(254 days)
Not Found
No
The summary describes a device that applies localized heat therapy with temperature control and a timed cycle. There is no mention of AI, ML, image processing, or any data analysis that would suggest the use of such technologies. The clinical studies focus on temperature accuracy and device fit, not on the performance of any AI/ML algorithm.
Yes
The intended use statement explicitly states that the device is "intended for the application of localized heat therapy in adult patients with evaporative dry eye disease due to meibomian gland dysfunction (MGD)". Therapy is a recognized purpose for therapeutic devices.
No.
The device is intended for "application of localized heat therapy" to treat meibomian gland dysfunction (MGD), which is a therapeutic function, not a diagnostic one. It applies heat to melt meibum, preparing the glands for manual expression, rather than identifying or characterizing a medical condition.
No
The device description explicitly lists multiple hardware components including the SmartLids, SmartHub, SmartCable, Charging Nest, and mentions electrical safety and EMC testing, indicating it is a hardware device with integrated software.
Based on the provided information, the TearCare MGX™ System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TearCare MGX™ System Function: The TearCare MGX™ System applies localized heat therapy to the external surface of the eyelids. It does not analyze any biological samples taken from the patient.
- Intended Use: The intended use is for applying heat therapy to treat evaporative dry eye disease due to MGD, in conjunction with manual expression. This is a therapeutic intervention, not a diagnostic test.
- Device Description: The description focuses on the physical components and how they deliver heat to the eyelids. There is no mention of sample collection or analysis.
- Performance Studies: The performance studies described focus on the device's ability to reach and maintain target temperatures and its fit and retention, not on the accuracy of a diagnostic measurement.
Therefore, the TearCare MGX™ System is a therapeutic device, not an IVD.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
ORZ
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)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyelid(s)
Indicated Patient Age Range
adult patients
Intended User / Care Setting
Eye Care Practitioner, In-Office
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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.
Additionally, 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.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation Study of the TearCare MGX System:
- Study Type: Acute clinical study
- Sample Size: 15 adult subjects (30 eyes), 15 females.
- Key Results:
- No adverse events, nor any clinically significant changes observed in slit lamp exams.
- Mean Tissue Temperatures at Lowest Temperature Setting (41°C):
- Outer Eyelida,c: Baseline 34.6 ± 0.42 (33.6 - 35.5) °C; End of Procedure 41.2 ± 0.31 (40.1 - 41.8) °C
- Corneab,c: Baseline 33.7 ± 0.63 (32.3 - 34.8) °C; End of Procedure 35.0 ± 0.70 (33.4 - 36.7) °C
(ª Measured with thermocouples; includes upper and lower lids; b Measured with IR camera; c 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)
- Mean Tissue Temperatures at Highest Temperature Setting (45°C):
- Outer Eyelida,c: Baseline 33.7 ± 0.56 (32.4 - 35.0) °C; End of Procedure 44.2 ± 0.46 (42.9 - 45.1) °C
- Cornea b,c: Baseline 33.4 ± 0.72 (32.1 - 35.2) °C; End of Procedure 35.6 ± 0.78 (34.0 - 36.9) °C
(a Measured with thermocouples; includes upper and lower lids; b Measured with IR camera; c 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)
- 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.
Additional Clinical Validation Study for Earloop Fitment:
- Study Type: Clinical validation study
- Sample Size: 21 subjects.
- Key Results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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).
1
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
2
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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3
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 100 | |
| Menlo Park, CA 94025 | |
| Tel: (877) 266-1144 | |
| Contact Person: | Rachel M. Franco |
| Sr. Regulatory Affairs Specialist | |
| 4040 Campbell Ave., Suite 100 | |
| Menlo Park, CA 94025 | |
| Tel: 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 |
4
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)
5
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.
6
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.
7
Table 1Comparison of Technological Characteristics with the Predicate Device
| Characteristic | TearCare MGX™ System
Subject Device | TearCare® System
K213045
Predicate Device | Comparison between TearCare MGX
System and Predicate Device |
|------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Classification | Class II | Class II | Equivalent |
| Classification
Product Code | ORZ | ORZ | Equivalent |
| Regulation Number | 886.5200 | 886.5200 | Equivalent |
| 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. | 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. | Equivalent |
| Technological Characteristics | | | |
| System
Components | • TearCare MGX System Kit (P/N
06985) (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 have
been updated.
In the predicate device, the cable was
incorporated within the disposable SmartLid
assembly. In the subject TearCare MGX System
the cable is removed from the SmartLid
assembly and is a reusable component, the
SmartCable. The cable maintains connection of
the SmartLids to the SmartHub similar to the
connection present in the predicate device.
However, the SmartCable adds an additional
interconnect to permit re-use of the cable |
| Device Description | • Disposable SmartLid components
are attached to the external surface | • Disposable SmartLid components are
attached to the external surface of | section for reduced waste. |
| Characteristic | TearCare MGX™ System
Subject Device | TearCare® System
K213045
Predicate Device | Comparison between TearCare MGX
System and Predicate Device |
| | of the eyelids and connect via a
reusable SmartCable to the reusable
SmartHub touchscreen controller
which generates the heat that is
delivered to the eyelids
• A separate, sterile disposable
Clearance Assistant™ is used in
conjunction with the TearCare MGX
System to perform manual
expression of the meibomian glands
immediately following heat
treatment with TearCare MGX
System | the eyelids and connect to a reusable
SmartHub controller which generates
the heat that is delivered to the
eyelids
• A separate, sterile disposable
Clearance Assistant™ is used in
conjunction with the TearCare System
to perform manual expression of the
meibomian glands immediately
following heat treatment with
TearCare System | Equivalent |
| SmartHub therapy
control | SmartHub provides control to power
on, 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 user
interface | Touchscreen display with graphic user
interface (GUI).
During a therapy the health care
provider can use the GUI to initiate,
stop and adjust the warmth setting. | Push-button interface with graphic
symbols and light indicators.
During a therapy the health care
provider can use the push buttons to
initiate, stop and adjust the warmth
setting. | Use of the predicate TearCare System device
requires consultation of the IFU to interpret
system status and light indicators. Individual
flashing lights or combination of flashing lights
of the power button, battery level indicators,
timer counter, or SmartLid connection and
audible tones provided information on system
status and error codes.
The TearCare MGX subject device with the
graphic user interface provides indication of
system status and notification of errors through
text description and audible error tones.
Additional screens of the TearCare MGX
SmartHub display allows for control of
additional features present with the display
such as system settings, date/time, practice |
| Characteristic | TearCare MGX™ System
Subject Device | TearCare® System
K213045
Predicate Device | Comparison between TearCare MGX
System and Predicate Device |
| | | | information, battery charging display, and error
log.
The functions of the SmartHub regarding
therapy control are Equivalent. |
| SmartLids
configuration | Eye lid flexible element
Ear loop
Ear loop housing (connection for
reusable SmartCable) | Eye lid flexible element
Temple pad housing
Wired cable | The eyelid flexible elements are the same size
and construction in the TearCare MGX System
as in the predicate TearCare System device.
SmartLid features proximal to the heated
portion have been updated where the temple
pad housing that attaches to the patient's
temple via adhesive foam has been replaced
with an earloop that wraps around the ear.
The positioning of the eyelid flexible elements
on the patient's eyelids is maintained the same
as in the predicate device when the Earloop is
secured to the ear with surgical tape.
The predicate TearCare System SmartLids
configuration contained a wired cable to
connect to the SmartHub. The TearCare MGX
System SmartLid device has removed the wired
cable for direct connection to the SmartHub
and replaced with a housing. The housing
allows for connection of the SmartCable, an
additional component, as detailed above in the
"System Components" section. The SmartCable
maintains connection and communication of
the SmartLids to the SmartHub similar to the
connection present in the predicate device. |
| Characteristic | TearCare MGX™ System
Subject Device | TearCare® System
K213045
Predicate Device | Comparison between TearCare MGX
System and Predicate Device |
| Sterilization | The TearCare MGX SmartHub and
SmartLids are non-sterile | The TearCare SmartHub and SmartLids
are non-sterile | Equivalent |
| Single Use or
Reusable | • SmartLids: single use
• SmartHub and SmartCable: reusable | • SmartLids: single use
• SmartHub: reusable | Equivalent |
| Operation Control | Eye Care Practitioner | Eye Care Practitioner | Equivalent |
| Mechanism for
Heat Generation | Polymer encapsulated resistive heating
element | Polymer encapsulated resistive heating
element | Equivalent |
| Power source | Batteries, DC power | Batteries, DC power | Equivalent |
| Point of Use | In-Office | In-Office | Equivalent |
| Duration of
Treatment | 15 minutes of heat treatment with the
TearCare MGX System, followed by
manual expression of all four eyelids
using the Clearance Assistant which
typically requires 5-10 minutes.
An optional extended warming hold is
available following heat treatment to
allow flexibility to perform expression
while the eyelids are warm. | 15 minutes of heat treatment with the
TearCare System, followed by manual
expression of all four eyelids using the
Clearance Assistant which typically
requires 5-10 minutes. | Equivalent
The additional thermal dose of the extended
warming time feature does not significantly
impact the overall thermal dose of the system
as compared to the predicate, and therefore
does not impact device safety and
effectiveness. |
| Temperature
regulation | Temperature at the SmartLids are
continuously monitored by the
SmartHub to ensure it does not exceed
the maximum allowable temperature | Temperature at the SmartLids are
continuously monitored by the
SmartHub to ensure it does not exceed
the maximum allowable temperature | Equivalent
Frequency of temperature monitoring for
thermistor reading from the SmartLid has
increased. This increased monitoring frequency
allows for tighter precision of temperature
control while the performance output remains
the same as the predicate device. |
| Characteristic | TearCare MGX™ System
Subject Device | TearCare® System
K213045
Predicate Device | Comparison between TearCare MGX
System and Predicate Device |
| 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 | Automatic ramp from 41 to 45°C in five
1°C steps. User can adjust to any of
these 5 temperature settings | Equivalent |
| Temperature
Accuracy | ± 0.7°C | ± 0.7°C | Equivalent |
| Maximum
Sustainable
Therapeutic
Temperature (i.e.,
for the duration of
the procedure) | 46.74°C | 46.74°C | Equivalent |
| Maximum Absolute
Temperature Limit
(at any exposure
time) | 47°C | 47°C | Equivalent |
| Maximum Outer
Eyelid Surface
Temperature Limit
(Safety Limit) | 46.99°C for 2 seconds prior to
automatic temperature
downregulation | 46.99°C for 2 seconds prior to automatic
temperature downregulation | Equivalent |
| Maximum Absolute
Temperature Limit
during Extended
Warming Time | 43°C | N/A | Extended Warming Time is set to the same
temperature set point as system warmth
setting level 1. This maximum temperature limit
is the same as level 1 temperature limit as in
the predicate. The additional thermal dose of
the extended warming time feature does not
significantly impact the overall thermal dose of
the system as compared to the predicate, and
therefore does not impact device safety and
effectiveness. |
| Characteristic | TearCare MGX™ System
Subject Device | TearCare® System
K213045
Predicate Device | Comparison between TearCare MGX
System and Predicate Device |
| | | | Equivalent |
| Rate of Heating
(time to reach
target
temperature) |