(30 days)
Focus® DAILIES® and Focus® DAILIES® Toric (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.
Focus® DAILIES® Progressives (nelfilcon A) One-Day soft contact lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia or hyperopia) and/or presbyopia in not-aphakic persons with non-diseased eyes who require a reading addition of +3.00 diopters (D) or less and who may have 2.00 diopters (D) or less of astigmatism that does not interfere with visual acuity.
The lenses are to be prescribed for single use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.
The lens material is 69% water and 31% nelfilcon A polymer (polyviny) alcohol partially acetalized with N-formylmethyl acrylamide). For VISITINT® lenses, the color additive phthalocyanine blue (also known as copper phthalocyanine) is added to the lens material to create a light blue edge to edge color to make them easier to see when handling. The lenses may be printed with inks containing one or more of the following color additives: phthalocyanine blue, phthalocyanine green.
Nelfilcon A lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Power Range: -20.00 D to +20.00 D
Center Thickness varies with design and power (0.10 mm for -3.00 D spherical)
Lenses have the following properties:
Refractive index: 1.38
Light transmittance: approximately 96 %T
Water content: 69% by weight
Oxygen permeability 26 barrer measured at 35°C (single point Dk-Polarographic method)
Lenses are supplied sterile in sealed blister packs containing buffered saline. The compatibility and package integrity of the blister-pack packaging system has been demonstrated and successfully used for other Alcon marketed lens products and packaged lenses are effectively steam sterilized in a validated autoclave. Blister-pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility).
This submission (K153643) concerns a modification to Alcon's Focus® DAILIES® family of contact lenses. The modification specifically relates to an "Ink Shelf Life Change" and the use of the same print technology already established for these lenses. The FDA has determined that the modified device is substantially equivalent to the predicate device (K0833216).
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that a "successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met." However, the specific quantitative acceptance criteria for this process validation are not explicitly detailed in the provided text. The reported device performance is that the modified device meets these implicit acceptance criteria, demonstrating equivalence to the predicate.
| Acceptance Criteria Category | Specific Acceptance Criteria (Not explicitly detailed in document) | Reported Device Performance |
|---|---|---|
| Material Equivalence | (Implicit: Demonstrates no adverse change in material properties with ink shelf life change) | Modified device uses same print technology, material (nelfilcon A), water content (69%), power range, visibility tint type (copper phthalocyanine), manufacturing method, sterilization, packaging, and package storage solution as predicate. Implies no change in fundamental material properties. |
| Process Validation | (Implicit: Demonstrates that the manufacturing process, with the ink shelf life change, consistently produces devices that meet specifications and are equivalent to the predicate.) | "A successful process validation was performed on the modified device to verify equivalence of the device to the predicate device. This resulted in the acceptance criteria being met." |
| Safety & Effectiveness | (Implicit: No adverse effect on safety and effectiveness due to the modification.) | The modification "did not require clinical testing to establish safety and effectiveness of the modified device." The device remains "substantially equivalent" and any differences "do not adversely affect the safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The scope of the device modification did not require clinical testing to establish safety and effectiveness of the modified device." This indicates that no new clinical test set with human subjects was used for this specific modification. The validation was primarily based on non-clinical testing (process validation) and comparison to the predicate device's established safety and effectiveness.
- Sample Size (Test Set): Not applicable for human-in-the-loop or standalone clinical testing. For process validation, the sample size would be determined by the validation protocol, but this detail is not provided.
- Data Provenance: Not applicable for a clinical test set in this specific submission. The data provenance would be related to the prior predicate device's studies and in-house process validation data, which are not described in detail here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable, as no new clinical testing was performed on a test set to establish ground truth in the context of device performance in patients.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical testing was performed involving adjudication of patient outcomes or assessments.
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 device is a contact lens, not an AI-assisted diagnostic or therapeutic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is a physical contact lens, not a software algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission relies on the established safety and effectiveness of the predicate device (K083216) and the successful process validation of the modified manufacturing process. The "ground truth" here is that the modified device, due to the ink shelf life change, maintains the same physical and chemical properties and performs equivalently to the previously cleared predicate, thus not adversely altering its safety or effectiveness. This is affirmed by successful process validation and material equivalence.
8. The Sample Size for the Training Set
Not applicable. As this is not an AI/machine learning device, there is no "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, for the same reasons as above.
§ 886.5925 Soft (hydrophilic) contact lens.
(a)
Identification. A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of water.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.