Who is the manufacturer of IEEG?

Jordan Neuroscience, Inc. filed the 510(k) submission for IEEG (K131944).

What is the FDA product code for IEEG?

OMC. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for IEEG?

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

What are the predicate devices for IEEG?

BrainScope Zoom-100 (K082886); Lifelines Trackit Recorder (K010460).

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

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.

IEEG

K131944 · Jordan Neuroscience, Inc. · OMC · Apr 10, 2014 · Neurology

Device Facts

Record ID	K131944
Device Name	IEEG
Applicant	Jordan Neuroscience, Inc.
Product Code	OMC · Neurology
Decision Date	Apr 10, 2014
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2
Attributes	Pediatric

Indications for Use

The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare professional. The device is intended for use on all patient populations including pediatric.

Device Story

iEEG acquires and stores brain electrical activity; inputs via EEG electrodes (e.g., BraiNet Kit, Ives EEG electrode). Transmitter module captures signals; performs impedance checks; transmits data via Bluetooth to host computer. Software (iEEG viewer/recorder) collects, displays (8-channel signal graphic), and records data to digital files (EDF format). Used in hospitals, clinics, emergency rooms, or home environments under medical supervision. Physician/technician reviews output to assist in neurological disorder diagnosis. Benefits include portable, wireless EEG monitoring capability.

Clinical Evidence

Bench testing only. Device evaluated for safety and electromagnetic compatibility per IEC 60601-1, IEC 60601-1-1, and IEC 60601-2-26. Testing confirmed device meets design requirements and specifications for EEG performance.

Technological Characteristics

Battery-operated (rechargeable Lithium-Polymer) EEG device. 8-channel reduced-montage configuration. 16-bit ADC resolution; >115dB CMRR; 10MOhm input impedance. Bluetooth 2.4 GHz wireless connectivity. Uses standard off-the-shelf electrodes. Software-based signal processing and display. Complies with IEC 60601-1 and IEC 60601-2-26.

Indications for Use

Indicated for all patient populations, including pediatric, for the acquisition and storage of brain electrical activity to monitor the state of the brain. Intended for use in healthcare facilities, clinical research environments, or home settings under the supervision of a qualified healthcare professional.

Regulatory Classification

Identification

An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.

Predicate Devices

BrainScope Zoom-100 (K082886)
Lifelines Trackit Recorder (K010460)

Reference Devices

BraiNet Kit (K043009)
Ives EEG electrode (K062880)
Persyst Insight (K011397)

Submission Summary (Full Text)

{0}------------------------------------------------ # 4. 510(k) Summary દાદ્ગાવવાય APR 1 0 2014 Summary Date: November 4, 2013 Submitter Data: Jordan NeuroScience, Inc. 1660 Plum Lane Redlands, CA 92374 909-881-2694 Primary Contact: Anne Perry aperry@jordaneuro.com Device Name: iEEG (Intelligent Electroencephalograph) Common Name: electroencephalograph Device Classification Name: Electroencephalograph Regulation: 882.1400 - Electroencephalograph Requlatory Class: Class II #### Primary Product Code(s): OMC - Reduced- Montage Standard Electroencephalograph #### Predicate Information BrainScope Zoom-100 (K082886 cleared on 8/10/2009) Lifelines Trackit Recorder (K010460 cleared on 05/14/2001). #### Device Description The Intelligent Electroencephalogram (iEEG) device acquires and stores electrical activity of the brain and patient data. The iEEG can be used with other FDA cleared devices such as the BraiNet Kit (K043009) and Ives EEG electrode (K062880). The BraiNet Kit consists of the BraiNet Template (electrode cap), and Sub-dermal EEG Needle Electrodes and Cutaneous EEG Electrodes. The iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software. The wireless iEEG transmitter module provides an EEG electrode connection, electrode impedance (connection) status indicator(s), a single-user multi-function push button switch that provides power on/off, electrode impedance check. The wireless module is powered by an internal rechargeable energy source. {1}------------------------------------------------ The AC charger module provides a convenient means to recharge the wireless module's internal energy source when not in use. The device is not intended to be charged when attached to the patient. The iEEG viewer/recorder software provides, with the aid of host computer hardware and operating system, the ability to collect EEG electrode data from the wireless iEEG transmitter module, view EEG data, and record data to digital file. The iEEG viewer/recorder provides eight signal graphic display of selectable EEG montages (lead/electrode combinations). It also enables subject data entry (Name, DOB, ID number etc.) and control of EEG data recording to digital file. The Intelligent Electroencephalogram (iEEG) is designed to be capable of usage and storage in hospital, clinic, and emergency room environments. The iEEG transmitter modules communicate with the computer by using Bluetooth wireless technology. #### Intended Use The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a legally marketed digital EEG system to assist in the diagnosis of neurological disorders. The device is intended for use by medical personnel in any location within a medical facility. physician's office, laboratory, and clinic or outside of a medical facility under the supervision of a medical professional. The device is intended for use on all patient populations including pediatric. ## Technological Characteristics The proposed iEEG and both predicate devices are batterv operated reusable electro-medical devices used to acquire and store electrical activity of the brain within a medical facility. The proposed iEEG and the predicate devices are also used outside of a medical facility under the supervision of a medical professional. The proposed iEEG and the predicate devices have the added capability to export data via wireless Bluetooth technology. The different technological characteristics are included in the risk assessment and testing (see section 16, 17, and 18). No new questions of safety and effectiveness were introduced. Refer to the following Table of Technological Characteristics for a summary. #### Performance Data The device was tested to IEC 60601-1-1 for safety and IEC 60601-2 Electromagnetic Compatibility. The device was also evaluated to standard IEC 60601-2-26 for essential EEG performance specifications. The device with a suitable battery charger was evaluated to IEC 60601-1/A2:1995, IEC 60601-2-26 and applicable national requirements. All applicable tests according to the specified standards were completed and passed. Bench testing was performed and confirms that the device meets design requirements and specifications. {2}------------------------------------------------ ## Substantial Equivalence The proposed iEEG device is substantially equivalent in both function and use to the predicate device, BrainScope Zoom-100 (K082886 cleared on 8/10/2009). The iEEG device is substantially equivalent in EEG function and use of the reference device, Lifelines Trackit Recorder (K010460 cleared on 05/14/2001). The iEEG device is not used for a polysomnographs (sleep studies). Therefore the product code OLV of the device (Lifelines Trackit Recorder) does not apply. Trackit, Zoom-100 and Insight are Class II legally marketed devices. BrainScope Zoom-100 (K082886 cleared on 8/10/2009) is the predicate. The proposed device has equivalent intended use and has equivalent technology to the BrainScope Zoom-100 as indicated in the table below. Lifelines Trackit Recorder (K010460 cleared on 05/14/2001) is included as a reference device for the added technology of the Bluetooth wireless transmission of recorded data and for the additional application environment of outside of a medical facility under the supervision of a medical professional. {3}------------------------------------------------ | | | Device | iEEG (Subject) | BrainScope Z-100 (Predicate) | Trackit EEG (Predicate) The information is based on use of the device with Persyst software K010460 | Persyst Insight | Explanation of Variation | |------------------------|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k)# | | K882886 | K082886 | K010460 | K011397 | N/A | | | Class | | Class II | Class II | Class II | Class II | Same | | | Product code | | OMC | OMC | GWQ | GWQ/OMB | The two product codes OMC and GWQ have exactly the same definition except GWQ has 16 channels and above, OMC has less than 16. The number of channels does not affect the fundamental scientific technology of the device. The Trackit EEG device allows for both full and reduced channel configurations. | | | Regulation number | | 882.1400 | 882.1400 | 882.1400 | 882.1400 | Same | | Regulatory Information | Indications for Use | | The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the state of the brain. | The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of EEG signals and by the calculation of standard quantitative EEG parameters. | The Lifelines Trackit is a 10 to 36 channel ambulatory electroencephalo -graph that is designed for use in a variety of monitoring applications to record physiological data for EEG and Sleep Studies. | Persyt Insight (Reveal) software is universal EEG software for display of EEG data to be interpreted by a medical professional. | Equivalent. The Zoom-100 and Trackit devices are used to acquire and store electrical activity of the brain. Persyst only displays acquired data. | | | Clinical Application environment | The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healthcare professional | Hospitals and clinics | For use in any location within a medical facility or outside of a medical facility under the supervision of a medical professional | The software is intended for use by a trained EEG technologist or physician | Equivalent. All devices are usable within a medical facility. The iEEG and Trackit have the similar application in environment outside of a medical facility under the supervision of a medical professional. | | | | Modalities | EEG | EEG | EEG/PSG | EEG | Equivalent for EEG. The iEEG does not have the modality option of PSG. The PGS is used for monitoring sleep studies. | | | | | | | | | The product code OLV does not apply as IEEG is not used for a polysomnographs (PSG). | | | | EEG Channels | 8 | 8 | 10 to 32 | 4 to 64 | Equivalent. Reduced montage is the same for iEEG and Zoom- 100. The Trackit EEG reference device allows for both full and reduced montage. The number of | | | | | | | | | electrodes does not affect the fundamental scientific technology of the device. | | | | Montage | 10/20 system | 10/20 system | 10/20 system | 10/20 system | Same | | | | Sample Rate | 250 Hz | 200 Hz | 256 Hz | NA | Equivalent, sampling rate defines the number of samples per second taken to create a digital representation of the EEG | | | specifications | | | | | | waveforms. All devices provide a sampling rate well above the upper frequency content | | {4}------------------------------------------------ : . . . {5}------------------------------------------------ | | | | | | of the EEG waveforms to provide comparable and high fidelity representation of the EEG waveforms. | | |------------------------|----------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | ADC Resolution | 16 bit | 16 bit | 16 bit | NA | Same | | | ADC CMRR | > 115dB | >100dB | >100dB | NA | Equivalent, Common Mode Rejection Ratio (CMRR) is the measure of a system's ability to ignore or reject common background electrical noise from the EEG signals to be recorded (60 Hz line power noise for example) The greater the CMRR value the better the rejection of common noise sources. The iEEG device is slightly better than the predicate or reference device and would provide comparable performance | | | Input Impedance | 10MOhm | 10MOhm | 1 MOhm | NA | Equivalent, Same as The primary predicate (Zoom 100) (Trackit EEG) is lower in impedance, subject to a loss in EEG signal level. | | | Electrode Impedance | Yes | Yes | Yes | NA | Same | | | Wireless Output | Bluetooth 2.4 GHz | Bluetooth 2.4 GHz | Class 1 Bluetooth Connection | NA | Same | | | Data Format | edf | Unknown | edf | NA | Equivalent to Trackit device. | | | Electrode Material | Standard off shelf electrodes | Standard off shelf electrodes | Standard off shelf electrodes | NA | Same | | | Battery | Rechargeable Lithium-Polymer | Rechargeable Lithium Ion | Disposable Batteries or Rechargeable Lithium Ion | NA | Equivalent, Lithium Polymer and Lithium Ion use the same chemistries. | | | | Charger | Yes | Yes | Yes | NA | utilizes a micro pore polymer material as the battery plate separator. Same | | | Data format | iEEG edf | Zoom-100 unknown | Trackit edf | edf | edf is a universal data format for EEG | | | Data Review | Persyst Insight, or JNS Viewer or legally marketed edf reader | unknown | Persyst Insight or legally marketed edf reader | edf and various proprietary data formats | Same | | | Display Channels | 8 to 24 | unknown | NA | 4 to 64 | | | | Hi Filter Settings | off 10 Hz 13 Hz 15 Hz 20 Hz 25 Hz 35 Hz 50 Hz 70 Hz | NA | NA | off 1 Hz 5 Hz 10 Hz 15 Hz 20 Hz 25 Hz 35 Hz 40 Hz 80 Hz | Same or clinically insignificant differences | | Waveform Review | Low filter settings | off 0.3 Hz 0.5 Hz 1 Hz 2 Hz 3 Hz 10 Hz 15 Hz 20 Hz | NA | NA | off 0.3 Hz 0.5 Hz 1 Hz 2 Hz 3 Hz 10 Hz 15 Hz 20 Hz | Same | | | 60 Hz filter | yes | NA | NA | yes | Same | | | Gain | 1 uv/mm 1.5 uv/mm 3 uv/mm 5 uv/mm 7 uv/mm 10 uv/mm 15 uv/mm 20 uv/mm 25 uv/mm 35 uv/mm 50 uv/mm 125 uv/mm 250 uv/mm | NA | NA | 1 uv/mm 1.5 uv/mm 3 uv/mm 5 uv/mm 7 uv/mm 10 uv/mm 15 uv/mm 20 uv/mm 30 uv/mm 35 uv/mm 50 uv/mm 125 uv/mm 250 uv/mm 500 uv/mm | Same or clinically insignificant differences | | | Time Base | 1 Sec 2 Sec 5 Sec 10 Sec | NA | NA | 1 Sec 2 Sec 5 Sec 10 Sec 15 Sec | Same or clinically insignificant differences | | | 30 Sec 60 Sec 120 Sec | | | 20 Sec 30 Sec 60 Sec 120 Sec 240 Sec | | | | Display Montage | User selectable Transverse-AP Hatband Plus Hatband Double diamond Common Ave Ref Referential D-Banana | NA | NA | User selectable User definable Transverse Transverse- AP Common Ave Referential Referential Laplacian Double Banana BiPolar Double Diamond | Same or clinically insignificant differences | | · : , · · · : {6}------------------------------------------------ : . : . . {7}------------------------------------------------ : . . . . . . {8}------------------------------------------------ Image /page/8/Picture/0 description: The image is a black and white seal for the U.S. Department of Health and Human Services. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized design featuring three overlapping shapes that resemble waves or ribbons. The overall design is simple and professional, reflecting the department's role in public health and welfare. #### DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 #### April 10, 2014 Jordan Neuroscience Inc. Ms. Anne Perry VP Finance and Administration 1660 Plum Lane Redlands, CA 92374 Re: K131944 Trade/Device Name: iEEG Regulation Number: 21 CFR 882.1400 Regulation Name: Reduced- montage Standard Electroencephalograph Regulatory Class: Class II Product Code: OMC Dated: March 12, 2014 Received: March 13, 2014 Dear Ms. Perry: 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 that I Dr Haral 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 {9}------------------------------------------------ Page 2 - Ms. Anne Perry 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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, # Felipe Aquel -S Carlos L. Peña, PhD, MS for Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {10}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use 510(k) Number (if known) K131944 Device Name IEEG #### Indications for Use (Describe) The iEEG device is intended to acquire and store electrical activity of the brain and patient data for review by a medical professional using a digital EEG system to monitor the brain. The device is intended for use in a healthcare facility, clinical research environment, or in the home under the supervision of a qualified healtheare professional. The device is intended for use on all patient populations including pediatric. 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) # Please do not write below this line – continue on a separate page if needed. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # ം Date: 2014.04.10 2017:46:16 -04'00' Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. {11}------------------------------------------------ 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."

IEEG

Device Facts

Indications for Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Reference Devices

Submission Summary (Full Text)

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Device Story

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Predicate Devices

Reference Devices

Submission Summary (Full Text)

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