(175 days)
The DCM Kyphoplasty 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, such as kyphoplasty.
The DCM Kyphoplasty System is designed to reduce compression fracture and create 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.
DCM Kyphoplasty System contains balloon catheter, balloon inflator, puncture needle and tool kit.
The balloon catheter is used to position inside of the vertebral body where it is inflated to make a cavity. The balloon inflator is used to inflate the balloon catheter that is filled with a contrast agent. The puncture needle is used to percutaneous puncture during the surgery and have two types: locking and rotating. The tool kit is used to support to perform the surgery and fill the bone cement. All parts of DCM Kyphoplasty System are supplied sterile and are single use only.
The balloon catheter has four specifications: Φ9×15, Φ12×19, Φ14×17 and Φ17×22. Balloon Inflator has two specifications: 20ml/30atm, 25ml/30atm. Puncture Needle has seven specifications: Φ2.5×100, Ф2.5×130, Ф3.0×100, Ф3.2×100, Ф3.2×130, Ф3.5×126, Ф4.0×126.
The tool kit is consisting of bone expander, spiral propeller, guide needle, expansion tube, working cannula, solid vertebral drill, hollow vertebral drill, push rod, bone cement injector and locator. They are supplied sterile and are single use only.
The provided document is a 510(k) summary for the DCM Kyphoplasty System. It is a premarket notification to establish substantial equivalence to a predicate device, not a study describing the acceptance criteria and performance of an AI/ML device. Therefore, it does not contain the information requested in the prompt regarding AI/ML device performance.
The document discusses the physical characteristics, intended use, materials, sterilization, and non-clinical testing of the DCM Kyphoplasty System to demonstrate its equivalence to a predicate kyphoplasty system. It does not involve any artificial intelligence or machine learning components.
§ 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.”