Who is the manufacturer of FREMAP ELECTRODE?

Ad-Tech Medical Instrument Corporation filed the 510(k) submission for FREMAP ELECTRODE (K152769).

What is the FDA product code for FREMAP ELECTRODE?

ETN. It is classified under 21 CFR 874.1820 as a Class 2 device in the Ear, Nose, Throat panel.

What is the regulatory pathway for FREMAP ELECTRODE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for FREMAP ELECTRODE?

IOM Stimulator Probes (K133348); Cueva Cranial Nerve Electrode (K944061).

Who can help prepare an FDA 510(k) submission like FREMAP ELECTRODE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

FREMAP ELECTRODE

K152769 · Ad-Tech Medical Instrument Corporation · ETN · May 6, 2016 · Ear, Nose, Throat

Device Facts

Record ID	K152769
Device Name	FREMAP ELECTRODE
Applicant	Ad-Tech Medical Instrument Corporation
Product Code	ETN · Ear, Nose, Throat
Decision Date	May 6, 2016
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 874.1820
Device Class	Class 2

Intended Use

The FREMAP Cranial Nerve Electrodes are designed for intraoperative (≤ 10 hours) monitoring/recording from and stimulation to the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System.

Device Story

FREMAP Cranial Nerve Electrode; non-active, single-patient use, disposable, sterile electrode. Input: electrical signals from facial nerve/nerve root (monitoring) or electrical stimulation delivered to nerve (stimulation). Output: muscle action potentials recorded via connected Nihon Kohden MEE-1000A/MEE-2000 Neural Function Measuring System. Used intraoperatively by surgeons during skull-based procedures (e.g., acoustic neuroma, meningioma). Surgeon places monopolar electrode contact on nerve surface. Device facilitates nerve function preservation by allowing real-time monitoring of evoked muscle action potentials. Benefits patient by reducing risk of facial nerve damage during complex neurosurgery.

Clinical Evidence

Bench testing only. Evaluations included electrical resistance, connector compatibility, tensile testing (continuity and separation), and simulated use testing (10-hour duration). Biocompatibility testing included cytotoxicity, sensitization, intracutaneous testing, and acute systemic toxicity.

Technological Characteristics

Monopolar electrode with Platinum/Iridium contact. Single-patient use, disposable, sterile. Designed for intraoperative use (< 10 hours). Connects to Nihon Kohden MEE-1000A/MEE-2000 systems. No internal energy source; passive electrode.

Indications for Use

Indicated for intraoperative monitoring, recording, and stimulation of the facial nerve or facial nerve root at the CP angle during skull-based surgeries (e.g., acoustic neuroma, tumor removal). Contraindicated for patients at risk for infection or where the procedure cannot be performed safely; not for MRI use.

Regulatory Classification

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.

Predicate Devices

IOM Stimulator Probes (K133348)
Cueva Cranial Nerve Electrode (K944061)

Reference Devices

Subdural Electrode (K053363)

Related Devices

K112435 — RHYTHMLINK MONOPOLAR STIMULATING INSTRUMENT · Rhythmlink International, LLC · Sep 22, 2011
K050325 — DISPOSABLE CONCENTRIC PROBE, DISPOSABLE BIPOLAR PROBE, DISPOSABLE MONOPOLAR PROBE · Technomed Europe · May 5, 2005
K991583 — NEUROSIGN 400, 4 CHANNEL MOTOR NERVE MONITOR · The Magstim Company , Ltd. · May 19, 1999
K100912 — DISPOSABLE NERVE STIMULATING PROBE, BIPOLAR CONCENTRIC, DISPOSABLE NERVE STIMULATOR PROBE, BIPOLAR SIDE BY SIDE · Kirwan Surgical Products, Inc. · Aug 19, 2010
K152547 — DNAP Electrode · Ad-Tech Medical Instrument Corporation · Mar 4, 2016

Submission Summary (Full Text)

{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" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 May 6, 2016 Ad-tech Medical Instrument Corporation % Gary Syring Principal Consultant Quality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, WI 53589 Re: K152769 Trade/Device Name: FREMAP Electrode Regulation Number: 21 CFR 882.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN, GZL, GYC Dated: April 7, 2016 Received: April 8, 2016 Dear Mr. 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 Digitally signed by William J. Heetderks -A ON: c=US, o=U.S. Government, ou=HHS, ou=NIH, ou=People, 0.9.2342.19200300.100.1.1=0010149848, n=William J. Heetderks -A Date: 2016.05.06 08:44:04 -04'00' 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) K152769 Device Name FREMAP Cranial nerve Electrode Indications for Use (Describe) The FREMAP Cranial Nerve Electrodes are designed for intraoperative (=< 10 hours) monitoring/recording from and stimulation to the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when comnected to the MEE-1000A or MEE-2000 Neural Function Measuring System. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/>Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><input type="checkbox"/>Over-The-Counter Use (21 CFR 801 Subpart C)</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}------------------------------------------------ IMENT CORPORATION #### 5.0 510(k) Summary This summary is provided to support the 510(k) pre-market notification for the FREMAP 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: | May 5, 2016 | | Trade Name: | FREMAP Cranial Nerve Electrode | | Common Name: | Cortical Electrode | | Classification Name(s): (Predicates and Reference Devices) | 21 CFR 874.1820 Surgical Nerve Stimulator/Locator Product Code: ETN Class II 21 CFR 882.1330 Depth Electrode Product Code: GZL Class II 21 CFR 882.1310 Cortical Electrode Product Code: GYC Class II | | Predicate Devices: | K133348 IOM Stimulator Probes (Primary Predicate) K944061 Cueva Cranial Nerve Electrode | Reference Device: K053363 Subdural Electrode #### Product Description 5.1 The device under review is a Facial nerve Root Evoked Muscle Action Potential (FREMAP) electrode. The electrode is used to elicit the muscle action potentials by electric stimulation directly to the facial nerve. It is commonly placed on the facial nerve or facial nerve root at the CP-angle and is used for monitoring (elicit) the muscle action potential response to preserve the facial nerve function especially during acoustic neuroma surgery or tumor removal (such as meningioma) at the CP-angle. {4}------------------------------------------------ The FREMAP electrodes are non-active and are intended to be connected to Nihon Kohden Corporation's Neural Function Measuring System Neuromaster MEE-1000A or MEE-2000 #### 5.2 Intended Use of the Device The intended use of the FREMAP electrode is the same as predicate devices: The FREMAP Cranial Nerve Electrodes are designed for intraoperative (≤ 10 hours) monitoring/recording from and stimulation to the facial nerve or facial nerve root at the CP angle 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 FREMAP electrode to the predicate devices applied to support this pre-market notification. | Feature | FREMAP Electrode (Under Review) | Cueva Electrode (Predicate K944061) | IOM Stimulator Probes (Primary Predicate K133348) | FREMAP Electrode Equivalence Discussion | |--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use | The FREMAP cranial nerve electrodes are intended for nerve monitoring/recording and stimulation during acoustic neuroma surgery or tumor removal at the CP-angle. | The Cueva Cranial Nerve Electrode is intended for use to monitor cranial nerves during skull base type surgeries. | IOM Stimulator Probes are used by the surgeon as the medium to deliver electrical stimulation to tissue during intra-operative neurological monitoring, to identify nerves and spinal nerve roots and to assess nerve function. | The FREMAP cranial nerve electrodes combine the intended use of monitoring cranial nerves and a nerve contacting stimulation electrode (probe) for cranial nerves (facial nerve and facial nerve root). | | Indications for Use | The FREMAP Cranial Nerve Electrodes are designed for intraoperative (< 10 hours) monitoring/recording from the facial nerve or facial nerve root at the CP angle during skull based surgical procedures when connected to the MEE-1000A or MEE-2000 Neural Function Measuring System. | The 510(k) submission references use on the Cochlear cranial nerve, Facial nerve, Glossopharyngeal nerve, Hypoglossal nerve, Spinal accessory nerve and Vagus nerve. | IOM Stimulator Probes disposable surgical stimulators are indicated for tissue dissection and stimulation of cranial and peripheral nerves for location and identification during surgery, including spinal nerve roots. | The indication for use of the FREMAP electrode is the same as the predicate devices with regard to intraoperative use for monitoring (recording) from the surface of cranial nerves (the facial nerve is one of the predicate Cueva nerves monitored) and application of stimulation for an evoked response of the facial nerve and facial nerve root (the IOM Neural Stimulator Probe Insulated Monopolar is applied | | Feature | FREMAP Electrode (Under Review) | Cueva Electrode (Predicate K944061) | IOM Stimulator Probes (Primary Predicate K133348) | FREMAP Electrode Equivalence Discussion | | | | | | for stimulation of cranial nerves.) The facial nerve and facial nerve root are cranial nerves. | | Contraindications | The FREMAP 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 and stimulation 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. | Unknown | Same with regard to the risk for infection from the predicate Cueva Electrode. | | Clinical Use | The FREMAP electrode records cranial (facial nerve and facial nerve root) action potentials and may be used for stimulation of these nerves. | Cueva Cranial Nerve electrodes provide direct cranial nerve monitoring during skull based surgeries. | IOM Stimulator Probes provide direct cranial nerve stimulation (monitoring) during intraoperative skull based surgeries. | All electrodes (probes) are applied to the surface of the nerve to support nerve recording and stimulation within the skull during intraoperative procedures. | | Fundamental Technical Function | Monopolar electrode contact placed on the surface of the nerve by the user, in support of monitoring and stimulating the nerve. | Monopolar electrode contact placed on the surface of the nerve by the user, in support of monitoring nerve function. | Monopolar electrode contact placed on the surface of the nerve by the user, in support of stimulation of the nerve. | The fundamental technical function of the FREMAP electrode and the predicate Cueva electrode, IOM Stimulator Probe is the same. | | Single Patient Use, Disposable | Yes | Yes | Yes | Same | | Provided Sterile | Yes | Yes | Yes | Same | | Environment of Use | Intraoperative | Intraoperative | Intraoperative | Same intraoperative use | | Duration of Use | < 10 hours | < 10 hours | Intraoperative (Assumed to be < 10 hours) | Same intraoperative duration of use. | | Number of Electrode Contacts | One (1) | One (1) | One (1) | Monopolar, one electrode contact. | | Electrode Material | Platinum/Iridium | Platinum/Iridium | Stainless steel | Same as Cueva electrode for recording. A reference | | Feature | FREMAP Electrode (Under Review) | Cueva Electrode (Predicate K944061) | IOM Stimulator Probes (Primary Predicate K133348) | FREMAP Electrode Equivalence Discussion | | | | | | device with Platinum/Iridium as the nerve stimulating electrode contact is discussed. | {5}------------------------------------------------ {6}------------------------------------------------ Features of the FREMAP electrode compared to the Predicate and Reference device are addressed below. | FREMAP Electrode Discussion | | | | | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | FREMAP Electrode (Under Review) | Cueva Electrode (Predicate K944061) IOM Stimulator Probes (Primary Predicate K133348) | Subdural Electrode (Reference Device K05336) | Safety and Effectiveness Discussion | | Fundamental Technical Function | The FREMAP Electrode has a monopolar electrode disk contact. The monopolar electrode contact is placed on the surface of the nerve by the user. in support of recording from and stimulating to the nerve. | The Cueva electrode has a monopolar electrode contact on a C-shaped radius. The IOM stimulator probe (Neural Stimulator Probe Insulated Monopolar) electrode has a monopolar electrode contact as a sphere. For both predicates, the monopolar electrode contact is placed on the surface of the nerve by the user, in support of recording from and stimulating to the nerve. | The reference subdural electrodes are a circular disc. The electrode contacts are placed on the surface of the nerve (brain) by the user, in support of recording from and stimulation to the nerve. | The FREMAP electrode is equivalent to the circular disk of the reference Subdural Electrode. The Subdural electrodes are indicated for recording from and stimulation to a cranial nerve, the brain. | | Electrode Material | Platinum/Iridium | Cueva: Platinum/Iridium (Recording) IOM Probe: Stainless Steel (Stimulation) | Platinum/Iridium (Recording and Stimulation) or Stainless Steel (Recording and Stimulation) | The reference Subdural electrode applies the same Platinum/Iridium as the stimulating electrode contact material to nerve tissue. | ### Performance Tests to Demonstrate Substantial Equivalency 5.4 To establish the technical equivalency of the FREMAP electrode, evaluations were conducted to evaluate compliance with performance requirements, including: | Test | Summary of Requirement | |----------------------------------------------------------|---------------------------------------------------------------------------------------------------| | Electrical Resistance | Measure electrical resistance from the electrode contact to connector. | | FREMAP electrode Connector compatibility with monitor | Verify the FREMAP electrode Connector is able to connect to neural function measuring systems. | {7}------------------------------------------------ | Test | Summary of Requirement | |---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------| | equipment | | | Electrical continuity and resistance after tensile testing | Verify electrical continuity and resistance properties are met after tensile load was applied to the FREMAP electrode. | | Electrode separation under tensile test | Evaluate risk of electrode head separation with a load under tensile test. | | Electrical continuity and resistance after simulated use. | Apply a simulated stimulation potential for the 10 hour anticipated duration of intraoperative use. | | Overall length | Confirm dimensional requirements are met. | Test requirements were met or a process monitor is in place to confirm compliance. Biocompatibility evaluations of manufactured and sterilized FREMAP Electrodes were performed for Cytotoxicity, Sensitization, Intracutaneous Test and Acute System Toxicity. ### 5.5 Conclusion The FREMAP electrode meets performance requirements. The intended use and technology of the FREMAP electrode are the same as the predicate devices.