(116 days)
EMS-XL is indicated to acquire, filter, digitize, amplify, display and record electrical signals obtained during electrophysiological studies and related procedures conducted in an electrophysiological laboratory. Signal types acquired include ECG signals, direct cardiac signals and pressure recordings. Physiological parameters such as the diastolic, systolic and mean blood pressure, heart rate and cycle length are derived from the signal data, displayed and recorded.
The system allows the user to monitor, display and record the signal data.
The system allows the user to monitor the acquisition data, review the data, store the data, perform elementary caliper-type measurements of the data, and generate reports on the data. The system may display and record data received from other medical devices typically used during these procedures, such as Ablation RF generators. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the human heart.
The EMS-XL Cardiac Electrophysiology System consists of a software driven, multichannel amplifier and stimulator that are connected to a computer.
Input signals include 12 lead surfaces ECG, two Blood pressure channels and 18 or 50 channel intra-cardiac ECG.
The signals are digitized and sent to the computer for analysis, display and storage.
Signals are displayed with sweep speeds of 25 to 300mm/sec in either predefined or customized configurations.
The system consists of a computer, Front end amplifiers with integrated stimulator.
Two display screens, one used for Real Time signal display and the other for Non real Time display for analysis and review and playback of stored signals.
A Laser printer is used to print surface and intra-cardiac ECG and a CD or DVD is used for archive of signals.
The two display screens are used to show the signals. The real time display, RT, shows the real time signal waveforms. Each waveform channel is color-coded for easy identification. The non real time display, NRT, serves as a Review monitor allowing the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.
The stimulator is computer controlled and provides basic stimulation rate plus up to 4 stimulations delayed after the basic stimuli. Stimulation can be either synchronized to the cardiac electrical activity or non synchronized. Pacing protocols with automatic increment and decrement functions provides refractory period measurements.
A variety of stimulation sequences can be created and stored for future use.
The EMS-XL can be used for all types of electrophysiological procedures, including His bundle recording, Sinus Node Recovery Time - SNRT, Overdrive, Wenckebach, and tachy-arrhythmias. An interface to ablation generators provide Ablation Start and End information with data on the ablation parameters.
Each waveform is color-coded for easy identification.
The review monitor allows the manipulation and processing of data, including caliper measurements, event marking, snapshot storage and final report processing.
Special display options support the signal analysis
This includes Trigger mode and template comparison. Event marking. Holter mode: quick. minute-by-minute scrolls and jumps to event, On screen calipers: both real-time and review screen with auto measurement , Auto Tachycardia detection. Free text labeling, and Customized reports in Word™.
The input to the amplifiers is via a patient connection box, to which the intra-cardiac catheter electrodes (not manufactured and not supplied by Mennen Medical) are connected.
This 510(k) summary for the Mennen Medical EMS-XL Cardiac Electrophysiology System focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific performance acceptance criteria through clinical trials. The provided document is a predicate device comparison, which is a common approach for 510(k) submissions.
Therefore, the acceptance criteria and study detailed below are interpreted from the provided predicate comparison tables and the accompanying "Rational for claims of equivalence".
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the specifications of the predicate devices. The reported device performance (EMS-XL) is presented in direct comparison to these predicate specifications. The table below synthesizes information from the various comparison tables provided in the document (Amplifier Spec comparison, Stimulator Spec Comparison, Comparison of Systems).
| Feature | Acceptance Criteria (Predicate) | Reported Device Performance (EMS-XL) | Deviations & Rationale (Effect on Safety/Intended Use/Performance) |
|---|---|---|---|
| Amplifier Specifications | Cardiolab EP System (GE Prucka) | EMS-XL Amplifier | |
| Physical (HxWxD, 32/64 ch) | 9.5x 14.0x 14.0 in (64/32 ch) | 4.5x 11.5x 8 in (32 ch); 9.0x 11.5x 8 in (64 ch) | No (Smaller physical size, no effect) |
| Temperature Operating | 0°C to +35°C | Same | Same |
| Temperature Transport/Storage | -15°C to +50°C | -30°C to +65°C | No (Wider range, no effect on safety/intended use) |
| Humidity Operating | 1 Billion Ohms | Typical 20 MΩ (Above 2.5 MOhm req by ANSI/AAMI EC11 par 3.2.9) | No (Meets standard, no effect) |
| Leakage Current (Patient Source) |
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).