PROTEKTOR 32

K093304 · Natus Medical, Inc. · GWF · Aug 11, 2010 · Neurology

Device Facts

• Record ID: K093304
• Device Name: PROTEKTOR 32
• Applicant: Natus Medical, Inc.
• Product Code: GWF · Neurology
• Decision Date: Aug 11, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1870
• Device Class: Class 2

Intended Use

The Protektor32 channel system, composed of both hardware and software, is intended to be used for intracperative neurological monitoring. The instrument uses Electroencephalogical by (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery. The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, lornrovin, or compression) or vascular insufficiency. The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software's outputs is as follows: - The EEG, EP, and EMG waveforms are intended to help the user assess a patient's . neurological status during surgery. - Simple waveform parameters (e.g., amplitude, latency), and user-defined Fast Fourier . transform (FFT) displays (compressed spectral array or CSA, density spectral array or DSA) are intended to help the user analyze the EEG and EP waveforms. This device is intended to be used by qualified medical practitioners, trained in EEG, EP and EMG who will exercise professional judgment when using the information.

Device Story

Protektor32 is an intraoperative neurological monitoring system; inputs include EEG, EP, EMG, and TcMEP signals. System hardware and EPWorks software enable manual configuration of stimulation and acquisition parameters; allows creation of custom protocols. Outputs include raw waveforms, amplitude/latency parameters, and FFT-based displays (CSA, DSA). Used in surgical settings by qualified medical practitioners; provides real-time data to assist in assessing neurological status and identifying acute dysfunction during procedures. Benefits include early detection of corticospinal axonal conduction issues caused by mechanical trauma or vascular insufficiency, allowing for immediate clinical intervention.

Clinical Evidence

No clinical data provided; device relies on technological characteristics and intended use equivalence to existing intraoperative monitoring systems.

Technological Characteristics

Multi-channel system for EEG, EP, EMG, and TcMEP. Includes hardware and EPWorks software. Features manual configuration of stimulation/acquisition parameters and user-defined FFT displays (CSA, DSA).

Indications for Use

Indicated for intraoperative neurological monitoring in patients undergoing surgery. Used for diagnosis of acute dysfunction in corticospinal axonal conduction due to mechanical trauma or vascular insufficiency. Intended for use by qualified medical practitioners trained in EEG, EP, and EMG.

Regulatory Classification

Identification

An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.

Submission Summary (Full Text)

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

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#### Public Health Service

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

Natus Medical, Inc. c/o Ms. Goldy Singh Excel-Tech Ltd. 2568 Bristol Circle Oakville, Ontario Canada L6H 5S1

AUG11 2010

Re: K093304

Trade/Device Name: Protektor32 Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Electrical Stimulator Regulatory Class: Class II Product Code: GWF, OLT, GWE, GWJ Dated: May 7, 2010 Received: May 10, 2010

Dear Ms. Singh:

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, ilsting 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 maching.

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.

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Page 2 - Ms. Goldy Singh

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 net 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/uccn11158001/p/phase the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFFR Preat. 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 Small Manufacturers, International and Consumer Assistance at its tolloffree number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Eder R. m. fr.

Malvina B. Eydelman, M Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known): K093304

Device Name: Protektor32

## AUG 1 1 2010

Indications for Use:

The Protektor32 channel system, composed of both hardware and software, is intended to be used for intracperative neurological monitoring. The instrument uses Electroencephalogical by (EEG), Evoked Potentials (EP), Electromyography (EMG) and Transcranial Motor Evoked Potential (TcMEP ) stimulation techniques to provide the healthcare professionals with information to help assess a patient's neurological status during surgery.

The TcMEP mode is intended for intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction brought about by mechanical trauma (traction, shearing, lornrovin, or compression) or vascular insufficiency.

The EPWorks software, an integral part of the system, is intended to allow a medical professional to manually configure stimulation and acquisition parameters and to manually create EEG, EP, EMG and TcMEP protocols according to their own requirements. The intended use for each of the software's outputs is as follows:

- The EEG, EP, and EMG waveforms are intended to help the user assess a patient's . neurological status during surgery.
- Simple waveform parameters (e.g., amplitude, latency), and user-defined Fast Fourier . transform (FFT) displays (compressed spectral array or CSA, density spectral array or DSA) are intended to help the user analyze the EEG and EP waveforms.

This device is intended to be used by qualified medical practitioners, trained in EEG, EP and EMG who will exercise professional judgment when using the information.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear,

Nose and Throat Devices

510(k) Number K093304