The DNAP Cranial Nerve Electrodes are designed for intraoperative monitoring/recording for less than or equal to 10 hours from the cochlear cranial nerves during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

Device Description

The DNAP Cranial Nerve Electrode (DNAP electrode) is intended for intraoperative nerve monitoring/recording during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle during surgical procedures. The DNAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System MEE-1000A or MEE-2000 Neural Function Measuring System.

The DNAP electrode is a single patient use, disposable cranial nerve electrode used for recording cranial nerve action potentials. The DNAP electrode may be used for recording the action potentials of cochlear nucleus elicited by auditory stimulation. The user places the electrode on the dorsal cochlear nuclei. Access to the dorsal cochlear nuclei may be through the foremen of Luschka. This potential is called DNAP (dorsal cochlear nucleus action potential), and used to preserve cochlear nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle.

AI/ML Overview

The provided document is a 510(k) summary for the Ad-Tech Medical Instrument Corporation's DNAP Cranial Nerve Electrode. It outlines the device's indications for use and compares its technological characteristics and performance to a predicate device (Cueva Cranial Nerve Electrode K044061) to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Requirement	Reported Device Performance and Results
Electrical Resistance (from electrode contact to connector)	Pass
DNAP electrode Connector compatibility (with monitor equipment)	Pass
Electrical continuity and resistance after tensile testing	Pass
Electrode separation under tensile test	Pass (No electrode head separation)
Electrical continuity and resistance after simulated use (for ≤ 10 hours intraoperative use)	Pass
Overall length (dimensional requirements)	Pass
Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous, Acute Systemic Toxicity)	Performed and deemed acceptable

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify the exact sample size for the test sets used in the performance benches. It refers to "evaluations" and "tests" without detailing the number of devices or trials.
- Data provenance is not explicitly stated (e.g., country of origin, retrospective/prospective). Given these are bench tests for a medical device seeking premarket notification in the US, it's highly likely they were conducted in a controlled lab environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to the type of studies presented. The performance tests (electrical resistance, tensile strength, compatibility, biocompatibility) are objective bench tests, not requiring expert human interpretation or "ground truth" establishment in the clinical sense.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as the studies described are objective bench tests, not involving subjective human assessment or consensus methods for ground truth adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. This device is an electrode for intraoperative monitoring, not an AI-powered diagnostic tool that assists human readers/interpreters. The focus is on the physical and electrical performance of the electrode itself.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm performance study was not done. This device is a physical medical instrument (an electrode), not an algorithm or software. Its function is to record signals, which are then interpreted by human clinicians using an external Neural Function Measuring System.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of objective, predefined engineering and biocompatibility standards and specifications. For instance, electrical resistance must fall within a specified range, and tensile strength must meet a certain threshold without failure.
The sample size for the training set:
- This is not applicable. The device is an electrode, not a machine learning model. Therefore, there is no "training set."
How the ground truth for the training set was established:
- This is not applicable as there is no training set for this type of device.

Summary

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

March 4, 2016

Ad-tech Medical Instrument Corporation % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC. 800 Levanger Lane. Stoughton, Wisconsin 53589

Re: K152547

Trade/Device Name: DNAP Electrode Regulation Number: 21 CFR 882.1330 Regulation Name: Depth Electrode Regulatory Class: Class II Product Code: GZL, GYC Dated: September 2, 2015 Received: September 8, 2015

Dear Gary Syring:

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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

William J. Heetderks -A

for Carlos L. Peña, PhD, MS 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) K152547

Device Name DNAP Cranial Nerve Electrodes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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I MEDICAL INSTRUMENT CORPORATION

5.0 510(k) Summary

This summary is provided to support the 510(k) premarket notification for the DNAP Cranial Nerve Electrode.

Company Name:	Ad-Tech Medical Instrument Corporation1901 William StreetRacine, WI 53404Phone: (262) 634-1555
Company Contact:	Lisa Theama, Chief Operating Officer
Date Summary Prepared:	January 21, 2016
Trade Name:	DNAP Cranial Nerve Electrode
Common Name:	Cortical Electrode
Classification Name:	Depth Electrode21 CFR 882.1330Product Code: GZL, GYCClass II
Predicate Devices:	K044061 Cueva Cranial Nerve Electrode

Ad-Tech Medical Instrument Corporation

5.1 Product Description

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Intended Use of the Device 5.1

The intended use of the DNAP electrode is the same as the predicate device: The DNAP Cranial Nerve Electrodes are designed for intraoperative monitoring/recording for less than or equal to 10 hours from the cochlear cranial nerve during skull based surgical procedures when connected to the MEE-1000A or MEE- 2000 Neural Function Measuring System.

5.3 Summary of Technological Characteristics

The following table provides a side-by-side comparison the DNAP electrode to the predicate devices applied to support this notification.

Table 5.3-1: Substantial Equivalence Technical Characteristics
Feature	DNAP Electrode(Under Review)	Cueva Electrode(Predicate K944061)	Comment
Indications forUse	The DNAP Cranial NerveElectrodes are designed forintraoperativemonitoring/recording forless than or equal to 10hours from the cochlearcranial nerve during skullbased surgical procedureswhen connected to theMEE-1000A or MEE-2000Neural Function MeasuringSystem.	The Cueva Cranial NerveElectrode is intended foruse to monitor cranialnerves during skull basetype surgeries.	The indication for use of theDNAP electrode is the sameas the predicate device withregard to intraoperativemonitoring (recording) fromthe surface of cranialnerves. The DNAPElectrode is applied to thesurface of the CochlearNerve, which is anapplication of the CuevaElectrode.
ClinicalApplication	The DNAP electroderecords cranial nerve actionpotentials. The DNAPelectrode may be used forrecording the actionpotentials of cochlearnucleus elicited by auditorystimulation.	Cueva Cranial Nerveelectrodes provide directcranial nerve monitoringduring skull basedsurgeries.	Both electrodes are appliedto the surface of nerves tomonitor within the skullduring intraoperativeprocedures.
Contraindications	The DNAP cranial nerveelectrodes should not beused on any patient who thephysician/surgeon considersat risk for infection or forwhom the surgicalrecording procedure cannotbe performed safely andeffectively.This device is not intendedfor use in MRI procedures.	The Cueva Electrode shouldnot be used on any patientwho the physician/surgeonconsiders at risk forinfection.	Same
MagneticResonanceImaging (MRI)Compatibility	No	No	Same
Single patientuse, Disposable	Yes	Yes	Same
Provided Sterile	Yes	Yes	Same

| Table 5.3-1: Substantial Equivalence Technical Characteristics

Table 5.3-1: Substantial Equivalence Technical Characteristics

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Feature	DNAP Electrode(Under Review)	Cueva Electrode(Predicate K944061)	Comment
Duration of Use	$ \u2264 $ 10 hours	$ \u2264 $ 10 hours	Same intraoperative
Environment of Use	Intraoperative	Intraoperative	Same intraoperative use
ElectrodeMaterial	Platinum/Iridium	Platinum/Iridium	Same material
Number ofElectrodeContacts	One (1)	One (1)	Same

Performance Tests to Demonstrate Substantial Equivalency 5.4

To establish the technical equivalency of the DNAP electrode, evaluations were conducted to confirm compliance with performance requirements, including:

Test	Summary of Requirement	Result
Electrical Resistance.	Measure electrical resistance from the electrode contactto connector.	Pass
DNAP electrode Connectorcompatibility with monitorequipment.	Verify the DNAP electrode Connector is able to connectto neural function measuring systems.	Pass
Electrical continuity andresistance after tensile testing.	Verify electrical continuity and resistance properties aremet after tensile load applied to the DNAP electrode.	Pass
Electrode separation undertensile test.	No electrode head separation with a load under tensiletest.	Pass
Electrical continuity andresistance after simulated use.	Apply a simulated monitoring potential for the < 10hour anticipated duration of intraoperative use.	Pass
Overall length.	Confirm dimensional requirements are met.	Pass

Biocompatibility evaluations of manufactured and sterilized DNAP Electrodes were performed for Cytotoxicity, Sensitization, Intracutaneous and Acute Systemic Toxicity.

5.5 Conclusion

The DNAP electrode meets performance requirements. The intended use and technology of the DNAP electrode are equivalent to the predicate device.

Regulation Number and Section

§ 882.1330 Depth electrode.

(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).