URETRON MODEL URT

K111058 · Med-Sonics Corp. · FFK · Mar 30, 2012 · Gastroenterology, Urology

Device Facts

• Record ID: K111058
• Device Name: URETRON MODEL URT
• Applicant: Med-Sonics Corp.
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Mar 30, 2012
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

UreTron Multi Probe Lithotripter is an electromechanical system for fragmenting and removing urinary tract calculi. System components include a generator, hand piece, and probes. The hand piece utilizes piezo-electric ceramic elements as an ultrasonic transducer. The generator drives the hand piece at 21,000 +/- 1,000 Hz, creating mechanical vibrations transmitted through the probes to the calculi. Used in clinical settings by medical professionals for urological procedures. The device facilitates stone fragmentation, aiding in the removal of kidney, ureter, and bladder stones, thereby providing a therapeutic benefit for patients with urinary calculi.

Clinical Evidence

Bench testing only. Performance data included EMC and electrical safety testing per IEC 60601, along with verification and validation testing for functionality, sterility, and biocompatibility. Efficacy was demonstrated via comparative stone model fragmentation testing, probe life testing, and tissue perforation testing against predicate devices.

Technological Characteristics

Electromechanical ultrasonic lithotripter. System includes generator, hand piece with piezo-electric ceramic elements, and probes. Operates at 21,000 +/- 1,000 Hz. Sterilization and biocompatibility validated for intended use. Electrical safety and EMC tested per IEC 60601.

Indications for Use

Indicated for patients requiring fragmentation and removal of urinary tract calculi located in the kidney, ureter, or bladder.

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

• CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter (K102169)
• CyberWand Dual Probe Lithotripter (K052135)
• EMS Swiss Lithoclast Master / Swiss Lithoclast Ultra (K012445)

Submission Summary (Full Text)

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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

#### 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 Manufacturer: Cybersonics, Inc. CyberWand Hollow Semi-Flexible Ureteral Probe Lithotripter Trade Name:

510K Number: K052135 Manufacturer: Cybersonics, Inc. Trade Name: CyberWand Dual Probe Lithotripter

510K Number: K012445 Manufacturer: Electro Medical Systems SA. EMS Swiss Lithoclast Master / Swiss Lithoclast Ultra Trade Name:

4960 Pittsburgh Ave, Suite A * Erie, Pennsylvania 16509 · TEL [phone] · FAX [phone]

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K111058

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#### 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), the CyberWand Dual Probe Lithotripter (K052135) and EMS Swiss Lithoclast Master/Ultra (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

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 [phone] or [phone] 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

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)

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Biliam R. 3/30/2012
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