UROPOWER

K022721 · W.O.M. World of Medicine AG · EXY · Aug 26, 2003 · Gastroenterology, Urology

Device Facts

• Record ID: K022721
• Device Name: UROPOWER
• Applicant: W.O.M. World of Medicine AG
• Product Code: EXY · Gastroenterology, Urology
• Decision Date: Aug 26, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1800
• Device Class: Class 2

Intended Use

The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine flow and volume of men during the course of normal urination. The device is also intended to be used by health care professionals.

Device Story

Uropower measures urine flow and volume to identify micturition disturbances in men. System components: base unit, urinal-flow-transducer, mounting elements. Transducer installs in urinal; measures flow via through-flow principle (volume per time). Base unit provides user guidance via LCD display; calculates total voided volume, maximum flow rate, mean flow rate, total measuring time, time to max flow, and flow index. Results printed on thermo card. Used by laymen and healthcare professionals in clinical or home settings. Output assists providers in diagnosing urinary function.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

System consists of a base unit and a urinal-flow-transducer. Measurement principle: through-flow (volume per time). Output interface: LCD display and thermo card printer. Device is designed for installation in a urinal.

Indications for Use

Indicated for men to measure urine flow and volume during normal urination to identify micturition disturbances. Intended for both lay use and use by healthcare professionals.

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

• Ultracompact (K894968)

Submission Summary (Full Text)

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K022721

# 510(K) SUMMARY Uropower

#### I. Submitter:

W.O.M. WORLD OF MEDICINE AG Alte Poststraße 11 96337 Ludwigsstadt Germany

#### II. Device Names:

2.

3.

- Classification Name: l .
Proprietary Name:

Common or Usual Name:

Uroflowmetry System Uroflowmeter Uropower

-
## III. Classification:

Class II. This device is described in 21 C.F.R. § 876.1800. The product code for the device is EXY.

#### IV. Predicate Devices:

- Ultracompact (K894968) from Eutectic Electronics, Inc. ●
#### V. Intended Use:

The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine volume and flow of men during the course of normal urination. The device is also intended to be used by health care professionals.

### VI. Device Description:

The Uropower is a device intended to measure the urine flow and calculate the volume of males in order to identify micturition disturbances. It is designed to be used by health care professionals and by laymen. The system consists of a base unit, a urinal-flow-transducer and various mount elements. Due to its construction the transducer can be installed in a urinal. The user is guided by instructions shown on the LCD display of the base unit. The urinal flow transducer measures the flow of the urine in accordance with the through-flow-principle, a volume per time measurement. The base unit calculates the total voided volume, maximum flow rate, mean flow rate, total measuring time, time, time to max, flow and medical data like the flow index. All parameters are printed on a thermo card.

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Image /page/1/Picture/1 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The central graphic features three curved lines that resemble a stylized bird or abstract design, creating a sense of movement or flow within the emblem.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 2003

W.O.M. World of Medicine AG c/o Ms. Susan Raab Official Correspondent 368 N. Asaph Street ALEXANDRIA VA 22314

Re: K022721

Trade/Device Name: Uropower" Regulation Number: 21 CFR §876.1800 Regulation Name: Urine flow or volume measuring system Regulatory Class: II Product Code: 78 EXY Dated: July 28, 2003 Received: July 30, 2003

Dear Ms. Raab:

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.

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); 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.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# STATEMENT OF INDICATIONS FOR USE

| APPLICANT: | W.O.M. WORLD OF MEDICINE AG |
|---------------------------|-----------------------------|
| 510(K) NUMBER (if known): | K022721 |
| DEVICE NAME: | Uropower |

INDICATIONS FOR USE:

The Uropower is a urine flow and volume measuring system intended for lay use to measure the urine flow and volume of men during the course of normal urination. The device is also intended to be used by health care professionals.

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 C.F.R. § 801.109)

(Optional Format 1-2-96)

Over-The-Counter Use

David A. Seppanen

(Division Sign-Off) Division of Reproductive and Radiological Devices 510(k) Number