3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM

• K Number: K092853
• Device Name: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER MODEL GALIX GBI-3SM
• Manufacturer: GALIX BIOMEDICAL INSTRUMENTATION, INC.
• Date Cleared: 2010-07-09 ( 296 days)
• Product Code: MLO
• Regulation Number: 870.2800
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K010738 , K902598 , K002347 , K933427 , K020150 , K050851 , K073200 , K083163 , K100223 , K113840
• Predicate For: N/A

Intended Use

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.

Device Description

Not Found

AI/ML Overview

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.

Regulation Number and Section

§ 870.2800 Medical magnetic tape recorder.

(a)
Identification. A medical magnetic tape recorder is a device used to record and play back signals from, for example, physiological amplifiers, signal conditioners, or computers.(b)
Classification. Class II (performance standards).