(227 days)
Not Found
No
The document describes a computerized system for urodynamics testing that collects, analyzes, and reports data, but it does not mention any AI or ML capabilities. The description focuses on standard hardware and software components for data acquisition and processing.
No
The device is intended for urodynamics testing, which involves collecting and analyzing data to diagnose lower urinary tract problems, rather than directly treating them.
Yes
The "Intended Use / Indications for Use" states that the system is intended to assist practitioners in "collecting data during protocol execution, analyzing collected data, [and] preparing written reports," which are activities consistent with diagnosis. It also lists specific patient conditions it is used for, such as "incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction," implying it helps determine or confirm these conditions.
No
The device description explicitly lists numerous hardware components including a computer, monitor, printer, measurement electronics, transducers, pumps, and a mobile cart.
Based on the provided information, the Dantec Duet™ system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The Dantec Duet™ system is used to perform urodynamics testing directly on the patient to measure physiological parameters like pressure, flow, and EMG. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use and device description clearly indicate direct patient interaction and measurement. The system uses transducers connected to the patient and pumps to infuse fluids into the bladder, all of which are in-vivo procedures, not in-vitro.
Therefore, the Dantec Duet™ system falls under the category of a medical device used for physiological measurement and diagnosis, but not an IVD.
N/A
Intended Use / Indications for Use
The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information. General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.
Product codes
Not Found
Device Description
The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
The DANTEC Duet™ was developed and validated according to written validation procedures. Substantial equivalence is based on a comparison of intended use, labeling, and specifications between the Duet™ and the predicate devices. Specifications were confirmed by in house validation and augmented by EMC and ESD testing performed by qualified testing laboratories.
Key Metrics
Not Found
Predicate Device(s)
K912701, K904386, K860571, K924383
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
510(k) Summary of Safety and Effectiveness
This summary of 510(k) Safety and Effectiveness information is being submitted in accordance with the requirement of SMDA 1990 and 21 CFR § 807.92
SEP | 6 1996
| Prepared: | February 2, 1996 |
|---|---|
| Submitter: | Dantec Medical, Inc. |
| Address: | 3 Pearl Court |
| Allendale, NJ 07401 | |
| Phone: (201) 236-6330 | |
| Contact: | Alan Schaefer |
| President / CEO | |
| Device: | Trade/Proprietary Name: Dantec Duet™ |
| Common/Usual Name: Urodynamics System | |
| Classification Name: Urodynamics Measurement System |
Predicate Device
| Sponsor | Product | 510(k) No. |
|---|---|---|
| DANTEC | Menuet™ | K912701 |
| LifeTech | Janus | K904386 |
| Wiest | Jupiter | K860571 |
| Synectics | PolyUro | K924383 |
| Device Description: | The Dantec Duet™ is a computerized urodynamics measurement system. The system consists of a mobile cart or "trolley" with the following components mounted on it: a 486 based computer, color monitor, printer, dedicated keyboard, digital and analog measurement electronics, Windows™ based application software, transducers for measuring EMG, pressure, flow and weight, infusion stand, puller with arm, CO₂ gas pump, water pump, patient interface module and patient connecting accessories. |
|---|---|
| Intended Use: | The Dantec Duet™ system is intended for urodynamics testing. The Duet™ system is intended to assist practitioners in executing specific urodynamics test protocols, collecting data during protocol execution, analyzing collected data, preparing written reports and archiving patient and testing information. |
1
General indications for use include use in patients with lower urinary tract voiding or continence problems, and more specifically incontinent patients, patients with bladder outlet obstructions, patients with neurogenic bladder dysfunction and some children with complex voiding / incontinence problems.
Technological Characteristics:
These urodynamic systems are recorders of electrical signals from input devices connected to patients during the execution of urodynamics test protocols. In addition to data recording from electrical input devices, each system may consist of one or more accessory devices required to execute certain urological test protocols. Accessory devices typically include a puller mechanism, water pump and gas pump. (e.g., an H2O pump for infusion of water or saline during Water Cystometry, a CO2 pump for infusing gas during bladder testing, a puller mechanism for use during a urethral pressure measurement.)
Signal processing is performed by the system. Data acquisition is accomplished through a series of isolated inputs including: DC channels, EMG Channels, flow transducer channels, and pressure transducer channels.
The system electronics connect to the patient interfacing devices. Flow, pressure and weight transducers are connected to the transducer inputs. Electrode cables are connected to the EMG channels. Transducers and electrode cables are connected to the patient via disposable or sterilizable catheters, needle electrodes and surface electrodes. The gas and water pumps connect to the patient via catheters. The puller mechanism connects to patient catheters and is controlled by the system.
Software allows the user to control data acquisition and system accessories. The software and hardware act together to aid the clinician in performing Uroflowmetry, Urethral Pressure Measurement, Water Cystometry, Voiding Cystometry and Gas Cvstometry .
Once data is collected, each system allows for review of patient information on a computer screen and the production of reports from the data collected during protocol execution. Reports may contain raw and analyzed data generally consisting of waveform and statistical information printed in chart, graphic or tabular format. Each system is capable of storing patient data for archival and later analysis.
2
| Non Clinical Testing: | The DANTEC Duet™ was developed and validated according to written validation procedures. Substantial equivalence is based on a comparison of intended use, labeling, and specifications between the Duet™ and the predicate devices. Specifications were confirmed by in house validation and augmented by EMC and ESD testing performed by qualified testing laboratories. |
|---|---|
| Conclusion: | The Dantec Duet™ was developed and validated in accordance with the company's development procedures. System testing and validation demonstrate that the device meets the requirements of internationally recognized standards, meets its published specifications, performs as well or better than the currently marketed product and is safe and effective for its intended use. |