DCM Kyphoplasty System

• K Number: K162283
• Device Name: DCM Kyphoplasty System
• Manufacturer: Dragon Crown Medical Co., Ltd.
• Date Cleared: 2017-02-06 ( 175 days)
• Product Code: NDN HRX PFP
• Regulation Number: 888.3027

Intended Use

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.

Predicate Devices

K143006

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on mechanical components and their function in a surgical procedure, with no mention of AI or ML.

Therapeutic

Yes.
The device is used to reduce fractures and create a void in cancellous bone in the spine, which directly treats a medical condition.

Diagnostic

No

The device is described as a system for reducing fractures and creating a void in cancellous bone, which is a therapeutic rather than diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly lists multiple hardware components including balloon catheters, balloon inflators, puncture needles, and a tool kit.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use/Indications for Use: The intended use is for the reduction of fractures and creation of a void in bone in the spine, and for use with bone cement. This describes a surgical procedure performed directly on the patient's body.
• Device Description: The description details instruments used in a surgical procedure (balloon catheter, inflator, needles, tools for bone manipulation and cement delivery). These are all used in vivo (within the living body).
• Lack of IVD Characteristics: An IVD is a medical device intended for use in vitro (outside the living body) for the examination of specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The description of the DCM Kyphoplasty System does not involve the analysis of any biological specimens.

Therefore, the DCM Kyphoplasty System is a surgical device used in vivo, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

NDN, HRX

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Spine

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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 the acceptance 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K143006

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

Summary

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 [phone] or [phone] 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 [phone] or [phone] 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: [phone] Fax: [phone] E-mail: [e-mail]

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
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
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. The system is
to be used with cleared spinal
polymethylmethacrylate (PMMA)
bone cements indicated for use during
percutaneous vertebral augmentation,
such as kyphoplasty. | GUARDIAN-SG Inflatable Bone
Expander 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. The system is
to be used with cleared spinal
polymethylmethacrylate (PMMA)
bone cements indicated for use during
percutaneous vertebral augmentation,
such as kyphoplasty. | Same |
| 4 | Design | DCM Kyphoplasty System consists of
four components:

• Balloon Catheter
• Balloon Inflator
• Puncture Needle
• Tool Kit

The balloon catheter has four
specifications: Φ9×15, Φ12×19, | The GUARDIAN-SG IBES
components are Inflatable Bone
Tamp (balloon catheter,
compressor) and accessory kit.
and balloon catheter' main
components are the shaft, Yhub
and the inflatable balloon located
at the distal tip | Similar |
| | | | | |
| | | $Φ14×17$ and $Φ17×22$ | The balloon catheter has three | |
| | | Balloon Inflator: 20ml/30atm
25ml/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 of
Polyurethane, Platinum,
Polycarbonate(PC), Stainless Steel
S30408 | All materials used in the
GUARDIAN-SG Inflatable Bone
Expander System are Plastic and
Stainless Steel etc. | Similar |
| | | Balloon Inflator is made of
Polycarbonate(PC), Nylon reinforced
polyurethane, Brass, Stainless Steel
S30408, Nylon(PA6), ethylene
propylene diene monomer | | |
| | | Puncture Needle is made of Stainless
Steel S30408, S51740, ABS,
Polycarbonate(PC) | | |
| | | Other parts are made of Plastic and
Stainless Steel etc. | | |
| 6 | Biocompatibility | All materials are made of stainless
steel & plastic material etc. and used
in 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. | All materials used in
the GUARDIAN-SG Inflatable Bone
Expander System can meet the
requirements of FDA requirement
related to biocompatibility. | |
| 7 | Properties | Product testing of DCM Kyphoplasty
System was performed on final
sterilized devices. Testing was
completed, including: dimensional,
inflation/deflation, balloon size,
insertion/withdraw force, fatigue
testing and tensile strength. All testing
met the acceptance criteria.

Biocompatibility testing was
performed per AAMI/ANSI/ISO
10993 | The testing of the GUARDIAN-SG
Inflatable Bone Expander System
included functional, such as balloon
compliance, deflation time, insertion /
withdraw force and fatigue testing as
well as mechanical testing, such as
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.