(57 days)
The Karl Storz Calcusplit system is intended for use by qualified surgeons and provides for the pneumatic fragmentation of bladder calculi.
These instruments are intended for use by qualified surgeons and provide for the intracorporeal fragmentation of bladder calculi.
The Karl Storz Calcusplit is a pneumatic lithotriptor designed for the pneumatic fragmentation of urinary calculi. The Calcusplit system uses pneumatic energy converted to mechanical energy to disintegrate calculi. The force of the mechanical energy provided by this device is sufficient to fragment calculi of most sizes and composition.
This document describes the 510(k) submission for the Karl Storz Calcusplit Pneumatic Lithotriptor. The device is a pneumatic lithotriptor designed for the fragmentation of bladder calculi.
1. Acceptance Criteria and Reported Device Performance:
The provided document does not explicitly state quantitative acceptance criteria in terms of specific performance metrics (e.g., fragmentation time, stone clearance rate). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to a predicate device.
| Acceptance Criteria (Implicit from Substantial Equivalence) | Reported Device Performance |
|---|---|
| Safety no worse than predicate (EMS Swiss Lithoclast) | Bench testing of probe endurance and tissue effects demonstrated safety no worse than the EMS Swiss Lithoclast. |
| Effectiveness no worse than predicate (EMS Swiss Lithoclast) | Bench testing of probe endurance and tissue effects demonstrated effectiveness no worse than the EMS Swiss Lithoclast. |
| Same intended use as predicate | The Calcusplit has the same intended use as the predicate Swiss Lithoclast (pneumatic fragmentation of bladder calculi). |
| Same technological characteristics as predicate | Both the Calcusplit and the Lithoclast systems use compressed air and direct contact, rigid probes to fragment urinary tract stones under direct vision endoscopic control. |
2. Sample size used for the test set and the data provenance:
The document mentions "Bench testing of probe endurance and tissue effects." It does not specify the sample size for this bench testing, nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
No information is provided regarding experts or ground truth establishment for a test set. The evaluation relies on direct comparison to the predicate device's established safety and effectiveness.
4. Adjudication method for the test set:
Not applicable. There is no mention of a test set requiring expert adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The evaluation method described is bench testing and comparison to a predicate device, not a study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a pneumatic lithotriptor, not an AI algorithm. Its performance is inherent to its mechanical function.
7. The type of ground truth used:
The "ground truth" for the device's performance is established by the safety and effectiveness of the legally marketed predicate device (EMS Swiss Lithoclast Lithotriptor). The Karl Storz Calcusplit's performance is deemed acceptable if it is "no worse than" the predicate. A literature search also supported the general safety and effectiveness of Pneumatic Lithotripsy.
8. The sample size for the training set:
Not applicable. This device is a mechanical medical instrument, not an AI system that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this device.
§ 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.”