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 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.

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.

AI/ML Overview

The provided 510(k) summary for the iEEG (Intelligent Electroencephalograph) device does not contain a dedicated section detailing acceptance criteria or the specifics of a study conducted to prove the device meets such criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. This type of submission relies on showing that the new device is as safe and effective as a legally marketed device, rather than proving performance against specific pre-defined acceptance criteria through a clinical study.

The submission primarily lists technological characteristics and benchmarks them against predicate devices. The "Performance Data" section briefly mentions:

"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."

This indicates that various engineering and safety standards were met through bench testing, but these are not the "acceptance criteria" for a clinical performance study in the way implied by the request. There is no clinical study described with a test set, ground truth, or expert review for diagnostic performance.

Therefore, for the points requested by the user, most of the information is not available in the provided text.

Here's a breakdown of what can be inferred or explicitly stated based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory standards and predicate comparison)	Reported Device Performance and Justification
Safety and Essential Performance (General)	- "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."
Technological Equivalence (Relative to Predicate Devices)	- Channels: 8 (Equivalent to Zoom-100, within range of Trackit)- ADC Resolution: 16 bit (Same as Zoom-100 and Trackit)- ADC CMRR: >115dB (Slightly better than predicates (>100dB), deemed "comparable performance")- Input Impedance: 10MOhm (Same as Zoom-100, better than Trackit)- Electrode Impedance Check: Yes (Same as predicates)- Wireless Output: Bluetooth 2.4 GHz (Same as predicates)- Data Format: edf (Equivalent to Trackit)- Electrode Material: Standard off-shelf electrodes (Same as predicates)- Battery: Rechargeable Lithium-Polymer (Equivalent to Lithium-Ion in predicates)- Charger: Yes (Same as predicates)- Hi Filter Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)- Low Filter Settings: Ranges listed (Deemed "Same" to predicates)- 60 Hz Filter: Yes (Same as predicates)- Gain Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)- Time Base Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)- Display Montage: User selectable (Deemed "Same or clinically insignificant differences" to predicates)

Acceptance Criteria (Inferred from regulatory standards and predicate comparison)

Reported Device Performance and Justification

Safety and Essential Performance (General)

- "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."

Technological Equivalence (Relative to Predicate Devices)

- Channels: 8 (Equivalent to Zoom-100, within range of Trackit)- ADC Resolution: 16 bit (Same as Zoom-100 and Trackit)- ADC CMRR: >115dB (Slightly better than predicates (>100dB), deemed "comparable performance")- Input Impedance: 10MOhm (Same as Zoom-100, better than Trackit)- Electrode Impedance Check: Yes (Same as predicates)- Wireless Output: Bluetooth 2.4 GHz (Same as predicates)- Data Format: edf (Equivalent to Trackit)- Electrode Material: Standard off-shelf electrodes (Same as predicates)- Battery: Rechargeable Lithium-Polymer (Equivalent to Lithium-Ion in predicates)- Charger: Yes (Same as predicates)- Hi Filter Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)- Low Filter Settings: Ranges listed (Deemed "Same" to predicates)- 60 Hz Filter: Yes (Same as predicates)- Gain Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)- Time Base Settings: Ranges listed (Deemed "Same or clinically insignificant differences" to predicates)- Display Montage: User selectable (Deemed "Same or clinically insignificant differences" to predicates)

2. Sample size used for the test set and the data provenance

Not Available. The document describes bench testing against engineering standards and comparison of technical specifications against predicate devices. It does not mention any clinical test set or patient data used to evaluate diagnostic performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Available. No clinical test set or ground truth establishment based on expert consensus for diagnostic performance is described. The evaluation was based on conformance to engineering standards and comparison of technical specifications.

4. Adjudication method for the test set

Not Applicable / Not Available. No clinical test set or adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No. An MRMC comparative effectiveness study was not conducted or reported. The iEEG device is described as an "electroencephalograph" intended to acquire and store electrical activity for review by a medical professional, implying it is a data acquisition and display tool, not an AI-assisted diagnostic tool designed to improve human reader performance or automate diagnosis.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. The device is not an algorithm for standalone diagnostic performance. It is a hardware/software system for acquiring and displaying EEG data for human review.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Not Available. For its "performance data," the device primarily refers to meeting engineering and safety standards (IEC 60601 series). For demonstrating substantial equivalence, its technical specifications were compared to those of already cleared predicate devices. There is no mention of a clinical ground truth (like expert consensus, pathology, or outcomes data) being established for evaluating diagnostic accuracy.

8. The sample size for the training set

Not Applicable / Not Available. This device is an EEG acquisition and display system, not an AI/ML algorithm that requires a "training set" in the context of diagnostic performance. Any internal development or validation would be against technical specifications, not a clinical training set for an algorithm.

9. How the ground truth for the training set was established

Not Applicable / Not Available. As noted above, there is no mention of a "training set" or corresponding ground truth.

Summary

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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 iEEG consists of an iEEG transmitter module, a medical grade AC charging adapter/charging cable and an iEEG viewer/recorder software.

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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.

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.

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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.

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		Device	iEEG(Subject)	BrainScope Z-100(Predicate)	Trackit EEG(Predicate)The informationis based on useof the device withPersyst softwareK010460	PersystInsight	Explanation ofVariation
	510(k)#		K882886	K082886	K010460	K011397	N/A
	Class		Class II	Class II	Class II	Class II	Same
	Productcode		OMC	OMC	GWQ	GWQ/OMB	The twoproduct codesOMC and GWQhave exactlythe samedefinitionexcept GWQhas 16channels andabove, OMChas less than16. The numberof channelsdoes not affectthefundamentalscientifictechnology ofthe device.The TrackitEEG deviceallows for bothfull andreducedchannelconfigurations.
	Regulationnumber		882.1400	882.1400	882.1400	882.1400	Same
Regulatory Information	Indicationsfor Use		The iEEG device isintended to acquireand store electricalactivity of the brainand patient data forreview by a medicalprofessional using adigital EEG system tomonitor the state ofthe brain.	The ZOOM-100DCis used to measureand record theelectrical activity ofa patient's brain.The ZOOM-100DCis intended tomonitor the state ofthe brain byacquisition anddisplay of EEGsignals and by thecalculation ofstandardquantitative EEGparameters.	The LifelinesTrackit is a 10 to36 channelambulatoryelectroencephalo-graph that isdesigned for usein a variety ofmonitoringapplications torecordphysiologicaldata for EEG andSleep Studies.	Persyt Insight(Reveal)software isuniversalEEGsoftware fordisplay ofEEG data tobeinterpreted bya medicalprofessional.	Equivalent. TheZoom-100 andTrackit devices areused to acquire andstore electricalactivity of the brain.Persyst onlydisplays acquireddata.
	ClinicalApplicationenvironment	The device isintended for use in ahealthcare facility,clinical researchenvironment, or in thehome under thesupervision of aqualified healthcareprofessional	Hospitals andclinics	For use in anylocation within amedical facility oroutside of amedical facilityunder thesupervision of amedicalprofessional	The softwareis intendedfor use by atrained EEGtechnologistor physician	Equivalent. Alldevices are usablewithin a medicalfacility. The iEEGand Trackit havethe similarapplication inenvironmentoutside of amedical facilityunder thesupervision of amedicalprofessional.
	Modalities	EEG	EEG	EEG/PSG	EEG	Equivalent for EEG.The iEEG does nothave the modalityoption of PSG. ThePGS is used formonitoring sleepstudies.
						The product codeOLV does not applyas IEEG is not usedfor apolysomnographs(PSG).
	EEGChannels	8	8	10 to 32	4 to 64	Equivalent.Reduced montageis the same foriEEG and Zoom-100. The TrackitEEG referencedevice allows forboth full andreduced montage.The number of
						electrodes does notaffect thefundamentalscientifictechnology of thedevice.
	Montage	10/20 system	10/20 system	10/20 system	10/20 system	Same
	SampleRate	250 Hz	200 Hz	256 Hz	NA	Equivalent,sampling ratedefines the numberof samples persecond taken tocreate a digitalrepresentation ofthe EEG
specifications						waveforms. Alldevices provide asampling rate wellabove the upperfrequency content

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					of the EEGwaveforms toprovide comparableand high fidelityrepresentation ofthe EEGwaveforms.
ADCResolution	16 bit	16 bit	16 bit	NA	Same
ADC CMRR	> 115dB	>100dB	>100dB	NA	Equivalent,Common ModeRejection Ratio(CMRR) is themeasure of asystem's ability toignore or rejectcommonbackgroundelectrical noisefrom the EEGsignals to berecorded (60 Hzline power noise forexample) Thegreater the CMRRvalue the better therejection ofcommon noisesources. The iEEGdevice is slightlybetter than thepredicate orreference deviceand would providecomparableperformance
InputImpedance	10MOhm	10MOhm	1 MOhm	NA	Equivalent, Sameas The primarypredicate (Zoom100) (Trackit EEG)is lower inimpedance, subjectto a loss in EEGsignal level.
ElectrodeImpedance	Yes	Yes	Yes	NA	Same
WirelessOutput	Bluetooth 2.4 GHz	Bluetooth 2.4 GHz	Class 1 BluetoothConnection	NA	Same
Data Format	edf	Unknown	edf	NA	Equivalent toTrackit device.
ElectrodeMaterial	Standard off shelfelectrodes	Standard off shelfelectrodes	Standard off shelfelectrodes	NA	Same
Battery	RechargeableLithium-Polymer	RechargeableLithium Ion	DisposableBatteries orRechargeableLithium Ion	NA	Equivalent, LithiumPolymer andLithium Ion use thesame chemistries.
	Charger	Yes	Yes	Yes	NA	utilizes a micropore polymermaterial as thebattery plateseparator.Same
	Data format	iEEGedf	Zoom-100unknown	Trackitedf	edf	edf is a universaldata format forEEG
	Data Review	Persyst Insight, orJNS Viewer or legallymarketed edf reader	unknown	Persyst Insight orlegally marketededf reader	edf andvariousproprietarydata formats	Same
	DisplayChannels	8 to 24	unknown	NA	4 to 64
	Hi FilterSettings	off10 Hz13 Hz15 Hz20 Hz25 Hz35 Hz50 Hz70 Hz	NA	NA	off1 Hz5 Hz10 Hz15 Hz20 Hz25 Hz35 Hz40 Hz80 Hz	Same or clinicallyinsignificantdifferences
Waveform Review	Low filtersettings	off0.3 Hz0.5 Hz1 Hz2 Hz3 Hz10 Hz15 Hz20 Hz	NA	NA	off0.3 Hz0.5 Hz1 Hz2 Hz3 Hz10 Hz15 Hz20 Hz	Same
	60 Hz filter	yes	NA	NA	yes	Same
	Gain	1 uv/mm1.5 uv/mm3 uv/mm5 uv/mm7 uv/mm10 uv/mm15 uv/mm20 uv/mm25 uv/mm35 uv/mm50 uv/mm125 uv/mm250 uv/mm	NA	NA	1 uv/mm1.5 uv/mm3 uv/mm5 uv/mm7 uv/mm10 uv/mm15 uv/mm20 uv/mm30 uv/mm35 uv/mm50 uv/mm125 uv/mm250 uv/mm500 uv/mm	Same or clinicallyinsignificantdifferences
	Time Base	1 Sec2 Sec5 Sec10 Sec	NA	NA	1 Sec2 Sec5 Sec10 Sec15 Sec	Same or clinicallyinsignificantdifferences
	30 Sec60 Sec120 Sec			20 Sec30 Sec60 Sec120 Sec240 Sec
DisplayMontage	User selectableTransverse-APHatband PlusHatbandDouble diamondCommon Ave RefReferentialD-Banana	NA	NA	UserselectableUserdefinableTransverseTransverse-APCommon AveReferentialReferentialLaplacianDoubleBananaBiPolarDoubleDiamond	Same or clinicallyinsignificantdifferences

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. . . . . .

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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

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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

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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.

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Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
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.(b)
Classification. Class II (performance standards).