The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction of a licensed medical professional. The Bytellies Kit does not provide any diagnostic conclusions about the patient's condition.

Device Description

The Byteflies Kit is a wearable medical device for continuous recording of non-invasive physiological signals in healthcare and home settings. The Byteflies Kit is intended to be configured by a trained healthcare professional and consists of 3 main components:

Sensor Dot: a biopotential wearable sensor that measures up to 2 bipolar channels of electroencephalography (EEG). It is powered by a rechargeable battery, can record data for up to 24 hours on a single charge, and has an LED indicator to report the operating status to the user. The sample-level EEG data is continuously stored on the Sensor Dot for later retrieval.
Sensor Patch: the interface between a Sensor Dot and non-invasive biopotential electrodes (not provided). It attaches magnetically to the Sensor Dot and has four DIN 42802 connectors. Two commercial disposable EEG electrodes per Sensor Patch channel are connected to the head of the subject in a reduced EEG montage. The Sensor Dot attached to the Sensor Patch is carried by the patient to continuously measure electrical brain activity.
Docking Station: up to 5 Sensor Dots can connect magnetically to the Docking Station and transfer recorded data to the Docking Station, while charging their batteries. The recorded sample-level EEG signals can then be downloaded from the Docking Station's Management Interface to a computer via a local WiFi network for long-term storage and further review by a healthcare professional. An AC/DC adapter with micro-USB cable supplies power to the Docking Station.

AI/ML Overview

The provided text is a 510(k) summary for the Byteflies Kit, an electroencephalograph device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance data often found in clinical trial reports for AI/CAD devices.

Therefore, much of the requested information regarding acceptance criteria, test set details (sample size, provenance, expert adjudication), MRMC studies, standalone performance, and ground truth for training/testing is not available in the provided document. The document primarily relies on non-clinical (bench) testing and comparison to a predicate device.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

Acceptance Criteria and Device Performance

The Byteflies Kit is an electroencephalograph (EEG) device, not an AI/CAD system for diagnostic purposes. Its performance is evaluated against electrical safety and electromagnetic compatibility standards, and its ability to accurately acquire, record, and transmit two channels of EEG data. The document asserts that the device meets these requirements and is substantially equivalent to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for an EEG device primarily asserting substantial equivalence based on technical specifications and adherence to standards, explicit "acceptance criteria" and "reported device performance" in the context of an AI/CAD diagnostic study (like sensitivity, specificity, AUC) are not present. Instead, the "performance" is demonstrated through compliance with various safety and electrical standards.

Acceptance Criteria (Inferred from regulatory compliance)	Reported Device Performance (as stated in the document)
Electrical Safety Standards:
IEC 60601-1:2005	Meets the requirements of IEC 60601-1:2005
IEC 60601-1-11:2015 (Home Healthcare)	Meets the requirements of IEC 60601-1-11:2015
IEC 60601-2-26:2012 (Particular EEG requirements)	Complies with IEC 60601-2-26:2012
Electromagnetic Compatibility (EMC) Standards:
IEC 60601-1-2:2014	Meets the requirements of IEC 60601-1-2:2014
Biocompatibility Standards:
ISO 10993:2018 (Cytotoxicity, Sensitization, Skin Irritation)	Meets all applicable requirements of ISO 10993:2018; all external parts were tested
Usability Standards:
IEC 60601-1-6:2010	Meets all applicable requirements of IEC 60601-1-6:2010
Alarms and Alarms Systems Standards:
IEC 60601-1-8:2006	Meets all applicable requirements of IEC 60601-1-8:2006
Functional Equivalence to Predicate Device:
Acquire, record, and transmit two channels of EEG data	Acquires, records, and transmits two channels of EEG data
No diagnostic conclusions provided	Does not provide any diagnostic conclusions
Intended for prescription use	Intended for prescription use
Operates in home, healthcare, clinical research	Operates in home, healthcare, clinical research

2. Sample Size Used for the Test Set and the Data Provenance

The document states, "The Byteflies Kit is an electroencephalographic device comprised of hardware and software that has been bench tested to assess safety and effectiveness, and to establish substantial equivalence with the predicate device. We believe further clinical data is not required to demonstrate performance of the Byteflies Kit for the indications for use subject to this submission."

Sample Size for Test Set: Not applicable/not provided. The "testing" referred to is primarily bench testing for electrical, EMC, and biocompatibility standards, not a clinical test set of patient data.
Data Provenance (Country of origin, retrospective/prospective): Not applicable, as no clinical test set data is described. The tests were performed by "Independent UL-certified laboratory testing."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Number of Experts: Not applicable/not provided. No clinical ground truth establishment process is described as clinical data was deemed "not required."
Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable/not provided. No clinical test set requiring adjudication is described.

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

MRMC Study: No. This device is an EEG acquisition and recording system, not an AI or CAD (Computer-Aided Detection/Diagnosis) device that assists human readers with interpretation.

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

Standalone Performance: Not applicable. This device is not an algorithm for diagnostic interpretation. Its "performance" is in signal acquisition and adherence to technical standards.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Type of Ground Truth: Not applicable. The device's function is to acquire EEG signals. The accuracy and quality of these signals are determined by compliance with the aforementioned technical standards (e.g., signal fidelity under IEC 60601-2-26), rather than by comparison to a "ground truth" of a disease state. The document explicitly states the device "does not provide any diagnostic conclusions about the patient's condition," meaning it's not classifying or diagnosing.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is a hardware device for signal acquisition, not a machine learning model that requires a training set.

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

Ground Truth for Training Set: Not applicable. As it is not an AI/ML device, there is no training set or associated ground truth.

Summary

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June 22, 2020

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.

Byteflies NV % Benjamin Vandendriessche Chief Medical Officer MedicSense USA Borsbeeksebrug 22, 6th Floor Berchem Antwerpen, BEL 2600

Re: K192549

Trade/Device Name: Byteflies Kit Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMC Dated: March 27, 2020 Received: March 31, 2020

Dear Benjamin Vandendriessche:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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,

for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, 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

510(k) Number (if known)

K192549

Device Name Byteflies Kit

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Contact Details

Applicant	Byteflies NV
	Borsbeeksebrug 22, 6th floor
	2600 Berchem
	Belgium
	Tel: +32 32 94 74 99
Contact Person	Benjamin Vandendriessche, PhD
	Chief Medical Officer
	benjamin.vandendriessche@byteflies.com
	+1 (216) 777-9234
Date Prepared	March 25, 2020

Device Name

Trade Name	Byteflies Kit
Common Name	EEG Monitor
Classification	Reduced-Montage Standard Electroencephalograph (Class II)
Product Code	OMC
Regulation Number	21 CFR 882.1400

Predicate Device

NeuroWave Systems Inc, DiscoverEEG System, Model DE-401 (K142834, product code: OMC)

Description of Device

1. Sensor Dot: a biopotential wearable sensor that measures up to 2 bipolar channels of electroencephalography (EEG). It is powered by a rechargeable battery, can record data for up to 24 hours on a single charge, and has an LED indicator to report the operating

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status to the user. The sample-level EEG data is continuously stored on the Sensor Dot for later retrieval.

1. Sensor Patch: the interface between a Sensor Dot and non-invasive biopotential electrodes (not provided). It attaches magnetically to the Sensor Dot and has four DIN 42802 connectors. Two commercial disposable EEG electrodes per Sensor Patch channel are connected to the head of the subject in a reduced EEG montage. The Sensor Dot attached to the Sensor Patch is carried by the patient to continuously measure electrical brain activity.
1. Docking Station: up to 5 Sensor Dots can connect magnetically to the Docking Station and transfer recorded data to the Docking Station, while charging their batteries. The recorded sample-level EEG signals can then be downloaded from the Docking Station's Management Interface to a computer via a local WiFi network for long-term storage and further review by a healthcare professional. An AC/DC adapter with micro-USB cable supplies power to the Docking Station.

Intended Use

The Byteflies Kit is intended for prescription use in the home, healthcare facility, or clinical research environment to acquire, record, and transmit electrical activity of the brain by placing non-invasive electrodes on the head of patients. It acquires, records and transmits two channels of electroencephalogram (EEG) data. The medical use of data acquired by the Byteflies Kit is to be performed under the direction and interpretation of a licensed medical professional. The Byteflies Kit does not provide any diagnostic conclusions about the patient's condition.

Substantial Equivalence Comparison

The Byteflies Kit is technologically equivalent to other EEG monitoring devices. Both the Byteflies Kit and the predicate device are wearable devices that acquire analog EEG signals in a reduced montage, digitize the sample-level signal, and save them for later interpretation by a healthcare professional. Based on the results from our extensive testing, we believe that our device does not raise new safety or efficacy concerns. The table below summarizes the technological characteristics of the Byteflies Kit in comparison to the predicate device.

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510(k) Summary

Cyteflies

Features andCharacteristics	Byteflies Kit(subject device)	DiscoverEEG System(predicate device)	Comparison
Indications forUse	The Byteflies Kit isintended for prescriptionuse in the home,healthcare facility, orclinical researchenvironment to acquire,record, and transmitphysiological signals frompatients. It acquires,records, and transmitstwo channels ofelectroencephalogram(EEG) data, that areintended to be reviewedby a trained healthcareprofessional. It onlyacquires these signals;no diagnostic claims aremade about the patient'scondition.	The DiscoverEEG System,Model DE-401 isintended to be used formeasuring and recordingthe electrical activity of asubject's brain, obtainedby placing noninvasiveelectrodes on the head.The DiscoverEEG DE-401is indicated for use inacquiringelectroencephalographic(EEG) signals in the OR,ICU, ER, clinical settingsand at home and forclinical research. Themedical use of dataacquired by theDiscoverEEG is to beperformed under thedirection andinterpretation of alicensed medicalprofessional. TheDiscoverEEG DE-401does not provide anydiagnostic conclusionabout the subject'scondition.	Signal Type:EQUIVALENTBoth devices record areduced EEG montagevia noninvasiveelectrodes placed on theheadEnvironment:EQUIVALENTBoth devices areindicated for use inhome, clinical, andresearch environmentsMedical Use:EQUIVALENTBoth devices record rawEEG data and make thisavailable to a healthcareprofessional for furtherinterpretation; neitherdevice provides anydiagnostic claims aboutthe subject's condition
Modalities	EEG	EEG	EQUIVALENT
Environment ofUse	Home (data acquisition),Healthcare and ClinicalResearch Facility (dataacquisition, deviceconfiguration, and dataretrieval).	Operating room,intensive care unit,emergency room, clinicalsettings and at homewhere EEG monitoring isused.	EQUIVALENT
Power Source	Li-Ion battery (SensorDot) and a certified Class	Battery	EQUIVALENTThe components of bothdevices that are carried
	II AC/DC power supply(Docking Station)		by the patient are batterypowered. The DockingStation for the subjectdevice is powered via theincluded certified Class IIpower supply; thisdifference does not raisequestions of safety andefficacy as the DockingStation does not haveany AC wiring and wassubjected to allapplicable electricalsafety testing.
SystemComponents	Sensor Dot, SensorPatch, Docking Station	Electrode (Sensor) Array,Acquisition and MemoryModules, Data ViewerSoftware	EQUIVALENTBoth devices consist ofequivalent systemcomponents forconnecting tononinvasive EEGelectrodes, storing, andretrieving data. Onedifference exists: theByteflies Kit providescharging and dataretrieval functionality viathe Docking Station,which is separate fromthe main wearable device(Sensor Dot) to keep thelatter's size and weightdown. This is a usabilitydecision that does notraise questions of safetyand efficacy.
SensingElectrodes	User-supplied disposableEEG electrodes	Silver-silver chloridedisposable EEGelectrodes	EQUIVALENTBoth devices usedisposable noninvasivebiopotential electrodes.The Byteflies Kit does notinclude them as part ofthe device but uses FDA
			cleared DIN 42802 EEGelectrodes as accessorieswhich provides moreflexibility to the user. Thisis a usability decision thatdoes not raise questionson safety and efficacy.
Screen DisplayDetails	Not applicable	Data Viewer Software	EQUIVALENTThe Byteflies Kit containsno data viewer softwarealthough data files canbe imported into anysignal review softwarethat can read andvisualize EEG data, as isthe case for thepredicate device.
Stored EEG dataavailable	Sample-level EEG as textfile which can beaccessed via the DockingStation	Yes – SD card	EQUIVALENTSample-level EEG datacan be downloaded to acomputer for long-termstorage and furtheranalysis by a trainedhealthcare professional.
EEG Channels	Up to 2 EEG channels	Up to 4 EEG channels	EQUIVALENT
Contains patientisolation	Sensor Dot is batterypowered, thus noconnection betweenpatient and mains. TheDocking Station ispowered by a certifiedClass II AC/DC medicalpower supply andcontains now AC wiring.	Battery powered, thus noconnection betweenpatient and mains.	EQUIVALENTThe components of bothdevices that are carriedby the patient are batterypowered. The DockingStation for the subjectdevice is powered via theincluded certified Class IIpower supply; thisdifference does not raisequestions of safety andefficacy as the DockingStation does not haveany AC wiring and wassubjected to all
			applicable electricalsafety testing.
Display Interface	Yes, LEDs to ensureproper systemconnection andoperation.	Yes, LEDs to ensureproper systemconnection andoperation.	EQUIVALENT
Biocompatibility	All external parts weretested according to ISO10993 (Cytotoxicity - ISO10993-5, Sensitization -ISO 10993-10, and SkinIrritation - ISO 10993-10)	Electrode array wastested according to ISO10993 (Cytotoxicity - ISO10993-5, Sensitization -ISO 10993-10, and SkinIrritation - ISO 10993-10); test status for othercomponents unknown	EQUIVALENTAll external parts of theByteflies Kit meet therequirements of ISO10993.
Electrical SafetyandElectromagneticCompatibility	IEC60601-1, IEC60601-1-2, IEC60601-1-11,IEC60601-1-8, IEC60601-1-6, IEC60601-2-26	IEC60601-1, IEC60601-1-11, IEC60601-2-26,IEC60601-1-2	EQUIVALENTThe Byteflies Kit wassubjected to the sameelectrical safety andelectromagneticcompatibility testing asthe predicate device, andwas additionally verifiedagainst 60601-1-6 and60601-1-8.
510(k) #	K192549	K142834	NA
Regulatory	Product Code OMC 21CFR 882.1400	Product Code OMC andOLT 21 CFR 882.1400	EQUIVALENTBoth devices use thesame product code, butthe Byteflies Kit does notinclude any EEG viewingsoftware; this differencedoes not raise questionson safety and efficacy asboth devices allow 3rdparty signal viewers to beused.

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Cyteflies

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Cyteflies

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Cyteflies

Non-clinical Testing

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Design and verification tests were performed on the Byteflies Kit as a result of the risk analysis and product requirements. Independent UL-certified laboratory testing demonstrated that the Byteflies Kit meets the requirements of IEC 60601-1:2005 and IEC 60601-1-11:2015 for electrical safety, and IEC 60601-1-2:2014 for electromagnetic compatibility. The Byteflies Kit complies with the particular requirements of IEC 60601-2-26:2012 for the safety of electroencephalographs. Finally, it meets all applicable requirements of ISO 10993:2018, IEC 60601-1-6:2010 and IEC 60601-1-8:2006.

Clinical Tests

The Byteflies Kit is an electroencephalographic device comprised of hardware and software that has been bench tested to assess safety and effectiveness, and to establish substantial equivalence with the predicate device. We believe further clinical data is not required to demonstrate performance of the Byteflies Kit for the indications for use subject to this submission.

Conclusion

Based on the results of the performance testing and substantial equivalence comparison, the Byteflies Kit has the same intended use and principles of operations as the predicate device. Any differences in technological characteristics do not raise questions about safety and effectiveness. The presented information is sufficient to determine that the Byteflies Kit is substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).