(88 days)
Not Found
No
The description focuses on mechanical components and their function in a surgical procedure, with no mention of AI or ML capabilities.
Yes
The device is intended for the reduction and fixation of fractures and/or creation of a void in cancellous bone, specifically for percutaneous vertebral augmentation to reduce back pain and increase functional abilities, which are therapeutic effects.
No
The device is an inflatable bone expander system designed for the reduction and fixation of fractures and creation of voids in cancellous bone, primarily for percutaneous vertebral augmentation. Its purpose is to treat fractures and prepare the bone for cement insertion, not to diagnose a condition.
No
The device description explicitly lists hardware components such as an "Inflatable Bone Tamp (balloon catheter, compressor)" and an "accessory kit," which are physical medical devices, not software.
Based on the provided information, the GUARDIAN-SG Inflatable Bone Expander System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the device is for the "reduction and fixation of fractures and/or creation of a void in cancellous bone," specifically for use during "percutaneous vertebral augmentation." This describes a surgical procedure performed directly on the patient's body.
- Device Description: The description details a physical device (inflatable bone tamp, balloon catheter, compressor) used to manipulate bone and create space for cement. This is a therapeutic and procedural device, not a device used to examine specimens from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) outside of the body. IVD devices are designed for diagnostic purposes using such samples.
Therefore, the GUARDIAN-SG Inflatable Bone Expander System is a surgical device used in a medical procedure, not an IVD.
N/A
Intended Use / Indications for 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 polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
Product codes
NDN, HRX
Device 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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
fluoroscopic visualization
Anatomical Site
spine (vertebral body)
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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
1
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 (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 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:
-
- Applicant / Submitter: BM KOREA CO., LTD. 325-26, Dangjeong-dong, Gunpo-si, Republic of Korea 435-832 Tel: +82-31-451-9294~5
2. Submission Correspondent
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton CA 92831 Email: juhee.c@lkconsultinggroup.com
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.
4
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.