The Wavestate Neuromonitor System is intended to collect, record, and store up to 24 channels of adult EEG data for up to 24 hours. The System also can perform a post review of adult EEG data and identify burst suppression pattern in the stored EEG. The device displays the mean interburst interval reviewed up to that time point and the probability that the displayed value is within +/- 2 seconds of the mean of the interburst intervals for the entire dataset for that patient. The Wavestate Neuromonitor System does not provide any diagnostic conclusion about the patient's condition to the user. The Wavestate Neuromonitor is to be used under the guidance and interpretation of a licensed medical practitioner.

Device Description

Wavestate, Inc. has created a new application for the TrackIt-2, an FDA-approved ambulatory EEG hardware unit manufactured by Lifelines, Ltd (UK). Our proprietary software analyzes EEG data files recorded with the TrackIt-2. Data are displayed on an Xplore touch-screen tablet computer using Microsoft Windows XP.

Our application is used to quantify the inter-burst interval with 95% statistical confidence the duration of the interval within +/- 2 seconds.

The Trackit-2 system is FDA approved.

FDA-approved EEG electrodes will be bought separately by the end user.

AI/ML Overview

The Wavestate Neuromonitor is an application for an FDA-approved ambulatory EEG hardware unit. Its proprietary software analyzes EEG data, primarily identifying burst suppression patterns and quantifying the inter-burst interval with 95% statistical confidence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the software verification and validation summary, where the accuracy of specific features is tested against defined thresholds.

Feature Tested	Acceptance Criterion	Reported Device Performance
Burst Detection (Single EEG Channel)	Detect spikes of 10 microvolts or higher within 40-ms duration.	Achieved: "demonstrate the accuracy of detection as only spikes of 10 microvolts or higher are identified."
Burst Detection (Multiple Channels)	Accurately detect 10.5 microvolt spikes independently and simultaneously in each of 19 channels.	Achieved: "demonstrate accurate detection of 10.5 microvolt spikes identified independently and simultaneously in each EEG of the 19 channels tested."
EEG Suppression Detection	Detect suppression only when spikes are separated by 500 ms or longer (defined as 500 ms of activity below 10 microvolts).	Achieved: "demonstrate detection of suppression only when spikes are separated by 500 ms or longer."
Calculation and Display of Mean Interburst Interval	Accurately calculate and display the mean interburst interval as an integer, based on inserted spikes at increasing intervals.	Achieved: "demonstrate accurate calculation and display of the mean interburst interval as an integer."
Statistical Confidence Computation	Display the mean interburst interval once statistical confidence attains 95% within +/- 2 seconds, and not display it when confidence is below 95%.	Achieved: "demonstrate that the mean interburst interval is displayed once statistical confidence attains 95% and is not displayed when confidence is below 95%."

2. Sample Size for the Test Set and Data Provenance

The provided document does not specify a sample size for the test set in terms of actual patient data or real EEG recordings. Instead, the testing appears to be based on simulated or synthesized data.

For burst detection, "40-ms-duration spikes of varying amplitude are inserted into digitized EEG files consisting of background activity."
For multiple channel detection, "10.5 microvolt spikes identified independently and simultaneously in each EEG of the 19 channels tested."
For suppression detection, "Spikes of 10.5 microvolt amplitude are inserted, at increasing interval length, into an EEG file consisting of baseline background activity."
For mean interburst interval calculation, "Spikes of 10.5 microvolt amplitude are inserted at increasing intervals into an EEG file."
For statistical confidence, "A series of interburst intervals are constructed with 10.5 microvolt spikes."

This suggests the data provenance is synthetic/simulated, not derived from a specific country or retrospective/prospective patient studies.

3. Number of Experts and their Qualifications for Ground Truth

The document does not mention the use of human experts to establish ground truth for the test set. The ground truth for the verification and validation appears to be based on the known parameters of the artificially inserted spikes and constructed intervals.

4. Adjudication Method for the Test Set

Since human experts were not used to establish ground truth, there was no adjudication method described. The validation relied on the algorithm's ability to accurately detect or calculate pre-defined synthetic events.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study was mentioned in the provided summary. The device's validation focuses on its standalone algorithmic performance rather than its impact on human reader performance.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone study was performed. The entire "Software Verification and Validation Summary" describes the testing of the algorithm itself, without human-in-the-loop. The tests focused on the accuracy of burst detection, channel logic, suppression duration, interburst interval calculation, and statistical confidence, all as performed by the algorithm with synthetic data.

7. Type of Ground Truth Used

The ground truth used was synthetic/known parameters based on artificially injected spikes and constructed EEG patterns. For example, spikes of a known amplitude (e.g., 10 microvolts) were inserted, and the algorithm's ability to detect these known events was evaluated. Similarly, when testing the interburst interval and statistical confidence, known sequences of intervals were constructed.

8. Sample Size for the Training Set

The document does not provide information on the sample size used for a training set. Given the nature of the validation (inserting spikes into EEG files), it's possible the algorithm was developed based on theoretical EEG signal characteristics or a separate, unmentioned dataset. However, no specific training set size or methodology is presented in this 510(k) summary.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for a training set was established, as it doesn't mention a distinct training set. If such a set was used, its ground truth establishment method is not described here.

Summary

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510(k) Summary K092625 807.92(c)

JUN 2 9 2010

SPONSOR

Company Name:	Wavestate, Inc.
Company Address	333 Washington Blvd. #15Marina del Ray, CA 90292
Telephone:	310-591-8844
Fax:	310-591-8191
Contact Person:	Michael J. Bier Ph.D., President and CEO

807.92(a)(1)Summary Preparation Date: June 29, 2010

DEVICE NAME

Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:

PREDICATE DEVICE

807.92(a)(2)

Wavestate Neuromonitor EEG Electroencephalograph 882.1400 ORT / GWQ I I

807.92(a)(3)

510(k) # K021185

K061908 K010460

Legally Marketed Equivalent Device
Company	Product
Taugagreining HF	Nervus Monitor
Viasys NeuroCare, Inc.	NicoletOne System V32
Lifelines Ltd.	Lifelines Trackit

DEVICE DESCRIPTION

Our application is used to quantify the inter-burst interval with 95% statistical confidence the duration of the interval within +/- 2 seconds.

The Trackit-2 system is FDA approved.

FDA-approved EEG electrodes will be bought separately by the end user.

807.92(a)(4)

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DEVICE INTENDED USE

Caution: (USA law) Restricts this device to sale by or on the order of a physician.

Predicate Product Comparison

NONCLINICAL AND CLINICAL TEST 807.92(b) SAFETY and EFFECTIVENESS

Testing of the Wavestate Neuromonitor was performed. Testing included:

1. Software verification and validation
1. Electrical and EMC safety compliance to:
- IEC 60601-1 IEC 60601-1-2 IEC 60601-2-26

Software Verification and Validation Summary

V&V SUMMARY

The validation testing demonstrates how each feature of the burst suppression algorithm is accurately implemented. The algorithm consists of five features: (1) burst detection, (2) channel logic, (3) suppression duration, (4) interburst interval, and (5) statistical confidence.

First, the accuracy of burst detection is tested in a single EEG channel. 40-ms-duration spikes of varving amplitude are inserted into digitized EEG files consisting of background activity (< 5 microvolts). The results demonstrate the accuracy of detection as only spikes of 10 microvolts or higher are identified.

Second, the accuracy of burst detection is tested in multiple channels. Test results demonstrate accurate detection of 10.5 microvolt spikes identified independently and simultaneously in each EEG of the 19 channels tested.

Third, the accuracy of EEG suppression detection is tested. EEG suppression is defined as 500 ms of activity below 10 microvolts. Spikes of 10.5 microvolt amplitude are inserted, at increasing interval length, into an EEG file consisting of baseline background

807.92(a)(5)

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activity. Test results demonstrate detection of suppression only when spikes are separated by 500 ms or longer.

Fourth, the accuracy of calculating and displaying the statistical mean of the interburst interval is tested. Spikes of 10.5 microvolt amplitude are inserted at increasing intervals into an EEG file consisting of background activity. Test results demonstrate accurate calculation and display of the mean interburst interval as an integer.

Fifth, the accuracy of the statistical confidence computation is tested. A series of interburst intervals are constructed with 10.5 microvolt spikes. The series converge on a 10-second mean with variance decreasing initially, followed by increasing variance. This results in an initial mean of low statistical confidence and with increasing stability interburst interval stability the confidence interval reaches 95%. Test results demonstrate that the mean interburst interval is displayed once statistical confidence attains 95% and is not displayed when confidence is below 95%.

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COMPARISON OF TECHNICAL CHARACTERISTICS` 807.92(a)(6)

Caution: (USA law) Restricts this device to sale by or on the order of a physician.

Parameters	New Device	Predicate Device	Predicate Device	Predicate Device
Proprietary Name	Neuromonitor	Trakit	Nicolet OneViasys	Nervus
Manufacturer	Wavestate Inc.	Lifelines	NeuroCare, Inc	Taugagreining Hf
Intended User	Licensed medicalprofessional	Licensed medicalprofessional	Licensed medicalprofessional	Licensed medicalprofessional
Target population	Adult	Adult	Adult	Adult and pediatricpatients
No of EEGchannels	24 monopolartouchproof inputs	24 monopolar touchproofinputs	16 to 32 monopolartouchproof inputs	16 to 32 monopolartouchproof inputs
Max. commonmode inputvoltage	2V pk-pk	2V pk-pk		2V pk-pk
Input bias current	<25nA @25° C	<25nA @25° C		<20nA @25° C
Differential InputImpedance	>20 Mohms	>20 Mohms		>20 Mohms
Common modeinput impedance	>100 Mohms	>100 Mohms	>100 Mohms	>100 Mohms
Common moderejection ratio	>110d @ 0.16Hz to70Hz w/ active groundconnected	>110d @ 0.16Hz to 70Hzw/ active groundconnected	>110d @ 50/60 Hz	>110d @ 0.16Hz to70Hz w/ active groundconnected
Channel hardwaregain	1000 ± 2%	1000 ± 2%		500
Max. differentialAC input beforeclipping	10 mV pk-pk	10 mV pk-pk		10 mV pk-pk
DC Inputtolerance	±500mV	±500mV	±350mV
Burst Suppression	yes	no	yes	yes

Predicate Product Comparison

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

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

Wavestate, Inc. c/o Ned Devine Underwriters Laboratories, Inc. 333 Pfingsten Road Northbrook, IL 60062

JUN 2 9 2010

Re: K092625

Trade/Device Name: Wavestate Neuromonitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: ORT, GWO Dated: April 28, 2010 Received: April 30, 2010

Dear Mr. Devine:

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

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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/ucm115809.htm for 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" (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/ReportalProblem/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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resources.forYou/Industry/default.htm.

Sincerely yours,

Eithim im to

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): K092625

Device Name: Wavestate Neuromonitor

Indications for Use:

Caution: (USA law) Restricts this device to sale by or on the order of a physician.

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rick Rahn

Page 1 of 1

(Division Sign-Off). Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K092628

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).