The Urodynamic Analysis Module is a software program that has been designed to analyze pressure, volume and flow data recorded from the urological tract in pediatric and adult populations. The Urodynamic Analysis Module includes the following analyses: Uroflow analysis, Cystometry analysis, Pressure/flow voiding analysis, Urethral Pressure Profile. The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
Device Story
The Urodynamic Analysis Module is a Windows-based software add-on for the Polygram Software for Windows. It processes physiological pressure, flow, and volume data recorded from the urological tract. The software performs automated calculations and analyses, including Uroflow, Cystometry, Pressure/flow voiding, and Urethral Pressure Profile. The system is used in hospital environments by trained physicians to review tracings, calculate parameters (e.g., Qmax, compliance, leak point pressure), and generate reports. The output serves as a diagnostic and post-treatment evaluation tool, assisting physicians in clinical decision-making by comparing patient data against normal values.
Clinical Evidence
No clinical data. Performance testing consisted of internal alpha testing (integration testing) and beta testing at hospital sites to verify that the software met development objectives.
Technological Characteristics
Software-based analysis module for Windows PC. Performs physiological signal processing and parameter calculation for urological data. No hardware components described.
Indications for Use
Indicated for pediatric and adult patients undergoing urological tract pressure, volume, and flow data analysis.
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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APR - 3 1997
K963330
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# 510(k) Summary
## DRAERD 510(k)
### Summary of Safety and Effectiveness Information
| Submitter's name | Synectics Medical AB
Renetiernas gata 12
S-116 28 Stockholm
Sweden | Synectics Medical Inc
3850 Victoria Street North
Mail Stop V215
Shoreview, MN 55126 2078 |
| --- | --- | --- |
| Contact: | Anna Pettersson | Contact: Keith Jung |
| Name of device | Urodynamic Analysis Module | |
| Name of equivalent device | PolyUro Polygram Software (DOS environment)
(included in 924383 - PolyUro) | |
| | The Urodynamic Analysis Module is identical, in function and types of analyses that can be performed, to the PolyUro Polygram Software (DOS). The main difference is that the PolyUro Polygram Software (DOS) is written for the DOS environment and the Urodynamic Analysis Module is written for the Windows environment. PolyUro Polygram Software (DOS) works in the DOS environment and the Urodynamic Analysis Module works in the Windows environment. | |
| Description of device | The Polygram Software for Windows (K946322) was designed to record and handle/store physiological parameters. After a recording, the user is able to review the tracings on the computer screen and print the signal tracings or just parts of them. When reviewing the data on the computer screen, the user is able to mark certain segments and calculate certain parameters from the selected signal segments. These parameters include minimum and maximum values, length of selection. | |
| | By adding the Urodynamic Analysis Module to the Polygram Software for Windows, the user can also have all the pressure, flow and volume data analyzed in terms of physiological properties, comparison with normal values, etc. The analyzed data can thereafter be viewed on screen or printed out on a separate paper. | |
| | The analysis report includes sections such as patient demographics; interpretation and comment (for user to insert); procedure summary; Urodynamic tracing; analyses (as specified below); and physician signature section. | |
| | Analyses: | |
| | • Uroflow analysis: position, subjective grading, residual volume, numerical uroflow analysis, voided volume, bladder capacity, maximum flow (Q_{max}), average flow, voiding time, flow time, Tim to maximum flow, volume at maximum flow, urethral conductance, flow index. | |
| | • Cystometry analysis: position, infusion rate, infused volume, residual volume before procedure, maximum cystometric capacity, first sensation, compliance, detrusor activity, leakage during filling, catheter via, infusion stopped because, infusion time, diuresis, squeezing, sensation levels, leak point pressure analysis, pressure/infused volume graph. | |
| | • Pressure/flow voiding analysis: position, subjective grading, residual volume, voided volume, vesical capacity, maximum flow rate (Q_{max}), average flow rate, voiding time, flow time, time to maximum flow, volume at maximum flow, vesical pressure at Q_{max}, detrusor pressure at Q_{max}, urethral | |
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minimum operating pressure, urethral resistance, pressure/flow graph, manograms in the P/Q graph, filter in the P/Q loop, curve adaption in the P/Q loop, pressure minimal urethral opening (Pm00).
- Urethral pressure profile: static UPP, Pucp graphs, maximum closing pressure, urethral functional length, closure area, pull speed, cough profiles, Pucp graphs, Pves amplitude, closure pressure, transmission factor, relative length, pull speed, transmission graph.
The analysis report can then serve as a tool for the physician's diagnosis and post treatment evaluation.
## Performance Testing
The Urodynamic Analysis Module has been thoroughly tested during the development phase, that is, alpha testing in terms of integration testing has been performed and documented and beta testing in terms of hospital site testing has been done and documented.
It has been concluded that the alpha and beta testing has meet and passed the specified objectives and should therefore be released to the market.
## Statement of Intended use/Indication for use
The Urodynamic Analysis Module is a software program that has been designed to analyze pressure, volume and flow data recorded from the urological tract in pediatric and adult populations.
The Urodynamic Analysis Module includes the following analyses: Uroflow analysis, Cystometry analysis, Pressure/flow voiding analysis, Urethral Pressure Profile
The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physician. The analyzed data can be viewed on the computer screen or printed out on a separate paper.
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UROSUMM.DOC
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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.
