(209 days)
Not Found
No
The summary describes a system for acquiring, transmitting, displaying, and storing physiological signals (primarily EEG). There is no mention of any analytical or interpretive functions that would typically involve AI/ML, nor are there details about training or test sets which are characteristic of AI/ML development. The software components listed are described as firmware and applications for data management and display, not for signal analysis using AI/ML.
No.
The Flexset system is intended for acquiring, transmitting, displaying, and storing physiological signals (primarily EEG, and optionally ECG, EOG, EMG, etc.) for diagnostic or monitoring purposes, not for providing therapy or treatment.
Yes
The device acquires, transmits, displays, and stores physiological signals (EEG, ECG, EOG, EMG) which are used by healthcare professionals to evaluate and diagnose medical conditions.
No
The device description explicitly lists multiple hardware components (Headset, Electrodes, Charger, Display Unit, Extension Unit, Lead wires) in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is done outside of the body (in vitro).
- Flexset System Function: The Flexset system acquires and records physiological signals (EEG, ECG, EOG, EMG) directly from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use describes acquiring, transmitting, displaying, and storing these signals for diagnostic purposes, but this is done by measuring electrical activity on the body, not by testing samples from the body.
Therefore, the Flexset system falls under the category of a medical device that measures physiological signals, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / 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), electrocculogram (EOG), electromyogram (EMG), orientation sensor data, photic sensor data, external trigger signals and video.
Product codes (comma separated list FDA assigned to the subject device)
GWQ, GXY
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 ●
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Scalp (for EEG)
Indicated Patient Age Range
Adults and children, not including newborns.
Intended User / Care Setting
Prescription use in a healthcare facility, home, and specific transport environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
April 30, 2024
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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"
1
(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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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,
2
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
3
Indications for Use
Submission Number (if known)
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
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. (833) 938-6334
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.
5
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 ●
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."
6
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.
7
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
(This submission) | WR19 System
(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
Code | GXY | GXY | Same |
| Manufacturer | Zeto, Inc. | Zeto, Inc. | Same |
| User
Interface | Operator control, visual indicators | Operator control, visual indicators | Same |
| System
Components | • Flexset (Headset)
• Electrodes
• Charger with cable
• Display Unit
• Extension Unit
• Lead wires
• Software
o Firmware and Display Unit Software
o Data center application (same as
K172735)
o Client application (same as K172735) | • Headset
• Electrodes
• Charger
• Charging cable
• Software
o Headset firmware
o Data center application
o Client application | No significant
difference.
Substantially
equivalent. The Display
Unit provides easier
control and additional
display capability. |
| Signals Acquired | • Scalp EEG
· Orientation Sensor (accelerometer)
• Optional non-EEG signals:
o ECG
o EOG
o EMG
o Photic trigger detection
o External trigger input
o Video | • Scalp EEG
• Accelerometer
• Optional non-EEG signals:
o ECG
o Photic trigger detection
o External trigger input
o Video | Same in measuring
EEG, but offers
additional, optional
auxiliary signal
measurements. |
| Power Supply | 1 × 3950mAh 3.85V Lithium-lon battery | 1 x 2050mAh 3.7V Lithium-lon battery | No significant
difference. Flexset
system uses a higher
capacity battery. |
| Battery Charging | Medical grade wall charger | Via USB connector
connected to USB wall charger. | No significant
difference. Both
accomplish safe and
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
difference. Flexset
system can be used for
longer relative to
predicate as it weighs
less and is more
comfortable. |
| Dimensions | 7.25 x 7.25 x 5.25" or
184 x 184 x 133 mm | 8.5 x 10.8 x 5.7" or
214 x 274 x 144 mm | No significant
difference |
| Weight | Approx 400 g or 14 oz | 120 dB
Input impedance: 1 TΩ
Noise: 1 µV RMS
A/D Conversion: 24 Bit | Sampling rate: 500 Hz
Dynamic range: ± 375 mV
Resolution: 44.7 nV
Peak to peak noise: 4 µV
Common Mode Rejection Ratio: > 120dB
Input Impedance: 1 TΩ
Noise: 1 µV RMS
A/D Conversion: 24 Bit | No significant
difference. Both satisfy
clinical EEG
requirements |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|
| Headset material | Semi-rigid and flexible polymer material (e.g.:
Polyamide PA12, polyetherimide,
polypropylene, polyimide,
polydimethylsiloxane) | Semi-rigid and flexible polymer material
(e.g., Polyamide PA12, ABS, Polyurethane
and Polycarbonate) | No significant
difference. Both use
safe, biocompatibility
tested plastic materials |
| Electrode type | Active, dry | Active, dry | Same |
| Contact
quality/Impedance
measurement | Contact quality monitoring performed real
time throughout the test. Additionally,
impedance measurement mode is available,
typically performed by the operator before
the start of EEG study. | Contact quality monitoring performed
real time throughout the test | No significant
difference.
Flexset system offers
additional impedance
monitoring |
| Contact Quality
Indicators | LED indicators (tuned on optionally) for
contact quality of each electrode on the
headset. Same as shown on the client
application of predicate | None on the headset itself | No significant
difference.
Flexset offers
additional status
display, redundant to
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
Measurements | Flexset System
(This submission) | WR19 System
(Predicate device K172735) | Remarks |
|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|
| Channels | Single Differential ECG using non-active
(passive), gel-based leads/electrodes
(optional) | Single Differential ECG using non-active
(passive), gel-based leads/electrodes
(optional) | Same |
| Accuracy,
performance | Sampling rate: 500 Hz
Dynamic range: +/- 3900 mV
Resolution: 0.536 µV
Peak to peak noise: 4 µV
Common Mode Rejection Ratio: > 110 dB
Input Impedance: >1 TΩ
A/D Conversion: 24 Bit | Sampling rate: 500 Hz
Dynamic range: +/- 3900 mV
Resolution: 0.536 µV
Peak to peak noise: 4 µV
Common Mode Rejection Ratio: > 110dB
Input Impedance: 500 MOhm
A/D Conversion: 24 Bit | No significant
difference. |
11
3.3.5. Comparison – Accelerometer
The following table provides a comparison of accelerometer characteristics between the Flexset System and the WR19 System:
| Comparison -
Accelerometer | Flexset System
(This submission) | WR19 System
(Predicate device K172735) | Remarks |
|-------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------|
| Scope of use | Used primarily as an aid for motion detection
and hence finding EEG artifacts | Used primarily as an aid for motion
detection and hence finding EEG artifacts | Same |
| Channels | Dynamic Range: -180° to 180°
Three channels (X, Y, Z) used by software to
measure movement and position | Dynamic Range: -180° to 180°
Three channels (X, Y, Z) used by software
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
Characteristics | Flexset System
(This submission) | WR19 System
(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
center application (same as K172735) in the
cloud. | WR19 headset sends data to the data
center application in the cloud. | Same |
| Client application | Client application (same as K172735) presents waveforms,
controls EEG session, and offers
standard EEG transformations such as
low-pass, high-pass and notch filters and
montage transformations. | Client application presents waveforms,
controls EEG session, and offers standard
EEG transformations such as low-pass,
high-pass and notch filters and montage
transformations. | Same |
| | Client application (same as K172735) records
and retrieves EEG waveforms. | Client application records and retrieves
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
Comparison | Flexset System
(This submission) | WR19 System
(Predicate device K172735) | Remarks |
|-----------------------------|--------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|
| Electrode material | Ag/AgCl coated with optional gel tip | Ag/AgCl coated | No significant
difference. Optional
gel tip increases
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
stretched and put on the head. | Semi-rigid wearable headset with each
band adjusted via dials. | No significant
difference. Both |
12
| conform to the head. | |||
|---|---|---|---|
| Electrode mounting | |||
| mechanism | Electrode positions are fixed and stretch | ||
| based on head size. Flexible electrode legs. | Electrode positions can be adjusted to a | ||
| limited extent. Spring-loaded mechanism | |||
| in the electrode holder. | No significant | ||
| difference. Both make | |||
| stable electrode | |||
| contact with the scalp. | |||
| Typical usage | |||
| setting | Intended for use for healthcare, research, | ||
| home, ground and air transport settings per | |||
| the 10-20 EEG system | Intended for use for Routine clinical EEG | ||
| where rapid placement of EEG electrodes | |||
| as per the 10-20 EEG system is required | No significant | ||
| difference. Flexset | |||
| system offers | |||
| 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
(This submission) | X-Series System
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
• Orientation Sensor (accelerometer)
• Optional non-EEG signals:
o ECG
o EOG
o EMG
o Photic trigger detection
o External trigger input
o Video | • Scalp EEG
• 3-D actigraphy
• Optional non-EEG signals:
o ECG
o EOG
o EMG | No significant
difference. Other
non-EEG signals
covered against
predicate. |
| Non-ECG auxiliary
measurements definition | Up to 8 auxiliary lead wire ports (2 on the
sides of the Flexset Unit and 6 on the
Extension Unit)
Provided as accessories: Lead wires for
HEOG+, HEOG-, VEOG+, VEOG-, EMG1+ and | Up to 4 optional single channels either
dual lead electrooculogram (EOG) or
electromyogram (EMG) | More available
channels in the
submitted device.
Same |
13
| EMG1- | |||
|---|---|---|---|
| Signal processing | |||
| techniques for non-ECG | |||
| auxiliary measurements | Software: high-pass, low-pass, notch with | ||
| configurable frequencies. | 0.1 Hz High Pass, hardware | ||
| 100 Hz Low Pass, hardware | Same as predicate | ||
| device, additional | |||
| configurability in | |||
| submitted device | |||
| Accuracy of non-ECG | |||
| auxiliary measurements | Sampling rate (for all types): 500 Hz | ||
| Dynamic range (for all types): ± 375 mV | |||
| Resolution (for all types): 44.7 nV | |||
| Peak-to-peak noise: 4 µV | Sampling rate in both cases 256 Hz | ||
| EOG: | |||
| Dynamic Range: +/- 2 mV | |||
| Resolution: 60 nV | |||
| Peak-to-peak noise: 4.2 µV | |||
| EMG: | |||
| Dynamic Range: +/- 1 mV | |||
| Resolution: 30 nV | |||
| Peak-to-peak noise: 3.7 µV | Same, higher sampling | ||
| rate in the submitted | |||
| device. | |||
| Typical usage | |||
| setting | Intended for use for healthcare, research, | ||
| home and transport settings per the 10-20 | |||
| EEG system | Home (data acquisition) | ||
| Healthcare facility (data acquisition, | |||
| analysis and reporting) | |||
| Clinical Research Environment | No significant | ||
| difference except for | |||
| addition of air | |||
| transport for subject | |||
| device. Supporting | |||
| 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 (