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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.

Device Description

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

AI/ML Overview

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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K Number

K220306

Device Name

ECGenius System

Manufacturer

CathVision ApS

Date Cleared

2022-05-03

(90 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K183266

Intended Use

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.

Device Description

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

AI/ML Overview

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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