The Neurovision Ink Printed Endotracheal Tube Electrode is intended for use during surgery and parasurgical care only, with any compatible monitoring system, for continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as for providing an open airway for patient ventilation.

Device Description

The Neurovision Ink Printed Endotracheal Tube Electrode is an endotracheal tube with integrated electrodes for electromyographic (EMG) monitoring during surgery. The ET tube is made of a flexible PVC material with an inflatable low pressure cuff. The Neurovision Ink Printed Endotracheal Tube Electrode is provided as a sterile, single use disposable accessory that connects to a compatible EMG monitor to provide an open airway for patient ventilation during EMG neuromonitoring of the Recurrent Laryngel Nerve (RLN).

AI/ML Overview

The provided 510(k) summary for K130806, the Neurovision Ink Printed Endotracheal Tube Electrode, does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the manner typically expected for AI/ML devices. This submission for the Neurovision Ink Printed Endotracheal Tube Electrode is a Special 510(k), which is used for modifications to a legally marketed device where the modification does not affect the device's fundamental scientific technology. In such cases, the primary focus is on demonstrating that the modified device remains substantially equivalent to the predicate device and that the modifications do not introduce new questions of safety or effectiveness.

The document states that nonclinical testing was performed to demonstrate substantial equivalence. These tests focused on the functional and material characteristics of the modified device in comparison to the predicate device.

Here's an analysis of the provided information, focusing on aspects that might loosely correspond to "acceptance criteria" and "study results" in the context of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

(Note: The document does not explicitly list "acceptance criteria" with quantitative targets as one might find for a new AI/ML device. Instead, it focuses on demonstrating equivalence to the predicate device through various non-clinical tests.)

Characteristic/Test Performed	Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Summary from Document)
Device Name	No change from Predicate Device	No Change
Indicated Use	No change from Predicate Device	No Change
Operating Principle	No change from Predicate Device (Receives EMG signal)	No Change
Shelf Life	3 years (same as Predicate Device)	No Change (Implied to meet 3 years)
Reinforcing Material	Functionally equivalent to Predicate Device's dielectric coating	Dielectric coating attached to tube by non-phthalate PVC adhesive (Modified, but presumably equivalent performance)
Valve functionality	Functionally equivalent to Predicate Device's valve functionality	Demonstrated to be substantially equivalent to the predicate.
Electrode Impedance	Performance equivalent to Predicate Device's electrode impedance	Demonstrated to be substantially equivalent to the predicate.
Bend Tests	Performance equivalent to Predicate Device's bend performance	Demonstrated to be substantially equivalent to the predicate.
Biocompatibility (Systemic Toxicity, Intracutaneous Sensitivity, Irritation and Skin Sensitization)	Meet ISO 10993-1, 10993-10, 10993-11 standards (as applicable to the predicate)	Pass (Testing included these standards)

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

Test Set Sample Size: The document does not specify a "test set" sample size in terms of patient data or clinical cases. The tests described (valve functionality, electrode impedance, bend tests, biocompatibility) are non-clinical, bench-top tests performed on device samples. The specific number of device units tested for each non-clinical test is not provided in this summary.
Data Provenance: Not applicable in the context of clinical data for this submission. The tests are non-clinical (bench testing and biocompatibility).

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

Not applicable. The ground truth for the non-clinical tests (e.g., whether a valve functions, impedance values, bend resistance, biocompatibility) is established through standardized testing protocols and measurements, not expert human interpretation of clinical data or images.

4. Adjudication Method for the Test Set

Not applicable. There is no human adjudication for non-clinical, objective measurements like impedance or bend tests.

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 not an AI/ML diagnostic or assistive technology for human readers. It is a medical device for EMG monitoring.

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

Not applicable. This device is not an algorithm or AI system.

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

The "ground truth" for the non-clinical tests is based on objective, quantifiable measurements against established engineering specifications, material standards (e.g., ISO 10993 for biocompatibility), and functional equivalence to the legally marketed predicate device.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is not an AI/ML algorithm.

Summary of the Study that Proves the Device Meets the Acceptance Criteria:

The "study" described in the 510(k) summary is a collection of nonclinical tests designed to demonstrate that the modified Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to its predicate device (K110989 Neurovision Ink Printed Endotracheal Tube Electrode) and that the modification (change in reinforcing material's attachment adhesive) does not alter the fundamental safety or effectiveness.

The document states:
"Nonclinical testing, including valve functionality, electrode impedance and bend tests demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate."

Additionally, biocompatibility testing was performed following ISO standards:
"Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization."

These tests, by demonstrating equivalence in critical functional aspects and meeting safety standards for biological interaction, serve as the evidence that the modified device "meets acceptance criteria" in the context of a Special 510(k) submission. The inherent acceptance criteria for such a submission are successful completion of these tests, confirming that the device performs functionally the same as the predicate and is safe for its intended use, despite the minor material modification.

Summary

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K130806

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Special 510k - Ink Printed Endotracheal Tube Electrode Modification

JUL 1 2 2013

510K Summary

Date: 5/1/2013

In accordance with Title 21 of the Code of Federal Requlations. Part 807 and in particular 21 CFR §807.92, the following summary of information is provided:

Applicant Information

Christine Vergely Regulatory Affairs Manager Neurovision Medical Products, Inc. 2225 Sperry Ave., Suite 1000 Ventura, CA 93003 PH 805-866-6999 Fax: 413-410-4579 christie@neurovisionmedical.com

Device Identification:

Trade or Proprietary Name: Common or Usual Name:

Neurovision Ink Printed Endotracheal Tube Electrode. Endotracheal Tube with Electromyography (EMG) monitoring Electrodes. Class II

Device Class: Product Code:

Predicate Device

The subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the following predicate devices concurrently distributed commercially in the U.S.:

. K110989 Neurovision Ink Printed Endotracheal Tube Electrode
ETN

Device Description

Intended Use

Technological Characteristics of Device in Relation to Predicate Devices

The Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicated device in intended use and technological characteristics including design,

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Image /page/1/Picture/0 description: The image shows the logo for Neurovision Medical. The word "neurovision" is written in large, outlined letters. Below that, the word "MEDICAL" is written in smaller, block letters, underlined by three horizontal lines that are connected by a small, jagged line in the middle.

Special 510k - Ink Printed Endotracheal Tube Electrode Modification

material composition, function, packaging, and sterilization.

Comparison with the Predicate Device

	Predicate Device	Subject Device
Device Name	Neurovision Ink PrintedEndotracheal Tube Electrode	No Change
Indicated Use	The Neurovision Ink PrintedEndotracheal Tube Electrode isintended for use during surgeryand parasurgical care only,with any compatible monitoringsystem, for continuous EMGmonitoring and statusassessment of the nervessupplying the laryngealmusculature as well asproviding an open airway forpatient ventilation.	No Change
Operating Principle	Receives EMG signal	No Change
Shelf Life	3 years	No Change
LaryngealSurfaceElectrode	YES	No Change
EndotrachealLocation	YES	No Change
NumberofElectrodes	2 or 4	No Change
ElectrodeSurfaceMaterial	Conductive Silver Ink	No Change
Tube&CuffMaterials	PVC	No Change
Reinforcing Material	Dielectric coating	Dielectric coating attachedto tube by non-phthalatePVC adhesive.
Tube Dimensions	Various Dimensions	No Change
SterilizationandPackaging	Sterile, Single Use Only	No Change
Labeling,Instructions for Use,Intended Use	See attachments 1 and 2	No Change

Nonclinical testing, including valve functionality, electrode impedance and bend tests demonstrated that the subject Neurovision Ink Printed Endotracheal Tube Electrode is substantially equivalent to the predicate.

Biocompatibility testing included ISO 10993-11 Systemic Toxicity, ISO 10993-10 Intracutaneous Sensitivity and ISO 10993-10 Irritation and Skin Sensitization.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the caduceus.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 12, 2013

Neurovision Medical Product, Inc. Ms. Christine Vergely Regulatory Affairs Manager 2225 Sperry Avenue, Suite 1000 Ventura, CA 93003

Re: K130806

Trade/Device Name: Neurovision Ink Printed Endotracheal Tube Electrode Regulation Number: 21 CFR 874.1820 Regulation Name: Neurosurgical Nerve Locator Regulatory Class: Class II Product Code: PDO, ETN, BTR, GWF Dated: June 12, 2013 Received: June 13, 2013

Dear Ms. Vergely:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class }] (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

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Page 2 - Ms. Christine Vergely

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fdagov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K130806

Device Name: Neurovision Ink Printed Endotracheal Tube Electrode

Indications For Use:

Prescription Use _ × (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)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer: -S 2013.07.12 16:49:43 -04'00'

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number

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.