(29 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 eve or lipid deficiency dry eve.
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 labeled as "Console") and a patient interface (Disposable component labeled as "Activator II"). 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 with the Activator II Disposable.
This 510(k) submission is for modification of the proposed Activator II Disposable (Model LFD-2100) and labeling changes to the predicate Activator II (Model LFD-2000). The proposed devices have the same intended use, indications for use and fundamental scientific technology as the legally marketed predicate device. The proposed Activator II Model (LFD-2100) is the same as the predicate Activator II Models (LFD-2000) except for the following:
- . Eye Cup Assembly Redesign: the Activator II eye cup, which consists of the bladder and substrate, will be redesigned to allow the eye cup to be manufactured as a single versus seven-piece molded bladder assembly while still attaching to the lid warmer in the same location.
- Back Surface Overmold Redesign: the back surface overmold of the lid warmer will be ● redesigned to accommodate the modified Single Piece Eye Cup. The design change will be limited to the removal of the t-extrusion in the Z-direction used to hold the original Eye Cup in position.
- The material for the non-patient contact bladder substrate will be changed from Valox (PBT) to polycarbonate.
The labeling for the predicate Activator II Model (LFD-2000) will also be updated to replace special storage and handling conditions with the statement: "Store at room temperature".
Compared to the predicate Activator II Model, the patient interface portion of the proposed Activator II Model is identical in patient-contact materials, electrical safety, packaging, sterility, shelf-life, method of preventing re-use, and temperature and pressure performance and safety. The proposed Activator II Model (LFD-2100) will remain fully backwards compatible with the current LipiFlow Console and Semi-permanent Cable. There are no changes to the Console and Cable from the predicate device.
The provided text describes a 510(k) submission for modifications to the LipiFlow® Thermal Pulsation System, specifically the Activator II Disposable (Model LFD-2100) and labeling changes to the existing Model LFD-2000. The submission argues for substantial equivalence to a legally marketed predicate device (LipiFlow® Thermal Pulsation System cleared under K161357).
The key point is that this submission focuses on modifications to an existing device and its equivalence to a predicate, rather than presenting a de novo study with novel acceptance criteria for a new device's clinical performance. Therefore, the "acceptance criteria" and "device performance" in this context refer to demonstrating that the modified device maintains the safety and effectiveness of the predicate device, especially regarding its physical and performance characteristics, rather than establishing efficacy for a new clinical endpoint.
Here's a breakdown of the information based on your request, with the caveat that many aspects (like human reader studies, ground truth for training) are not applicable or explicitly mentioned for a 510(k) modification submission of this nature.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the existing performance standards and specifications of the predicate device. The performance testing aims to demonstrate that the modified device (LFD-2100) and the updated predicate (LFD-2000) meet these same standards.
| Acceptance Criteria (Implied from Predicate Device Standards) | Reported Device Performance (for subject device LFD-2100 and updated LFD-2000) |
|---|---|
| Electrical Safety & Electromagnetic Compatibility (EMC): Conformance to relevant performance standards. | "Performance testing demonstrates that the LipiFlow® System using the proposed Activator II Model (LFD-2100) conforms to the same electrical safety and EMC performance standards as for the predicate Activator II Model (LFD-2000)." |
| Temperature and Pressure Performance & Safeguard Functions: Equivalent performance and safety during normal and fault conditions. Meeting known safe and effective temperature and pressure specifications. | "Performance testing shows that the LipiFlow® System using the proposed Activator II Model (LFD-2000) and Cable has equivalent temperature and pressure performance and safeguard functions, including during fault conditions, as the predicate Activator models. The modified device meets the same design requirements as the predicate device based on known safe and effective temperature and pressure specifications..." |
| Packaging, Sterility, and Shelf-life: Same as the predicate Activator Model, meeting existing performance standards. | "The packaging, sterility and shelf-life for the proposed Activator II Model are the same as for the predicate Activator Model. The proposed Activator II Model meets the same performance standards for sterility and shelf-life as the predicate Activator II Model." |
| Biocompatibility: Patient-contacting materials must be the same as the predicate. Non-patient-contacting material changes must meet biocompatibility standards. | "The patient-contacting materials for the proposed Activator II Model are the same as for the predicate Activator II Models. The non-patient-contacting materials for the proposed Activator II Model (LFD-2100) will be changed from Valox to polycarbonate from the predicate Activator II Model (LFD-2000). The modified Activator II Model (LFD-2100) meets the same biocompatibility performance standards as the predicate Activator II Model." |
| No New Questions of Safety and Effectiveness: The modifications should not introduce new safety or effectiveness concerns, nor adversely affect the current safety and effectiveness of the device. (This is an overarching requirement for 510(k) substantial equivalence.) | "Performance testing shows that the proposed Activator II Model does not raise new questions of safety and effectiveness, and does not adversely affect safety and effectiveness of the device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The type of testing described (electrical safety, EMC, temperature/pressure performance, sterility, shelf-life, biocompatibility) typically involves testing a certain number of manufactured units or batches, rather than a "test set" of clinical data in the way one would for an AI algorithm. The document states: "No animal or clinical studies were performed as there is no change to the indications for use or the fundamental scientific technology when compared to the predicate device."
- Data Provenance: Not applicable in the context of clinical data for a study. The "data" here comes from bench testing of the modified device components themselves.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission concerns device hardware and labeling modifications, and the "ground truth" is defined by established engineering and regulatory performance standards (e.g., electrical safety standards, temperature specifications, material biocompatibility). There is no "ground truth" derived from expert clinical assessment for this type of submission.
4. Adjudication Method for the Test Set
Not applicable. There is no clinical test set requiring adjudication in this type of submission.
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. This is not an AI/software device submission focusing on diagnostic performance or human reader improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/software device submission.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to established engineering specifications, performance standards (e.g., ISO, IEC for electrical safety), and regulatory requirements for biocompatibility, sterility, and shelf-life. It is not expert consensus, pathology, or outcomes data, as those apply to clinical efficacy or diagnostic performance.
8. The Sample Size for the Training Set
Not applicable. There is no AI component or "training set" for this hardware modification submission.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #8)
§ 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.