3M RED DOT ECG LEAD WIRES A

K954900 · Minnesota Mining and Mfg. Co. · DSA · Jul 15, 1996 · Cardiovascular

Device Facts

• Record ID: K954900
• Device Name: 3M RED DOT ECG LEAD WIRES A
• Applicant: Minnesota Mining and Mfg. Co.
• Product Code: DSA · Cardiovascular
• Decision Date: Jul 15, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2900
• Device Class: Class 2

Indications for Use

The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.

Device Story

Device consists of patient lead wires; connects ECG electrodes to ECG monitor trunk cables or directly to monitors/transmitters; conducts patient ECG signals. Used in clinical settings; operated by healthcare professionals. Configurations include disposable, reusable, x-ray translucent, or non-x-ray translucent options. Facilitates continuous ECG signal transmission for patient monitoring.

Clinical Evidence

Bench testing only. Device meets AAMI specifications for flex life, tensile strength, and electrical continuity.

Technological Characteristics

Electronic conductors and insulating materials; configurations include disposable, reusable, x-ray translucent, and non-x-ray translucent. Passive electrical conduction. Meets AAMI specifications for flex life, tensile strength, and electrical continuity.

Indications for Use

Indicated for patients requiring ECG monitoring; connects ECG electrodes to monitoring equipment to conduct ECG signals.

Regulatory Classification

Identification

A patient transducer and electrode cable (including connector) is an electrical conductor used to transmit signals from, or power or excitation signals to, patient-connected electrodes or transducers.

Predicate Devices

• Tronomed (K771645)
• Vital Connections (K880320)

Submission Summary (Full Text)

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510(k) Submission
3M Red Dot ECG Lead Wires
K954900
JUL 15 1996

# 510(k) Summary
## 3M Red Dot™ ECG Lead Wires

1. Name and address of Device Manufacturer submitting 510(k) Notification:

3M
Medical Products Group
3M Health Care
3M Center
St. Paul, MN 55144-1000

2. Regulatory Correspondent of Device Manufacturer:

Linda Johnsen
Senior Regulatory Affairs Associate
3M Health Care
Building 275-3E-08
St. Paul, MN 55144-1000
612 737-4376

3. Date Summary was prepared: October 23, 1995

4. Name of Devices:

(a) 3M Red Dot™ ECG Lead Wires
(b) Common, usual name: Lead Wires
(c) Proprietary names of the devices: 3M Red Dot™ ECG Lead Wires
(d) Regulatory Class: ECG Lead Wires have been classified as a Class II device. See 21 C.F.R. 870.2360. This device was reviewed by the Cardiovascular Device Panel.

5. Predicate Devices to which 3M is claiming Substantial Equivalence:

Tronomed 510(k) K771645 P/N D-3A1505-8-C
Vital Connections 510(k) K880320 P/N RTR 5925

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{1}

510(k) Submission
3M Red Dot ECG Lead Wires

6. Description of the Devices:

Components of the Device:

This device is a patient lead wire. These patient lead wires are manufactured from a variety of electronic conductors, electronic insulating materials, patient end termination and patient lead wire connectors. This variety of materials and assembly configurations is needed to allow for designs that would be disposable, reusable, x-ray translucent or non x-ray translucent. These materials are all typically and commonly used by other companies participating in the market. The following matrix demonstrates for the purpose of substantial equivalence the similarity of product features:

| PRODUCT FEATURE | 3M DISPOSABLE | 3M STANDARD | 3M HIGH FLEX | D-3A1505-8-C Tronomed | RTR 6925 Vital Connections |
| --- | --- | --- | --- | --- | --- |
| WIRE | YES | YES | YES | YES | YES |
| X-RAY TRANSLUCENT | YES | YES | YES | NO | YES |
| SHIELDED | YES | YES | YES | YES | YES |
| PATIENT LEADWIRE CONNECTOR | YES | YES | YES | YES | YES |
| PATIENT END TERMINATION | YES | YES | YES | YES | YES |

Principle of Operation:

The ECG lead wire is intended only for the purpose of connecting an ECG monitoring electrode to either an ECG monitor trunk cable or directly into a monitor or transmitter and conducting the patients ECG signal.

7. Effectiveness:

3M will meet the minimum requirements established by proposed AAMI specifications as to Flex Life, Tensile Strength, and Electrical Continuity.

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