K Number
K142425
Device Name
Uroflowmeter
Date Cleared
2014-10-27

(59 days)

Product Code
Regulation Number
876.1800
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The UFM is a urine flow measuring system.
Device Description
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.
More Information

UroCap is 510(k) exempt.

Not Found

No
The description focuses on sound analysis and calculation of standard flow metrics, with no mention of AI or ML terms or concepts.

No
The device measures urine flow and provides data for analysis, but it does not directly treat a condition or provide therapy.

No
The device measures urine flow and provides metrics like maximum flow, average flow, volume, time to maximum, and void time. While this information could be used by a clinician to make a diagnosis, the device itself is not making a diagnosis or classifying disease/conditions. It is a measurement system.

No

The device description explicitly states the system consists of a laptop with proprietary software and a microphone to capture sound. The microphone is a hardware component, making the device a combination of software and hardware, not software-only.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
  • Device Function: The UFM system measures urine flow by analyzing the sound produced by the urine stream. It does not analyze the chemical composition or biological markers within the urine itself. It's a physical measurement of the flow rate.
  • Intended Use: The intended use is to measure urine flow, which is a physical characteristic, not to diagnose a disease or condition based on the composition of the urine.

Therefore, the UFM system falls under the category of a medical device that performs a physical measurement, rather than an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The UFM is a urine flow measuring system.

Product codes (comma separated list FDA assigned to the subject device)

EXY

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

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.
The UFM and predicate device have an equivalent accuracy related to flow and volume.

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.

UroCap is 510(k) exempt.

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

§ 876.1800 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.

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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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6.0 510(k) Summary

| Submitter: | BE Technologies, Inc.
2939 20th Avenue
San Francisco, CA, 94132
(415) 307-8531
Edward Belotserkovsky
edbelo@sbcglobal.net |
|--------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Angela Mallery
Sr. Medical Research Manager, Regulatory
NAMSA |
| Date Prepared: | August 25, 2014 |
| Device Name: | Urine Flow Monitor |
| Device Common
Name | Uroflow meter |
| Device Class and | Uroflow meter |
| Classification | 21 CFR 876.180 |
| Regulation: | Product Code EXY |
| Predicate Device: | Company Name: Laborie
Brand Name: Uroflowmetry Analyzer; UroCap.
510(k) Number: UroCap is 510(k) exempt. |
| Device Description: | 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. |
| Indication for use | The UFM is a urine flow measuring system. |
| Device Characteristics
Compared to the
Predicate | The predicate device calculates flow based on weight; the UFM
is based on sound, both methods are scientifically sound.
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. |
| Performance Data: | The UFM and predicate device have an equivalent accuracy
related to flow and volume. |
| Software Verification
and Validation
Testing | Software verification and validation testing were conducted and
documentation was provided as recommended by FDA's
Guidance for Industry and FDA Staff, "Guidance for the
Content of Premarket Submissions for Software Contained in
Medical Devices." The software for this device was considered
as a "MINOR" level of concern. |
| Conclusion: | BE Technologies believes the UFM is substantially equivalent to
the predicate device. The conclusions drawn from the
performance testing demonstrate that the device is equivalent
and is as safe and effective as the predicate device. |

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