LOG-A-RYTHM MODEL 100 AND MODEL 1001

K952790 · Nian-Crae, Inc. · DRT · Oct 17, 1996 · Cardiovascular

Device Facts

• Record ID: K952790
• Device Name: LOG-A-RYTHM MODEL 100 AND MODEL 1001
• Applicant: Nian-Crae, Inc.
• Product Code: DRT · Cardiovascular
• Decision Date: Oct 17, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Indications for Use

Log-a-Rhythm Model 100 is a cardiotachometer and ECG recorder.

Device Story

Log-a-Rhythm Model 100; non-invasive cardiotachometer and ECG recorder; battery-powered (two 9V). Device measures/stores consecutive beat-to-beat intervals during sinus rhythm. Data transferred to computer (80386 processor or higher) running display software; software calculates, displays, and prints heart rate and RR interval data. Used by clinicians for cardiac monitoring; provides objective interval data to assist in rhythm assessment.

Clinical Evidence

Bench testing only. Accuracy validated using American Heart Association (AHA) ECG database; concordance with expert-scored values reported at >97%.

Technological Characteristics

Non-invasive cardiotachometer/ECG recorder; battery-powered (2x 9V). Software-based processing on PC (80386+).

Indications for Use

Indicated for patients requiring non-invasive measurement and storage of consecutive beat-to-beat intervals during sinus rhythm.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

{0}

K95 2790

OCT 17 1996

Summary & Certification

OCT 17 1996

# Summary of safety and effectiveness

Log-a-Rhythm Model 100 is a cardiotachometer and ECG recorder. It is completely non-invasive and is operated with two 9 Volt batteries. Use of Log-a-Rhythm Model 100 poses no hazards, electrical, chemical, or physical, to the patient. Log-a-Rhythm is effective in accurately measuring and storing consecutive beat-to-beat intervals during sinus rhythm. Its accuracy in measuring intervals was tested using the American Heart Association ECG database, which has been scored by medical experts. Concordance of Log-a-Rhythm with the scored values was better than 97 percent. Log-a-Rhythm display software calculates, displays, and optionally prints the heart rate and RR interval data using a computer with a 80386 processor or higher.