(268 days)
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Not Found
No
The provided text describes a standard 3-channel digital ambulatory ECG recorder (Holter monitor) and its intended uses for evaluating cardiac arrhythmias. There is no mention of AI or ML in the description of the device or its functionality.
No.
The device is used for diagnostic purposes by recording electrocardiographic data to document a patient's arrhythmia, not for direct treatment or therapy.
Yes
The text explicitly states that Holter monitoring is indicated for "evaluation of suspected or known cardiac rhythm disorders" and "diagnostic studies to determine whether a new cardioactive drug has either antiarrhythmic or proarrhythmic effects." These uses clearly fall under the definition of a diagnostic device.
No
The device description explicitly states "3 CHANNEL DIGITAL AMBULATORY ECG RECORDER," which indicates a hardware component for recording ECG data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is an "Electrocardiographic recording" and a "3 CHANNEL DIGITAL AMBULATORY ECG RECORDER". This means it records electrical activity of the heart from the surface of the body.
- Intended Use: The intended use describes monitoring cardiac rhythm and detecting arrhythmias, which is done by placing electrodes on the patient's skin, not by analyzing samples taken from the body.
Therefore, this device falls under the category of in vivo diagnostic devices, as it performs measurements directly on the living patient.
N/A
Intended Use / Indications for Use
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 OT 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.
Product codes
74 DSH
Device Description
3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
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
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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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
JAN 2 9 136
Mr. Jordan Gavrielides President Galix Biomedical Instrumentation, Inc. 2555 Collins Avenue Suite C-5 33140 Miami Beach, FL
K971670 Re : GBI-3S Ambulatory ECG Holter Recorder Regulatory Class: II 74 DSH Product Code: January 5, 1998 Dated: Received: January 7, 1998
Dear Mr. Gavielides:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality . System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions.
Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Jordan Gavrielides
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding described in your 510(x) promation vevice to a legally marketed or business cresults in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation "Misbranding by reference to premarket notification" entitled, (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
MH6101A
- 2 9 900
Page 1 of 3
510 (k) Number: K 971670
Device Name: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
Indications for use:
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.
Continue in page 2..
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. Segarra NMD
510(k) Number
Presciption Use V (Per 21 CFR 801.109)
» ﺍ
OR
Over-The-Counter Use (Optional Format 1-2-96)
3
510 (k) Number: K 971670
Device Name: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
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 OT 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.
4
510 (k) Number: K 971670
:
Device Name: 3 CHANNEL DIGITAL AMBULATORY ECG RECORDER
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.