(172 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 meibomian glands. The LipiFlow® System is comprised of a physician interface (Control component) and a patient interface (Disposable component). The Control component (labeled as 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 Disposable component (labeled as Activator).
This 510(k) submission is for the device modification of new model of the Disposable component (labeled Activator II, Model LFD-2000), a new semi-permanent Cable (Model CBL-2000), and a hardware and software update to the Control component (labeled as Console, Model LFTP-1000). The modified LipiFlow® System has the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device.
The provided text describes a 510(k) premarket notification for a modified version of the LipiFlow® Thermal Pulsation System. A 510(k) submission generally aims to demonstrate substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy with novel acceptance criteria and studies demonstrating the device meets those criteria.
Therefore, the document does not contain information about:
- A table of acceptance criteria and reported device performance (in the context of new clinical endpoints).
- Sample sizes for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for establishing ground truth for a test set in the context of proving new performance claims.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or effect sizes of human readers with/without AI assistance.
- Standalone algorithm performance studies.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for novel clinical claims.
- Sample size for training sets.
- How ground truth for training data was established.
Instead, the document focuses on demonstrating that the modified LipiFlow® System (specifically, changes to the disposable component, a new cable, and hardware/software updates to the console) is substantially equivalent to the predicate LipiFlow® System.
Here's what the document does provide regarding performance testing and conclusions:
Acceptance Criteria and Device Performance (in the context of substantial equivalence):
The performance testing focused on demonstrating that the modified device maintained the same safety and effectiveness as the predicate device, conforming to special controls. Instead of "acceptance criteria" in the sense of novel clinical endpoints, the "criteria" are essentially the established performance and safety profiles of the predicate device and relevant standards.
| Feature/Aspect | Studied Conformance/Performance |
|---|---|
| Electrical Safety and EMC | Performance testing demonstrates that the modified LipiFlow® System conforms to the same electrical safety and EMC performance standards as for the predicate device. |
| Temperature and Pressure Performance/Safeguards | Performance testing shows that the modified LipiFlow® System has equivalent temperature and pressure performance and safeguard functions, including during fault conditions, as the predicate device. |
| The modified device meets the same design requirements as the predicate device based on known safe and effective temperature and pressure specifications, previously validated in bench, animal, and clinical studies of the LipiFlow® System. | |
| Packaging, Sterility, Shelf-life (Activator II) | The packaging, sterility, and shelf-life for the new Activator II model are the same as for the predicate Activator models. The new Activator II model meets the same performance standards for sterility and shelf-life as the predicate Activator models. |
| Biocompatibility (Activator II Patient Contact) | The patient contact materials for the new Activator II model are the same as for the predicate Activator models. Therefore, the new Activator II model meets the same biocompatibility performance standards as the predicate Activator models. |
| Effect on Safety and Effectiveness | Performance testing shows that the device modifications do not raise new questions of safety and effectiveness, and do not adversely affect safety and effectiveness of the device. |
| Software Verification & Validation | Conducted and documented as recommended by FDA guidance for "moderate" level of concern software. |
Study Information Pertaining to Substantial Equivalence:
- Study Type: The document describes "performance testing" rather than a clinical trial with novel efficacy endpoints. This testing aimed to demonstrate that the modifications did not alter the safety or effectiveness profile previously established for the predicate device.
- Sample Sizes / Data Provenance / Ground Truth / Experts / Adjudication: These details are not provided because the submission is for device modification and substantial equivalence, not a new clinical efficacy study. The "ground truth" for the performance comparisons is implicitly the established performance of the predicate device and relevant industry standards.
- MRMC / Standalone AI Performance: Not applicable, as this is not an AI/algorithm-focused submission. The device is a physical thermal pulsation system.
- Training Set Sample Size/Ground Truth: Not applicable for this type of submission. The performance testing is about ensuring the modified device operates to the same specifications as the predicate. The "ground truth" for the predicate device's efficacy was established through previous bench, animal, and clinical studies, but details of those studies are not provided here.
§ 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.