Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "image/video processing algorithms" but does not explicitly state or imply the use of AI or ML techniques. The focus is on traditional algorithmic processing of video frames.

Therapeutic

No.
The Explanation of the Device and the Intended Use indicate it is a diagnostic device that measures and displays the mechanically induced blink reflex. It is not intended for treatment or therapy.

Diagnostic

Yes

The device measures and displays the mechanically induced blink reflex, providing quantitative data (latency of blink) that can be used by medical personnel to assess a patient's neurological function. This measurement aids in the evaluation or diagnosis of conditions affecting the blink reflex.

SaMD (Software as a Medical Device)

No

The device description explicitly mentions hardware components like an eyepiece, high-speed cameras, and a mechanism for delivering a puff of air (sterile food grade CO2). Performance studies also include electrical safety and EMC testing, which are relevant to hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the EyeStat device is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The EyeStat device directly interacts with the patient's eye by applying a puff of air and using cameras to observe the blink reflex. It does not analyze biological samples like blood, urine, or tissue.
The intended use describes a direct measurement of a physiological response (blink reflex). This is a measurement taken in vivo (within the living body), not in vitro (in glass or outside the body).
The device description focuses on mechanical stimulation and optical measurement of a physical movement. This aligns with a diagnostic device that assesses a physiological function, not an IVD that analyzes biological components.

Therefore, the EyeStat device falls under the category of a diagnostic device that performs a measurement on a living patient, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

GZP

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.

Mentions image processing

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.

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

High speed camera

Anatomical Site

outer canthus of the eye

Indicated Patient Age Range

adults and children

Intended User / Care Setting

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.

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)

Biocompatibility
Test Method Summary: Biocompatibility testing in accordance with ISO 10993-5 and ISO 10993-1
Results: All patient contacting parts of the device pass biocompatibility testing.

Electrical Safety and EMC
Test Method Summary: Electrical Safety and EMC testing in accordance with IEC 60601-1 and IEC 60601-1-2:2014
Results: Device passes Electrical Safety and EMC testing.

Battery Testing
Test Method Summary: Battery testing in accordance with IEC 62133
Results: Battery passes testing.

Accuracy
Test Method Summary: Accuracy of eye lid tracking algorithm as compared to contours made by an expert reviewer
Results: The eye lid tracking has been shown to be adequate as compared to contouring by an expert reviewer.

Precision
Test Method Summary: Test - retest reliability of all measurements made by the subject device
Results: The precision of the measurements is equivalent to cleared evoked response measurement devices

Pressure of stimulus
Test Method Summary: Comparison of air pressures at various distances from the exit point of subject device against a non-contact tonometer device (reference device)
Results: The air pressures associated with a stimulus are less than the reference device.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120397

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K802419, K913604

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

Regulation Number and Section

§ 882.1880 Evoked response mechanical stimulator.

(a)
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.(b)
Classification. Class II (performance standards).

Summary

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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

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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)

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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.

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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

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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.