(59 days)
The UFM is a urine flow measuring system.
The UFS provides real-time urine flow measurement, in men, by analyzing specific sound areas that are produced by the urine as it impacts the water surface.
The system consists of a laptop with proprietary software and a microphone to capture the sound. Real time urine flow is displayed on the monitor during the test and Maximum Flow; Average Flow; Volume; Time to Maximum and Void Time are calculated and displayed on the monitor upon completion of the test.
The provided document is a 510(k) summary for a Uroflow meter (UFM) by BE Technologies, Inc. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed study results, acceptance criteria, or performance metrics that would allow a comprehensive answer to all the questions posed.
Based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states: "The UFM and predicate device have an equivalent accuracy related to flow and volume." and "Performance testing has demonstrated the UFM and the predicate device have equivalent technological characteristic for measuring urine flow. Both devices have the ability to capture flow rates at the maximum limits of male urination."
However, specific numerical acceptance criteria (e.g., within X% of the predicate or gold standard) and detailed reported performance metrics are not provided in this summary. The document only makes a general statement about equivalence.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| (Not explicitly stated in the document, but implied to be equivalence to predicate in accuracy for flow and volume, and the ability to capture maximum flow rates.) | Demonstrated equivalent accuracy related to flow and volume compared to the predicate device. |
| Demonstrated equivalent technological characteristics for measuring urine flow compared to the predicate device. | |
| Able to capture flow rates at the maximum limits of male urination. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The document mentions "Performance Data" but does not detail the study design, sample size, or data provenance (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. For a uroflowmeter, ground truth is typically established by direct measurement (e.g., weighing urine over time), not by expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used for subjectively interpreted data where human experts disagree. A uroflow meter measures physiological parameters, and its performance is validated against a reference measurement, not expert consensus on interpretations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
This information is not provided and is not applicable in the context of a uroflowmeter. MRMC studies are used for diagnostic imaging or similar devices where human readers interpret data. A uroflowmeter is an automated measurement device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, based on the description, the UFM is a standalone device. Its performance data refers to the device's ability to measure urine flow independently. The statement "The UFS provides real-time urine flow measurement... by analyzing specific sound areas" and "The system consists of a laptop with proprietary software and a microphone to capture the sound" indicates a standalone algorithm.
7. The Type of Ground Truth Used
The document implicitly suggests that the ground truth for comparison was the predicate device's measurement based on weight. The text states: "The predicate device calculates flow based on weight; the UFM is based on sound, both methods are scientifically sound." This implies that the UFM's sound-based measurements were compared against the weight-based measurements of the predicate device as a reference.
8. The Sample Size for the Training Set
This information is not provided in the document. The document mentions "Performance Data" and "Software Verification and Validation Testing" but does not detail a training set for the algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. If a training set was used for the sound-based algorithm, its ground truth would presumably be established via a reference measurement method (e.g., direct gravimetric measurement of urine flow) corresponding to the sound signatures.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 27, 2014
BE Technologies, Inc. % Angela Mallery Sr. Medical Research Manager, Regulatory NAMSA 4050 Olson Memorial Highway, Suite 450 Minneapolis, MN 55442
Re: K142425
Trade/Device Name: Uroflowmeter Regulation Number: 21 CFR 876.1800 Regulation Name: Urine Flow or Volume Measuring System Regulatory Class: Class II Exempt Product Code: EXY Dated: August 29, 2014 Received: August 29, 2014
Dear Angela Mallery,
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 and Part 809); medical device reporting (reporting of
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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 and Part 809), 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 yours.
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for
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) K142425
Device Name Urine Flow Monitor
Indications for Use (Describe) The UFM is a urine flow measuring system.
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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Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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6.0 510(k) Summary
| Submitter: | BE Technologies, Inc.2939 20th AvenueSan Francisco, CA, 94132(415) 307-8531Edward Belotserkovskyedbelo@sbcglobal.net |
|---|---|
| Contact Person: | Angela MallerySr. Medical Research Manager, RegulatoryNAMSA |
| Date Prepared: | August 25, 2014 |
| Device Name: | Urine Flow Monitor |
| Device CommonName | Uroflow meter |
| Device Class and | Uroflow meter |
| Classification | 21 CFR 876.180 |
| Regulation: | Product Code EXY |
| Predicate Device: | Company Name: LaborieBrand Name: Uroflowmetry Analyzer; UroCap.510(k) Number: UroCap is 510(k) exempt. |
| Device Description: | The UFS provides real-time urine flow measurement, in men, byanalyzing specific sound areas that are produced by the urine asit impacts the water surface.The system consists of a laptop with proprietary software and amicrophone to capture the sound. Real time urine flow isdisplayed on the monitor during the test and Maximum Flow;Average Flow; Volume; Time to Maximum and Void Time arecalculated and displayed on the monitor upon completion of thetest. |
| Indication for use | The UFM is a urine flow measuring system. |
| Device CharacteristicsCompared to thePredicate | The predicate device calculates flow based on weight; the UFMis based on sound, both methods are scientifically sound.Performance testing has demonstrated the UFM and thepredicate device have equivalent technological characteristic formeasuring urine flow. Both devices have the ability to captureflow rates at the maximum limits of male urination. |
| Performance Data: | The UFM and predicate device have an equivalent accuracyrelated to flow and volume. |
| Software Verificationand ValidationTesting | Software verification and validation testing were conducted anddocumentation was provided as recommended by FDA'sGuidance for Industry and FDA Staff, "Guidance for theContent of Premarket Submissions for Software Contained inMedical Devices." The software for this device was consideredas a "MINOR" level of concern. |
| Conclusion: | BE Technologies believes the UFM is substantially equivalent tothe predicate device. The conclusions drawn from theperformance testing demonstrate that the device is equivalentand is as safe and effective as the predicate device. |
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§ 876.1800 Urine flow or volume measuring system.
(a)
Identification. A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.(b)
Classification. (1) Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.