Search Results

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.

Device Description

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

AI/ML Overview

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, 100 dB, 20 MΩ,

Ask a Question

Ask a specific question about this device

K Number

K161245

Device Name

EP-TRACER System

Manufacturer

CARDIO TEK, BV

Date Cleared

2016-08-05

(94 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K134044

Predicate For

K183266

Intended Use

Device Description

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

AI/ML Overview

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

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.
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.
Adjudication method for the test set: Not applicable. The testing involves standardized engineering and software validation protocols with pass/fail criteria.
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.
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.
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.).
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.
How the ground truth for the training set was established: Not applicable, as there is no mention of a training set for machine learning.

Ask a Question

Ask a specific question about this device

Page 1 of 1