Who is the manufacturer of EyeStat?

Blinktbi, Inc. filed the 510(k) submission for EyeStat (K191700).

What is the FDA product code for EyeStat?

GZP. It is classified under 21 CFR 882.1880 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for EyeStat?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like EyeStat?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

EyeStat

K191700 · Blinktbi, Inc. · GZP · Dec 9, 2019 · Neurology

Device Facts

Record ID	K191700
Device Name	EyeStat
Applicant	Blinktbi, Inc.
Product Code	GZP · Neurology
Decision Date	Dec 9, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1880
Device Class	Class 2
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).

Indications for Use

Indicated for measuring and displaying mechanically induced blink reflex in any patient population, including adults and children, as determined by a medical professional.

Regulatory Classification

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)

Reference Devices

American Optical 12415 AO Non-Contact Tonometer (K802419)
Somatosensory Stimulus System (K913604)

Submission Summary (Full Text)

{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) | | |-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### 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.

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Indications for Use

Device Story

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