← Product Code [GZP](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP) · K191700 # EyeStat (K191700) _Blinktbi, Inc. · GZP · Dec 9, 2019 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP/K191700 ## Device Facts - **Applicant:** Blinktbi, Inc. - **Product Code:** [GZP](/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP.md) - **Decision Date:** Dec 9, 2019 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.1880 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Pediatric ## Indications for Use The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children. ## Device Story EyeStat measures mechanically induced blink reflex; inputs: light puff of sterile food-grade CO2 to outer canthus of eye; device uses two high-speed cameras to track eyelid movement; software algorithms process video frames to detect blink initiation; latency calculated as time difference between air puff application and blink initiation; used in hospitals, clinics, labs, nursing homes, or under professional supervision; output: latency, differential latency, excursion, time under threshold, and oscillations displayed on screen; aids clinicians in assessing blink reflex; benefits include objective measurement of reflex response. ## Clinical Evidence Bench testing only. Performance evaluation included biocompatibility (ISO 10993-1, -5), electrical safety/EMC (IEC 60601-1, -1-2), and battery safety (IEC 62133). Accuracy of eyelid tracking algorithm was validated against expert reviewer contours. Precision (test-retest reliability) was shown equivalent to cleared evoked response devices. Stimulus pressure was verified against a reference non-contact tonometer. ## Technological Characteristics Materials: patient-contacting parts biocompatible per ISO 10993-1/5. Sensing: dual high-speed cameras. Stimulus: sterile food-grade CO2 air puff. Connectivity: Cloud Portal (MDDS) for data storage. Software: moderate level of concern. Standards: IEC 60601-1 (Electrical Safety), IEC 60601-1-2 (EMC), IEC 62133 (Battery). ## Regulatory Identification An evoked response mechanical stimulator is a device used to produce a mechanical stimulus or a series of mechanical stimuli for the purpose of measuring a patient's evoked response. ## Predicate Devices - Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System ([K120397](/device/K120397.md)) ## Reference Devices - American Optical 12415 AO Non-Contact Tonometer ([K802419](/device/K802419.md)) - Somatosensory Stimulus System ([K913604](/device/K913604.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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. BlinkTbi Inc. % Sonali Mathur Regulatory Consultant 635 Rutledge Ave. Suite 102 Charleston, South Carolina 29403 Re: K191700 Trade/Device Name: EyeStat Regulation Number: 21 CFR 882.1880 Regulation Name: Evoked Response Mechanical Stimulator Regulatory Class: Class II Product Code: GZP Dated: November 6, 2019 Received: November 7, 2019 Dear Ms. Sonali Mathur: 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 probibitions 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting (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 (QS) 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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device (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, 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191700 Device Name EyeStat #### Indications for Use (Describe) The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children. | 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." {3}------------------------------------------------ # Premarket Notification 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92. ## Applicant Information: | Date Prepared: | November 5, 2019 | |-------------------|-----------------------------------------------------------------------| | Name:
Address: | BlinkTbi Inc.
635 Rutledge Ave., Suite 102
Charleston, SC 29403 | | Contact Person: | S Mathur, Consultant
smathconsulting@gmail.com | ### Device Information: | Trade Name: | EyeStat | |---------------------------|---------------------------------------| | Common Names: | EyeStat | | Classification Name(s): | Evoked Response Mechanical Stimulator | | Product Code/ Regulation: | GZP / 21 CFR 882.1880 | | Classification: | Class II | #### Predicate Device: - Nihon Kohden MEB-2300A Neuropack Evoked Potential and EMG Measuring System ● (K120397) ### Reference Device: - American Optical 12415 AO Non-Contact Tonometer (K802419) - Somatosensory Stimulus System (K913604) ### Device Description: The operating principle of the EyeStat device is that the application of a light puff of air (sterile food grade CO2) to the outer canthus of the eye acts as a stimulus that elicits a blink reflex. The puff of air is delivered while the patient's eyes are positioned within an eyepiece that allows the movement of the eye lid to be tracked using two high-speed cameras. The device uses software to evaluate the video frames containing the movement of the eyelid of the eye to which the puff of air was applied (ipsilateral) and detect the frame containing the initiation of a blink using image/video processing algorithms. The time associated with the video frame containing the initiation of the ipsilateral blink is then compared to the time associated with the application of the puff of air, and the difference represents the latency. {4}------------------------------------------------ ## Indications for Use: The EyeStat is intended to measure and display the mechanically induced blink reflex. The device is intended to be used by medical personnel within a hospital, laboratory, clinic or nursing home setting or outside of a medical facility under the direct supervision of a medical professional. The device is available for use on any patient as determined by the medical professional including adults and children. ## Summary Comparison to Predicate: The following tables provide a summary of substantial equivalence between the subject device and the cited predicate. The subject device has the same intended use and substantially equivalent characteristics that do not raise different questions of safety or effectiveness. ### Comparison to Predicate Device: The following table provides a comparison of the detection features of the EyeStat device and the predicate device: | Features | BlinkTbi | Nihon Kohden | | |--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | EyeStat | MEB-2300A
Neuropack
(K120397) | Comparison | | General Characteristics | | | | | Classification | Class II, 21 CFR 882.1880 | Class II, 21 CFR 882.1870 | Equivalent - The predicate
device has multiple intended
uses, including measuring
and displaying reflex times.
K913604 uses mechanical
stimulus to evoke response. | | Product Code | GZP | GWF | Equivalent - The predicate
device has multiple
intended uses, including
measuring and displaying
reflex response time | | Intended Use | Measurement of
mechanically evoked
reflex response | Evoked Potential
Measurement Device,
EMG Measuring System,
GSR Measuring Device.
EEG Measuring System,
and Nerve Conduction
Velocity Measurement
Device | Equivalent - The predicate
device has multiple
intended uses, including
measuring and displaying
reflex response time.
K913604 uses mechanical
stimulus to evoke response | | Indications for
Use | The EyeStat is intended to
measure and display the
mechanically induced
blink reflex. | The Nihon Kohden
MEB-2300A Neuropack
Evoked Potential and
EMG Measuring System
is intended to monitor,
record and display the
bioelectric signals | Equivalent - The predicate
device has multiple
intended uses, including
measuring and displaying
reflex response time. | | | BlinkTbi | Nihon Kohden | | | Features | EyeStat | MEB-2300A
Neuropack
(K120397) | Comparison | | | The device is intended to
be used by medical
personnel within a
hospital, laboratory, clinic
or nursing home setting or
outside of a medical
facility under the direct
supervision of a medical
professional.
The device is available for
use on any patient as
determined by the medical
professional including
adults and children. | produced by muscles, to
stimulate peripheral
nerves, and to monitor,
record and display the
electrical activity produced
by nerves to aid the
clinician in the diagnosis
and prognosis of
neuromuscular disease
(EMG). The device is also
intended to measure and
display nerve conduction
time by applying a
stimulus to a patient's
nerve (NCV). The device
may use electrical
stimulus, visual stimulus,
or sound stimulus for use
in evoked response
measurements (EP). The
device may be used to
determine autonomic
responses as psychological
indicators by measuring the
electrical resistance of the
skin and the tissue path
between two electrodes
applied to the skin. The
device may also measure
and record the electrical
activity of the patient's
brain obtained by placing
two or more electrodes on
the head (EEG).
The device is intended for
use by medical personnel
within a hospital,
laboratory, clinic or
nursing home setting or
outside of a medical
facility under direct
supervision of a medical
professional. The device
may also be placed in the
intensive care unit or | K913604 uses a non-
electrical stimulus to elicit
a response. | | | BlinkTbi | Nihon Kohden | | | Features | EyeStat | MEB-2300A
Neuropack
(K120397) | Comparison | | | | operating room for
continuous recording. | | | | | The device is available for
use on any patient as
determined by the medical
professional including
adults and children. | | | Environment
of Use | Hospital, laboratory, clinic
or nursing home setting or
outside of a medical
facility under direct
supervision of a medical
professional | Hospital, laboratory, clinic
or nursing home setting or
outside of a medical
facility under direct
supervision of a medical
professional. The device
may also be placed in the
intensive care unit or
operating room for
continuous recording. | Equivalent – the predicate
device offers additional
environments of use (ICU
or OR), but is indicated to
be used in all the
environments as the
subject device. | | Target
Population | Any patient as determined
by the medical
professional including
adults and children | Any patient as determined
by the medical
professional including
adults and children | Equivalent | | Technological Characteristics | | | | | Principle of
Operation | Application of stimulus
and measurement of
latency until physiological
response to stimulus | Application of stimulus and
measurement of latency
until physiological
response to stimulus | Equivalent – both devices
have the same principle of
operation. | | Stimulus
Method | Physical – light puff of air
onto the outer canthus of
the eye | Electrical – mild electrical
stimulus applied to the eye
lid (for nerve conduction
studies of the blink reflex) | Equivalent – both devices
apply a stimulus to elicit a
response. The specific
method of stimulus is
different, but this does not
raise different questions of
safety and effectiveness.
The cited reference devices
provides a scientific method
to evaluate the effect of this
difference on safety and
effectiveness. | | Stimulus
Modes | Manual (i.e. single light
puff of air) or Train (5
light puffs of air) | Single, Double, Train,
Train series (Multi train,
Number of train: 1 to 10) | Equivalent – both devices
offer the user to apply
single or multiple stimuli. | | | BlinkTbi | Nihon Kohden | | | Features | EyeStat | MEB-2300A
Neuropack
(K120397) | Comparison | | Measurement
Method | High speed camera | Surface EMG sensor | Equivalent - both devices
measure the physiological
response to a stimulus. The
specific type of sensor
used by each device varies,
but this does not raise
different questions of
safety and effectiveness | | Display | Camera feed displayed on
screen during study | Sensed waveform
displayed on screen during
study | Equivalent - both devices
display a view of the
response to the stimulus. | | Data Storage | Computed parameters
may be saved to Cloud
Portal (MDDS) for
future review. | Waveforms may be
printed, or permanently
stored to storage medial
for future retrieval. | Equivalent - Both devices
offer means to review data
at a later time. | | Specific
Reflex
Measured | Blink Reflex | Motor nerve conduction,
sensory nerve conduction,
nerve conduction studies,
repetitive stimulation, F-
WAVE, H-WAVE, blink
reflex, collision method | Equivalent - while the
predicate device is cleared
for multiple types of nerve
conduction studies, it is
specifically cleared for
performing tests of the
blink reflex, just as the
subject device. | | Parameter
s Measured | Latency, Differential
Latency, Excursion, Time
Under Threshold,
Oscillations | Motor nerve conduction,
sensory nerve conduction,
nerve conduction studies,
repetitive stimulation, F-
WAVE, H-WAVE, blink
reflex, collision method | Equivalent - both devices
measure latency and
differential latency. The
subject device measures
additional specific
parameters associated with
the physical movement of
the eye lid, while the
predicate device measures
additional parameters
associated with the bio-
electrical response signal.
This difference does not
raise different questions of
safety and effectiveness. | | Features | BlinkTbi
EyeStat | Nihon Kohden
MEB-2300A
Neuropack
(K120397) | Comparison | | Software | Yes, MODERATE Level
of Concern | Yes, MODERATE Level
of Concern | Equivalent - the specific
software implementation
varies, but this does not
raise different questions of
safety and effectiveness. | | Alarm System | No | No | Equivalent | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ {8}------------------------------------------------ # Summary of Performance Testing Biocompatibility testing in accordance with ISO 10993-10 was performed. In addition, Electrical Safety testing and EMC testing was performed on the device in accordance to IEC 60601. The device passed all testing. The battery of the device was also shown to be safe in accordance with IEC 62133. A complete list of performance testing is provided in the table below: | Test | Test Method Summary | Results | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Biocompatibility | Biocompatibility testing in accordance with ISO 10993-5
and ISO 10993-1 | All patient contacting parts of the device pass biocompatibility testing. | | Electrical
Safety and EMC | Electrical Safety and EMC testing in accordance with IEC 60601-1 and
IEC 60601-1-2:2014 | Device passes Electrical
Safety and EMC testing. | | Battery Testing | Battery testing in accordance
with IEC 62133 | Battery passes testing. | | Accuracy | Accuracy of eye lid tracking
algorithm as compared to
contours made by an expert
reviewer | The eye lid tracking has been
shown to be adequate as
compared to contouring by an
expert reviewer. | | Precision | Test - retest reliability of all
measurements made by the
subject device | The precision of the measurements
is equivalent to cleared evoked
response measurement devices | | Pressure of
stimulus | Comparison of air pressures at
various distances from the exit
point of subject device against a
non-contact tonometer device
(reference device) | The air pressures associated with a
stimulus are less than the
reference device. | {9}------------------------------------------------ ## Software The software in the device is a moderate level of concern. Software V&V testing has demonstrated that the device meets the applicable software requirements. # Conclusion Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the EyeStat has been shown to be substantially equivalent to the legally-marketed predicate. --- **Source:** [https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP/K191700](https://fda.innolitics.com/submissions/NE/subpart-b%E2%80%94neurological-diagnostic-devices/GZP/K191700) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com