URONIRS, MODEL 2000

K082701 · Urodynamix Technologies, Ltd. · FEN · Dec 18, 2008 · Gastroenterology, Urology

Device Facts

• Record ID: K082701
• Device Name: URONIRS, MODEL 2000
• Applicant: Urodynamix Technologies, Ltd.
• Product Code: FEN · Gastroenterology, Urology
• Decision Date: Dec 18, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1620
• Device Class: Class 2

Intended Use

The URONIRS 2000 device is intended to be used in conjunction with commercially available uroflowmeters and bladder ultrasound systems for noninvasive testing of bladder activity, aiding in the diagnosis of urinary incontinence and lower urinary tract symptoms. The device is used under the direction of a licensed physician or health care professional.

Device Story

URONIRS 2000 is an active medical device for non-invasive bladder activity testing. It utilizes Near-Infrared Spectroscopy (NIRS) to measure concentration changes in oxygenated hemoglobin (HbO2), de-oxygenated hemoglobin (Hb), and cytochrome (Cyt) during voiding. The system includes a base station with three laser diodes (785 nm, 808 nm, 830 nm) providing pulsed energy, an optical sensor, and a medical-grade Tablet PC. The base station acquires NIRS data and transmits it via Bluetooth to the Tablet PC, which simultaneously receives uroflow data (flow and volume) from a commercial uroflowmeter. The system displays these parameters to clinicians to assist in diagnosing urinary incontinence and lower urinary tract symptoms. It is intended for use in clinical or hospital environments under the direction of a licensed physician or healthcare professional.

Clinical Evidence

Performance validation was conducted using actual clinical data to compare the URONIRS 2000 against the predicate device. Results demonstrated that the URONIRS 2000 has the same performance as the predicate device.

Technological Characteristics

Medical-grade Tablet PC; base station with 3 laser diodes (785, 808, 830 nm); pulsed operation (4 µsec pulse width); energy output up to 350 mJ; Class I laser product; Class I equipment, Type BF applied parts; IP20 ingress protection; Bluetooth connectivity; continuous mode of operation.

Indications for Use

Indicated for non-invasive testing of bladder activity in office or hospital settings to aid in the diagnosis of urinary incontinence and lower urinary tract symptoms.

Regulatory Classification

Identification

A urodynamics measurement system is a device used to measure volume and pressure in the urinary bladder when it is filled through a catheter with carbon dioxide or water. The device controls the supply of carbon dioxide or water and may also record the electrical activity of the muscles associated with urination. The device system may include transducers, electronic signal conditioning and display equipment, a catheter withdrawal device to enable a urethral pressure profile to be obtained, and special catheters for urethral profilometry and electrodes for electromyography. This generic type of device includes the cystometric gas (carbon dioxide) device, the cystometric hydrualic device, and the electrical recording cystometer, but excludes any device that uses air to fill the bladder.

Special Controls

*Classification.* 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

• Urodynamic System Tetra Accessory (K073552)

Submission Summary (Full Text)

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K082701

## 510(k) Summary

(per 21 CFR 807.92)

I. Applicant: DEC 1 8 2008

Urodynamix Technologies Ltd #1485-555 Burrard St. Box 213 Vancouver, BC Canada V7X 1M9

Contact Person: André Kindsvater, Director of QA & RA Tel: [phone] Fax: [phone] e-mail: [e-mail]

Date prepared: September 15, 2008

#### []. Device Name

| Common/Usual Name: | Urodynamics System |
|----------------------|--------------------------------|
| Classification Name: | Urodynamics measurement system |
| Regulation Number: | 876.1620 |
| Product Code: | FEN |
| Classification: | 2 |

#### III. Predicate Device

The URONIRS 2000 is substantially equivalent to the following predicate device:

- Urodynamic System Tetra Accessory (K073552) from Laborie Medical . Technologies Inc.
#### IV. Intended Use of the Device

The URONIRS 2000 device is intended to be used in conjunction with commercially available uroflowmeters and bladder ultrasound systems for noninvasive testing of bladder activity, aiding in the diagnosis of urinary incontinence and lower urinary tract symptoms. The device is used under the direction of a licensed physician or health care professional.

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#### V. Description of the Device

The URONIRS 2000 is an active medical device indicated for non-invasive testing of bladder activity in an office or hospital setting.

The device consists of a medical grade Tablet PC running the URONIRS application software, a URONIRS base station for data acquisition, a custom designed cable with an optical sensor end and a single use, disposable patch.

The base station provides the laser output and accepts NIRS data input from the sensor via the sensor cable and charges the Tablet PC when plugged in. The base station communicates with the tablet PC via Bluetooth.

During bladder voiding, URONIRS 2000 measures concentration changes in oxygenated haemoglobin (HbO2), de-oxygenated haemoglobin (Hb) and cytochrome (Cyt) while a commercial uroflowmeter simultaneously measures uroflow data (flow and volume). The data is sent to the tablet PC via Bluetooth connection for display to the clinical users.

Note: The technology and intended use of the URONIRS 2000 is identical to the predicate device Tetra Accessory cleared under K073552

| Processing Unit | Medical grade Tablet PC |
|-----------------------------------------------|-----------------------------------------|
| Mode of Operation | Continuous |
| Communication | Bluetooth |
| Uroflow Rate | 0 to 50 ml/s |
| Uroflow Volume | 0 to 1000 ml |
| 3 Laser Diodes: | |
| Wavelengths | 785 nm, 808nm and 830nm |
| Energy Output | Up to 350 mJ |
| Type of Operation | Pulsed Only, 4 $\mu$ sec Pulse Width |
| Class of Laser Products | Class I |
| Electrical Classification | Class I Equipment Type BF Applied Parts |
| Degree of Protection Against Ingress of Water | IP20 Equipment |

#### VI. Technical Characteristics

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#### VII. Testing

Verification and Validation was conducted according to written protocols and the test outcomes were documented with test reports including pass/fail determination. Verification was monitored and cross referenced in the Traceability Matrix to ensure all requirements are implemented and verified.

System Validation was undertaken to demonstrate that the URONIRS 2000 device consistently meets the requirements within the intended use and operates as intended under actual operating conditions by accepting the required parameters as input and by returning the expected output, and that the user interface provides a display that is consistent with the data that has been given.

Performance Validation using actual clinical data showed that the URONIRS 2000 has the same performance as the predicate device.

The Safety testing was performed including electrical safety testing, laser safety testing and electromagnetic compatibility testing.

## VIII. Safety and Effectiveness

There are no substantial differences between the URONIRS 2000 defined in this 510(k) submission and the stated predicate devices. They are similar to the technologies that are currently used in other similar medical devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized eagle symbol. The eagle is depicted with three swooping lines representing its wings and body. The text is in all caps and reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. André Kindsvater, P.E. Director of QA and RA Urodynamix Technologies Ltd. #1485-555 Burrard Street, Box 213 Vancouver, BC, V7X 1M9 CANADA

DEC 1 8 2008

Re: K082701

Trade/Device Name: URONIRS 2000 Regulation Number: 21 CFR 876.1620 Regulation Name: Urodynamics measurement system Regulatory Class: II Product Code: FEN and EXQ Dated: November 26, 2008 Received: November 28, 2008

Dear Mr. Kindsvater:

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 such 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.

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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.

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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act 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/industry/support/index.html.

Sincerely yours,

hope Mr. Whang

Joyce M. Whang, Ph.D. Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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URODYNAMIX
TECHNOLOGIES LTD

510(k) Number (if known):

Device Name: URONIRS 2000

Indications for Use:

The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.

Prescription Use __X (Part 21 CFR 801 Subpart D) Over-The-Counter Use _ (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hulda Reimer

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