K Number

Device Name

DNAP Electrode

Manufacturer

Ad-Tech Medical Instrument Corporation

Date Cleared

2016-03-04

(178 days)

Product Code

GZL GYC

Regulation Number

882.1330

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K044061

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the physical characteristics and function of a passive electrode for recording nerve signals, with no mention of data processing or analysis that would involve AI/ML.

Therapeutic

No
The device is used for monitoring/recording nerve activity during surgery, not for treating a condition or disease.

Diagnostic

The device is described as an "electrode" used for "monitoring/recording" cranial nerve activity "intraoperatively" to "preserve cochlear nerve function." It records "action potentials" and is connected to a "Neural Function Measuring System." This suggests it is a measurement or monitoring tool used during surgery rather than a device that diagnoses a condition or disease.

SaMD (Software as a Medical Device)

The device is a physical electrode intended for surgical use and explicitly described as "non-active" and "disposable," indicating it is a hardware component.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnostic purposes.
Device Function: The DNAP Cranial Nerve Electrodes are designed for intraoperative monitoring/recording of nerve activity directly from the cochlear cranial nerves during surgery. They are placed on the dorsal cochlear nuclei.
No Specimen Collection: The device does not collect or analyze specimens taken from the body. It directly interacts with and measures electrical activity from the nerves in situ.
Purpose: The purpose is to monitor nerve function during a surgical procedure to help preserve nerve function, not to diagnose a condition based on analysis of a bodily fluid or tissue sample.

The device is a surgical accessory used for real-time physiological monitoring during surgery, not an in vitro diagnostic test.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GZL, GYC

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

cochlear cranial nerves, dorsal cochlear nuclei

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Test: Electrical Resistance. Summary of Requirement: Measure electrical resistance from the electrode contact to connector. Result: Pass
Test: DNAP electrode Connector compatibility with monitor equipment. Summary of Requirement: Verify the DNAP electrode Connector is able to connect to neural function measuring systems. Result: Pass
Test: Electrical continuity and resistance after tensile testing. Summary of Requirement: Verify electrical continuity and resistance properties are met after tensile load applied to the DNAP electrode. Result: Pass
Test: Electrode separation under tensile test. Summary of Requirement: No electrode head separation with a load under tensile test. Result: Pass
Test: Electrical continuity and resistance after simulated use. Summary of Requirement: Apply a simulated monitoring potential for the

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).

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

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

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 Corporation
1901 William Street
Racine, WI 53404
Phone: (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 Electrode
21 CFR 882.1330
Product Code: GZL, GYC
Class II |
| Predicate Devices: | K044061 Cueva Cranial Nerve Electrode |

Ad-Tech Medical Instrument Corporation

5.1 Product Description

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 for
Use	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.	The Cueva Cranial Nerve
Electrode is intended for
use to monitor cranial
nerves during skull base
type surgeries.	The indication for use of the
DNAP electrode is the same
as the predicate device with
regard to intraoperative
monitoring (recording) from
the surface of cranial
nerves. The DNAP
Electrode is applied to the
surface of the Cochlear
Nerve, which is an
application of the Cueva
Electrode.
Clinical
Application	The DNAP electrode
records cranial nerve action
potentials. The DNAP
electrode may be used for
recording the action
potentials of cochlear
nucleus elicited by auditory
stimulation.	Cueva Cranial Nerve
electrodes provide direct
cranial nerve monitoring
during skull based
surgeries.	Both electrodes are applied
to the surface of nerves to
monitor within the skull
during intraoperative
procedures.
Contraindications	The DNAP cranial nerve
electrodes should not be
used on any patient who the
physician/surgeon considers
at risk for infection or for
whom the surgical
recording procedure cannot
be performed safely and
effectively.
This device is not intended
for use in MRI procedures.	The Cueva Electrode should
not be used on any patient
who the physician/surgeon
considers at risk for
infection.	Same
Magnetic
Resonance
Imaging (MRI)
Compatibility	No	No	Same
Single patient
use, 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

| 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 |
| Electrode
Material | Platinum/Iridium | Platinum/Iridium | Same material |
| Number of
Electrode
Contacts | 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 contact
to connector.	Pass
DNAP electrode Connector
compatibility with monitor
equipment.	Verify the DNAP electrode Connector is able to connect
to neural function measuring systems.	Pass
Electrical continuity and
resistance after tensile testing.	Verify electrical continuity and resistance properties are
met after tensile load applied to the DNAP electrode.	Pass
Electrode separation under
tensile test.	No electrode head separation with a load under tensile
test.	Pass
Electrical continuity and
resistance after simulated use.	Apply a simulated monitoring potential for the