TearCare MGX System

K231084 · Sight Sciences, Inc. · ORZ · Dec 27, 2023 · Ophthalmic

Device Facts

• Record ID: K231084
• Device Name: TearCare MGX System
• Applicant: Sight Sciences, Inc.
• Product Code: ORZ · Ophthalmic
• Decision Date: Dec 27, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5200
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The TearCare MGX™ 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 Story

TearCare MGX System provides localized heat therapy for evaporative dry eye disease. System consists of reusable SmartHub controller, reusable SmartCable, and disposable SmartLids. SmartLids adhere to external eyelid surface using medical-grade silicone adhesive; earloops secure positioning. SmartHub powers resistive heating elements in SmartLids to target 41-45°C, melting meibum. Core thermal cycle lasts 15 minutes, with optional 10-minute extended warming. Eye care professional operates system via touchscreen interface, adjusting warmth levels. Following heat treatment, professional uses separate Clearance Assistant instrument to manually express meibomian glands. System monitors eyelid temperature via thermistors to ensure safety limits. Benefits include improved meibomian gland function by melting blockages. Used in clinical office settings.

Clinical Evidence

Clinical validation study (n=15, 30 eyes) confirmed device met temperature specifications (41-45°C) with 95% confidence and 90% reliability. No adverse events or clinically significant slit lamp findings observed. Additional study (n=21) validated earloop retention using surgical tape over 25-minute simulated treatment. Bench testing verified thermal safety, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993).

Technological Characteristics

Powered eyelid thermal pulsation system. Components: SmartHub (Li-ion battery, touchscreen, microprocessor), SmartCable, disposable SmartLids (polyimide, medical-grade silicone/acrylic tape, polyolefin foam). Heating: Polymer encapsulated resistive elements. Temp range: 41-45°C. Accuracy: ±0.7°C. Connectivity: Proprietary cable interface. Sterilization: Non-sterile. Software: Moderate level of concern.

Indications for Use

Indicated for adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD). Used in conjunction with manual expression of meibomian glands.

Regulatory Classification

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.

Special Controls

In addition to the general controls of the Act, the LipiFlow® Thermal Pulsation System is subject to the following special controls:

*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.

Predicate Devices

• TearCare® System (K213045)

Submission Summary (Full Text)

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December 27, 2023

Sight Sciences, Inc. Rachel M. Franco Sr. Regulatory Affairs Specialist 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025

Re: K231084

Trade/Device Name: TearCare MGXTM System Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: November 20, 2023 Received: November 21, 2023

Dear Rachel M. Franco:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketingsafety-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# J Angelo Green -S

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

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# Indications for Use

510(k) Number (if known) K231084

Device Name TearCare™ MGX System

Indications for Use (Describe)

The TearCare MGX™ 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.

| Type of Use (Select one or both, as applicable) |
|--------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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Image /page/3/Picture/1 description: The image shows the logo for Sight Sciences. The logo consists of a blue circular graphic on the left and the words "SIGHT SCIENCES" on the right. The word "SIGHT" is on the top line and the word "SCIENCES" is on the bottom line.

# 510(k) SUMMARY

| Submitter Information | |
|-----------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number: | K231084 |
| 510(k) Owner: | Sight Sciences, Inc.<br>4040 Campbell Ave., Suite 100<br>Menlo Park, CA 94025<br>Tel: [phone] |
| Contact Person: | Rachel M. Franco<br>Sr. Regulatory Affairs Specialist<br>4040 Campbell Ave., Suite 100<br>Menlo Park, CA 94025<br>Tel: [phone] |

# Device Name and Classification

Date Prepared:

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

December 11, 2023

# Predicate Device

| Device Name: | TearCare® System |
|-----------------|----------------------|
| 510(k) Holder: | Sight Sciences, Inc. |
| 510(k) Number: | K213045 |
| Clearance Date: | December 21, 2021 |

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#### Indications for Use

The TearCare MGX™ 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

The TearCare MGX™ System is a powered device intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD).

The TearCare MGX™ System is comprised of a TearCare SmartLids" device (PN 07064) and a TearCare System Kit (PN 06985), containing the TearCare SmartHub™ (PN 07066), SmartCable (PN 06998), Charging Nest (PN 07067), and IFU (PN 06988). The TearCare MGX™ System warms the eyelid(s) by heating the SmartLids to a maximum set point of 45°C. Heat is applied to the external or cutaneous surface of the eyelids via the adherent, disposable SmartLids that are powered by the SmartHub. The TearCare MGX™ System can warm the eyelids of one or both eyes at a time. A medical grade silicone adhesive on the SmartLid device surface physically and thermally couples the devices to the external (cutaneous) surface of the eyelids. The SmartHub includes a device port for SmartLid device attachment via a SmartCable. Additionally, the SmartHub includes an intuitive touchscreen interface, temperature control processor, and a rechargeable battery. The operator affixes the devices to the patient's eyelids to initiate a treatment session and may adjust the system warmth level during a session. After completion of the core thermal cycle, an extended warming time will automatically begin and stay active for up to 10 minutes at a set target temperature of 41°C that is not permitted to not exceed 43°C. The SmartLid devices are disposable and are not intended to contact the cornea or conjunctival surfaces of the eye. 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 glands. The core thermal cycle lasts 15 minutes, followed by an optional extended warming time which may last up to an additional 10 minutes.

After TearCare MGX 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 MGX System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare MGX System has not been established without manual meibomian gland expression. The TearCare MGX™ System consists of the following components:

- TearCare System Kit (P/N 06985) (includes):
- o TearCare SmartHub (P/N 07066)
- IFU (P/N 06988) .
- o SmartCable (P/N 06998)
- o Charging Nest (P/N 07067)
- TearCare SmartLids (P/N 07064)

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Image /page/5/Picture/0 description: The image shows the logo for Sight Sciences. The logo consists of a blue abstract symbol on the left and the words "SIGHT SCIENCES" on the right. The word "SIGHT" is in a larger font size than the word "SCIENCES", which is placed below it.

#### SmartHub

The SmartHub is a battery-powered component that powers the SmartLids device assembly(s). It features a circuit board, microprocessor, a port for receiving the SmartCable, and a multi-pin contact for connecting to the Charging Nest. The SmartHub features a rechargeable Li-ion battery that when fully charged supplies power for at least 4 therapies when using two SmartLids "device assemblies. The SmartHub may be used with one or two SmartLids device assemblies connected. The SmartLids device assemblies are connected to the SmartHub through the SmartHub is charged via a multi-pin charging port when not in use and when placed into the TearCare MGX™ System SmartHub Charging Nest. The SmartHub consists of a physical push button for power and a capacitive touchscreen with graphic user interface (GUI). Various types of soft button inputs and controls are utilized throughout the GUI to control display, system status information, configuration parameters, and error information.

Image /page/5/Picture/4 description: The image shows a gray rectangular device with rounded corners, possibly a tablet or a smart display, standing on a white surface. The device has a silver frame around the screen and a silver base that supports it at an angle. The background is a plain white, which helps to highlight the device's design and features.

# Figure 1, SmartHub

#### SmartLids

The SmartLids" are flexible, software and sensor-controlled, single-use heat treatment components. The device assembly consists of a right and left configuration comprised of an earloop and two flexible laminated heating elements. The flexible heating element components adhere to the user's eyelid to provide heat during the therapy. The SmartHub regulates the power to the SmartLid" devices through connection with the SmartCable to provide the targeted temperature to the eyelids.

The SmartLid devices warm to a temperature set point of 41°- 45°C when affixed to the eyelids and powered by the SmartHub. A thin medical grade adhesive holds the SmartLids on the user's eyelids and positioning is stabilized by placement of the earloops.

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Image /page/6/Picture/1 description: The image contains the logo for Sight Sciences. The logo consists of a stylized, abstract symbol on the left and the text "SIGHT SCIENCES" on the right. The symbol is made up of three curved lines that overlap and create a sense of depth. The text is in a sans-serif font, with "SIGHT" in a larger size than "SCIENCES."

#### SmartCable

The SmartCable is a reusable cable that connects the SmartHub. The reusable SmartCable magnetically connects to the SmartLids earloops to provide the connection from the SmartLids to the SmartHub.

Image /page/6/Picture/4 description: The image shows a SmartLid and a SmartCable. The SmartLid is a round, white device with a gray rim. The SmartCable is a white cable that is plugged into the SmartLid. The SmartLid has a long gray handle.

Figure 2, SmartLid" Device Assembly and SmartCable

# Charging Nest and Charger Adapter

The SmartHub requires periodic charging from the Charging Nest and Charger Adapter. The Charger Adapter is inserted into the rear of the Charging Base and can remain plugged-into the Charging Base even when charging is not occurring. The Charging Base charges the SmartHub via a proprietary interface in the base of the SmartHub and the Nest.

Image /page/6/Picture/8 description: The image shows a white, plastic desk organizer with multiple compartments. The organizer has a sleek, modern design with rounded edges and a glossy finish. There are three compartments of varying sizes, suitable for holding pens, pencils, and other small office supplies. The organizer appears to be sitting on a white surface, with a soft shadow indicating the lighting.

Figure 3 (left), Charging Nest

Image /page/6/Picture/10 description: The image shows a sleek, modern device that appears to be a smart display or tablet docked in a charging station. The screen is black, suggesting it is either off or displaying a dark interface. The device has a silver trim around the screen and sits on a white base with a gray accent, giving it a clean and minimalist aesthetic.

Figure 4 (right), SmartHub in Charging Nest

The TearCare MGX System patient applied heating elements remain similar to compared to the predicate TearCare System, however, the user interfaces of the system are redesigned and utilize touchscreen graphics for an intuitive and high-tech aesthetic. A comparison of the technological characteristics between the subject TearCare MGX System compared with the predicate TearCare System device is shown in Table 1 below.

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## Table 1Comparison of Technological Characteristics with the Predicate Device

| Characteristic | TearCare MGX™ System<br>Subject Device | TearCare® System<br>K213045<br>Predicate Device | Comparison between TearCare MGX<br>System and Predicate Device |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification | Class II | Class II | Equivalent |
| Classification<br>Product Code | ORZ | ORZ | Equivalent |
| Regulation Number | 886.5200 | 886.5200 | Equivalent |
| Indications For Use | The TearCare® MGX System is<br>intended for the application of<br>localized heat therapy in adult patients<br>with evaporative dry eye disease due<br>to meibomian gland dysfunction<br>(MGD), when used in conjunction with<br>manual expression of the meibomian<br>glands. | The TearCare® System is intended for<br>the application of localized heat therapy<br>in adult patients with evaporative dry<br>eye disease due to meibomian gland<br>dysfunction (MGD), when used in<br>conjunction with manual expression of<br>the meibomian glands. | Equivalent |
| Technological Characteristics | | | |
| System<br>Components | • TearCare MGX System Kit (P/N<br>06985) (includes):<br>TearCare SmartHub (P/N 07066) SmartCable (P/N 06998) Charging Nest kit (P/N 07067) IFU Guide (P/N 06988) • TearCare SmartLids (P/N 07064)<br>SmartLid consists of: eyelid flexible heating elements Earloop | • SmartHub Kit (P/N 06041) (includes): SmartHub (P/N 07412) Charging kit (P/N 06124) IFU Guide (P/N 07418 • SmartLids (P/N 06115) SmartLid consists of: eyelid flexible heating elements Templepad | The TearCare MGX System components have<br>been updated.<br><br>In the predicate device, the cable was<br>incorporated within the disposable SmartLid<br>assembly. In the subject TearCare MGX System<br>the cable is removed from the SmartLid<br>assembly and is a reusable component, the<br>SmartCable. The cable maintains connection of<br>the SmartLids to the SmartHub similar to the<br>connection present in the predicate device.<br>However, the SmartCable adds an additional<br>interconnect to permit re-use of the cable |
| Device Description | • Disposable SmartLid components<br>are attached to the external surface | • Disposable SmartLid components are<br>attached to the external surface of | section for reduced waste. |
| Characteristic | TearCare MGX™ System<br>Subject Device | TearCare® System<br>K213045<br>Predicate Device | Comparison between TearCare MGX<br>System and Predicate Device |
| | of the eyelids and connect via a<br>reusable SmartCable to the reusable<br>SmartHub touchscreen controller<br>which generates the heat that is<br>delivered to the eyelids<br>• A separate, sterile disposable<br>Clearance Assistant™ is used in<br>conjunction with the TearCare MGX<br>System to perform manual<br>expression of the meibomian glands<br>immediately following heat<br>treatment with TearCare MGX<br>System | the eyelids and connect to a reusable<br>SmartHub controller which generates<br>the heat that is delivered to the<br>eyelids<br>• A separate, sterile disposable<br>Clearance Assistant™ is used in<br>conjunction with the TearCare System<br>to perform manual expression of the<br>meibomian glands immediately<br>following heat treatment with<br>TearCare System | Equivalent |
| SmartHub therapy<br>control | SmartHub provides control to power<br>on, start, stop, and resume therapy,<br>increase or decrease warmth levels | SmartHub provides control to power on,<br>start, stop, and resume therapy,<br>increase or decrease warmth levels | Equivalent |
| SmartHub user<br>interface | Touchscreen display with graphic user<br>interface (GUI).<br>During a therapy the health care<br>provider can use the GUI to initiate,<br>stop and adjust the warmth setting. | Push-button interface with graphic<br>symbols and light indicators.<br>During a therapy the health care<br>provider can use the push buttons to<br>initiate, stop and adjust the warmth<br>setting. | Use of the predicate TearCare System device<br>requires consultation of the IFU to interpret<br>system status and light indicators. Individual<br>flashing lights or combination of flashing lights<br>of the power button, battery level indicators,<br>timer counter, or SmartLid connection and<br>audible tones provided information on system<br>status and error codes.<br>The TearCare MGX subject device with the<br>graphic user interface provides indication of<br>system status and notification of errors through<br>text description and audible error tones.<br>Additional screens of the TearCare MGX<br>SmartHub display allows for control of<br>additional features present with the display<br>such as system settings, date/time, practice |
| Characteristic | TearCare MGX™ System<br>Subject Device | TearCare® System<br>K213045<br>Predicate Device | Comparison between TearCare MGX<br>System and Predicate Device |
| | | | information, battery charging display, and error<br>log.<br>The functions of the SmartHub regarding<br>therapy control are Equivalent. |
| SmartLids<br>configuration | Eye lid flexible element<br>Ear loop<br>Ear loop housing (connection for<br>reusable SmartCable) | Eye lid flexible element<br>Temple pad housing<br>Wired cable | The eyelid flexible elements are the same size<br>and construction in the TearCare MGX System<br>as in the predicate TearCare System device.<br>SmartLid features proximal to the heated<br>portion have been updated where the temple<br>pad housing that attaches to the patient's<br>temple via adhesive foam has been replaced<br>with an earloop that wraps around the ear.<br>The positioning of the eyelid flexible elements<br>on the patient's eyelids is maintained the same<br>as in the predicate device when the Earloop is<br>secured to the ear with surgical tape.<br>The predicate TearCare System SmartLids<br>configuration contained a wired cable to<br>connect to the SmartHub. The TearCare MGX<br>System SmartLid device has removed the wired<br>cable for direct connection to the SmartHub<br>and replaced with a housing. The housing<br>allows for connection of the SmartCable, an<br>additional component, as detailed above in the<br>"System Components" section. The SmartCable<br>maintains connection and communication of<br>the SmartLids to the SmartHub similar to the<br>connection present in the predicate device. |
| Characteristic | TearCare MGX™ System<br>Subject Device | TearCare® System<br>K213045<br>Predicate Device | Comparison between TearCare MGX<br>System and Predicate Device |
| Sterilization | The TearCare MGX SmartHub and<br>SmartLids are non-sterile | The TearCare SmartHub and SmartLids<br>are non-sterile | Equivalent |
| Single Use or<br>Reusable | • SmartLids: single use<br>• SmartHub and SmartCable: reusable | • SmartLids: single use<br>• SmartHub: reusable | Equivalent |
| Operation Control | Eye Care Practitioner | Eye Care Practitioner | Equivalent |
| Mechanism for<br>Heat Generation | Polymer encapsulated resistive heating<br>element | Polymer encapsulated resistive heating<br>element | Equivalent |
| Power source | Batteries, DC power | Batteries, DC power | Equivalent |
| Point of Use | In-Office | In-Office | Equivalent |
| Duration of<br>Treatment | 15 minutes of heat treatment with the<br>TearCare MGX System, followed by<br>manual expression of all four eyelids<br>using the Clearance Assistant which<br>typically requires 5-10 minutes.<br>An optional extended warming hold is<br>available following heat treatment to<br>allow flexibility to perform expression<br>while the eyelids are warm. | 15 minutes of heat treatment with the<br>TearCare System, followed by manual<br>expression of all four eyelids using the<br>Clearance Assistant which typically<br>requires 5-10 minutes. | Equivalent<br>The additional thermal dose of the extended<br>warming time feature does not significantly<br>impact the overall thermal dose of the system<br>as compared to the predicate, and therefore<br>does not impact device safety and<br>effectiveness. |
| Temperature<br>regulation | Temperature at the SmartLids are<br>continuously monitored by the<br>SmartHub to ensure it does not exceed<br>the maximum allowable temperature | Temperature at the SmartLids are<br>continuously monitored by the<br>SmartHub to ensure it does not exceed<br>the maximum allowable temperature | Equivalent<br>Frequency of temperature monitoring for<br>thermistor reading from the SmartLid has<br>increased. This increased monitoring frequency<br>allows for tighter precision of temperature<br>control while the performance output remains<br>the same as the predicate device. |
| Characteristic | TearCare MGX™ System<br>Subject Device | TearCare® System<br>K213045<br>Predicate Device | Comparison between TearCare MGX<br>System and Predicate Device |
| Therapeutic<br>Temperature Range | Automatic ramp from 41 to 45°C in five<br>1°C steps. User can adjust to any of<br>these 5 temperature settings | Automatic ramp from 41 to 45°C in five<br>1°C steps. User can adjust to any of<br>these 5 temperature settings | Equivalent |
| Temperature<br>Accuracy | ± 0.7°C | ± 0.7°C | Equivalent…