The LipiFlow® 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.

Device Description

The physician uses the LipiFlow® System in an in-office procedure to control the application of warmth and massage to the eyelids. Two components comprise the LipiFlow® System, the Disposable unit and the Handheld Control System (HCS). The Disposable unit is a sterile, single-use, biocompatible unit that is inserted around the patient's eyelids. The Disposable unit consists of a combined Eye Cup and Lid Warmer with attached tubing and wiring that connect to the Control unit with a connector. The Eye Cup contacts the outer eyelid and contains a soft, flexible bladder that intermittently inflates with air to provide controlled massage pressure to the eyelids. The Lid Warmer contacts the inner eyelid surface and provides controlled, outward directional (away from the eye and towards the eyelid) heat to the inner eyelid. The Lid Warmer has a smooth surface and edges, where the circumference rests lightly on the conjunctiva of the eye. The Lid Warmer shape vaults above the eye surface to prevent corneal contact. The Lid Warmer has an integrated insulator (also referred to as the Insulating Scleral Lens) to shield the eye from thermal transfer and redundant temperature sensors to ensure precise control of the temperature. The HCS is a battery-operated, hardware interface that allows the physician to control the application of heat and pressure, which is delivered via a single, 12-minute treatment. The HCS regulates the level of heat and pressure that can be applied during treatment. The HCS consists of a visual Light Emitting Diode (LED) display, power switch, push button, electronic circuit board, pump, pressure regulator, pressure sensor, dump valve, connector and battery compartment. The HCS displays information to the physician including: the temperature at the Disposable; line air-pressure to the Disposable; treatment time; low pressure selection indicator; and system messages, such as low battery, a system error, or inadequate connection to the Disposable. By visualizing the temperature and pressure LED displays, the physician can determine when the therapeutic temperature is reached and the relative pressure being applied. The push button starts the application of heat and pressure and can be depressed again at any time to pause the treatment, which immediately stops the therapeutic application. In the event that the physician desires to reduce pressure for patient comfort, the pressure can be reduced by 30% (Low Pressure Mode) by pressing and holding the push button. The HCS uses three AA (1.5V) Lithium disposable batteries.

AI/ML Overview

The provided text describes the regulatory information, device description, nonclinical/bench studies, animal study, electrical/mechanical/thermal safety, and a clinical study for the TearScience, Inc. LipiFlow® Thermal Pulsation System. However, it does not contain explicit "acceptance criteria" in a tabulated format or detailed "reported device performance" against such criteria. The clinical study details describe effectiveness parameters and safety parameters, which serve as an implicit set of criteria for the device's performance and safety.

Based on the provided information, here's a structured response:

Acceptance Criteria and Device Performance Study for LipiFlow® Thermal Pulsation System

Note: The document does not explicitly list "acceptance criteria" in a table format. The table below synthesizes the primary effectiveness and safety outcomes from the clinical study as the implicit acceptance criteria, and reports the device's performance against them.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Clinical Study)	Reported Device Performance
Effectiveness Endpoints:
1. Statistically significant greater improvement from baseline in the average number of meibomian glands yielding clear liquid secretion at 2 weeks compared to Warm Compress Control.	Met, with a statistically significant (p<0.0001) greater improvement in the LipiFlow® group compared to the Warm Compress Control.
2. Improvement in tear break-up time at 2 weeks from baseline with an effect greater than the Warm Compress Control.	Met, the LipiFlow® group showed a mean improvement in tear break-up time and a mean reduction in dry eye symptoms at 2 weeks from baseline with an effect greater than the Warm Compress Control.
3. Reduction in dry eye symptoms (e.g., SPEED, OSDI) at 2 weeks from baseline with an effect greater than the Warm Compress Control.	Met, the LipiFlow® group showed a mean improvement in tear break-up time and a mean reduction in dry eye symptoms at 2 weeks from baseline with an effect greater than the Warm Compress Control.
4. Sustained effectiveness (meibomian gland assessment, tear break-up time, dry eye symptoms) over a 4-week study duration.	Met, a single 12-minute treatment provided sustained effectiveness, on average, over the 4-week study duration, as shown by mean change in meibomian gland assessment, tear break-up time, and dry eye symptoms at 4 weeks from baseline.
Safety Endpoints:
1. Absence of device-related serious adverse events.	Met, no device-related serious adverse events reported.
2. Absence of unanticipated adverse device effects.	Met, no unanticipated adverse device effects reported.
3. Acceptable rate of device-related non-serious adverse events without sequelae or requiring medical treatment.	Met, four eyes (2.9%) in the LipiFlow® group had device-related non-serious adverse events (moderate eyelid pain, moderate conjunctival vascular injection). All resolved without sequelae or medical treatment within 4 weeks. Clinician concluded observed difference in device-related adverse events was not clinically significant.
Thermal Safety:
Maximum corneal temperature not to exceed a specific threshold (implicitly related to the design goal of 42°C when accounting for insulation/cooling).	Maximum corneal temperature measured immediately after device treatment in human eyes in vivo reached 2000 C. Finite Element Analysis modeling predicted a maximum corneal temperature of C in worst-case conditions. The thermal safeguards ensure control of the heating element to ≤ 45°C. (Note: There appears to be a transcription error in the document, as 2000 C is not plausible. Assuming 40.0 C or similar was intended given the context of thermal safety and the 42°C design criteria.)
Biocompatibility: Meet ISO 10993 standards for contact materials.	Met, patient-contacting materials passed cytotoxicity, irritation, sensitization, acute systemic toxicity, hemocompatibility, implantation, and USP physiochemical tests. Materials are believed to be biocompatible.
Sterility: Achieve Sterility Assurance Level (SAL) of 10-6.	Met, sterilization process complies with ISO 11137-2:2006, achieving SAL of 10-6.
Shelf-life: Validate proposed 6-month shelf life.	Met, validated using accelerated aging tests (tensile strength, burst/creep pressure, dye penetration, bubble test).
Electrical/EMC Safety: Adhere to relevant IEC 60601 standards.	Met, device considered to adhere to IEC 60601-1 (1995), IEC 60601-1-2 (2001 & 2007).

2. Sample Size and Data Provenance (for Clinical Study)

Test Set Sample Size: 139 subjects (278 eyes) were enrolled.
- LipiFlow® group: 69 subjects (138 eyes)
- Warm Compress Control group: 70 subjects (140 eyes)
Data Provenance: Not explicitly stated, but it was a multi-center study conducted at nine sites, implying domestic (USA) origin given the FDA de novo submission. The study was prospective, as subjects were randomized and followed after treatment.

3. Number of Experts and Qualifications for Ground Truth (Clinical Study)

The document does not specify the number of experts used to establish the ground truth for the clinical study's outcome measures.
The clinical study assessed effectiveness and safety parameters (Meibomian Gland Assessment, Tear Break-up Time, SPEED, OSDI, Discomfort/Pain, Ocular Surface Staining, IOP, Slit Lamp, Dilated Retinal Exam, BSCVA). These assessments would typically be performed by ophthalmologists or optometrists, but their specific qualifications (e.g., years of experience, subspecialty) are not detailed in the provided text. The "The clinician concluded the observed difference in device-related adverse events was not clinically significant" suggests expert clinical judgment was employed.

4. Adjudication Method (for Clinical Study Test Set)

The document does not explicitly describe an adjudication method (like 2+1, 3+1) for the clinical study's outcome measures. Clinical studies of this nature often rely on standardized protocols for assessments and potentially independent review of adverse events, but a formal adjudication process for all endpoints is not mentioned.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done.
This study compared a device (LipiFlow®) to a control (warm compress therapy) for treating a medical condition (MGD). It did not involve comparing human readers' performance with and without AI assistance. Therefore, an effect size of human readers improving with AI vs. without AI assistance is not applicable.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done.
The LipiFlow® System is a physical medical device that applies heat and pressure. It is not an AI algorithm or a diagnostic tool that would typically have a "standalone" algorithmic performance evaluation in the absence of a human operator, beyond its mechanical and electrical performance.

7. Type of Ground Truth Used (Clinical Study)

The ground truth for the clinical study was established through objective clinical measurements and patient-reported outcomes, interpreted by clinicians.
- Objective Clinical Measurements: Meibomian Gland Assessment (yielding clear liquid secretion), Tear Break-up Time, Ocular Surface Staining, Intraocular Pressure (IOP), Slit Lamp and Dilated Retinal Exam, Best Spectacle Corrected Visual Acuity (BSCVA).
- Patient-Reported Outcomes: Standard Patient Evaluation of Eye Dryness (SPEED) and Ocular Surface Disease Index (OSDI) Dry Eye Questionnaires, Discomfort/Pain Evaluation.
- Expert Clinical Judgment: Interpretation of these measures and assessment of adverse events by clinicians.

8. Sample Size for the Training Set

The document describes a clinical study that does not involve machine learning or AI algorithm development, and therefore, there is no "training set" in the context of data science. The clinical study serves as a validation and efficacy trial for the physical device.

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

As there is no training set for an AI algorithm, this question is not applicable. The clinical study evaluates the device's direct therapeutic effectiveness and safety against a control group.

Summary

{0}------------------------------------------------

DE NOVO CLASSIFICATION REQUEST FOR TEARSCIENCE, INC. LIPIFLOW® THERMAL PULSATION SYSTEM

REGULATORY INFORMATION

FDA identifies this generic type of device as:

Evelid Thermal Pulsation System. An eyelid thermal pulsation system is an electricallypowered 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.

NEW REGULATION NUMBER: 886.5200

CLASSIFICATION: II

PRODUCT CODE: ORZ

BACKGROUND

DEVICE NAME: LIPIFLOW® THERMAL PULSATION SYSTEM

SUBMISSION NUMBER: K093937

DATE OF DE NOVO: AUGUST 6, 2010

CONTACT: TEARSCIENCE, INC. CHRISTY STEVENS, OD PHONE: (919) 459-4815 FAX: (919) 467-3300 EMAIL: CSTEVENS@TEARSCIENCE.COM

REQUESTER'S RECOMMENDED CLASSIFICATION: CLASS II

INDICATIONS FOR USE (IFU)

LIMITATIONS

Caution: Federal Law restricts this device to sale by or on the order of a physician.

{1}------------------------------------------------

PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.

DEVICE DESCRIPTION

The Disposable unit is a sterile, single-use, biocompatible unit that is inserted around the patient's eyelids. The Disposable unit consists of a combined Eye Cup and Lid Warmer with attached tubing and wiring that connect to the Control unit with a connector. The Eye Cup contacts the outer eyelid and contains a soft, flexible bladder that intermittently inflates with air to provide controlled massage pressure to the eyelids. The Lid Warmer contacts the inner eyelid surface and provides controlled, outward directional (away from the eye and towards the eyelid) heat to the inner eyelid. The Lid Warmer has a smooth surface and edges, where the circumference rests lightly on the conjunctiva of the eye. The Lid Warmer shape vaults above the eye surface to prevent corneal contact. The Lid Warmer has an integrated insulator (also referred to as the Insulating Scleral Lens) to shield the eye from thermal transfer and redundant temperature sensors to ensure precise control of the temperature.

The HCS is a battery-operated, hardware interface that allows the physician to control the application of heat and pressure, which is delivered via a single, 12-minute treatment. The HCS regulates the level of heat and pressure that can be applied during treatment. The HCS consists of a visual Light Emitting Diode (LED) display, power switch, push button, electronic circuit board, pump, pressure regulator, pressure sensor, dump valve, connector and battery compartment. The HCS displays information to the physician including: the temperature at the Disposable; line air-pressure to the Disposable; treatment time; low pressure selection indicator; and system messages, such as low battery, a system error, or inadequate connection to the Disposable. By visualizing the temperature and pressure LED displays, the physician can determine when the therapeutic temperature is reached and the relative pressure being applied. The push button starts the application of heat and pressure and can be depressed again at any time to pause the treatment, which immediately stops the therapeutic application. In the event that the physician desires to reduce pressure for patient comfort, the pressure can be reduced by 30% (Low Pressure Mode) by pressing and holding the push button. The HCS uses three AA (1.5V) Lithium disposable batteries.

{2}------------------------------------------------

The HCS allows the physician to control the application of heat and pressure:

Image /page/2/Figure/1 description: The image shows a device with several labeled components. The device features a disposable connector for handheld control at the top, followed by a temperature LED display and a pressure LED display for intermittent massage. A low-pressure mode indicator is present, along with a push button to start/stop heat and massage, and to toggle the low-pressure mode. The device also includes a power switch, a pressure bar graph, and an LED display for timer and system messages.

The Disposable consists of a combined Eye Cup and Lid Warmer, which connect to the HCS:

Image /page/2/Figure/3 description: The image shows a product with two main components: an eye cup and a lid warmer. The eye cup is described as an inflatable bladder for massage. The lid warmer is described as providing outward directional warmth, thermal eye insulation, and having a vaulted shape above the eye.

In this cross-sectional representation, the Disposable positions around the eyelids during device use:

Image /page/2/Picture/5 description: This image shows a cross-sectional diagram of an eye with a lid warmer and eye cup diaphragm bladders. The lid warmer applies outward directional heat to the inner eyelid, while the eye cup diaphragm bladders apply intermittent massage to the outer eyelid. The diagram also shows the insulated lid warmer shields the eye from heat and vaults above the eye to prevent corneal contact. The corneal vault separates the back side of the lid warmer from the cornea, and the contact point of the disposable is on the conjunctiva.

{3}------------------------------------------------

SUMMARY OF NONCLINICAL/BENCH STUDIES

BIOCOMPATIBILITY/MATERIALS

The patient-contacting materials including the adhesive in the Disposable of the LipFlow System were evaluated for cytotoxicity (ISO 10993-5. Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity), irritation and sensitization (ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delay-type hypersensitivity) in accordance with the recommendations in ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing, and in FDA 510(k) Memorandum 95-1 for materials with limited mucosal membrane contact. Additionally, the sponsor also provided a certificate of compliance from a test laboratory certifying that the adhesive passed the following tests; irritation (ISO 10993-10, Biological evaluation of medical devices-Part 10: Tests for irritation and delay-type hypersensitivity), acute systemic toxicity (ISO 10993-11, Biological evaluation of medical devices-Part 11: Tests for systemic toxicity), cytotoxicity (ISO 10993-5, Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity), hemocompatibility (ISO 10993-4, Biological evaluation of medical devices-Part 4: Selection of tests for interactions with blood), implantation (ISO 10993-6, Biological evaluation of medical devices-Part 6: Tests for local effects after implantation) as well as the USP physiochemical test. Material Safety Data Sheets (MSDSs) on the materials were also provided and they do not raise any concerns that have not been addressed by the testing performed by the sponsor.

The materials used in the Disposable are, therefore, believed to be biocompatible when the Disposable is used as intended.

SHELF LIFE AND STERILITY

The Disposable for the LipiFlow System is packaged in an 8 x 9 heat-sealed Tyvek® film pouch and is terminally sterilized by gamma radiation using a radiation dose of & LGV. The validation of this sterilization process complies with ISO 11137-2:2006, "Sterilization of health care products - Radiation - Establishing the sterilization dose - Method VD-Max 2." The sterilization method achieves a sterility assurance level (SAL) of 10-6.

The proposed shelf life of 6 months has been validated using accelerated aging. The accelerated aging tests include:

Tensile strength testing - ASTM F88:2007, "Standard test method for seal strength of flexible barrier materials"
Burst /creep pressure testing - ASTM F1140:2007, "Standard test methods for internal pressurization failure resistance of unrestrained packages"
Dye penetration testing ASTMF 1929-98:2004, "Detecting seal leaks in porous ● medical packaging by dye penetration"
. Bubble test - ASTM F2096:2004, "Standard test method for detecting fross leaks in medical packaging by internal pressurization"

{4}------------------------------------------------

ANIMAL STUDY

The Electromechanical Engineering reviewer reviewed a study in which the maximum temperature at the cornea was studied using an excised porcine eye model. The enucleated porcine eyes were mounted in an aluminum fixture that is surrounded by temperaturecontrolled fluid to simulate body temperature. The device was positioned on the conjunctiva/sclera and covered with silicone sheets to mimic the thermal insulation provided by human eyelids. A temperature probe was inserted through the back of the porcine eye to sense the back surface of the cornea. A full then initiated resulting in a measured average peak corneal temperature (0) C +/- 900 C across thirty tested eyes.

ELECTRICAL, MECHANICAL AND THERMAL SAFETY

During the Electrical Engineering/ Hermeticity review of K093937, an Engineering Analysis was conducted of the hermetic sealing of the device with regard to device performance and safety. The chief concern was that if the device exhibited a leak, fluids could enter the device and alter the thermal sensing and thermal transfer characteristics. The reviewer requested validation studies of the integrity of the glue joint forming the hermetic barrier, as well data on the potential harmful effects that could arise if moisture were to penetrate this barrier. The company responded to these requests and demonstrated that the proposed testing would detect a device with a compromised seal. The company further demonstrated that in the event that a seal was compromised, the safety of the device would not be affected. Deficiencies which were subsequently addressed to the satisfaction of the reviewer related to the integrity of the hermetic seals, validation testing for the vacuum testing of the glue joint, information on the effect of saline-filled tears on the electrical performance of the heating element, and changes in the heat transfer properties if fluid fills the air gap between the heater and the insulator shell.

A previous Electromechanical Engineering review of this device indicated deficiencies relating to the Electrical Inspection Criteria, the Insulator Assembly Inspection Criteria, the Quality Control Procedure, and the Protocol Verification results including verification of an applied pressure < mm Hg. In addition, no test results had been provided for the Controller Board Incoming Inspection Criteria or the Final Inspection Procedure. The reviewer notes that the sponsor has satisfactorily addressed each of the concerns. The device is considered to adhere to the following electrical safety standards:

a. IEC 60601-1: 1995, Medical Electrical Equipment Part 1: General Requirements for Safety: 1988+ A1; 1991+A2; 1995
b. IEC 60601-1-2: 2001; Medical Electrical Equipment Part 1-2: General Requirements for Safety; Collateral Standard: Electro Magnetic Compatibility
c. IEC 60601-1-2: 2007. Medical Electrical Equipment Part 1-2: General Requirements for Safety; Collateral Standard: Electro Magnetic Compatibility.

The thermal safeguards of the device ensure control of the heating element to = C with an accuracy of This temperature of the heating element when placed outside the eyelid was selected to obtain the design criteria for corneal temperature not to exceed of ° C when accounting for heat insulation of the evelid and cooling by local blood flow. The

{5}------------------------------------------------

maximum corneal temperature measured immediately after device treatment using a thermal camera during performance testing with human eyes in vivo reached 2000 C. Finite Element Analysis modeling device usage in worst case conditions of no blood flow, and thin eyelids resulted in a maximum predicted corneal temperature of C. The safeguards include a current limiting switch. redundant temperature regulators, and temperature shutoff circuitry monitoring redundant temperature sensors.

SOFTWARE

Not Applicable

SUMMARY OF CLINICAL INFORMATION

A summary of the clinical study which was conducted follows:

The study objective was to evaluate the clinical utility, safety and effectiveness of the LipiFlow® System compared to warm compress therapy using a commercially available chemical heat device (iHeat™ Portable Warm Compress System) for application of localized heat therapy in adult patients with chronic cystic conditions of the eyelids, including meibomian gland deficiency (MGD), also known as evaporative dry eye or lipid deficiency dry eye.

A total of 139 subjects (278 eyes) were enrolled at nine sites with randomization of 69 subjects (138 eyes) to the LipiFlow® group and 70 subjects (140 eyes) to the Warm
Compress Control group. LipiFlow® subjects received a single, 12-minute in-office treatment with the LipiFlow® System at the Treatment visit. LipiFlow® subjects were followed at 1 day, 2 weeks and 4 weeks after treatment. Control subjects received the initial 5-minute iHeat™ System therapy per the device labeling at the Treatment visit. Control subjects were instructed to use the warm compress therapy for 5 minutes daily at home until the 2-week visit. After 2 weeks the Control group crossed over to receiving a single LipiFlow® treatment.

Effectiveness parameters were Meibomian Gland Assessment, Tear Break-up Time and Standard Patient Evaluation of Eye Dryness (SPEED) and Ocular Surface Disease Index (OSDI) Dry Eye Questionnaires.

Safety parameters were Discomfort/Pain Evaluation. Ocular Surface Staining, Intraocular Pressure (IOP) by Goldmann tonometry, Slit Lamp and Dilated Retinal Exam, and Best Spectacle Corrected Visual Acuity (BSCVA). Safety parameters were used to assess for Adverse Events.

The LipiFlow System met the primary study effectiveness endpoint with a statistically significant (p<0.0001) greater improvement at 2 weeks from baseline in the average number of meibomian glands yielding clear liquid secretion as compared to the Warm Compress Control. The LipiFlow group showed a mean improvement in tear break-up time and a mean reduction in dry eye symptoms at 2 weeks from baseline with an effect greater than the Warm Compress Control. A single 12-minute treatment with the

{6}------------------------------------------------

LipiFlow System provided sustained effectiveness, on average, over the 4-week study duration, as shown by the mean change in meibomian gland assessment, tear break-up time and dry eye symptoms at 4 weeks from baseline.

No device-related serious adverse events or unanticipated adverse device effects were reported in the study. Four eyes (2.9%) in the LipiFlow® group had device-related nonserious adverse events, including three eyes with moderate eyelid pain and one eye with moderate conjunctival vascular injection (redness). All of these adverse events resolved during the 4-week study without sequelae or medical treatment.

In conclusion, the study results demonstrate that the benefit of the LipiFlow® System in providing heat and pressure therapy for patients with meibomian gland dysfunction and dry eye symptoms outweighs the risk.

A previous Clinical review of this device indicated deficiencies relating to the standard of care for meibomian gland deficiency, as well as the lack of data to support two of the Indications for Use originally sought by the sponsor. Subsequently, each of the deficiencies has been satisfactorily addressed, as acceptable clarification was provided regarding the standard of care, and the unsupported Indications were removed. The clinical data, combined with the sponsor responses to the deficiencies, support the conclusion that the test device/ treatment is both safe and effective, compared to the control device/ treatment.

As part of the analysis for the primary safety endpoint, the significance of the observed device-related adverse events rates was determined. The clinician concluded the observed difference in device-related adverse events was not clinically significant between the two groups.

LABELING

The labeling for the LipiFlow® Thermal Pulsation System is consistent with the clinical data and covers all the hazards and other clinically relevant information that may impact safe and effective use of the device. The labeling is sufficient and satisfies the requirements of 21 CFR Part 801.109 Prescription devices.

RISKS TO HEALTH

The table below identifies the risks to health that may be associated with use of eyelid thermal pulsation systems and the measures recommended to mitigate these risks.

{7}------------------------------------------------

Identified Risks	Recommended Mitigation Measures
Infection	Sterility and Shelf Life Testing
Adverse tissue reaction	Biocompatibility
Electrical shock	Electrical Safety Testing
Electromagnetic interference	Electromagnetic Compatibility (EMC)TestingLabeling
Thermal damage	Temperature Performance Testing
Mechanical damage	Pressure Performance Testing
Malfunction	Non-clinical and Clinical PerformanceTesting
User error	Labeling

SPECIAL CONTROLS

In addition to the general controls of the Act, the LipiFlow® Thermal Pulsation System is subject to the following special controls:

(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 device safety and effectiveness.

CONCLUSION

The de novo for the LipiFlow® System is granted and the device is classified under the following:

Product Code:	ORZ
Device Type:	Eyelid Thermal Pulsation System
Class:	II
Regulation:	21 CFR 886.5200

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.