MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE

K071186 · Ambu A/S · IKT · Jul 30, 2007 · Physical Medicine

Device Facts

• Record ID: K071186
• Device Name: MODIFICATION TO: AMBU NEUROLINE CONCENTRIC NEEDLE ELECTRODE
• Applicant: Ambu A/S
• Product Code: IKT · Physical Medicine
• Decision Date: Jul 30, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.1385
• Device Class: Class 2

Intended Use

Ambu Neuroline Disposable Concentric needle electrodes is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. This is used to assess whether muscle impairment is due to disturbances in the motor neurones, the motor nerve fibres or in the muscle itself. It is used mainly to tell the difference between muscle diseases and nerve diseases.

Device Story

Ambu Neuroline is a sterile, single-patient-use concentric needle electrode for electromyography (EMG). Device consists of stainless steel cannula (reference point) and inner conductor (active measure point) separated by insulation; cannula coated with low-friction polymer. Used by clinicians to record electrical activity within muscle; signal transmitted to external EMG equipment via 5-pin reusable cable. Data used to differentiate between muscle and nerve diseases by assessing motor neurons, nerve fibers, or muscle tissue. Device provides diagnostic input for clinical decision-making regarding neuromuscular system health.

Clinical Evidence

No clinical tests were performed. Substantial equivalence is supported by bench testing, including penetration and friction force testing (per DIN 13097), electrical property verification, shelf-life aging tests, and biocompatibility testing (cytotoxicity, sensitization, intracutaneous, and systemic injection per ISO 10993-1).

Technological Characteristics

Concentric needle electrode; stainless steel cannula (reference) and inner conductor (active) with insulation layer; cannula coated with low-friction polymer. Connectivity via 5-pin cable to external EMG equipment. Sterile. Bench testing per DIN 13097 for penetration/friction force.

Indications for Use

Indicated for muscle activity recording during Electromyography (EMG) applications for single patient use.

Regulatory Classification

Identification

A diagnostic electromyograph needle electrode is a monopolar or bipolar needle intended to be inserted into muscle or nerve tissue to sense bioelectrical signals. The device is intended for medical purposes for use in connection with electromyography (recording the intrinsic electrical properties of skeletal muscle).

Predicate Devices

• Neuroline, Disposable Concentric needle electrode (K973529)
• Medelec Elite Disposable Concentric Needle Electrode (K961013)
• DCNtm Disposable Concentric Needle Electrode (K931966)

Submission Summary (Full Text)

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Special 510(k) Application - Neuroline, Disposable Concentric needle electrode

# 510(k) Summary

1. 510(k) owner: Ambu A/S JUL 3 0 2007 Baltorpbakken 13 DK-2750 Ballerup Denmark Tel.: [phone] Fax.: [phone] Contact person: Anne Bielefeldt Regulatory Affairs Specialist 2. Preparation date of the 510(k) summary: April 2007 3. Name of device: Device Common name: Disposable Concentric needle electrode Neuroline, Disposable Concentric needle 4. Device Trade name: electrode Electrode, needle, diagnostic electromyography 5. Classification Name: 21 CFR 890.1385 IKT 6. Product Code:

# 7. Identifies the legally marketed device to which equivalence is claimed

| Manufacturer | Trade Name | 510k number | Product code |
|---------------------------|--------------------------------------------------------------|-------------|--------------|
| Ambu A/S | Neuroline, Disposable<br>Concentric needle<br>electrode | K973529 | IKT |
| Viasys Healthcare<br>Inc. | Medelec Elite Dispos-<br>able Concentric Needle<br>Electrode | K961013 | IKT |
| Medtronic Inc. | DCNtm Disposable<br>Concentric Needle<br>Electrode | K931966 | IKT |

- 8. Description of device

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The Ambu Neuroline Concentric Needle is a Single Patient EMG Needle Electrode and is used to measure an EMG signal when connected to the EMG equipment through a 5 pins reusable cable. The Electromyogram (EMG) records electrical activity within the muscle. It is used mainly to tell the difference between muscle diseases and nerve diseases. The Ambu Neuroline Concentric Needle is a sterile product.

#### 9. The intended use

Ambu Neuroline Disposable Concentric needle electrodes is used for electromyography (EMG) recording for examination of the peripheral neuromuscular system, by registration of the electrical activity from the muscles. This is used to assess whether muscle impairment is due to disturbances in the motor neurones, the motor nerve fibres or in the muscle itself. It is used mainly to tell the difference between muscle diseases and nerve diseases.

#### 10.Indications for Use

The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.

#### 11. Summary of the technoloqical Characteristics

Ambu Neuroline Concentric Needle consists of a cannula made of stainless steel and an inner conductor. In between these two conductors there is an insulation layer. The inner conductor is the active measure point and the outer conductor of stainless steel is the reference point. The Stainless steel cannula is coated with a low friction polymer.

#### 12. Brief discussion of the nonclinical tests submitted

The non-clinical tests performed are laboratory tests to verify the functionality of the Ambu Neuroline Disposable Concentric needle electrode. The Ambu Neuroline Disposable Concentric needle electrode is tested for penetration and friction force and electrical properties. The verification of the penetration and the friction force of the needle were performed according to DIN 13097.

Ageing tests are performed to verify and ensure the functionality during the shelf life of the product.

#### 13. Brief discussion of the clinical tests submitted

No clinical tests were performed for the updated version of the Ambu Neuroline Disposable Concetric needle because it has the same intended use and similar characteristics as the currently commercially available Ambu Neuroline Disposable Concentric needle.

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### 14. Biocompatibility testing - Summary

The biological safety of the Ambu Neuroline Concentric Needle 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 Device.

The following tests were performed:

- Cytotoxicity assay in vitro -
- Contact hypersensitivity in the guinea pig Maximization study -
- Intracutaneous test in the rabbit -
- Systemic Injection test in the mice -

# 15. Conclusions drawn from the non clinical and biocompatibility tests

From the results of the non clinical verification test and biocompatibility test, it has been concluded that Ambu Neuroline Disposable Concentric Needle electrode fulfils the product specifications set for the design. It is concluded that Ambu Neuroline Disposable Concentric Needle electrode is a safe and effective Concentric needle electrode and comparable to the predicate devices.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized eagle-like symbol with three curved lines representing the bird's body and wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 0 2007

Ambu A/S % Ambu Inc. Mr. Sanjay Parikh Technical & Regulatory Affairs Specialists US Agent and FDA Contact 6740 Baymeadow Drive Glen Burnie, MD 21060

Re: K071186

Trade/Device Name: Ambu Neuroline, Disposable Concentric Needle Electrode Regulation Number: 21 CFR 890.1385 Regulation Name: Diagnostic electromyograph needle electrode Regulatory Class: II Product Code: IKT Dated: July 23, 2007 Received: July 24, 2007

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 (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.

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Page 2 -- Mr. Sanjay Parikh

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 toll-free number [phone] or [phone] or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

for Mark N. Melkerson
Director

7/30/07

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

510(k) Number:

1071186

Device Name: Ambu Neuroline, Disposable Concentric needle electrode

Indications For Use:

The Neuroline, Disposable Concentric needle electrodes are made for muscle activity recording for Electromyography (EMG) applications. The electrodes are for single patient use only.

Prescription Use X (Part 21 CFR 801 Subpart D)

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)

AND/OR

Section D - Page 1 of 1

Division of General, Restorative, and Neurological Devices

510(k) Number LC071184