(483 days)
Not Found
No
The description focuses on traditional ECG analysis and comparison to a predicate device without mentioning AI/ML terms or concepts. The "interpretative program" and "criteria" are described in a way that suggests rule-based or statistical analysis, not AI/ML.
No
The device is described as performing ECGs (Electrocardiograms), which are diagnostic tools used to record the electrical activity of the heart, not to provide therapy.
Yes.
The device performs and analyzes resting ECGs, which are used to identify abnormalities, indicating a diagnostic function.
No
The device description explicitly states it performs the same functions as the Marquette MAC PC, which is a hardware ECG machine. While it mentions an "interpretative program," the context suggests this program is part of a larger hardware system for acquiring and analyzing ECG data.
Based on the provided information, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Device Description: It performs resting ECGs and analyzes data from standard leads to identify abnormalities. ECG analysis, while often considered a physiological measurement, is used to diagnose or aid in the diagnosis of medical conditions based on the electrical activity of the heart. This falls under the scope of in vitro diagnostics, which are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of disease.
- Training Set Description: The description of the training set explicitly mentions a study of neonates, infants, and children for the pediatric criteria. This indicates that the device is used to analyze data from patients to provide diagnostic information.
While the "Intended Use / Indications for Use" section is "Not Found," the description of the device's function and the context of the training data strongly suggest its use in a diagnostic capacity. The comparison to the Marquette MAC PC, which also performs resting ECGs and identifies abnormalities, further supports this conclusion.
N/A
Intended Use / Indications for Use
Not Found
Product codes (comma separated list FDA assigned to the subject device)
Not Found
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
patients ranging in age from birth to 99 years.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The GRI pediatric criteria is based on a large study of 2,196 neonates, infants and children.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
K94681
APR 2 3 1996
1946281
510(k) Summary
Effectiveness
The pediatric enhancement to the interpretative program was developed by Dr. Peter MacFarlane in the University of Glasgow developed of Cardiology, Glasgow Royal Infirmary (GRI), Glasgow, GMI), Glasgow, CCC Dr. MacFarlane has been involved in computerized ECG Scotland. interpretation since its inception in the 1960s. The GRI pediatric criteria is based on a large study of 2,196 neonates, infants and children.
The Burdick Eclipse 4 performs the same functions and meets the same performance standards as the Marquette MAC PC. This version of the Burdick GRI interpretative program and Marquette s interpretative program used in the MAC PC both provide adult and pediatric resting ECGs on patients ranging in age from birth to 99 years. Both programs analyze 10 seconds of data simultaneously from the 12 standard leads and identify essentially the same set of abnormalities.
Safety
The addition of pediatric interpretation does not change the analysis of potential risks as outlined in the Eclipse 4 510(k) submittal (# K943959) concerning electrical shock, misrepresentation of the patient's ECG, inability of the operator to sucessfully record an ECG, mechanical pinch points and device falling.
Burdick conducted a review of the literature pertaining to safety of pediatric interpretative capabilities in electrocardiographs. Appropriate safeguards have been incorporated in the design of the Eclipse 4.
The device labeling includes instructions for safe and effective use. It includes warnings, cautions, and guidance for installation and maintenance.