The Neurosign Avalanche Motor Nerve Monitor is a 2 or 4 channel nerve monitor for intraoperative use in general surgery, skull-base surgery and ENT. The Neurosign Avalanche Motor Nerve Monitor allows the user to detect motor nerves and to check their integrity by acquiring the compound muscle action potentials at the target muscles. The acquired signals are processed by the monitor and displayed as waveforms on the monitor screen and played back acoustically via the built in audio amplifier and loudspeaker.

The Neurosign Avalanche Motor Nerve Monitor provides additional information to the user, helping the surgeon to locate nerves by using an electrical stimulator. The sound is independent from the waveform display on the monitor's screen.

The displayed waveforms can be printed along with the patient information via the built in thermal array printer, or as a generated report in Word format.

AI/ML Overview

The provided document describes the Neurosign Avalanche Motor Nerve Monitor and establishes its substantial equivalence to a predicate device, the Neurosign 400. However, it does not contain a comprehensive study with acceptance criteria and detailed device performance results in the format requested. The document focuses on comparing the features and intended uses of the new device to the predicate device in a non-clinical setting.

Here's an analysis of the provided text with respect to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria or report device performance in terms of metrics like sensitivity, specificity, or accuracy. Instead, it relies on a comparison of features and intended use to establish substantial equivalence. The "Non-Clinical Tests Undertaken" section (Section 5.4) lists features that were found to be "similar."

Feature	Predicate Device (Neurosign 400)	Subject Device (Neurosign Avalanche)	Reported Similarity/Performance
Intended use	Cranial motor nerve monitoring	Cranial motor nerve monitoring	Similar, Thyroid version restricted to simpler applications
Method of operation	EMG monitor and stimulator	EMG monitor and stimulator	Similar (detects EMG, amplifies, graphical display)
Stimulation frequency	3 or 30Hz	3 or 30Hz	All machines use the same frequencies, pulse width, and rectangular waveform
Method of display	Amplitude triggered response for continuous monitoring, stimulator triggered response	Screen divided into 2 sections (amplitude triggered, stimulator triggered)	Information displayed is the same, but presented differently
Audio	14W rms amplifier	10W rms amplifier	All machines amplify the EMG signal for audible response. Proportional to input.
Signal detection	Needle and Laryngeal electrode	Needle and Laryngeal electrode	The same electrodes and stimulating probes are used
Bandwidth	10Hz - 5kHz ±3dB	8Hz - 8kHz ±3dB	(Not directly stated as similar in the table, but the Subject Device has a broader range compared to the Predicate. This is a technical specification, not performance.)
Signal Gain	477	500	(A technical specification, Subject Device has slightly higher gain.)
Stimulation Range	0.05mA - 5mA	0.05mA - 10mA	(A technical specification, Subject Device has a wider range.)
Software/Screen	C++ proprietary code, 6" electroluminescent display	Windows XP Embedded, 15" color touchscreen	(Differences noted, but no performance impact assessed in the summary.)
Method of Control	Dedicated buttons or software via menus	Touchscreen (all controls via software except power ON/OFF)	(Differences noted, but no performance impact assessed in the summary.)

2. Sample Size Used for the Test Set and Data Provenance:

The document explicitly states that the assessment was conducted in a "non-clinical setting" (Section 5.4). This means there was no patient data, and therefore no "test set" in the traditional sense of a clinical study. The comparison was based on the functional and technical specifications of the devices.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

Since no clinical study or test set with patient data was involved, there was no need for experts to establish ground truth or interpret results. The comparison was based on engineering and design specifications.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set or clinical data requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. The submission is a 510(k) for substantial equivalence, which primarily relies on technological comparison and intended use, not clinical efficacy studies demonstrating improvement for human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

The device is a medical instrument (nerve monitor) used in real-time by a surgeon "with human-in-the-loop," meaning a standalone algorithmic performance isn't applicable in the context of this device. The information it provides is directly interpreted and used by the surgeon.

7. The Type of Ground Truth Used:

The "ground truth" in this context is the manufacturer's own documentation of the technical specifications, design, and intended use of both the predicate device and the new device. There is no external "ground truth" such as pathology, expert consensus, or outcomes data mentioned for this substantial equivalence submission.

8. The Sample Size for the Training Set:

Not applicable. This is a medical device, not an AI/machine learning algorithm that requires a "training set" of data in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there was no training set.

In summary:

This 510(k) submission (K083242) for the Neurosign Avalanche Motor Nerve Monitor relies on a non-clinical comparison of technical specifications and intended use against a previously cleared predicate device (Neurosign 400). It establishes "substantial equivalence" based on these comparisons rather than presenting clinical study data with acceptance criteria, sample sizes, ground truth establishment, or human-in-the-loop performance metrics. The document explicitly states that both devices were "assessed in a non-clinical setting and were determined to be similar."

Summary

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K083242
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SECTION 5: 510(k) Summary or 510(k) Statement

JUL 2 9 2009

Image /page/0/Picture/4 description: The image shows the word "magstim" in a bold, sans-serif font. The letters are outlined in black and filled with a textured pattern. The word appears to be a logo or brand name.

Spring Gardens · W Carmarthenshire · Wa

4 (0) 1994 240798 (0) 1994 240061 info@magstim.com www.magstim.com

Food and Drug Administration Center for Devices and Radiological Health Document Mail Center (HFZ-401) 9200 Corporate Boulevard Rockville, Maryland 20850 17 July 2009

Contact information:

Anwen Evans (Ms) 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:

Neurosign Avalanche Motor Nerve Monitor

Product:	Neurosign Avalanche
Class:	Class CFR 874.1820
Panel:	Ear, Nose and Throat
Product Code:	ETN

Classification name: Surgical Nerve Stimulator/Locator Common or usual names: Nerve Monitor Proprietary name: Neurosign Avalanche Motor Nerve Monitor

C The Magstim Company Ltd

5-2

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

5.1 Description of the Devices

The displayed waveforms can be printed along with the patient information via the built in thermal array printer, or as a generated report in Word format.

5.2 Intended Use of the Devices

The Neurosign Avalanche Motor Nerve Monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery.

The intended uses of the Neurosign Avalanche Motor Nerve Monitor are:

thyroidectomy and parathyroidectomy, mastoidectomy 2 channel
4 channel parotidectomy, mastoidectomy, skull-base

Predicate Devices 5.3

The predicate device used in this submission is:

Neurosign® 400 Motor Nerve Monitor (reference K991583). .

Comparison with the predicate device 5.3.1

5-3

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K083242
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SECTION 5: 510(k) Summary or 510(k) Statement

	Neurosign AvalancheThyroid Motor NerveMonitor(Subject Device)	Neurosign AvalancheEMG Motor NerveMonitor(Subject Device)	Neurosign 400 MotorNerve Monitor(Predicate Device)
Description	Motor Nerve Monitor,based upon standardcomputer components,running Windows XPembedded operatingsystem; information isprovided to the surgeonvia a waveform graph ofEMG activity, and audioamplification of thissignal so that thesurgeon hears this ashe/she is operating	Motor Nerve Monitor,based upon standardcomputer components,running Windows XPembedded operatingsystem; information isprovided to the surgeonvia a waveform graph ofEMG activity, and audioamplification of thissignal so that thesurgeon hears this ashe/she is operating	Motor Nerve Monitor,based upon proprietaryhardware and software;information is providedto the surgeon via awaveform graph ofEMG activity, and audioamplification of thissignal so that thesurgeon hears this ashe/she is operating
IntendedUse	Intra-operativemonitoring andstimulation of peripheralmotor nerves	Intra-operativemonitoring andstimulation of cranialand peripheral motornerves	Intra-operativemonitoring andstimulation of cranialand peripheral motornerves
SpecificIndicationsFor Use	Thyroidectomy,parathyroidectomy,mastoidectomy, cochlearimplant	Thyroidectomy,parathyroidectomy,mastoidectomy,parotidectomy, cochlearimplant, acousticneuroma, facial nerveneuroma, meningioma	Mastoidectomy,parotidectomy, skull-base
Hardware	Standard PC	Standard PC	Proprietary
(main unit)HeadboxBandwidth	components2 channel8Hz - 8kHz ±3dB	components4 channel8Hz - 8kHz ±3dB	microprocessor design4 channel10Hz - 5kHz ±3dB
Signal Gain	500	500	477
SoftwareScreen	Windows XP Embedded15" colour touchscreen	Windows XP Embedded15" colour touchscreen	C++ proprietary code6" electroluminescentdisplay
Method ofcontrol	Touchscreen - allcontrols via softwareexcept power ON/OFF	Touchscreen - allcontrols via softwareexcept power ON/OFF	Controls via dedicatedbuttons or via softwareusing menus selectedusing front-panelbuttons
Manner of	Electrical stimulation via	Electrical stimulation via	Electrical stimulation via
Stimulation	a probe	a probe	a probe
Stimulation	0.05mA - 10mA	0.05mA - 10mA	0.05mA - 5mA
RangeStimulationType	Square wave, negativeedge, 200µs pulse width,constant current	Square wave, negativeedge, 200µs pulsewidth, constant current	Square wave, negativeedge, default 200µspulse width, selectablefrom 100 to 500µs,constant current,constant voltage
	3 or 30Hz	3 or 30Hz	3 or 30 Hz
StimulationFrequency
StimulationProbes	Monopolar, bipolar,concentric	Monopolar, bipolar,concentric	Monopolar, bipolar,concentric
Electrodes	Laryngeal electrode;needle electrodes	Laryngeal electrode;needle electrodes	Laryngeal electrode;needle electrodes
TrainingRequiredfor Use	Yes; both for surgeonand OR staff	Yes; both for surgeonand OR staff	Yes; both for surgeonand OR staff
Location ofUse	Operating Room	Operating Room	Operating Room
Audio	Amplified raw EMG toprovide audio (10Woutput)	Amplified raw EMG toprovide audio (10Woutput)	Amplified raw EMG toprovide audio (14Woutput)
Display andStorage	Waveform signalsdisplayed on screen;stimulated responsesmay be optionallyautomatically recordedto disc	Waveform signalsdisplayed on screen;stimulated responsesmay be optionallyautomatically recordedto disc	Waveform signalsdisplayed on screen;individual screens maybe stored in non-volatilememory
PrintCapacity	Waveform data andpatient information canbe printed using theinternal thermal printeror via an external Lettersized inkjet printer forthe generation of reportsusing stored data andannotated comments	Waveform data andpatient information canbe printed using theinternal thermal printeror via an external Lettersized inkjet printer forthe generation of reportsusing stored data andannotated comments	Waveform data can beprinted to a proprietaryexternal thermal printer
Power	110/230V 50/60Hz	110/230V 50/60Hz	110/230V 50/60Hz
ElectricalSafety	EN60601-1; Type BF,Class IIA	EN60601-1; Type BF,Class IIA	UL260601-1; Type BF,Class I
ComplianceStandards	CE Mark; EN ISO 13485	CE Mark; EN ISO 13485	CE Mark; BS EN 9001;EN ISO13485

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K083242
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SECTION 5: 510(k) Summary or 510(k) Statement

5.4 Non-Clinical Tests Undertaken

、

The Neurosign 400 and the Neurosign Avalanche XT Thyroid and EMG nerve monitors were assessed in a non-clinical setting and were determined to be similar in the following areas:

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K083242
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SECTION 5: 510(k) Summary or 510(k) Statement

Feature	Neurosign 400	Neurosign Avalanche	Comments
Intended use	Cranial motor nerve monitoring	Cranial motor nerve monitoring	All the machines are intended for the same purpose, with the Thyroid version restricted to simpler applications
Method of operation	EMG monitor and stimulator	EMG monitor and stimulator	All machines detect EMG and amplify it so it is audible to the surgeon, as well as displaying the EMG in a graphical format
Stimulation frequency	3 or 30Hz	3 or 30Hz	All machines use the same frequencies, pulse width and rectangular waveform
Method of display	Display shows amplitude triggered response for continuous monitoring, and switches to stimulator triggered response when using the stimulator	Screen is divided into 2 sections, 1 showing amplitude triggered responses in real time, the other showing stimulator triggered responses	The information displayed is the same, but presented in different manner
Audio	14W rms amplifier	10W rms amplifier	All machines amplify the EMG signal to generate an audible response. The sound is simply amplified and is proportional to the input signal. It is intended to interact directly with the surgeon
Signal detection	Needle and Laryngeal electrode	Needle and Laryngeal electrode	The same electrodes and stimulating probes are used

Based upon these criteria, it was considered that the Neurosign 400 was a suitable predicate device for the Neurosign Avalanche XT Thyroid and XT EMG monitors.

5.5 Conclusions

The Neurosign Avalanche Motor Nerve Monitor is both safe and effective and is similar in its risks and benefits, as well as its manner of performance, to the predicate device listed above.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/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 an emblem featuring a stylized eagle-like bird with three wing-like extensions, representing the department's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The Magstim Company Limited c/o Anwen Evans Regulatory Affairs Manager Spring Gardens, Whitland Carmarthenshire, Wales, UK SA34 OHR

IJUL 2 9 2009

Re: K083242

Trade/Device Name: Neurosign® Avalanche Motor Nerve Monitor Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: July 9, 2009 Received: July 14, 2009

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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.

Q. C. Riem, m. f.

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

Enclosure

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Indications for Use

510(k) Number (if known): K 083242

Device Name: Neurosign® Avalanche Motor Nerve Monitor

Indications for Use:

The Neurosign Avalanche nerve monitor is intended to help surgeons locate, identify, and preserve cranial motor nerves during surgery.

The intended uses of the Neurosign Avalanche Motor Nerve Monitor is:

2 channel thyroidectomy and parathyroidectomy, mastoidectomy

parotidectomy, mastoidectomy, skull-base 4 channel

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)

scription Use.
er 21 CFR 801.109)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign Off)
Division of Ophthalmic, Neurological and Ear,
Nose and Throat Devices

Page1of1

K083242

510(k) Number.

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.