(285 days)
The Vertebral Body Balloon 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 procedures, such as kyphoplasty.
The VBB System consists of a Vertebral Body Balloon Catheter, Inflation System, and Vertebral Augmentation Access Kit. The Vertebral Body Balloon Catheter is a bone tamp with an inflatable component (balloon) at the distal end. A stainless steel radiographic marker (ISO 5832-1) is located at the distal tip of the balloon. The balloon is inflated by the Inflation System within the vertebral body. The Vertebral Body Balloon 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 procedures, such as kyphoplasty.
The provided text is a 510(k) Summary for the Synthes VBB System, which is a medical device for vertebral augmentation. It describes the device, its intended use, and states that mechanical and biomechanical testing was performed to support its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria or detailed study results in a format that allows for a direct comparison table as requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: The document states, "Mechanical and biomechanical testing was performed in order to provide data to support a substantial equivalence determination. These tests were performed to characterize the properties and functionality of the VBB System, as well as to allow comparison with established acceptance criteria." However, the document does not explicitly list the "established acceptance criteria" themselves.
- Reported Device Performance: Similarly, it only provides a general statement: "The conclusions drawn from testing demonstrate that the VBB System is as safe and effective as the predicate devices identified." It does not provide specific performance metrics or values for the device.
Therefore, a table cannot be populated from the given text as the specific criteria and performance metrics are not detailed.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Mechanical and biomechanical testing" but does not provide any information regarding the sample size for these tests (e.g., number of balloons tested, number of vertebral models used). It also does not specify the data provenance (e.g., retrospective or prospective, country of origin). The testing would likely have been conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The study described is mechanical and biomechanical testing of a medical device's physical properties and functionality. It does not involve human interpretation of images or clinical data that would require experts to establish a "ground truth" in the diagnostic context.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. As explained above, the study focuses on mechanical testing, not diagnostic performance requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical data was not needed for this device." The study focused on mechanical and biomechanical properties.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical medical instrument (Vertebral Body Balloon System), not an algorithm or a software-based diagnostic tool. Therefore, "standalone" algorithm performance is not relevant.
7. The Type of Ground Truth Used
The "ground truth" for the mechanical and biomechanical testing would have been based on engineering specifications, material science standards, and established physical and mechanical testing protocols for similar devices, ensuring characteristics like burst pressure, volume limitations, and ability to create a void in cancellous bone meet target values or compare favorably to predicate devices. It is not dependent on expert consensus, pathology, or outcomes data in the diagnostic sense.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device is a physical instrument, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided, as there is no training set for a physical device.
In summary:
The provided document describes physical device testing for regulatory clearance. It does not involve diagnostic performance evaluation, AI/ML, or the types of studies and ground truth establishment typically associated with those fields. The document primarily attests that mechanical and biomechanical tests were performed against "established acceptance criteria" to demonstrate substantial equivalence to predicate devices, without detailing those criteria or the specific results.
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K11.06.04
DEC 1 3 2011-2
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Spine
@ SYNTHES®
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5 510(k) Summary
| Name of Firm: | Synthes Spine1302 Wrights Lane EastWest Chester, PA 19380 |
|---|---|
| 510(k) Contact: | Jason LipmanManager, Spine Regulatory AffairsTelephone: 610-719-5629 Facsimile: 610-719-5102Email: Lipman.jason@synthes.com |
| Date Prepared: | March 1, 2011 |
| Trade Name: | Synthes VBB System |
| Classification: | 21 CFR 888.3027 - Cement, Bone, VertebroplastyClass IIOrthopaedic and Rehabilitation Devices PanelProduct Code: NDN, HRX |
| Predicate Devices: | CareFusion Avamax (K093463)Kyphon KyphX Xpander Inflatable Bone Tamp (K041454)Stryker iVAS (K093419)Cardinal Health Inflatable Bone Tamp (K090211)Boston Scientific Sterling Monorail PTA Balloon Dilatation Catheters (K053118, K080982)Synthes Click'X (K992739) |
| Device Description: | The VBB System consists of a Vertebral Body Balloon Catheter,Inflation System, and Vertebral Augmentation Access Kit. TheVertebral Body Balloon Catheter is a bone tamp with an inflatablecomponent (balloon) at the distal end. A stainless steel radiographicmarker (ISO 5832-1) is located at the distal tip of the balloon. Theballoon is inflated by the Inflation System within the vertebral body. TheVertebral Body Balloon System is intended to be used for the reductionof fractures and/or creation of a void in cancellous bone in the spine.This includes use during percutaneous vertebral augmentation. Thesystem is to be used with cleared spinal Polymethylmethacrylate(PMMA) bone cements indicated for use during percutaneous vertebralaugmentation procedures, such as kyphoplasty. |
| Intended Use /Indications for Use: | The Vertebral Body Balloon System is intended to be used for thereduction of fractures and/or creation of a void in cancellous bone in thespine. 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 procedures, such as kyphoplasty. |
| Comparison of thetechnologicalcharacteristics of thedevice to thepredicate device: | The design features, material, and indications for use of the VBBSystem are substantially equivalent to the predicate devices identified.Additionally, the safety and effectiveness of this system is adequatelysupported by documentation within this premarket notification. |
| Performance Data(Non-clinical and/or | Mechanical and biomechanical testing was performed in order toprovide data to support a substantial equivalence determination. These |
| Clinical) | tests were performed to characterize the properties and functionality ofthe VBB System, as well as to allow comparison with establishedacceptance criteria. Mechanical and biomechanical testing wasperformed to assess balloon pressure and volume limitations, burst,characteristics, system usability, and ability of the device to be used forthe reduction of fractures and/or creation of a void in cancellous bone.The conclusions drawn from testing demonstrate that the VBB System isas safe and effective as the predicate devices identified. Clinical datawas not needed for this device. |
Traditional 510(k) - Synthes Vertebral Body Balloon (VBB) System
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@ SYNTHES® Spine
Traditional 510(k) - Synthes Vertebral Body Balloon (VBB) System
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રું મું
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three lines representing its wings and tail feathers. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 3 2011
Synthes Spine % Mr. Jason Lipman Manager, Spine Regulatory Affairs 1302 Wrights Lane East West Chester, Pennsylvania 19380
Re: - K110604
Trade/Device Name: Synthes VBB System Regulation Number: 21 CFR 888,3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Class II Product Code: NDN, HRX Dated: December 07, 2011 Received: December 08, 2011
Dear Mr. Lipman:
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. Jason Lipman
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/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 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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Sincerely, yours,
Evin S. Keith
Fr 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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@ SYNTHES® Spine
4 Indications for Use Statement
510(k) Number: Device Name: Synthes VBB System
Indications for Use:
The Vertebral Body Balloon System is intended to be used for the reduction of fractures and/or creation of a void in cancellous bone in the spinc. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percuaneous vertebral augmentation procedures, such as kyphoplasty.
Prescription Use X AND / OR Over-the-Counter Use (21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Signature
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
K 110604 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Traditional 510(k) - Synthes Vertebral Body Balloon (VBB) System
§ 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.”