(486 days)
Not Found.
Not Found.
No
The summary does not mention AI, ML, or any related terms, and the description focuses on basic physiological measurement and recording.
No
The device is a cardiotachometer and ECG recorder, which are diagnostic tools for measuring and recording heart activity, not for treating conditions.
Yes
The device is described as a "cardiotachometer and ECG recorder," and its performance studies mention "accuracy in measuring intervals" and "concordance... with scored values." These functions are for measuring and recording physiological signals to aid in diagnosis.
No
The device description explicitly states it is operated with two 9 Volt batteries, indicating it includes hardware components beyond just software.
Based on the provided information, the Log-a-Rhythm Model 100 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description states the Log-a-Rhythm Model 100 is a cardiotachometer and ECG recorder that is "completely non-invasive". This means it interacts directly with the patient's body (to record electrical activity of the heart) rather than analyzing a sample taken from the body (like blood, urine, or tissue).
- The intended use is to measure heart rate and record ECGs. This is a physiological measurement taken directly from the patient, not an analysis of a biological specimen.
Therefore, the Log-a-Rhythm Model 100 falls under the category of a medical device that interacts with the patient's body, not an IVD.
N/A
Intended Use / Indications for Use
Not Found.
Product codes
Not Found.
Device Description
Log-a-Rhythm Model 100 is a cardiotachometer and ECG recorder. It is completely non-invasive and is operated with two 9 Volt batteries.
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
Not Found.
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
Its accuracy in measuring intervals was tested using the American Heart Association ECG database, which has been scored by medical experts.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Concordance of Log-a-Rhythm with the scored values was better than 97 percent.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Not Found.
Reference Device(s)
Not Found.
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
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.(b)
Classification. Class II (performance standards).
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.