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.

Device Description

The DCM Kyphoplasty 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.

AI/ML Overview

The provided document is a 510(k) summary for the DCM Kyphoplasty System. It is a premarket notification to establish substantial equivalence to a predicate device, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding AI/ML device performance.

The document discusses the physical characteristics, intended use, materials, sterilization, and non-clinical testing of the DCM Kyphoplasty System to demonstrate its equivalence to a predicate kyphoplasty system. It does not involve any artificial intelligence or machine learning components.

Summary

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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

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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

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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)

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)

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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
1. 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

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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.

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.

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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	Comparison 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 intendedto be used for the reduction andfixation of fractures and/or creation ofa void in cancellous bone in the spine.This includes use during percutaneousvertebral augmentation. The system isto be used with cleared spinalpolymethylmethacrylate (PMMA)bone cements indicated for use duringpercutaneous vertebral augmentation,such as kyphoplasty.	GUARDIAN-SG Inflatable BoneExpander System is intended to beused for the reduction and fixation offractures and/or creation of a void incancellous bone in the spine. Thisincludes use during percutaneousvertebral augmentation. The system isto be used with cleared spinalpolymethylmethacrylate (PMMA)bone cements indicated for use duringpercutaneous vertebral augmentation,such as kyphoplasty.	Same
4	Design	DCM Kyphoplasty System consists offour components:* Balloon Catheter* Balloon Inflator* Puncture Needle* Tool KitThe balloon catheter has fourspecifications: Φ9×15, Φ12×19,	The GUARDIAN-SG IBEScomponents are Inflatable BoneTamp (balloon catheter,compressor) and accessory kit.and balloon catheter' maincomponents are the shaft, Yhuband the inflatable balloon locatedat the distal tip	Similar

		$Φ14×17$ and $Φ17×22$	The balloon catheter has three
		Balloon Inflator: 20ml/30atm25ml/30atm	specifications: BMK10, BMK15,BMK20
		Puncture Needle: $Φ2.5×100$ , $Φ$$2.5×130$ , $Φ3.0×100$ , $Φ3.2×100$ , $Φ3.2×130$ , $Φ3.5×126$ , $Φ4.0×126$
5	Material	Balloon Catheter is made ofPolyurethane, Platinum,Polycarbonate(PC), Stainless SteelS30408	All materials used in theGUARDIAN-SG Inflatable BoneExpander System are Plastic andStainless Steel etc.	Similar
		Balloon Inflator is made ofPolycarbonate(PC), Nylon reinforcedpolyurethane, Brass, Stainless SteelS30408, Nylon(PA6), ethylenepropylene diene monomer
		Puncture Needle is made of StainlessSteel S30408, S51740, ABS,Polycarbonate(PC)
		Other parts are made of Plastic andStainless Steel etc.
6	Biocompatibility	All materials are made of stainlesssteel & plastic material etc. and usedin the DCM Kyphoplasty System canmeet the requirements ofAAMI/ANSI/ISO 10993, biologicalevaluation of medical devices -- part 1:evaluation and testing within a riskmanagement process.	All materials used inthe GUARDIAN-SG Inflatable BoneExpander System can meet therequirements of FDA requirementrelated to biocompatibility.
7	Properties	Product testing of DCM KyphoplastySystem was performed on finalsterilized devices. Testing wascompleted, including: dimensional,inflation/deflation, balloon size,insertion/withdraw force, fatiguetesting and tensile strength. All testingmet the acceptance criteria.Biocompatibility testing wasperformed per AAMI/ANSI/ISO10993	The testing of the GUARDIAN-SGInflatable Bone Expander Systemincluded functional, such as ballooncompliance, deflation time, insertion /withdraw force and fatigue testing aswell as mechanical testing, such astensile 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

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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.

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”