Flexset System

K233403 · Zeto, Inc. · GWQ · Apr 30, 2024 · Neurology

Device Facts

• Record ID: K233403
• Device Name: Flexset System
• Applicant: Zeto, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Apr 30, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrocculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.

Device Story

Flexset System is a wearable EEG headset for acquiring, transmitting, displaying, and storing EEG and auxiliary physiological signals. Input data includes scalp EEG, ECG, EOG, EMG, orientation (accelerometer), photic/external triggers, and video. The device consists of a headset, electrodes, display unit, extension unit, and software. It is used in healthcare facilities, homes, and transport environments (ambulances, cars, trains, boats, air) by healthcare professionals. The system provides real-time contact quality monitoring and impedance measurement. Data is transmitted via Wi-Fi or LTE to a cloud-based data center application. A client application allows clinicians to view waveforms, control sessions, and apply standard EEG transformations (filters, montage). The device aids in clinical EEG monitoring by providing stable, full-montage recordings. Benefits include portability, ease of use, and extended monitoring capabilities compared to traditional systems.

Clinical Evidence

Bench testing only. Performance verified per IEC 80601-2-26:2019 (EEG), IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), and wireless coexistence testing. Biocompatibility testing (ISO 10993-1, -5, -10, -23) confirmed no toxic potential. Functionality of auxiliary signals (ECG, EOG, EMG) verified against performance requirements.

Technological Characteristics

Headset uses semi-rigid/flexible polymers (Polyamide PA12, polyetherimide, polypropylene, polyimide, polydimethylsiloxane). Features 19 active dry EEG electrodes and 8 auxiliary ports. Power: 3950mAh Li-ion battery. Connectivity: Wi-Fi (802.11 a/b/g/n/ac) and LTE. A/D conversion: 24-bit, 500 Hz sampling. Software performs signal filtering (LPF/HPF/Notch) and montage transformations. Compliant with IEC 60601-1, IEC 60601-1-2, IEC 80601-2-26, and IEC 60601-1-11.

Indications for Use

Indicated for prescription use in healthcare, home, and transport environments for adults and children (excluding newborns) to acquire, transmit, display, and store EEG and auxiliary physiological signals (ECG, EOG, EMG, orientation, photic/external triggers, video).

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

• Zeto WR19 System (K172735)
• X-Series System (K131383)

Submission Summary (Full Text)

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April 30, 2024

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Zeto, Inc. % Mary Vater Consulting Partner Medical Device Academy, Inc. 345 Lincoln Hill Road Shrewsbury, Vermont 05738

Re: K233403

Trade/Device Name: Flexset System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GXY Dated: March 22, 2024 Received: March 29, 2024

Dear Mary Vater:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

Image /page/1/Picture/8 description: The image contains the name "Patrick Antkowiak -S". The text is written in a clear, sans-serif font, and the name is split into two lines. To the left of the name is a faded FDA logo.

for Jay Gupta, MS Assistant Director DHT5A: Division of Neurosurgical,

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Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Submission Number (if known)

K233403

Device Name

Flexset System

### Indications for Use (Describe)

The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrocculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.

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)

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# 510(k) SUMMARY

# In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the Flexset System

Device Common Name: Full-montage standard electroencephalograph

Device Trade Name: Flexset System

Applicant: Zeto, Inc. 4917 Waters Edge Dr. Suite #221 Raleigh, NC, 27606

- Contact: Aswin Gunasekar CEO, Zeto, Inc. [phone]
Classification Name: Electroencephalograph

Classification Regulation: 21 CFR 882.1400, Class II

Panel: Neurology

Primary Product Code: GWQ

Secondary Product Code: GXY

Predicate Devices: Zeto WR19 System (K172735, primary), X-Series System (K131383, secondary)

Submission number: K233403

Date: 2024-04-29

# 1. Indications for use

The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.

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# 2. Device Description

The Flexset System is intended to acquire, transmit, display and store primarily EEG and optionally auxiliary signals. Specific transport environments in the Indications for Use include ambulances, cars, buses, trains, boats and via air, per stipulation in the user manual of the device. The Flexset headset is designed to record a full montage EEG, with optional external references and additionally up to 8 auxiliary channels using lead wires for EEG, EOG, ECG or EMG. The device consists of the following components:

- Flexset (Headset) .
- Electrodes
- Charger with cable ●
- Display Unit ●
- Extension Unit ●
- Lead wires ●
- Software ●
- Display Unit firmware o
- Data center application (same as K172735) O
- O Client application (same as K172735)

## SUBSTANTIAL EQUIVALENCE DISCUSSION 3.

#### 3.1. Predicate Devices

The cited predicate device is the WR19 System, manufactured by Zeto, Inc., and cleared under K172735. The secondary predicate device, X-Series System by Advanced Brain Monitoring, Inc., cleared under K131383 is cited for the following features:

- . EOG
- . EMG
- Home environment ●

#### Indications for Use Comparison 3.2.

#### 3.2.1. Indications for Use, Predicate Device (WR19 System)

"The WR19 System is intended for prescription use in the health care facility or clinical research environment to acquire, transmit, display and store primarily EEG and optionally auxiliary signals for adults and children, not including newborns. The Flexset System requires operation by a healthcare professional familiar with EEG. The Flexset System acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), accelerometer, photic trigger detection, external trigger signals and video."

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### Indications for Use, Secondary Predicate Device (ABM X-Series 3.2.2. System, K131383)

"The X-Series System is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, transmit, display and store physiological signals from patients ages 6 and older. The X-Series system requires operation by a trained technician. The X-Series System acquires, transmits, displays and stores electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), and/or electromyogram (EMG), and accelerometer signals.

The X-Series System only acquires and displays physiological signals, no claims are being made for analysis of the acquired signals with respect to the accuracy, precision and reliability."

#### 3.2.3. Indications for Use, Flexset System

"The Flexset system is intended for prescription use in a healthcare facility, home, and specific transport environments to acquire, transmit, display and store EEG and auxiliary signals for adults and children, not including newborns. The Flexset system acquires, transmits, displays and stores electroencephalogram (EEG), and optionally electrocardiogram (ECG), electrooculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video."

#### 3.2.4. Similarities

- Both devices are intended for prescription use.
- Both devices are intended for use in a healthcare facility or clinical research environment.
- Both devices cover adults and children, not including newborns.
- Both devices acquire, transmit, display, and store their respective signals.
- Both devices operate on electroencephalogram (EEG), electrocardiogram (ECG), accelerometer (same as orientation sensor), photic trigger detection, external trigger signals and video.

#### 3.2.5. Differences

- . The WR19 System in addition to 'prescription use' is indicated for use by 'a healthcare professional familiar with EEG'. Since the latter phrase is redundant with 'prescription use', the Flexset system specifies only 'prescription use' to remove inconsistencies and hence raises no new concerns.
- . The Flexset System is indicated for use in the home and air transport environments as well, whereas the WR19 System is not; the secondary predicate (X-Series System, K131383 which was the predicate of our WR19, K172735 submission) has been added for home use. Listed transport environments have also been covered. Additionally, compatibility with elevated EMC environments in air transport use has been validated for compliance with RTCA DO-160F. This raises no new concerns because compliance to safety and efficacy standards for the additional environments have been validated in this submission.
- The Flexset System is indicated to operate on optional EOG and EMG signals, whereas the WR19 System is not; the X-Series System contains EOG and EMG and comparison details have been added to the substantial equivalence table.

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This raises no new concerns as these two signals use the same essential physiological measurement circuitry as EEG and ECG.

#### Conclusion of the comparison of the indications for use 3.2.6.

The differences in indications for use between the subject device and the predicate devices, indicate that the intended use of the devices are the same; the differences do not raise any concerns of safety and effectiveness not raised for the predicate devices, nor do the indications have the potential to significantly increase a safety or effectiveness concern raised for the predicate devices.

#### Substantial equivalence comparison tables 3.3.

#### Comparison – Overview 3.3.1.

The following table provides a comparison of overview of the technological characteristics between the Flexset System and the WR19 System:

| Comparison - overview | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 | Same |
| Regulation Name | Electroencephalograph | Electroencephalograph | Same |
| Regulatory Class | II | II | Same |
| Product Code | GWQ | GWQ | Same |
| Subsequent Product<br>Code | GXY | GXY | Same |
| Manufacturer | Zeto, Inc. | Zeto, Inc. | Same |
| User<br>Interface | Operator control, visual indicators | Operator control, visual indicators | Same |
| System<br>Components | • Flexset (Headset)<br>• Electrodes<br>• Charger with cable<br>• Display Unit<br>• Extension Unit<br>• Lead wires<br>• Software<br>o Firmware and Display Unit Software<br>o Data center application (same as<br>K172735)<br>o Client application (same as K172735) | • Headset<br>• Electrodes<br>• Charger<br>• Charging cable<br>• Software<br>o Headset firmware<br>o Data center application<br>o Client application | No significant<br>difference.<br>Substantially<br>equivalent. The Display<br>Unit provides easier<br>control and additional<br>display capability. |
| Signals Acquired | • Scalp EEG<br>· Orientation Sensor (accelerometer)<br>• Optional non-EEG signals:<br>o ECG<br>o EOG<br>o EMG<br>o Photic trigger detection<br>o External trigger input<br>o Video | • Scalp EEG<br>• Accelerometer<br>• Optional non-EEG signals:<br>o ECG<br>o Photic trigger detection<br>o External trigger input<br>o Video | Same in measuring<br>EEG, but offers<br>additional, optional<br>auxiliary signal<br>measurements. |
| Power Supply | 1 × 3950mAh 3.85V Lithium-lon battery | 1 x 2050mAh 3.7V Lithium-lon battery | No significant<br>difference. Flexset<br>system uses a higher<br>capacity battery. |
| Battery Charging | Medical grade wall charger | Via USB connector<br>connected to USB wall charger. | No significant<br>difference. Both<br>accomplish safe and<br>quick charging |
| Typical Charging Time | 0.5-6.0 hours | 0.5-6.0 hours | Same |
| Operating Time | 6-7 hours | 6-7 hours | Same |
| Typical use duration | 20 mins to several hours | 20 - 60 minutes | No significant<br>difference. Flexset<br>system can be used for<br>longer relative to<br>predicate as it weighs<br>less and is more<br>comfortable. |
| Dimensions | 7.25 x 7.25 x 5.25" or<br>184 x 184 x 133 mm | 8.5 x 10.8 x 5.7" or<br>214 x 274 x 144 mm | No significant<br>difference |
| Weight | Approx 400 g or 14 oz | < 650g or 23 oz with battery | No significant<br>difference.<br>Lighter, Substantially<br>equivalent |
| Cleaning | Cleaned and disinfected by rubbing or<br>immersion in isopropyl alcohol | Cleaned and disinfected by rubbing with<br>isopropyl alcohol | No significant<br>difference.<br>Flexset can be<br>immersion cleaned as<br>well. |
| Comparison - Data<br>Transfer & Storage | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
| Internal data Storage | Built-in device memory, 64 GB | SD card, Minimum 8GB | No significant<br>difference.<br>Substantially<br>equivalent. |
| File Size per 8 hr<br>recording | 1.5 GB | 1.5 GB | Same |
| Wireless Data Transfer | Wi-Fi 802.11 a/b/g/n/ac 2.4 GHz or 5 GHz LTE | Wi-Fi 802.11 b/g/n | No significant<br>difference. Flexset<br>system provides more<br>options. |
| Maximum wireless<br>transfer distance | Display unit includes commercially available,<br>FCC-certified, Wi-Fi device that works for<br>standard transfer distance from WiFi Router,<br>typically up to 30 meters. | Headset includes commercially available,<br>FCC-certified, Wi-Fi module that works<br>for standard transfer distance from WiFi<br>Router, typically up to 30 meters. | Same |

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#### 3.3.2. Comparison - Data Transfer & Storage

The following table provides a comparison of data transfer and storage characteristics between the Flexset System and the WR19 System:

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#### 3.3.3. Comparison - EEG Measurements

The following table provides a comparison of EEG measurement characteristics between the Flexset System and the WR19 System:

| Comparison - EEG<br>Measurements | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Definition | 19 EEG electrodes + Up to 8 auxiliary<br>electrode lead wire ports (2 on the sides of<br>the Flexset Unit and 6 on the Extension Unit) | 19 EEG | Same in measuring<br>EEG. The subject<br>device offers<br>additional optional<br>auxiliary signals for<br>measurement.<br>Auxiliary EMG and<br>EOG channels covered<br>by secondary<br>predicate below. |
| Signal Processing<br>Techniques | Sampling Rate: 500 s/s | Sampling Rate: 500 s/s | Same |
| Signal Processing<br>Techniques | No hardware LPF/HPF/Notch filters.<br>Software Filtering:<br>Following are optional: LPF and HPF (Cutoff<br>frequency selectable by operator), 50Hz, 60Hz<br>notch | No hardware LPF/HPF/Notch filters.<br>Software Filtering:<br>Following are optional: LPF and HPF<br>(Cutoff frequency selectable by<br>operator), 50Hz, 60Hz notch | Same |

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| Accuracy, Performance | Sampling rate: 500 Hz<br>Dynamic range: ± 375 mV<br>Resolution: 44.7 nV<br>Peak-to-peak noise: 4 µV<br>Common-mode rejection ratio: > 120 dB<br>Input impedance: 1 TΩ<br>Noise: 1 µV RMS<br>A/D Conversion: 24 Bit | Sampling rate: 500 Hz<br>Dynamic range: ± 375 mV<br>Resolution: 44.7 nV<br>Peak to peak noise: 4 µV<br>Common Mode Rejection Ratio: > 120dB<br>Input Impedance: 1 TΩ<br>Noise: 1 µV RMS<br>A/D Conversion: 24 Bit | No significant<br>difference. Both satisfy<br>clinical EEG<br>requirements |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Headset material | Semi-rigid and flexible polymer material (e.g.:<br>Polyamide PA12, polyetherimide,<br>polypropylene, polyimide,<br>polydimethylsiloxane) | Semi-rigid and flexible polymer material<br>(e.g., Polyamide PA12, ABS, Polyurethane<br>and Polycarbonate) | No significant<br>difference. Both use<br>safe, biocompatibility<br>tested plastic materials |
| Electrode type | Active, dry | Active, dry | Same |
| Contact<br>quality/Impedance<br>measurement | Contact quality monitoring performed real<br>time throughout the test. Additionally,<br>impedance measurement mode is available,<br>typically performed by the operator before<br>the start of EEG study. | Contact quality monitoring performed<br>real time throughout the test | No significant<br>difference.<br>Flexset system offers<br>additional impedance<br>monitoring |
| Contact Quality<br>Indicators | LED indicators (tuned on optionally) for<br>contact quality of each electrode on the<br>headset. Same as shown on the client<br>application of predicate | None on the headset itself | No significant<br>difference.<br>Flexset offers<br>additional status<br>display, redundant to<br>onscreen display |

#### 3.3.4. Comparison - ECG Measurements

The following table provides a comparison of ECG measurement characteristics between the Flexset System and the WR19 System:

| Comparison - ECG<br>Measurements | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Channels | Single Differential ECG using non-active<br>(passive), gel-based leads/electrodes<br>(optional) | Single Differential ECG using non-active<br>(passive), gel-based leads/electrodes<br>(optional) | Same |
| Accuracy,<br>performance | Sampling rate: 500 Hz<br>Dynamic range: +/- 3900 mV<br>Resolution: 0.536 µV<br>Peak to peak noise: 4 µV<br>Common Mode Rejection Ratio: > 110 dB<br>Input Impedance: >1 TΩ<br>A/D Conversion: 24 Bit | Sampling rate: 500 Hz<br>Dynamic range: +/- 3900 mV<br>Resolution: 0.536 µV<br>Peak to peak noise: 4 µV<br>Common Mode Rejection Ratio: > 110dB<br>Input Impedance: 500 MOhm<br>A/D Conversion: 24 Bit | No significant<br>difference. |

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#### 3.3.5. Comparison – Accelerometer

The following table provides a comparison of accelerometer characteristics between the Flexset System and the WR19 System:

| Comparison -<br>Accelerometer | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
|-------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------|
| Scope of use | Used primarily as an aid for motion detection<br>and hence finding EEG artifacts | Used primarily as an aid for motion<br>detection and hence finding EEG artifacts | Same |
| Channels | Dynamic Range: -180° to 180°<br>Three channels (X, Y, Z) used by software to<br>measure movement and position | Dynamic Range: -180° to 180°<br>Three channels (X, Y, Z) used by software<br>to measure movement and position | Same |

#### 3.3.6. Comparison - Software Characteristics

The following table provides a comparison of software technological characteristics between the Flexset System and the WR19 System:

| Comparison - Software<br>Characteristics | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
|------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| Firmware | Flexset headset is controlled by firmware. | WR19 headset is controlled by firmware. | Same |
| Data center application | Flexset Display Unit sends data to the data<br>center application (same as K172735) in the<br>cloud. | WR19 headset sends data to the data<br>center application in the cloud. | Same |
| Client application | Client application (same as K172735) presents waveforms,<br>controls EEG session, and offers<br>standard EEG transformations such as<br>low-pass, high-pass and notch filters and<br>montage transformations. | Client application presents waveforms,<br>controls EEG session, and offers standard<br>EEG transformations such as low-pass,<br>high-pass and notch filters and montage<br>transformations. | Same |
| | Client application (same as K172735) records<br>and retrieves EEG waveforms. | Client application records and retrieves<br>EEG waveforms. | Same |

#### 3.3.7. Electrode technological comparison

The following table provides a comparison of electrode technological characteristics between the Flexset System and the WR19 System:

| Technological<br>Comparison | Flexset System<br>(This submission) | WR19 System<br>(Predicate device K172735) | Remarks |
|-----------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|
| Electrode material | Ag/AgCl coated with optional gel tip | Ag/AgCl coated | No significant<br>difference. Optional<br>gel tip increases<br>comfort. |
| Type of electrodes | Active, dry | Active, dry | Same |
| Electrode shapes | Flat and bristle type electrodes | Flat and bristle type electrodes | Same |
| Fitting to the head | Flexible, wearable headset that can be<br>stretched and put on the head. | Semi-rigid wearable headset with each<br>band adjusted via dials. | No significant<br>difference. Both |

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| | | | conform to the head. |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Electrode mounting<br>mechanism | Electrode positions are fixed and stretch<br>based on head size. Flexible electrode legs. | Electrode positions can be adjusted to a<br>limited extent. Spring-loaded mechanism<br>in the electrode holder. | No significant<br>difference. Both make<br>stable electrode<br>contact with the scalp. |
| Typical usage<br>setting | Intended for use for healthcare, research,<br>home, ground and air transport settings per<br>the 10-20 EEG system | Intended for use for Routine clinical EEG<br>where rapid placement of EEG electrodes<br>as per the 10-20 EEG system is required | No significant<br>difference. Flexset<br>system offers<br>additional use settings |

#### 3.3.8. Comparison - Secondary Predicate Device

The following table provides a comparison of the Flexset System and the X-Series System, with s focus on non-ECG auxiliary signals and use environment:

| Specification | Flexset System<br>(This submission) | X-Series System<br>secondary predicate device, K131383) | Remarks |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|
| Regulation Number | 21 CFR 882.1400 | 21 CFR 882.1400 | Same |
| Regulation Name | Electroencephalograph | Electroencephalograph | Same |
| Regulatory Class | II | II | Same |
| Product Code | GWQ | GWQ | Same |
| Manufacturer | Zeto, Inc. | Advanced Brain Monitoring, Inc. | Different |
| Signals Acquired | • Scalp EEG<br>• Orientation Sensor (accelerometer)<br>• Optional non-EEG signals:<br>o ECG<br>o EOG<br>o EMG<br>o Photic trigger detection<br>o External trigger input<br>o Video | • Scalp EEG<br>• 3-D actigraphy<br>• Optional non-EEG signals:<br>o ECG<br>o EOG<br>o EMG | No significant<br>difference. Other<br>non-EEG signals<br>covered against<br>predicate. |
| Non-ECG auxiliary<br>measurements definition | Up to 8 auxiliary lead wire ports (2 on the<br>sides of the Flexset Unit and 6 on the<br>Extension Unit)<br>Provided as accessories: Lead wires for<br>HEOG+, HEOG-, VEOG+, VEOG-, EMG1+ and | Up to 4 optional single channels either<br>dual lead electrooculogram (EOG) or<br>electromyogram (EMG) | More available<br>channels in the<br>submitted device.<br>Same |

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| | EMG1- | | |
|-----------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|
| Signal processing<br>techniques for non-ECG<br>auxiliary measurements | Software: high-pass, low-pass, notch with<br>configurable frequencies. | 0.1 Hz High Pass, hardware<br>100 Hz Low Pass, hardware | Same as predicate<br>device, additional<br>configurability in<br>submitted device |
| Accuracy of non-ECG<br>auxiliary measurements | Sampling rate (for all types): 500 Hz<br>Dynamic range (for all types): ± 375 mV<br>Resolution (for all types): 44.7 nV<br>Peak-to-peak noise: 4 µV | Sampling rate in both cases 256 Hz<br>EOG:<br>Dynamic Range: +/- 2 mV<br>Resolution: 60 nV<br>Peak-to-peak noise: 4.2 µV<br>EMG:<br>Dynamic Range: +/- 1 mV<br>Resolution: 30 nV<br>Peak-to-peak noise: 3.7 µV | Same, higher sampling<br>rate in the submitted<br>device. |
| Typical usage<br>setting | Intended for use for healthcare, research,<br>home and transport settings per the 10-20<br>EEG system | Home (data acquisition)<br>Healthcare facility (data acquisition,<br>analysis and reporting)<br>Clinical Research Environment | No significant<br>difference except for<br>addition of air<br>transport for subject<br>device. Supporting<br>information provided. |

# STERILIZATION, SHELF LIFE, CLEANING, 4. REUSE

The Flexset System is neither shipped nor intended to be sterile. The device is reusable, is intended for multi-patient use, and is intended to be cleaned and disinfected between uses.

# Biocompatibility 5.

The patient-contacting materials of the Flexset System are all either limited duration (<24 h) skin or hair-contacting. Accordingly, cytotoxicity, maximization sensitization, and skin irritation testing were done as per the following standards:

- . ISO 10993-1:2018
- ISO 10993-5: 2009(E)
- ISO 10993-10: 2021(E) ●
- ISO 10993-23:2021(E) ●

The results of all tests showed no evidence of toxic potential or adverse reactions.

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# 6. PERFORMANCE DATA

The following standards' performance tests were conducted to support the performance claims of the product:

- EEG performance testing, as per IEC 80601-2-26:2019
- · IEC 60601-1-2:2014+AMD1:2020
- · Testing to verify functionality of optional auxiliary signals
- IEC TR 60601-4-2:2016

# 7. SOFTWARE DOCUMENTATION

The documentation level evaluation concluded that the device requires basic documentation.

# ELECTRICAL SAFETY TESTING 8.

The Flexset System was evaluated as per IEC 60601-1:2005+AMD1:2012+AMD2:2020 , and found to be compliant.

# ELECTROMAGNETIC COMPATIBILITY 9. TESTING

The Flexset System was evaluated as per IEC 60601-1-2:2014+AMD1:2020, and found to be compliant. In addition, wireless coexistence testing was conducted.

## STANDARDS 10.

The table below provides the list of standards that are used in the 510(k) to establish device performance and support substantial equivalence:

| Standard | Title |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC<br>60601-1:2005+AMD1:2012+AMD<br>2:2020 | Medical electrical equipment - Part 1: General requirements for<br>basic safety and essential performance |
| IEC 60601-1-2:2014+AMD1:2020 | Amendment 1 - Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential performance -<br>Collateral Standard: Electromagnetic disturbances -<br>Requirements and tests |
| IEC 80601-2-26:2019 | Medical electrical equipment - Part 2-26: Particular<br>requirements for the basic safety and essential performance of<br>electroencephalographs |
| ISO 14971:2019 | Medical devices - Application of risk management to medical<br>devices |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation and<br>testing within a risk management process |
| ISO 10993-5: 2009(E) | Biological evaluation of medical devices — Part 5: Tests for in<br>vitro cytotoxicity |
| ISO 10993-10: 2021(E) | Biological evaluation of medical devices — Part 10: Tests for skin<br>sensitization |
| ISO 10993-23:2021(E) | Biological evaluation of medical devices — Part 23: Tests for<br>irritation |
| IEC 62304:2006 + A1:2015 | Medical device software - Software life cycle processes -<br>Amendment 1 |
| IEC<br>60601-1-11:2015+AMD1:2020 | Medical electrical equipment — Part 1-11: General requirements<br>for basic safety and essential performance — Collateral standard:<br>Requirements for medical electrical equipment and medical<br>electrical systems used in the home healthcare environment -<br>Amendment 1 |
| IEC 60601-1-6:2010 + AMD1:2013<br>+ AMD2:2020 | Medical electrical equipment - Part 1-6: General requirements for<br>basic safety and essential performance - Collateral standard:<br>Usability |
| IEC TR 60601-4-2 Edition 1.0<br>2016-05 | Medical electrical equipment - Part 4-2: Guidance and<br>interpretation - Electromagnetic immunity: performance of<br>medical electrical equipment and medical electrical systems |

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# 11. Substantial Equivalence Conclusion

Based on the detailed comparison of specifications to the previously cleared WR19 System (K172735) and the previously cleared X-Series System (K131383), functional and performance testing, and conformance with applicable standards as well as the comparison of indications; the differences do not raise new concerns of safety and effectiveness and the Flexset System can be found substantially equivalent to the predicate devices.