(28 days)
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.
Not Found
This FDA 510(k) summary does not contain the detailed information necessary to complete most of the requested fields regarding acceptance criteria and study design. This document is a clearance letter, indicating that the device has been found substantially equivalent to a predicate device, rather than a clinical trial report or a summary of performance data.
Here's what can be inferred and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Missing. This document does not specify any quantitative acceptance criteria or report device performance data against such criteria. The 510(k) clearance process focuses on substantial equivalence to a legally marketed predicate device, not necessarily on meeting pre-defined performance metrics articulated in this letter.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing. No information on sample size, data provenance, or study type (retrospective/prospective) of any test set is 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)
- Missing. No information about experts or ground truth establishment is included.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing. No information regarding adjudication methods is provided.
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
- Not applicable / Missing. This device (UreTron PF Series Probes for lithotripsy) is an electrohydraulic lithotriptor probe, not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study related to human readers improving with AI assistance would not be relevant. The document does not indicate any AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Missing. As above, this is a medical device for treatment, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing. This document does not mention any ground truth associated with performance evaluation.
8. The sample size for the training set
- Not applicable / Missing. There is no indication of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable / Missing. This information is not relevant for this type of device and is not present in the document.
Summary of available information from the document:
- Device Name: UreTron PF Series Probes
- Intended Use: Used with UreTron Multi Probe Lithotripsy System for the fragmentation and removal of urinary tract calculi in the kidney, ureter, and bladder.
- Regulatory Status: Cleared via 510(k) as substantially equivalent to a predicate device.
- Regulatory Class: Class II
- Product Code: FFK
- Regulation Name: Electrohydraulic Lithotriptor
To obtain the detailed performance data and study design information, one would typically need to refer to the full 510(k) submission, which is not publicly released in its entirety but may have a publicly accessible summary (510(k) Summary). This letter only confirms the clearance.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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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§ 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.”