AMBU WHITE SENSOR CFM, CFL

K052944 · Ambu A/S · DRX · Oct 25, 2006 · Cardiovascular

Device Facts

• Record ID: K052944
• Device Name: AMBU WHITE SENSOR CFM, CFL
• Applicant: Ambu A/S
• Product Code: DRX · Cardiovascular
• Decision Date: Oct 25, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2360
• Device Class: Class 2

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 Story

Ambu® White Sensor CFM/CFL are non-sterile, single-patient-use, disposable ECG electrodes. Device construction consists of a metal stud, plastic eyelet sensor, hydrogel, foam with medical adhesive, and a polymer topfilm. Electrodes are applied to the patient's skin surface to capture electrical signals, which are then transmitted to an external ECG processor for monitoring. Used by or on the order of a physician in clinical settings. The device facilitates the acquisition of electrocardiogram or vectorcardiogram data, aiding healthcare providers in cardiac monitoring and clinical decision-making.

Clinical Evidence

No clinical tests were performed. Evidence is based on bench testing and biocompatibility evaluation.

Technological Characteristics

Multi-layer construction: metal stud, plastic eyelet sensor, hydrogel, foam with medical adhesive, polymer topfilm. Passive sensing principle. Complies with ANSI/AAMI EC12:2000 for disposable ECG electrodes. Biocompatibility established per ISO 10993-1.

Indications for Use

Indicated for multipurpose ECG monitoring in patients requiring surface electrical signal transmission to an ECG or vectorcardiogram processor. For single patient use only; prescription 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

• Ambu® Disposable ECG Electrode (K052944)
• 3M Red Dot 2560 (K052944)

Submission Summary (Full Text)

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## 510(k) Summary

K052944

| 1. 510(k) owner:<br>Ambu A/S<br>Baltorpbakken 13<br>2750 Ballerup<br>Denmark<br>Tel.: [phone]<br>Fax.: [phone] | OCT 25 2006 |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------|
| Contact person:<br>Poul Ottosen<br>Corporate Quality Manager | |
| Preparation date of the 510(k) summary: | 10 October 2005 |
| 2. Name of device:<br>Device Common name: | Disposable ECG electrode |
| Device Trade name: | Ambu® White Sensor CFM<br>Ambu® White Sensor CFL |
| Classification Name: | Electrode, Electrocardiograph.<br>21 CFR 870.2360 |
| Product Code: | DRX |

- 3. Identifies the legally marketed device to which equivalence is claimed

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

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- 4. 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.

- 5. The intended use Ambu® White Sensor CFM/CFL are for multipurpose ECG monitoring.
- 6. 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.
- 7. 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.
- 8. 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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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.

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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 [phone]. 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 [phone] or [phone] 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

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## 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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