K073552 · Laborie Medical Technologies, Corp. · FEN · Mar 5, 2008 · Gastroenterology, Urology
Device Facts
Record ID
K073552
Device Name
LABORIE URODYNAMIC SYSTEM WITH TETRA ACCESSORY
Applicant
Laborie Medical Technologies, Corp.
Product Code
FEN · Gastroenterology, Urology
Decision Date
Mar 5, 2008
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.1620
Device Class
Class 2
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.
Device Story
System combines traditional urodynamic measurement (uroflowmetry, cystometry, micturition, EMG, urethral pressure profiles) with Tetra accessory for non-invasive bladder activity assessment. Tetra uses near-infrared spectroscopy (NIRS) via 785nm, 808nm, and 830nm pulsed laser (4 µsec) to monitor bladder activity. System inputs include pressure, flow, and NIRS signals; outputs are diagnostic data for lower urinary tract symptoms. Operated by clinicians in hospitals or offices. Data aids diagnosis of urinary incontinence. Safety features include electrical, laser, and electromagnetic compatibility testing.
Clinical Evidence
Bench and clinical studies confirmed efficacy. Additional safety testing included electrical safety, laser safety, and electromagnetic compatibility testing.
Technological Characteristics
Class I Equipment, Type BF Applied Parts. IPX0. Continuous operation. Uroflow rate 0-50 ml/s; pressure -40 to 350 cm H2O; EMG -225 to 225 µV (2-800 Hz). Tetra accessory: Class I laser, wavelengths 785/808/830 nm, pulsed 4 µsec, energy up to 350 mJ. Data conversion 10-1000 Hz (up to 5000 Hz optional).
Indications for Use
Indicated for patients with lower urinary tract symptoms, specifically urinary incontinence, requiring urodynamic testing. For use under direction of licensed physician or healthcare professional in office or hospital settings.
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.
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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, cystometer<br>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.
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#### 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<br>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<br>(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
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
