Predicate Devices

KD46322,924383

Reference Devices

KD46322

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard data analysis and calculation of parameters from physiological signals, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is a software program that analyzes existing data and does not directly interact with the patient to provide therapy.

Diagnostic

Yes

The device analyzes pressure, volume, and flow data from the urological tract, providing analyses such as Uroflow analysis, Cystometry analysis, and Pressure/flow voiding analysis, along with comparisons to normal values, which are all indicative of a diagnostic function to assess physiological properties and aid in medical interpretation.

SaMD (Software as a Medical Device)

Yes

The device is described as a "software program" and "software for Windows" that analyzes data. While it interacts with recorded data, the description focuses solely on the software's functionality and does not mention any accompanying hardware components that are part of the device itself.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs analyze samples taken from the body (in vitro), such as blood, urine, or tissue. The Urodynamic Analysis Module analyzes data recorded from the urological tract (pressure, volume, flow). This data is physiological measurements taken in vivo (within the living body), not samples analyzed outside the body.
The intended use is to analyze physiological data for diagnostic purposes related to the function of the urological tract. This is a clinical diagnostic tool, but not an in vitro one.

The device is a software program that processes and analyzes physiological data collected from a patient's urological system. This falls under the category of a clinical diagnostic device, but specifically one that works with in vivo measurements rather than in vitro samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications 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

Product codes

Not Found

Device Description

The Polygram Software for Windows (KD46322) 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 (Qmax), 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 (Qmax). average flow rate, voiding time, flow time, time to maximum flow, volume at maximum flow, vesical pressure at Qmax, detrusor pressure at Qmax, urethral minimum operating pressure, urethral resistance, pressure/flow graph, nomograms in the P/Q graph, filter in the P/Q loop, curve adaption in the P/Q loop, pressure minimal urethral opening (Pmuo).
Urethral pressure profile: static UPP, Pucp graphs, maximum closing pressure, urethral functional length, closure area, pull speed, cough profiles, Pucp graphs, Pvcs amplitude, closure pressure, transmission tactor, relative length, pull speed, transmission graph.
The analysis report can then serve as a tool for the physician's diagnosis and post treatment cvaluation.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

urological tract

Indicated Patient Age Range

pediatric and adult populations

Intended User / Care Setting

The program is to be used on a personal computer analyzing patient data in the hospital environment under supervision of a trained physiclan.

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)

The Urodynamic Analysis Module has been thoroghly 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 theretore be released to the market.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

924383

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

APR -3 1997

11.07.2

93330

142

510(k) Summary

DRAERD 510(K)

Summary of Safety and Effectiveness Information

| Submitter's
name | Synectics Medical AB
Renstiernos gata 12
S-116 28 Stockholm
Sweden | Synectics Medical Inc
3850 Victoria Street North
Mail Stop V215
Shoreview, MN 55126 2978 |
|-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact: Anna Pettersson | Contact: Keith Jung |
| Name of device | Urodynamic Analysis Module | |
| Name of
equivalent
device | Poly Uro 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. Poly Uro 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 (KD46322) 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 (Qmax),
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 (Qmax).
average flow rate, voiding time, flow time, time to maximum flow, volume at
maximum flow, vesical pressure at Qmax, detrusor pressure at Qmax, urethral |
| | minimum operating pressure, urethral resistance, pressure/flow graph,
nomograms in the P/Q graph, filter in the P/Q loop, curve adaption in the P/Q
loop, pressure minimal urethral opening (Pmuo).
• Urethral pressure profile: static UPP, Pucp graphs, maximum closing
pressure, urethral functional length, closure area, pull speed, cough profiles,
Pucp graphs, Pvcs amplitude, closure pressure, transmission tactor, relative
length, pull speed, transmission graph. | |
| | The analysis report can then serve as a tool for the physician's diagnosis and post
treatment cvaluation. | |
| Performance
Testing | The Urodynamic Analysis Module has been thoroghly 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 theretore 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 | |

UROSUMM.DOC

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hospital environment under supervision of a trained physiclan. The analyzed data can be viewed on the computer screen or printed out on a separate paper.

UROSUMM.DOC