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510(k) Data Aggregation
(228 days)
The ECGenius™ System is an electrophysiology measurement system and analysis tool used to acquire, filter, digitize, amplify, display, record, and analyze data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
The ECGenius™ System is an electrophysiology (EP) recording system used in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. ECGenius™ System (with ECGenius™ Software V3.0) is similar to ECGenius™ System (with ECGenius™ Software V2.0) but has two additional software modules.
The Signal Complexity™ software module analyzes various properties of the signals from a connected 10-pole catheter and visualizes them on a colormap. No clinical claims are made for Signal Complexity™.
The PVI Analyzer™ software module aids the user in evaluating the isolation status of a pulmonary vein. The module performs automated real time analysis of electrograms (EGM) from compatible connected 8- or 10-pole circular mapping catheters during a PVI procedure. The result of the analysis (Isolated vs Non-isolated) is presented in a visual plot to the user. The PVI Analyzer™ feature is a secondary measure of pulmonary vein isolation and should not replace traditional methods of confirming isolation.
The ECGenius™ System consists of an electrophysiology amplifier (Cube Amplifier), recording system software (ECGenius™ Software) running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, and digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, analysis, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.
The ECGenius™ System includes the following items:
- Cube Amplifier
- Two IECG pin box cables for connection of catheters
- Surface ECG trunk cable and ECG leadwires
- Blood pressure cables
- Data cable to host computer
- Stimulator cable
- Analog-out and analog-in cables
- ECGenius™ Software with the PVI Analyzer™ and Signal Complexity™ software modules
- Host computer (PC), monitors and printer
- Isolation transformers
The provided document is a 510(k) Summary for the CathVision ApS ECGenius™ System. Section 510(k) summaries disclose information to FDA about how a specific device is substantially equivalent to other devices already legally marketed in the U.S. This document outlines the device description, indications for use, comparison to a predicate device, and various performance testing conducted. However, it does not contain details about specific acceptance criteria or a study design that quantitatively evaluates the device's performance against pre-defined metrics.
The document states that the ECGenius™ System with ECGenius™ Software V3.0 introduces two new software modules: PVI Analyzer™ and Signal Complexity™.
- The PVI Analyzer™ is described as a "secondary measure of pulmonary vein isolation" and explicitly states it "should not replace traditional methods of confirming isolation."
- The Signal Complexity™ module "analyzes various properties of the signals" and "No clinical claims are made for Signal Complexity™."
Given this, the document asserts that these new modules "do not present different questions of safety or effectiveness because they are only intended to provide the physician with additional information that supplements common clinical practice and do not alter the Intended Use."
Therefore, based solely on the provided text, a detailed table of acceptance criteria and a study proving the device meets these criteria cannot be constructed as the necessary information is not present in this 510(k) summary. The document focuses on demonstrating substantial equivalence to a predicate device and outlines general performance testing (e.g., software verification, cybersecurity, biocompatibility), but not a specific clinical performance study with acceptance criteria for the new features.
The document does not contain the following information typically found in a clinical performance study write-up:
- A table of acceptance criteria and reported device performance for the new features.
- Sample sizes used for a test set.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication methods.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
The document details the device's technological characteristics and compares them to those of its predicate and reference devices, focusing on demonstrating equivalence rather than proving clinical performance against specific quantitative metrics for the new features.
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(90 days)
The ECGenius™ System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record clinical data obtained during electrophysiological studies and related procedures. The system is compatible with a 3rd-party stimulator, intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.
The ECGenius™ System consists of an electrophysiology amplifier (commercial name "Cube Amplifier" in the technical documentation also called "EP Amplifier" or "EPAMP"), recording system software (commercial name "ECGenius™ Software" in technical documentation also called "Recorder Software" or "Recorder SW" or abbreviated as "RecSW") running on a PC, and additional components including external cable assemblies, PC monitors, and a printer. Electrophysiological signals are filtered, amplified, digitized in the Cube Amplifier, and sent to the PC and recording system software for further processing, visualization, and recording. The ECGenius™ System works in an EP laboratory or operating room in hospitals in conjunction with several other devices from other manufacturers.
The ECGenius™ System is an electrophysiology (EP) recording system used in EP procedures as part of the diagnosis and treatment of cardiac arrhythmias. The ECGenius™ System includes the following items:
- Cube Amplifier
- Two IECG pin box cables for connection of catheters
- Surface ECG trunk cable and ECG leadwires
- Blood pressure cables
- Data cable to host computer
- Stimulator cable
- Analog-out and analog-in cables
- ECGenius™ Software
- Host computer (PC), monitors and printer
The provided document is a 510(k) Summary for the ECGenius™ System. It discusses the device's substantial equivalence to a predicate device, the EP-TRACER. However, it does NOT contain the specific details required to fulfill all parts of your request regarding acceptance criteria and a study proving the device meets those criteria.
Here's what can be extracted from the document based on your request:
1. A table of acceptance criteria and the reported device performance:
The document doesn't provide specific quantitative "acceptance criteria" for performance that the device was tested against and then reports the performance against those criteria in a table format as you've requested. Instead, it offers a "Characteristics" table comparing the ECGenius™ System to its predicate device, the EP-TRACER, to demonstrate substantial equivalence. This comparison implies that meeting or exceeding the predicate device's performance would be a form of acceptance.
Table: Comparison of ECGenius™ System (Subject Device) vs. Predicate Device (EP-TRACER)
| ATTRIBUTE | SUBJECT DEVICE ECGenius™ System K220306 | PREDICATE DEVICE Schwarzer CardioTek GmbH EP-TRACER K183266 | COMPARISON |
|---|---|---|---|
| Indications for use | As described in the summary. | As described in the summary. | Similar except that the ECGenius™ System does not incorporate a stimulator. |
| FDA Product code | DQK | DQK | Same |
| Classification | Programmable diagnostic computer, 21 CFR §870.1425 | Programmable diagnostic computer, 21 CFR §870.1425 | Same |
| Amplifier Dimensions WxDxH (cm) | 43x43x31 | 28x27x12 | Different but both can be installed and used in an EP lab. |
| Temperature Operating | +10°C to +30°C | +10°C to +30°C | Same |
| Temperature Transport/Storage | -15°C to +50°C | -29°C to +66°C | As both systems are intended for use in air-conditioned hospital EP labs and operating rooms, the minor difference in environmental humidity is insignificant. Similarly, both systems are able to withstand the expected temperature and humidity variations to be experienced during transport/storage. |
| Humidity Operating | 30 - 75 % rH (non-condensing) | 20 - 80 % rH (non-condensing) | (See above for combined humidity comparison, stating "minor difference in environmental humidity is insignificant.") |
| Humidity Transport/Storage | 10 - 95 % rH (non-condensing) | < 95 % rH (non-condensing) | (See above for combined humidity comparison, stating "minor difference in environmental humidity is insignificant." and "both systems are able to withstand the expected temperature and humidity variations to be experienced during transport/storage.") |
| Power Requirements | 100 - 240 V AC, 50 - 60 Hz | 100 - 240 V AC, 50 - 60 Hz | Same |
| Current Draw | 0.7A @ 110VAC, 0.35A @ 240VAC | 15A @ 115V, 7A @ 230V | ECGenius™ System consumes less power. |
| Sampling Rate | 2kHz | 1 kHz | The ECGenius™ System is capable of acquiring data at 2kHz, with a common mode rejection ratio (CMRR) of >120dB, where the EP-TRACER CMRR is >100dB. (Implies better performance for ECGenius) |
| CMRR | > 120dB | > 100 dB | (See above for combined Sampling Rate/CMRR comparison, stating that ECGenius™ CMRR is >120dB compared to EP-TRACER's >100dB.) |
| Input Impedance | >2.5MΩ | Typical 20 MΩ | The EP-TRACER claims that typical input impedance is 20MΩ. CathVision has tested the ECGenius™ System to verify that the input impedance is >2.5MΩ, in accordance with IEC 60601-2-27 §201.12.1.101.3. Typical values have not been established. |
| IECG Inputs | 128 channels + 2 references | 84 channels | The two systems are able to acquire multiple intracardiac ECG signals, and all specifications for the ECGenius™ System are at least as good as for the EP-TRACER. (Implies better/equivalent performance for ECGenius) |
| IECG Switching | Each channel can be either bipolar or unipolar with manual switching | Each channel can be either bipolar or unipolar with manual switching | (Combined with IECG Inputs comparison, stating "all specifications for the ECGenius™ System are at least as good as for the EP-TRACER.") |
| IECG High Pass Filter | None, 0.01 Hz, 0.05 Hz, 0.1 Hz, 0.5 Hz, 1 Hz, 10 Hz, 30 Hz, 100 Hz | 0.05 Hz, 0.2 Hz, 40 Hz, 80 Hz | Specifically, the ECGenius™ System has a greater range of high-pass and low-pass filter choice, a larger input range and offset, plus a greater maximum gain. (Implies better range/flexibility for ECGenius) |
| IECG Low Pass Filter | 50 Hz, 100 Hz, 250 Hz, 500 Hz, None | 350 Hz | (Combined with IECG High Pass Filter comparison, stating "greater range of high-pass and low-pass filter choice.") |
| IECG RF Filtering | All inputs | All inputs | (Within the context of IECG signals, implying equivalence.) |
| IECG Gain | Between 0.01 and 5120 mm/mV – discrete intervals | Between 0 and 255 mm/mV – continuous | (Combined with IECG High Pass Filter comparison, stating "greater maximum gain.") |
| IECG Saturation Recovery | < 1 s (auto reset) | < 1 s (manual reset) | (Within the context of IECG signals, implying equivalence in recovery time, but ECGenius™ has "auto reset" which is an improvement.) |
| IECG Notch Filter | 50/60Hz, None | 50/60 Hz, None | (Within the context of IECG signals, implying equivalence.) |
| IECG Dynamic Range | ±100 mV | ±5 mV | (Combined with IECG High Pass Filter comparison, stating "larger input range and offset.") |
| IECG Baseline Correction | ±1000 mV | ±300 mV | (Combined with IECG High Pass Filter comparison, stating "larger input range and offset.") |
| ECG Inputs | 10 ECG inputs (= 12 leads) | 10 ECG inputs (=12 leads) | Same |
| ECG High Pass Filter | None, 0.01 Hz, 0.05 Hz, 0.1 Hz, 0.5 Hz, 1 Hz, 10 Hz | 0.05 Hz, 0.2 Hz | The two systems are able to acquire multiple surface ECG signals, and all specifications for the ECGenius™ System are at least as good as for the EP-TRACER. Specifically, the ECGenius™ System has a greater range of high-pass and low-pass filter choice, a larger input range and offset, plus a greater maximum gain. (Implies better range/flexibility for ECGenius) |
| ECG Low Pass Filter | 100 Hz, 150 Hz, 250 Hz, 500 Hz, None | 150 Hz | (Combined with ECG High Pass Filter comparison, stating "greater range of high-pass and low-pass filter choice.") |
| ECG RF Filtering | All inputs | All inputs | Note: the EP-TRACER claims to support 12 ECG 'channels', but the number corresponds to the ECG leads (derived from the standard 10 electrodes). (Within the context of ECG signals, implying equivalence in RF filtering.) |
| ECG Gain | Between 0.01 and 5120 mm/mV – discrete intervals | Between 0 and 255 mm/mV - continuous | (Combined with ECG High Pass Filter comparison, stating "greater maximum gain.") |
| ECG Saturation Recovery | < 1 s (auto reset) | < 1 sec (manual reset) | (Within the context of ECG signals, implying equivalence in recovery time, but ECGenius™ has "auto reset" which is an improvement.) |
| ECG Notch Filter | 50/60Hz, None | 50/60 Hz, None | (Within the context of ECG signals, implying equivalence.) |
| ECG Dynamic Range | ±10mV | ±5 mV | (Combined with ECG High Pass Filter comparison, stating "larger input range and offset.") |
| Baseline Correction | ±300mV | ±300 mV | (Within the context of ECG signals, implying equivalence.) |
| Auxiliary Inputs Channels | 4 pressure, 2 auxiliary (analog in) | 6 auxiliary (pressure) | Both systems offer 6 input channels. In the case of the EP-TRACER, these are all pressure inputs. For the ECGenius™ System, 4 channels are dedicated to pressure signals, but the remaining two can be utilized for any type of analog signal. (Implies greater flexibility for ECGenius) |
| Output channels | 12 lead ECG produced | 12 lead ECG produced | The EP-TRACER provides the user with analog output signals representing the 12 ECG leads. In comparison, the ECGenius™ System allows the user to output 12 ECG signals and 1 bipolar intracardiac ECG signal. The ECGenius™ System also has a single channel analog output dedicated to the ECG lead II. Although the systems differ in the signals made available, this feature is not part of the core functionality of an EP recording system and the differences are not significant. (Implies slightly different but not clinically significant output capabilities) |
| Isolated Stimulus Channels, Stimulator | 2 (external stimulator) | 2 | The EP-TRACER contains an internal cardiac stimulator, with 2 independent channels, each of which can be assigned, under software control, to any of the intracardiac channels. ECGenius™ System is compatible with an external 2-channel stimulator, whereby each stimulator signal can be independently routed under software control, to any of the intracardiac channels. (Difference in stimulator integration, but both support 2 channels.) |
| Backup | Connect catheters to stimulator bypass connections | Use external backup stimulator | For the EP-TRACER, the user is expected to use an external backup stimulator in the event of the system failing. For the ECGenius™ System, a system failure could result in the user not being able to select the correct routing for the stimulation signal. In this case, the user is expected to connect the appropriate electrodes to the ECGenius™ System's dedicated stimulator bypass connections (which are hardwired to the external stimulator). (Different backup methods for stimulator, but both have a plan) |
| Display Ablation Parameters | Connection to RF ablation generator(s) | Connection to RF ablation generator(s) | Same |
| Standards | IEC 60601-1: 2005+A1:2012, IEC 60601-1-2: 2014, etc. | IEC 60601-1: 2005+A1:2012, IEC 60601-1-2: 2014, etc. | The same standards are used; however, some have been updated for the ECGenius™ System. |
| Leakage Current Patient | < 10 μΑ | < 10 μΑ | Same |
| Leakage Current Patient (single fault conditions) | < 50 μΑ | < 50 μΑ | Same |
| Leakage Current Touch current | < 100 μΑ | < 100 μΑ | Same |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Performance testing for this submission has been limited to bench testing. There are no animal or clinical studies."
Therefore, there is no clinical "test set" in the context of patient data, sample size, or data provenance to report. The testing was laboratory-based.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since there were no clinical or animal studies, there was no "test set" requiring expert ground truth establishment for diagnostic accuracy or similar performance metrics. The testing was focused on engineering performance and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical "test set" and no diagnostic performance evaluation requiring adjudication.
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
Not applicable. The ECGenius™ System is an electrophysiology measurement system, not described as an AI-powered diagnostic tool that assists human readers/clinicians in interpreting findings for improved effectiveness through an MRMC study. The document states "Performance testing ... has been limited to bench testing."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable in the context of an algorithm's diagnostic performance. The device is a "Programmable Diagnostic Computer" for acquiring, filtering, digitizing, amplifying, displaying, and recording clinical data. Its performance was assessed through bench testing against engineering specifications and standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since the testing was limited to bench testing against engineering specifications and international standards, the "ground truth" would be the expected performance values based on those specifications and standards. For example, a "ground truth" for CMRR performance would be ">100 dB" (predicate) or ">120 dB" (subject device), as derived from design specifications and standard requirements, and verified through laboratory measurements.
8. The sample size for the training set
Not applicable. The document states "Performance testing ... has been limited to bench testing. There are no animal or clinical studies." There is no mention of a "training set" for an algorithm or AI model.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI model.
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