3M RED DOT ECG LEAD WIRES A

• 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
• Type: Traditional
• Panel: Cardiovascular
• Reference & Predicate Devices: K771645 , K880320
• Predicate For: N/A

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.

AI/ML Overview

The provided text describes a 510(k) submission for 3M Red Dot™ ECG Lead Wires and does not contain information about acceptance criteria or a study proving device performance against such criteria. The document focuses on the device description, regulatory classification, and predicate devices.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

Summary

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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
• 2. 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
• 3. Date Summary was prepared: October 23, 1995
• 4. 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:

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

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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:

PRODUCTFEATURE	3MDISPOSABLE	3MSTANDARD	3MHIGH FLEX	D-3A1505-8-CTronomed	RTR 5925Vital Connections
WIRE	YES	YES	YES	YES	YES
X-RAY TRANSLUCENT	YES	YES	YES	NO	YES
SHIELDED	YES	YES	YES	YES	YES
PATIENT LEADWIRECONNECTOR	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.

Regulation Number and Section

§ 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).