(93 days)
Not Found
No
The summary describes data acquisition and display, but does not mention any analytical or interpretive functions that would typically involve AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
No.
The device is used for noninvasive testing and diagnosis, not for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device aids "in the diagnosis of urinary incontinence and lower urinary tract symptoms," directly indicating its diagnostic purpose.
No
The device description explicitly states it consists of hardware components including a Tablet PC, a base station, a custom cable with an optical sensor, and a disposable patch, in addition to the software.
Based on the provided information, the URONIRS 2000 device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The URONIRS 2000 is described as a non-invasive device that measures changes in hemoglobin and cytochrome during bladder voiding. It does not analyze a sample (like urine or blood) that has been removed from the body.
- The device description focuses on in vivo measurements. The device uses an optical sensor and disposable patch applied to the body to measure physiological changes directly.
- The intended use is for non-invasive testing of bladder activity. This reinforces that the measurements are being taken directly from the body, not from a sample.
Therefore, the URONIRS 2000 falls under the category of an in vivo diagnostic or monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
The URONIRS 2000 device is indicated for non-invasive testing of bladder activity in an office or hospital setting.
Product codes
FEN, EXQ
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
bladder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed physician or health care professional, office or hospital setting.
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
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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1620 Urodynamics measurement system.
(a)
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.(b)
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.
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Image /page/0/Picture/0 description: The image shows the logo for Urodynamix Technologies LTD. The logo is in a sans-serif font and is in all caps. The word "URODYNAMIX" is on the top line, and the words "TECHNOLOGIES LTD" are on the bottom line. The letter "O" in "URODYNAMIX" is a circle.
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: 1-604-638-0244 Fax: 1-604-694-7771 e-mail: akindsvater@urodynamix.com
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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URI
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
2
UR (
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 (800) 638-2041 or (240) 276-3150 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 ________________________________________________________________________________________________________________________________________________________________