(224 days)
No
The description focuses on the electrode's function for electrical stimulation and monitoring, and explicitly states it is a non-active device connected to a separate measuring system. There is no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for monitoring and recording nerve function, not for treating a condition or disease.
Yes
The intended use and device description state that the device is used for intraoperative monitoring and recording from and stimulation to the facial nerve, specifically to elicit and monitor muscle action potential responses to preserve facial nerve function during surgery. This process of obtaining information about the physiological state of a tissue or system for clinical decision-making is a diagnostic process.
No
The device is a physical electrode designed to be connected to a separate measuring system, indicating it is a hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for "intraoperative monitoring/recording from and stimulation to the facial nerve or facial nerve root". This involves direct interaction with the patient's body during surgery.
- Device Description: The description reinforces this by stating the electrode is used to "elicit the muscle action potentials by electric stimulation directly to the facial nerve". This is a physiological measurement taken from a living organism.
- IVD Definition: In Vitro Diagnostics are defined as medical devices intended to be used in vitro for the examination of specimens derived from the human body in order to provide information for diagnostic, monitoring or compatibility purposes. This device does not examine specimens in vitro.
The device is a surgical electrode used for neuromonitoring during surgery, which falls under the category of medical devices used in vivo.
N/A
Intended Use / Indications for Use
The FREMAP Cranial Nerve Electrodes are designed for intraoperative (
§ 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.
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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
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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 (=Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.
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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 (