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510(k) Data Aggregation
(84 days)
The LipiFlow Thermal Pulsation 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 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 pressure to the outer eyelid to facilitate release of lipid from the cystic neibomian glands. The LipiFlow System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Console (Control component) 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 (Disposable component). No changes to the Console are proposed in this 510(k). The Activator (Disposable) is a sterile; single-use. biocompatible eyepiece made of polycarbonate and silicone and is inserted around the patient's eyelids. 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. There are two models of the Activator (Disposable). Except for the addition of a memory device, Activator (Disposable) Models LFD-1000 (cleared under K093937) and LFD-1100 (modified under design controls) are equivalent with no difference in device performance, safety or effectiveness. This 510(k) submission is for a device modification of new materials for the LipiFlow Activator (Disposable). The proposed changes to the Activator (Disposable) are to provide a second source for the raw materials used in the eyecup bladder (diaphragm), lid warnier glue and heater components to facilitate manufacturing. The model numbers of the Activator (Disposable) will not change as a result of this change. The LipiFlow Activator (Disposable) with the new second source materials has the same intended use and same fundamental scientific technology as the predicate cleared device (LipiFlow® Activator (Disposable) with cleared materials, as described in K093937 and K.I. 2704). Accordingly, this 510(k) submission for a design change to use second source new materials in the Activator (Disposable) applies to both model numbers (LFD-1000 and LFD-1100) of the Disposable component.
Below is a description of the acceptance criteria and the study that proves the device meets them, based on the provided text.
Acceptance Criteria and Device Performance Study for LipiFlow® Thermal Pulsation System (K133127)
This 510(k) submission (K133127) describes a device modification involving new materials for the LipiFlow Activator (Disposable) component. The primary objective was to demonstrate that these material changes do not adversely affect the safety and effectiveness of the device, maintaining substantial equivalence to the predicate devices (K093937 and K112704).
1. Table of Acceptance Criteria and Reported Device Performance
The performance testing focused on demonstrating conformance to special controls for an eyelid thermal pulsation system per 21 CFR 886.5200.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (New Activator Materials) |
|---|---|---|
| Special Controls (21 CFR 886.5200) | ||
| EMC and Safety | Testing to validate EMC and safety of exposure to non-ionizing radiation. | The LipiFlow System with the Activator with new materials passed all design verification and validation tests. This implies conformance to EMC and non-ionizing radiation safety, as these are typically part of a comprehensive safety validation. |
| Safeguards (Temp & Pressure) | Design, description, and performance data validating safeguards related to the temperature and pressure aspects of the device, including during fault conditions. | The temperature and pressure safeguards related to the Activator operate as designed and are substantially equivalent between the new and original materials. The material changes in the Activator do not affect any of the temperature or pressure safeguards. (Passed) |
| Sterility & Shelf-life | Performance data demonstrating the sterility of patient contacting components and the shelf-life of these components. | The text states the system passed all design verification and validation tests, which would include sterility and shelf-life of patient-contacting components. Although not explicitly detailed for this modification, it's inferred based on the overall "passed all tests" statement and the requirement of special controls. |
| Biocompatibility | Performance data demonstrating biocompatibility of patient contact materials. | The new second source materials for the eyecup bladder (diaphragm), lid warmer glue, and heater components were selected based on their similarities in material properties including biocompatibility. The system passed all design verification and validation tests, which confirms biocompatibility. |
| Effect of Tech Changes | Performance data demonstrating that any technological changes do not adversely affect safety and effectiveness. This implicitly includes demonstrating equivalent temperature and pressure performance to the predicate device specifications. | The temperature and pressure performance of the Activator with new second source materials is substantially equivalent to the predicate Activator with original materials. The Activator with new materials meets the same design requirements as the Activator with existing materials based on known safe and effective temperature and pressure specifications. These specifications were "previously validated in bench, animal and clinical studies of the LipiFlow System (refer to K093937 and K112704)." |
2. Sample Size Used for the Test Set and Data Provenance
The document primarily describes bench testing for design verification and validation of the material changes. There is no information provided regarding a specific "test set" of patient data or sample size in terms of human subjects for this 510(k) submission (K133127). The evaluation focused on engineering and material performance rather than clinical performance on a new patient cohort.
The data provenance for the original safety and effectiveness of the LipiFlow System (K093937 and K112704) involved "bench, animal and clinical studies." However, the details of these are not provided within this specific document, and they pertain to the predicate device, not directly to the current material modification under K133127.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission concerns material modifications evaluated through bench testing and engineering verification/validation, not a clinical study requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set data was used for this specific 510(k) given the nature of the device modification (material change).
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
Not applicable. The LipiFlow System is a medical device for localized heat and pressure therapy, not an AI-powered diagnostic imaging or interpretation tool that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The LipiFlow System is a physical device that performs a therapeutic action, not an algorithm. Performance was evaluated through the device's adherence to its operational specifications and safety parameters.
7. The Type of Ground Truth Used
For the material modifications in K133127, the "ground truth" was established based on:
- Engineering specifications and design requirements: The new materials needed to meet the same physical, electrical, and performance specs as the original materials.
- Biocompatibility standards: The new patient contact materials had to meet established biocompatibility requirements.
- Safety standards: The device operating with new materials had to pass tests ensuring all safety safeguards (temperature, pressure) function correctly, even under fault conditions.
For the original LipiFlow System's safety and effectiveness (predicate device), the ground truth was established through "bench, animal and clinical studies" (as referenced in K093937 and K112704), which would have involved clinical outcomes and possibly expert assessment for efficacy, and direct measurement for safety parameters.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device. The "training" for the device's performance would be the extensive design, engineering, and testing processes to ensure it meets its predefined specifications.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is not an AI/machine learning device with a training set. The "ground truth" for the device's design and operational parameters was established through established engineering principles, regulatory standards, and clinical validation studies for the original device.
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