(78 days)
931574
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the technology as traditional urodynamic methods and near infrared spectroscopy, with no mention of AI/ML in the device description or performance studies.
No
The device is used for diagnosing lower urinary tract symptoms and aiding in the diagnosis of urinary incontinence, not for treating these conditions.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device is "aiding in the diagnosis of patients with lower urinary tract symptoms".
No
The device description explicitly states that the complete device includes "traditional Urodynamic system and the Tetra accessory," which are hardware components for uroflowmetry, pressure measurement, and near infrared spectroscopy.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description of the Laborie Urodynamic System with Tetra Accessory indicates it performs tests on the patient (uroflowmetry, cystometry, EMG, urethral pressure profiles, and near infrared spectroscopy on the bladder). It does not mention analyzing samples like blood, urine, or tissue outside the body.
- The intended use describes testing and aiding in diagnosis of patients with lower urinary tract symptoms. While it aids in diagnosis, the methods described are physiological measurements taken directly from the patient, not analysis of biological specimens.
- The input imaging modality is Near infrared spectroscopy, which is applied to the bladder (an anatomical site). This is a non-invasive method applied to the body, not a method for analyzing a specimen.
Therefore, the Laborie Urodynamic System with Tetra Accessory falls under the category of a medical device used for physiological measurement and diagnosis, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.
All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.
Product codes (comma separated list FDA assigned to the subject device)
FEN, EXQ
Device Description
The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.
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 physical or health care professional in an 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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory. Additional safety testing included electrical safety testing, laser safety testing and electromagnetic compatibility testing.
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.
931574
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
§ 876.1620 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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Laborie Medical Technologies Urodynamic System with Tetra Accessory 510(k) Summary (per 21 CFR 807.92)
I. Applicant
Laborie Medical Technologies, Inc. 6415 Northwest Drive, Unit 10 Mississauga Ontario Canada L4V 1X1 MAR - 5 2008
Contact Person: Barbara Mornet, Regulatory Affairs Deputy Tel: (802) 857-1300 Fax: (802) 878-1122 Email: bmornet@laborie.com
December 14, 2007 Date Prepared:
II. Device Name
| Proprietary Name: | Laborie Urodynamic System with Tetra Accessory |
|---|---|
| Common/ Usual Name: | Urodynamics Measurement System |
| Classification Name: | Device, cystometric, hydraulic, cystometer |
| electrical recording | |
| Regulation Number: | 876.1620, 876.1800 |
| Product Codes: | FEN, EXQ |
| Classification: | 2 |
| Classification Panel: | Gastroenterology/Urology |
III. Predicate Device
The Laborie Urodynamic System with Tetra accessory is substantially equivalent to the Laborie Urodynamic Analyzer with 510(k) 931574 and all subsequent models that are now 510(k) exempt.
IV. Intended Use of the Device
Laborie Urodynamic systems are intended for Urodynamics testing. The traditional equipment performs standard tests including uroflowmeter, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra, uses near infrared spectroscopy, for non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms - that is patients who suffer from Urinary Incontinence.
Indications for Use
All Urodynamic equipment including the Laborie Urodynamic System with Tetra Accessory are for use under the direction of a licensed physical or health care professional in an office or hospital setting.
1
V. Description of the Device
The complete device includes traditional Urodynamic system and the Tetra accessory. That is all the standard components, for uroflowmetry and pressure measurement, and the new non-invasive component the Tetra accessory to detect bladder activity.
VI. Summary of the Technical Characteristics
| UDS-94 | |
|---|---|
| Electrical Classification | Class I Equipment Type BF Applied Parts |
| Degree of Protection Against Ingress of Water | IPX0 Equipment |
| Mode of Operation | Continuous |
| Uroflow Rate | 0 to 50 ml/s |
| Uroflow Volume | 0 to 1100 ml |
| Pressure | -40 to 350 cm H2O |
| EMG† | -225 to 225 μV |
| Frequency: 2 to 800 Hz | |
| Pump | 5 to 140 ml/min * |
| UPP Puller | 0.5 to 3 mm/s |
| Infusion | 0 to 1000 ml |
| T-Doc | -68 to 408 cmH2O |
| Data Conversion Rate | Min 10 Hz (min) up to 1000 Hz |
| (optional up to 5000 Hz) | |
| Tetra Accessory | |
| Wavelengths | 785 nm, 808nm and 830nm |
| Energy Output | Up to 350 mJ |
| Type of Operation | Pulsed Only, 4 µsec |
| Class of Laser Products | Class I |
- Maximum pump rate is limited by size of catheter used
- Sensitivity Range: +/- 1000 µV; High Pass: 800 Hz; Low Pass: 20 Hz
VII. Testing
Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory. Additional safety testing included electrical safety testing, laser safety testing and electromagnetic compatibility testing.
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VIII. Safety & Effectiveness
The Laborie Urodynamic with Tetra Accessory is substantially equivalent to the Laborie Urodynamic Analyzer K931574 .There are no substantial differences except for the additional technology of the Tetra component for non invasive diagnostic testing. Both devices have the same intended use and the new technology does not introduce any issues of safety and effectiveness.
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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR - 5 2008
Ms. Barbara Mornet Regulatory Affairs Deputy and Official Correspondent Laborie Medical Technologies Corporation 400 Avenue D. Suite 10 WILLISTON VT 05495
Re: K073552
Trade/Device Name: Laborie Urodynamic System with Tetra Accessory Regulation Number: 21 CFR 876.1620 Regulation Name: Urodynamics measurement system Regulatory Class: II Product Code: FEN and EXQ Dated: December 14, 2007 Received: December 20, 2007
Dear Ms. Mornet:
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 (Premarket Approval), 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.
Image /page/3/Picture/10 description: The image is a circular logo with the letters "FDA" in large, bold font in the center. Above the letters, the numbers "1906 - 2006" are displayed. Below the letters, the word "Centennial" is written in a cursive font. The entire logo is surrounded by a circular border with text that is difficult to read due to the image quality.
Protesting and Promoting Public Health
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (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 Biometric's (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/cdrb/industry/support/index.html.
Sincerely vours.
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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Traditional 510(k) Urodynamic Tetra Accessory Laborie Medical Technologies
5100(k) Number (IF KNOWN): Page 1 of 1
DEVICE NAME: Urodynamic System Tetra Accessory
INDICATIONS FOR USE:
Laborie Urodynamic systems are intended for Urodynamic testing. The traditional equipment performs standard test including uroflometry, cystometry, micturition, electromyography and urethral pressure profiles. The accessory to our standard equipment, Tetra near infrared spectroscopy, uses non-invasive testing of bladder activity, aiding in the diagnosis of patients with lower urinary tract symptoms, that is patients who suffer from urinary incontinence
All Urodynamic equipment including the Laborie Urodynamic system with Tetra Accessory are for use under the direction of a licensed physician or health care professional in an office or hospital setting.
Prescription Use X
Heilut Lemer
ision of Reproductive, Abdominal, and Radiological Devices 510(k) Number