NEUROSIGN LARYNGEAL ELECTRODES

K071349 · The Magstim Company , Ltd. · ETN · Dec 12, 2007 · Ear, Nose, Throat

Device Facts

• Record ID: K071349
• Device Name: NEUROSIGN LARYNGEAL ELECTRODES
• Applicant: The Magstim Company , Ltd.
• Product Code: ETN · Ear, Nose, Throat
• Decision Date: Dec 12, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1820
• Device Class: Class 2

Intended Use

The non-invasive Laryngeal Electrode is intended for use as an intraoperative method of monitoring the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery. The monitoring is performed by a surface electrode held in position against the vocal cords through an attachment to a normal endotracheal tube. The electrode is then connected to a Neurosign® machine for readout. A connector allows the cable to connect with the Neurosign® Nerve Monitor Pre-Amplifier Pod. The electrode detects EMG in the vocalis or the posterior cricoarvenoid muscles and will also detect stimulation of the superior laryngeal nerves during radical neck dissections. The Neurosign® Laryngeal Electrode is indicated for use when it is necessary to continuously monitor the laryngeal nerves, the Xth cranial nerve or the laryngeal musculature during surgery. The device will mainly be used in adults, as thyroidectory is very rarely undertaken in children.

Device Story

Neurosign® Laryngeal Electrode is a single-use, non-invasive surface electrode system for intraoperative EMG monitoring. Input: EMG signals from vocalis or posterior cricoarytenoid muscles. Operation: Electrode attaches to standard endotracheal tube; detects nerve stimulation during thyroid, parathyroid, or skull-base surgery. Output: Electrical signals transmitted via cable to Neurosign® nerve monitor (100, 400, or 800 models) for clinician readout. Usage: Intraoperative setting; operated by surgeons/anesthesiologists. Benefit: Reduces risk of damage to laryngeal/Vagus nerves; non-invasive design minimizes infection risk compared to invasive alternatives. Clinical decision-making: Provides real-time feedback on nerve integrity, allowing surgeons to adjust maneuvers to avoid nerve injury.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing and comparison of technological characteristics and intended use to legally marketed predicate devices.

Technological Characteristics

Single-use surface electrode; conductive medical-grade inks on polyester substrate; polypropylene connector; cable assembly. Two sizes (6/7mm and 8/9mm) for endotracheal tube compatibility. 2-channel monitoring. Non-invasive. Connects to Neurosign® nerve monitor pre-amplifier pod.

Indications for Use

Indicated for continuous intraoperative monitoring of laryngeal nerves, Xth cranial nerve, or laryngeal musculature during thyroid, parathyroid, or skull-base surgery. Primarily for adult patient population.

Regulatory Classification

Identification

A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.

Predicate Devices

• Neurovision LSE500 Laryngeal Surface Electrodes (K003745)
• Medtronic NIM™ EMG Endotracheal Tube (K925640)

Submission Summary (Full Text)

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K071349

Neurosign® Laryngeal Electrode: FDA 510(k) Submission

Confidential

Section 5: 510(k) Summary or 510(k) Statement

Image /page/0/Picture/4 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are black, and the word is presented in a simple, straightforward manner. The dot on the "i" is a circle.

Spring Gardens . Whitland Carmarthenshire · Wales · UK SA34 OHR

> [phone] [phone] [e-mail] www.magstim.com

### SECTION 5: 510(k) SUMMARY

DEC ] 2 2007

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 04 May 2007

### Contact information:

Anwen Evans The Magstim Company Ltd Spring Gardens, Whitland Carmarthenshire, Wales, UK SA34 OHR Tel: [phone] Fax: [phone] E-mail: [e-mail]

The product information is as follows:

Product: Laryngeal Electrode for use with the Neurosign® 100, 400 and 800 nerve monitors Class: Class II CFR \$874.1820 Surgical Nerve Stimulator and Locator Panel: Ear, Nose and Throat Product Code: ETN

Classification name: Nerve Stimulator (Class II) Common or usual names: Laryngeal Electrode Proprietary name: Neurosign® Laryngeal Electrode

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Section 5: 510(k) Summary or 510(k) Statement

#### Description of the Device 5.1

The Neurosign® Laryngeal Electrode, which was specially developed for use with the Neurosign® 100, 400 and 800 models, consists of: a single-use electrode constructed from medical-grade inks suspended in a polyester substrate; a connector made of polypropylene; and a cable assembly. The electrode is available in two sizes to suit different sexes and age groups. The 6/7mm electrode should be used with a 6 or 7mm endotracheal tube; the 8/9mm electrode should be used with an 8 or 9mm tube. The cable assembly is available separately and will have a long life if it is not abused and is stored appropriately.

Using the laryngeal electrode lowers the risk of damage to the laryngeal or Xth cranial nerve (the Vagus nerve) during thyroidectomy or parathyroidectomy and, since it is noninvasive, it also lessens the risk of infection during the monitoring procedure.

#### 5.2 Intended Use of the Device

The non-invasive Laryngeal Electrode is intended for use as an intraoperative method of monitoring the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery. The monitoring is performed by a surface electrode held in position against the vocal cords through an attachment to a normal endotracheal tube. The electrode is then connected to a Neurosign® machine for readout. A connector allows the cable to connect with the Neurosign® Nerve Monitor Pre-Amplifier Pod. The electrode detects EMG in the vocalis or the posterior cricoarvenoid muscles and will also detect stimulation of the superior laryngeal nerves during radical neck dissections.

The Neurosign® Laryngeal Electrode is indicated for use when it is necessary to continuously monitor the laryngeal nerves, the Xth cranial nerve or the laryngeal musculature during surgery. The device will mainly be used in adults, as thyroidectory is very rarely undertaken in children.

#### 5.3 Predicate Devices

The predicate devices used in this submission are:

- � Neurovision LSE500 Laryngeal Surface Electrodes (reference K003745); and
- Medtronic NIM™ EMG Endotracheal Tube (reference K925640). �

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# Neurosign® Laryngeal Electrode: FDA 510(k) Submission

.

Section 5: 510(k) Summary or 510(k) Statement

#### 5.3.1 Comparison with the predicate devices

| | NeurosignⓇ<br>Laryngeal<br>Electrode<br>(Subject Device) | Medtronic NIMTM<br>EMG<br>Endotracheal Tube<br>(Predicate Device) | Neurovision<br>LSE500 Laryngeal<br>Surface Electrode<br>(Predicate Device) |
|-------------------------------------------------|----------------------------------------------------------|-------------------------------------------------------------------|----------------------------------------------------------------------------|
| Laryngeal surface<br>electrode | Yes | Yes | Yes |
| Monitoring site | Trachea/larynx | Larynx | Oesophagus |
| Monitoring type | Continuous EMG<br>monitoring | Continuous EMG<br>monitoring | Continuous EMG<br>monitoring |
| May be used with<br>all commercial<br>EMG units | Yes | Yes | Yes |
| Method of<br>electrode<br>attachment | Attached to the<br>surface of the<br>endotracheal tube | Embedded within<br>the endotracheal<br>tube | Attached to the<br>surface of the<br>endotracheal tube |
| Number of<br>electrodes utilised | 2 | 4 | 2 |
| Number of<br>channels | 2 | 2 | 1 |
| Surface of<br>electrode | Conductive ink on a<br>polyester substrate | Stainless steel wire | Carbon w/Ag |
| Single-use only | Yes | Yes | Yes |
| Safety<br>characteristics | Non-invasive | Non-invasive | Non-invasive |

#### 5.4 Conclusions

The Neurosign® Laryngeal Electrode is both safe and is similar in its risks and benefits, as well as its manner of performance, to the predicate devices listed above (see Section 12 for further discussion).

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Magstim Company, LTD. c/o Anwen Evans Spring Gardens Whitland Carmarthenshire, Wales United Kingdom, SA34 OHR

Re: K071349

Trade/Device Name: Neurosign® Laryngeal Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator and locator Regulatory Class: Class II Product Code: ETN Dated: May 4, 2007 Received: May 14, 2007

Dear Mr. Evans:

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.

DEC 1 2 2007

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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## Page 2 - Mr. Anwen Evans

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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,

M.B. Eylerhs, MD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

# SECTION 4: INDICATIONS FOR USE STATEMENT

# Indications for Use

510(k) Number (if known): K944902

Device Name: Laryngeal Electrodes

Indications for Use:

Non-invasively monitoring of the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kaua H. bota
(Off)

hthalmic Ear Throat Devise

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