AMBU NEUROLINE GROUND

K051529 · Ambu, Inc. · GXY · Aug 4, 2005 · Neurology

Device Facts

• Record ID: K051529
• Device Name: AMBU NEUROLINE GROUND
• Applicant: Ambu, Inc.
• Product Code: GXY · Neurology
• Decision Date: Aug 4, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1320
• Device Class: Class 2

Indications for Use

The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. The electrode is for single patient use only.

Device Story

Ambu Neuroline Ground is a disposable, single-patient-use cutaneous electrode used during neurophysiological examinations. It functions to maintain equal electrical potential between the amplifier and the measurement site. The device consists of a multi-layer construction including hydrogel, a conductive film, a non-woven backing, and a lead wire with a 1.5 mm touch-proof connector. It is intended for use by or on the order of a physician in a clinical setting. The device provides a stable electrical reference point, facilitating accurate signal acquisition during nerve and muscle testing.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by non-clinical laboratory testing, including aging tests and comparative electrical and mechanical functionality assessments against predicate devices.

Technological Characteristics

Multi-layer cutaneous electrode; materials include hydrogel, conductive film, and non-woven backing. Features a 1.5 mm touch-proof connector. Passive electrical component; no energy source. Non-sterile, single-patient-use disposable device.

Indications for Use

Indicated for patients undergoing neurophysiological examinations of muscles and/or nerves. For use by or on the order of a physician.

Regulatory Classification

Identification

A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.

Predicate Devices

• Disposable Ground Plate Electrode (Viasys Healthcare/Nicolet Biomedical Instruments)
• TECA NCS 2000 Disposable Ground Electrode (Oxford Instruments/Medical Medelec Instruments)

Submission Summary (Full Text)

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## AUG 4 - 2005

## 510(k) Summary

- 1. 510(k) owner: Ambu A/S Baltorpbakken 13 2750 Ballerup Denmark Tel.: [phone] Fax.: [phone] Contact person: Poul Ottosen Corporate Quality Manager 1. June 2005 Preparation date of the 510(k) summary: 2. Name of device: Ground Electrode Device Common name: Disposable Ground Plate Electrode Disposable Ground Electrode Device Trade name: Ambu Neuroline Ground Classification Name: Electrode, Cutaneous. 21 CFR 882.1320 Product Code: GXY
- 3. Identifies the legally marketed device to which equivalence is claimed

| Manufacturer | Trade Name | Product<br>code |
|--------------------------------------------------------|----------------------------------------------|-----------------|
| Viasys Healthcare<br>Nicolet Biomedical<br>Instruments | Disposable Ground Plate<br>Electrode | GXY |
| Oxford Instruments<br>Medical<br>Medelec Instruments | TECA NCS 2000 Disposable<br>Ground Electrode | GXY |

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- 4. Description of device
Ambu Neuroline Ground electrode should only be used by or on the order of a physician.

Ambu Neuroline Ground electrode is used to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination.

Ambu Neuroline Ground electrode is provided non-sterile. Ambu Neuroline Ground electrode is a single patient use disposable device.

Ambu Neuroline Ground electrode is a multi-layer construction containing a hydrogel, a conductive film and a lead wire.

- 5. The intended use Ground electrode for standard neurophysiological examinations.
- 6. Summary of the technological Characteristics

The technological characteristics of the Ambu Neuroline Ground electrode are identical to the predicate devices.

The electrode is a multi-layer construction consisting of Hydrogel, conducting film, non-wowen backing material and lead wire with 1,5 mm touch proof connector.

- 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
- 8. Brief discussion of the clinical tests submitted No clinical tests are performed
- 9. Conclusions drawn from the nonclinical and clinical tests Aging test of Ambu Neuroline Ground electrode and comparison test to predicate devices have been performed. From the results it has been concluded that Ambu Neuroline Ground electrode has equivalent electrical and mechanical functionality as the predicate device. The device meets mandatory performance standards. The biocompatibility of the electrode has been established. It is concluded that Ambu Neuroline Ground electrode is as safe and effective as the predicate devices.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

AUG 4 - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Sanjay Parikh Technical and Regulatory Affairs Ambu Inc. 6740 Baymeadow Drive Glen Burnie, Maryland 21060

Re: K051529

Trade/Device Name: Ambu Neuroline Ground Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: II Product Code: GXY Dated: July 13, 2005 Received: July 18, 2005

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.

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.

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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/dsma/dsmamain.html

Sincerely yours,

Mark N. Melkerson

Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

Ko51529 510(k) Number (if known):

Ambu Neuroline Ground Device Name: Indications For Use:

The intended use of Ambu Neuroline Ground electrode is to ensure the presence of the same electrical potential at the amplifier and the measuring point during a neurophysiological examination of muscles and/or nerves. 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)

Styet Alurd
(Division Sign-Off)

I i vision of General, Restorative, and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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