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510(k) Data Aggregation
(98 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:
EP-TRACER hardware – Amplifier/stimulator
EP-TRACER Software – Software pre-installed
This document describes the EP-TRACER System V2.2, an electrophysiology measurement system. The FDA 510(k) clearance (K183266) states its substantial equivalence to the predicate device, EP-TRACER System V2.0 (K161245). This submission primarily focuses on software modifications affecting the user interface, with no changes to the hardware.
Here's an analysis of the acceptance criteria and the study information provided:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in a quantitative, measurable format like sensitivity/specificity thresholds for a diagnostic device. Instead, the "acceptance criteria" for this submission are implicitly defined by demonstrating that the modifications to the device (V2.2 compared to V2.0) do not adversely affect safety and effectiveness and that the device conforms to relevant harmonized standards.
The "device performance" is therefore described by showing that the new device (V2.2) maintains the same fundamental technological characteristics and meets all applicable standards as the predicate device (V2.0).
| Characteristic / Acceptance Criteria Type | Predicate Device EP-TRACER V2.0 Performance (Implicit Acceptance Baseline) | New Device EP-TRACER V2.2 Performance (Reported) | Met? |
|---|---|---|---|
| Hardware Components | Same as listed in "Technological Characteristics" table | Same | Yes |
| Amplifier Dimensions | 38 channels: 28x27x7 cm; 70/102 channels: 28x27x12 cm | Same | Yes |
| Environmental Specs (Temp, Humidity) | Operating: +10°C to +30°C, 20-80% rH; Storage: -29°C to +66°C, <95% rH | Same | Yes |
| Power Specs (Input, Requirements) | 100-240 V AC, 50-60 Hz; specific V/A for channels | Same | Yes |
| Design (Sampling Rate, CMRR, Impedance, Leakage, Filters, Gain, Dynamic Range, Baseline Correct.) | 1 kHz, >100 dB, 20 MΩ, <10 μA patient, <100 μA chassis, various filters, etc. | Same | Yes |
| Stimulator Specs (Pulse Amplitude/Duration, ISI, etc.) | Specific ranges and accuracies as listed in table | Same | Yes |
| Pacing Channels (Isolated, Isolation) | 2 isolated channels, IEC 60601-1 compliant | Same | Yes |
| Computer Controlled Stimulus Pulses | Ranges and accuracies for current, pulse duration, load impedance, etc. | Same | Yes |
| Programmed Protocols | BASIC 1, 2, 3; ACUTE, Multi-Sx, Pace, etc. | Same | Yes |
| Programmed Protocol Key | 10 | Same | Yes |
| Number of Extra-Stimuli | 5 (S2 - S6) | Same | Yes |
| Sensing (ECG Sync) | Internal from surface/intracardiac, trigger lockup, ECG delay | Same | Yes |
| Backup Stimulation | Use external backup stimulator | Same | Yes |
| Compliance with Standards | EN ISO 13485:2012, EN ISO 14971:2012, EN 60601-x series, EN 10993-1, etc. | Conformance demonstrated | Yes |
| Software User Interface (New) | |||
| Pressure mode display | Full-screen only | Full-screen and "minimized" display | N/A |
| Calipers | Horizontal only | Horizontal and vertical | N/A |
| Eport Generation | Limited format transfer | Customizable, preconfigured template transfer | N/A |
| Clock | Real-time clock | Real-time clock + procedure clock | N/A |
| New Icons | No (keystrokes for these functions) | Yes (for split-screens, pressure mode, stimulator settings, add comment/mark, screenshot, toggle stimulator windows) | N/A |
| Software Compatibility | Windows 7 (32 bit) | Windows 7 (64 bit) and (32 bit) | N/A |
| Overall Safety and Effectiveness | No adverse effects from modifications due to V&V activities. | Yes | Yes |
N/A for "Met?" column for new software features as they are additions/improvements, not criteria to be met against a baseline.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a clinical study with patients or data from a test set in the traditional sense of evaluating diagnostic accuracy. This submission is for an electrophysiology measurement system, with the current iteration (V2.2) involving only software modifications to the user interface. The performance testing primarily focused on demonstrating conformity to harmonized standards and verifying that the software changes did not negatively impact the device's safety and effectiveness.
Therefore, there is no specific mention of a "test set" sample size or data provenance (country of origin, retrospective/prospective) related to patient data or clinical outcomes. The evaluation is based on engineering verification and validation activities against the pre-existing design specifications and regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
Given that this is a modification to an electrophysiology measurement system focusing on user interface changes and compliance with standards, there is no indication of "experts" being used to establish ground truth for a test set in a diagnostic or clinical performance context. The "ground truth" here would relate to the correct functioning of the system's electrical measurements and stimulation based on engineering specifications and adherence to standards, likely assessed by qualified engineers and domain experts internal to the manufacturer.
4. Adjudication Method for the Test Set
As there is no described "test set" involving human interpretation or clinical data requiring ground truth establishment, there is no mention of an adjudication method.
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 MRMC comparative effectiveness study was mentioned or performed. This device is an electrophysiology measurement system, not an AI-assisted diagnostic tool for image interpretation or similar. The "user interface convenience features" are productivity enhancements rather than AI-driven diagnostic assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The EP-TRACER System is an electrophysiology measurement system used by human operators (clinicians) for acquiring, displaying, and recording signals and performing diagnostic cardiac stimulation. It is not an algorithm designed to perform a standalone diagnostic task without human intervention. The software updates are improvements to the human-machine interface.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For this submission, the "ground truth" essentially refers to:
- The engineering specifications of the device (e.g., accuracy of pulse amplitude, sampling rate, filter characteristics).
- Compliance with harmonized standards (e.g., electrical safety, EMC, usability).
- The predicate device (EP-TRACER V2.0) as a baseline for safety and effectiveness of the core functionality.
The performance testing (verification and validation) demonstrated that the updated software met predetermined design and performance specifications and that modifications did not adversely affect the safety and effectiveness compared to the predicate.
8. The Sample Size for the Training Set
There is no mention of a "training set" in the context of machine learning or AI, as this submission doesn't describe an AI/ML algorithm being developed or deployed. The software modifications are user interface improvements.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI/ML algorithm mentioned.
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(94 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 System is comprised of these major components,
- EP-TRACER hardware – Amplifier/stimulator
- EP-TRACER Software – Software pre-installed
The EP-TRACER System is an electrophysiology measurement system. The acceptance criteria and supporting study are described below.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Performance |
|---|---|---|
| Radiated emission, Conducted emission, Radiated immunity, Conducted immunity | Pass | Pass |
| Conducted emission (harmonics), Radiated immunity (PMF), Conducted immunity | Pass | Pass |
| IEC 60601-1:2005 + CORR. 1:2006 + CORR. 2:2007 + AM1:2012 | Pass | Pass |
| Amendment - IEC 60601-1:2005 (Third Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 | Pass | Pass |
| IEC 60601-1-6:2010 (Third Edition) + A1:2013 | Pass | Pass |
| IEC 62366:2007 (First Edition) + A1: 2014 for use in conjunction with IEC 60601-1-6: 2010 | Pass | Pass |
| IEC 60601-1-27:2011 (Third Edition) for use in conjunction with IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) | Pass | Pass |
| IEC 60601-2-34 (Third Edition): 2011 | Pass | Pass |
Study Information
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Sample size used for the test set and data provenance: Not explicitly stated. The document indicates that "Testing has been conducted through software and/or user verification/validation protocols" and electrical safety and electromagnetic compatibility testing was performed. The data provenance (e.g., country of origin, retrospective/prospective) is not provided.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The testing primarily focuses on the device's adherence to electrical safety and electromagnetic compatibility standards, and software functionality, rather than diagnostic performance against a medical ground truth established by experts.
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Adjudication method for the test set: Not applicable. The testing involves standardized engineering and software validation protocols with pass/fail criteria.
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Multi-reader multi-case (MRMC) comparative effectiveness study: No, a MRMC comparative effectiveness study was not done. The device is an electrophysiology measurement system, not an AI-assisted diagnostic tool.
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Standalone (algorithm only without human-in-the-loop performance) study: Yes, the performance testing described appears to be a standalone evaluation of the device's compliance with safety and performance standards. The "results" provided in the table indicate whether the device "Passed" tests against specific IEC standards for electrical safety and electromagnetic compatibility.
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Type of ground truth used: The ground truth for the performance testing is based on the requirements and standards set forth by the listed IEC and other electrical safety and EMC standards (e.g., IEC 60601-1, IEC 60601-1-2, etc.).
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Sample size for the training set: Not applicable. This device is an electrophysiology measurement system with software (V2.0) that "maintains the capabilities in the previous version, adding user interface enhancements." It's not described as a machine learning or AI-driven system that would typically require a training set in the sense of predictive modeling.
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How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for machine learning.
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(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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