EMS SWISS LITHOCLAST LITHOTRIPTER

K963285 · Electro Medical Systems SA · FFK · Feb 13, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963285
• Device Name: EMS SWISS LITHOCLAST LITHOTRIPTER
• Applicant: Electro Medical Systems SA
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Feb 13, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The EMS SWISS LITHOCLAST LITHOTRIPter is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.

Device Story

Pneumatic lithotripter; fragments urinary tract calculi (renal, ureteral, bladder) via rigid/semirigid endoscopes. Device operates via pneumatic energy to drive a probe against stones; mechanical impact causes fragmentation. Used in clinical settings by urologists. Output is mechanical energy for stone disintegration; assists in stone removal procedures. Benefits include minimally invasive stone treatment.

Clinical Evidence

Retrospective clinical study of 83 kidneys with renal stones treated at two investigational sites. Data demonstrates safety and effectiveness equivalent to predicate devices.

Technological Characteristics

Pneumatic lithotripter; mechanical energy source; probe-based delivery; used with rigid/semirigid endoscopes. No changes to technological characteristics.

Indications for Use

Indicated for fragmentation of renal, ureteral, and bladder calculi in patients requiring endoscopic lithotripsy.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”

Predicate Devices

• EMS SWISS LITHOCLAST LITHOTRIPter (K951531)
• Wolf 2270 Ultrasound Generator and Sonatrodes
• Wolf 2280 Electrohydraulic Lithotripter (K923487)
• Candela LaserTripter (K863642/K885255)

Submission Summary (Full Text)

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# 510(k) Summary for the Expansion of the Indications for Use of the Electro Medical Systems SA EMS SWISS LITHOCLAST LITHOTRIPter (per 21 CFR 807.92)

1. Date Prepared: August 16, 1996

2. Sponsor/Applicant: Electro Medical Systems SA
Chemin de la Vaurpilliere 31
CH-1260 Nyon
Switzerland

3. Contact Person: Manfred Schulz

4. Device Name:
Trade/Proprietary Name: EMS SWISS LITHOCLAST LITHOTRIPter
Common/Usual Name: Endoscopic intracorporeal pneumatic lithotripter
Classification Name: Electrohydraulic Lithotripter

5. Device Classification: Class III

6. Predicate Devices:
- EMS SWISS LITHOCLAST LITHOTRIPter (for ureteral and bladder stones) K951531
- Wolf 2270 Ultrasound Generator and Sonatrodes
- Wolf 2280 Electrohydraulic Lithotripter (K923487)
- Candela LaserTripter (K863642/K885255)

7. Intended Use:
The EMS SWISS LITHOCLAST LITHOTRIPter is intended for use in fragmenting urinary tract calculi (renal, ureteral, and bladder) through rigid or semirigid endoscopes.

EMS SWISS LITHOCLAST LITHOTRIPter - 510(k) for Renal Stones - - 8/16/96
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8. Operational and Technological Characteristics:

The operational and technological characteristics of the LITHOCLAST are unchanged.

A retrospective clinical study of the results on 83 kidneys with renal stones treated by two investigational sites was provided to support the safety and effectiveness of the EMS SWISS LITHOCLAST for treatment of renal stones. The clinical data demonstrates that the EMS SWISS LITHOCLAST is substantially equivalent in safety and effectiveness to that of the predicate devices cited above as reported in the medical literature.

EMS SWISS LITHOCLAST LITHOTRIPTER - 510(k) for Renal Stones - - 8/16/96 Page F-2