(323 days)
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Not Found
No
The device description details a system that applies controlled heat and pressure based on pre-set parameters and physician input, without mentioning any adaptive learning, pattern recognition, or data analysis that would indicate AI/ML. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Applicable".
Yes
The device is described as applying "localized heat and pressure therapy" to treat chronic cystic conditions of the eyelids, which directly indicates a therapeutic purpose.
No.
The LipiFlow® System is intended for therapy (localized heat and pressure therapy), not for diagnosis. Although it monitors temperature and pressure, these are for controlling the therapeutic application, not for diagnosing a condition.
No
The device description clearly outlines hardware components including a Disposable unit with an Eye Cup, Lid Warmer, tubing, and wiring, and a Handheld Control System (HCS) with a display, power switch, push button, electronic circuit board, pump, pressure regulator, pressure sensor, dump valve, connector, and battery compartment. This is not a software-only device.
Based on the provided information, the LipiFlow® 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.
- LipiFlow® System Function: The LipiFlow® System is a therapeutic device that applies localized heat and pressure directly to the eyelids of the patient. It does not analyze any biological specimens.
- Intended Use: The intended use is for the application of therapy for a specific condition (MGD), not for diagnosing or analyzing a sample.
- Device Description: The description details a system that physically interacts with the patient's eyelids to deliver heat and pressure. There is no mention of collecting or analyzing samples.
Therefore, the LipiFlow® System falls under the category of a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
ORZ
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.
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
Physician / In-office procedure
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
§ 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.
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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)
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.
LIMITATIONS
- Caution: Federal Law restricts this device to sale by or on the order of a physician.
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PLEASE REFER TO THE LABELING FOR A MORE COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
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.
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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.
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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"
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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