The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® previously cleared under K951531 and K963285. Three possible modes of operation are available using the Swiss LithoClast® Master: (1) pneumatic lithotripsy alone; (2) ultrasound lithotripsy alone; (3) and combined pneumatic and ultrasound lithotripsy. The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch. The pneumatic unit of the system is essentially the same as the Swiss LithoClast® Operation of this unit requires a supply of medical quality compressed air from either a compressor or a central hospital supply. The compressed air provides the pressure a compresses ve a be projectile within the Swiss LithoClast® handpiece toward the proximal end of the probe. The pressure pulse propagates to the distal tip of the probe and is transferred to the stone, resulting in fragmentation. The pneumatic unit prood and in combination with the Swiss LithoVac® for suction of stone fragments. The LithoClast® probes can be inserted through the LithoVac® probes for simultaneous lithotripsy and suction. The ultrasound handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating at approximately 24 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and probes are hollow, permitting simultaneous suction. Two probe sizes are available: 3.3 mm and 3.8 mm. Combined operation of the pneumatic and ultrasound units is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasound handpieces must be mounted together to form a LithoClast® Master handpiece using an adjustment interface. The 1 mm pneumatic probe is inserted through the adjustment interface and through either the 3.3 mm or 3.8 mm ultrasound probe. The probes must be length-adjusted by turning the nut of the adjustment interface so that the tip of the pneumatic probe is flush with the tip of the ultrasound probe.

AI/ML Overview

The provided text describes a 510(k) submission for the Electro Medical Systems SA SWISS LITHOCLAST® MASTER. It is a premarket notification to establish substantial equivalence to a legally marketed predicate device, not a study designed to prove the device meets specific performance acceptance criteria in the way a clinical trial or a novel AI device study would.

Therefore, many of the requested categories are not directly applicable or explicitly detailed in this type of regulatory document. The focus of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to set new performance benchmarks with explicit acceptance criteria.

However, based on the information provided, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance:

This document does not specify formal, quantitative acceptance criteria for device performance as would be found in a study for a novel device. Instead, the "acceptance criteria" for a 510(k) submission revolve around demonstrating substantial equivalence to predicate devices. The performance reported is in relation to this goal.

Acceptance Criteria (Inferred for 510(k) Equivalence)	Reported Device Performance
Intended Use Equivalence: The device has the same intended use as predicate devices.	The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder, which is stated to be the same as predicate devices. The pneumatic module was previously cleared for kidney, ureter, and bladder stones.
Technical Specifications Equivalence: The device has similar technical specifications as predicate devices.	The Swiss LithoClast® Master is a modified version of the Swiss LithoClast® (K951531, K963285). The pneumatic unit is essentially the same. The ultrasound module is substantially equivalent to predicate ultrasonic lithotripters (e.g., Storz Ultrasound Lithotripters, Richard Wolf Ultrasound Generator).
Performance Equivalence (Fragmentation): The device demonstrates equivalent or superior stone fragmentation compared to predicate devices.	Stone fragmentation testing confirmed that the Swiss LithoClast® Master results in equivalent or faster fragmentation of a variety of standard artificial stone materials (ranging from soft to hard) when tested against various predicate ultrasound lithotripters.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "stone fragmentation testing" on "a variety of standard artificial stone materials."

Sample Size for Test Set: Not explicitly stated. It refers to "a variety of standard artificial stone materials," implying multiple types of stones were tested, but the number of tests or specific sample sizes are not provided.
Data Provenance: Not explicitly stated. The testing was likely conducted by the manufacturer, Electro Medical Systems SA, located in Nyon, Switzerland. This would imply an in vitro laboratory test rather than a clinical study with patient data. As such, it's not "retrospective or prospective" in the clinical sense.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The "stone fragmentation testing" likely involves objective physical measurements (e.g., time to fragmentation, fragment size analysis) in a laboratory setting, not expert clinical assessment of "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept applies to human expert review of clinical cases. The stone fragmentation testing would involve laboratory protocols and measurement.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device or a diagnostic imaging device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a medical device for intervention (lithotripsy), not an algorithm or AI. The performance discussed is the device's physical ability to fragment stones.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the stone fragmentation testing would be defined by objective physical measurements of stone fragmentation parameters (e.g., time to fragment, fragment morphology, completeness of fragmentation) against a "standard" or established performance benchmark for predicate devices. It is based on in vitro laboratory measurements rather than expert clinical judgment or pathology.

8. The sample size for the training set

Not applicable. This is not an AI device. The device's design and operation are based on established pneumatic and ultrasonic lithotripsy principles, refined from previous versions.

9. How the ground truth for the training set was established

Not applicable. As this is not an AI/ML device, there isn't a "training set" in that context. The "ground truth" for its development would be based on engineering principles, clinical experience with previous generations of the device (Swiss LithoClast®), and a scientific understanding of lithotripsy mechanisms, rather than a data-driven training set.

Summary

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10/2445 PG-10-3

510(k) Summary for Electro Medical Systems SA SWISS LITHOCLAST® MASTER

1. SPONSOR

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

Giani Campana Contact Person: Quality Manager

July 31, 2001 Date Prepared:

2. DEVICE NAME

Trade/Proprietary Name:	EMS Swiss LithoClast® Master (a.k.a. SwissLithoClast® Ultra
Common/Usual Name:	Endoscopic intracorporeal pneumatic and ultrasoniclithotripsy
Classification Name:	Electrohydraulic lithotripsy

INTENDED USE 3.

The EMS Swiss LithoClast® Master is intended for the intracorporeal fragmentation of ureteral calculi in the kidney, ureter, and bladder.

DEVICE DESCRIPTION 4.

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The system consists of two independent operating units in one housing, which allows for independent operation of the two modalities. Delivery of energy is controlled using a common two-pedal footswitch.

The pneumatic unit of the system is essentially the same as the Swiss LithoClast® Operation of this unit requires a supply of medical quality compressed air from either a compressor or a central hospital supply. The compressed air provides the pressure a compresses ve a be projectile within the Swiss LithoClast® handpiece toward the proximal end of the probe. The pressure pulse propagates to the distal tip of the probe and is transferred to the stone, resulting in fragmentation. The pneumatic unit prood and in combination with the Swiss LithoVac® for suction of stone fragments. The LithoClast® probes can be inserted through the LithoVac® probes for simultaneous lithotripsy and suction.

The ultrasound handpiece consists of an ultrasound transducer containing the piezoelectric elements, which are driven by a generator operating at approximately 24 kHz. The resulting longitudinal waves are propagated along the ultrasound probe to the target stone. The ultrasound transducer and probes are hollow, permitting simultaneous suction. Two probe sizes are available: 3.3 mm and 3.8 mm.

Combined operation of the pneumatic and ultrasound units is desirable for certain hard kidney and bladder stones. In order to use the combined energy, the pneumatic and ultrasound handpieces must be mounted together to form a LithoClast® Master handpiece using an adjustment interface. The 1 mm pneumatic probe is inserted through the adjustment interface and through either the 3.3 mm or 3.8 mm ultrasound probe. The probes must be length-adjusted by turning the nut of the adjustment interface so that the tip of the pneumatic probe is flush with the tip of the ultrasound probe.

BASIS FOR SUBSTANTIAL EQUIVALENCE ડ.

The pneumatic module of the Swiss LithoClast® Master is substantially equivalent to the Swiss LithoClast®, which was previously cleared for intracorporeal fragmentation of ureteral and bladder stones under K951531 and for kidney stones under K963285. The ultrasound module of the Swiss LithoClast® Master is substantially equivalent to predicate ultrasonic lithotripters, including the Storz Ultrasound Lithotripters and the Richard Wolf Ultrasound Generator. The Swiss LithoClast® Master has the same intended use and similar technical specifications as compared with the predicate devices. Substantial equivalence has also been demonstrated by stone fragmentation testing. These tests confirmed that use of the Swiss LithoClast® Master results in

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equivalent or faster fragmentation of a variety of standard artificial stone materials (ranging from soft to hard) when tested against various predicate ultrasound lithotripters. .

. .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the circumference. Inside the circle is a stylized symbol resembling three human profiles facing right, stacked on top of each other, with flowing lines suggesting movement or connection.

Public Health Service

AUG 2 4 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Electro Medical Systems SA % Ms. Sheila Hemeon-Heyer, J.D., R.A.C. Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street NORTH ATTLEBORO MA 02760

Re: K012445

EMS Swiss LithoClast® Master (a.k.a. Swiss LithoClast® Ultra) Lithotripter Dated: July 31, 2001 Received: August 1, 2001 Regulatory Class: II 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 We live 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 marketed in merslate onlinetee provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, that have bear to assimos in accordance marked provisions of the Act. The general controls provisions of the Act thelefore, market the device, subjor to the Edical of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class III (Premarket Approval), it may be subject It your device is classince (so above) and tions affecting your device can be found in the Code of Federal Regulations, to such additional comrol. "Discusivally equivalent determination assumes compliance with the Current Good Manufacturing I I die 21, I all 800 to 02-71 11 de Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 1 rache requirements, to set tour in the Quant the Food and Drug Administration (FDA) will verify such assumptions. Failure o comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements to compy with the Unit Togulation ind Tecan in regerates to your premarket notification submission does not concenting your dorited in the Four 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 If you desire specific at ree to your confice of Compliance at (301) 594-4639. 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, advanting of your are to premarket notification" (21CFR 807.97). Other general information on your responsibilities under Intelligence of tecented to premained in Manufacturers International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely vours

Nancy C. Brogdon

Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K012445 510(k) Number (if known):

Device Name: SWISS LITHOCLAST® MASTER

Indications For Use:

The EMS Swiss LithoClast® Master is intended to be used for the fragmentation of urinary tract calculi in the kidney, ureter, and bladder.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broxton

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devic 510(k) Number

Prescription Use _ ﮨﮯ ﺍﻭﺭ ﺍﺱ ﮐﮯ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﮏ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ ﺍﯾﺮﺍﻥ ﮐﮯ ﺷﮩﺮ (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

Electro Medical Systems SA Special 510(k) SWISS LITHOCLAST® MASTER

July 31, 2001

Page vi

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.”