(36 days)
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.
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.
This document describes the safety and efficacy of the 3M Red Dot™ 2560 and 2570 Monitoring Electrodes. However, it does not provide the information requested in the prompt regarding acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, or ground truth for a study proving the device meets acceptance criteria.
The document primarily focuses on:
- Biocompatibility Testing: Stating that materials were selected based on ISO 10993-1.
- Performance Testing: Stating that electrical performance meets ANSI/AAMI EC12/1991 for Disposable ECG Electrodes.
Therefore, I cannot populate the requested tables and information based on the provided text. The prompt asks for details related to a study proving the device meets acceptance criteria, which is not present in this 510(k) summary excerpt beyond a general statement of compliance with a standard.
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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.
§ 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.