3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES

K971444 · 3M Medical Products Group · DRX · Jun 11, 1997 · Cardiovascular

Device Facts

• Record ID: K971444
• Device Name: 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES
• Applicant: 3M Medical Products Group
• Product Code: DRX · Cardiovascular
• Decision Date: Jun 11, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring. The 2234 and 2266 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 3 days) monitoring. These devices are a single use, non-sterile, and disposable ECG electrode. These devices adhere to the patient's skin. These electrodes will include the precaution statement: USA Federal Law restricts this device to sale by or on the order of a physician.

Device Story

Self-adhesive, single-use, non-sterile, disposable ECG electrodes; silver/silver chloride sensing element; conductive gel; carbon-modified snap. Applied to patient skin for short or long-term (up to 3 days) ECG signal acquisition. Used in clinical settings for standard ECG monitoring procedures. Output is electrical signal transmission from patient to monitoring equipment. Benefits include radiolucency for imaging compatibility and secure skin adhesion for continuous monitoring.

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 gel; carbon-modified snap; self-adhesive tape backing. Complies with ANSI/AAMI EC12/1991. Biocompatibility per ISO 10993-1. Single-use, non-sterile.

Indications for Use

Indicated for patients requiring ECG monitoring, including short-term and long-term (up to 3 days) applications where standard ECG monitoring electrodes are used.

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.

Predicate Devices

• 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312)

Submission Summary (Full Text)

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## 510(k) Summary

1971444

Name and address of device Manufacturer submitting 510(k) Notification: ر ال رب ال رب / 1 / 2 / 2 / 7 / 7 / 7 / 7 / 7 / 7 / 7 / 7 / 7 / / / / / / / / / / / / / / / / / / / /

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

Requiatory Correspondent of Device Manufacturer:

Linda Johnsen Senior Regulatory Affairs Associate 612 737-4376

Date Summary was prepared: April 17, 1997

Name of Device: 3M™ - Red Dot™ 2234 Radiolucent Monitoring Electrode with Clear Tape and 3MTM Red Dot™ 2266 Radiolucent Monitoring Electrode with Breathable Comfort Back

Classification: Electrocardiograph electrodes, class II, 21 CFR 870.2360

Description: The 3MTM Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are a selfadhesive, non-sterile, single use, disposable electrode which includes a silver/silver chloride sensing element and conductive gel. These electrodes include a self-adhesive tape backing which holds the conductive elements of the electrode in place on the patient's skin for short or long term (up to 3 days) for ECG monitoring. The 3MTM Red Dot™ 2234 & Radiolucent Monitoring Electrode with Clear Tape is composed of the same materials as the predicate device 3MTM Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the snap which has been modified to include a higher percentage of carbon. The 3M™ Red Dot™ 2266 Radiolucent Monitoring Electrode with Breathable Comfort Backing is composed of the same materials as the predicate device 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode (K939312) with the exception of the sensing snap which has been modified to include a higher percentage of carbon and the tape backing and adhesive.

Indications for use: The 3MTM Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring Procedures. The 2234 & 2266 Radiolucent Monitoring 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 3 days) monitoring.

Safety and Efficacy: (Devices are acceptable for their intended use based on testing results)

## Biocompatibility Testing:

The biological safety of the 3M™ Red Dot™ 2234 and 2266 Radiolucent 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 3MTM Red Dot™ 2234 and 2266 Radiolucent Monitoring Electrodes meets the voluntary standard requirements under ANSI/AAMI EC12/1991, for Disposable ECG Electrodes.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 11 1997

Ms. Linda Johnsen 3M Health Care 3m Center, Building 275-3E=08 ... ... St. Paul, Minnesota 55144-1000

Re: K971444 * 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes (Modified) Regulatory Class: II (two) Product Code: 74 DRX Dated: April 18, 1997 Received: April 21, 1997

Dear Ms. Johnsen:

We have reviewed your Section 510 (k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 A substantially equivalent determination assumes compliance to 895. with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market. ------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K971444 510(k) Number (if Known):

Device Name: 3M™ Red Dot™ 2234 Radiolucent Monitoring Electrode with Clear Tape and 3MM Red Doling 2266 Radiolucent Monitoring Electrode with Breathable Comfort Back

Indications For Use:

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The 3M™ Red Dot™ 2234 & 2266 Radiolucent Monitoring Electrodes are intended for use in ECG Monitoring. The 2234 and 2266 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 3 days) monitoring.

These devices are a single use, non-sterile, and disposable ECG electrode. These devices adhere to the patient's skin.

These electrodes will include the precaution statement: USA Federal Law restricts this device to sale by or on the order of a physician.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

• Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-------------------------------------------------------------------|---------|
| Division of Cardiovascular, Respiratory, and Neurological Devices | |
| 510(k) Number | K971444 |

| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---------------------------------------|---|
| OR | |
| Over-the Counter Use | |

(Optional Format 1-2-96)