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510(k) Data Aggregation
(90 days)
The EP-Tracer System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The EP-Tracer system is a computerized electrophysiology measurement system designed for both regular and experimental EP studies. The EP-Tracer is comprised of these major components, 1. EP-Tracer hardware - Amplifier/stimulator 2. EP-Tracer Software - Software pre-installed
The provided text focuses on the 510(k) summary for the EP-Tracer system, primarily comparing its technological characteristics to a predicate device (Mennen Medical EMS-XL Cardiac Electrophysiology System) to demonstrate substantial equivalence.
From the provided text, there is no detailed experimental study proving the device meets specific performance acceptance criteria beyond demonstrating substantial equivalence to a predicate device. The document outlines the technological characteristics of the new device and the predicate device, indicating that the EP-Tracer system aligns with the predicate's specifications or improves upon them.
Therefore, many of the requested items (sample size, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and training set ground truth establishment) are not explicitly described for this specific 510(k) submission. This is common for 510(k) clearances that rely heavily on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical performance data from scratch.
However, I can extract the available information about the device's technical specifications, which are implicitly its acceptance criteria based on its predicate.
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EP-Tracer system are inferred from its technological characteristics being "Same" or improved compared to the predicate device, Mennen Medical EMS-XL. No specific quantitative "acceptance criteria" are explicitly stated with corresponding "reported performance" against those criteria in a tabular format as if it were a direct test. Instead, the comparison demonstrates equivalency.
Below is a table summarizing the technological characteristics that were compared between the EP-Tracer and its predicate, acting as the de facto "acceptance criteria" for substantial equivalence. The "Reported Device Performance" for the EP-Tracer is simply its measured characteristic as stated in the document.
| Device Characteristic | Acceptance Criteria (Predicate: Mennen EMS-XL) | Reported Device Performance (EP-Tracer™) |
|---|---|---|
| Environmental Specifications | ||
| Temperature Operating | 0°C to +35°C | +10°C to +30°C |
| Temperature Transport/Storage | -15°C to +50°C | -29°C to -66°C |
| Humidity Operating | < 95 % rH at -35°C (non-condensing) | 20 - 80 % rH (non-condensing) |
| Humidity Transport/Storage | < 95 % rH at -35°C (non-condensing) | < 95 % rH (non-condensing) |
| Power Specifications | ||
| Power Requirements | 100 - 240 V AC, 50 - 60 Hz | Same |
| Power Input | -5 V, 0.0 - 0.2 A; +12 V, 0.0 - 0.3 A; -12V, 0.0 - 0.3 A | (38 ch) ±5 V, 0.3 A & +12 V, 0.9 A; (70 ch) +5 V, 0.3 A & -12 V, 1.5 A; (102 ch) +5 V, 0.3 A & -12 V, 2 A |
| Design | ||
| Sampling and Hold | Each channel sampled prior acquisition | Same |
| Sampling Rate | 1 kHz | Same |
| CMRR | > 100 dB | Same |
| Input Impedance | Typical 20 MΩ | Same |
| Leakage Current Patient Source | < 10 µA | Same |
| Leakage Current Patient Sink | < 10 µA | Same |
| Leakage Current Patient Sink (single fault) | < 50 µA | Same |
| Chassis Leakage Current | < 100 µA | Same |
| ECG Input | ||
| Outputs | 12 lead ECG produced | Same |
| High Pass Filter | 0.05 Hz, 0.2 Hz, 40 Hz, 80 Hz | 0.05 Hz, 0.2 Hz (for ECG); Same (for other inputs) |
| Low Pass Filter | 100 Hz (ECG) / 500 Hz (Inputs) | 150 Hz (ECG) / 350 Hz (Inputs) |
| RF Filtering | All inputs | Same |
| Gain | Between 0 and 255 mm/mV - continuous | Same |
| Saturation Recovery | < 1 sec | < 1 sec (manual reset) |
| Notch Filter | Power line (50/60 Hz) | Same |
| Dynamic Range | ±5 mV | Same |
| Baseline Correction | ±300 mV | Same |
| Input/Output (Channels) | ||
| 32/38 channels | 18 intracardiac, 2 pressure, 12 ECG | 20 intracardiac, 6 auxiliary, 12 ECG |
| 64/70 channels | 50 intracardiac, 2 pressure, 12 ECG | 52 intracardiac, 6 auxiliary, 12 ECG |
| 102 channels | N/A | 84 intracardiac, 6 auxiliary (pressure), 12 ECG |
| Outputs | No outputs | Same |
| Switching | Bipolar or unipolar with manual switching | Same |
| Stimulator | ||
| Isolated Stimulus Channels | 2 | Same |
| Pulse Amplitude Range | 0.1 - 25 mA into 1500 Ω load | 0 - 25.5 mA into 1000 Ω load |
| Increment (Pulse Amplitude) | 0.1 ms | Same |
| Accuracy (Pulse Amplitude) | ±0.15 ms | Same |
| Pulse Duration Range | 0.1 - 9.9 ms | Same |
| Increment (Pulse Duration) | 0.1 ms | Same |
| Accuracy (Pulse Duration) | ±0.15 ms | Same |
| Inter-Stimulus Interval (ISI) Range | 180 ms to 9990 ms +1ms or ±0.1% (whichever is larger) | 10 - 9999 ms |
| ISI Range (Burst) | 30 ms to 9900 ms ±1ms or ±0.1% (whichever is larger) | 10 - 9999 ms |
| Increment (ISI) | 10 ms | Same |
| Sequential Delay (AV) Range | 11 - 250 ms | Same |
| Increment (Sequential Delay) | 1 ms | Same |
| Programmed Protocols | Threshold, SNRT, Vent./Atrial Burst/Overdrive, Multi-Sx, Pace, User defined | BASIC 1/2/3, ACUTE, Multi-Sx, Pace, Automatic mode, Wenkebach mode, User defined protocols |
| Prog. Protocol Key | 5 | 10 |
| Number of Extra-Stimuli | 4 (S2 - S5) | 5 (S2 - S6) |
| Trigger Lockup (Refractory Time) | 5 - 5000 ms | Same |
| ECG Delay | 5 - 5000 ms | Same |
| Pacing Channels Isolated | (i) atrial, (ii) ventricular, (iii) emergency fixed pace output to ventricle | (i) atrial, (ii) ventricular, (iii) emergency fixed pace output to atrium and ventricle |
| Circuit Isolation | IEC 60601-1, Class CF, 5 kV | Same |
| Current Output (Computer Controlled) | 0.1 - 25.5 mA into 1500 Ω load 40 V | 0 - 25.5 mA into 1000 Ω load |
| Current Steps | 0.1 mA | Same |
| Accuracy (Current) | ±0.1 mA | Same |
| Accuracy (Pulse Duration) | ±0.1 mA (likely error, should be time unit) | Same |
| Load Impedance | 1500 Ω | 1000 Ω |
| Max. Output Voltage | 40 V | 25 V |
| Si Range | 180 - 9990 ms (pace); 30 - 9990 ms (Burst pace) | 10 - 9999 ms |
| Stability | Quartz clock, ±30 ppm at --25°C | Same |
| Coupling Interval Accuracy | ±10 ms | Same |
| Auto decrement/increment | Yes | Same |
| Backup Stimulation/Pacing | Use external backup stimulator | Same |
| Compliance with Standards | ||
| Standards | CL 2601-1, IEC 60601-1-2 | EN 60601-1, EN 60601-1-2 (and others listed in Section 5, implying compliance as "performance data") |
| Device Directive | EU Medical Device Directive (CE Marked) | Same |
| MDD Device Class | Class IIb | Same |
| IEC 60601-1 | Certified | Same |
| EMC Compliance | Certified | Same |
| CE Marking | Certified CE 0473 | Certified CE 0459 |
| US Regulations | 510(k) cleared | Current submission |
Regarding the specific study details:
- Sample size used for the test set and the data provenance: Not provided. The submission relies on technological comparison to a predicate device. Performance data is stated as "Based upon the documentation presented in this 510(k) it has been demonstrated that the EP-Tracer System is safe and effective for its intended use." This implies that the demonstration of compliance with harmonized standards and comparison to the predicate serve as the "study" for safety and effectiveness, rather than a clinical trial with a specific test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided. The ground truth for this type of submission is typically based on established engineering standards and the performance of the predicate device.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
- 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: Not applicable. This device is an electrophysiology measurement system and stimulator, not an AI-based diagnostic image interpretation tool. No "human readers" or "AI assistance" are mentioned in the context of improving interpretation.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of an AI algorithm. The device itself is a "standalone" system in that it measures and stimulates, but its "performance" is about accurate signal acquisition and stimulation, not algorithm output.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" implicitly relies on established engineering principles, international harmonized standards (e.g., IEC 60601 series, EN ISO 14971), and the performance characteristics of the legally marketed predicate device.
- The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In summary, the 510(k) submission for the EP-Tracer system uses substantial equivalence to a predicate device as its primary method for demonstrating safety and effectiveness. The "study" for this submission consists of a detailed comparison of technological characteristics to show that the new device is as safe and effective as the predicate, along with compliance with relevant international and national harmonized standards.
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