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.

AI/ML Overview

The Neurosign® Laryngeal Electrode is a device intended for intraoperative monitoring of laryngeal nerves during thyroid surgery and the Xth cranial nerve (Vagus nerve) during skull-base surgery. The device consists of a single-use electrode attached to an endotracheal tube, which then connects to a Neurosign® machine for EMG readout.

The submission does not contain specific acceptance criteria for performance metrics (like sensitivity, specificity, accuracy) of the device. Instead, the FDA's clearance is based on a determination of substantial equivalence to predicate devices. This means that the Neurosign® Laryngeal Electrode is considered as safe and effective as existing legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission based on substantial equivalence, there are no predefined numerical acceptance criteria or reported performance metrics in the traditional sense (e.g., sensitivity, specificity, accuracy) as would be found in a clinical study evaluating diagnostic performance. The "acceptance" is based on the device having similar characteristics, intended use, and safety/effectiveness profiles to the predicate devices.

Feature	Acceptance Criteria (based on predicate equivalence)	Reported Device Performance (Neurosign® Laryngeal Electrode)
Laryngeal surface electrode	Yes	Yes
Monitoring site	Trachea/larynx or Larynx/Oesophagus	Trachea/larynx
Monitoring type	Continuous EMG monitoring	Continuous EMG monitoring
Compatibility	May be used with commercial EMG units	Yes (implicitly, for Neurosign® 100, 400, 800 models)
Electrode attachment	Attached to surface or embedded within endotracheal tube	Attached to the surface of the endotracheal tube
Number of electrodes	2 or 4	2
Number of channels	1 or 2	2
Surface of electrode	Conductive materials (Stainless steel wire, Carbon w/Ag)	Conductive ink on a polyester substrate
Single-use only	Yes	Yes
Safety characteristics	Non-invasive	Non-invasive

2. Sample size used for the test set and the data provenance:

This document does not describe a clinical study with a "test set" for performance evaluation in the typical sense of diagnostic or AI device studies. The clearance is based on substantial equivalence to existing devices. Therefore, there is no sample size for an independent test set or information on data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable, as no clinical study with a "test set" requiring expert-established ground truth is described in this submission.

4. Adjudication method for the test set:

Not applicable, as no clinical study with a "test set" and adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This device is a laryngeal electrode for nerve monitoring, not an AI-powered diagnostic tool requiring human reader interpretation or MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable. This device is a physical electrode used in conjunction with a nerve monitor, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable. The basis for clearance is substantial equivalence based on technical characteristics and intended use, not a clinical trial with a ground truth established by expert consensus or other clinical endpoints.

8. The sample size for the training set:

Not applicable. This device is a physical electrode, not a machine learning algorithm.

9. How the ground truth for the training set was established:

Not applicable. This device is a physical electrode, not a machine learning algorithm.

Summary of the "Study" (Basis for Acceptance):

The "study" or basis for acceptance in this 510(k) submission is a comparison to predicate devices to demonstrate substantial equivalence. The manufacturer, The Magstim Company Ltd., compared the Neurosign® Laryngeal Electrode to two predicate devices:

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

The comparison focused on technical characteristics, intended use, and safety features. The conclusion drawn by the manufacturer (and accepted by the FDA for clearance) is that 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." This substantial equivalence determination means the new device is considered as safe and effective as the predicate devices that are already legally marketed. No new clinical trials demonstrating specific performance metrics for the Neurosign® Laryngeal Electrode were necessary for this type of submission.

Summary

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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

+44 (0) 1994 240798 +44 (0) 1994 240061 info@magstim.com 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: +44 (0) 1994 242902 Fax: +44 (0) 1994 240061 E-mail: anwen.evans@magstim.com

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

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ⓇLaryngealElectrode(Subject Device)	Medtronic NIMTMEMGEndotracheal Tube(Predicate Device)	NeurovisionLSE500 LaryngealSurface Electrode(Predicate Device)
Laryngeal surfaceelectrode	Yes	Yes	Yes
Monitoring site	Trachea/larynx	Larynx	Oesophagus
Monitoring type	Continuous EMGmonitoring	Continuous EMGmonitoring	Continuous EMGmonitoring
May be used withall commercialEMG units	Yes	Yes	Yes
Method ofelectrodeattachment	Attached to thesurface of theendotracheal tube	Embedded withinthe endotrachealtube	Attached to thesurface of theendotracheal tube
Number ofelectrodes utilised	2	4	2
Number ofchannels	2	2	1
Surface ofelectrode	Conductive ink on apolyester substrate	Stainless steel wire	Carbon w/Ag
Single-use only	Yes	Yes	Yes
Safetycharacteristics	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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three stripes forming its body and wing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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

: 参 omber Page 1 of 1

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
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.(b)
Classification. Class II.