanical testing, such as<br>tensile strength. | Similar | | 8 | Sterilization | DCM Kyphoplasty System is provided | The Balloon catheter, compressor and | Similar | | | | | | | | | | sterile and is for single use only. The | the accessory kit are supplied sterile | | | | | ETO gas sterilization process is | and disposable use. | | | | | validated with a resulting sterility | | | | | | assurance level (SAL) of 10-6. It meets | | | | | | requirements of ISO 11135, ETO | | | | | | residual testing was also performed | | | | | | and the test result meets specification. | | | | 9 | Standards met | AAMI / ANSI / ISO 10993-1:2009/(R) | AAMI / ANSI / ISO 10993-1, | Same | | | | 2013, biological evaluation of medical | biological evaluation of medical | | | | | devices -- part 1: evaluation and | devices -- part 1: evaluation and | | | | | testing within a risk management | testing within a risk management | | | | | process. (Biocompatibility) | process. (Biocompatibility) | | | | | ISO 11135 Second edition 2014, | ISO 11135, sterilization of health-care | | | | | sterilization of health-care products ¿ | products, ethylene oxide - | | | | | ethylene oxide - requirements for the | requirements for the development, | | | | | development, validation and routine | validation and routine control of a | | | | | control of a sterilization process for | sterilization process for medical | | | | | medical devices. (Sterility) | devices. (Sterility) | | | 10 | Single use | Yes | Yes | Same | | 11 | Package | The package of parts of DCM | The components are placed in a | Similar | | | | Kyphoplasty System has four levels. | thermoformed PETG/PET tray. The | | | | | Firstly each parts is placed in the | heat sealed pouches are placed in | | | | | sterilization package and heat sealed. | white shelf cartons and then packaged | | | | | The top plastic is APET and bottom | in a corrugated shipper box. | | | | | paper is Tyvek1073B. Secondly each | | | | | | sterilization package is placed in inner | | | | | | box. Thirdly four inner boxes are | | | | | | packaged in middle box. Finally, this | | | | | | middle box is placed in a shipping | | | | | | box. | | | #### 11. Comparison Table of the Technological Characteristics {6}------------------------------------------------ . {7}------------------------------------------------ # 12. Substantially Equivalent Conclusion DCM Kyphoplasty System has same intended use than the predicate device and similar technological characteristics as the predicate device. The proposed device, DCM Kyphoplasty System, is determined to be Substantially Equivalent (SE) to the predicate device, K143006 GUARDIAN-SG Inflatable Bone Expander System, in respect of safety and effectiveness.