(322 days)
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 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 document is a 510(k) Premarket Notification for ElectroBlue® ECG Electrodes. It describes the safety and effectiveness of the device by comparing it to an established standard and existing market products.
Here's an analysis of the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (from ANSI/AAMI EC12-1991) | Reported Device Performance |
|---|---|
| Electrical Performance: | Met all listed requirements |
| - AC impedance | |
| - DC offset Voltage | |
| - Combined offset instability and internal noise | |
| - Defibrillation overload recovery | |
| - Bias current tolerance | |
| Biological Response: | Met all listed requirements |
| - Cytotoxicity | |
| - Sensitization | |
| - Irritation | |
| - Intracutaneous reactivity | |
| Performance, Packaging and Shelf life: | Met all listed requirements |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size used for the test set (i.e., the number of ElectroBlue® ECG Electrodes tested). It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of the testing). It only states that the "results are on file at LMI Medical."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The "ground truth" for this device's performance is established by meeting the objective, standardized physical and biological requirements outlined in the ANSI/AAMI EC12-1991 standard, not by expert consensus on interpretations of data.
4. Adjudication method for the test set
Not applicable. As mentioned above, the performance is measured against objective standards, not subject to expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human interpretation is involved. For ECG electrodes, the effectiveness is determined by their adherence to electrical and biological performance standards.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to an ECG electrode. An ECG electrode is a passive device; it does not have an "algorithm" or standalone "performance" in the sense of AI or software. Its performance is measured by its material properties and ability to conduct electrical signals and be biologically safe.
7. The type of ground truth used
The "ground truth" for demonstrating the device's safety and effectiveness is compliance with the established technical and biological performance requirements of the ANSI/AAMI standard EC12-1991. This standard specifies objective, measurable criteria for various aspects like electrical performance, biological response, and packaging/shelf life.
8. The sample size for the training set
This concept is not applicable to the evaluation of this device. A "training set" is relevant for machine learning algorithms. The ElectroBlue® ECG Electrodes are physical medical devices, and their performance is proven through direct testing against a standard.
9. How the ground truth for the training set was established
Not applicable. As explained above, there is no "training set" in the context of this device's evaluation.
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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
§ 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.