(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.
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Piq.3
510(k) Summary
EMS LITHOVAC SUCTION/ASPIRATION PROBE
Sponsor/Applicant 1.
DEC I 6 1996
Electro Medical Systems SA Chemin de la Vuarpilliere 31 CH-1260 Nyon Switzerland
Contact Person:
Mr. Wolfgang Merkle EMS Deutschland Steigstr. 14 D-88709 Meersburg Germany
Date Prepared: October 11, 1996
2. Device Name
| Trade or Proprietary Name: | LITHOVAC Suction/Aspiration Probe |
|---|---|
| Common/Usual Name: | Suction/aspirator, evacuator |
| Classification Name: | Gastroenterology-urology evacuators |
3. Identification of the Predicate or Legally Marketed Device(s) to Which Equivalence is Being Claimed
Uromat Suction Pump/Calcuson Ultrasonic Lithotrite System, the Olympus Ureteromat Pump/LUS Lithotripsy device, and numerous other vacuum aspiration systems such as the Corson Disposable Suction Irrigation Probe, and the Nezhat-Dorsey Hydro-Dissection Reusable Suction Irrigation Probe.
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Device Description 4.
K964111
p2073
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.
ડ. Intended Use
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.
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6. Technological Characteristics
K964111 P3073
The EMS LITHOVAC Probe technological characteristics are the same as the predicate devices in that they are suction/aspiration devices that consist of probes or tubes for evacuating fluids and debris during or after lithotripsy treatment.
7. Performance Testing
Animal studies were performed in the pig model to assess the effectiveness and the potential for injury of the EMS LITHOVAC Probe used with the EMS LITHOCLAST Lithotripter in fragmenting and aspirating stones in the pig bladder and ureter.
The LITHOVAC/LITHOCLAST Probes were used to fragment and aspirate four stones in the pig bladder using maximum LITHOVAC suction. Immediately after treatment, only mild ecchymosis was noted at the areas where the stones were treated.
The LITHOVAC was then applied directly to three separate areas of the bladder mucosa at maximum suction for 10 seconds each. Only, mild ecchymosis was observed. At one week post-treatment, the bladder was harvested and showed no macroscopic or microscopic perforation, or fibrosis. The urothelium was intact demonstrating that even with the minimal mucosal damage immediately posttreatment, complete regeneration of normal urothelium had taken place within one week.
§ 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.