GUARDIAN-SG Inflatable Bone Expander System

K143006 · Bm Korea Co., Ltd. · NDN · Jan 16, 2015 · Orthopedic

Device Facts

• Record ID: K143006
• Device Name: GUARDIAN-SG Inflatable Bone Expander System
• Applicant: Bm Korea Co., Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Jan 16, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GUARDIAN-SG Inflatable Bone Expander System is intended to the reduction and fixation of fractures and/or creation of a void in cancellous bone in this includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Device Story

GUARDIAN-SG Inflatable Bone Expander System (IBES) is an inflatable bone tamp used for spinal compression fracture reduction and sagittal alignment restoration. Device consists of a balloon catheter (shaft, Y-hub, distal inflatable balloon) and a compressor. Balloon surface coated with silicone fluid (max 0.03g) for lubricity. Radiopaque markers at balloon ends allow fluoroscopic visualization for precise positioning. Used in clinical settings by physicians during percutaneous vertebral augmentation. Device creates a void in the vertebral body to facilitate subsequent injection of cleared spinal PMMA bone cement. By restoring vertebral height and stabilizing the fracture, the system aims to reduce back pain and improve patient functional mobility. Components are supplied sterile for single-use.

Clinical Evidence

No clinical data. Substantial equivalence is supported by non-clinical bench testing, including functional testing (balloon compliance, deflation time, insertion/withdrawal force, fatigue) and mechanical testing (tensile strength).

Technological Characteristics

Inflatable bone tamp system comprising a balloon catheter and compressor. Balloon catheter features a shaft, Y-hub, and distal inflatable balloon. Materials include silicone fluid coating (max 0.03g) for lubricity. Radiopaque markers included for fluoroscopic visualization. Sterile, single-use, disposable. No electronic or software components.

Indications for Use

Indicated for patients requiring reduction and fixation of spinal fractures or creation of a void in cancellous bone during percutaneous vertebral augmentation (kyphoplasty).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• GUARDIAN Inflatable Bone Expander System (K111593)
• Kyphon Inflatable Bone Tamp (K981251)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 16, 2015

BM Korea Company, Ltd. % Ms. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Incorporated 2651 East Chapman Avenue, Suite 110 Fullerton, California 92831

Re: K143006

Trade/Device Name: GUARDIAN-SG Inflatable Bone Expander System Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) Bone Cement Regulatory Class: Class II Product Code: NDN, HRX Dated: October 10, 2014 Received: October 20, 2014

Dear Ms. Chung:

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 (QS) 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 yours,

# Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: December 31, 2013

See PRA Statement on last page

### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

510(k) Number (if known) K143006

Device Name GUARDIAN-SG Inflatable Bone Expander System

Indications for Use (Describe)

The GUARDIAN-SG Inflatable Bone Expander System is intended to the reduction and fixation of fractures and/or creation of a void in cancellous bone in this includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.

Type of Use (Select one or both, as applicable)

|X 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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Image /page/3/Picture/0 description: The image shows the logo for BMK Global Medical Company. The logo consists of two parts: a circular image on the left and the company name on the right. The circular image contains a human figure with arms outstretched, surrounded by the words "DREAM CREATION PASSION". The company name "BMK" is written in large, bold letters, with the top half of the letters in red and the bottom half in blue. Below the company name, the words "Global Medical Company" are written in smaller, black letters.

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92(c).

Date:

- 1. Applicant / Submitter: BM KOREA CO., LTD. 325-26, Dangjeong-dong, Gunpo-si, Republic of Korea 435-832 Tel: [phone]~5
#### 2. Submission Correspondent

Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Email: [e-mail]

#### 3. Device:

Proprietary Name – GUARDIAN-SG Inflatable Bone Expander System Common Name – Inflatable Bone Tamp

Classification Name - Arthroscope

Cement, bone, vertebroplasty

#### 4. Predicate Device:

GUARDIAN Inflatable Bone Expander System by BM Korea, K111593 Kyphon Inflatable Bone Tamp by Medtronic Inc., K981251

- ട. Product Code & Regulation Number: HRX, NDN
21 CFR 888.3027

#### 6. Description:

The GUARDIAN-SG Inflatable Bone Expander System (IBES) 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 and using cement dispensing plunger, the major benefits of GUARDIAN-SG IBES are the significant reduction in back pain and increase patient`s functional abilities, allow a return to the previous level of activity.

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Image /page/4/Picture/0 description: The image contains two logos. The first logo is a circle with a white silhouette of a person with their arms outstretched. The circle is divided into red and blue sections, with the words "DREAM PASSION CREATION" written around the circle. The second logo is the letters "BMK" in red and blue, with the words "Global Medical Company" written below. There is a registered trademark symbol next to the "K".

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 and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. 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 catheter, compressor and the accessory kit are supplied sterile and disposable use.

#### 7. Indication for use:

The 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.

#### 8. Non-Clinical Testing:

The GUARDIAN-SG Inflatable Bone Expander System met the specifications and performance characteristics and is substantially equivalent to the predicate devices. The testing included functional, such as balloon compliance, deflation time, insertion / withdraw force and fatigue testing as well as mechanical testing, such as tensile strength.

#### 9. Substantial Equivalence:

The GUARDIAN-SG Inflatable Bone Expander System has the equivalent device characteristics as the predicate devices; intended use, material, design and use concept are similar.

Based on the comparison of intended use and technical features, the GUARDIAN-SG Inflatable Bone Expander System is substantially equivalent to the predicate devices.

#### 10. Conclusions:

Based on the information provided in this premarket notification, BM KOREA Co., Ltd. concludes that the GUARDIAN-SG Inflatable Bone Expander System is substantially equivalent to predicate devices as described herein.