ECLIPSE 4 ELECTROCARDIOGRAPH

K946281 · Burdick, Inc. · LOS · Apr 23, 1996 · CV

Device Facts

• Record ID: K946281
• Device Name: ECLIPSE 4 ELECTROCARDIOGRAPH
• Applicant: Burdick, Inc.
• Product Code: LOS · CV
• Decision Date: Apr 23, 1996
• Decision: SESE
• Submission Type: Traditional
• Attributes: Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Pediatric resting ECG interpretation	—	—	—	Study of 2,196 neonates, infants and children	—	—	—

Indications for Use

The Burdick Eclipse 4 provides adult and pediatric resting ECGs on patients ranging in age from birth to 99 years. It analyzes 10 seconds of data simultaneously from the 12 standard leads and identifies abnormalities.

Device Story

Burdick Eclipse 4; 12-lead electrocardiograph; performs resting ECG analysis. Inputs: 10 seconds of 12-lead ECG data. Processing: Glasgow Royal Infirmary (GRI) pediatric interpretative program; identifies cardiac abnormalities. Output: ECG interpretation/report. Usage: Clinical setting; operated by healthcare professionals. Benefit: Automated pediatric and adult ECG interpretation to assist clinical decision-making.

Clinical Evidence

GRI pediatric criteria based on study of 2,196 neonates, infants, and children. No additional clinical trial data provided for this specific 510(k) submission; relies on literature review and established performance of Glasgow interpretative program.

Technological Characteristics

12-lead electrocardiograph; software-based interpretative program (Glasgow criteria). Connectivity: Standard ECG lead interface. Safety features: Electrical shock protection, mechanical pinch point mitigation.

Indications for Use

Indicated for patients ranging in age from birth to 99 years requiring resting ECG analysis for identification of cardiac abnormalities.

Predicate Devices

• Marquette MAC PC (K943959)

Submission Summary (Full Text)

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K946281

APR 23 1996

k946281

510(k) Summary

## Effectiveness

The pediatric enhancement to the interpretative program was developed by Dr. Peter MacFarlane in the University of Glasgow Department of Cardiology, Glasgow Royal Infirmary (GRI), Glasgow, Scotland. Dr. MacFarlane has been involved in computerized ECG 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 successfully 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.