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 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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided text.

Based on the provided text, the device in question is the EyeStat, an "Evoked Response Mechanical Stimulator" intended to measure and display the mechanically induced blink reflex.

The available information describes the general performance testing and does not provide typical acceptance criteria in specific numerical thresholds (e.g., Sensitivity > X%, Specificity > Y%) for blink reflex measurements. Instead, the performance evaluations focus on the functionality and accuracy of the device's components and measurements.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Biocompatibility	All patient-contacting parts of the device pass biocompatibility testing (in accordance with ISO 10993-5 and ISO 10993-1).
Electrical Safety and EMC	Device passes Electrical Safety and EMC testing (in accordance with IEC 60601-1 and IEC 60601-1-2:2014).
Battery Safety	Battery passes testing (in accordance with IEC 62133).
Accuracy (Eye Lid Tracking)	The eye-lid tracking algorithm's accuracy is "adequate as compared to contouring by an expert reviewer." (No specific quantitative metric provided for accuracy, e.g., Dice score, IoU).
Precision (Measurements)	The precision (test-retest reliability) of all measurements made by the device is "equivalent to cleared evoked response measurement devices." (No specific quantitative metrics provided).
Pressure of Stimulus	The air pressures associated with a stimulus are "less than the reference device" (a non-contact tonometer, K802419).
Software V&V	Software V&V testing has demonstrated that the device meets the applicable software requirements (for a moderate level of concern software).

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

Accuracy (Eye Lid Tracking): Not explicitly stated. The text only mentions "an expert reviewer" and does not provide the number of cases or data provenance.
Precision: Not explicitly stated. The text reports "test-retest reliability of all measurements," but the sample size for patients or measurements is not given, nor is the data provenance.
Pressure of Stimulus: The text mentions comparing the EyeStat's air pressures against a non-contact tonometer (reference device). It does not specify the sample size of these comparisons or their provenance.

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

Accuracy (Eye Lid Tracking): "an expert reviewer" was used. No specific qualifications (e.g., years of experience, specialty) for this expert are provided.

4. Adjudication Method for the Test Set

The text does not describe any specific adjudication method (e.g., 2+1, 3+1). For eye-lid tracking accuracy, it appears to be a direct comparison against a single expert's contouring, rather than a consensus approach.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a MRMC comparative effectiveness study was not described. The provided text focuses on the device's intrinsic performance characteristics and comparison to elements of a predicate device but does not mention a study evaluating human readers' improvement with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Yes, a standalone study was implicitly done for "Accuracy (Eye Lid Tracking)." The algorithm's eye-lid tracking performance was compared against an expert's contouring, which assesses the algorithm's capability independently of a human operator, at least for that specific function. The "Precision" testing also appears to be standalone, evaluating the device's inherent measurement consistency.

7. The Type of Ground Truth Used

Accuracy (Eye Lid Tracking): Expert contouring/review served as the ground truth.
Precision: The "ground truth" for precision is implicitly the device's own repeat measurements, aiming for high consistency.
Pressure of Stimulus: A "non-contact tonometer device" (a reference device, K802419) was used for comparison, implying its measurements served as a benchmark for the stimulus pressure.

8. The Sample Size for the Training Set

Not specified. The document does not provide any information about a training set or its sample size. This is common if the algorithm development process is not detailed, or if a specific "training set" in the machine learning sense was not explicitly defined or reported in the regulatory submission.

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

Not applicable / Not specified. Since no information regarding a training set is provided, how its ground truth was established is also not detailed.

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

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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 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 102Charleston, SC 29403
Contact Person:	S Mathur, Consultantsmathconsulting@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:

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Indications for Use:

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-2300ANeuropack(K120397)	Comparison
General Characteristics
Classification	Class II, 21 CFR 882.1880	Class II, 21 CFR 882.1870	Equivalent - The predicatedevice has multiple intendeduses, including measuringand displaying reflex times.K913604 uses mechanicalstimulus to evoke response.
Product Code	GZP	GWF	Equivalent - The predicatedevice has multipleintended uses, includingmeasuring and displayingreflex response time
Intended Use	Measurement ofmechanically evokedreflex response	Evoked PotentialMeasurement Device,EMG Measuring System,GSR Measuring Device.EEG Measuring System,and Nerve ConductionVelocity MeasurementDevice	Equivalent - The predicatedevice has multipleintended uses, includingmeasuring and displayingreflex response time.K913604 uses mechanicalstimulus to evoke response
Indications forUse	The EyeStat is intended tomeasure and display themechanically inducedblink reflex.	The Nihon KohdenMEB-2300A NeuropackEvoked Potential andEMG Measuring Systemis intended to monitor,record and display thebioelectric signals	Equivalent - The predicatedevice has multipleintended uses, includingmeasuring and displayingreflex response time.
	BlinkTbi	Nihon Kohden
Features	EyeStat	MEB-2300ANeuropack(K120397)	Comparison
	The device is intended tobe used by medicalpersonnel within ahospital, laboratory, clinicor nursing home setting oroutside of a medicalfacility under the directsupervision of a medicalprofessional.The device is available foruse on any patient asdetermined by the medicalprofessional includingadults and children.	produced by muscles, tostimulate peripheralnerves, and to monitor,record and display theelectrical activity producedby nerves to aid theclinician in the diagnosisand prognosis ofneuromuscular disease(EMG). The device is alsointended to measure anddisplay nerve conductiontime by applying astimulus to a patient'snerve (NCV). The devicemay use electricalstimulus, visual stimulus,or sound stimulus for usein evoked responsemeasurements (EP). Thedevice may be used todetermine autonomicresponses as psychologicalindicators by measuring theelectrical resistance of theskin and the tissue pathbetween two electrodesapplied to the skin. Thedevice may also measureand record the electricalactivity of the patient'sbrain obtained by placingtwo or more electrodes onthe head (EEG).The device is intended foruse by medical personnelwithin a hospital,laboratory, clinic ornursing home setting oroutside of a medicalfacility under directsupervision of a medicalprofessional. The devicemay also be placed in theintensive care unit or	K913604 uses a non-electrical stimulus to elicita response.
	BlinkTbi	Nihon Kohden
Features	EyeStat	MEB-2300ANeuropack(K120397)	Comparison
		operating room forcontinuous recording.
		The device is available foruse on any patient asdetermined by the medicalprofessional includingadults and children.
Environmentof Use	Hospital, laboratory, clinicor nursing home setting oroutside of a medicalfacility under directsupervision of a medicalprofessional	Hospital, laboratory, clinicor nursing home setting oroutside of a medicalfacility under directsupervision of a medicalprofessional. The devicemay also be placed in theintensive care unit oroperating room forcontinuous recording.	Equivalent – the predicatedevice offers additionalenvironments of use (ICUor OR), but is indicated tobe used in all theenvironments as thesubject device.
TargetPopulation	Any patient as determinedby the medicalprofessional includingadults and children	Any patient as determinedby the medicalprofessional includingadults and children	Equivalent
Technological Characteristics
Principle ofOperation	Application of stimulusand measurement oflatency until physiologicalresponse to stimulus	Application of stimulus andmeasurement of latencyuntil physiologicalresponse to stimulus	Equivalent – both deviceshave the same principle ofoperation.
StimulusMethod	Physical – light puff of aironto the outer canthus ofthe eye	Electrical – mild electricalstimulus applied to the eyelid (for nerve conductionstudies of the blink reflex)	Equivalent – both devicesapply a stimulus to elicit aresponse. The specificmethod of stimulus isdifferent, but this does notraise different questions ofsafety and effectiveness.The cited reference devicesprovides a scientific methodto evaluate the effect of thisdifference on safety andeffectiveness.
StimulusModes	Manual (i.e. single lightpuff of air) or Train (5light puffs of air)	Single, Double, Train,Train series (Multi train,Number of train: 1 to 10)	Equivalent – both devicesoffer the user to applysingle or multiple stimuli.
	BlinkTbi	Nihon Kohden
Features	EyeStat	MEB-2300ANeuropack(K120397)	Comparison
MeasurementMethod	High speed camera	Surface EMG sensor	Equivalent - both devicesmeasure the physiologicalresponse to a stimulus. Thespecific type of sensorused by each device varies,but this does not raisedifferent questions ofsafety and effectiveness
Display	Camera feed displayed onscreen during study	Sensed waveformdisplayed on screen duringstudy	Equivalent - both devicesdisplay a view of theresponse to the stimulus.
Data Storage	Computed parametersmay be saved to CloudPortal (MDDS) forfuture review.	Waveforms may beprinted, or permanentlystored to storage medialfor future retrieval.	Equivalent - Both devicesoffer means to review dataat a later time.
SpecificReflexMeasured	Blink Reflex	Motor nerve conduction,sensory nerve conduction,nerve conduction studies,repetitive stimulation, F-WAVE, H-WAVE, blinkreflex, collision method	Equivalent - while thepredicate device is clearedfor multiple types of nerveconduction studies, it isspecifically cleared forperforming tests of theblink reflex, just as thesubject device.
Parameters Measured	Latency, DifferentialLatency, Excursion, TimeUnder Threshold,Oscillations	Motor nerve conduction,sensory nerve conduction,nerve conduction studies,repetitive stimulation, F-WAVE, H-WAVE, blinkreflex, collision method	Equivalent - both devicesmeasure latency anddifferential latency. Thesubject device measuresadditional specificparameters associated withthe physical movement ofthe eye lid, while thepredicate device measuresadditional parametersassociated with the bio-electrical response signal.This difference does notraise different questions ofsafety and effectiveness.
Features	BlinkTbiEyeStat	Nihon KohdenMEB-2300ANeuropack(K120397)	Comparison
Software	Yes, MODERATE Levelof Concern	Yes, MODERATE Levelof Concern	Equivalent - the specificsoftware implementationvaries, but this does notraise different questions ofsafety 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 10993-5and ISO 10993-1	All patient contacting parts of the device pass biocompatibility testing.
ElectricalSafety and EMC	Electrical Safety and EMC testing in accordance with IEC 60601-1 andIEC 60601-1-2:2014	Device passes ElectricalSafety and EMC testing.
Battery Testing	Battery testing in accordancewith IEC 62133	Battery passes testing.
Accuracy	Accuracy of eye lid trackingalgorithm as compared tocontours made by an expertreviewer	The eye lid tracking has beenshown to be adequate ascompared to contouring by anexpert reviewer.
Precision	Test - retest reliability of allmeasurements made by thesubject device	The precision of the measurementsis equivalent to cleared evokedresponse measurement devices
Pressure ofstimulus	Comparison of air pressures atvarious distances from the exitpoint of subject device against anon-contact tonometer device(reference device)	The air pressures associated with astimulus are less than thereference device.

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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.

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).