SWISS LITHOCLAST MULTIPURPOSE PROBE

K992251 · Electro Medical Systems SA · FFK · Jul 27, 1999 · Gastroenterology, Urology

Device Facts

• Record ID: K992251
• Device Name: SWISS LITHOCLAST MULTIPURPOSE PROBE
• Applicant: Electro Medical Systems SA
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Jul 27, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.

Device Story

The Swiss LITHOCLAST® Multipurpose Probe is a rigid, 3 Fr (1.0 mm) Type 304 stainless steel rod accessory for the EMS Swiss LITHOCLAST® Lithotripter. It functions by coupling shockwaves from the lithotripter handpiece to ureteral stones. The distal end features a lateral notch designed to fixate mobile ureteral stones, preventing stone migration (push back) during the procedure. Used in clinical settings by physicians via rigid or semi-rigid endoscopes, the probe facilitates stone fragmentation. It is reusable up to five times and requires steam sterilization between uses.

Clinical Evidence

Clinical use assessment was performed to support substantial equivalence. No specific clinical trial data, sample sizes, or statistical metrics were provided in the summary.

Technological Characteristics

Material: Type 304 surgical grade stainless steel. Dimensions: 3 Fr (1.0 mm) diameter rod. Design: Rigid rod with distal lateral notch for stone fixation. Energy: Mechanical coupling of pneumatic shockwaves. Sterilization: Steam sterilization. Reusability: Up to five times.

Indications for Use

Indicated for patients requiring fragmentation of ureteral calculi using rigid or semi-rigid endoscopes.

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 1.0 mm Probe (K951531, K963285)

Submission Summary (Full Text)

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K992251

## 510(k) Summary for ELECTRO MEDICAL SYSTEMS SA SWISS LITHOCLAST® MULTIPURPOSE PROBE

- 1. SPONSOR
ELECTRO MEDICAL SYSTEMS SA Chemin de la Vaurpilliere 31 CH-1260 Nyon Switzerland

Contact Person: Giani Campana Quality Manager

June 30, 1999 Date Prepared:

### 2. DEVICE NAME

| Trade/Proprietary Name: | Swiss LITHOCLAST® Multipurpose Probe |
|-------------------------|------------------------------------------------------------------|
| Common/Usual Name: | Accessory to endoscopic intracorporeal pneumatic<br>lithotripter |
| Classification Name: | Accessory to electrohydraulic lithotripter (Class III) |

### INTENDED USE 3.

The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.

### 4. DEVICE DESCRIPTION

# Swiss LITHOCLAST® Multipurpose Probe

The Multipurpose Probe is a rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece of the target to the stone. A lateral notch in the distal end of the probe allows for fixation of mobile ureteral stones, thus reducing the risk of stone push back in the ureter. The probe can be reused five times and may be sterilized by steam sterilization according to standard hospital procedures.

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#### 5. BASIS FOR SUBSTANTIAL EQUIVALENCE

The Multipurpose Probe is substantially equivalent to the EMS 1.0 mm Probe. This predicate device was cleared for use in fragmenting ureteral and bladder stones under K951531 and renal stones under K963285. The main difference between these devices is the distal, lateral notch of the Multipurpose Probe which serves for tangential fixation of mobile stones. The Multipurpose Probe is specifically intended for use in fragmenting of stones in the ureter.

Probe longevity testing, probe tip velocity and displacement testing, and clinical use assessment were performed to support the substantial equivalence of the Multipurpose Probe to the 1.0 mm LITHOCLAST ® Probe.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 27 1999

Electro Medical Systems SA c/o Ms. Sheila M. Hemeon-Heyer, Esq., RAC Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K992251 Swiss LITHOCLAST® Multipurpose Probe Dated: July 2, 1999 Received: July 6, 1999 Requiatory Class: III 21 CFR §876.4480/Procode: 78 FFK

Dear Ms. Hemeon-Heyer:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Requation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), piease contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone], or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _K992251

SWISS LITHOCLAST® MULTIPURPOSE PROBE Device Name:

Indications For Use:

The Swiss LITHOCLAST® Multipurpose Probe is intended to be used as an accessory to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of ureteral calculi through rigid or semi-rigid endoscopes.

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| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use __________ |
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| (Division Sign-Off) |
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| Division of Reproductive, Abdominal, ENT, and Radiological Devices |

| 510(k) Number | K992251 |
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| Electro Medical Systems SA Special 510(k)<br>SWISS LITHOCLAST® MULTIPURPOSE PROBE | 7/2/99 | CONFIDENTIAL<br>Page vi |
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