DNAP Electrode

{0}------------------------------------------------ Image /page/0/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 a stylized symbol featuring three human profiles facing to the right, with flowing lines above them, possibly representing hair or movement. 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K152547 Device Name DNAP Cranial Nerve Electrodes ### Indications for Use (Describe) 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. Type of Use (Select one or both, as applicable) | <div> <span> <span style="font-size:16px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | |-------------------------------------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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<br>1901 William Street<br>Racine, WI 53404<br>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<br>21 CFR 882.1330<br>Product Code: GZL, GYC<br>Class II | | Predicate Devices: | K044061 Cueva Cranial Nerve Electrode | ## Ad-Tech Medical Instrument Corporation #### 5.1 Product 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. {4}------------------------------------------------ #### 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<br>(Under Review) | Cueva Electrode<br>(Predicate K944061) | Comment | | Indications for<br>Use | The DNAP Cranial Nerve<br>Electrodes are designed for<br>intraoperative<br>monitoring/recording for<br>less than or equal to 10<br>hours from the cochlear<br>cranial nerve during skull<br>based surgical procedures<br>when connected to the<br>MEE-1000A or MEE-2000<br>Neural Function Measuring<br>System. | The Cueva Cranial Nerve<br>Electrode is intended for<br>use to monitor cranial<br>nerves during skull base<br>type surgeries. | The indication for use of the<br>DNAP electrode is the same<br>as the predicate device with<br>regard to intraoperative<br>monitoring (recording) from<br>the surface of cranial<br>nerves. The DNAP<br>Electrode is applied to the<br>surface of the Cochlear<br>Nerve, which is an<br>application of the Cueva<br>Electrode. | | Clinical<br>Application | The DNAP electrode<br>records cranial nerve action<br>potentials. The DNAP<br>electrode may be used for<br>recording the action<br>potentials of cochlear<br>nucleus elicited by auditory<br>stimulation. | Cueva Cranial Nerve<br>electrodes provide direct<br>cranial nerve monitoring<br>during skull based<br>surgeries. | Both electrodes are applied<br>to the surface of nerves to<br>monitor within the skull<br>during intraoperative<br>procedures. | | Contraindications | The DNAP cranial nerve<br>electrodes should not be<br>used on any patient who the<br>physician/surgeon considers<br>at risk for infection or for<br>whom the surgical<br>recording procedure cannot<br>be performed safely and<br>effectively.<br>This device is not intended<br>for use in MRI procedures. | The Cueva Electrode should<br>not be used on any patient<br>who the physician/surgeon<br>considers at risk for<br>infection. | Same | | Magnetic<br>Resonance<br>Imaging (MRI)<br>Compatibility | No | No | Same | | Single patient<br>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 {5}------------------------------------------------ | Feature | DNAP Electrode<br>(Under Review) | Cueva Electrode<br>(Predicate K944061) | Comment | |------------------------------------|----------------------------------|----------------------------------------|-------------------------| | Duration of Use | $ \u2264 $ 10 hours | $ \u2264 $ 10 hours | Same intraoperative | | Environment of Use | Intraoperative | Intraoperative | Same intraoperative use | | Electrode<br>Material | Platinum/Iridium | Platinum/Iridium | Same material | | Number of<br>Electrode<br>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<br>to connector. | Pass | | DNAP electrode Connector<br>compatibility with monitor<br>equipment. | Verify the DNAP electrode Connector is able to connect<br>to neural function measuring systems. | Pass | | Electrical continuity and<br>resistance after tensile testing. | Verify electrical continuity and resistance properties are<br>met after tensile load applied to the DNAP electrode. | Pass | | Electrode separation under<br>tensile test. | No electrode head separation with a load under tensile<br>test. | Pass | | Electrical continuity and<br>resistance after simulated use. | Apply a simulated monitoring potential for the < 10<br>hour 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.