(347 days)
Not Found
No
The description focuses on the electromechanical nature of the device and its ultrasonic vibration mechanism, with no mention of AI or ML capabilities.
Yes
The device is intended for the fragmentation and removal of urinary tract calculi, which is a direct treatment of a medical condition.
No
This device is described as a lithotripter system intended for the fragmentation and removal of urinary tract calculi, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is an "electromechanical device" consisting of a generator, hand piece, and probes, which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The UreTron Multi Probe Lithotripter system is a therapeutic device. Its intended use is to fragment and remove urinary tract calculi (kidney stones) directly within the body. It physically interacts with the stones inside the patient.
The description clearly states its function is to break up stones using mechanical vibration through probes inserted into the urinary tract. This is a direct intervention on the patient, not an analysis of a sample taken from the patient.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FFK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
kidney, ureter and bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
0
Med-Sonics
PAGE 1 of 2
# 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
**1**
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.
**2**
# 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
**3**
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
**4**
### 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)