(90 days)
Not Found
No
The description details a heat therapy device with manual temperature adjustment and a fixed treatment duration. There is no mention of algorithms that learn or adapt based on data, which are characteristic of AI/ML. The "SmartLids" contain sensors and a microprocessor for accurate thermal energy delivery, but this is standard control system technology, not AI/ML.
Yes
The device is intended for the application of localized heat therapy to treat evaporative dry eye disease due to meibomian gland dysfunction (MGD), which aligns with the definition of a therapeutic device.
No
The device is described as a heat therapy system for treating evaporative dry eye disease due to meibomian gland dysfunction, primarily focusing on delivering heat to the eyelids. It is not mentioned to diagnose or analyze patient conditions.
No
The device description clearly outlines multiple hardware components including the SmartHub, Charging Nest, Charging Adapter and Wall Plug, and SmartLids, which are essential for the device's function of delivering heat therapy. While the SmartHub contains software, the device is not solely software.
Based on the provided information, the TearCare® System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- TearCare's Function: The TearCare System is a therapeutic device. Its intended use is to apply localized heat therapy to the eyelids to treat evaporative dry eye disease due to meibomian gland dysfunction (MGD). It does not analyze any biological specimens.
- Mechanism of Action: The device works by applying heat externally to the eyelids to melt blocked meibum, which is a physical process, not a diagnostic analysis of a sample.
- Intended Use/Indications for Use: The stated intended use clearly describes a therapeutic application ("application of localized heat therapy") and not a diagnostic one.
- Device Description: The description focuses on the components and how they deliver heat to the eyelids. There is no mention of collecting or analyzing biological samples.
- Performance Studies: The performance studies evaluate the device's ability to deliver heat effectively and safely, and its clinical effectiveness in improving signs and symptoms of dry eye. They do not involve diagnostic performance metrics like sensitivity or specificity.
In summary, the TearCare System is a therapeutic device designed to treat a condition, not to diagnose it by analyzing biological samples.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ORZ
Device Description
To use the TearCare System, the flexible SmartLids are applied to the external surface of the upper and lower eyelids of the right and left eye of the patient. The SmartLids are then connected to the SmartHub. When the SmartHub is turned on and the eye care professional initiates the procedure, the TearCare System begins delivering heat to the eyelids. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian gland orifices. A complete TearCare session lasts 15 minutes.
After TearCare treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare System has not been established when used without manual meibomian gland expression.
The TearCare System is comprised of the following key components and accessories:
- . SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination.
- . Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery.
- Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest.
- SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyelids
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Validation Study Summary
Study Type: Acute Clinical Study
Sample Size: 15 adult subjects (30 eyes)
Key Results: Tested that the temperatures achieved met key performance and safety criteria. Testing demonstrated that the TearCare System met the minimum and maximum temperature specifications with 95% confidence and 90% reliability. Corneal temperature increase was minimal and remained within a safe range. Inner eyelid temperatures demonstrated that the TearCare System maintains a minimum therapeutic temperature even at the lowest temperature setting. Ocular tissues returned to near baseline levels within 5 minutes after completion of the TearCare thermal procedure.
Randomized Clinical Trial Summary
Study Type: Prospective, multicenter, randomized, non-inferiority, masked, controlled clinical trial ("OLYMPIA")
Sample Size: 235 subjects (470 eyes) from 10 investigative centers in the United States.
Key Results:
Primary effectiveness endpoints (change from baseline to 1 month for Tear Break-up Time (TBUT) and total Meibomian Gland Secretion Score (MGSS)) showed statistically significant and clinically meaningful improvement in both treatment groups. The TearCare arm established non-inferiority relative to the LipiFlow arm for both TBUT and MGSS.
Secondary endpoints (OSDI, corneal and conjunctival staining scores, and meibomian gland function) also showed improvements in both groups.
Primary safety endpoint (ocular adverse events (AEs)) showed few device-related AEs, with no serious adverse events reported. The observed rate of device related AEs was 2.1% in Cohort 1 and 2.1% in Cohort 2 of the TearCare group.
Secondary safety endpoints (pain and discomfort, BCVA, IOP) indicated initial higher pain/discomfort with TearCare but reduced by Day 1. No significant change in BCVA (with some exceptions deemed unrelated) or IOP. Overall safety results are similar between the TearCare System and the LipiFlow System.
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
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 21, 2021
Sight Sciences, Inc. Edward J. Sinclair Consultant 4040 Campbell Ave., Suite 100 Menlo Park, CA 94025
Re: K213045
Trade/Device Name: TearCare® System Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: September 21, 2021 Received: September 24, 2021
Dear Edward J. Sinclair:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation titled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213045
Device Name TearCare® System
Indications for Use (Describe)
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.
| 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
510(k) SUMMARY
Submitter Information
| 510(k) Number: | K213045 |
|---|---|
| 510(k) Owner: | Sight Sciences, Inc. |
| 4040 Campbell Ave., Suite 100 | |
| Menlo Park, CA 94025 | |
| Tel: (877) 266-1144 | |
| Contact Person: | Edward J. Sinclair |
| Consultant | |
| 4040 Campbell Ave., Suite 100 | |
| Menlo Park, CA 94025 | |
| Tel: 650-218-9149 | |
| Date Prepared: | November3, 2021 |
Device Name and Classification
| TRADE NAME: | TearCare® System |
|---|---|
| COMMON NAME: | N/A |
| CLASSIFICATION NAME: | Eyelid Thermal Pulsation System |
| REGULATION NUMBER: | 21 CFR 886.5200 |
| DEVICE CLASSIFICATION: | Class II |
| PRODUCT CODE: | ORZ |
Predicate Device
| Device Name: | LipiFlow® Thermal Pulsation System |
|---|---|
| 510(k) Holder: | Johnson and Johnson (formerly TearScience, Inc.) |
| 510(k) Number: | K161357 |
| Clearance Date: | November 4, 2016 |
Indications for Use
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.
4
Device Description
To use the TearCare System, the flexible SmartLids are applied to the external surface of the upper and lower eyelids of the right and left eye of the patient. The SmartLids are then connected to the SmartHub. When the SmartHub is turned on and the eye care professional initiates the procedure, the TearCare System begins delivering heat to the eyelids. The system automatically and gradually increases the temperature over 2-3 minutes until it reaches the target range of 41-45°C to melt the meibum blocking the meibomian gland orifices. A complete TearCare session lasts 15 minutes.
After TearCare treatment the eye care professional then uses a separately available Clearance Assistant™ to express the meibomian glands manually immediately following the eyelid heat treatment. The separately packaged sterile, single-use Clearance Assistant instrument is available from Sight Sciences and used in conjunction with the TearCare product. The Clearance Assistant instrument is a Class I, 510(k) exempt, meibomian gland expressor (Classification Product Code HNS, Regulation Number 886.4350). Safety and effectiveness of the TearCare System has not been established when used in conjunction with any other meibomian gland expressor. Effectiveness of the TearCare System has not been established when used without manual meibomian gland expression.
The TearCare System is comprised of the following key components and accessories:
- . SmartHub – a reusable component that incorporates hardware and software to power the SmartLids during treatment. The SmartHub has 5 temperature set points (ranging from 41 to 45°C), which allow the user to manually adjust the temperature up or down to a level that is comfortable for the patient. The SmartHub is powered by an internal lithium-ion battery and has an intuitive 4-function, 3-button interface which provides the user the status and control of treatment initiation, treatment temperature setting, remaining treatment duration, and treatment termination.
- . Charging Nest - a reusable plastic desktop cradle that holds one SmartHub in order to recharge the SmartHub battery.
- Charging Adapter and Wall Plug - a reusable AC/DC wall-mount adapter that accommodates 80-264 VAC input voltage and provides 9.0 VDC output voltage to the SmartHub through the Charging Nest.
- SmartLids – a single use component of the TearCare System that is designed to conform to the upper and lower eyelid. They contain flexible circuits, sensors and a microprocessor which provide accurate and precise thermal energy to the eyelids to melt oil in the meibomian glands. Medical grade adhesive on the skin-facing surface of the SmartLids allow them to be affixed to the external surface of the eyelids during the procedure and easily removed at the end of the procedure. Each SmartLid is connected to the SmartHub by a cable integrated into the SmartLid. The integrated cable is four feet in length.
A comparison of the technological characteristics between the subject TearCare System compared with the predicate LipiFlow device is shown in Table 1 below.
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| Characteristic | TearCare® System
(Sight Sciences, Inc.)
Subject Device | LipiFlow® Thermal Pulsation System
(Johnson & Johnson)
K161357
Predicate Device |
|---------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Classification | Class II | Class II |
| Classification Product
Code | ORZ | ORZ |
| Regulation Number | 886.5200 | 886.5200 |
| Indications For Use | 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. | The LipiFlow® Thermal Pulsation System is
intended for the application of localized
heat and pressure therapy 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 |
| Technological Characteristics | | |
| Device Description | • Disposable SmartLid components are
attached to the external surface of 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 | • Disposable EyeCup is applied to the
outside of the eyelid to automatically
apply pressure using a bladder that
intermittently inflates with air. The
disposable LidWarmer contacts the
inner eyelid surface and provides
unidirectional heat to the inner eyelid
• The Disposable portions connect to a
Control Unit
• System applies heat and pressure to the
eyelids |
| Sterilization | The TearCare SmartHub and SmartLids
are non-sterile | EyeCup/Lid Warmer are provided sterile
by ethylene oxide to 10-6 SAL |
| Single Use or Reusable | • SmartLids: single use
• SmartHub: reusable | • EyeCup/Lid Warmer: single use
• Control Unit: reusable |
| Operation Control | Eye Care Practitioner | Eye Care Practitioner |
| Mechanism for Heat
Generation | Polymer encapsulated resistive heating
element | Resistive (plastic) electric heater |
| Power source | Batteries, DC power | AC power |
| Point of Use | In-Office | In-Office |
| Duration of Treatment | 15 minutes of heat treatment with the
TearCare System, followed manual
expression of all four eyelids using the
Clearance Assistant which typically
requires 5-10 minutes | 12 minutes of heat/pressure treatment |
| 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 surface of the eye is
regulated by the Control System |
| Therapeutic Temperature Range | Automatic ramp from 41 to 45°C in five 1°C steps. User can adjust to any of these 5 temperature settings | 42.5°C (constant temperature) |
| Temperature Accuracy | $\pm$ 0.7°C | $\pm$ 0.5°C |
| Maximum Inner Eyelid Surface Temperature Limit | No inner eyelid sensor or temperature limit | 44°C |
| Maximum Sustainable Therapeutic Temperature (i.e., for the duration of the procedure) | 46.74°C | Not reported |
| Maximum Absolute Temperature Limit (at any exposure time) | 47°C | Not reported |
| Maximum Outer Eyelid Surface Temperature Limit (Safety Limit) | 46.99°C for 2 seconds prior to automatic temperature downregulation | No outer eyelid sensor or temperature limit |
| Rate of Heating (time to reach target temperature) |