(254 days)
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.
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 provided text describes the nonclinical bench testing and a clinical validation study performed for the TearCare MGX System to demonstrate its substantial equivalence to the predicate TearCare System. The device is a thermal pulsation system for treating evaporative dry eye disease due to meibomian gland dysfunction (MGD).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define a column titled "Acceptance Criteria" with pass/fail thresholds for a broad set of performance metrics. Instead, it details that the device "met the minimum and maximum temperature specifications with 95% confidence and 90% reliability" in the clinical study, and that bench testing demonstrated compliance with applicable requirements. The core performance is related to maintaining a specific temperature range on the eyelid and ensuring corneal safety.
Based on the "Clinical Validation Study Summary" section (pages 16-17):
| Parameter | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Outer Eyelid Temperature | Maintain 41°C ± 2°C (lowest setting) Maintain 45°C ± 2°C (highest setting) | Lowest Setting (41°C): Mean 41.2°C ± 0.31°C (Range 40.1 - 41.8°C) |
| Highest Setting (45°C): Mean 44.2°C ± 0.46°C (Range 42.9 - 45.1°C) | ||
| Corneal Temperature (Safety) | Maintain safe corneal temperature (No specific numerical acceptance criterion given, but implicitly below damaging levels) | Lowest Setting (41°C): Mean 35.0°C ± 0.70°C (Range 33.4 - 36.7°C) |
| Highest Setting (45°C): Mean 35.6°C ± 0.78°C (Range 34.0 - 36.9°C) | ||
| Minimal/Maximal Temperature Specifications | Met with 95% confidence and 90% reliability | Met |
| Adverse Events | No adverse events | No adverse events reported |
| Slit Lamp Exams | No clinically significant changes | No clinically significant changes observed |
| Earloop Fit and Retention | Earloop components remain securely affixed throughout simulated treatment. | All Earloop components remained affixed to the ears in all subjects for the duration of the 25-minute simulated treatment when secured with surgical tape. |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Validation Study):
- Sample Size: 15 adult subjects (30 eyes)
- Data Provenance: Retrospective or Prospective is not explicitly stated, but the description "clinical validation testing... to demonstrate in acute clinical study" implies a prospective study. Country of origin not specified, but the submission is to the US FDA.
- Additional Clinical Validation Study (for Earloop Fit):
- Sample Size: 21 subjects
- Data Provenance: Similar to the above, likely prospective and in the US.
3. Number of Experts and Qualifications for Ground Truth
The text does not mention the use of experts to establish a "ground truth" in the traditional sense of image interpretation for AI. The clinical study focused on direct physiological measurements (temperature) and clinical observations (slit lamp exams, adverse events) to assess performance and safety. Therefore, this section is not directly applicable to the described studies. The measurements themselves are the "ground truth."
4. Adjudication Method for the Test Set
Not applicable, as the data are direct quantitative measurements (temperatures) and clinical observations (adverse events, slit lamp findings) rather than subjective interpretations requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study was a clinical validation of the device's thermal performance and safety, not a study evaluating human reader performance with or without AI assistance. The device itself is not an AI-assisted diagnostic tool, but rather a therapeutic heat delivery system.
6. Standalone (Algorithm Only) Performance
Not applicable. The device is a physical system that applies heat; it does not have a standalone algorithm for diagnostic or interpretative purposes. The software controls the device's function, and its functionality was verified through bench testing, alongside the hardware performance.
7. Type of Ground Truth Used
- For Thermal Performance: Direct temperature measurements using thermocouples (outer eyelid) and an IR camera (cornea).
- For Safety: Clinical observations including slit lamp exams and adverse event reporting.
- For Earloop Fit: Direct observation of earloop retention (whether they remained affixed with tape).
8. Sample Size for the Training Set
The document does not mention an AI/machine learning model that would require a "training set." The studies described are for validation of a medical device, not for the development or testing of an AI algorithm based on patient data.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no apparent training set for an AI model mentioned in the document.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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.4040 Campbell Ave., Suite 100Menlo Park, CA 94025Tel: (877) 266-1144 |
| Contact Person: | Rachel M. FrancoSr. Regulatory Affairs Specialist4040 Campbell Ave., Suite 100Menlo Park, CA 94025Tel: 408-221-7376 |
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)
- o TearCare SmartHub (P/N 07066)
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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™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
|---|---|---|---|
| DeviceClassification | Class II | Class II | Equivalent |
| ClassificationProduct Code | ORZ | ORZ | Equivalent |
| Regulation Number | 886.5200 | 886.5200 | Equivalent |
| Indications For Use | The TearCare® MGX System isintended for the application oflocalized heat therapy in adult patientswith evaporative dry eye disease dueto meibomian gland dysfunction(MGD), when used in conjunction withmanual expression of the meibomianglands. | The TearCare® System is intended forthe application of localized heat therapyin adult patients with evaporative dryeye disease due to meibomian glanddysfunction (MGD), when used inconjunction with manual expression ofthe meibomian glands. | Equivalent |
| Technological Characteristics | |||
| SystemComponents | • TearCare MGX System Kit (P/N06985) (includes):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)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 havebeen updated.In the predicate device, the cable wasincorporated within the disposable SmartLidassembly. In the subject TearCare MGX Systemthe cable is removed from the SmartLidassembly and is a reusable component, theSmartCable. The cable maintains connection ofthe SmartLids to the SmartHub similar to theconnection present in the predicate device.However, the SmartCable adds an additionalinterconnect to permit re-use of the cable |
| Device Description | • Disposable SmartLid componentsare attached to the external surface | • Disposable SmartLid components areattached to the external surface of | section for reduced waste. |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| of the eyelids and connect via areusable SmartCable to the reusableSmartHub touchscreen controllerwhich generates the heat that isdelivered to the eyelids• A separate, sterile disposableClearance Assistant™ is used inconjunction with the TearCare MGXSystem to perform manualexpression of the meibomian glandsimmediately following heattreatment with TearCare MGXSystem | the eyelids and connect to a reusableSmartHub controller which generatesthe heat that is delivered to theeyelids• A separate, sterile disposableClearance Assistant™ is used inconjunction with the TearCare Systemto perform manual expression of themeibomian glands immediatelyfollowing heat treatment withTearCare System | Equivalent | |
| SmartHub therapycontrol | SmartHub provides control to poweron, start, stop, and resume therapy,increase or decrease warmth levels | SmartHub provides control to power on,start, stop, and resume therapy,increase or decrease warmth levels | Equivalent |
| SmartHub userinterface | Touchscreen display with graphic userinterface (GUI).During a therapy the health careprovider can use the GUI to initiate,stop and adjust the warmth setting. | Push-button interface with graphicsymbols and light indicators.During a therapy the health careprovider can use the push buttons toinitiate, stop and adjust the warmthsetting. | Use of the predicate TearCare System devicerequires consultation of the IFU to interpretsystem status and light indicators. Individualflashing lights or combination of flashing lightsof the power button, battery level indicators,timer counter, or SmartLid connection andaudible tones provided information on systemstatus and error codes.The TearCare MGX subject device with thegraphic user interface provides indication ofsystem status and notification of errors throughtext description and audible error tones.Additional screens of the TearCare MGXSmartHub display allows for control ofadditional features present with the displaysuch as system settings, date/time, practice |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| information, battery charging display, and errorlog.The functions of the SmartHub regardingtherapy control are Equivalent. | |||
| SmartLidsconfiguration | Eye lid flexible elementEar loopEar loop housing (connection forreusable SmartCable) | Eye lid flexible elementTemple pad housingWired cable | The eyelid flexible elements are the same sizeand construction in the TearCare MGX Systemas in the predicate TearCare System device.SmartLid features proximal to the heatedportion have been updated where the templepad housing that attaches to the patient'stemple via adhesive foam has been replacedwith an earloop that wraps around the ear.The positioning of the eyelid flexible elementson the patient's eyelids is maintained the sameas in the predicate device when the Earloop issecured to the ear with surgical tape.The predicate TearCare System SmartLidsconfiguration contained a wired cable toconnect to the SmartHub. The TearCare MGXSystem SmartLid device has removed the wiredcable for direct connection to the SmartHuband replaced with a housing. The housingallows for connection of the SmartCable, anadditional component, as detailed above in the"System Components" section. The SmartCablemaintains connection and communication ofthe SmartLids to the SmartHub similar to theconnection present in the predicate device. |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| Sterilization | The TearCare MGX SmartHub andSmartLids are non-sterile | The TearCare SmartHub and SmartLidsare non-sterile | Equivalent |
| Single Use orReusable | • SmartLids: single use• SmartHub and SmartCable: reusable | • SmartLids: single use• SmartHub: reusable | Equivalent |
| Operation Control | Eye Care Practitioner | Eye Care Practitioner | Equivalent |
| Mechanism forHeat Generation | Polymer encapsulated resistive heatingelement | Polymer encapsulated resistive heatingelement | Equivalent |
| Power source | Batteries, DC power | Batteries, DC power | Equivalent |
| Point of Use | In-Office | In-Office | Equivalent |
| Duration ofTreatment | 15 minutes of heat treatment with theTearCare MGX System, followed bymanual expression of all four eyelidsusing the Clearance Assistant whichtypically requires 5-10 minutes.An optional extended warming hold isavailable following heat treatment toallow flexibility to perform expressionwhile the eyelids are warm. | 15 minutes of heat treatment with theTearCare System, followed by manualexpression of all four eyelids using theClearance Assistant which typicallyrequires 5-10 minutes. | EquivalentThe additional thermal dose of the extendedwarming time feature does not significantlyimpact the overall thermal dose of the systemas compared to the predicate, and thereforedoes not impact device safety andeffectiveness. |
| Temperatureregulation | Temperature at the SmartLids arecontinuously monitored by theSmartHub to ensure it does not exceedthe maximum allowable temperature | Temperature at the SmartLids arecontinuously monitored by theSmartHub to ensure it does not exceedthe maximum allowable temperature | EquivalentFrequency of temperature monitoring forthermistor reading from the SmartLid hasincreased. This increased monitoring frequencyallows for tighter precision of temperaturecontrol while the performance output remainsthe same as the predicate device. |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| TherapeuticTemperature Range | Automatic ramp from 41 to 45°C in five1°C steps. User can adjust to any ofthese 5 temperature settings | Automatic ramp from 41 to 45°C in five1°C steps. User can adjust to any ofthese 5 temperature settings | Equivalent |
| TemperatureAccuracy | ± 0.7°C | ± 0.7°C | Equivalent |
| MaximumSustainableTherapeuticTemperature (i.e.,for the duration ofthe procedure) | 46.74°C | 46.74°C | Equivalent |
| Maximum AbsoluteTemperature Limit(at any exposuretime) | 47°C | 47°C | Equivalent |
| Maximum OuterEyelid SurfaceTemperature Limit(Safety Limit) | 46.99°C for 2 seconds prior toautomatic temperaturedownregulation | 46.99°C for 2 seconds prior to automatictemperature downregulation | Equivalent |
| Maximum AbsoluteTemperature Limitduring ExtendedWarming Time | 43°C | N/A | Extended Warming Time is set to the sametemperature set point as system warmthsetting level 1. This maximum temperature limitis the same as level 1 temperature limit as inthe predicate. The additional thermal dose ofthe extended warming time feature does notsignificantly impact the overall thermal dose ofthe system as compared to the predicate, andtherefore does not impact device safety andeffectiveness. |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| Equivalent | |||
| Rate of Heating(time to reachtargettemperature) | < 60 seconds to initial target level 1,then additional 30 seconds to reacheach additional level (total of 5temperature levels) | < 60 seconds to initial target level 1,then additional 30 seconds to reacheach additional level (total of 5temperature levels) | EquivalentThe TearCare MGX SmartLid therapy initiationtemperature ramp up from baseline has beenupdated compared to the predicate, but thetime limit and set point to reach target warmthlevel 1 are the same in the subject TearCareMGX device as the predicate. |
| Pressure Control | Manual: Eye Care Practitioner, usingseparately provided expressor forcepsdetermines pressure (based on patientfeedback and direct viewing of glands) | Manual: Eye Care Practitioner, usingseparately provided expressor forcepsdetermines pressure (based on patientfeedback and direct viewing of glands) | Equivalent |
| Pressure Type | Manual expression using separatelyprovided Clearance Assistantexpression forceps | Manual expression using separatelyprovided Clearance Assistant expressionforceps | Equivalent |
| Treatment of upperand lower eyelids | Concurrent for upper and lower eyelidsof both right and left eye | Concurrent for upper and lower eyelidsof both right and left eye | Equivalent |
| Packaging(pertinent todisposable) | PETG tray within a carton | Sealed pouch with sulfur bleachedsulfide (SBS) tray | EquivalentAccelerated Aging per ASTM F1980-21,Environmental and transit testing per ASTMD4169 and ASTM D4332 |
| Performance Testing | |||
| Biocompatiblepatient-contactingmaterials(ISO 10993-1) | Limited contact duration device per10993-1Yes, medical-grade silicone/acrylictape, Polyolefin Foam, polyimide | Limited contact duration device per10993-1Yes, medical-grade silicone/acrylic tape,Polyolefin Foam and polyimide | EquivalentEvaluation of materials compliant to 10993-1 |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| Santoprene, and makrolonpolycarbonate supported bycytotoxicity testing per ISO 10993-5,primary skin irritation per ISO 10993-23, and repeated patch dermalsensitization testing per ISO 10993-10.Primary skin irritation, intracutaneousirritation, guinea pig maximization, andocular irritation testing per ISO 10993-10 for medical-grade silicone/acrylictape, Polyolefin Foam and polyimide.Santoprene and makrolonpolycarbonate supported bycytotoxicity testing per ISO 10993-5,primary skin irritation per ISO 10993-23, and guinea pig maximizationtesting per ISO 10993-10. | supported by cytotoxicity testing perISO 10993-5, primary skin irritation perISO 10993-23, and repeated patchdermal sensitization testing per ISO10993-10.Primary skin irritation, intracutaneousirritation, guinea pig maximization, andocular irritation testing per ISO 10993-10 for medical-grade silicone/acrylictape, Polyolefin Foam and polyimide. | ||
| SmartLid - eyelid element materials- Polyimide- Medical-grade silicone/acrylic tape | SmartLid - eyelid element materials- Polyimide- Medical-grade silicone/acrylic tape | ||
| Polyolefin Foam | Polyolefin Foam | ||
| Earloop materials- Santoprene- Makrolon | N/A | ||
| N/A | Temple Pad housing materials- 3M Foam Medical Tape (1772)- 3M 467MP adhesive | ||
| Shelf Life | Testing was performed to demonstratea 25-month shelf life for the SmartLids | Testing was performed to demonstratea 25-month shelf life for the SmartLids | Equivalent |
| Characteristic | TearCare MGX™ SystemSubject Device | TearCare® SystemK213045Predicate Device | Comparison between TearCare MGXSystem and Predicate Device |
| Thermal Safety | • TearCare MGX System bench testingverified function of thermal safetyrequirements• Clinical testing measured the cornealand eyelid temperatures to validatethermal safety requirements | • TearCare System bench testingverified function of thermal safetyrequirements• Clinical testing measured the cornealand eyelid temperatures to validatethermal safety requirements | Equivalent |
| Software | Testing was performed toverify/validate that the systemsoftware met all requirements | Testing was performed toverify/validate that the system softwaremet all requirements | Equivalent |
| Electrical Safety perIEC 60601-1 | Meets requirements | Meets requirements | Equivalent |
| ElectromagneticCompatibility (EMC)per IEC 60601-1-2 | Meets requirements | Meets requirements | Equivalent |
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Image /page/8/Picture/0 description: The image shows the logo for Sight Sciences. The logo consists of a stylized blue "S" made of three curved lines, followed by the word "SIGHT" in bold, dark blue letters. Below "SIGHT" is the word "SCIENCES" in a smaller font, also in dark blue.
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Image /page/9/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a stylized "S" symbol on the left, followed by the text "SIGHT" in a bold, sans-serif font. Below "SIGHT" is the word "SCIENCES" in a smaller font size. The logo is in a blue color scheme.
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Image /page/10/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a stylized blue symbol on the left, resembling three overlapping 'S' shapes. To the right of the symbol is the text 'SIGHT' in a bold, sans-serif font, with the word 'SCIENCES' appearing below it in a smaller font size.
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Image /page/11/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a stylized "S" symbol on the left, followed by the word "SIGHT" in bold, sans-serif font. Below "SIGHT" is the word "SCIENCES" in a smaller, similar font. The logo uses a gradient of blue colors, with the "S" symbol and the top of the text in a lighter blue, transitioning to a darker blue at the bottom.
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Image /page/12/Picture/0 description: The image contains the logo for Sight Sciences. The logo consists of a stylized letter "S" made up of three curved lines in shades of blue. To the right of the symbol is the word "SIGHT" in a bold, sans-serif font, stacked above the word "SCIENCES" in a smaller font.
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Image /page/13/Picture/0 description: The image shows the logo for Sight Sciences. The logo consists of a stylized blue "S" made of three curved lines, followed by the word "SIGHT" in bold, dark blue letters. Below "SIGHT" is the word "SCIENCES" in a smaller font, also in dark blue.
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Image /page/14/Picture/0 description: The image shows the logo for Sight Sciences. The logo consists of a stylized blue "S" made of three curved lines, followed by the word "SIGHT" in bold, dark blue letters. Below "SIGHT" is the word "SCIENCES" in a smaller font, also in dark blue.
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Summary of Testing Performed
The nonclinical bench testing conducted on the TearCare MGX System in accordance with risk analysis and design control requirements included design verification and functional product testing including software validation, sterilization, packaging and shelf-life testing, electrical safety testing, and EMC and biocompatibility testing. Results of the nonclinical testing demonstrate that the TearCare MGX System components and accessories meet the design intent and complies with the applicable requirements.
- Thermal and Functional Requirements: The thermal and functional performance of the TearCare MGX SmartHub and SmartLids were evaluated in a benchtop simulated use condition.
- Visual Inspection and Measurement of Physical/Operational Requirements: TearCare MGX 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 limited exposure (<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 evelid 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: Software Verification and Validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.
- . Electrical Safety: Testing was performed to demonstrate that the System meets the electrical safety requirements specified in IEC 60601-1.
- Electromagnetic Compatibility: Testing was performed to demonstrate that the System meets the electromagnetic requirements specified in IEC 60601-1-2.
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Risk Analvsis
The risk management process at Sight Sciences complies with ISO 14971:2019 "Medical devices --Application of risk manaqement 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 MGX System.
Clinical Validation Study Summary
In addition to bench testing, Sight Sciences performed clinical validation testing of the current TearCare MGX 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, 15 females. Testing demonstrated that the TearCare System met the minimum and maximum temperature specifications with 95% confidence and 90% reliability.
There were no adverse events, nor any clinically significant changes observed in slit lamp exams.
A summary of the outer eyelid and corneal tissue temperatures measured at the lowest SmartHub setting is presented in Table 2 below.
| Baseline (°C)Mean ± SD (Range) | End of Procedure (°C)Mean ± SD (Range) | |
|---|---|---|
| Outer Eyelida,c | 34.6 ± 0.42 (33.6 - 35.5) | 41.2 ± 0.31 (40.1 - 41.8) |
| Corneab,c | 33.7 ± 0.63 (32.3 - 34.8) | 35.0 ± 0.70 (33.4 - 36.7) |
Table 2 Mean Tissue Temperatures at Lowest Temperature Setting (41°C)
ª Measured with thermocouples; includes upper and lower lids
ኮ Measured with IR camera
< Mean (SD) values are mean of all measurements for upper and lower, OS, and OD for outer eyelids, and mean of all OD and OS measurements for inner eyelids and cornea
A summary of the outer eyelid and corneal tissue temperatures measured at the highest SmartHub temperature setting is presented in Table 3 below.
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| Baseline (°C)Mean ± SD (Range) | End of Procedure (°C)Mean ± SD (Range) | |
|---|---|---|
| Outer Eyelida,c | 33.7 ± 0.56 (32.4 - 35.0) | 44.2 ± 0.46 (42.9 - 45.1) |
| Cornea b,c | 33.4 ± 0.72 (32.1 - 35.2) | 35.6 ± 0.78 (34.0 - 36.9) |
Table 3 Mean Tissue Temperatures at Highest Temperature Setting (45°C)
a Measured with thermocouples; includes upper and lower lids
b Measured with IR camera
^ Mean (SD) values are mean of all measurements for uper and lower, OS, and OD for outer eyelids, and mean of all OD and OS measurements for inner
eyelids and cornea
Based on the outer evelid temperatures, the TearCare MGX System maintains the minimum steady state temperature of the device (41°C ± 2°C) and does not exceed the maximum temperature setting (45°C ± 2°C), as in the predicate TearCare System device. The effectiveness of the device is demonstrated in the final temperature of the outer eyelid targeted at 41-45°C to melt the meibum blocking the meibomian glands, not the difference in temperatures from the baseline. The temperature output of the subject device is substantially equivalent to the predicate.
During the Clinical Validation Study of the TearCare MGX device, three out of 15 subjects noted loose fitment of the earpieces and felt the need to support the earpieces. Therefore, an additional clinical validation study was performed to validate the fit and retention of the TearCare MGX System Earloop using modified Instructions for Use. In this additional clinical validation study, the TearCare MGX System was applied to 21 subjects, and surgical tape was used to secure the Earloop components to both ears of all subjects. All Earloop components remained affixed to the ears in all subjects for the duration of the 25 minute simulated treatment. The results of this additional clinical validation study demonstrate that the TearCare MGX device components remain securely affixed to the eyelid and head throughout a simulated 25 minute treatment when the Earloop component is secured to the head with tape.
Conclusions Drawn from Bench and Clinical Performance Testing
The results of the bench and clinical evaluations demonstrate that the TearCare MGX System is substantially equivalent to the TearCare System.
§ 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.