LITHOVAC SUCTION/ASPIRATION PROBE

K964111 · Electro Medical Systems SA · KQT · Dec 16, 1996 · Gastroenterology, Urology

Device Facts

• Record ID: K964111
• Device Name: LITHOVAC SUCTION/ASPIRATION PROBE
• Applicant: Electro Medical Systems SA
• Product Code: KQT · Gastroenterology, Urology
• Decision Date: Dec 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4370
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

LITHOVAC Suction/Aspiration Probe facilitates removal of urinary calculi, fragments, and debris during or after lithotripsy. Device connects to standard vacuum sources (wall vacuum, suction pump, or peristaltic pump up to -0.8 bar). Features a suction tube with a trumpet valve and adapters for integration with EMS Swiss LITHOCLAST lithotripter handpiece. Allows simultaneous lithotripsy and aspiration. Used by clinicians in urological procedures via rigid or semi-rigid endoscopes. Benefits patient by enabling efficient clearance of stone fragments, reducing procedure time and potential for residual debris.

Clinical Evidence

Animal study (pig model) assessed effectiveness and safety. LITHOVAC used with LITHOCLAST to fragment/aspirate bladder stones; only mild ecchymosis observed. Direct application of maximum suction to bladder mucosa for 10 seconds caused only mild ecchymosis. One-week follow-up showed no macroscopic/microscopic perforation or fibrosis, with complete regeneration of normal urothelium.

Technological Characteristics

Suction tube constructed of type 304 stainless steel. Available in four configurations: 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), and 4 mm OD/430 mm length (reusable non-sterile). Operates via external vacuum source. Includes trumpet valve and lithotripter probe adapters.

Indications for Use

Indicated for suction and aspiration of urinary tract calculi fragments through rigid or semi-rigid endoscopes in patients undergoing lithotripsy or requiring removal of stone debris.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Uromat Suction Pump/Calcuson Ultrasonic Lithotrite System
• Olympus Ureteromat Pump/LUS Lithotripsy device
• Corson Disposable Suction Irrigation Probe
• Nezhat-Dorsey Hydro-Dissection Reusable Suction Irrigation Probe

Submission Summary (Full Text)

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K964111
p173

# 510(k) Summary
## EMS LITHOVAC SUCTION/ASPIRATION PROBE

### 1. Sponsor/Applicant

Electro Medical Systems SA
Chemin de la Vuarpilliere 31
CH-1260 Nyon
Switzerland

DEC 16 1996

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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# 4. Device Description

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.

# 5. 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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K964111
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## 6. Technological Characteristics

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 post-treatment, complete regeneration of normal urothelium had taken place within one week.

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