(61 days)
The intended use of the Duet SP Extracorporeal Shock Wave Lithotripter is the fragmentation of urinary tract stones (i.e. renal calyceal, renal pelvic, and upper ureteral stones).
The Duet is a transportable Electrohydraulic Extracorporeal Shock Wave Lithotripter, which consists of a Shock Wave Generator (SWAG), a Motorized Floating Treatment Table (MFT), and control means.
The provided text states that no clinical tests were performed for the Duet SP Extracorporeal Shock Wave Lithotripter.
Therefore, the device did not undergo a study to prove it meets acceptance criteria, meaning there is no information available for the following points:
- A table of acceptance criteria and the reported device performance: Not applicable as no clinical tests were performed.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The submission is a "special 510(k)" based on the device being a minor modification of predicate devices, and that these modifications "do not change the fundamental technology or reduce safety and effectiveness."
Acceptance Criteria/Regulatory Basis:
The device's acceptance is based on its substantial equivalence to predicate devices (Duet K023535 and Duet SLO K041582) for the fragmentation of urinary tract stones. The modification (inclusion of a sonographic localization option) was deemed minor and not requiring new clinical data to prove safety and effectiveness.
§ 876.5990 Extracorporeal shock wave lithotripter.
(a)
Identification. An extracorporeal shock wave lithotripter is a device that focuses ultrasonic shock waves into the body to noninvasively fragment urinary calculi within the kidney or ureter. The primary components of the device are a shock wave generator, high voltage generator, control console, imaging/localization system, and patient table. Prior to treatment, the urinary stone is targeted using either an integral or stand-alone localization/imaging system. Shock waves are typically generated using electrostatic spark discharge (spark gap), electromagnetically repelled membranes, or piezoelectric crystal arrays, and focused onto the stone with either a specially designed reflector, dish, or acoustic lens. The shock waves are created under water within the shock wave generator, and are transferred to the patient's body using an appropriate acoustic interface. After the stone has been fragmented by the focused shock waves, the fragments pass out of the body with the patient's urine.(b)
Classification. Class II (special controls) (FDA guidance document: “Guidance for the Content of Premarket Notifications (510(k)'s) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi.”)