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.

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.

AI/ML Overview

The provided 510(k) summary for the Laborie Medical Technologies Urodynamic System with Tetra Accessory is for a Class II medical device that measures urodynamic parameters. It's important to note that this submission is primarily focused on demonstrating substantial equivalence to a predicate device, rather than proving novel effectiveness through rigorous clinical trials with specific acceptance criteria in the same way a new drug or a high-risk AI device might.

Therefore, the study information requested regarding acceptance criteria and performance metrics (e.g., sensitivity, specificity, reader improvement with AI) is not applicable in the context of this 510(k) summary. The summary focuses on bench testing and a clinical study to confirm the efficacy of the system and its accessory, as well as safety testing, but these are not described with specific acceptance criteria in terms of diagnostic performance.

Here's an breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

This information is not provided in the 510(k) summary in the traditional sense of diagnostic performance metrics with defined acceptance criteria. The summary lists technical specifications for the UDS-94 and Tetra Accessory, which are inherent design parameters rather than performance outcomes against a gold standard in a diagnostic context.

Metric (UDS-94 System)	Reported Performance
Uroflow Rate	0 to 50 ml/s
Uroflow Volume	0 to 1100 ml
Pressure	-40 to 350 cm H2O
EMG Frequency	2 to 800 Hz
Pump Rate	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 up to 1000 Hz (optional up to 5000 Hz)

Metric (Tetra Accessory)	Reported Performance
Wavelengths	785 nm, 808nm, 830nm
Energy Output	Up to 350 mJ
Type of Operation	Pulsed Only, 4 µsec
Class of Laser Products	Class I

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

The 510(k) summary states "Bench and clinical studies have confirmed the efficacy of the Laborie Urodynamic System with Tetra Accessory," but does not provide details on the sample size, data provenance, or study design (retrospective/prospective) for these studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the 510(k) summary. Since the submission focuses on substantial equivalence for a device measuring physiological parameters, the method of "establishing ground truth" for diagnostic accuracy involving expert consensus would not typically be a primary focus for this type of device.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader multi-case (MRMC) comparative effectiveness study is not applicable and was not performed. The Tetra Accessory uses near-infrared spectroscopy for non-invasive bladder activity detection; it is a measurement device, not an AI diagnostic tool designed to assist human readers in interpreting complex images or data in a way that would require an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

A standalone algorithm performance study is not applicable as the device is not an AI algorithm. The Tetra accessory is a physical component that uses near-infrared spectroscopy to detect bladder activity. It's a measurement device intended for use by a healthcare professional, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The 510(k) summary does not specify the "ground truth" used for the efficacy confirmation. For a urodynamic system, "efficacy" would likely relate to the accuracy and reliability of its physiological measurements compared to established standards or clinical observations, rather than a diagnostic 'ground truth' like pathology.

8. The sample size for the training set:

As this is not an AI/ML device, there is no training set in the conventional sense.

9. How the ground truth for the training set was established:

As mentioned above, there is no training set and therefore no ground truth establishment for a training set.

In summary:

The provided document describes a 510(k) submission for a medical device that measures physiological parameters. The primary goal of this submission is to demonstrate substantial equivalence to a predicate device, focusing on technical specifications and safety rather than a detailed performance study with diagnostic acceptance criteria. As such, many of the requested details regarding AI/ML device performance validation metrics are not applicable to this submission.

Summary

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K073552

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, cystometerelectrical 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

Indications for Use

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V. Description of the Device

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 μVFrequency: 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

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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 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

Regulation Number and Section

§ 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.