Who is the manufacturer of 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

3M Healthcare filed the 510(k) submission for 3M RED DOT 2560 & 2570 MONITORING ELECTRODES (K970796).

What is the FDA product code for 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

DRX. It is classified under 21 CFR 870.2360 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like 3M RED DOT 2560 & 2570 MONITORING ELECTRODES?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

3M RED DOT 2560 & 2570 MONITORING ELECTRODES

K970796 · 3M Healthcare · DRX · Apr 9, 1997 · Cardiovascular

Device Facts

Record ID	K970796
Device Name	3M RED DOT 2560 & 2570 MONITORING ELECTRODES
Applicant	3M Healthcare
Product Code	DRX · Cardiovascular
Decision Date	Apr 9, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2360
Device Class	Class 2

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.

Device Story

Self-adhesive, single-use, non-sterile disposable ECG monitoring electrodes; silver/silver chloride sensing element; conductive sticky gel; pressure-sensitive adhesive foam tape; 2570 model includes abrader. Used by clinicians for short or long-term ECG signal acquisition. Electrodes adhere to patient skin to facilitate electrical signal transmission to ECG monitoring equipment. Benefits include reliable signal monitoring for up to 5 days.

Clinical Evidence

Bench testing only. Electrical performance verified against ANSI/AAMI EC12/1991 standards for disposable ECG electrodes. Biocompatibility assessed per ISO 10993-1.

Technological Characteristics

Silver/silver chloride sensing element; conductive sticky gel; pressure-sensitive adhesive foam tape; 2570 includes abrader. Complies with ANSI/AAMI EC12/1991. Non-sterile, single-use.

Indications for Use

Indicated for patients requiring short or long-term (up to 5 days) ECG monitoring in any clinical setting where standard ECG electrodes are utilized.

Regulatory Classification

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.

Special Controls

*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.

Related Devices

K971444 — 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES · 3M Medical Products Group · Jun 11, 1997
K020003 — ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE · Bio Protech, Inc. · Nov 7, 2002
K982521 — SKINTACT ECG ELECTRODES, S&W ECG ELECTRODES · Leonhard Lang Co. · Oct 26, 1999
K030509 — SKINTACT ECG TAB ELECTRODE · Leonhard Lang GmbH · Mar 4, 2003
K083148 — TELECTRODE WET GEL ECG ELECTRODE · Bio Protech, Inc. · Nov 7, 2008

Submission Summary (Full Text)

{0} 510(K) Premarket Notification Submission 3M Red Dot™ 2560 & 2570 Monitoring Electrodes KG70796 Page 52 of 54 # 510(K) Summary APR - 9 1997 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 self-adhesive, 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.