URETRON MODEL URT by MED-SONICS CORP

The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

Device Description

The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder. The system is an electromechanical device and consists of a generator, hand piece and probes. The hand piece is an ultrasonic transducer containing piezo-electric ceramic elements. The generator drives the hand piece at 21000 +/- 1000 Hz to get mechanical vibration through the probes to urinary tract calculi.

AI/ML Overview

The provided text describes the UreTron Multi Probe Lithotripter, but it does not contain the detailed information necessary to complete the requested table and study questions. The document focuses on demonstrating substantial equivalence to predicate devices through performance data, but it does not specify acceptance criteria in quantitative terms or provide the specifics of the studies in the way requested.

Here's a breakdown of what can be extracted and what information is missing:

Information present in the document:

Intended Use: Fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
Performance Data: Verification and Validation tests were conducted to demonstrate functionality, sterility, and biocompatibility. Substantial equivalence was demonstrated by "stone model fragmentation testing, probe life testing and tissue perforation testing." The test data "proves UreTron's efficacy with stone model penetration rates as compared to the predicate devices."
Product Name: UreTron™ Multi Probe Lithotripter
Manufacturer: Med-Sonics, Corp.

Information NOT present in the document (and thus cannot be provided in the requested format):

A table of specific, quantitative acceptance criteria.
Reported device performance values against those specific criteria.
Sample sizes used for any test sets mentioned (e.g., stone model fragmentation, probe life, tissue perforation).
Data provenance (country of origin, retrospective/prospective for any test data).
Number of experts or their qualifications for establishing ground truth.
Adjudication method for any test set.
Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size for human reader improvement with AI assistance (as this is an electromechanical device, not an AI/imaging device).
Whether a standalone (algorithm only) performance study was done (again, not applicable for this type of device in the AI context).
The type of ground truth used (e.g., expert consensus, pathology, outcomes data) with specific details. The document mentions "stone model fragmentation", which implies synthetic ground truth.
Sample size for the training set (not applicable as this is not an AI/ML device that requires a training set).
How ground truth for the training set was established (not applicable).

Based on the provided text, here's what can be answered, with clear indications of missing information:

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

Acceptance Criteria (Quantitative)	Reported Device Performance
Missing: Specific quantitative criteria are not provided.	Missing: Specific quantitative performance values are not reported.
(e.g., Stone fragmentation rate of X%; Probe life of Y hours; Tissue perforation depth < Z mm)	(e.g., Achieved stone fragmentation rate of X.X%; Probe life of Y.Y hours; No tissue perforation beyond Z.Z mm)
General Statement: Demonstration of functionality, sterility, biocompatibility.	Verification and Validation tests conducted and substantiated safety and effectiveness.
Substantial equivalence in stone model penetration rates compared to predicate devices.	Data proves UreTron's efficacy with stone model penetration rates as compared to the predicate devices.

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

Sample Size for Test Set: Not specified in the document for stone model fragmentation, probe life, or tissue perforation tests.
Data Provenance: Not specified. The tests were "conducted" but no details on their location or whether they were retrospective/prospective are provided.

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)

Not applicable / Not specified. The document mentions "stone model fragmentation testing," which typically involves objective measurements on synthetic models (e.g., BegoStone or similar). This type of testing usually doesn't involve "experts" establishing a subjective ground truth in the way medical imaging interpretation does.

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

Not applicable / Not specified. The nature of the tests (stone model fragmentation, probe life, tissue perforation) does not typically involve human adjudication in the sense of consensus reading for diagnostic accuracy.

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

No. This is an electromechanical medical device for lithotripsy, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is not relevant or applicable.

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

Not applicable. This device is a physical lithotripter entirely operated with human intervention (human-in-the-loop), not an algorithm that can perform standalone.

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

The primary type of "ground truth" implied for efficacy testing is performance against stone models (e.g., successful fragmentation, specified penetration rates) and controlled testing for probe life and tissue perforation under laboratory conditions. This is a form of engineered or synthetic ground truth, not clinical ground truth like pathology or patient outcomes, nor expert consensus for diagnostic tasks.

8. The sample size for the training set

Not applicable. This device is an electromechanical device, not an AI/machine learning algorithm, and therefore does not have a "training set" in that context.

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

Not applicable. See point 8.

Summary

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Med-Sonics

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# MAR 3 0

SECTION - 5

### 510(k) Summary per 21 CFR 807.92

# UreTron™ Multi Probe Lithotripter

## 510K #: [K111058](https://510k.innolitics.com/search/K111058)

#### SPONSOR

| MED-SONICS, CORP.            |                  |
|------------------------------|------------------|
| 4960 Pittsburgh Ave, Suite A |                  |
| Erie, Pennsylvania 16509 USA |                  |
| Phone:                       | 814-899-6500     |
| Fax:                         | 814-899-6501     |
| Contact Person:              | William A. Stoll |
| Date Prepared:               | April 15, 2011   |

#### DEVICE NAME

Trade/Proprietary Name: UreTron Multi Probe Lithotripter Common/Usual Name: Intracorporeal ultrasonic lithotripter Classification Name: Lithotripter, Ultrasonic [21 CFR 876.4480] Product Code: FFK Class: Il

#### PREDICATE DEVICES

510K Number: [K102169](https://510k.innolitics.com/search/K102169) Manufacturer: Cybersonics, Inc. CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter Trade Name:

510K Number: [K052135](https://510k.innolitics.com/search/K052135) Manufacturer: Cybersonics, Inc. Trade Name: CyberWand Dual Probe Lithotripter

510K Number: [K012445](https://510k.innolitics.com/search/K012445) Manufacturer: Electro Medical Systems SA. EMS Swiss Lithoclast Master / Swiss Lithoclast Ultra Trade Name:

4960 Pittsburgh Ave, Suite A * Erie, Pennsylvania 16509 · TEL (814) 899-6500 · FAX (814) 899-6501

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Image /page/1/Picture/0 description: The image shows a logo for Med-Sonics. The logo features a stylized waveform above the text "Med-Sonics". The waveform is composed of a series of connected horizontal and vertical lines, creating a pattern reminiscent of a medical device or technology symbol. The text "Med-Sonics" is in a simple, sans-serif font.

[K111058](https://510k.innolitics.com/search/K111058)

PAGE 2 of 2

#### DEVICE DESCRIPTION

The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder. The system is an electromechanical device and consists of a generator, hand piece and probes. The hand piece is an ultrasonic transducer containing piezo-electric ceramic elements. The generator drives the hand piece at 21000 +/- 1000 Hz to get mechanical vibration through the probes to urinary tract calculi.

#### INTENDED USE

The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

#### BASIS FOR SUBSTANTIAL EQUIVALENCE

Med-Sonics UreTron Multi Probe Lithotripter system is substantially equivalent to the CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter ([K102169](https://510k.innolitics.com/search/K102169)), the CyberWand Dual Probe Lithotripter ([K052135](https://510k.innolitics.com/search/K052135)) and EMS Swiss Lithoclast Master/Ultra ([K012445](https://510k.innolitics.com/search/K012445)), which were previously cleared for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder. The UreTron has the same intended use and similar technical specifications as compared with predicate devices.

## PERFORMANCE DATA

The UreTron was tested by NRTL labs for EMC and Electrical Safety according to IEC 60601. Verification and Validation tests were conducted to demonstrate the UreTron's functionality. sterility and biocompatibility for its intended use. These verification and validation test results substantiated safety and effectiveness compared to the predicate devices.

Substantial equivalence with predicate devices is demonstrated by stone model fragmentation testing, probe life testing and tissue perforation testing. The test data proves UreTron's efficacy with stone model penetration rates as compared to the predicate devices.

#### CONCLUSION

Med-Sonics' UreTron Multi Probe Lithotripter system is substantially equivalent to the legally marketed devices compared herein.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

MAR 30 2012

Mr. William A. Stoll VP Quality & Regulatory Med-Sonics Corp. 4960 Pittsburgh Ave, Suite A ERIE PA 16509

Re: [K111058](https://510k.innolitics.com/search/K111058)

Trade/Device Name: UreTron Multi Probe Lithotripter Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic lithotriptor Regulatory Class: II Product Code: FFK Dated: March 2, 2012 Received: March 5, 2012

Dear Mr. Stoll:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 (Act) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 Jo a to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerély yours,

Sincerely yours,

Benjamin K. Ticho

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### SECTION - 4

# Indications for Use

510(k) Number (if known): [K111058](https://510k.innolitics.com/search/K111058)

Device Name: UreTron Multi Probe Lithotripter

Indications for Use:

The UreTron Multi Probe Lithotripter system is intended to be used for the fragmentation and removal of urinary tract calculi in the kidney, ureter and bladder.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of of

Biliam R. 3/30/2012
(Division Sign Off)

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.”