(107 days)
An endoscopic intracorporeal pneumatic lithotripter probe for use in fragmenting urinary calculi, including renal, ureteral and bladder stones through rigid, semi-rigid and flexible endoscopes.
Endoscopic Intracorporeal Pneumatic Lithotripter Probe
The provided text is a 510(k) Premarket Notification for a Lithotripsy Probe from 1997. It describes the device, its intended use, and claims substantial equivalence to existing products. However, it does not contain any information regarding acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment.
The document primarily focuses on:
- Administrative details: Sponsor information, contact person, submission date, common/usual names, device classification, and substantial equivalence claim.
- FDA Communication: The FDA letter confirms the review of the 510(k) notification and a finding of "substantial equivalence" to a legally marketed predicate device, allowing the manufacturer to market the device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided text, as this information is absent. The sections of your request (1-9) cannot be answered.
§ 876.4480 Electrohydraulic lithotriptor.
(a)
Identification. An electrohydraulic lithotriptor is an AC-powered device used to fragment urinary bladder stones. It consists of a high voltage source connected by a cable to a bipolar electrode that is introduced into the urinary bladder through a cystoscope. The electrode is held against the stone in a water-filled bladder and repeated electrical discharges between the two poles of the electrode cause electrohydraulic shock waves which disintegrate the stone.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”