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K Number
K954900
Device Name
3M RED DOT ECG LEAD WIRES A
Manufacturer
MINNESOTA MINING AND MFG. CO.
Date Cleared
1996-07-15

(264 days)

Product Code
DSA
Regulation Number
870.2900
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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 Description
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.
More Information

K771645, K880320

Not Found

No
The document describes a simple ECG lead wire and its materials, with no mention of AI or ML capabilities.

No
The device is described as an ECG lead wire intended for connecting an ECG monitoring electrode to a monitor and conducting the patient's ECG signal. It does not perform any therapeutic function; its purpose is solely for signal transmission for monitoring.

No
Explanation: This device is an ECG lead wire, which is used to connect an ECG monitoring electrode to a monitor to conduct the patient's ECG signal. It facilitates the transfer of a signal but does not perform any diagnostic analysis or interpretation of the signal itself.

No

The device description explicitly states it is a patient lead wire manufactured from physical materials like electronic conductors and insulating materials, indicating it is a hardware device.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is clearly stated as connecting an ECG electrode to a monitor or transmitter to conduct the patient's ECG signal. This is a direct connection to the patient for physiological monitoring, not for testing samples in vitro (outside the body).
  • Device Description: The description focuses on the physical components and function of a lead wire for electrical signal transmission from the patient.
  • Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process that would be performed in vitro.

IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This ECG lead wire does not fit that description.

N/A

Intended Use / 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.

Product codes

Not Found

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K771645, K880320

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

§ 870.2900 Patient transducer and electrode cable (including connector).

(a)
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.(b)
Classification. Class II (performance standards).

0

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

K954900

11 1 5 1996

510(k) Summarv 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
    1. Regulatory Correspondent of Device Manufacturer:
      Linda Johnsen Senior Regulatory Affairs Associate 3M Health Care Buildina 275-3E-08 St. Paul, MN 55144-1000 612 737-4376
    1. Date Summary was prepared: October 23, 1995
    1. Name of Devices:

7

  • ** (a) 3M Red Dot™ ECG Lead Wires
    • (b) Common, usual name: Lead Wires
    • Proprietary names of the devices: 3M Red Dot™ ECG Lead Wires (c)
    • Regulatory Class: ECG Lead Wires have been classified as a (d) Class II device. See 21 C.F.R. 870.2360. This device was reviewed by the Cardiovascular Device Panel.
  • ട്. Predicate Devices to which 3M is claiming Substantial Equivalence:
Tronomed510(k) K771645P/N D-3A1505-8-C
Vital Connections510(k) K880320P/N RTR 5925

-30-

1

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 5925
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.
    1. Effectiveness:

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