(136 days)
The Stryker® iVAS Inflatable Vertebral Augmentation System (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 Stryker® IVAS balloon catheter is a bone tamp with an inflatable component (balloon) at the distal end. The balloon is inflated to create a void within the vertebral body.
This 510(k) summary for the Stryker® IVAS Balloon Catheter (K093419) does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document is a submission for substantial equivalence to a predicate device (Kyphx Xpander Inflatable Bone Tamps, K041454). The core of the argument is that the Stryker® IVAS balloon catheter is "equivalent in intended use, technological characteristics, safety, and effectiveness" to the predicate, and does not "raise any new safety and efficacy concerns."
Therefore, I cannot populate the table or answer the questions based on the provided text. The document focuses on establishing equivalence rather than presenting an independent performance study with defined acceptance criteria.
§ 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.”