AMBU BLUE SENSOR NEO AND NEO X

K053550 · Ambu A/S · DRX · Oct 25, 2006 · Cardiovascular

Device Facts

• Record ID: K053550
• Device Name: AMBU BLUE SENSOR NEO AND NEO X
• 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
• Attributes: Pediatric

Intended Use

The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are 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 electrodes are for single patient use only.

Device Story

Ambu® Blue Sensor NEO/NEO X are disposable, self-adhesive ECG electrodes; multi-layer construction includes pre-attached lead wire with connector, top disc, top film, sensor, and hydrogel adhesive. Used by or on order of physician for neonatal and paediatric ECG monitoring. Electrodes applied to body surface to transmit electrical signals to external processor for electrocardiogram/vectorcardiogram generation. Device facilitates cardiac monitoring; provides interface between patient skin and monitoring equipment.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ANSI/AAMI EC12:2000 for electrical and mechanical functionality. Biocompatibility established per ISO 10993-1.

Technological Characteristics

Multi-layer disposable ECG electrode. Components: pre-attached lead wire, connector, top disc, top film, sensor, hydrogel adhesive. Non-sterile. Complies with ANSI/AAMI EC12:2000. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for ECG monitoring of neonatal and paediatric patients. 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

• Ambu® Blue Sensor NF (K053550)
• Ambu® Blue Sensor BRS (K053550)

Submission Summary (Full Text)

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## 510(k) Summary

K053550

OCT 2 5 2006

1. 510(k) owner: Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark Tel.: [phone] Fax.: [phone]

> Contact person: Laila Strange Lundtoft Regulatory Affairs Manager

- 8. December 2005 2. Preparation date of the 510(k) summary:

| 3. Name of device:<br>Device Common name: | Disposable ECG electrode |
|-------------------------------------------|---------------------------------------------------|
| Device Trade name: | Ambu® Blue Sensor NEO<br>Ambu® Blue Sensor NEO X |
| Classification Name: | Electrode, Electrocardiograph.<br>21 CFR 870.2360 |
| Product Code: | DRX |

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

| Manufacturer | Trade Name | Product<br>code |
|--------------|-----------------------|-----------------|
| Ambu A/S | Ambu® Blue Sensor NF | DRX |
| Ambu A/S | Ambu® Blue Sensor BRS | DRX |

E-1

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#### 5. Description of device

Ambu® Blue Sensor NEO/NEO X is non-sterile, self-adhesive ECG electrodes. Ambu® Blue Sensor NEO/NEO X should only be used by or on the order of a physician.

Ambu® Blue Sensor NEO/NEO X is single patient use disposable devices.

Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor and a hydrogel adhesive.

- 6. The intended use
Ambu® Blue Sensor NEO/NEO X is for ECG monitoring of Neonatal and Paediatric care.

- 7. Summary of the technological Characteristics The technological characteristics of Ambu® Blue Sensor NEO/NEO X are identical to the predicate devices. Ambu® Blue Sensor NEO/NEO X is a multi-layer construction containing a pre-attached lead wire with an attached connector, a top disc, a top film, a sensor and a hydrogel adhesive.
- 8. 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.
- 9. Brief discussion of the clinical tests submitted No clinical tests are performed
- 10.Biocompatibility testing

The biological safety of the Ambu® Blue Sensor NEO/NEO X has 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.

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

The Ambu® Blue Sensor NEO/NEO X meet the mandatory performance standard requirements under ANSI/AAMI EC12:2000 ~ Disposable ECG electrodes.

The biocompatibility of the Ambu® Blue Sensor NEO/NEO X have been established.

It is concluded that Ambu® Blue Sensor NEO/NEO X are safe and effective electrodes and comparable to the predicate devices.

F-2

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 25 2006

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

Re: K053550

Trade Name: Ambu® Blue Sensor NEO & Ambu® Blue Sensor NEO-X Regulation Number: 21 CFR 870.2360 Regulation Name: Electrocardiograph Electrode Regulatory Class: II (two) Product Code: DRX Dated: October 10, 2006 Received: October 12, 2006

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 (QS) 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 yours,

Bhimama 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):

/1053550

### Device Name: Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X

Indications For Use:

The Ambu® Blue Sensor NEO and Ambu® Blue Sensor NEO X electrodes are made for ECG monitoring of neonatal and paediatric patients. The ECG electrodes are 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 electrodes are for single patient use only.

Prescription Use x (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)

Bhimma

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number Kn53550

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