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 Description

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.

AI/ML Overview

The provided text does not contain detailed acceptance criteria or a comprehensive study report with the specific information requested in the prompt. This document is a 510(k) summary for a medical device (Swiss LITHOCLAST® Multipurpose Probe), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial data with specific statistical metrics.

However, based on the available information, I can extract and infer the following:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Inferred)	Reported Device Performance
Probe Longevity	Expected to be at least as good as the predicate device (EMS 1.0 mm Probe).	Testing was performed to support substantial equivalence. (Specific cycles/durability not quantified in this summary)
Probe Tip Velocity	Expected to be within acceptable ranges for stone fragmentation, comparable to the predicate device.	Testing was performed to support substantial equivalence. (Specific velocity ranges not quantified in this summary)
Probe Tip Displacement	Expected to be within acceptable ranges for stone fragmentation, comparable to the predicate device.	Testing was performed to support substantial equivalence. (Specific displacement ranges not quantified in this summary)
Clinical Performance	Effective fragmentation of ureteral calculi through rigid or semi-rigid endoscopes, with potential benefit of reduced stone push-back.	Clinical use assessment was performed, suggesting equivalence and the benefit of the lateral notch for stone fixation.
Sterilization	Ability to be sterilized by steam sterilization according to standard hospital procedures.	The probe "may be sterilized by steam sterilization according to standard hospital procedures."
Material	Device constructed from specified surgical grade material.	Made of "rigid, 3 Fr (1.0 mm) Type 304 surgical grade stainless steel rod."

Note: The acceptance criteria are largely inferred based on what would typically be evaluated for substantial equivalence in medical device submissions, as specific quantitative criteria are not explicitly stated in this summary.

2. Sample Size and Data Provenance

Test Set Sample Size: Not specified. The document mentions "clinical use assessment" but does not provide details on the number of patients or cases included in this assessment.
Data Provenance: Not specified. It's likely that the testing (longevity, velocity, displacement, clinical use assessment) was conducted by the manufacturer (ELECTRO MEDICAL SYSTEMS SA) in Switzerland, but this is not explicitly stated. It is presented as an assessment to support substantial equivalence, not a formal clinical trial with geographic details. The type of data (retrospective or prospective) is also not stated.

3. Number of Experts and Qualifications for Ground Truth

This information is not provided in the given text. The "clinical use assessment" and "basis for substantial equivalence" do not specify the involvement of experts in establishing a ground truth for a test set in the way a typical clinical study would. The summary focuses on comparing the new device to a predicate device through technical and basic clinical assessments, not on establishing a "ground truth" via expert consensus for a diagnostic task.

4. Adjudication Method for the Test Set

This information is not applicable/provided. There is no mention of a formal adjudication process for a test set, as this is not a study involving expert readers interpreting results against a consensus ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done based on the provided summary. The submission focuses on demonstrating substantial equivalence through technical testing and a general "clinical use assessment," not a comparative study of human reader performance with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. This device is a mechanical lithotripter probe, not an algorithm or AI-powered system, so a standalone algorithm performance study would not be relevant.

7. Type of Ground Truth Used

The concept of "ground truth" as typically used in AI/diagnostic studies (e.g., pathology, outcomes data, expert consensus on images) is not directly applicable to this device submission.
Instead, the "truth" for this submission revolves around the performance characteristics of the probe (longevity, tip velocity, displacement) and its ability to fragment stones in a clinical setting, as compared to a predicate device.
The "clinical use assessment" would have likely relied on clinical observations/outcomes (e.g., successful stone fragmentation, absence of complications) rather than a defined ground truth like pathology reports.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or algorithmic system trained on data, so there is no training set in the conventional sense.

9. How Ground Truth for Training Set was Established

Not applicable. As a physical medical device, there is no training set or ground truth in the context of machine learning.

Summary

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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 pneumaticlithotripter
Classification Name:	Accessory to electrohydraulic lithotripter (Class III)

INTENDED USE 3.

4. DEVICE DESCRIPTION

Swiss LITHOCLAST® Multipurpose Probe

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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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three heads, each head facing a different direction. The eagle's body is represented by flowing lines, giving it a sense of movement and dynamism.

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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597, 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:

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

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

510(k) Number	K992251
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Electro Medical Systems SA Special 510(k)SWISS LITHOCLAST® MULTIPURPOSE PROBE	7/2/99	CONFIDENTIALPage vi
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Regulation Number and Section

§ 876.4480 Electrohydraulic lithotriptor.

(a)
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.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notifications for Intracorporeal Lithotripters.”