(94 days)
The LipiFlow Thermal Pulsation System is intended for the application of localized heat and pressure therapy in adult patients with chronic cystic condictions of the eyelids, including meibomian gland dysfunction (MGD), also known as evaporative dry eye or lipid deficiency dry eye.
The LipiFlow® Thermal Pulsation System is used by a physician in an in-office procedure for patients with chronic cystic conditions of the eyelids to provide controlled heat to the inner eyelid surface, close to the location of the meibomian glands, and intermittent prossure the outer eyelid to facilitate release of lipid from the cystic meibomian glands. The LipiFlow System is comprised of physician interface (Control component) and a patient interface (Disposable component). There are two models of the Control component: Model LFH-1000, Handheid Control System (HCS) and Model LFTP-1000, Console. The Console is a rhange in design from the HCS predicate device model. The LipiFlow® Console was developed fring the same treatment control technology as in the LipiFlow® FICS with enhancements in the user interface and power source. Both the Console and HCS work with the same Disposable component (Model LFD-1000), now labeled as Activator (Disposable).
The Activator (Disposable) is a sterile, single-use, biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's cyelids. The Activator (Disposable) consists of a combined eye cup and lid warmer with attached tubing and wiring that connect to the Console with a connector.
The Console is an AC-powered, bench-top device used by the physician to control the application of heat and pressure to the patient's eyelids. The Console consists of a Windows XP embedded computer subsystem with touchscreen display and a software graphical user interface; and treatment hardware for treatment of the patient's right and left eyes using two Activators (Disposables). The Console provides the electrical power, user interface, treatment monitoring, treatment control and safeguard circuitry used for controlling the heat and pressure applied to the patient's eyelids by the Activators (Disposables).
Here's an analysis of the provided text regarding the acceptance criteria and the study proving the device meets them:
Preamble:
It's important to note that this document is a 510(k) summary for a premarket notification, where the manufacturer is seeking to demonstrate substantial equivalence to a legally marketed predicate device. As such, the "study" described is primarily focused on demonstrating that a new model (LipiFlow® Console, Model LFTP-1000) is equivalent to a predicate model (LipiFlow® HCS, Model LFH-1000) and meets existing safety and performance standards for Eyelid Thermal Pulsation Systems. It's not a clinical trial establishing efficacy against a placebo or a direct standalone performance study in the way one might expect for a novel device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Requirement | Reported Device Performance (LipiFlow® Console) |
|---|---|---|
| Electrical Safety & EMC | Conformance to electrical safety and EMC performance standards (same as predicate HCS). | Console conforms to the same electrical safety and EMC performance standards as the HCS, supporting the change in power source (AC power instead of battery). |
| Temperature & Pressure | Equivalent temperature and pressure performance and safeguard functions as the HCS, including normal operation, fault conditions, and direct comparison during human eyelid treatment. Meets design requirements based on known safe and effective temperature and pressure specifications (previously validated in bench, animal, and clinical studies for predicate K093937). | Console shows equivalent temperature and pressure performance and safeguard functions as the HCS. Meets same design requirements. Minor improvements in treatment hardware (e.g., temperature/pressure sensing accuracy, redundant pressure sensor tracking) do not raise new questions of safety/effectiveness. |
| Sterility & Shelf-life | Meets performance standards for sterility and shelf-life testing of the Disposable. | Disposable (LFD-1000), used with both Console and HCS, meets performance standards for sterility and shelf-life testing. |
| Biocompatibility | Meets performance standards for biocompatibility of the Disposable. | Disposable (LFD-1000), used with both Console and HCS, meets performance standards for biocompatibility (referenced K093937). |
| Software V&V | Console software meets design input requirements and user needs. Usability validated to standards. Software does not control treatment; software failure would not affect hardware's treatment control or safety circuits. | Software verification and validation testing shows Console software meets design input requirements and user needs. Usability of Console bench-top design and user interface validated to usability standards. Software does not control treatment; failure would not affect hardware's treatment control or safety circuits. |
| Additional User Functions | Additional user functions (e.g., independent treatment of both eyes, modify pressure sequence) do not adversely affect safety and effectiveness. | Bench performance testing of additional user functions shows they do not adversely affect safety and effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for specific tests (e.g., a "test set" in the context of AI/ML). The performance testing described is primarily bench performance testing and software verification/validation.
- For the "direct comparison during treatment of human eyelids" for temperature and pressure performance, the number of human eyelids or subjects tested is not specified.
- Data Provenance: The studies mentioned for the predicate device (K093937) included "bench, animal and clinical studies." For the current submission, the testing type described is predominantly bench testing and software validation. There is no mention of country of origin, retrospective or prospective data collection specifically for this K112704 submission, beyond referencing the predicate's studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This documentation does not describe a traditional "test set" with ground truth established by experts in the context of classification or diagnostic performance (as one might find for an AI/ML diagnostic device).
- The criteria are technical performance specifications (e.g., temperature accuracy, pressure consistency, electrical safety, software function). The "ground truth" here is adherence to engineering specifications, regulatory standards (e.g., 21 CFR 886.5200, electrical safety, EMC), and equivalence to the predicate device's proven performance.
- The "experts" involved would implicitly be the engineers, software developers, and quality assurance personnel performing the verification and validation, as well as the regulatory reviewers at the FDA. Their specific qualifications are not detailed.
4. Adjudication Method for the Test Set
- Not applicable in the typical sense of expert adjudication for diagnostic accuracy. The testing described focuses on engineering performance, software validation, and comparison to a predicate device's established specifications. The "adjudication" would be a determination of whether the device meets the predefined technical and regulatory acceptance criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No MRMC comparative effectiveness study was done. This device is a therapeutic device (applying heat and pressure), not an AI-assisted diagnostic imaging device. Therefore, the concept of "human readers improve with AI vs. without AI assistance" does not apply to its function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical therapeutic system with an operator (physician) in the loop, administering the treatment. While it has software, that software controls the hardware's treatment parameters, it does not function as a standalone diagnostic algorithm. The software is part of the overall system's function, not a separate "algorithm only" component. The document explicitly states: "Additionally, the Console's software does not control treatment, and a software failure would not affect the hardware's treatment control or the safety circuits." This implies the critical treatment control is hardware-based, with software for user interface, monitoring, and secondary functions.
7. The Type of Ground Truth Used
- For the current submission (K112704), the "ground truth" is primarily based on:
- Engineering Specifications: Adherence to defined temperature, pressure, electrical, and mechanical criteria.
- Regulatory Standards: Conformance to relevant national and international standards (e.g., electrical safety, EMC, biocompatibility).
- Predicate Device Performance: Demonstrating substantial equivalence to the established safety and effectiveness profile of the predicate device (LipiFlow® HCS, K093937), which itself relied on prior "bench, animal and clinical studies."
- Design Input Requirements and User Needs: For software validation.
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set in the conventional sense for a diagnostic algorithm. The device's operational parameters (temperature, pressure profiles) were established through prior engineering design, bench testing, animal studies, and clinical studies for the predicate device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. Since there is no "training set" for an AI/ML algorithm, the concept of establishing ground truth for it does not apply. The functional "ground truth" for the device's therapeutic parameters was established through the design and testing processes of the original predicate device, validated through various studies (bench, animal, clinical) to be safe and effective.
§ 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.