(258 days)
The LMA StoneBreaker™ is indicated for use via a rigid or semi-rigid endoscope with a straight working channel, for the fragmentation of urinary tract (i.e. kidney, ureter and bladder) stones.
The LMA StoneBreaker™ is a portable, non-electrical, pneumatic contact intracorporeal lithotripter, intended for use to fragment stones in the urinary tract (i.e. kidney, ureter and bladder). Its weight of approximately 500g with a probe, and with no extraneous electrical or pneumatic connections, makes this device highly portable. It is recommended for use with endoscopes equipped with a straight working channel. The device is powered by a detachable cartridge of high pressure carbon dioxide gas, with a maximum pre-adjusted operating pressure of 31 bars. The mechanical shock generated by the device is transferred through the length of the probe to the tip, which is in direct contact with the stone to be fragmented, providing high speed fragmentation of the calculus in situ.
Three sizes of probe (1.0mm, 1.6mm and 2.0mm) are available for use with the LMA StoneBreaker™
A LMA StoneBreaker™ Carbon Dioxide (CO2) gas cartridge provides the necessary energy for one surgical procedure. Once the cartridge is perforated by the built-in screw system, the compressed gas passes through a pre-adjusted pressure regulator in the device and a mechanical shockwave required for fragmentation of urinary stone is generated when the trigger is depressed.
Expended gas will leave the device through a specially designed exhaust port and the attached exhaust line The trigger snaps back to its starting position when the gas is expended through the exhaust port, and the device is now ready for further use.
The LMA StoneBreaker™, Probes, Exhaust Line and accessories are delivered non-sterile and it must be cleaned, disinfected and sterilized before initial use and before each subsequent use.
The provided context is a 510(k) summary for the LMA StoneBreaker™ and related FDA correspondence. It does not contain information about specific acceptance criteria, device performance tables, sample sizes for test sets, data provenance, number of experts, adjudication methods, multi-reader multi-case studies, standalone performance studies, types of ground truth, training set sample sizes, or how ground truth for training was established.
The document states that "Performance and clinical data are shown in Section 2" (page 2, Section 6 of the 510(k) Summary), but Section 2 (Device Information) and Section 6 (Performance Characteristics) actually provide a general statement that "The operational, technological and clinical data demonstrate that the LMA StoneBreaker™ is substantially equivalent in safety and effectiveness to that of the predicated devices cited above," without detailing the specific data or studies that led to this conclusion.
Therefore, I cannot fulfill the request using the provided information as it does not contain the specific details about acceptance criteria, study methodologies, and results you are asking for.
§ 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.”