K Number
K052944
Device Name
AMBU WHITE SENSOR CFM, CFL
Manufacturer
Date Cleared
2006-10-25

(370 days)

Product Code
Regulation Number
870.2360
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode 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. The electrode is for single patient use only.
Device Description
Ambu® White Sensor CFM/CFL are non-sterile, self adhesive, multifunction ECG electrodes. Ambu® White Sensor CFM/CFL should only be used by or on the order of a physician. Ambu® White Sensor CFM/CFL are single patient use disposable devices. Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydrogel, foam with medical adhesive and a polymer topfilm.
More Information

Not Found

Not Found

No
The document describes a standard ECG electrode and its physical properties and performance against a recognized standard. There is no mention of any processing or analysis of the signal using AI/ML.

No
The device is described as an ECG electrode used for monitoring, not for treating a disease or condition.

Yes

The device transmits electrical signals from the body surface to a processor to produce an electrocardiogram (ECG) or vectorcardiogram, which are diagnostic tools used to assess heart function.

No

The device description explicitly states it is a multi-layer construction containing physical components like a metal stud, plastic eyelet sensor, hydrogel, foam, and polymer topfilm, indicating it is a hardware device, not software-only.

Based on the provided information, the Ambu® White Sensor electrode is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
  • The Ambu® White Sensor electrode is applied to the surface of the body to transmit electrical signals. It does not analyze biological specimens.
  • Its purpose is to facilitate ECG monitoring, which is a measurement of electrical activity of the heart, not an analysis of a biological sample.

Therefore, the device falls under the category of a medical device used for physiological monitoring, not an IVD.

N/A

Intended Use / Indications for Use

Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode 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. The electrode is for single patient use only.

Product codes (comma separated list FDA assigned to the subject device)

DRX

Device Description

Ambu® White Sensor CFM/CFL are non-sterile, self adhesive, multifunction ECG electrodes. Ambu® White Sensor CFM/CFL should only be used by or on the order of a physician.

Ambu® White Sensor CFM/CFL are single patient use disposable devices.

Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydrogel, foam with medical adhesive and a polymer topfilm.

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

by or on the order of a physician.

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

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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)

The non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode meets the standard ANSI/AAMI EC12:2000 - Disposable ECG Electrodes. No clinical tests are performed. Aging test of Ambu® White Sensor CFM/CFL and comparison test to predicate devices have been performed. From the results it has been concluded that the Ambu® White Sensor CFM/CFL have equivalent electrical and mechanical functionality as the predicate devices. The Ambu® White Sensor CFM/CFL meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000 - Disposable ECG electrodes. The biocompatibility of the Ambu® White Sensor CFM/CFL have been established. It is concluded that Ambu® White Sensor CFM/CFL are safe and effective electrodes and comparable to the predicate devices.

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

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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.

Not Found

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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.2360 Electrocardiograph electrode.

(a)
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.(b)
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.

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510(k) Summary

K052944

| 1. 510(k) owner:
Ambu A/S
Baltorpbakken 13
2750 Ballerup
Denmark
Tel.: +45 72252000

Fax.: +45 72252050OCT 25 2006
Contact person:
Poul Ottosen
Corporate Quality Manager
Preparation date of the 510(k) summary:10 October 2005
2. Name of device:
Device Common name:Disposable ECG electrode
Device Trade name:Ambu® White Sensor CFM
Ambu® White Sensor CFL
Classification Name:Electrode, Electrocardiograph.
21 CFR 870.2360
Product Code:DRX
    1. Identifies the legally marketed device to which equivalence is claimed

| Manufacturer | Trade Name | Product
code |
|--------------|-----------------------------------|-----------------|
| Ambu A/S | Ambu® Disposable ECG
Electrode | DRX |
| 3M | Red Dot 2560 | DRX |

E-1

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    1. Description of device
      Ambu® White Sensor CFM/CFL are non-sterile, self adhesive, multifunction ECG electrodes. Ambu® White Sensor CFM/CFL should only be used by or on the order of a physician.

Ambu® White Sensor CFM/CFL are single patient use disposable devices.

Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydrogel, foam with medical adhesive and a polymer topfilm.

    1. The intended use Ambu® White Sensor CFM/CFL are for multipurpose ECG monitoring.
    1. Summary of the technological Characteristics The technological characteristics of Ambu® White Sensor CFM/CFL are identical to the predicate devices. Ambu® White Sensor CFM/CFL are multi-layer constructions containing a metal stud, a plastic eyelet sensor, hydroqel, foam with medical adhesive and a polymer topfilm.
    1. Brief discussion of the nonclinical tests submitted The non-clinical tests performed are laboratory tests to ensure the electrical and mechanical functionality of the electrode meets the standard ANSI/AAMI EC12:2000 - Disposable ECG Electrodes.
    1. Brief discussion of the clinical tests submitted No clinical tests are performed

9. Biocompatibility testing

The biological safety of the Ambu® White Sensor CFM/CFL have been assured through the selection of materials which demonstrate appropriate levels of biocompatibility. Tests were selected on the basis of ISO 10993-1 - Biological evaluation of Medical Devices.

10.Conclusions drawn from the nonclinical, clinical and biocompatibility tests Aging test of Ambu® White Sensor CFM/CFL and comparison test to predicate devices have been performed. From the results it has been concluded that the Ambu® White Sensor CFM/CFL have equivalent electrical and mechanical functionality as the predicate devices.

The Ambu® White Sensor CFM/CFL meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000 - Disposable ECG electrodes.

The biocompatibility of the Ambu® White Sensor CFM/CFL have been established.

It is concluded that Ambu® White Sensor CFM/CFL are safe and effective electrodes and comparable to the predicate devices.

E-Z

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2

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 5 2006

Ambu Inc. c/o Mr. Sanjay Parikh Technical and Regulatory Affairs 6740 Baymeadow Dr. Glen Burnie, MD 21060

Re: K052944

Trade Name: Ambu® White Sensor CFM & Ambu® White Sensor CFL Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: September 26, 2006 Received: September 29, 20()6

Dear Mr. Parikh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). 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 against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

3

Page 2 – Mr. Sanjay Parikh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

B/bimmimar for

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

Enclosure

4

Indications for Use

510(k) Number (if known):

K052944

Device Name: Ambu® White Sensor Indications For Use:

Ambu® White Sensor electrode is for multipurpose ECG monitoring. The ECG electrode 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. The electrode is for single patient use only.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Blomman
(Division Sign-Off)

Division of Cardiovascular Devices
510(k) Number K052944

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