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The primary use of ambulatory monitoring are listed below.

• 1 Evaluation of suspected of known cardiac rhythm disorders.
• 2 Evaluation of symptoms suggestive of an arrhythmia disorder.
• 3 Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death.
• 4 Patients who have suspected pacemaker malfunction may also require long term monitoring to document an intermittent episode of failure to capture or failures to sense.
• 5 Evaluation of chest pain.
• 6 Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment.
• 7 The Galix GBI-3SM Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record Very High Resolution ECG, at a sampling rate of 1000 samples per second.

The ECG data stored is then analyzed with the Late Potential Software.

Warning: The clinical significance of Late Potential measures should be determined by a qualified physician.

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This document is a 510(k) summary for the Galix Biomedical Instruments Inc., 3 Channel Digital Ambulatory ECG Recorder, GBI-3SM. It does NOT contain the detailed information required to answer your specific questions regarding acceptance criteria and the study used to prove the device meets them. This document is primarily an Indication for Use statement and the FDA's letter of "substantial equivalence" determination, comparing it to legally marketed predicate devices.

Specifically, the document does not provide:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method for the test set.
5. Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes.
6. Information on standalone algorithm performance.
7. The type of ground truth used in studies (beyond stating "clinical significance of Late Potential measures should be determined by a qualified physician").
8. Sample size for the training set.
9. How ground truth for the training set was established.

Therefore, based on the provided text, I cannot answer your questions.

To obtain this information, you would typically need to refer to the full 510(k) submission, specifically the sections detailing performance testing and clinical data, which are not included in this excerpt.

Ask a specific question about this device

Electrocardiographic recording to document a patient's arrhythmia has had widespread application as a non invasive tool in cardiology. A patient's arrhythmia may be with application as a lectrocardingram; however the use of techniques with longer monitoring periods, usually for 24 hours or more (Holter monitoring), increases the likelihood of documenting the arrhythmia. Since the original description by Dr Norman Holter in the 1950 s, Holter monitoring or continuous ambulatory electrocardiographic monitoring has been a useful technique for patients with cardiac arrhythmias.

Indications for Holter monitoring are listed in Table I. The primary use of ambulatory monitoring is for the evaluation of cases of suspected cardiac rhythm disturbances. Since these archythmias can be episodic, detection of complex ventricular arrhythmias will vary, depending of the duration of the recording.

A 24 - hour Holter recording permits the recording of cardiac rhythm during both sleep and awake states. Thus the variation of arrhythmias during waking hours and during physical and mental stress can be demonstrated.

TABLE I: Indications for Holter monitoring
1 - Evaluation of suspected or known cardiac rhythm disorders.
2 - Evaluation of symptoms suggestive of an arrhythmia disorder.
3 - Evaluation of clinical syndromes in which arrhythmias may increase the risk of sudden death.
4 - Evaluation of pacemaker function.
5 - Evaluation of chest pain.

Holter monitors are used in a serial fashion to judge the efficacy of antiarrhythmic drug treatment.

Holter monitors are frequently used as part of diagnostic studies to determine whether a new cardioactive drug has either antiarrhythmic or proarrhythmic effects. Because of spontaneous variability of a patient's arrhythmia these studies are often limited and should be viewed with caution.

Studies that have used longer monitoring periods may be more accurate.

Holter monitors may also be used for screening patients with symptoms suggestive of sinus node or AV node conduction problems.

Holter monitoring can be useful in correlating episodes of chest pain with diagnostic ST segment abnormalities.

Holter recordings are also used to screen patients who have clinical syndromes in which the presence of an arrhythmia may increase the risk of sudden death.

Such situations include the period after myocardial infarction." Congestive heart failure and dilated cardiomyopathy, hypertrophic obstructive cardiomyopathy, and the congenital prolonged QT syndrome.

Holter recordings may also be useful in screening for arrhythmias in patients with the mitral valve prolapse syndrome and in those recovering from coronary artery bypass surgery.

Holter monitoring can also be used to screen patients with symptomatic or asymptomatic Wolff - Parkinson - White syndrome.

Patients who have suspected pacemaker malfunction may also require longterm monitoring to document an intermittent episode of failure to capture or failure to sense. These abnormalities and oversensing problems may be easily documented during ambulatory monitoring.

3 CHANNEL DIGITAL AMBULATORY ECG RECORDER

This document is a 510(k) premarket notification decision letter from the FDA regarding the GBI-3S Ambulatory ECG Holter Recorder. It indicates that the device has been found substantially equivalent to predicate devices, allowing it to be marketed.

However, this document does not contain information about acceptance criteria, device performance, a study to prove acceptance criteria, sample sizes, ground truth establishment, or any comparative effectiveness studies.

The document primarily covers:

• The FDA's decision to clear the device for marketing.
• The regulatory classification (Class II).
• General controls and applicable regulations.
• Indications for use of the device (Holter monitoring).

Therefore, based solely on the provided text, I cannot answer your specific questions regarding acceptance criteria and performance studies. The information you're asking for would typically be found in the 510(k) submission itself or a separate performance study report, neither of which are provided here.

Ask a specific question about this device