The Inomed Adhesive Laryngeal Electrodes are intended to be used as a disposable, selfadhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.

Device Description

The Inomed Adhesive Laryngeal Electrodes are single used electrodes constructed from an medical grade ink with a conductive polymer film covered by an insulating coating, a connector made of polypropylene: and a cable assembly. The electrodes are designed to monitor the recurrent nerve during thyroid, anterior cervical, carotid endartecrectomy surgery and vagus nerve monitoring during brain surgery. The monitoring is performed with a surface electrode that is attached to an endotracheal tube placed on the vocal cord. A neutral adhesive electrode is placed on the patient's shoulder. Both adhesive electrodes are connected to a reusable recording cable and to the nerve monitor

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Inomed Adhesive Laryngeal Electrodes. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with detailed acceptance criteria and performance metrics in the way a clinical trial would for a novel device.

Here's an analysis of the information provided based on your request, highlighting what is present and what is absent:

Acceptance Criteria and Study Details for Inomed Adhesive Laryngeal Electrodes

No explicit "acceptance criteria" table with reported device performance is provided in the document. The submission is a 510(k) summary, which demonstrates substantial equivalence by comparing the new device's technical characteristics and intended use to a legally marketed predicate device. The "acceptance criteria" are implicitly met by demonstrating that the new device is as safe and effective as the predicate and introduces no new questions of safety or effectiveness.

The document states: "After analyzing performance and safety testing, it is the conclusion of Inomed that the inomed adhesive laryngeal electrodes are as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness." This implies that the device successfully passed relevant tests, but the specific quantitative criteria and results are not detailed in this summary.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, a formal table of quantitative acceptance criteria and reported numerical performance is not provided in this 510(k) summary for the Inomed Adhesive Laryngeal Electrodes. Instead, the comparison table focuses on qualitative and design characteristics between the new device and the predicate devices. The "performance" assessment is summarized as the device being "as safe and effective as the predicate devices."

The comparison table provided (page 2) lists characteristics to demonstrate equivalence, but not quantitative performance criteria:

Parameters...	New Device (Inomed Laryngeal Electrode)	Predicate Device (Neurosign Laryngeal Electrodes)	Predicate Device (Laryngeal Surface Electrode - Endotracheal Tube)
Intended Use	The Laryngeal Surface Electrode-Endotracheal Tube is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.	Laryngeal electrodes intended for non-invasively monitoring the laryngeal nerves during thyroid surgery, and of the Xth cranial nerve during skull-base surgery	The Laryngeal Surface Electrode-Endotracheal Tube is intended to be used as a disposable, self-adhesive electrode attached to an endotracheal tube and positioned for continuous EMG monitoring of the larynx during surgical procedures.
Monitoring site	Trachea/larynx	Trachea/larynx	Trachea/larynx
Monitoring type	Continuous EMG monitoring	Continuous EMG monitoring	Continuous EMG monitoring
May be used with all commercial EMG units	yes	Yes	Yes
Method of electrode attachment	Attached to the surface of the endotracheal tube	Attached to the surface of the endotracheal tube	Attached to the surface of the endotracheal tube
Number of electrodes utilized	2	2	2
Number of channels	2	2	2
Device design	-Medical grade inks suspended in a polyester substrate -polypropylene connector - cable assembly	-Medical grade inks suspended in a polyester substrate -polypropylene connector - cable assembly	-Two-plate laryngeal electrode -adhesive on back surface
Electrical insulation	-Adhesive back surface Electrical insulation on head of the electrode	-Adhesive back surface Electrical insulation on head of the electrode	Two plate laryngeal electrode head of the electrode
Single use only	Yes	Yes	Yes
Safety characteristics	Non-invasive	Non-invasive	(Not explicitly stated for this predicate, but implied by nature)
Biocompatibility ISO 10993-1	Yes	(Not explicitly stated)	Yes
IEC 60601-1 Protected	Connector touch proof	Unknown	Unknown
Sterilization	ETO	ETO	ETO

The "agreement criteria" for this type of submission are that the new device performs equivalently to the predicate devices in terms of these characteristics.

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

The document mentions "performance and safety testing" and adherence to "appropriate electrical testing standard and biocompatibility standards," but does not specify a patient-based "test set" sample size or data provenance (e.g., country of origin, retrospective/prospective clinical data). The tests performed are primarily non-clinical (electrical and biocompatibility) to support substantial equivalence, not a clinical effectiveness trial.

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

This information is not applicable/not provided as there is no described clinical study involving expert interpretation or "ground truth" establishment in the context of device performance in a diagnostic or interpretive sense. The testing focuses on product safety and functional equivalence to the predicate, likely through laboratory and engineering tests.

4. Adjudication method for the test set:

This is not applicable/not provided for the same reasons as point 3.

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:

This is not applicable/not provided. The device is a laryngeal electrode for EMG monitoring, not an AI-assisted diagnostic or interpretive tool that would involve human readers.

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

This is not applicable/not provided. The device is an electrode, not an algorithm. Its function is to facilitate EMG monitoring.

7. The type of ground truth used:

Given the nature of the device and the submission, the "ground truth" for the non-clinical tests would be established by engineering specifications, international standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601-1 for electrical safety), and comparison to the predicate device's documented characteristics. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" in this summary.

8. The sample size for the training set:

This is not applicable/not provided. There is no "training set" in the context of this device, as it is a medical device (electrode) and not a machine learning model.

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

This is not applicable/not provided for the same reason as point 8.

Summary

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K091874
P. 1 of 3

510(k) Summary 807.92(c)

SPONSOR Company Name:

Company Address

807.92(a)(1)

Inomed Medizintechnik GmbH

Tullastrasse Sa Teningen, Germany 79331

Telephone: Fax:

49-7641-9414-0 49-7641-9414-94

Contact Person: Telephone:

Sascha Busch 049-7641-9414-87

Summary Preparation Date: March 23, 2009

DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

PREDICATE DEVICE

Legally Marketed Equivalent Device Company Magstim Co.,Ltd. RLN Systems. Inc.

DEVICE DESCRIPTION

Inomed Adhesive Laryngeal Electrode Laryngeal Electrode. Stimulator, Nerve CFR §874.1820 ETN Class II

807.92(a)(3)

510(k) # K071349 K003745

807.92(a)(4)

Product

Neurosign Laryngeal electrodes Laryngeal Surface Electrode

NOV 1 8 2009

807.92(a)(2)

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46916743 S. S. Ox. S. C. S. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C. C.

DEVICE INTENDED USE

807.92(a)(5)

COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6)

Parameters...	New Device	Predicate Device	Predicate Device
Device	Inomed LaryngealElectrode	Neurosign LaryngealElectrodes	Laryngeal surfaceElectrode -Endotracheal Tube
Manufacturer	Inomed	Magstim Co., Ltd.	RLN Systems, Inc.(Neurovision Medical)
510(k)	N/A	K071349:	K003745
Product Code	ETN	ETN	ETN
Intended Use	The Laryngeal SurfaceElectrode-EndotrachealTube is intended to beused as a disposable,self-adhesive electrodeattached to anendotracheal tube andpositioned forcontinuous EMGmonitoring of the larynxduring surgicalprocedures.	Laryngeal electrodesintended for non-invasively monitoringthe laryngeal nervesduring thyroid surgery,and of the Xth cranialnerve during skull-basesurgery	The Laryngeal SurfaceElectrode-EndotrachealTube is intended to beused as a disposable,self-adhesive electrodeattached to anendotracheal tube andpositioned forcontinuous EMGmonitoring of the larynxduring surgicalprocedures.
Monitoring site	Trachea/larynx	Trachea/larynx	Trachea/larynx
Monitoring type	Continuous EMGmonitoring	Continuous EMGmonitoring	Continuous EMGmonitoring
May be used with allcommercial EMG units	yes	Yes	Yes
Method of electrodeattachment	Attached to the surfaceof the endotracheal tube	Attached to the surfaceof the endotracheal tube	Attached to the surfaceof the endotracheal tube
Number of electrodesutilized	2	2	2
Number of channels	2	2	2
Device design	-Medical grade inkssuspended in a polyestersubstrate-polypropyleneconnector- cable assembly	-Medical grade inkssuspended in a polyestersubstrate-polypropyleneconnector- cable assembly	-Two-plate laryngealelectrode-adhesive on backsurface
Electrical insulation	-Adhesive back surfaceElectrical insulation on	-Adhesive back surfaceElectrical insulation on	Two plate laryngealelectrode
	head of the electrode	head of the electrode	head of the electrode
Single use only	Yes	Yes	Yes
Safety characteristics	Non-invasive	Non-invasive
Biocompatibility ISO10993-1	Yes		Yes
IEC 60601-1 Protected	Connector touch proof	Unknown	Unknown
Pin design
Sterilization	ETO	ETO	ETO

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0918574
p. 3 of 3

Conclusions:

The Inomed Adhesive Laryngeal Electrodes are similar to the predicate device in intended use and technological characteristics. After analyzing performance and safety testing, it is the conclusion of Inomed that the inomed adhesive laryngeal electrodes are as safe and effective as the predicate devices and introduce no new questions concerning safety and effectiveness.

NONCLINICAL AND CLINICAL TEST

807.92(b)

SAFETY and EFFECTIVENESS

The Inomed adhesive electrodes have been tested to the appropriate electrical testing standard and biocompatibility standards and have been found safe for their intended use

CONCLUSION

807.92(b)(3)

Conclusions:

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

NOV 1 8 2009

Inomed Medizintechnik GmbH c/o Ms. Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, MD 21114

Re: K091874

Trade/Device Name: Inomed Adhesive Laryngeal Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: II Product Code: ETN Dated: October 2, 2009 Received: October 5, 2009

Dear Ms. Smith:

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/CDRH/CDRHOffices/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,

Eile. then, m

Malvina B. Eydelman, M.D. 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): KO91874

Device Name: Inomed Adhesive Laryngeal Electrodes

Indications for Use:

Prescription Use V (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use.
(Per 21 CFR 801.109)

John Doucet
(Division Sign-On)
Division of Ophthalmic, Neurological and Ear,
and Tatum Devices

510(k) Number:
K091874

Page _ of _

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.