The iLux System is indicated for the application of localized heat and pressure therapy in adult patients with chronic diseases of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye.

Device Description

The iLux System is a medical device intended for use by Licensed Eye Care Professionals (ECP) to apply localized heat and pressure therapy to adult patients' lower and/or upper eyelids. The il.ux System consists of a hand-held Instrument coupled to a single-use sterile Disposable component that is positioned behind the eyelid. The iLux System allows the ECP to view the eyelid margin through a magnifier, then warm the eyelid tissue to a target range of 40 to 42 °C to melt the meibum blocking the gland orifices and then apply compression to the eyelid to express the melted meibum through the orifices. The inner eyelid temperature and the amount of force applied to the eyelid are both displayed on the Instrument allowing the clinician to titrate the ideal amount of heating and compression to optimize unclogging of the blocked glands.

The Disposable is a sterile, single-use component that is attached to the iLux Instrument. It includes all parts intended to contact the patient's eyelid.

The iLux Instrument is a handheld device that allows the ECP to view, heat, and compress the portion of the eyelid that is in contact with the Disposable. The source of heating is lime-green and infrared optical radiation produced by LEDs in the Instrument. The ilux Instrument is powered by a rechargeable lithium ion battery. The software Level of Concern is Moderate.

Ancillary accessories include the charging stand with AC power supply.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" as a separate table. Instead, it details that the iLux System was studied for non-inferiority against the predicate device (LipiFlow System) for specific effectiveness and safety endpoints. The "reported device performance" are the findings from this non-inferiority study.

Acceptance Criteria (Non-inferiority)	Reported Device Performance (compared to LipiFlow)
Effectiveness Endpoints:
Meibomian Gland Score (MGS) improvements from baseline	Non-inferior: MGS improved significantly from baseline in both groups at week 2 and week 4. Improvements did not differ significantly between the two groups.
Tear Break-Up Time (TBUT) improvements from baseline	Non-inferior: TBUT improved significantly from baseline in both groups at week 2 and week 4. Improvements did not differ significantly between the two groups.
Ocular Surface Disease Index (OSDI) improvements from baseline	Non-inferior: OSDI improved significantly from baseline in both groups at week 2 and week 4. Improvements did not differ significantly between the two groups.
Safety Endpoints:
Device/procedure-related adverse events (AEs)	Comparable (minor differences): Four AEs occurred in iLux arm (burning sensation, petechial hemorrhage, transient decrease in BSCVA with superficial punctate keratitis). All self-limited and resolved without sequelae.
Discomfort and pain scores (relative to baseline and predicate)	Comparable (minor differences): Pain and discomfort scores significantly lower from baseline in both groups. Immediately post-treatment, pain/discomfort was significantly lower for LipiFlow, but scores did not differ significantly between groups at day 1, week 2 (pain), or week 4 (pain). At week 4, iLux discomfort score was significantly lower.
Ocular surface staining changes from baseline	Comparable: Significantly increased immediately post-treatment in both groups, then significantly reduced relative to baseline at day 1, week 2, and week 4. No significant difference between groups.
Intraocular pressure (IOP) changes	Comparable: No clinically significant changes in IOP observed in either group.
Best Spectacle Corrected Visual Acuity (BSCVA) changes	Comparable: Significantly reduced immediately post-treatment in both groups (not clinically meaningful). Significantly improved relative to baseline at week 2 and week 4 in both groups, with no significant difference between groups.
Non-Clinical Performance Requirements (implicitly met via verification and validation)	Met: Biocompatibility, Sterility and EO Residual, Packaging Integrity, Transportation, Optical Radiation Safety, Electromagnetic Compatibility and Electrical Safety, Stability/Shelf-Life, Performance/Functionality/Safety, Software. Outcomes demonstrated the iLux System met safety and performance requirements for its indication for use.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: 142 subjects (284 eyes). The subjects were randomized into two treatment groups (iLux vs. LipiFlow) in a 1:1 ratio.
Data Provenance: The study was a clinical study, implying prospective data collection. The document does not specify the country of origin, but it was submitted to the U.S. FDA, so it's likely a study conducted in the U.S. or under international standards acceptable to the FDA.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical study endpoints (Meibomian Gland Score, Tear Break-Up Time, Ocular Surface Disease Index, pain/discomfort scores, adverse events, etc.). These metrics are typically assessed by trained clinical personnel (e.g., ophthalmologists, optometrists, or research coordinators) according to standardized protocols.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study endpoints. The assessment of endpoints like MGS, TBUT, OSDI, and adverse events would typically follow pre-defined protocols and may involve single assessors or dual assessments with a consensus process, but this is not detailed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Human-in-the-loop/MRMC study was not performed, nor was it relevant for this device. The iLux System is a therapeutic device that applies heat and pressure, not a diagnostic AI system requiring human interpretation. The study was a direct comparison of the therapeutic effect of the iLux device versus a predicate device, each operated by a licensed eye care professional.

6. Standalone (Algorithm Only Without Human-in-the-loop) Performance:

Not applicable/Not done. The iLux System is a medical device operated by a Licensed Eye Care Professional for treatment. It is not an imaging analysis algorithm or a diagnostic tool that operates independently to provide "standalone" performance. Its "performance" is its therapeutic efficacy when used by a human operator, which was assessed in the clinical study.

7. Type of Ground Truth Used:

The "ground truth" for the clinical study was established through:

Clinical Endpoints/Measurements: Meibomian Gland Score (MGS), Tear Break-Up Time (TBUT), Ocular Surface Disease Index (OSDI), pain scores, discomfort scores, ocular surface staining, Intraocular Pressure (IOP), and Best Spectacle Corrected Visual Acuity (BSCVA). These are objective and subjective measurements commonly used in ophthalmology to assess the condition of the eyes and patient well-being for MGD.
Adverse Event Reporting: Direct observation and patient reporting of any device/procedure-related adverse events.

8. Sample Size for the Training Set:

Not applicable/Not mentioned. This device does not use machine learning or AI that would require a "training set" of data in the conventional sense. It's a physical medical device. The "training" for the device would involve training the eye care professionals on how to use it.

9. How the Ground Truth for the Training Set Was Established:

Not applicable/Not mentioned. As there's no data-driven "training set" for an AI algorithm, this question is not relevant to the iLux System.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

December 26, 2016

Tear Film Innovations, Inc. John Slate Vice President, R&D 12625 High Bluff Drive, Suite 107 San Diego, CA 92130

Re: K172645

Trade/Device Name: iLux System Regulation Number: 21 CFR 886.5200 Regulation Name: Eyelid Thermal Pulsation System Regulatory Class: Class II Product Code: ORZ Dated: November 28, 2017 Received: November 29, 2017

Dear John Slate:

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. 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Srinivas Nandkumar -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172645

Device Name iLux System

Indications for Use (Describe)

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/0 description: The image shows the logo for Tearfilm Innovations. The logo features a stylized eye on the left, with a blue and green gradient. To the right of the eye is the word "tearfilm" in blue and green, with "tear" in blue and "film" in green. Below "tearfilm" is the word "innovations" in blue.

510(K) SUMMARY - K172645

Submitter Information

Company Name:	Tear Film Innovations, Inc.
Company Address:	12625 High Bluff Drive, Suite 107San Diego, CA 92130
Company Phone:	(844) 458-9776
Company Facsimile:	N/A
Contact Person:	John Slate PhDVice President of Research and Developmentjslate@tearfilm.com
Date:	December 12, 2017
Device Identification
Device Trade Name:	iLux® System
Common Name:	N/A
Classification Name(s):	Eyelid Thermal Pulsation System
Classification Regulation(s):	21 CFR 886.5200
Device Class:	Class II
Product Code(s):	ORZ
Advisory Panel:	Ophthalmic

Identification of Predicate Devices

The iLux System is substantially equivalent to the following device, which was cleared for commercial distribution in the United States:

The LipiFlow Thermal Pulsation System manufactured by TearScience, Inc. and cleared for commercial distribution under 510(k): K133127.

Device Description

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the melted meibum through the orifices. The inner eyelid temperature and the amount of force applied to the eyelid are both displayed on the Instrument allowing the clinician to titrate the ideal amount of heating and compression to optimize unclogging of the blocked glands.

The Disposable is a sterile, single-use component that is attached to the iLux Instrument. It includes all parts intended to contact the patient's eyelid.

Ancillary accessories include the charging stand with AC power supply.

Indications for Use

Comparison Feature	The iLux® SystemTear Film Innovations Inc.	LipiFlow® Thermal Pulsation SystemTearScience, Inc.
Single Patient Use?	Yes	Yes
Provided Sterile?	Yes	Yes
Method of sterilization, SAL(Pertinent to Disposable)	Ethylene Oxide, SAL 10-6	Gamma, SAL 10-6
Biocompatibility Testing (ISO10993-1), of Patient ContactMaterials(Pertinent to Disposable)	Yes, Silicone Cover	Yes, Silicone and UV Cured Adhesive
Packaging(Pertinent to Disposable)	Sealed Pouch	Sealed Tray
Controller ComponentCharacteristics	Instrument, Model 2020	Console, Model LFTP-1000
Operating Orientation	Handheld	Desktop
Temperature accuracy	+/- 1.0°	+/- 0.5°
Target temperature range	40 to 42 °C	40 to 43 °C
Maximum Inner Eyelid Surfacetemperature limit	44 °C	44 °C
Maximum Outer EyelidSurface temperature limit	45 °C	No outer eyelid sensor ortemperature limit
Heat Source	LEDs (lime-green and IRwavelengths)	Resistive (plastic) electric heater
Rate of heating(time to target temperature)	15 to 50 seconds	10 to 60 seconds
Glands can be viewed duringprocedure	Yes, through magnifier	Not visible

Comparison of Technological Characteristics with Predicate Device

Tear Film Innovation, Inc. Traditional 510(k) Premarket Notification iLux System

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Comparison Feature	The iLux® SystemTear Film Innovations Inc.	LipiFlow® Thermal Pulsation SystemTearScience, Inc.
Pressure Control	Manual: Eye Care Professionaldetermines (based on patientfeedback and direct viewing ofglands)	Automatic: Pre-programmed with someadjustment allowed by Eye CareProfessional
Pressure type	Compression, repeated asnecessary	Massage
Treatment of upper and lowerevelids	Sequential	Concurrent
Treatment Time	Typically, 8-12 minutes	12 minutes
Software	Yes	Yes
Power Source	Batteries, DC Power	AC Power
Safety per IEC 60601-1 & -2	Meets Requirements	Meets Requirements

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
Stabilitv/Shelf-Life .
Performance/Functionality/Safety ●
Software
Clinical performance ●

Results of the evaluations demonstrate that the iLux System met the safety and performance requirements as it relates to its indication for use.

Clinical Study Summary

A clinical study was conducted to verify that the technological differences between the iLux System and the LipiFlow System (i.e., predicate) do not adversely affect safety and effectiveness as it relates to indications for use.

142 subjects (284 eyes) participated in the study, comprised of 101 women and 41 men, ages 19 to 86 years (mean = 54.9 ± 15.3 years). The subjects were randomized for treatment, in a 1:1 ratio into the treatment groups (i.e., iLux, LipiFlow).

The iLux arm of the study met the criteria for non-inferiority relative to the LipiFlow arm for the coprimary effectiveness endpoints - Meibomian Gland Score (MGS) and Tear Break-Up Time (TBUT) and the secondary effectiveness endpoint - Ocular Surface Disease Index (OSDI).

. MGS improved significantly from baseline in both treatment groups at both week 2 and week 4. MGS improvements did not differ significantly between the two treatment groups at either follow-up visit.

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. TBUT improved significantly from baseline in both treatment groups at both week 2 and week 4. TBUT improvements did not differ significantly between the two treatment groups at either follow-up visit.
OSDI improved significantly from baseline in both treatment groups at both week 2 and . week 4. OSDI improvements did not differ significantly between the two treatment groups.

There was a total of four device/procedure-related adverse events (AEs) of any type. All AEs were observed in the iLux arm and consisted of: burning sensation without skin findings (n=2), petechial hemorrhage in lower lids (n=1), and transient decrease in BSCVA with findings of superficial punctate keratitis (n=1). All were self-limited, transient, and resolved without sequelae.

The secondary safety endpoints were: 1) discomfort and pain, and 2) changes from baseline for ocular surface staining, Intraocular pressure (IOP), and BSCVA (Best Spectacle Corrected Visual Acuity).

. Pain scores were significantly lower from the baseline for both treatment groups, immediately post-treatment, and at day 1, week 2 and week 4. Immediately posttreatment, the mean pain score was significantly lower for the LipiFlow arm than for the iLux. Pain scores did not differ significantly between the two treatment groups at day 1, week 2, or week 4.
. Discomfort scores were significantly lower from the baseline for both treatment groups, immediately post-treatment, and at day 1, week 2 and week 4. Immediately posttreatment, the mean discomfort score was significantly lower for the LipiFlow arm than for the iLux. Improvements in discomfort scores did not differ significantly between the two treatment groups at day 1 or week 2. At week 4, however, the discomfort score was significantly lower for the iLux group.
Ocular surface staining was significantly increased immediately following treatment in both . treatment groups. At day 1, week 2, and week 4, the ocular surface staining significantly reduced relative to baseline in both treatment groups however did not differ significantly between the two treatment groups.
. No clinically significant changes in IOP were observed immediately post-treatment or throughout follow-up in either treatment group.
BSCVA was significantly reduced relative to baseline immediately post-treatment in both . treatment groups but not to a clinically meaningful level. At week 2 and week 4, BSCVA was significantly improved relative to baseline in both treatment groups, but the change was not different between treatment groups.

Conclusions Drawn from Nonclinical & Clinical Evaluation

The results of the evaluation demonstrate that the iLux System is substantially equivalent to the LipiFlow Thermal System as it pertains to the indications for use and device performance.

Regulation Number and Section

§ 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.

Srinivas Nandkumar -S

Indications for Use

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510(K) SUMMARY - K172645

Submitter Information

Identification of Predicate Devices

Device Description

Indications for Use

Comparison of Technological Characteristics with Predicate Device

Summary of Testing Performed

Clinical Study Summary

Conclusions Drawn from Nonclinical & Clinical Evaluation

§ 886.5200 Eyelid thermal pulsation system.

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