(93 days)
Not Found
No
The document describes a device for heat and pressure therapy and image/video capture, but there is no mention of AI or ML being used for image analysis, treatment control, or any other function. The control of heat and pressure is explicitly stated to be under the direct control of the Eye Care Professional.
Yes
The device is indicated for "application of localized heat and pressure therapy" to treat Melbonian Gland Dysfunction (MGD), directly addressing a medical condition.
Yes
The device captures and stores digital images and video of the meibomian glands, and these images can be used in meibography (visual morphology of meibomian glands) for visualization and assessment.
No
The device description explicitly states that the "Reusable, Hand-Held Instrument Incorporates hardware, software, and mechanics" and lists several other hardware components like a docking station, AC power supply, photography tip, and smart tip. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, the Systane iLux2 is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens from the human body. The Systane iLux2 directly interacts with the patient's eyelid and meibomian glands. It does not analyze samples like blood, urine, or tissue that have been removed from the body.
- The primary function is treatment and imaging. While it captures images for meibography, its core function is applying heat and pressure therapy to treat Meibomian Gland Dysfunction.
- The imaging is for visualization and assessment, not for analyzing a specimen. The images are used by the Eye Care Professional to visualize the glands and assess their morphology, not to perform a diagnostic test on a biological sample.
The device is a therapeutic device with an imaging component that aids in the diagnosis and monitoring of the condition, but it does not fit the definition of an IVD.
N/A
Intended Use / Indications for Use
The Systane iLux2 is indicated for the application of localized heat and pressure therapy in adult patients with Melbonian Gland Dysfunction (MGD), which is associated with evaporative dry eye, and to capture/store digital images and video of the meibomian glands.
Product codes (comma separated list FDA assigned to the subject device)
ORZ, HKI
Device Description
The Subject Device is indicated for the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye. The device can capture images and videos of the eyelid margin and meibomian glands. These images can be use in meibography (i.e., visual morphology of meibomian glands).
In treatment mode, light-based heat is used to warm the eyelid tissue to a target range of 38-44 ℃ to melt the meibum blocking the gland orifices. The Eye Care Professionals (ECP) can apply compression to the eyelid to express the meibum through the orifices. At all times, the amount of the heat and pressure applied is under direct control of the ECP who monitors the response of the glands and the comfort of the patient. The inner eyelid temperature is displayed during the treatment process. The source of heating is lime-green and IR optical radiation produced by LEDs incorporated in the Instrument. Images and video can be captured during treatment.
In meibography mode, infrared (IR) light is used in the visualization of meibomian gland morphology. Images can be captured with IR or white light. Video is captured only with white light.
The Subject Device consists of the following:
- Reusable, Hand-Held Instrument Incorporates hardware, software, and . mechanics to facilitate treatment and imaging.
The Instrument incorporates an LCD touchscreen user interface that is used to view the eyelid margin as well as provides instructions to the ECP during use. Selections can be made through the user interface and images/video can be viewed.
The Instrument is powered by a rechargeable lithium ion battery.
- Docking Station Is used to charge the Instrument's internal battery and transfer . images/video to an external monitor or PC.
- . AC Power Supply - Transfer electricity for the AC electrical outlet to the Docking Station.
- . Photography Tip (Photo Tip) - Is reusable, up to a specified number of attachments, and when coupled with the Instrument it is used to capture images and video. There is electronics in the Photo Tip that interfaces with the Instrument. The Photo Tip is positioned on the cheek bone or eyebrow. The patient contacting material is biocompatible.
- . Smart Tip Patient Interface (Smart Tip) - Is sterile and single-use that when coupled with the Instrument treatment can be provided. There is electronics in the Smart Tip that interfaces with the Instrument. A feature of the Smart Tip is positioned behind the eyelid during the treatment process. The patient contacting material is biocompatible.
- USB & HMDI Cable Attaches Docking Station to external monitor/PC. .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyelids, meibomian glands
Indicated Patient Age Range
Adult patients
Intended User / Care Setting
Eye Care Professionals (ECP)
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)
A program of design verification and validation testing was performed that includes the following:
- Biocompatibility ●
- Sterility and EO Residual
- Packaging Integrity (i.e., Sterile Barrier)
- Transportation
- Optical Radiation Safety ●
- Electromagnetic Compatibility and Electrical Safety
- Stability/Shelf-Life
- Performance/Functionality/Safety ●
- Software .
- Simulated Use (Human Factors Evaluation) ●
Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.
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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The seal features a stylized depiction of a human figure, while the text is in a clear, sans-serif font, with "FDA" in a blue square.
May 21, 2020
Tear Film Innovations, Inc. Neal Hartman Sr. Director, Regulatory Affairs/Quality Assurance 5924 Balfour Court, Suite 100 Carlsbad, CA 92008
Re: K200400
Trade/Device Name: Systane iLux2 Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ, HKI Dated: April 15, 2020 Received: April 16, 2020
Dear Neal Hartman:
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.
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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products
1
(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 entitled, "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-device-safety/medical-device-reportingmdr-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K200400
Device Name Systane iLux2
Indications for Use (Describe)
The Systane iLux2 is indicated for the application of localized heat and pressure therapy in adult patients with Melbonian Gland Dysfunction (MGD), which is associated with evaporative dry eye, and to capture/store digital images and video of the meibomian glands.
Type of Use (Select one or both, as applicable)
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/0 description: The image contains the logo for Tearfilm Innovations. The logo features a stylized eye on the left, with the words "tearfilm" in blue and green to the right of the eye. Below "tearfilm" is the word "innovations" in blue.
510(K) SUMMA
Submitter Information
| Company Name: | Tear Film Innovations, Inc. |
|---|---|
| Company Address: | 5924 Balfour Court, Suite 100 |
| Carlsbad, CA 92008 | |
| Company Phone: | (760) 444-9555 |
| Company Facsimile: | (442) 244-4696 |
| Contact Person: | Neal Hartman |
| Sr. Director of Regulatory Affairs/Quality Assurance | |
| nhartman@tearfilm.com | |
| Date: | May 20, 2020 |
Device Identification
| Device Trade Name: | Systane iLux² | |
|---|---|---|
| Common Name: | N/A | |
| Classification Names | Eyelid Thermal Pulsation | |
| System | Camera, Ophthalmic, | |
| Ac-Powered | ||
| Regulations | 886.5200 | 886.1120 |
| Device Class | 2 | 2 |
| Product Codes | ORZ | HKI |
| Advisory Panel | Ophthalmic | Ophthalmic |
ldentification of Predicate Devices
The System Device is substantially equivalent to the following device:
| Device Name | Classification Regulation | Product Code | 510(K) Number | Clearance Date |
|---|---|---|---|---|
| iLux System | 886.8200 – Eyelid Thermal Pulsation System | ORZ | K172645 | 12/26/2017 |
Device Description
The Subject Device is indicated for the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with evaporative dry eye. The device can capture images and videos of the eyelid margin and meibomian glands. These images can be use in meibography (i.e., visual morphology of meibomian glands).
4
In treatment mode, light-based heat is used to warm the eyelid tissue to a target range of 38-44 ℃ to melt the meibum blocking the gland orifices. The Eye Care Professionals (ECP) can apply compression to the eyelid to express the meibum through the orifices. At all times, the amount of the heat and pressure applied is under direct control of the ECP who monitors the response of the glands and the comfort of the patient. The inner eyelid temperature is displayed during the treatment process. The source of heating is lime-green and IR optical radiation produced by LEDs incorporated in the Instrument. Images and video can be captured during treatment.
In meibography mode, infrared (IR) light is used in the visualization of meibomian gland morphology. Images can be captured with IR or white light. Video is captured only with white light.
The Subject Device consists of the following:
- Reusable, Hand-Held Instrument Incorporates hardware, software, and . mechanics to facilitate treatment and imaging.
The Instrument incorporates an LCD touchscreen user interface that is used to view the eyelid margin as well as provides instructions to the ECP during use. Selections can be made through the user interface and images/video can be viewed.
The Instrument is powered by a rechargeable lithium ion battery.
- Docking Station Is used to charge the Instrument's internal battery and transfer . images/video to an external monitor or PC.
- . AC Power Supply - Transfer electricity for the AC electrical outlet to the Docking Station.
- . Photography Tip (Photo Tip) - Is reusable, up to a specified number of attachments, and when coupled with the Instrument it is used to capture images and video. There is electronics in the Photo Tip that interfaces with the Instrument. The Photo Tip is positioned on the cheek bone or eyebrow. The patient contacting material is biocompatible.
- . Smart Tip Patient Interface (Smart Tip) - Is sterile and single-use that when coupled with the Instrument treatment can be provided. There is electronics in the Smart Tip that interfaces with the Instrument. A feature of the Smart Tip is positioned behind the eyelid during the treatment process. The patient contacting material is biocompatible.
- USB & HMDI Cable Attaches Docking Station to external monitor/PC. .
Indications for Use
The Systane iLux2 is indicated for the application of localized heat and pressure therapy in adult patients with Meibomian Gland Dysfunction (MGD), which is associated with
5
evaporative dry eye, and to capture/store digital images and video of the meibomian glands
| Comparison
| Feature | Subject Device | Predicate Device | Reference Device |
|---|---|---|---|
| Device name | Systane iLux² | iLux System | LipiScan Dynamic |
| Meibomian Imager | |||
| Manufacturer | Tear Film Innovations, Inc. | Tear Film Innovations, Inc. | TearScience, Inc |
| (Johnson & Johnson) | |||
| Device | |||
| classification | 2 | 2 | 2 |
| Product Code | ORZ | ORZ | HKI |
| Indications for | |||
| Use | The Systane iLux² is indicated | ||
| for the application of localized | |||
| heat and pressure therapy in | |||
| adult patients with Meibomian | |||
| Gland Dysfunction (MGD), | |||
| which is associated with | |||
| evaporative dry eye, and to | |||
| capture/store digital images and | |||
| video of the meibomian glands | The iLux System is indicated | ||
| for the application of localized | |||
| heat and pressure therapy in | |||
| adult patients with chronic | |||
| disease of the eyelids, | |||
| including meibomian gland | |||
| dysfunction (MGD), also known | |||
| as evaporative dry eye. | LipiScan Dynamic | ||
| Meibomian Imager is an | |||
| ophthalmic imaging device | |||
| intended for use by a | |||
| physician in adult patients to | |||
| capture, archive, manipulate | |||
| and store digital images of | |||
| the meibomian glands. | |||
| System | |||
| components | • Reusable Handheld | ||
| Instrument | |||
| • Smart Tip Patient Interface | |||
| • Photography Tip | |||
| • Charging/Image Transfer | |||
| Station | • Reusable Handheld | ||
| Instrument | |||
| • Smart Tip Patient Interface | |||
| • Charging Station | • Computer system | ||
| • Electronics | |||
| • Chin and forehead rest | |||
| • Camera and attached | |||
| lens | |||
| • Illuminator | |||
| • Touchscreen display | |||
| • Handheld near-infrared | |||
| (IR) lid everter | |||
| • Power supply | |||
| Patient contact | |||
| system | |||
| component | • Smart Tip Patient Interface | ||
| • Photography Tip | • Smart Tip Patient Interface | • Chin and forehead rest | |
| • Handheld near-infrared | |||
| (IR) lid everter | |||
| Single use | • Smart Tip Patient Interface | • Smart Tip Patient Interface | N/A |
| Sterile | • Smart Tip Patient Interface | • Smart Tip Patient Interface | N/A |
| Method of | |||
| sterilization, | |||
| SAL | Ethylene Oxide, SAL 10-6 | Ethylene Oxide, SAL 10-6 | N/A |
| Packaging, | |||
| Sterile Barrier | Thermoform Tray/Tyvek Lidding | ||
| Stock | Tyvek Pouch | N/A | |
| System control | |||
| component | Reusable Handheld Instrument | Reusable Handheld Instrument | Window based PC |
| Software | Yes | Yes | Yes |
| Operating | |||
| orientation | Handheld | Handheld | Stationary |
| User Interface | • Touchscreen OLED Display | ||
| • Control Button | |||
| • Smart Tip Patient Interface | • Control Button | ||
| • Smart Tip Patient Interface | • Chin and forehead rest | ||
| • Touchscreen display | |||
| Comparison | |||
| Feature | Subject Device | Predicate Device | Reference Device |
| Device name | Systane iLux2 | iLux System | LipiScan Dynamic |
| Meibomian Imager | |||
| • Photography Tip | • Handheld near-infrared | ||
| (IR) lid everter | |||
| System's | |||
| component for | |||
| viewing glands | OLED Display | Magnifying Lens | Integrated Monitor |
| Tip Attachment | |||
| to Handheld | |||
| Instrument | Mechanical (identical to | ||
| Predicate) | Mechanical | N/A | |
| Patient interface | |||
| during treatment | Smart Tip Patient Interface | ||
| (identical to Predicate) | Smart Tip Patient Interface | N/A | |
| Treatment of | |||
| upper and lower | |||
| eyelids | Sequential | Sequential | N/A |
| Treatment Time | Typically, 8-12 minutes | Typically, 8-12 minutes | N/A |
| Safety-Related | |||
| Power/ Heat | |||
| Management | Dedicated Processor | Dedicated FPGA | N/A |
| Heat Source | LEDs (lime-green and IR | ||
| wavelengths) with reflective | |||
| shroud (identical to Predicate) | LEDs (lime-green and IR | ||
| wavelengths) with reflective | |||
| shroud | N/A | ||
| Rate of heating | |||
| (time to target | |||
| temperature) | 15 to 50 seconds | 15 to 50 seconds | N/A |
| Temperature, | |||
| accuracy | +/- 1.0° | +/- 1.0° | N/A |
| Target | |||
| temperature | |||
| range | 38 to 44 °C | 38 to 44 °C | N/A |
| Maximum Inner | |||
| Eyelid Surface | |||
| temperature | |||
| limit | 44 °C | 44 °C | N/A |
| Maximum Outer | |||
| Eyelid Surface | |||
| temperature | |||
| limit | 45 °C | 45 °C | N/A |
| Compression | |||
| Mechanism | Mechanical (identical to | ||
| Predicate) | Mechanical | N/A | |
| Pressure | |||
| Control | Manual via control button | ||
| (identical to Predicate): Eye | |||
| Care Professional determines | |||
| (based on patient feedback and | |||
| direct viewing of glands) | Manual via control button: Eye | ||
| Care Professional determines | |||
| (based on patient feedback | |||
| and direct viewing of glands) | N/A | ||
| Pressure type | Compression, repeated as | ||
| necessary | Compression, repeated as | ||
| necessary | N/A | ||
| Patient Interface | |||
| during Imaging | Photography Tip | N/A | • Chin and forehead rest |
| • Handheld near-infrared | |||
| (IR) lid everter | |||
| Imaging | |||
| Controls | Touchscreen display | N/A | Touchscreen display |
| Comparison | |||
| Feature | Subject Device | Predicate Device | Reference Device |
| Device name | Systane iLux2 | iLux System | LipiScan Dynamic |
| Meibomian Imager | |||
| Illumination, | |||
| Imaging | White light or infrared (IR) | No | Infrared (IR) |
| Ability to | |||
| capture images | Yes, Photography Tip use to | ||
| maintain focal point | No | Yes | |
| Meibography | |||
| imaging | Yes, Photography Tip use to | ||
| maintain focal point | No | Yes | |
| Ability to | |||
| capture video | Yes, Photography Tip use to | ||
| maintain focal point | No | No | |
| Resolution, | |||
| Onboard | 240 x 170 (Portrait) | ||
| 320 x 240 (Landscape) | N/A | Unknown | |
| Resolution, | |||
| External | 1080p (Video) | ||
| 2304 x 1536 (Images) | N/A | Unknown | |
| Image Transfer | |||
| Method | Docking station-to-HDMI cable- | ||
| to-external monitor | |||
| Docking station-to-USB cable- | |||
| to-PC | |||
| SD card-to-PC | N/A | HDMI cable to monitor | |
| USB 2.0 | |||
| Power Source/ | |||
| Charging | Batteries, DC/ Charging/Image | ||
| Transfer station via AC power | |||
| adapter | Batteries, DC/ charging station | ||
| via AC power adapter | AC | ||
| Installation | |||
| required | No | No | No |
Comparison of Technological Characteristics with Predicate and Reference Devices
6
7
Summary of Testing Performed
A program of design verification and validation testing was performed that includes the following:
- Biocompatibility ●
- Sterility and EO Residual
- Packaging Integrity (i.e., Sterile Barrier)
- Transportation
- Optical Radiation Safety ●
- Electromagnetic Compatibility and Electrical Safety
- Stability/Shelf-Life
- Performance/Functionality/Safety ●
- Software .
- Simulated Use (Human Factors Evaluation) ●
Results of the evaluations demonstrate that the Subject Device met the safety and performance requirements as it relates to its indication for use.
Conclusions Drawn from Nonclinical Evaluation
The results of the evaluation demonstrate that the Subject Device is substantially equivalent to the Predicate and Reference Devices as it pertains to the indications for use and device performance.