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510(k) Data Aggregation
(35 days)
The WaveLight FS200 Patient Interface 1515 is indicated to be used only with the WaveLight FS200 Laser System, consistent with the cleared Indications for Use for this ophthalmic surgical laser.
The WaveLight® FS200 Patient Interface 1515 is a patient consumable (disposable) consisting of a tubing system with an integrated suction ring and an applanation cone. The flat bottom of the cone is used as an applanation plate for the patient's cornea.
This document is a 510(k) Premarket Notification for the WaveLight FS200 Patient Interface 1515. It is a Class II medical device (product codes GEX/HNO) intended for use with the WaveLight FS200 Laser System in ophthalmic surgical procedures.
The device is a sterile, disposable consumable consisting of a tubing system with an integrated suction ring and an applanation cone. The application being considered here is for a Patient Interface device, which connects a patient's eye to a laser system. This is a physical component, not a software or AI-driven diagnostic device. Therefore, the typical "acceptance criteria" and "study" questions related to AI/software performance (e.g., sensitivity, specificity, human reader improvement with AI assistance, ground truth establishment by experts) are not applicable in this context.
Instead, the acceptance criteria and supporting studies for this type of device focus on manufacturing, material, sterility, packaging, and functional performance, demonstrating equivalence to an existing (predicate) device.
Here's the information extracted and formatted as requested, with "N/A" for sections not relevant to this device type:
Acceptance Criteria and Study for WaveLight FS200 Patient Interface 1515
The acceptance criteria for this device are demonstrated through non-clinical testing to ensure its safety, performance, and substantial equivalence to a predicate device, the WaveLight FS200 Patient Interface 1505. The studies performed are primarily engineering and laboratory-based tests.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criterion | Reported Device Performance |
|---|---|---|
| Material Safety (Biocompatibility) | Materials coming into contact with the patient or fluid path must be safe and not introduce chemicals that raise biocompatibility concerns, as per ISO 10993 standards. | Biocompatibility evaluations successfully performed against applicable ISO 10993 standards (specifically ISO 10993-1:2009 for biological evaluation) and FDA-recognized consensus standards. Materials do not introduce biocompatibility concerns. |
| Sterility | The device must achieve and maintain a sterility assurance level (SAL) of 10⁻⁶. Sterilization process (EtO) must be validated according to FDA-recognized consensus standards. | The product is sterilized using ethylene oxide (EtO). The EtO sterilization cycle has been validated according to ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Requirements for the Development, Validation and Routine Control of a Sterilization Process for Medical Devices (Recognition number 14-452). The sterilization process has been validated to achieve a sterility assurance level (SAL) of 10⁻⁶. |
| Packaging and Shelf Life | The sterile barrier system must be maintained during sterilization, distribution, and for the stated shelf life (up to 3 years). Validation according to FDA-recognized consensus standards. | Packaging and shelf life were successfully validated according to ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems and ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices (Recognition Number 14-497). The sterile barrier system is maintained during sterilization, distribution, and a shelf life of up to 3 years. |
| Transport Stability | The sterile barrier system must be maintained after subjecting the device to extreme transport challenge scenarios, validated according to FDA-recognized consensus standards. | Transport stability was successfully validated according to ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials sterile barrier systems and packaging systems. The sterile barrier system is maintained after subjecting the subject device to extreme transport challenge scenarios. |
| Functional Equivalence | The performance of the subject device (WaveLight FS200 Patient Interface 1515) must be equivalent to that of the predicate device (WaveLight FS200 Patient Interface 1505) after sterilization, transportation, and aging (accelerated and real-time). This includes ensuring the operating principles, mechanism of action, and dimensions are the same. Key differences in materials (DEHP-free tubing/filter housing) and packaging must not negatively impact functional performance. | Functional tests were performed after sterilization, transportation, and aging (accelerated and real-time). Tests demonstrated that the performance of the WaveLight FS200 Patient Interface 1515 is equivalent to that of the predicate device, the WaveLight FS200 Patient Interface 1505. The report states the operating principles, mechanism of action, and dimensions are the same between the subject and predicate devices. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not explicitly stated as a number of devices/units, but functional testing was performed on units after sterilization, transportation, and aging (accelerated and real-time). The specific number of units tested for each non-clinical test (biocompatibility, sterility, packaging, transport stability, functional testing) is not provided in this summary. These are typically engineering validation tests with defined sample sizes based on statistical methods/standards rather than patient data cohorts.
- Data Provenance: The studies are non-clinical, meaning they are laboratory and engineering tests conducted by the manufacturer (Alcon Research, Ltd.). The data originates from these controlled testing environments. Given this is a 510(k) submission to the US FDA, the tests would be expected to meet international and US-specific standards. This is retrospective in the sense that the studies detailed were completed prior to submitting the 510(k) application.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- N/A. This device is a physical consumable, not an AI/diagnostic imaging device that requires expert review for "ground truth" establishment in a clinical performance study context. Ground truth is established through validated testing methodologies and adherence to recognized consensus standards (e.g., ISO for sterility, biocompatibility, packaging; ASTM for aging).
4. Adjudication Method for the Test Set
- N/A. Adjudication methods (e.g., 2+1, 3+1) refer to procedures for resolving discrepancies in expert clinical assessments (e.g., image interpretations). This is not relevant to non-clinical engineering and laboratory validation tests.
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
- N/A. This is a physical medical device, not an AI or software product. MRMC studies are not applicable.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical medical device, not an algorithm. Standalone performance as typically described for AI/software is not applicable.
7. The Type of Ground Truth Used
- Engineering and Laboratory Standards / Test Results: The "ground truth" for this device's performance is established by demonstrating adherence to recognized consensus standards (e.g., ISO 10993, ISO 11135, ISO 11607, ASTM F1980) and by comparative functional testing against the predicate device. For example, sterility "ground truth" is meeting a 10⁻⁶ SAL, biocompatibility "ground truth" is passing specific ISO 10993 tests, and functional "ground truth" is equivalence to the predicate device's measured performance.
8. The Sample Size for the Training Set
- N/A. This device does not involve a "training set" in the context of machine learning or AI models.
9. How the Ground Truth for the Training Set Was Established
- N/A. As above, no training set for AI/ML is involved.
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