(30 days)
The Osseoflex® SB 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. This system is to be used with cleared spinal polymethymethacrylate (PMMA) bone cements for use during percutaneous vertebral augmentation, such as kyphoplasty.
The Osseoflex® SB is designed for use in balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. After the bone is disrupted, PMMA is injected through an Osseoflex® needle to fill the previously created void(s).
An access channel is required for Osseoflex® SB placement. The Osseoflex® SB device does not create an access channel; the Osseoflex® SB is designed to follow a pre-existing channel created by an access channel device.
This document describes the performance testing for the Osseoflex SB, 10 Gauge Straight Balloon.
Here's the breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Bench Tests Performed | Acceptance Criteria | Reported Device Performance (Implied from Conclusion) |
|---|---|---|
| Balloon Profile and Tamp (Catheter) Working Length (TM-003) | • Balloon profile ≤ 2.79 mm (0.109 in) | |
| • Balloon catheter working length > 16.5 cm | Met or exceeded requirements | |
| Balloon Compliance (TM-004) | • Balloon working length (L) ≤ 24 mm | |
| • Balloon diameter (D) ≤ 19 mm | Met or exceeded requirements | |
| Maximum Pressure (TM-006) | The inflatable bone tamp exceeds the maximum inflation pressure, 27 atm (~400 psi) without failure. | Met or exceeded requirements (device withstood pressure without failure) |
| Bond Tensile Strengths (TM-007) | Bond tensile strength ≥ 15 N (3.37 lbf). The tensile force specification was adopted directly from ISO 10555 (Single Use Intravascular Catheters). This tensile force may be applied to the device during use when the balloon is deflated and retracted back through the access cannula. | Met or exceeded requirements |
| Balloon Maximum Volume (TM-008) | Maximum inflation volume to be greater than the maximum recommended volume with 95% confidence and 90% reliability. | Met or exceeded requirements |
| Balloon Fatigue, Unconstrained (TM-009) | Inflate to maximum recommended volume of, hold for 30 seconds / deflate; without leaks for 20 cycles. | Met or exceeded requirements (device performed without leaks for 20 cycles) |
| Balloon Inflation, Deflation Time (TM-010) | Deflation times to be |
§ 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.”