(367 days)
The Kyphoplasty Balloon System (KYBS) is intended to be used for the reduction and fixation 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 Kyphoplasty Balloon System (KYBS) is designed to reduce spinal compression fracture and restore sagittal alignment. The device creates a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger. The KYBS components are balloon catheter, cement dispenser and balloon dilator.
The main components of the balloon catheter are the shaft, hub and the inflatable balloon located at the distal tip and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning.
This document describes a medical device submission (K221142) for a Kyphoplasty Balloon System. The FDA has determined the device to be substantially equivalent to a legally marketed predicate device.
However, the provided text does not contain any information regarding acceptance criteria, reported device performance in terms of clinical accuracy or effectiveness, sample sizes for test or training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth details beyond non-clinical testing.
The document focuses on:
- Regulatory clearance: Confirmation of substantial equivalence.
- Device description: Components (balloon catheter, cement dispenser, balloon dilator), materials, and mechanisms.
- Intended Use/Indications for Use: Reduction and fixation of fractures, creation of a void in cancellous bone in the spine, and use with PMMA bone cements.
- Non-clinical performance tests: Biocompatibility, bacterial endotoxin, packaging stability, and device characterization (referencing ISO and ASTM standards). These are primarily safety and engineering performance criteria, not clinical performance for detection or diagnostic accuracy.
- Comparison to predicate device: Similarities in balloon size, material, production method, and use, with a noted difference in the twisting capability of the balloon part for easier insertion.
Therefore, based solely on the provided text, it is not possible to answer the detailed questions regarding acceptance criteria and the study proving the device meets them in the context of clinical performance or AI diagnostic accuracy. The device described is a medical instrument (Kyphoplasty Balloon System), not an AI/ML-driven diagnostic or image analysis tool.
If the request was based on a misunderstanding of the device type, and if this were an AI/ML device, the information would typically be found in a performance study section or clinical validation report, which is absent here.
§ 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.