Uroflowmeter

K142425 · Be Technologies, Inc. · EXY · Oct 27, 2014 · Gastroenterology, Urology

Device Facts

• Record ID: K142425
• Device Name: Uroflowmeter
• Applicant: Be Technologies, Inc.
• Product Code: EXY · Gastroenterology, Urology
• Decision Date: Oct 27, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1800
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The UFM is a urine flow measuring system.

Device Story

Urine Flow Monitor (UFM) measures urine flow in men by analyzing sound produced as urine impacts water surface. System comprises laptop with proprietary software and microphone. Microphone captures acoustic input; software processes sound to calculate and display real-time flow, maximum flow, average flow, volume, time to maximum, and void time. Used in clinical settings to assist providers in assessing urinary function. Output displayed on monitor for clinical review; aids in diagnosis and monitoring of urinary conditions.

Clinical Evidence

Bench testing only. Performance testing demonstrated equivalent accuracy for flow and volume measurements compared to the predicate device.

Technological Characteristics

Acoustic-based urine flow measurement system. Components: laptop, proprietary software, microphone. Measures flow by analyzing sound of urine impacting water surface. Standalone system.

Indications for Use

Indicated for urine flow measurement in men.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Laborie Uroflowmetry Analyzer; UroCap (510(k) exempt)

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

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 [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 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.<br>2939 20th Avenue<br>San Francisco, CA, 94132<br>[phone]<br>Edward Belotserkovsky<br>[e-mail] |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Angela Mallery<br>Sr. Medical Research Manager, Regulatory<br>NAMSA |
| Date Prepared: | August 25, 2014 |
| Device Name: | Urine Flow Monitor |
| Device Common<br>Name | Uroflow meter |
| Device Class and | Uroflow meter |
| Classification | 21 CFR 876.180 |
| Regulation: | Product Code EXY |
| Predicate Device: | Company Name: Laborie<br>Brand Name: Uroflowmetry Analyzer; UroCap.<br>510(k) Number: UroCap is 510(k) exempt. |
| Device Description: | The UFS provides real-time urine flow measurement, in men, by<br>analyzing specific sound areas that are produced by the urine as<br>it impacts the water surface.<br>The system consists of a laptop with proprietary software and a<br>microphone to capture the sound. Real time urine flow is<br>displayed on the monitor during the test and Maximum Flow;<br>Average Flow; Volume; Time to Maximum and Void Time are<br>calculated and displayed on the monitor upon completion of the<br>test. |
| Indication for use | The UFM is a urine flow measuring system. |
| Device Characteristics<br>Compared to the<br>Predicate | The predicate device calculates flow based on weight; the UFM<br>is based on sound, both methods are scientifically sound.<br>Performance testing has demonstrated the UFM and the<br>predicate device have equivalent technological characteristic for<br>measuring urine flow. Both devices have the ability to capture<br>flow rates at the maximum limits of male urination. |
| Performance Data: | The UFM and predicate device have an equivalent accuracy<br>related to flow and volume. |
| Software Verification<br>and Validation<br>Testing | Software verification and validation testing were conducted and<br>documentation was provided as recommended by FDA's<br>Guidance for Industry and FDA Staff, "Guidance for the<br>Content of Premarket Submissions for Software Contained in<br>Medical Devices." The software for this device was considered<br>as a "MINOR" level of concern. |
| Conclusion: | BE Technologies believes the UFM is substantially equivalent to<br>the predicate device. The conclusions drawn from the<br>performance testing demonstrate that the device is equivalent<br>and is as safe and effective as the predicate device. |

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