GUARDIAN INFLATABLE BONE EXPANDER SYSTEM

K111593 · Bm Korea Co., Ltd. · NDN · Nov 18, 2011 · Orthopedic

Device Facts

• Record ID: K111593
• Device Name: GUARDIAN INFLATABLE BONE EXPANDER SYSTEM
• Applicant: Bm Korea Co., Ltd.
• Product Code: NDN · Orthopedic
• Decision Date: Nov 18, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.3027
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The GUARDIAN 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 vertebralaugmentation, such as kyphoplasty.

Device Story

The GUARDIAN Inflatable Bone Expander System is a surgical tool used by physicians to treat spinal compression fractures. The system includes an inflatable bone tamp (balloon catheter and inflation syringe) and an accessories kit (access needles, introducers, drills, and bone filler device). During percutaneous vertebral augmentation, the physician inserts the balloon catheter into the vertebral body; the balloon is inflated to create a void and reduce the fracture. Radiopaque markers on the catheter allow for fluoroscopic visualization during positioning. Once the void is created, the physician uses the bone filler device to inject cleared PMMA bone cement into the space. The device aims to restore sagittal alignment, reduce back pain, and improve patient functional abilities. The balloon surface is coated with silicone fluid to enhance lubricity during insertion.

Clinical Evidence

Bench testing only. Testing included functional performance (balloon compliance, deflation time, insertion/withdrawal force, fatigue) and mechanical testing (tensile strength) to verify specifications and demonstrate substantial equivalence.

Technological Characteristics

System includes balloon catheter, inflation syringe, and accessories (needles, introducers, drills). Balloon catheter features shaft, hub, and inflatable balloon coated with max 0.03g silicone fluid. Radiopaque markers provided for fluoroscopic visualization. Materials and design are similar to predicate inflatable bone tamps. No software or electronic 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 procedures.

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

• Kyphon Inflatable Bone Tamp (K981251)
• KyphX Xpander Inflatable Bone Tamps (K041454)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for BMK Global Medical Company. The logo consists of two parts: a circular emblem on the left and the company name on the right. The emblem features a stylized cross-like shape within a circle, surrounded by text. The company name "BMK Global Medical Company" is displayed in bold, sans-serif font, with the letters "BMK" in a larger size and a registered trademark symbol next to the "K".

## 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: __ May 17, 2011 -

1. Company and Correspondent making the submission:

| | Company |
|--------------|-----------------------------------------------------------------------------------|
| Name | BM KOREA Co., Ltd. |
| Address | 325-26,<br>Dangjeong-dong,<br>Gunpo-si,<br>Gyeonggi-do, Republic of Korea 435-832 |
| Phone<br>Fax | [phone]<br>[phone] |
| Contact | Ju Yun / R&D Assistant Manager |

- 2. Device:
Proprietary Name - GUARDIAN Inflatable Bone Expander System Common Name - Inflatable Bone Tamp Classification Name - Arthroscope Cement, Bone Vertebroplasty

- 3. Predicate Device:
Kyphon Inflatable Bone Tamp, K981251 KyphX Xpander Inflatable Bone Tamps, K041454

- 4. Product Code & Regulation Number: HRX, 21C.F.R. 880.1100 NDN, 21C.F.R. 888.3027
- 5. Description:

The GUARDIAN, 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 are the significant reduction in back pain and increase patient's functional abilities, allow a return to the previous level of activity.

BM KOREA CO., LTD

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Image /page/1/Picture/0 description: The image shows a logo with two distinct parts. On the left, there is a circular emblem with a stylized cross-like figure inside. To the right of the emblem, the letters "BMK" are displayed in a bold, sans-serif font, with the words "Global Medical Company" written in a smaller font size beneath them. A registered trademark symbol is located to the upper right of the letter "K".

The GUARDIAN, Inflatable Bone Expander System components are Inflatable Bone Tamp (balloon catheter, inflation syringe) and accessories kit. And balloon catheter' main components are the shaft, hub 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.

Accessories kit consists of GUARDIAN Bone Access Needle (starting needle cannula, starting needle trocar), GUARDIAN Osteo Introducer System (guide wire, cannula, trocar-R, trocar-S, drill), GUARDIAN Bone Filler Device (cement bar, cement infusion) and guide impactor.

6. Indication for use:

The GUARDIAN 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 vertebralaugmentation, such as kyphoplasty.

- 7. Testing:
The GUARDIAN Inflatable Bone Expander System met the specifications and performance characteristics and are 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.

- 8. Substantial Equivalence:
The GUARDIAN Inflatable Bone Expander System has the equivalent device characteristics as the predicate device, the Kyphon and KyphX Xpander Inflatable Bone Tamps; intended use, material, design and use concept are similar.

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

- 9. Conclusions:
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification BM KOREA Co., Ltd. concludes that the GUARDIAN Inflatable Bone Expander System is safe and effective and substantially equivalent to predicate devices as described herein.

BM KOREA CO., LTD

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the snake and staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

## Public Health Service

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

NOV 1 8 2011

BM KOREA Co., Ltd. % Arkin Consulting Group, L.L.C. Mr. Ronald Arkin 1733 Canton Lane Marietta, Georgia 30062

Re: K111593

Trade Name: GUARDIAN® 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 13, 2011 Received: October 24, 2011

Dear Mr. Arkin:

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

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Page 2 - Mr. Ronald Arkin

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson

Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for BMK Global Medical Company. The logo consists of two parts: a circular emblem on the left and the company name on the right. The emblem features a stylized cross within a circle, and the company name is written in bold, sans-serif font with the words "Global Medical Company" underneath. There is a registered trademark symbol next to the K in BMK.

## Indications for Use

510(k) Number (if known) _ K111593 Device Name: GUARDIAN® Inflatable Bone Expander System Indications for Use:

The GUARDIAN 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 vertebralaugmentation, such as kyphoplasty.

Prescription Use X AND/OR (Part 21CFR 801 Subpart D)

Over-The-Counter Use_ (21CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Divisi Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K 111593

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BM KOREA CO., LTD