(45 days)
The KYPHON ELEMENT™ Inflatable Bone Tamp (IBT) is intended to be used as a conventional bone tamp for the reduction of fractures and/or creation of a void in cancellous bone in the spine (including use during a balloon kyphoplasty procedure with a PMMA-based bone cement that is cleared for use in kyphoplasty procedures), hand, tibia, radius, and calcaneus.
The KYPHON ELEMENT™ Inflatable Bone Tamp is designed for the reduction of fractures. The main components are a single lumen shaft, Y-Adapter with a port to connect the inflation syringe for inflation/deflation, and the inflatable balloon located at the distal tip.
This document is a 510(k) summary for a medical device (KYPHON ELEMENT™ Inflatable Bone Tamp). It describes the device, its intended use, and its substantial equivalence to a previously cleared device. However, it does not contain any information about acceptance criteria, device performance metrics, or any clinical studies to prove these criteria are met.
The document primarily focuses on non-clinical testing to demonstrate substantial equivalence, stating:
- "Mechanical testing, biocompatibility testing and other verification activities were conducted to confirm that the modified device functions as intended and does not raise any new issues of safety or effectiveness."
- This refers to bench testing and material compatibility, not clinical performance studies with human subjects or expert evaluations against ground truth in a clinical setting.
Therefore, I cannot provide the requested information from the provided text as it is not present in the document.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.