(36 days)
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No
The device description and intended use clearly define the product as passive ECG monitoring electrodes, with no mention of data processing, analysis, or any computational capabilities that would involve AI or ML.
No
The device is described as "Monitoring Electrodes" for "ECG Monitoring" and its purpose is related to "electrical performance" for "Disposable ECG Electrodes", indicating a diagnostic rather than therapeutic function.
No
The device is described as an "ECG Monitoring Electrode" intended for "ECG Monitoring," which are primarily used for collecting physiological signals, not for diagnosing conditions. It facilitates the monitoring process but does not interpret the data to make a diagnosis.
No
The device description explicitly states it is a self-adhesive, non-sterile, single-use disposable electrode with physical components like a silver/silver chloride sensing element, conductive sticky gel, and pressure-sensitive adhesive foam tape. This indicates it is a hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ECG Monitoring." This involves measuring electrical signals from the patient's body, which is a physiological measurement, not an in vitro test of a sample taken from the body.
- Device Description: The description details a self-adhesive electrode applied to the patient's skin to capture electrical signals. This is consistent with a device used for direct physiological monitoring.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or performing tests on substances outside of the body, which are hallmarks of IVD devices.
Therefore, the 3M Red Dot™ 2560 & 2570 Monitoring Electrodes are devices used for physiological monitoring, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The 3M Red Dot™ 2560 & 2570 Monitoring Electrodes are intended for use in ECG Monitoring. The 2560 and 2570 electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 5 Days) monitoring.
Product codes
870.2360
Device Description
The 3M Red Dot™ 2560 & 2570 ECG Monitoring Electrodes are a selfadhesive, non-sterile, single use disposable electrode which includes a silver/silver chloride sensing element and conductive sticky gel. These electrodes include a pressure sensitive adhesive foam tape which hold the conductive elements of the electrode in place on the patient's skin for short or long term ECG procedures.
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 electrical performance of the 3M Red Dot™ 2560 and 2570 Monitoring Electrodes meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG Electrodes.
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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510(K) Summary
Name and address of device Manufacturer submitting 510(k) Notification:
3M Health Care 3M Center St. Paul. MN 55144-1000
Regulatory Correspondent of Device Manufacturer:
Linda Johnsen Senior Regulatory Affairs Associate 612 737-4376
Date Summary was prepared: March 3, 1997
Name of Device:
3M Red Dot™ 2560 Monitoring Electrode with Foam Tape and Sticky Gel
3M Red Dot™ 2570 Radiolucent Monitoring Electrode with Foam Tape, Sticky Gel and Abrader
Classification: Electrocardiograph electrodes, class II, 21 CFR 870.2360
Description: The 3M Red Dot™ 2560 & 2570 ECG Monitoring Electrodes are a selfadhesive, non-sterile, single use disposable electrode which includes a silver/silver chloride sensing element and conductive sticky gel. These electrodes include a pressure sensitive adhesive foam tape which hold the conductive elements of the electrode in place on the patient's skin for short or long term ECG procedures.
Intended Use: The 3M Red Dot™ 2560 & 2570 Monitoring Electrodes are intended for use in ECG Monitoring. The 2560 and 2570 electrodes can be used in all ECG applications where standard ECG monitoring electrodes are used. These electrodes can be used for short term and long term (up to 5 Days) monitoring.
Safety and Efficacy:
Biocompatibility Testing:
The biological safety of the Red Dot™ 2560 and 2570 Monitoring Electrodes has been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of Part-1 of ISO 10993-1, "Biological Evaluation of Medical Devices".
Performance Testing:
The electrical performance of the 3M Red Dot™ 2560 and 2570 Monitoring Electrodes meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG Electrodes.