The WAVI™ Headset is an EEG electrode positioning system used to quickly place the electrodes in a uniform and consistent manner in accordance with the international standard Ten-Twenty System (10-20) to acquire electrophysiological EEG signals from an individual to a suitable EEG data collection device.

The device consists of the WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Electrode Contacts; the head set comes in five models/sizes (XS, S, M, L, XL). This device is portable, nonsterile, non-invasive, non-radiation emitting, point-of-care use device for use in healthcare facilities and hospitals.

Device characteristics include the eSoc™ Single Use Electrode Contacts which are soaked in 0.9% Normal Saline which is unique as it serves as the electro-conductive material and patient contact allowing the brain's electrical signals to be read through an EEG data collection device. Typical set-up and procedure time is less than twenty minutes.

The device does not contain software, biologics, drugs, coatings or any claim of sterility.

The WAVI™ Headset, eSoc™ Single Use and Ear Electrode Contacts are made from wellestablished medical grade materials; the Headset is made from a proprietary EVA material with tin plated ring electrode ports for placement of the Nylon 101 WAVi™ eSoc™ Single Use Electrode Contacts, and two ear electrodes are also made from Tin. A wire harness is embedded between two layers of EVA and is attached to each electrode port. The wire harness exits the headset to a 32-pin connector port.

AI/ML Overview

This document describes the WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts, a device intended for rapid placement of EEG electrodes in clinical and research settings.

Here's an analysis of the provided information concerning acceptance criteria and the study proving device performance:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a formal table of "acceptance criteria" for the device's technical or diagnostic performance in the way one might expect for an AI algorithm. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Electro-Cap™ System) based on technical characteristics and a comparative study.

However, we can infer performance requirements from the comparison table on page 5 and the non-clinical testing section:

Acceptance Criteria (Implied)	Reported Device Performance
Primary Function: Transmit electrophysiological signals from an individual to data collection devices.	The WAVi™ Headset and accessories are designed to acquire electrical activity of the brain via 0.9% Normal Saline soaked eSoc™ inserted into electrode ports, connecting through a wiring harness to a patient cable which is connected to an EEG device where brain activity is recorded for evaluation.
Safety: Does not transmit electrical current or provide stimulation.	The device explicitly states it "Does not transmit electrical current, nor are they intended to be used for stimulation." This is consistent with the predicate device. Additionally, the device uses well-established medical grade materials (EVA, nylon 6/6 (101), tin) with prior 510(k) clearances, indicating no further biocompatibility testing was needed.
Performance (EEG Quality): Ability to provide EEG signals comparable to the predicate device.	A side-by-side comparison on three test subjects using a Lexicor Neurosearch-24 Brain mapper (K915820) showed that "the spectral shape and maximum frequency of the corresponding WAVi Headset and Electro-Cap spectrums at each of the 10/20 EEG locations were consistently similar within each subject."
Electrode Placement Accuracy: Consistent placement according to the International 10-20 System.	The device is an "EEG electrode positioning system used to quickly place the electrodes in a uniform and consistent manner in accordance with the international standard Ten-Twenty System (10-20)." The comparison found "The International 10-20 System is used as a basis for the electrode placement" for both the WAVi and the predicate.
Quality/Reliability: Meets performance specifications through manufacturing QA.	"The WAVi™ Headset and accessories meet all performance specifications" through Quality Assurance testing including visual inspection, label verification, dimensional verification, and individual electrode resistance checks.
Impedance (Predicate's criteria): Maximum impedance of 5 K/Ohms (for predicate).	While the WAVi's direct impedance target isn't stated, the "similar spectral shape and maximum frequency" results from the comparative analysis imply that the electrical characteristics, including impedance (after taking into account the saline-soaked eSoc), are functionally equivalent to the predicate, which has this specified impedance.
Biocompatibility: No adverse reactions from materials.	No biocompatibility testing was conducted as multiple 510(k)'s have been cleared for each of the medical grade materials used, demonstrating safety.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: 3 test subjects.
Data Provenance: Not specified, but likely from the US, given the submission to the US FDA. The study appears to be prospective as it involved a direct comparison on test subjects.

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

The concept of "experts" establishing ground truth in the context of diagnostic interpretation (e.g., radiologists for images) is not directly applicable here. The device is an EEG electrode positioning system, not a diagnostic interpretation tool. The "ground truth" for its performance is the direct comparison of its generated EEG signals against those from a legally marketed predicate device on the same subjects, as measured by an objective EEG device (Lexicor Neurosearch-24 Brain mapper). There's no mention of human interpretive "experts" in this part of the study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

None. Adjudication methods are typically used when human interpretation or labeling creates the "ground truth" and discrepancies need to be resolved. In this device comparison, the output (EEG spectral shapes and maximum frequencies) was objectively measured by an EEG Brain Mapper (Lexicor Neurosearch-24). The consistency of these measurements between the two devices across subjects was the metric.

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. This is not an AI-assisted diagnostic device, nor does it involve human readers interpreting output that would then be compared to AI assistance. It's an electrode placement device; the comparison is between its raw signal output and that of a predicate device.

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

Yes, in spirit. The study primarily assesses the device's ability to consistently acquire EEG signals in comparison to the predicate. The "performance" being evaluated is of the device itself (headset and electrodes) in generating electrical signals, rather than an algorithm's output. The Lexicor Neurosearch-24 Brain mapper served as the objective measurement tool, not a human interpreter.

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

The "ground truth" in this context is the EEG signals generated by the legally marketed predicate device (Electro-Cap™ System) under the same conditions, as objectively measured by a Lexicor Neurosearch-24 Brain mapper. The assumption is that the predicate device's output represents acceptable EEG signal acquisition.

8. The sample size for the training set

Not applicable. This device is a hardware accessory for EEG signal acquisition, not an algorithm that requires a training set. The approval is based on substantial equivalence to an existing device and its physical and electrical characteristics.

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

Not applicable. No training set was used for this device.

Summary

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

April 28, 2017

WAVi, Co. David Jones FDA Consultant 3535 S Irving St. Englewood, Colorado 80110

Re: K162460

Trade/Device Name: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 22, 2017 Received: March 31, 2017

Dear Mr. Jones:

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

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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.

for

Sincerely.

Michael J. Hoffmann -S

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) K162460

Device Name

WAVi™ Headset and WAVi™ eSocTM Single Use Electrode Contacts

Indications for Use (Describe)

The WAV Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitted by:	WAVi Co.3535 S. Irving StreetEnglewood, CO 80110804-909-2389
Contact Person:	David Jones281-989-8515
Date Prepared:	April 28, 2017
Proprietary Name:	WAVi™ Headset and WAVi™ eSoc™ Single Use ElectrodeContacts
Model Numbers:	WH-100: XS HeadsetWH-200: S HeadsetWH-300: M HeadsetWH-400: L HeadsetWH-500: XL Headset
Common Name:	EEG 10-20 Electrode Headset and Electrodes
Classification:	Class II:	21 CFR § 882.1320
Classification Name:	Cutaneous Electrode – GXY
Predicate Devices:	Electro-Cap™ System (K112319)Electro-Cap™ Intl., Inc.1011 West Lexington Rd.Eaton, OH 45320

Device Description:

The device does not contain software, biologics, drugs, coatings or any claim of sterility.

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Intended Use:

The WAVi Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

Technological Characteristics

Manufacturer	WAVi Co.	Electro-Cap
Trade Name	WAVi Headset	Electro-Cap System (K780045)
Indication for Use	The WAVi Headset is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.	The Electro-Cap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired.
Environmental Use	Electrophysiological	Electrophysiological
Target Patient	Adults and Children	Adults and Children
Where Used	On the head	On the head
Anatomical Contact Sites	Patient's skin (scalp)	Patient's skin (scalp)
Number of Contacts	22	2 to 256
Sterile	No	No
Size of Cap	Various- Extra Small to Extra Large	Various- Extra Small to Large
Style of Cap	Full Head Cap	Full Head Cap
Cap Material	EVA	Spandex
Location of Wiring	Inside Cap	Inside Cap
Type of Cables	Standard Ribbon Cable and Lead Wires	Standard Ribbon Cable and Lead Wires
Type of Electrode Drop	Detachable and Non Detachable	Detachable and Non Detachable
Electrode Material	Nylon 6/6 (101) and Pure Tin	Pure Tin
Electrode Placement System	The International 10-20 System is used as a basis for the electrode placement.	The International 10-20 System is used as a basis for the electrode placement.
Number of Recording Channels	19	19
Electrode Positions Utilized	Fp1, Fp2, F7, F3, Fz, F4, F8, T3, C3, Cz, C3, T4, T5, P3, Pz, P4, T6, 01, 02, A1, A2	Fp1, Fp2, F7, F3, Fz, F4, F8, T3, C3, Cz, C3, T4, T5, P3, Pz, P4, T6, 01, 02, A1, A2
Type of Connectors	D-Sub Connectors, Touch Proof Din Sockets and Special Connectors to Match EEG Equipment and Computers	D-Sub Connectors, Touch Proof Din Sockets and Special Connectors to Match EEG Equipment and Computers
Biocompatibility Testing	None was conducted	None was conducted

The following is a side-by-side of the WAVi device compared to the Predicate:

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PerformanceRequirements	Needs to transmitelectrophysiological signals from anindividual to data collection devices.Does not transmit electrical current,nor are they intended to be used forstimulation.	Needs to transmitelectrophysiological signals from anindividual to data collection deviceswith a maximum impedance of5K/Ohms. Does not transmitelectrical current, nor are theyintended to be used for stimulation.
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The electrical activity of the brain is acquired through 0.9% Normal Saline soaked eSocTM inserted into the electrode ports and connected through the Headset's wiring harness to the Patient Cable which is connected to the EEG device where brain activity may be recorded for evaluation.

Non-Clinical Testing:

The WAVI™ Headset and accessories are manufactured of medical grade materials including ethylene vinyl acetate (EVA), nylon 6/6 (101) and tin. Multiple 510 (k)'s have been cleared for each of these materials demonstrating no need for further biocompatibility testing.

The WAVI™ Headset and accessories' Quality Assurance testing includes visual inspection of the headset, label and labeling, dimensional verification, and individual electrode resistance of the components and finished product. The WA Vi™ Headset and accessories meet all performance specifications.

The WAVi™ Headset and the Electro-Cap™ System were compared for sizing, electrode placement and labeling, and was found to be substantially equivalent.

The WAVI™ Headset and the Electro-Cap™ were also compared side-by-side on three test subjects using a Lexicor Neurosearch-24 Brain mapper (K915820); the spectral shape and maximum frequency of the corresponding WAVi Headset and Electro-Cap spectrums at each of the 10/20 EEG locations were consistently similar within each subject.

Substantial Equivalence

The WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Ear Electrode Contacts are portable, non-sterile, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) devices, and is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.

All non-clinical tests demonstrate that the WAVI™ Headset and accessories are as safe, as effective, and perform as well as or better than the legally marketed predicate device.

The WAVi™ Headset is substantially equivalent to the predicate devices in the following manner:

. Same intended use
Same operating principle ●
Same fundamental scientific technology
Same or substantially equivalent materials, including headset and electrodes. .

There are no other substantial or significant differences between the WA Vi™ Headset and its' accessories and the predicate that would affect safety, effectiveness or performance, therefore the WAVi™ Headset and accessories' are substantially equivalent to the predicate device.

Regulation Number and Section

§ 882.1320 Cutaneous electrode.

(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).