(164 days)
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.
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. 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.
The provided text describes a 510(k) summary for the GUARDIAN Inflatable Bone Expander System (IBES). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a full clinical study with specific acceptance criteria in the same way a novel device might. Therefore, many of the typical clinical study elements like expert ground truth, adjudication methods, or MRMC studies are not applicable or detailed in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically related to meeting established performance standards for similar predicate devices, and demonstrating that the new device performs at least as well as the predicate device or meets defined engineering specifications.
| Acceptance Criteria (from Text) | Reported Device Performance (from Text) |
|---|---|
| Specifications and performance characteristics relevant to predicate devices | The GUARDIAN Inflatable Bone Expander System met the specifications and performance characteristics and are substantially equivalent to the predicate devices. |
| Functional testing standards | Testing included functional tests such as balloon compliance, deflation time, insertion/withdraw force, and fatigue testing. |
| Mechanical testing standards | Testing included mechanical tests such as tensile strength. |
| Substantial Equivalence Criteria | The GUARDIAN Inflatable Bone Expander System has equivalent device characteristics as the predicate device, the Kyphon and KyphX Xpander Inflatable Bone Tamps; intended use, material, design and use concept are similar. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a clinical "test set" in the traditional sense. The testing mentioned (functional and mechanical) was likely bench testing of the device itself, not human subjects.
- Test Set Sample Size: Not applicable/not specified in the context of a clinical test set. The tests mentioned are likely bench tests performed on device prototypes or production samples.
- Data Provenance: The tests are described as being performed to show that the device "met the specifications and performance characteristics." This implies in-house engineering and laboratory testing by the manufacturer (BM Korea Co., Ltd.). There is no indication of clinical data from human subjects or country of origin for such data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The "ground truth" for this type of submission is the established performance and safety profile of the predicate devices and the engineering specifications for the new device. There is no mention of external experts establishing ground truth for a clinical dataset.
- Qualifications of Experts: Not applicable in this context. The "experts" involved would be the engineers and quality assurance personnel at BM KOREA Co., Ltd. who conducted the functional and mechanical testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Given that this involves bench testing for mechanical and functional properties, there would be no need for clinical adjudication methods like 2+1 or 3+1. Performance is measured against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. The document does not describe any clinical study, let alone an MRMC comparative effectiveness study involving human readers or AI assistance. The submission is based on demonstrating substantial equivalence through non-clinical (bench) testing.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical device (an inflatable bone expander system), not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission relies on:
- Engineering Specifications: The device's functional and mechanical properties were tested against predefined engineering specifications.
- Predicate Device Performance: The underlying assumption and "truth" for substantial equivalence is that the predicate devices are safe and effective, and the new device performs comparably in terms of its characteristics and intended use.
- Material Compatibility/Safety Standards: Implied, but not explicitly detailed as "ground truth." The use of silicone fluid for lubricity would be evaluated against established material safety standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no training set for a physical medical device.
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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 -
- Company and Correspondent making the submission:
| Company | |
|---|---|
| Name | BM KOREA Co., Ltd. |
| Address | 325-26,Dangjeong-dong,Gunpo-si,Gyeonggi-do, Republic of Korea 435-832 |
| PhoneFax | +82 31-451-9294+82 31-451-9248 |
| Contact | Ju Yun / R&D Assistant Manager |
-
- Device:
Proprietary Name - GUARDIAN Inflatable Bone Expander System Common Name - Inflatable Bone Tamp Classification Name - Arthroscope Cement, Bone Vertebroplasty
- Device:
-
- Product Code & Regulation Number: HRX, 21C.F.R. 880.1100 NDN, 21C.F.R. 888.3027
-
- 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.
- 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.
-
- 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.
- Testing:
-
- 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.
- Substantial Equivalence:
Based on the comparison of intended use and technical features, the GUARDIAN Inflatable Bone Expander System is substantially equivalent to the predicate devices.
-
- 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.
- Conclusions:
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 (800) 638-2041 or (301) 796-7100 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
Page 1 / 1
BM KOREA CO., LTD
§ 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.”