(322 days)
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No
The summary describes a passive electrode device for transmitting electrical signals, with no mention of processing or analysis that would involve AI/ML.
No
Explanation: The device is described as an ECG electrode used for detecting and transmitting electrical impulses to an electrocardiograph monitor for diagnostic purposes (recording and plotting the electric activity of the myocardium), not for treating a condition.
Yes
The device (ECG electrodes) is used to detect and transmit electrical impulses to electrocardiograph monitors, which are then used to record the electrical activity of the myocardium to detect abnormal transmission of impulses. This process is a key step in diagnosing heart conditions.
No
The device description clearly outlines physical components like foam, cloth, vinyl, adhesive, snaps, and hydrogel, indicating it is a hardware device (electrodes).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the electrodes are used with electrocardiograph monitors to record the electrical activity of the myocardium (heart muscle). This is a measurement of physiological signals from within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details the physical components of the electrodes, which are designed to be placed on the skin to pick up electrical signals.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to directly measure electrical activity from the body.
N/A
Intended Use / Indications for Use
LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product. The function of the LMI Medical ElectroBlue® Electrodes is to detect and transmit these small electrical impulses to the electrocardiograph monitors where they are processed and plotted.
Product codes
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Device Description
The products are all the same in their construction using medical grade foam, polypropylene cloth, clear vinyl, medical grade adhesive, silver coated carbon loaded ABS snaps, and a conductive hydrogel with a polyurethane cover release liner.
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
The safety issues of these devices were evaluated to the ANSI/AAMI specification EC12-1991 whereby this standard "establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiograph (ECG) or ECG monitoring ". The ANSI/AAMI standard EC12-1991 covers all facets of Disposable ECG electrodes. The LMI Medical ElectroBlue® disposable ECG electrodes were tested according to section: 3.2.2 "Electrical Performance", which covers AC impedance, DC offset Voltage, Combined offset instability and internal noise, Defibrillation overload recovery, Bias current tolerance; section 3.3.1 which covers Biological response; Section 4.2 which covers Performance, Packaging and shelf life, Tests for electrical performance; and section 4.3 Safety requirements, which covers Biological response evaluation, Cytotoxicity, Sensitization, Irritation, and Intracutaneous reactivity. LMI Medical's ElectroBlue® disposable ECG electrodes met these listed requirements of the ANSI/AAMI standard EC12-1991. These results are on file at LMI Medical.
Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.
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Image /page/0/Picture/0 description: The image shows the date JUN 21 1998 on the left side. On the right side of the image, the text "LMI MEDICAL" is visible. There are also some graphic elements above the text, including a triangle and other shapes. The text and graphics are in black and white.
SUMMARY OF SAFETY AND EFFECTIVENESS
510(k) Premarket Notification ElectroBlue® ECG Electrodes LMI Medical Division of Ludlow Technical Products 4275 Airwest Drive S. E. Grand Rapids, MI 49512
LMI Medical considers their ElectroBlue® ECG Electrodes to be safe and effective for use with electrocardiograph monitors which are used for recording the electric activity of the myocardium to detect abnormal transmission of small electrical impulses through the conductive tissue surrounding the heart, when used according to the intended procedures as related in the instructions accompanying the product. The function of the LMI Medical ElectroBlue® Electrodes is to detect and transmit these small electrical impulses to the electrocardiograph monitors where they are processed and plotted.
The safety issues of these devices were evaluated to the ANSI/AAMI specification EC12-1991 whereby this standard "establishes minimum labeling, safety, and performance requirements for disposable electrodes used for diagnostic electrocardiograph (ECG) or ECG monitoring ". The ANSI/AAMI standard EC12-1991 covers all facets of Disposable ECG electrodes. The LMI Medical ElectroBlue® disposable ECG electrodes were tested according to section: 3.2.2 "Electrical Performance", which covers AC impedance, DC offset Voltage, Combined offset instability and internal noise, Defibrillation overload recovery, Bias current tolerance; section 3.3.1 which covers Biological response; Section 4.2 which covers Performance, Packaging and shelf life, Tests for electrical performance; and section 4.3 Safety requirements, which covers Biological response evaluation, Cytotoxicity, Sensitization, Irritation, and Intracutaneous reactivity. LMI Medical's ElectroBlue® disposable ECG electrodes met these listed requirements of the ANSI/AAMI standard EC12-1991. These results are on file at LMI Medical.
The LMI Medical ElectroBlue® disposable ECG electrodes are substantially equivalent to products existing in the market place. NDM and Nikomed are two companies which offer products like LMI Medical ElectroBlue® disposable ECG electrodes. The LMI Medical electrode functions the same as the NDM and the Nikomed disposable ECG electrodes. The products are all the same in their construction using medical grade foam, polypropylene cloth, clear vinyl, medical grade adhesive, silver coated carbon loaded ABS snaps, and a conductive hydrogel with a polyurethane cover release liner.
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92
Waiver of Liability
Date: 08/02/95
Warren Howland Director of Development, Hydrogels