The LITHOCLAST® MASTER Handpiece and the 3.2 mm probe have the same intended use as their predicate accessories, that is, for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or The 3.2 mm probe is specifically indicated for use in semirigid endoscopes. fragmenting large stones in the bladder and kidney.

Device Description

MASTER Handpiece: The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.

3.2 mm Probe: The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.

AI/ML Overview

The provided text describes a 510(k) summary for the ELECTRO MEDICAL SYSTEMS SA LITHOCLAST® MASTER Handpiece and 3.2 mm Probe, seeking clearance based on substantial equivalence to predicate devices. The submission details various tests performed to support this claim for both the handpiece and the probe.

Here's an analysis of the acceptance criteria and study information, based on the provided document:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. Instead, it describes various tests performed to demonstrate substantial equivalence to existing predicate devices. The implication is that the performance of the new device (MASTER Handpiece and 3.2 mm Probe) was considered acceptable if it performed comparably to, or improved upon, the predicate devices in the specific tests mentioned.

Here's an interpretation of the performance and implied criteria based on the text:

Acceptance Criteria (Implied)	Reported Device Performance
MASTER Handpiece:
Equivalent/Improved Lifetime	"Life time... tests were performed to support the substantial equivalence of the MASTER Handpiece." (The new sealed design is stated to "prolong the life time of the handpiece").
Equivalent/Improved Probe Displacement	"Probe displacement tests were performed to support the substantial equivalence of the MASTER Handpiece."
Maintain Sterility during Probe Changes	The sealed design "allows for the changing of probes during a treatment without the risk of breaking sterility." (This is a design feature offering an advantage over the predicate, which required a silicone sleeve).
3.2 mm Probe:
Equivalent/Appropriate Probe Velocity	"Probe velocity... tests... were performed to support the substantial equivalence of the 3.2 mm probe."
Equivalent/Appropriate Probe Displacement	"Probe... displacement tests... were performed to support the substantial equivalence of the 3.2 mm probe."
Equivalent/Appropriate Impact Pressure	"Impact pressure... studies were performed to support the substantial equivalence of the 3.2 mm probe."
Equivalent/Appropriate Disintegration Efficiency	"Disintegration efficiency... studies were performed to support the substantial equivalence of the 3.2 mm probe."
Safe In-vitro Tissue Impact (No excessive collateral damage)	"in-vitro tissue impact studies were performed to support the substantial equivalence of the 3.2 mm probe."
Reusable and Sterilizable by Steam	"The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures." (Implied criterion: ability to withstand standard sterilization methods without degradation).
Efficacy for fragmenting large stones in bladder and kidney (New indication)	The 3.2 mm probe is "specifically indicated for use in fragmenting large stones in the bladder and kidney." The tests listed above collectively support the safety and effectiveness for this indication, comparing its performance to smaller diameter predicate probes. While not a direct "criterion" in the same way as a numerical threshold, demonstrating its suitability for this specific use is a key aspect of its clearance.

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 does not specify sample sizes for any of the tests performed (lifetime, displacement, velocity, impact pressure, disintegration efficiency, in-vitro tissue impact studies).

The data provenance (country of origin, retrospective/prospective) is also not mentioned in this summary. It's likely these were in-house laboratory tests conducted by ELECTRO MEDICAL SYSTEMS SA, which is based in Nyon, Switzerland.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this submission. The tests described are bench or in-vitro performance studies, not clinical studies involving expert interpretation of patient data to establish ground truth.

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

This section is not applicable. No human interpretation or adjudication of results is mentioned for these performance tests.

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

There is no MRMC study mentioned, as this is a device for fragmenting kidney stones, not an AI-assisted diagnostic tool where human readers would be involved.

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

This is not applicable in the context of an AI algorithm. The device itself (handpiece and probe) is the standalone entity, and its performance was evaluated in various bench and in-vitro tests without human assistance during the actual fragmentation process, although a surgeon would operate it.

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

For the performance tests mentioned, the "ground truth" would be established by:

Measurement of physical parameters: For "lifetime," "probe displacement," "probe velocity," and "impact pressure," the ground truth would be directly measured physical quantities using appropriate sensors and equipment.
Quantitative results of efficacy: For "disintegration efficiency," the ground truth would be objectively measurable outcomes like the extent of stone fragmentation or reduction in stone mass.
Observable effects: For "in-vitro tissue impact studies," the ground truth would involve observable or measurable effects on the tissue, often compared against a control or predicate device's effects.

8. The sample size for the training set

This is not applicable. This is a hardware medical device clearance, not an AI/machine learning application requiring a training set.

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

This is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

K 974164

Jor i ok

510(k) Summary

DEC 18 1997

ELECTRO MEDICAL SYSTEMS SA LITHOCLAST® MASTER Handpiece and

3.2 mm Probe

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

Manfred Schulz Contact Person: General Manager

Date Prepared: October 31, 1997

1. Device Name

Trade/Proprietary Name:	LITHOCLAST® MASTER Handpiece and 3.2 mm Probe
Common/Usual Name:	Accessories to endoscopic intracorporeal pneumatic lithotripter
Classification Name:	Accessories to electrohydraulic lithotripter (Class III)

3. Intended Use

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K974164
fg 2 of 3

Device Description 4.

MASTER Handpiece

The MASTER Handpiece is 18 mm in diameter, 228 mm long, and is constructed of aluminum alloy. The proximal end of the handpiece is connected to the LITHOCLAST pressure regulator. The chosen treatment probe is attached to the distal end of the handpiece using a screw cap. The metal projectile inside the handpiece is driven forward by the pressure from the pressure regulator. The energy from the projectile is transmitted to the probe by a shock transmitter at the distal end of the handpiece. The handpiece is sealed at both the distal and proximal ends, which: (1) prolongs the life time of the handpiece by preventing dirt, moisture and other particles from entering the handpiece; and (2) allows for the changing of probes during a treatment without the risk of breaking sterility.

3.2 mm Probe

The 3.2 mm probe is a rigid Type 304 surgical grade stainless steel rod that acts to couple the shockwave from the handpiece to the target stone. The probe is reusable and may be sterilized by steam sterilization according to standard hospital procedures.

5. Basis For Substantial Equivalence

MASTER Handpiece

The MASTER Handpiece is substantially equivalent to the EMS Standard Handpiece that was cleared for marketing under K951531 and K963285. The main difference between the two devices is that the MASTER Handpiece is sealed at both the distal and proximal ends, while the Standard Handpiece is open and requires the use of a silicone sleeve to provide a watertight seal between the probe and the handpiece. Life time and probe displacement tests were performed to support the substantial equivalence of the MASTER Handpiece.

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3.2 mm Probe

K 974/64

rg3 q3

The EMS 3.2 mm probe is substantially equivalent to the EMS probes with smaller diameters (0.8, 1.0, 1.6, 2.0 mm). These predicate devices were cleared for marketing under K951531 and K963285. The main difference between these devices is the probe diameter. The larger 3.2 mm probe is specifically intended for use in fragmenting large stones in the bladder and kidney. Probe velocity and displacement tests, impact pressure, disintegration efficiency, and in-vitro tissue impact studies were performed to support the substantial equivalence of the 3.2 mm probe.

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DEPARTMENT OF HEALTH & HUMAN SERVICES - ......

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 18 1997

Re: K974164

ELECTRO MEDICAL SYSTEMS SA c/o Ms. Rosina Robinson Senior Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

EMS Swiss LITHOCLAST® MASTER Handpiece and 3.2mm Probe Dated: October 31, 1997 Received: November 5, 1997 Regulatory class: III 21 CFR §876.4480/Product code: 78 FFK

Dear Ms. Robinson:

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 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 (Act). You may, therefore, subject to the general controls provisions of 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 (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 requirement, as set forth in the Quality System Regulation (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 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 predication 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), please 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/dsmamain.html".

Sincerely yours,

W.Liau Yu

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Swiss LITHOCLAST® MASTER HANDPIECE and 3.2 MM Device Name: PROBE

Indications For Use:

The Swiss LITHOCLAST® MASTER HANDPIECE and the 3.2 MM PROBE are intended to be used as accessories to the EMS Swiss LITHOCLAST® Lithotripter for the fragmentation of urinary tract calculi, including renal, ureteral and bladder stones, through rigid or semirigid endoscopes. The 3.2 mm Probe is specifically indicated for use in fragmenting large stones in the bladder and kidney.

(Please do not write below this line - Continue on another page if necessary)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert P. Satting

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices K974164 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

Over-the-Counter Use_

(Optional Format 1-2-96)

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.”