URODYNAMIC ANALYSIS MODULE

K963330 · Synectics Medical, Inc. · FAP · Apr 3, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K963330
• Device Name: URODYNAMIC ANALYSIS MODULE
• Applicant: Synectics Medical, Inc.
• Product Code: FAP · Gastroenterology, Urology
• Decision Date: Apr 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1620
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended 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.

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.

Predicate Devices

• PolyUro Polygram Software (DOS environment) (924383)

Reference Devices

• Polygram Software for Windows (K946322)

Submission Summary (Full Text)

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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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