The iTEAR100 Neurostimulator is an electromechanical nerve stimulator device, indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.

Device Description

The iTEAR100 device is a prescription only, non-implantable, electromechanical stimulator intended to increase tear production acutely (over 30 days) through vibratory stimulation of the external nasal nerve in adult patients. The device's technological principle is the application of mechanical vibration to specific sensory neurons on the side of the nose. The device is battery-operated with a single vibratory tip. As the tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device consists of a handheld unit with a plastic shell, power button, charging port, and effector tip accessible from the exterior. The interior includes mechanical and electrical subsystems comprised of a motor, supercapacitor, printed circuit board assembly (PCBA) including driver board, control board and Bluetooth microprocessor, vibrating cantilever beam attached to the effector tip, and real-time clock. The iTEAR100 Neurostimulator connects via Bluetooth Low Energy to a mobile application downloaded onto the user's mobile device (compatible with iOS or Android operating system). The mobile application is necessary to activate the device for initial use and collects device usage data which the user may upload to a cloud database at the user's discretion.

AI/ML Overview

The Olympic Ophthalmics iTEAR100 Neurostimulator is a medical device for temporarily increasing tear production. The provided text, a 510(k) Summary, focuses on demonstrating substantial equivalence to a previously cleared predicate device (iTEAR100 Neurostimulator, DEN190026), rather than presenting a study designed to prove the device meets specific clinical acceptance criteria for effectiveness in human subjects.

The core of the acceptance criteria described in the document is the claim of "substantial equivalence" to the predicate device. This is primarily demonstrated through comparative performance testing of mechanical outputs and other technical specifications, alongside adherence to relevant safety standards.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document doesn't explicitly define "acceptance criteria" in terms of specific clinical outcomes for tear production for this submission. Instead, the acceptance criteria are implicitly that the subject device's performance regarding safety and technical characteristics is comparable to, or improved from, the predicate device, and that these changes do not raise new questions of safety or effectiveness. The reported device "performance" is primarily a demonstration of this equivalence across various technical aspects.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance and Comparison to Predicate
Intended Use / Indications for Use: Maintain the same clinical purpose and target population as the predicate.	Same: The iTEAR100 Neurostimulator is indicated for temporary use (up to 30 days) to increase acute tear production during vibratory stimulation of the external nasal nerve in adults, under prescription of an eye care provider.
Key Technological Characteristics: Changes should not raise different questions of safety or effectiveness.	Change from wired to Bluetooth communication: The subject device uses Bluetooth Low Energy for wireless communication, a mobile app, and a cloud database, while the predicate used wired (USB) communication. This change is deemed not to raise different questions of safety or effectiveness. Other core components (cantilever, weighted motor, PCBA, etc.) remain the same.
Physical Dimensions: Be similar to the predicate.	Similar: Subject device: 80 mm x 58 mm x 25 mm. Predicate device: 80 mm x 58 mm x 23.5 mm. Tip Protrusion: Subject device 5.1 mm, Predicate 5.0 mm.
Effector Tip Thickness: Remain the same.	Same: 2.9 mm for both.
Power Source: Remain the same.	Same: 3.7 V rechargeable battery for both.
Frequency and Amplitude of Vibration: Remain within specified ranges and be comparable to the predicate.	Same: Frequency: 200 - 300 Hz (270 unloaded) for both. Amplitude: < 1.0 mm for both. Bench testing confirmed equal performance in frequency, amplitude, acceleration, force-displacement, temperature, and noise compared to the predicate device.
Safety Features: Maintain existing safety features and ensure any new features do not introduce new risks.	Improved/Additional Safety Features: Subject device has "Tip retraction (< 6.0 N)", "Vibration damping at 2 mm", "Disable device after 30 days of use", and "Prescription and user verification required prior to device activation". The prescription and user verification processes are additional safety features that do not raise different questions.
Materials / Biocompatibility: Any changes in patient-contacting materials should be biocompatible and not raise new safety concerns.	Material Reduction and Bio-compatibility: Patient-contacting materials reduced from plastic (ABS) and silicone to only plastic (ABS). The ABS is the same as the predicate. The power button is now ABS, removing the need for a silicone coating. Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993-1, -5, -10) was performed and found acceptable for surface device with limited (≤ 24 hours) contact with intact skin.
Software Functional Equivalence and Safety: Software should perform intended functions safely, and any changes should not introduce new risks.	Added Secure Prescription Activation: The subject device includes a "Secure prescription activation" feature in its key software functions, which is considered an additional safety feature. Both devices utilize firmware for voltage control, on-off, data logging, power level indication, and disabling after 30 days. Software verification and validation (IEC 62304) was performed, and the software maintains a "moderate" level of concern, same as the predicate.
Electrical Safety and EMC: Compliance with relevant international standards.	Compliance: Testing performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, and ANSI C63.27 (the latter specifically for Bluetooth). These are the same tests as the predicate, with the addition of ANSI C63.27 for Bluetooth communication.
Life Testing: Demonstrate expected useful life.	Simulated Life: Life testing simulated 12 months of twice-daily, bilateral use. The stated use life is 6 months, same as the predicate.
Other Technical Differences (e.g., charging port, memory): Should not affect safety or effectiveness.	Different Charging Port and Memory: USB-C vs. Micro-USB charging port; EEPROM vs. SD Card for memory. These differences are deemed not to affect device safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and biocompatibility testing, not a clinical test set on human subjects to prove effectiveness.

Bench Testing: No sample size is indicated for the comparative mechanical output testing. This testing would be performed on manufactured devices.
Biocompatibility Testing: The testing (Cytotoxicity, Sensitization, Irritation) is performed on materials, not human subjects. No sample size of devices/materials is specified.
Software Verification & Validation: This refers to testing of the software itself.
Life Testing: "Simulated 12 months of twice-daily, bilateral use." The number of devices tested is not specified.
The document does not provide information on the country of origin or whether any data was retrospective or prospective, as it does not describe clinical studies for performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable to the provided text. The submission focuses on demonstrating substantial equivalence through engineering and safety testing, not clinical studies requiring expert ground truth establishment for a diagnostic or therapeutic outcome.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable to the provided text. No clinical test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable to the provided text. The device is a neurostimulator for tear production, not an AI-assisted diagnostic imaging system. No human reader studies are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable. The device is a physical electromechanical nerve stimulator, not a standalone algorithm. While it has software, its performance is intertwined with the hardware and user application. The "performance data" presented relates to the hardware, software, and biocompatibility, not an isolated algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the engineering and safety tests performed:

Bench Testing: The "ground truth" is typically objective measurements (e.g., using calibrated sensors) of physical outputs (frequency, amplitude, acceleration, etc.) compared against the predicate device's measured outputs or design specifications.
Biocompatibility: The "ground truth" comes from established ISO standards (ISO 10993 series) and their respective pass/fail criteria.
Electrical Safety and EMC: The "ground truth" comes from compliance with international standards (e.g., IEC 60601 series, ANSI C63.27) and their specified limits.
Software Verification & Validation: The "ground truth" is the adherence to software requirements and IEC 62304 standards.

8. The sample size for the training set

This information is not applicable. This submission describes a hardware medical device with software, not a machine learning model that requires a "training set" in the context of AI/ML.

9. How the ground truth for the training set was established

This information is not applicable for the same reasons as point 8.

Summary

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March 16, 2022

Olympic Ophthalmics % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Floor 23 Philadelphia, PA 19103

Re: K213623

Trade/Device Name: iTEAR100 Neurostimulator Regulation Number: 21 CFR 886.5305 Regulation Name: Electromechanical Tear Stimulator Regulatory Class: Class II Product Code: QKV Dated: February 7, 2022 Received: February 7, 2022

Dear Janice Hogan:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies.

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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 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/combinationproducts/guidance-regulatory-information/postmarketing-safety-reporting-combination-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-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)

K213623

Device Name

iTEAR100 Neurostimulator

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Olympic Ophthalmics, Inc. iTEAR100 Neurostimulator

The assigned 510(k) number is K213623.

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Olympic Ophthalmics, Inc. 160 NW Gilman Blvd No. 412 lssaquah, WA 98027 Phone: 650-283-9388 Facsimile: 206-984-1564 Contact Person: Michael Gertner

Date Prepared: November 16, 2021

Device Information

Name of Device: iTEAR100 Neurostimulator

Classification Name: Electromechanical tear stimulator

Requlatory Class: Class II

Product Code: QKV

Regulation: 21 CFR 886.5305

Predicate Device

iTEAR100 Neurostimulator (DEN190026)

Device Description

The iTEAR100 device is a prescription only, non-implantable, electromechanical stimulator intended to increase tear production acutely (over 30 days) through vibratory stimulation of the external nasal nerve in adult patients. The device's technological principle is the application of mechanical vibration to specific sensory neurons on the side of the nose. The device is batteryoperated with a single vibratory tip. As the tip is pushed against the tissue, the beam deflects inward until it is deflected fully into the device consists of a handheld unit with a plastic shell, power button, charging port, and effector tip accessible from the exterior. The interior includes mechanical and electrical subsystems comprised of a motor, supercapacitor, printed circuit board assembly (PCBA) including driver board, control board and Bluetooth microprocessor, vibrating cantilever beam attached to the effector tip, and real-time clock.

The iTEAR100 Neurostimulator connects via Bluetooth Low Energy to a mobile application downloaded onto the user's mobile device (compatible with iOS or Android operating system). The mobile application is necessary to activate the device for initial use and collects device usage data which the user may upload to a cloud database at the user's discretion.

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Intended Use / Indications for Use

Substantial Equivalence

The iTEAR100 is substantially equivalent to the iTEAR100 previously cleared by FDA under DEN190026. The primary difference between the iTEAR100 and the predicate device is the addition of Bluetooth connectivity. which enables wireless transmission of device usage data and remote activation of the iTEAR100 for use by authorized patients (i.e., users with a prescription). Whereas the predicate device connected to a computer via a cable to transmit usage data, the subject iTEAR100 connects via Bluetooth to a smartphone (iOS or Android platforms) to transmit device usage data wirelessly. And whereas the predicate device was activated for patient use by the manufacturer through a wired connection to a computer before the device was shipped to the patient, the subject iTEAR100 is activated / reactivated after the patient receives the device and has verified their identity and prescription through a mobile application connected to the iTEAR100 via Bluetooth. These modifications did not change the functions of the device but rather changed the ways those functions are performed: wirelessly rather than through wired connections. Furthermore, these changes have no impact on the device's intended use as a tear stimulator. In addition to Bluetooth connectivity, the patientcontacting materials were reduced from both plastic (ABS) and silicone to only plastic (ABS). The material in the subject device is manufactured and processed in the same way as the predicate device. Therefore, these modifications do not raise different questions of safety or effectiveness and the devices are substantially equivalent.

Performance Data

The following test data were submitted in support of substantial equivalence:

. Biocompatibility – The iTEAR100 is a surface device with limited (≤ 24 hours) contact with intact skin. In accordance with ISO 10993-1, the following testing was performed:
- Cytotoxicity (ISO 10993-5), o
- Sensitization (ISO 10993-10), о
- Irritation (ISO 10993-10). O
. Electrical safety and electromagnetic compatibility testing was performed per IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11, IEC 62366-1, and ANSI C63.27. These tests were the same as those performed for the predicate device (except the ANSI C63.27:2017 for the Bluetooth communication).
Software verification and validation testing was performed in conformance with IEC 62304 Edition 1.1 2015-06. The subject device software, like the predicate device, presents a "moderate" level of concern.
. Life testing was performed to assess the useful life of the iTEAR100. The life testing simulated 12 months of twice-daily, bilateral use.

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Comparative Testing Bench testing was conducted to demonstrate equal performance . by the subject device and predicate device in the following mechanical outputs:
- Frequency o
- Amplitude O
- Acceleration O
- Force-displacement O
- o Temperature
- o Noise

Conclusions

The iTEAR100 has the same intended and indications for use and similar technological characteristics and principles of operation as the predicate device. The minor technological differences between the iTEAR100 and its predicate device raise no new or different questions of safety or effectiveness. Performance data demonstrate that the iTEAR100 is as safe and effective as the iTEAR100. Therefore, the iTEAR100 is substantially equivalent.

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Substantial Equivalence Table

	iTEAR100 Neurostimulator(Subject Device)(K213623)	iTEAR100 Neurostimulator(Predicate Device)(DEN190026)	Comparison
Classification	21 CFR 886.5305 (product code QKV)	21 CFR 886.5305 (product code QKV)	Same
Intended Use	Increase tear production via mechanical stimulation.	Increase tear production via mechanical stimulation.	Same
Indications for Use	The iTEAR100Neurostimulator is anelectromechanical nervestimulator device, indicatedfor temporary use (up to 30days) to increase acute tearproduction during vibratorystimulation of the externalnasal nerve in adults, underprescription of an eye careprovider.	The iTEAR100Neurostimulator is anelectromechanical nervestimulator device, indicatedfor temporary use (up to 30days) to increase acute tearproduction during vibratorystimulation of the externalnasal nerve in adults, underprescription of an eye careprovider.	Same
User Population	Adults	Adults	Same
Key TechnologicalCharacteristics	• Cantilever• Weighted Motor• Maximum input to motor using step up• PCBA with motor control, data logging, wireless communication (Bluetooth)• Mobile app• Cloud database	• Cantilever• Weighted Motor• Maximum input to motor using step up• PCBA with motor control, data logging, wired communication (USB)	Change from wired communication to Bluetooth communication and the addition of a mobile app and cloud database do not raise different questions of safety or effectiveness.
Accessories	Charge cord, protective pouch	Charge cord, protective pouch	Same
Dimensions(l x w x h)	80 mm x 58 mm x 25 mm	80 mm x 58 mm x 23.5 mm	Similar
Effector Tipthickness	2.9 mm	2.9 mm	Same
Tip Protrusion fromhousing (no load)	5.1 mm	5.0 mm	Similar
Power Source	3.7 V rechargeable battery	3.7 V rechargeable battery	Same
Frequency	200 - 300 Hz (270 unloaded)	200 - 300 Hz (270 unloaded)	Same
Amplitude	< 1.0 mm	< 1.0 mm	Same
	iTEAR100 Neurostimulator	iTEAR100 Neurostimulator
	(Subject Device)(KXXXXXXX)	(Predicate Device)(DEN190026)	Comparison
Safety Features	Tip retraction (< 6.0 N)Vibration damping at 2 mmDisable device after 30 daysof usePrescription and userverification required prior todevice activation	Tip retraction (< 6.0 N)Vibration damping at 2 mmDisable device after 30 daysof usePrescription required prior todevice activation	The prescription anduser verificationprocesses in thesubject device areadditional safetyfeatures that do notraise differentquestions.
Materials /Biocompatibility	ABS Lustran 348 (housing,cantilever, power button)	ABS Lustran 348 (housing,cantilever), Silicone (powerbutton)	All materials used inthe subject device,including the ABSare the same as thematerials used in thepredicate. The powerbutton is now madefrom the samematerials as thehousing andcantilever andtherefore no longerneeds to be coatedin silicone.
Key SoftwareFunctions	Secure prescriptionactivation, firmware tocontrol voltage to battery,on-off, data logging, powerlevel indication, disabledevice after 30 days of use	Firmware to control voltageto battery, on-off, datalogging, power levelindication, disable deviceafter 30 days of use	The subject devicesecure prescriptionactivation is anadditional safetyfeature that does notraise new questions.
Data Transfer	Wireless (Bluetooth LowEnergy)	Wired (USB)	The difference doesnot raise differentquestions of safetyor effectiveness.
Sterilization	Non-sterile	Non-Sterile	Same
Charging Port	USB-C	Micro-USB	The difference incharging connectorsdoes not affectdevice safety oreffectiveness.
Use Life	6 months	6 months	Same
Memory	EEPROM	SD Card	The difference inmemory does notaffect device safetyor effectiveness.

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Regulation Number and Section

§ 886.5305 Electromechanical tear stimulator.

(a)
Identification. An electromechanical tear stimulator is a non-implantable device intended to increase tear production via mechanical stimulation.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing under anticipated conditions of use must evaluate tear production and all adverse events, including tissue damage, pain, headache, and discomfort.
(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be conducted:
(i) An assessment of mechanical output specifications, including vibration amplitude and frequency, pressure and force, and acoustic (noise level) properties;
(ii) Mechanical safety testing to validate safeguards related to the pressure aspects of the device; and
(iii) Use life testing.
(3) Performance data must demonstrate the electrical safety, thermal safety, and electromagnetic compatibility (EMC) of all electrical components of the device.
(4) All patient-contacting components of the device must be demonstrated to be biocompatible.
(5) Software verification, validation, and hazard analysis must be performed.
(6) Physician and patient labeling must include:
(i) A detailed summary of the device's technical parameters;
(ii) Instructions for use, including an explanation of all user-interface components and information regarding proper device placement;
(iii) Information related to electromagnetic compatibility classification;
(iv) Instructions on how to clean and maintain the device;
(v) A summary of the clinical performance testing conducted with the device;
(vi) Language to direct end users to contact the device manufacturer and MedWatch if they experience any adverse events with this device; and
(vii) Information on how the device operates and the typical sensations experienced during treatment.