UreTron PF Series Probe

K162119 · Med-Sonics Corp. · FFK · Aug 29, 2016 · Gastroenterology, Urology

Device Facts

• Record ID: K162119
• Device Name: UreTron PF Series Probe
• Applicant: Med-Sonics Corp.
• Product Code: FFK · Gastroenterology, Urology
• Decision Date: Aug 29, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.4480
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

UreTron PF Series Probes are to be used with UreTron Multi Probe Lithotripsy System. UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Device Story

UreTron PF Series Probes are accessory probes designed for use with the UreTron Multi Probe Lithotripsy System. The system functions as an electrohydraulic lithotripter to fragment urinary tract calculi (kidney, ureter, bladder stones). The probes deliver energy to the target calculi to facilitate fragmentation and subsequent removal. The device is intended for use by trained clinicians in a clinical or surgical setting. The output (mechanical energy for fragmentation) assists the physician in stone removal procedures, potentially reducing the need for more invasive surgical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Electrohydraulic lithotriptor probe; accessory to the UreTron Multi Probe Lithotripsy System. Operates via electrohydraulic energy delivery for stone fragmentation. Class II device (21 CFR 876.4480).

Indications for Use

Indicated for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder in patients requiring lithotripsy. Prescription use only.

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.”

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29, 2016

Med-Sonics Corp. Jennifer Rautine Director of Regulatory and Clinical Affairs 4960 Pittsburgh Avenue. Suite A Erie, PA 16509

Re: K162119

> Trade/Device Name: UreTron PF Series Probes Regulation Number: 21 CFR§ 876.4480 Regulation Name: Electrohydraulic Lithotriptor Regulatory Class: II Product Code: FFK Dated: July 29, 2016 Received: August 1, 2016

Dear Jennifer Rautine:

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.

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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 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

## Benjamin R. Fisher -S

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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## Indications for Use

510(k) Number (if known) K162119

Device Name UreTron PF Series Probes

Indications for Use (Describe)

UreTron PF Series Probes are to be used with UreTron Multi Probe Lithotripsy System.

UreTron Multi Probe Lithotripter System is intended for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.

Type of Use (Select one or both, as applicable)

| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) |

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