AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S

K041026 · Ambu, Inc. · DRX · Jun 28, 2004 · Cardiovascular

Device Facts

• Record ID: K041026
• Device Name: AMBU BLUE SENSOR, MRX, ECG ELECTRODE PRODUCT #:MRX-00-S
• Applicant: Ambu, Inc.
• Product Code: DRX · Cardiovascular
• Decision Date: Jun 28, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

Intended Use

The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram. The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent. The electrode is for single patient use only.

Device Story

Ambu Blue Sensor MRX is a disposable, non-sterile ECG electrode. It captures electrical signals from the body surface and transmits them to an ECG processor. The device features a foam backing with adhesive, a wet gel-filled sponge, an Ag/AgCl sensor point, and a carbon-filled polymer snap. The non-ferromagnetic construction ensures MR safety and X-ray translucency. Used in clinical settings where patients undergo MR imaging or X-ray procedures; operated by healthcare professionals. The output is an ECG signal used by clinicians for cardiac monitoring and diagnostic decision-making. Benefits include compatibility with diagnostic imaging environments without requiring electrode removal.

Clinical Evidence

Bench testing only. The device meets AAMI EC12 2000 standards for ECG electrodes.

Technological Characteristics

Materials: Foam backing, adhesive, wet gel, Ag/AgCl sensor point, carbon-filled polymer snap. Non-ferromagnetic construction. Dimensions/Form: Foil sheet with 8 electrodes, packed in 32-count laminated pouches. Standards: AAMI EC12 2000. Connectivity: Passive electrical transmission. Sterilization: Non-sterile.

Indications for Use

Indicated for patients requiring ECG or vectorcardiogram monitoring. Designed for use in MR environments and X-ray procedures. Single patient use only.

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

• Blue Sensor SUPAtab ECG Electrode (K983689)

Submission Summary (Full Text)

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JUN 2 8 2004

# 510(k) Summary

Summery prepared: 31 of March 2004

# Name and address of Device Manufacturer Submitting 510(k) Notification:

Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark

# Regulatory Correspondent of Device Manufacturer:

US Agent:

Sanjay Parikh Technical & Regulatory Affairs Manager

Ambu Inc. 611 N. Hammonds Ferry Road Linthicum, Maryland 21090-1356

Phone: [phone] x 1136 Cell Phone: [phone]

## Name of device:

Ambu® Blue Sensor MRX, ECG electrode Catalogue number: MRX-00-S

#### Classification:

Class II 21 CFR 870.2360 Electrocardiograph electrode.

#### Intended Use:

The Ambu® Blue Sensor MRX electrode is applied to the surface of the body to transmit the electrical signal at the body surface to a processor in order to produce an electrocardiogram or vectorcardiogram.

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The electrode is designed for use in MR environment, therefore the electrode is MR safe, and for X-ray purposes, therefore the electrode is x-ray translucent.

The electrode is for single patient use only.

## Predicate Device:

The predicate device used for the purpose of substantial equivalence under this submission was the Blue Sensor SUPAtab ECG Electrode (K983689).

The MRX electrode under this submission is almost identical with the SUPAtab electrode. The most important change is that the metal snap on the SUPAtab electrode has been changed to a snap made from a carbon filled polymer on the MRX electrode.

Both electrodes have an Ag/AgCl sensor material and they consist of the same materials except from the snap.

The SUPAtab electrode is not X-ray translucent and MR safe, however, the MRX electrode is X-ray translucent and MR safe. Both electrode types meet the AAMI EC12 2000 standard and have a shelf life of 2 years. They are both designed for single patient use only.

## Description:

Each electrode consists of a foam material with an adhesive to be mounted on the patient.

The sensor element consists of a foil furnished with a conductive carbon filled polymer snap and a Ag/AgCl sensor point.

On top of the sensor point a sponge is positioned filled with a wet gel that conducts the signal from the patient further on to the electrode. The choise of materials ensures a non-ferromagnetic electrode which makes it x-ray translucent and MR safe.

The electrodes are delivered on a foil sheet with 8 electrodes and 32 electrodes are packed in a laminated foil pouch.

The electrode is non sterile and intended for single use.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread, which is a common symbol of the United States. The eagle is depicted in a simple, graphic style.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 8 2004

Ambu, Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs Manager 611 North Hammonds Ferry Road Linthicum, MD 21090

Re: K041026

Trade Name: Ambu® Blue Sensor MRX, ECG Electrode Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: April 20, 2004 Received: April 21, 2004

Dear Mr. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 510(x) prematic is substantially equivalent (for the indications for referenced above and have delemined the devices marketed in interstate commerce
use stated in the enclosure) to legally market in the institute in to devices that use stated in the enclosure) to icgaily hiarkets preasure Amendments, or to devices that prior to May 28, 1976, the enactivent date of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provisions of the Features (PMA). You may have been reclassified in accordance with the provisions of the Act. The Act. The general Act (Act) that do not require approval of a premaincomponsisions of the Act. The general therefore, market the device, subject to the general securements for annual registration, listing of devices, good
controls provisions of the Act include requirements for and controls provisions of the Act mende requirements of the misbranding and adulteration.
manufacturing practice, labeling, and prohibitions against misbranding and adulteration

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (See above) more in the energing in the may be vice can be
may be subject to such additional controls. may be subject to such additional controls. Έλλοιή του 89%. In addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to Analy found in the Code of I ederal Regarming your device in the Federal Register

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Page 2 – Mr. Sanjay Parikh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA 's issuance of a substantial order requirements of the Act or
that FDA has made a determination that your device complies with arener. that FDA has made a determination that your device with benevies. You must comply with
any Federal statutes and regulations administical by other for and listing (2) CFR Par any Federal statutes and regulations administered by toner resuation and listing (21 CFR Part 807);
all the Act's requirements, including, but not limited to: reguirements as all the Act's requirements, including, but not institutions as es forth in the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as es forth in the labeling (21 CFR Part 801); good mandations (21 cm if applicable, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electroni systems (QS) regulation (21 CF CF te act); 21 CFR 1000-1050.
control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. control provisions (Sections 331-542 of the Act, 21-21-21 described in your Section 510(k)
This letter will allow you to begin marketing your device of your device to a legal This letter will allow you to begin marketing your active of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your device premarket notification. The FDA finding of substannal equivation of your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
rst the regulation of the 1901) 504 1648 - Algo, mlease note the regulati If you desire specific advice for your uevice on our a sening segments the regulation entitled,
contact the Office of Compliance at [phone]. Also, please not of the re contact the Office of Compliance at (301) 53+440. " (212) 17). You may obtain other
"Misbranding by reference to premarket notification of Sun Pixision of Small "Misbranding by reference to premaince homreation Act from the Division of Small
general information on your responsibilities under the Act from the (800) 6 general information on your responsibilities that its toll-free number [phone] or
Manufacturers, International and Consumer Assistance at its toll-free addremamain htm Manufacturers, International and Consumer Assistantes and coloridation and smamain.html

Sincerely yours,

Neil R.P. Ogden

Bram D. Zuckerman, M.I. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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of 1 Page l

510 (k) Number (if known):

K04/020

Device Name: Ambu® Blue Sensor MRX , ECG electrode

## Indications For Use:

The MRX disposable ECG electrode is applied to the surface of the body to transmit the electrical signal at The MICA disposation DOS creen or app
the body surface to a processor in order to produce an electrocardiogram.

the oody surface to a processor in arest to promment and made for X-ray purposes, therefore is MR safe and X-ray translucent.

The electrode is made for single patient use only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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| | (Division Sign-Off) |
| | Division of Cardiovascular Devices |
| 510(k) Number | K041026 |

| Prescription Use<br>(Per 21 CFR 801.109) | OR | Over-The-Counter Use<br>(Optional format 1-2-96) |
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