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510(k) Data Aggregation
(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 | <95% RH at 35°C non-condensing | 30% - 75% non-condensing | No (Within predicate range, no effect) |
| Humidity Transport/Storage | <95% RH at 35°C non-condensing | 5% - 95% non-condensing | No (Wider range, no effect) |
| Power Requirements | 100-240 V AC; 50-60 Hz | Same | Same |
| Sampling Rate | 1K, 2K and 4K | 1KHz | No (Meets clinical requirements, Note 2) |
| CMMR | 100 dB min | Same | Same |
| Input Impedance | >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) | <10 uA | Same - Per ISO 60601-1 | Same |
| Leakage Current (Patient Sink) | <10 uA | Same - Per ISO 60601-1 | Same |
| Leakage Current (Chassis) | <100 uA | Same - Per ISO 60601-1 | Same |
| ECG Outputs | 12 lead ECG produced | Same | Same |
| ECG High Pass Filter | 0.05 Hz, 0.5 Hz, 5 Hz | 0.05, 0.2, 40, 80 Hz | No (Provides necessary filtration, Note 3) |
| ECG Low Pass Filter | 100 Hz | Same | Same |
| Gain | 50-10,000 in 8 settings | Between 0 and 255 mm/mVolt – Continuous | No (Equivalent gain, different terms/control, Note 4) |
| Saturation Recovery | Less than 1 sec | Same | Same |
| Notch Filter | Power line (50/60 Hz) | Same | Same |
| Intracardiac Inputs (32ch) | 32 intracardiac, 4 pressure, 10 ECG | 36 intracardiac (18 ch), 2 pressure, 10 ECG (12 ch) | No (Covers wide range of clinical applications, Note 5) |
| Channel Switching | Any input can be switched to any output within a Block | Each channel can be Bipolar or Unipolar with Manual switching | No (Difference overcome by manual switching, Note 6) |
| IECG High Pass Filter | DC, 0.05 Hz, 0.5 Hz, 5.0 Hz, 30 Hz, 100 Hz | 0.05, 0.2, 40, 80 Hz | No (Provides necessary filtration, Note 7) |
| IECG Low Pass Filter | 500 Hz, 2,000 Hz | 500 Hz | No (500Hz same, 2000Hz not relevant for 1KHz sampling, Note 8) |
| Pressure Inputs | Compatible with all standard external pressure transducers. 5uV/V/mmHg | Same | Same |
| Excitation Voltage | 5V DC | 10 V DC (+5 to -5V) | No (Sensitivity is important parameter, which is same, Note 9) |
| Pressure Channels Outputs | Up to 4 pressure channels | 2 pressure channels | No (Covers wide range of clinical applications, Note 5) |
| Stimulator Specifications | Micropace model EPS 320 | EMS-XL (integrated) | |
| Isolated Stimulus channels | 2 | 2 | Same |
| Pulse Amplitude Range | 0.1 to 25 mA into 800 Ω load | 0.1 to 25 mA into 1500 Ω load | No (Same current range, higher load impedance source, Note 10) |
| Pulse Amplitude Increment | 0.1 mA up to 1 mA Amplitude | 0.1 mA within whole range | No |
| Pulse Amplitude Accuracy | +/- 2% or +/- 0.2 mA (whichever is larger) | Same | Same |
| Pulse Duration Range | 0.5 to 10 msec | 0.1 to 9.9 msec | No |
| Pulse Duration Increment | 0.5 - 10 msec, increment of 1-10 msec | 0.1 msec | No (Smaller increments, no effect on performance) |
| ISI Range (Pace) | 180 msec to 9990 msec | Same | Same |
| ISI Range (Burst) | 30 - 9900 msec | Same | Same |
| ISI Increment | 1 msec | 10 msec | No (Easier control, Note 11) |
| Sequential Delay (AV) Range | 10-1000+/- 1 msec (maximum ISI - 50 msec) | 11 - 250 msec | No (No clinical significance for longer intervals, Note 12) |
| Number of Extra-stimuli | 6 (S2-S7) | 4 (S2-S5) | No (4 extra sufficient for most clinical apps, Note 13) |
| Sensing (ECG sync) | External: 50 – 2000 mV; Internal: Pacing catheter tip | Internal from any surface or intra-cardiac channel | No |
| Sync Output | Multiple sync outputs for external devices | No | No (Integrated system doesn't need external sync, Note 14) |
| Power Source (Stimulator) | Mains 220/110 to 14.5 VDC, 750 mA low voltage power supply. Backup battery | Integrated with Amplifier power (+5V, -+12V, -12V) | Yes (Integrated, but safety covered by other precautions, Note 15) |
| Programmed Protocols (Auto TP/Ectopic/Stop Tachycardia) | Yes | No | Yes (Physician decision used instead due to safety burden, Note 16) |
| Backup Stimulator | Integrated | No backup stimulator (Requires external backup) | Yes (User manual requires external backup, Note 17) |
| System Specifications | Carto® XP System (GE Prucka) | EMS-XL | |
| Processor | Intel® 2.66GHz Pentium IV Xeon or greater | Intel® 2.4GHz Pentium IV or greater | No |
| RAM | 512 MB | Same | Same |
| Hard drives | 2 x 40 GB | 80 GB | No |
| Monitors | 1 or 2 | 2 | No |
| Holter Mode | Yes | Integrated Holter mode with full disclosure | No |
| Ablation Connectivity | Connectivity to RF Ablation generator(s) | Same | Same |
| Statistics and Inventory | Xi2 Data Management System | No | No (Administrative package, no direct use on EP procedure, Note 18) |
| Mapping | Isochronal and Isopotential Maps | No | No (External devices can be used for mapping, Note 19) |
| Vital Signs | Integrated Vitals Monitoring with Audible Indicators | Not integrated (Integrated tachycardia message; recommends external monitor, Note 20) | No |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a predicate comparison for a 510(k) submission, not a direct clinical study with a specified "test set" as one might find for an AI/ML device.
- Sample Size: Not applicable in the context of a prospective or retrospective clinical study of user data. The "sample" here refers implicitly to the specifications and functionalities of the two predicate devices being compared.
- Data Provenance: The data provenance is the technical specifications and reported features of the two predicate devices:
- K993414 Cardiolab EP system (Prucka Engineering, Inc)
- K011826 Micropace model EPS 320 (Micropace Pty Ltd.)
The submission itself is from Mennen Medical Ltd., Israel. The clinical experience mentioned for EMS-XL notes use by clinics "out of the USA" since December 2003, implying international (likely European) usage.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable in this type of submission. The "ground truth" for this submission is the established and legally marketed performance and specifications of the predicate devices. The review and interpretation of these specifications for equivalence determination would be performed by the manufacturer's regulatory affairs team and then by FDA reviewers.
4. Adjudication Method for the Test Set
Not applicable. This is a technical specification comparison, not a clinical trial requiring adjudication of patient outcomes or expert reads. The "adjudication" is essentially the manufacturer's justification (Rational for claims of equivalence) and the FDA's acceptance of those justifications for "substantial equivalence."
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
No, an MRMC study was not done. This device is a cardiac electrophysiology system, which includes signal acquisition, display, recording, and stimulation capabilities. It is not an AI/ML diagnostic interpretation tool that would typically undergo an MRMC study to assess reader performance with and without AI assistance. The submission confirms that the EMS-XL system is a software-driven, multichannel amplifier and stimulator connected to a computer, focused on acquiring and analyzing physiological signals.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly. The comparison tables are a standalone comparison of the technical specifications and functions of the EMS-XL device against the technical specifications and functions of its predicate devices. The "performance" being evaluated is the device's inherent functional capabilities as designed and manufactured, not an AI algorithm's interpretive ability.
7. The Type of Ground Truth Used
The "ground truth" used is the published and legally established technical specifications and performance characteristics of the predicate devices (Cardiolab EP system and Micropace model EPS 320) as detailed in their 510(k) clearances and product documentation. This is a regulatory "truth" rather than a clinical "truth" (like pathology or outcomes data).
8. The Sample Size for the Training Set
Not applicable. This document does not describe the development of an AI/ML algorithm that would require a "training set." The EMS-XL is a hardware and software system for electrophysiological studies.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for an AI/ML algorithm is described.
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