(581 days)
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No
The summary does not mention AI, ML, or related terms, and the description focuses on standard ECG recording and analysis.
No
Explanation: The device is a diagnostic tool for recording ECG data and analyzing late potentials. It does not provide any therapy or treatment.
Yes
The device is described as a "Digital Holter Recorder" intended to record ECG data, which is then "analyzed with the Late Potential Software." The warning states, "The clinical significance of Late Potential measures should be determined by a qualified physician," implying that the device provides data that aids in the diagnosis of cardiac conditions.
No
The device description explicitly states "GALIX GBI - 3S - LP Digital Holter Recorder," indicating a hardware component (the recorder) is part of the device. While it includes "Late Potential Software" for analysis, the device itself is not solely software.
Based on the provided information, the Galix GBI-3S-LP Digital Holter Recorder is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The Galix GBI-3S-LP records electrical activity of the heart (ECG) directly from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to record ECG data for analysis, which is a direct measurement of a physiological process, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device that performs a physiological measurement, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of 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.
Product codes
74 MLO
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.)
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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.
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 5 2001
Mr. Jordan Gavrielides Galix Biomedical Instrumentation, Inc. 2555 Collins Avenue, Suite C-5 Miami Beach, FL 33140
K992706 Re: GALIX GBI -- 3S - LP Regulatory Class: II (two) Product Code: 74 MLO Dated: February 12, 2001 Received: February 20, 2001
Dear Mr. Gavrielides:
We have reviewed your Section 510(k) notification of intent to market the device referenced we nave and we have determined the device is substantially equivalent (for the indications for use above and we nave acteriment of the marketed predicate devices marketed in interstate commerce stated in the enoroute, to regarly and date of the Medical Device Amendments, or to devices that prove to may 20, 1977, 10, 1977, 19, 1977, 1997, 1999, 1999, 1999, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls Cosments of the Act. The general controls provisions of the Act include requirements for annual provisions of the Fea. "The generood 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 ( remarket rippt vary will be of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good A subscribury Practice requirements, 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 mspections, the Four and Diam may result in regulatory action. In addition, FDA may publish
1
Page 2 - Mr. Jordan Gavrielides
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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed nonicate device results 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 entitled "Misbranding by reference to premarket notification"(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/dsma/dsmamain.html".
Sincerely yours,
A. Htip Rhodes
James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
GALIX BIOMEDICAL INSTRUMENTATION, INC.
2555 Collins Avenue Suite C-5 Miami Boach, FL 33140 U,S.A. Phone Nº (305) 534-5905 Fax Nº (305) 534-8222
510 (k) Nº K992706
Device Name: GALIX GBI - 3S - LP
Indications For Use:
The Galix GBI-3S-LP Digital Holter Recorder is intended primarily as a 24 hour ECG Ambulatory Holter Recorder. However the unit has the ability to record up to 10 minutes of 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.
T. Garrido
Jordan Gavrielides
President
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number K992706