(62 days)
The Electro Medical Systems SA LITHOVAC Suction/Aspiration Probe is designed for the suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes. It can be used alone, or it can be used during and after fragmentation of urinary tract calculi with the EMS Swiss LITHOCLAST intracorporeal lithotripter. It is specifically designed so that an EMS LITHOCLAST lithotripsy probe can be inserted through the LITHOVAC suction tube so that stone fragments and debris can be aspirated through the LITHOVAC suction tube simultaneously with lithotripsy.
The EMS SA LITHOVAC Suction/Aspiration Probe is intended to be used to aspirate out urinary calculi. fragments and debris using a standard vacuum source, i.e. a regulated wall vacuum, a standard suction pump, or a peristaltic pump which can supply up to -0.8 bar vacuum. Accessory adapters are provided to permit it to be used to aspirate urinary stone fragments or debris produce during fragmentation of urinary stones with the EMS Swiss LITHOCLAST lithotripter.
The LITHOVAC consists of a suction tube with a trumpet valve, and accessories for connecting the EMS Swiss LITHOCLAST handpiece and probe to the suction tube.
The LITHOVAC suction tube is made of type 304 stainless steel and is available in four diameter/length combinations as follows:
- 1.6 mm OD/445 mm length disposable sterile .
- 1.6 mm OD/555 mm length disposable sterile .
- 3.5 mm OD/460 mm length reusable non-sterile .
- 4 mm OD/430 mm length reusable non-sterile ●
The size of the suction tube is chosen according to the size of the endoscope to be used, e.g., the 4 mm LITHOVAC Probe is used through a 12 Fr or greater endoscope.
The provided text does not contain information on acceptance criteria for device performance or a study demonstrating the device meets those criteria. The submission is a 510(k) summary for the EMS LITHOVAC Suction/Aspiration Probe, primarily focusing on establishing substantial equivalence to predicate devices and describing the device's intended use and technological characteristics.
The "Performance Testing" section describes animal studies in a pig model to assess effectiveness and potential injury, but it does not specify acceptance criteria (e.g., success rates, aspiration volume, fragmentation efficiency targets) or detailed results against such criteria. The study mainly reports observations of mild ecchymosis and complete regeneration of urothelium, indicating safety rather than quantifiable performance against specific metrics.
Therefore, I cannot populate the table or answer the subsequent questions as the requested information is absent from the provided text.
§ 876.4370 Gastroenterology-urology evacuator.
(a)
Identification. A gastroenterology-urology evacuator is a device used to remove debris and fluids during gastroenterological and urological procedures by drainage, aspiration, or irrigation. This generic type of device includes the fluid evacuator system, manually powered bladder evacuator, and the AC-powered vacuum pump.(b)
Classification. (1) Class II (special controls) for the gastroenterology-urology evacuator when other than manually powered. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.(2) Class I for the gastroenterology-urology evacuator when manually powered. The device subject to this paragraph (b)(2) is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.