The TearCare® System is intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD), when used in conjunction with manual expression of the meibomian glands.

Device Description

To use the TearCare System, the flexible SmartLids are applied to the external surface of the upper and lower eyelids of the right and left eye of the patient. The SmartLids are then connected to the SmartHub. When the SmartHub is turned on and the eye care professional initiates the procedure, the TearCare System begins delivering heat to the eyelids. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian gland orifices. A complete TearCare session lasts 15 minutes.

After TearCare treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare System has not been established when used without manual meibomian gland expression.

The TearCare System is comprised of the following key components and accessories:

. SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination.
. Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery.
Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest.
SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.

AI/ML Overview

The provided text details the acceptance criteria and a clinical validation study for the TearCare® System, however, it does not describe an AI/ML device. Therefore, some of the requested information (like effect size of AI assistance, standalone algorithm performance, number and qualifications of experts for ground truth, and adjudication method) is not applicable or cannot be extracted from the given text.

Here's the available information presented in the requested format:

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

The document focuses on demonstrating substantial equivalence to a predicate device (LipiFlow® Thermal Pulsation System) rather than explicit, quantifiable acceptance criteria with pass/fail thresholds for each performance metric as would be typical for an AI/ML device. However, it does present performance data for various safety and effectiveness endpoints that implicitly serve as criteria for demonstrating equivalence.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (TearCare® System)
Effectiveness Endpoints (Non-inferiority to LipiFlow for Cohort 2):
Change from baseline to 1 month for Tear Break-up Time (TBUT)	Statistically significant and clinically meaningful improvement, non-inferior to LipiFlow.
Change from baseline to 1 month for total Meibomian Gland Secretion Score (MGSS)	Statistically significant and clinically meaningful improvement, non-inferior to LipiFlow.
Dry eye symptoms (OSDI)	Improvement from baseline.
Corneal and conjunctival staining scores	Similar and statistically significant decreases compared to LipiFlow.
Meibomian gland health (number of glands yielding liquid/clear liquid)	Statistically significant improvements.
Safety Endpoints:
Ocular Adverse Events (AEs)	2.1% (Cohort 1) and 2.1% (Cohort 2) device-related AEs (3 subjects) in TearCare group. Overall ocular AEs: 4.3% (Cohort 2, 4 eyes). No serious adverse events (SAEs). Rates similar to LipiFlow group.
Pain and Discomfort (Visual Analog Scale)	Initially higher than LipiFlow during and immediately after procedure, but reduced by Day 1 to less than LipiFlow.
Change in Best Corrected Visual Acuity (BCVA)	No significant change in most subjects; 2 subjects experienced temporary/unrelated changes.
Change in Intraocular Pressure (IOP)	No significant change.
Thermal Safety (Clinical Validation Study):
Meet minimum and maximum temperature specifications (95% confidence, 90% reliability)	Confirmed.
Corneal temperature increase within safe range	Mean rise of 2.2°C (lowest setting) and 1.5°C (highest setting). Post-procedure mean corneal temperature 36.2°C (lowest) and 36.4°C (highest). Max measured 37.1°C.
Inner eyelid temperature for therapeutic effect	Maintains a minimum therapeutic temperature even at lowest setting.

2. Sample size used for the test set and the data provenance

Sample Size for Clinical Validation Study (Thermal Safety): 15 adult subjects (30 eyes).
Sample Size for Randomized Clinical Trial ("OLYMPIA"): 235 subjects (470 eyes) from 10 investigative centers. This was split into two cohorts due to a SmartLid design change:
- Cohort 1: 93 subjects (47 LipiFlow / 46 TearCare)
- Cohort 2: 142 subjects (73 LipiFlow / 69 TearCare)
- Effectiveness endpoints assessed using data from Cohort 2.
- Safety endpoints evaluated separately for Cohort 1 and 2.
Data Provenance:
- Clinical Validation Study: Not explicitly stated, but likely prospective.
- Randomized Clinical Trial ("OLYMPIA"): Prospective, multicenter, randomized, non-inferiority, masked, controlled clinical trial conducted in the United States (10 investigative centers).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The study evaluates the device's performance based on clinical measurements (e.g., TBUT, MGSS, OSDI, staining scores, temperature measurements) and adverse event reporting, rather than expert-established ground truth for an AI/ML diagnostic output.

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

This information is not provided in the document. As this is not an AI/ML diagnostic device, an adjudication method for establishing ground truth from multiple expert interpretations would not be directly applicable in the same way.

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

Not applicable. The device is a thermal pulsation system for treating meibomian gland dysfunction, not an AI/ML diagnostic or assistive tool for human readers.

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

Not applicable. The device is a physical medical device (thermal pulsation system), not an AI/ML algorithm.

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

For the "clinical validation study" (thermal safety): The ground truth for temperature measurements was established using physical sensors (thermocouples) and an IR camera, directly measuring tissue temperatures.

For the "randomized clinical trial" ("OLYMPIA"): The "ground truth" for effectiveness and safety was established by direct clinical measurements and patient-reported outcomes, comparing the TearCare System to a predicate device (LipiFlow). This includes metrics like Tear Break-up Time (TBUT), Meibomian Gland Secretion Score (MGSS), Ocular Surface Disease Index (OSDI), corneal and conjunctival staining scores, meibomian gland function, adverse event reporting, pain/discomfort scores, visual acuity, and intraocular pressure.

8. The sample size for the training set

Not applicable. The described device is a physical medical device, not an AI/ML system that requires a "training set."

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

Not applicable. The described device is a physical medical device, not an AI/ML system that requires a "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and 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.

December 21, 2021

Sight Sciences, Inc. Edward J. Sinclair Consultant 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025

Re: K213045

Trade/Device Name: TearCare® System Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: September 21, 2021 Received: September 24, 2021

Dear Edward J. Sinclair:

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.

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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 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-safetyreporting-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 titled, "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/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.

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 Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213045

Device Name TearCare® System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) SUMMARY

Submitter Information

510(k) Number:	K213045
510(k) Owner:	Sight Sciences, Inc.4040 Campbell Ave., Suite 100Menlo Park, CA 94025Tel: (877) 266-1144
Contact Person:	Edward J. SinclairConsultant4040 Campbell Ave., Suite 100Menlo Park, CA 94025Tel: 650-218-9149
Date Prepared:	November3, 2021

Device Name and Classification

TRADE NAME:	TearCare® System
COMMON NAME:	N/A
CLASSIFICATION NAME:	Eyelid Thermal Pulsation System
REGULATION NUMBER:	21 CFR 886.5200
DEVICE CLASSIFICATION:	Class II
PRODUCT CODE:	ORZ

Predicate Device

Device Name:	LipiFlow® Thermal Pulsation System
510(k) Holder:	Johnson and Johnson (formerly TearScience, Inc.)
510(k) Number:	K161357
Clearance Date:	November 4, 2016

Indications for Use

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Device Description

The TearCare System is comprised of the following key components and accessories:

. SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination.
. Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery.
Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest.
SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.

A comparison of the technological characteristics between the subject TearCare System compared with the predicate LipiFlow device is shown in Table 1 below.

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Characteristic	TearCare® System(Sight Sciences, Inc.)Subject Device	LipiFlow® Thermal Pulsation System(Johnson & Johnson)K161357Predicate Device
Device Classification	Class II	Class II
Classification ProductCode	ORZ	ORZ
Regulation Number	886.5200	886.5200
Indications For Use	The TearCare® System is intended for theapplication of localized heat therapy inadult patients with evaporative dry eyedisease due to meibomian glanddysfunction (MGD), when used inconjunction with manual expression ofthe meibomian glands.	The LipiFlow® Thermal Pulsation System isintended for the application of localizedheat and pressure therapy in adultpatients with chronic cystic conditions ofthe eyelids, including meibomian glanddysfunction (MGD), also known asevaporative dry eye or lipid deficiency dryeye
Technological Characteristics
Device Description	• Disposable SmartLid components areattached to the external surface of theeyelids and connect to a reusableSmartHub controller which generatesthe heat that is delivered to the eyelids• A separate, sterile disposableClearance Assistant™ is used inconjunction with the TearCare Systemto perform manual expression of themeibomian glands immediatelyfollowing heat treatment withTearCare	• Disposable EyeCup is applied to theoutside of the eyelid to automaticallyapply pressure using a bladder thatintermittently inflates with air. Thedisposable LidWarmer contacts theinner eyelid surface and providesunidirectional heat to the inner eyelid• The Disposable portions connect to aControl Unit• System applies heat and pressure to theeyelids
Sterilization	The TearCare SmartHub and SmartLidsare non-sterile	EyeCup/Lid Warmer are provided sterileby ethylene oxide to 10-6 SAL
Single Use or Reusable	• SmartLids: single use• SmartHub: reusable	• EyeCup/Lid Warmer: single use• Control Unit: reusable
Operation Control	Eye Care Practitioner	Eye Care Practitioner
Mechanism for HeatGeneration	Polymer encapsulated resistive heatingelement	Resistive (plastic) electric heater
Power source	Batteries, DC power	AC power
Point of Use	In-Office	In-Office
Duration of Treatment	15 minutes of heat treatment with theTearCare System, followed manualexpression of all four eyelids using theClearance Assistant which typicallyrequires 5-10 minutes	12 minutes of heat/pressure treatment
Temperature regulation	Temperature at the SmartLids arecontinuously monitored by the SmartHubto ensure it does not exceed themaximum allowable temperature	Temperature at the surface of the eye isregulated by the Control System
Therapeutic Temperature Range	Automatic ramp from 41 to 45°C in five 1°C steps. User can adjust to any of these 5 temperature settings	42.5°C (constant temperature)
Temperature Accuracy	$\pm$ 0.7°C	$\pm$ 0.5°C
Maximum Inner Eyelid Surface Temperature Limit	No inner eyelid sensor or temperature limit	44°C
Maximum Sustainable Therapeutic Temperature (i.e., for the duration of the procedure)	46.74°C	Not reported
Maximum Absolute Temperature Limit (at any exposure time)	47°C	Not reported
Maximum Outer Eyelid Surface Temperature Limit (Safety Limit)	46.99°C for 2 seconds prior to automatic temperature downregulation	No outer eyelid sensor or temperature limit
Rate of Heating (time to reach target temperature)	< 60 seconds to initial target level 1, then additional 30 seconds to reach each additional level (total of 5 temperature levels)	10 to 60 seconds
Pressure Control	Manual: Eye Care Practitioner, using separately provided expressor forceps determines pressure (based on patient feedback and direct viewing of glands)	Automatic: pre-programmed with some adjustment allowed by Eye Care Professional
Pressure Type	Manual expression using separately provided Clearance Assistant expression forceps	Automatic massage by EyeCup
Treatment of upper and lower eyelids	Concurrent for upper and lower eyelids of both right and left eye	Concurrent
Packaging (pertinent to disposable)	Sealed pouch with sulfur bleached sulfide (SBS) tray	Sealed Tray
Performance Testing
Biocompatible patient-contacting materials (ISO 10993-1)	Yes, medical-grade silicone/acrylic tape, Polyolefin Foam and polyimide supported by cytotoxicity testing per ISO 10993-5, primary skin irritation, intracutaneous irritation, repeated patch dermal sensitization, guinea pig maximization, and ocular irritation testing per ISO 10993-10	Yes, silicone and UV cured adhesive
Shelf Life	Testing was performed to demonstrate a 25-month shelf life for the SmartLids	Testing was performed to demonstrate a 6-month shelf life for the EyeCup/LidWarmer
Thermal Safety	• TearCare System bench testing verified function of thermal safety requirements	• Animal testing was performed to measure the peak corneal temperature during use• Clinical testing measured the maximum
	• Clinical testing measured the corneal, inner and outer eyelid temperatures to validate thermal safety requirements	device use to validate the thermal safety requirements
Software	Testing was performed to verify/validate that the system software met all requirements	Testing performed. Results not publicly available.
Electrical Safety per IEC 60601-1	Meets requirements	Meets requirements
Electromagnetic Compatibility (EMC) per IEC 60601-1-2	Meets requirements	Meets requirements

Table 1. Comparison of Technological Characteristics with the Predicate Device

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Summary of Testing Performed

The nonclinical bench testing conducted on the TearCare System in accordance with risk analysis and design control requirements included design verification and functional product testing including software validation, sterilization validation, packaging and shelf-life testing, electrical safety testing, and EMC and biocompatibility testing. Results of the nonclinical testing demonstrate that the TearCare System components and accessories meet the design intent and complicable requirements.

Thermal and Functional Requirements: The thermal and functional performance of the TearCare SmartHub and SmartLids were evaluated in a benchtop simulated use condition.
Visual Inspection and Measurement of Physical/Operational Requirements: TearCare system physical and operational requirements were successfully verified by visual inspection or quantified with measurements by calibrated instruments such as a ruler, calipers, scale, and so forth.
Verification of Component Specifications: Inspection activities were utilized to verify the component specifications and label requirements.
. Mechanical Testing: Testing was performed to demonstrate that the system meets mechanical strength requirements.
Shipping and Storage: Testing was performed to demonstrate that the TearCare System meets functional requirements after being exposed to shipping and storage conditions.
Shelf-Life and Packaging Testing: Accelerated aging and functional testing of the TearCare System and its packaging was performed to support a minimum 25-month shelf life for the disposable SmartLids.
Biocompatibility: All patient-contacting materials were reviewed to confirm that they are biocompatible for short-term (<24 hours), intact skin contact as demonstrated by cytotoxicity testing per ISO 10993-5, and primary skin irritation, repeated patch dermal sensitization, and guinea pig maximization testing per ISO 10993-10. In addition, the eyelid contacting materials that are heated during a TearCare procedure were successfully met the acceptance criteria for intracutaneous irritation and ocular irritation per ISO 10993-10.
Software Functionality: Testing was performed to demonstrate that the software in the SmartHub and SmartLids meet all software and related user requirements.
Electrical Safety: Testing was performed to demonstrate that the System meets the electrical safety requirements specified in IEC 60601-1.

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· Electromagnetic Compatibility: Testing was performed to demonstrate that the System meets the electromagnetic requirements specified in IEC 60601-1-2.

Risk Analysis

The risk management process at Sight Sciences complies with ISO 14971:2019 "Medical devices --Application of risk management to medical devices." As required by this standard, risk analyses are conducted according to defined procedures, using experienced, qualified personnel from multiple functions throughout the organization with prior experience in risk assessment. All the identified hazards were mitigated to an acceptable level of risk. The potential benefits to patients outweigh the low residual risk, taking into consideration the indications for use of the TearCare System.

Clinical Validation Study Summary

In addition to bench testing, Sight Sciences performed clinical validation testing of the current TearCare System design to demonstrate in acute clinical study that the temperatures achieved met key performance and safety criteria. A total of 15 adult subjects (30 eyes) were enrolled in the study, 12 females and 3 males. Testing demonstrated that the TearCare System met the minimum and maximum temperature specifications with 95% confidence and 90% reliability.

One female study subject had a baseline visual acuity of 20/25 in her right eye that decreased to 20/40 immediately after completion of both the low temperature tests. No clinical findings were reported in the slit lamp examinations conducted before and after the treatment. The subject was seen two days later, and her visual acuity had improved to 20/20 in the right eye (1 line better compared to baseline). The change in visual acuity noted immediately after Teatment was temporary and was deemed clinically insignificant by the investigator.

There were no other adverse events or clinically significant changes in visual acuity.

A total of 30 SmartLids were tested at the lowest and then the highest temperature settings in 15 Clinical Validation Study subjects (i.e., the left and right eye of each subject). At the lowest temperature setting of the SmartHub, the outer eyelid temperature rose an average of 7.1°C from baseline to the test (from 33.8 to 41.0°C) while the average inner eyelid temperature rose 4.4°C (from 34.3 to 38.7°C). The mean corneal temperature rose 2.2℃ during the TearCare procedure when performed at the lowest temperature setting. Post-procedure mean corneal temperature was 36.2℃, while the maximum measured corneal temperature was 37.1°C. A summary of the tissue temperatures measured at the lowest SmartHub setting is presented in Table 2 below.

	Baseline Tissue Temps (°C)Mean ± SD (Range)	End of Procedure Tissue Temps (°C)Mean ± SD (Range)
Outer Eyelida	33.8 ± 0.7 (32.4 - 35.5)	41.0 ± 0.8 (39.4 - 43.4)
Inner Eyelidb	34.3 ± 0.7 (32.9 - 35.3)	38.7 ± 0.8 (37.3 – 40.8)
Corneab	34.0 ± 0.7 (32.3 – 35.2)	36.2 ± 0.5 (35.1 – 37.1)

Table 2. Mean Tissue Temperatures at Lowest Temperature Setting (41°C)

ª Measured with thermocouples adhered to the skin-contacting surface of the SmartLid.

b Measured with IR camera directed at target tissue.

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At the highest temperature setting of the SmartHub, the outer eyelid rose an average of 8.8℃ from baseline to the end of test (from 35.0 to 43.8℃ ) while the average inner eyelid temperature rose 6.0℃ (from 35.2 to 41.1℃). The mean corneal temperature rose 1.5℃ during the TearCare procedure when performed at the highest temperature setting. Post-procedure mean corneal temperature was 36.4°C, while the maximum measured corneal temperature was 37.1℃. Five minutes after the TearCare procedure was completed, tissue temperatures had returned to within 0.6°C of the baseline temperatures. A summary of the tissue temperatures measured at the highest SmartHub temperature setting is presented in Table 3 below.

Tissue Temperatures (°C):	BaselineMean ± SD (Range)	End of ProcedureMean ± SD (Range)	5 Minutes Post-ProcedureMean ± SD (Range)
Outer Eyelida	35.0 ± 0.9 (32.3 – 36.9)	43.8 ± 0.9 (42.0 - 45.4)	35.6 ± 0.9 (33.0-37.5)
Inner Eyelidb	35.2 ± 0.7 (33.9 – 36.5)	41.1 ± 0.3 (40.3 – 42.0)	35.8 ± 0.6 (34.1-36.8)
Corneab	34.8 ± 0.7 (33.8-36.4)	36.4 ± 0.5 (34.8-37.1)	35.2 ± 0.6 (33.6-36.4)

			Table 3. Mean Tissue Temperatures at Highest Temperature Setting (45°C)
--	--	--	-------------------------------------------------------------------------	--	--	--	--	--

ª Measured with thermocouples adhered to the skin-contacting surface of the SmartLid.

b Measured with IR camera directed at target tissue.

Corneal temperature increase was minimal and remained within a safe range even at the highest temperature setting of the TearCare System after 15-minute duration. Inner eyelid temperatures demonstrated that the TearCare System maintains a minimum therapeutic temperature even at the lowest temperature setting of the TearCare SmartHub. Ocular tissues returned to near baseline levels within 5 minutes after completion of the TearCare thermal procedure.

Randomized Clinical Trial Summary

A prospective, multicenter, randomized, non-inferiority, masked, controlled clinical trial ("OLYMPIA") was performed to demonstrate the safety and effectiveness of a single TearCare System treatment compared to a single LipiFlow Thermal Pulsation System to treat the signs and symptoms of Dry Eye Disease (DED) in adult patients with Meibomian Gland Dysfunction (MGD). The study results demonstrated that the technological differences between the subject TearCare System and the predicate LipiFlow System do not adversely affect safety and effectiveness as it relates to the indications for use.

A total of 235 subjects (470 eyes) from 10 investigative centers in the United States participated in the study, comprised of 169 female and 66 males, ages 22 to 91 years (mean = 55.9 ± 14.4 years). Subjects were randomized 1:1 to receive either a single TearCare or LipiFlow treatment. Study subjects were grouped into two cohorts to account for a SmartLid design change made during the study. There were 93 subjects in Cohort 1, comprised of 47 LipiFlow and 46 TearCare subjects treated with the prior SmartLid design. There were 142 subjects in Cohort 2, comprised of 73 LipiFlow and 69 TearCare subjects treated with the current SmartLid design. The effectiveness endpoints were assessed using data from Cohort 2 and the safety endpoints were evaluated separately for Cohort 1 and 2.

The primary effectiveness endpoints were defined as the change from baseline to 1 month for Tear Break-up Time (TBUT) and total Meibomian Gland Secretion Score (MGSS) for both treatment groups in Cohort 2. Subjects in both treatment groups demonstrated a statistically significant and clinically meaningful

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improvement in TBUT and MGSS at 1-month post-procedure. The TearCare arm of the study established non-inferiority relative to the LipiFlow arm for both TBUT and MGSS.

The secondary endpoints compared the mean change from baseline to 1 month for both treatment groups in Cohort 2 and included: Ocular Surface Disease Index (OSDI), corneal and conjunctival staining scores, and meibomian gland function.

. Dry eye symptoms assessed by OSDI improved with treatment from baseline in both treatment groups.
. Similar and statistically significant decreases in mean corneal and conjunctival staining was demonstrated in both treatment groups.
. Statistically significant improvements in meibomian gland health as assessed by the number of meibomian glands yielding any liquid or the number of glands yielding clear liquid was seen in both groups.

The primary safety endpoint was defined as ocular adverse events (AEs). There were 4 device-related AEs in the TearCare group reported in 3 subjects (Chalazion-1, Superficial Punctate Keratitis-1) and 7 device related AEs in the LipiFlow group reported in 4 subjects (Blepharitis-2, Foreign Body Sensation-3, Dry Eye Disease-2). No serious adverse events (SAEs) were reported in either treatment group. The observed rate of device related AEs was 2.1% (n=2 AEs/92 eyes) and 2.1% (n=3 AEs/138 eyes) respectively in Cohort 1 and Cohort 2 of the TearCare group and 1.0% (n=1 AEs/94 eyes) and 2.1% (n=3 AEs/146 eyes) respectively in Cohort 1 and Cohort 2 of the LipiFlow group. There were 2.1% (n=1 subjects in Cohort 1 and 4.3% (n=3 subjects/69) of subjects in Cohort 2 experiencing one or more device-related adverse events of the TearCare group and there were 2.1% (n=1 subjects/47) of subjects in Cohort 1 and 4.1% (n=3 subjects/73) of subjects in Cohort 2 of the LipiFlow group. The observed rate of ocular AEs of any type was 4.3% (4 eyes/92 eyes) and 3.0% (4 eyes/138 eyes) respectively in Cohort 2 of the TearCare group and 3.2% (3 eyes/94 eyes) and 3.4% (5 eyes/146 eyes) respectively in Cohort 2 of the LipiFlow group.

The secondary safety endpoints included measurement of study subject pain and discomfort during and after treatment, change in best corrected visual acuity (BCVA) and change in intraocular pressure (IOP). There were subjects in both groups reporting pain and discomfort during and after the respective procedures. Subjects in the TearCare group initially reported higher pain/discomfort than LipiFlow subjects during and immediately following the procedure. However, by Day 1 the reported pain and discomfort was reduced and TearCare results were less than LipiFlow. Subjects were asked to indicate their level of pain and discomfort using a Visual Analog Scale with "0" indicating no pain/discomfort to "100″ indicating worst or maximum pain/discomfort, as shown in Tables 4 and 5 below.

	TearCare				LipiFlow
PainThresholds	DuringProcedureN (%)	DuringExpressionN (%)	AfterProcedureN (%)	1 day afterprocedureN (%)	DuringProcedureN (%)	AfterProcedureN (%)	1 day afterprocedureN (%)
	Cohort 1 (n=46)				Cohort 1 (n=47)

Table 4. Proportion of subjects reporting pain, stratified by treatment arm and cohort

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0-39	43 (93.5%)	32 (69.6%)	44 (95.7%)	44 (95.7%)	45 (95.7%)	47 (100.0%)	45 (95.7%)
40-69	2 (4.3%)	12 (26.1%)	2 (4.3%)	1 (2.2%)	2 (4.3%)	0 (0.8%)	2 (4.3%)
70-100	1 (2.2%)	2 (4.3%)	0 (0.0%)	1 (2.2%)	0 (0.0%)	0 (0.0%)	0 (0.0%)
	Cohort 2 (n=69)				Cohort 2 (n=73)
0-39	63 (91.3%)	49 (71.0%)	65 (94.2%)	67 (96.5%)	72 (98.6%)	72 (98.6%)	70 (95.9%)
40-69	4 (5.8%)	16 (23.2%)	4 (5.8%)	2 (2.9%)	1 (1.4%)	1 (1.4%)	2 (2.7%)
70-100	2 (2.9%)	4 (5.8%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	0 (0.0%)	1 (1.4%)

Table 5. Proportion of subjects reporting discomfort, stratified by treatment arm and cohort

	TearCare (n=115)				LipiFlow (n=120)
Discomfort	During	During	After	1 day after	During	After	1 day after
Thresholds	Procedure	Expression	Procedure	procedure	Procedure	Procedure	procedure
	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)	N (%)
	Cohort 1 (n=46)				Cohort 1 (n=47)
0-39	34 (73.9%)	21 (45.7%)	42 (91.3%)	41 (89.1%)	37 (78.7%)	47 (100.0%)	40 (85.1%)
40-69	11 (23.9%)	17 (37.0%)	4 (8.7%)	4 (8.7%)	10 (21.3%)	0 (0.0%)	6 (12.8%)
70-100	1 (2.2%)	8 (17.4%)	0 (0.0%)	1 (2.2%)	0 (0.0%)	0 (0.0%)	1 (2.1%)
	Cohort 2 (n=69)				Cohort 2 (n=73)
0-39	58 (84.1%)	36 (52.2%)	64 (92.8%)	61 (88.4%)	63 (86.3%)	71 (97.3%)	56 (76.7%)
40-69	9 (13.0%)	27 (39.1%)	5 (7.2%)	7 (10.1%)	9 (12.3%)	2 (2.7%)	13 (17.8%)
70-100	2 (2.9%)	6 (8.7%)	0 (0.0%)	1 (1.4%)	1 (1.4%)	0 (0.0%)	4 (5.5%)

One subject in the Cohort 1 and one subject in Cohort 2 of TearCare group and one in the Cohort 2 of LipiFlow group reported a decrease in visual acuity during the study. One subject treated in the Cohort 1 of TearCare group had a history of visual fluctuation in the right eye. The loss of visual acuity was reported at 2weeks which was recovered at 1-month visit. A second TearCare study subject treated under Cohort 2 experienced loss of 10 letters at two weeks following treatment and the visual acuity further was reduced by 15 letters at one month compared to baseline. All other ocular findings for this subject were within the normal limits. The investigator suspects an error in visual acuity measurement and reported that it is highly likely that the uncorrected visual acuity was measured in place of best corrected visual acuity. Both AEs were categorized as "unrelated to device or procedure". One subject treated in the Cohort 2 of LipiFlow group had a history of fluctuating vision in the left eye. The subject read 20 letters at baseline, 30 at 2-weeks and 10 at 1-month. The investigator did not consider this AE as device or procedure related. No other subjects reported any significant visual acuity change in either group compared to baseline.

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No significant change in IOP was noted in either group at any follow up visits compared to baseline. The overall safety results are similar between the TearCare System subject device and the LipiFlow System predicate device with respect to the safety profile.

Conclusions Drawn from Bench and Clinical Performance Testing

The results of the bench and clinical evaluations demonstrate that the TearCare System is substantially equivalent to the LipiFlow Thermal Pulsation System.

Regulation Number and Section

§ 886.5200 Eyelid thermal pulsation system.

(a)
Identification. An eyelid thermal pulsation system is an electrically-powered device intended for use in the application of localized heat and pressure therapy to the eyelids. The device is used in adult patients with chronic cystic conditions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye. The system consists of a component that is inserted around the eyelids and a component to control the application of heat and pressure to the eyelids.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Appropriate analysis/testing should validate electromagnetic compatibility (EMC) and safety of exposure to non-ionizing radiation;
(2) Design, description, and performance data should validate safeguards related to the temperature and pressure aspects of the device, including during fault conditions;
(3) Performance data should demonstrate the sterility of patient-contacting components and the shelf-life of these components;
(4) The device should be demonstrated to be biocompatible; and
(5) Performance data should demonstrate that any technological changes do not adversely effect safety and effectiveness.