(323 days)
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.
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.
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 |
§ 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.