(279 days)
Not Found
No
The summary describes a device for acquiring, recording, and transmitting EEG data. It explicitly states that the device does not provide any diagnostic conclusions and there is no mention of AI, ML, or any data processing beyond storage and transmission.
No
The device is used to acquire, record, and transmit EEG data, which is for monitoring and data collection, not for treating or preventing a disease or condition. The text explicitly states it "does not provide any diagnostic conclusions about the patient's condition."
No
The "Intended Use / Indications for Use" section explicitly states, "The Byteflies Kit does not provide any diagnostic conclusions about the patient's condition." Its purpose is to acquire, record, and transmit EEG data, which is then to be reviewed by a medical professional.
No
The device description explicitly lists hardware components: Sensor Dot (wearable sensor with battery and LED), Sensor Patch (interface for electrodes), and Docking Station (for data transfer and charging). The performance studies also mention testing of the "Byteflies Kit as a result of the risk analysis and product requirements," which includes hardware.
Based on the provided information, the Byteflies Kit is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Byteflies Kit Function: The Byteflies Kit directly measures electrical activity of the brain by placing electrodes on the head. It acquires, records, and transmits this data.
- Intended Use: The intended use explicitly states it acquires, records, and transmits EEG data. It also states that the medical use of this data is to be performed under the direction of a licensed medical professional and that the device does not provide any diagnostic conclusions.
The Byteflies Kit is a medical device that collects physiological data in vivo (from within the living body), not in vitro (outside the living body). It is a data acquisition and recording device, not a device that analyzes biological samples for diagnostic purposes.
N/A
Intended Use / Indications for 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 of a licensed medical professional. The Bytellies Kit does not provide any diagnostic conclusions about the patient's condition.
Product codes
OMC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescription use in the home, healthcare facility, or clinical research environment, under the direction and interpretation of a licensed medical professional.
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)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
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
1
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
2
Indications for Use
510(k) Number (if known)
Device Name Byteflies Kit
Indications for Use (Describe)
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.
| 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) |
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."
3
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
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
4
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.
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.
5
510(k) Summary
Cyteflies
| Features and
Characteristics | Byteflies Kit
(subject device) | DiscoverEEG System
(predicate device) | Comparison |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for
Use | The Byteflies Kit is
intended for prescription
use in the home,
healthcare facility, or
clinical research
environment to acquire,
record, and transmit
physiological signals from
patients. It acquires,
records, and transmits
two channels of
electroencephalogram
(EEG) data, that are
intended to be reviewed
by a trained healthcare
professional. It only
acquires these signals;
no diagnostic claims are
made about the patient's
condition. | The DiscoverEEG System,
Model DE-401 is
intended to be used for
measuring and recording
the electrical activity of a
subject's brain, obtained
by placing noninvasive
electrodes on the head.
The DiscoverEEG DE-401
is indicated for use in
acquiring
electroencephalographic
(EEG) signals in the OR,
ICU, ER, clinical settings
and at home and for
clinical research. The
medical use of data
acquired by the
DiscoverEEG is to be
performed under the
direction and
interpretation of a
licensed medical
professional. The
DiscoverEEG DE-401
does not provide any
diagnostic conclusion
about the subject's
condition. | Signal Type:
EQUIVALENT
Both devices record a
reduced EEG montage
via noninvasive
electrodes placed on the
head
Environment:
EQUIVALENT
Both devices are
indicated for use in
home, clinical, and
research environments
Medical Use:
EQUIVALENT
Both devices record raw
EEG data and make this
available to a healthcare
professional for further
interpretation; neither
device provides any
diagnostic claims about
the subject's condition |
| Modalities | EEG | EEG | EQUIVALENT |
| Environment of
Use | Home (data acquisition),
Healthcare and Clinical
Research Facility (data
acquisition, device
configuration, and data
retrieval). | Operating room,
intensive care unit,
emergency room, clinical
settings and at home
where EEG monitoring is
used. | EQUIVALENT |
| Power Source | Li-Ion battery (Sensor
Dot) and a certified Class | Battery | EQUIVALENT
The components of both
devices that are carried |
| | II AC/DC power supply
(Docking Station) | | by the patient are battery
powered. The Docking
Station for the subject
device is powered via the
included certified Class II
power supply; this
difference does not raise
questions of safety and
efficacy as the Docking
Station does not have
any AC wiring and was
subjected to all
applicable electrical
safety testing. |
| System
Components | Sensor Dot, Sensor
Patch, Docking Station | Electrode (Sensor) Array,
Acquisition and Memory
Modules, Data Viewer
Software | EQUIVALENT
Both devices consist of
equivalent system
components for
connecting to
noninvasive EEG
electrodes, storing, and
retrieving data. One
difference exists: the
Byteflies Kit provides
charging and data
retrieval functionality via
the Docking Station,
which is separate from
the main wearable device
(Sensor Dot) to keep the
latter's size and weight
down. This is a usability
decision that does not
raise questions of safety
and efficacy. |
| Sensing
Electrodes | User-supplied disposable
EEG electrodes | Silver-silver chloride
disposable EEG
electrodes | EQUIVALENT
Both devices use
disposable noninvasive
biopotential electrodes.
The Byteflies Kit does not
include them as part of
the device but uses FDA |
| | | | cleared DIN 42802 EEG
electrodes as accessories
which provides more
flexibility to the user. This
is a usability decision that
does not raise questions
on safety and efficacy. |
| Screen Display
Details | Not applicable | Data Viewer Software | EQUIVALENT
The Byteflies Kit contains
no data viewer software
although data files can
be imported into any
signal review software
that can read and
visualize EEG data, as is
the case for the
predicate device. |
| Stored EEG data
available | Sample-level EEG as text
file which can be
accessed via the Docking
Station | Yes – SD card | EQUIVALENT
Sample-level EEG data
can be downloaded to a
computer for long-term
storage and further
analysis by a trained
healthcare professional. |
| EEG Channels | Up to 2 EEG channels | Up to 4 EEG channels | EQUIVALENT |
| Contains patient
isolation | Sensor Dot is battery
powered, thus no
connection between
patient and mains. The
Docking Station is
powered by a certified
Class II AC/DC medical
power supply and
contains now AC wiring. | Battery powered, thus no
connection between
patient and mains. | EQUIVALENT
The components of both
devices that are carried
by the patient are battery
powered. The Docking
Station for the subject
device is powered via the
included certified Class II
power supply; this
difference does not raise
questions of safety and
efficacy as the Docking
Station does not have
any AC wiring and was
subjected to all |
| | | | applicable electrical
safety testing. |
| Display Interface | Yes, LEDs to ensure
proper system
connection and
operation. | Yes, LEDs to ensure
proper system
connection and
operation. | EQUIVALENT |
| Biocompatibility | All external parts were
tested according to ISO
10993 (Cytotoxicity - ISO
10993-5, Sensitization -
ISO 10993-10, and Skin
Irritation - ISO 10993-10) | Electrode array was
tested according to ISO
10993 (Cytotoxicity - ISO
10993-5, Sensitization -
ISO 10993-10, and Skin
Irritation - ISO 10993-
10); test status for other
components unknown | EQUIVALENT
All external parts of the
Byteflies Kit meet the
requirements of ISO
10993. |
| Electrical Safety
and
Electromagnetic
Compatibility | 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 | EQUIVALENT
The Byteflies Kit was
subjected to the same
electrical safety and
electromagnetic
compatibility testing as
the predicate device, and
was additionally verified
against 60601-1-6 and
60601-1-8. |
| 510(k) # | K192549 | K142834 | NA |
| Regulatory | Product Code OMC 21
CFR 882.1400 | Product Code OMC and
OLT 21 CFR 882.1400 | EQUIVALENT
Both devices use the
same product code, but
the Byteflies Kit does not
include any EEG viewing
software; this difference
does not raise questions
on safety and efficacy as
both devices allow 3rd
party signal viewers to be
used. |
6
Cyteflies
7
Cyteflies
8
Cyteflies
Non-clinical Testing
9
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.