(209 days)
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.
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:
The provided 510(k) summary for the Zeto, Inc. Flexset System does not contain the specific details about the acceptance criteria or a dedicated study proving the device meets those criteria in the way typically expected for an AI/ML-driven diagnostic device.
This document describes a device for acquiring, transmitting, displaying, and storing EEG and auxiliary signals. It focuses on demonstrating substantial equivalence to a predicate device (WR19 System) and a secondary predicate device (X-Series System) based on technological characteristics and intended use. The performance data section refers to compliance with general medical device standards (e.g., IEC 80601-2-26:2019 for EEG performance) rather than specific acceptance criteria for diagnostic performance outcomes.
Therefore, many of the requested items cannot be extracted directly from this document. However, I can infer some information based on the provided text.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from standards compliance) | Reported Device Performance (From Section 3.3.3 EEG Measurements, 3.3.4 ECG Measurements, 3.3.8 Non-ECG auxiliary measurements) |
|---|---|
| EEG Measurements (IEC 80601-2-26:2019 compliance implies meeting certain performance specs) | |
| Sampling Rate | 500 Hz |
| Dynamic Range | ± 375 mV |
| Resolution | 44.7 nV |
| Peak-to-peak noise | 4 µV |
| Common-mode rejection ratio | > 120 dB |
| Input impedance | 1 TΩ |
| Noise | 1 µV RMS |
| A/D Conversion | 24 Bit |
| ECG Measurements (Compliance implies meeting certain performance specs) | |
| 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 |
| Non-ECG Auxiliary Measurements (EOG/EMG) (Compliance implies meeting certain performance specs) | |
| Sampling rate | 500 Hz |
| Dynamic range | ± 375 mV |
| Resolution | 44.7 nV |
| Peak-to-peak noise | 4 µV |
| Electrical Safety (IEC 60601-1:2005+AMD1:2012+AMD2:2020) | Compliant |
| Electromagnetic Compatibility (IEC 60601-1-2:2014+AMD1:2020) | Compliant |
| Biocompatibility (ISO 10993-x series) | No evidence of toxic potential or adverse reactions |
Limitations: The document does not specify quantitative acceptance criteria (e.g., "EEG noise must be < 5 µV"). Instead, it states compliance with general standards, which inherently include such criteria. The reported performance metrics are directly from the device's technical specifications, not necessarily results of a comparative performance study against a ground truth for a diagnostic task.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document primarily focuses on technical specifications, safety, and regulatory compliance (electrical safety, EMC, biocompatibility). It describes the device's ability to acquire and display signals, not its performance in a diagnostic task that would typically involve a "test set" with ground truth from patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is an electroencephalograph for signal acquisition and display. It does not perform automated diagnoses or interpretations that would require expert-established ground truth for a test set in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for the same reasons as #3.
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
This information is not applicable/not provided. The Flexset System is described as acquiring, transmitting, displaying, and storing physiological signals. There is no mention of AI/ML components performing diagnostic interpretations or assisting human readers in a way that would necessitate an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device's function is signal acquisition and display, not automated interpretation or standalone diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. As a device for signal acquisition and display, "ground truth" in the diagnostic sense (e.g., for disease detection) is not relevant to the described performance evaluation in this document. The "ground truth" for its performance would be the accuracy and fidelity of the acquired signals, which is assessed against engineering standards and specifications.
8. The sample size for the training set
This information is not applicable/not provided. The device is not an AI/ML-driven diagnostic algorithm that would require a "training set." Its performance is based on hardware and software engineering design and adherence to established physiological measurement principles.
9. How the ground truth for the training set was established
This information is not applicable/not provided for the same reasons as #8.
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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 (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,
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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)
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. (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.
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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 ●
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(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 ProductCode | GXY | GXY | Same |
| Manufacturer | Zeto, Inc. | Zeto, Inc. | Same |
| UserInterface | Operator control, visual indicators | Operator control, visual indicators | Same |
| SystemComponents | • Flexset (Headset)• Electrodes• Charger with cable• Display Unit• Extension Unit• Lead wires• Softwareo Firmware and Display Unit Softwareo Data center application (same asK172735)o Client application (same as K172735) | • Headset• Electrodes• Charger• Charging cable• Softwareo Headset firmwareo Data center applicationo Client application | No significantdifference.Substantiallyequivalent. The DisplayUnit provides easiercontrol and additionaldisplay capability. |
| Signals Acquired | • Scalp EEG· Orientation Sensor (accelerometer)• Optional non-EEG signals:o ECGo EOGo EMGo Photic trigger detectiono External trigger inputo Video | • Scalp EEG• Accelerometer• Optional non-EEG signals:o ECGo Photic trigger detectiono External trigger inputo Video | Same in measuringEEG, but offersadditional, optionalauxiliary signalmeasurements. |
| Power Supply | 1 × 3950mAh 3.85V Lithium-lon battery | 1 x 2050mAh 3.7V Lithium-lon battery | No significantdifference. Flexsetsystem uses a highercapacity battery. |
| Battery Charging | Medical grade wall charger | Via USB connectorconnected to USB wall charger. | No significantdifference. Bothaccomplish safe andquick 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 significantdifference. Flexsetsystem can be used forlonger relative topredicate as it weighsless and is morecomfortable. |
| Dimensions | 7.25 x 7.25 x 5.25" or184 x 184 x 133 mm | 8.5 x 10.8 x 5.7" or214 x 274 x 144 mm | No significantdifference |
| Weight | Approx 400 g or 14 oz | < 650g or 23 oz with battery | No significantdifference.Lighter, Substantiallyequivalent |
| Cleaning | Cleaned and disinfected by rubbing orimmersion in isopropyl alcohol | Cleaned and disinfected by rubbing withisopropyl alcohol | No significantdifference.Flexset can beimmersion cleaned aswell. |
| Comparison - DataTransfer & Storage | Flexset System(This submission) | WR19 System(Predicate device K172735) | Remarks |
| Internal data Storage | Built-in device memory, 64 GB | SD card, Minimum 8GB | No significantdifference.Substantiallyequivalent. |
| File Size per 8 hrrecording | 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 significantdifference. Flexsetsystem provides moreoptions. |
| Maximum wirelesstransfer distance | Display unit includes commercially available,FCC-certified, Wi-Fi device that works forstandard transfer distance from WiFi Router,typically up to 30 meters. | Headset includes commercially available,FCC-certified, Wi-Fi module that worksfor standard transfer distance from WiFiRouter, 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 - EEGMeasurements | Flexset System(This submission) | WR19 System(Predicate device K172735) | Remarks |
|---|---|---|---|
| Definition | 19 EEG electrodes + Up to 8 auxiliaryelectrode lead wire ports (2 on the sides ofthe Flexset Unit and 6 on the Extension Unit) | 19 EEG | Same in measuringEEG. The subjectdevice offersadditional optionalauxiliary signals formeasurement.Auxiliary EMG andEOG channels coveredby secondarypredicate below. |
| Signal ProcessingTechniques | Sampling Rate: 500 s/s | Sampling Rate: 500 s/s | Same |
| Signal ProcessingTechniques | No hardware LPF/HPF/Notch filters.Software Filtering:Following are optional: LPF and HPF (Cutofffrequency selectable by operator), 50Hz, 60Hznotch | No hardware LPF/HPF/Notch filters.Software Filtering:Following are optional: LPF and HPF(Cutoff frequency selectable byoperator), 50Hz, 60Hz notch | Same |
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| Accuracy, Performance | Sampling rate: 500 HzDynamic range: ± 375 mVResolution: 44.7 nVPeak-to-peak noise: 4 µVCommon-mode rejection ratio: > 120 dBInput impedance: 1 TΩNoise: 1 µV RMSA/D Conversion: 24 Bit | Sampling rate: 500 HzDynamic range: ± 375 mVResolution: 44.7 nVPeak to peak noise: 4 µVCommon Mode Rejection Ratio: > 120dBInput Impedance: 1 TΩNoise: 1 µV RMSA/D Conversion: 24 Bit | No significantdifference. Both satisfyclinical EEGrequirements |
|---|---|---|---|
| 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, Polyurethaneand Polycarbonate) | No significantdifference. Both usesafe, biocompatibilitytested plastic materials |
| Electrode type | Active, dry | Active, dry | Same |
| Contactquality/Impedancemeasurement | Contact quality monitoring performed realtime throughout the test. Additionally,impedance measurement mode is available,typically performed by the operator beforethe start of EEG study. | Contact quality monitoring performedreal time throughout the test | No significantdifference.Flexset system offersadditional impedancemonitoring |
| Contact QualityIndicators | LED indicators (tuned on optionally) forcontact quality of each electrode on theheadset. Same as shown on the clientapplication of predicate | None on the headset itself | No significantdifference.Flexset offersadditional statusdisplay, redundant toonscreen 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 - ECGMeasurements | 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 HzDynamic range: +/- 3900 mVResolution: 0.536 µVPeak to peak noise: 4 µVCommon Mode Rejection Ratio: > 110 dBInput Impedance: >1 TΩA/D Conversion: 24 Bit | Sampling rate: 500 HzDynamic range: +/- 3900 mVResolution: 0.536 µVPeak to peak noise: 4 µVCommon Mode Rejection Ratio: > 110dBInput Impedance: 500 MOhmA/D Conversion: 24 Bit | No significantdifference. |
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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 -Accelerometer | Flexset System(This submission) | WR19 System(Predicate device K172735) | Remarks |
|---|---|---|---|
| Scope of use | Used primarily as an aid for motion detectionand hence finding EEG artifacts | Used primarily as an aid for motiondetection and hence finding EEG artifacts | Same |
| Channels | Dynamic Range: -180° to 180°Three channels (X, Y, Z) used by software tomeasure movement and position | Dynamic Range: -180° to 180°Three channels (X, Y, Z) used by softwareto 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 - SoftwareCharacteristics | 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 datacenter application (same as K172735) in thecloud. | WR19 headset sends data to the datacenter application in the cloud. | Same |
| Client application | Client application (same as K172735) presents waveforms,controls EEG session, and offersstandard EEG transformations such aslow-pass, high-pass and notch filters andmontage transformations. | Client application presents waveforms,controls EEG session, and offers standardEEG transformations such as low-pass,high-pass and notch filters and montagetransformations. | Same |
| Client application (same as K172735) recordsand retrieves EEG waveforms. | Client application records and retrievesEEG 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:
| TechnologicalComparison | Flexset System(This submission) | WR19 System(Predicate device K172735) | Remarks |
|---|---|---|---|
| Electrode material | Ag/AgCl coated with optional gel tip | Ag/AgCl coated | No significantdifference. Optionalgel tip increasescomfort. |
| 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 bestretched and put on the head. | Semi-rigid wearable headset with eachband adjusted via dials. | No significantdifference. Both |
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| conform to the head. | |||
|---|---|---|---|
| Electrode mountingmechanism | Electrode positions are fixed and stretchbased on head size. Flexible electrode legs. | Electrode positions can be adjusted to alimited extent. Spring-loaded mechanismin the electrode holder. | No significantdifference. Both makestable electrodecontact with the scalp. |
| Typical usagesetting | Intended for use for healthcare, research,home, ground and air transport settings perthe 10-20 EEG system | Intended for use for Routine clinical EEGwhere rapid placement of EEG electrodesas per the 10-20 EEG system is required | No significantdifference. Flexsetsystem offersadditional 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 Systemsecondary 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 ECGo EOGo EMGo Photic trigger detectiono External trigger inputo Video | • Scalp EEG• 3-D actigraphy• Optional non-EEG signals:o ECGo EOGo EMG | No significantdifference. Othernon-EEG signalscovered againstpredicate. |
| Non-ECG auxiliarymeasurements definition | Up to 8 auxiliary lead wire ports (2 on thesides of the Flexset Unit and 6 on theExtension Unit)Provided as accessories: Lead wires forHEOG+, HEOG-, VEOG+, VEOG-, EMG1+ and | Up to 4 optional single channels eitherdual lead electrooculogram (EOG) orelectromyogram (EMG) | More availablechannels in thesubmitted device.Same |
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| EMG1- | |||
|---|---|---|---|
| Signal processingtechniques for non-ECGauxiliary measurements | Software: high-pass, low-pass, notch withconfigurable frequencies. | 0.1 Hz High Pass, hardware100 Hz Low Pass, hardware | Same as predicatedevice, additionalconfigurability insubmitted device |
| Accuracy of non-ECGauxiliary measurements | Sampling rate (for all types): 500 HzDynamic range (for all types): ± 375 mVResolution (for all types): 44.7 nVPeak-to-peak noise: 4 µV | Sampling rate in both cases 256 HzEOG:Dynamic Range: +/- 2 mVResolution: 60 nVPeak-to-peak noise: 4.2 µVEMG:Dynamic Range: +/- 1 mVResolution: 30 nVPeak-to-peak noise: 3.7 µV | Same, higher samplingrate in the submitteddevice. |
| Typical usagesetting | Intended for use for healthcare, research,home and transport settings per the 10-20EEG system | Home (data acquisition)Healthcare facility (data acquisition,analysis and reporting)Clinical Research Environment | No significantdifference except foraddition of airtransport for subjectdevice. Supportinginformation 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 |
|---|---|
| IEC60601-1:2005+AMD1:2012+AMD2:2020 | Medical electrical equipment - Part 1: General requirements forbasic safety and essential performance |
| IEC 60601-1-2:2014+AMD1:2020 | Amendment 1 - Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance -Collateral Standard: Electromagnetic disturbances -Requirements and tests |
| IEC 80601-2-26:2019 | Medical electrical equipment - Part 2-26: Particularrequirements for the basic safety and essential performance ofelectroencephalographs |
| ISO 14971:2019 | Medical devices - Application of risk management to medicaldevices |
| ISO 10993-1:2018 | Biological evaluation of medical devices — Part 1: Evaluation andtesting within a risk management process |
| ISO 10993-5: 2009(E) | Biological evaluation of medical devices — Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10: 2021(E) | Biological evaluation of medical devices — Part 10: Tests for skinsensitization |
| ISO 10993-23:2021(E) | Biological evaluation of medical devices — Part 23: Tests forirritation |
| IEC 62304:2006 + A1:2015 | Medical device software - Software life cycle processes -Amendment 1 |
| IEC60601-1-11:2015+AMD1:2020 | Medical electrical equipment — Part 1-11: General requirementsfor basic safety and essential performance — Collateral standard:Requirements for medical electrical equipment and medicalelectrical systems used in the home healthcare environment -Amendment 1 |
| IEC 60601-1-6:2010 + AMD1:2013+ AMD2:2020 | Medical electrical equipment - Part 1-6: General requirements forbasic safety and essential performance - Collateral standard:Usability |
| IEC TR 60601-4-2 Edition 1.02016-05 | Medical electrical equipment - Part 4-2: Guidance andinterpretation - Electromagnetic immunity: performance ofmedical 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.
§ 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).