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510(k) Data Aggregation
(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) | 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 | 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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