(30 days)
DAILIES® AquaComfort Plus® (nelfilcon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in not-aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.
DAILIES® AquaComfort Plus® Toric (nelfileon A) One-Day Contact Lenses are indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia and asigmatism) in not-aphakic persons with non-diseased eyes with 6.0 diopters (D) or less of astigmatism.
DAILIES® AquaComfort Plus® Multifocal (nelfilcon A) Ore-Day 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 nondiseased 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.
DAILIES® (nelfilcon A) One-Day Contact 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 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: 92% (@ 610 nm)
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).
The provided text is a 510(k) premarket notification for Alcon's DAILIES® AquaComfort Plus® contact lenses. It addresses the substantial equivalence of a modified device to a previously cleared predicate device.
Crucially, this document is for a medical device (contact lenses) and not an AI/ML powered medical device. Therefore, the standard questions regarding AI/ML device performance, such as acceptance criteria based on metrics like sensitivity/specificity, sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, do not apply and are not addressed in this document.
The primary focus of this 510(k) is to demonstrate that a manufacturing modification (specifically, using a new print technology for the lenses) does not adversely affect the safety and effectiveness of the device, making it substantially equivalent to the predicate device.
Here's an analysis based on the information provided, explaining why certain requested points are not applicable:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: For this device modification, the core acceptance criterion was demonstrating that the manufacturing process change (new print technology) did not alter the fundamental characteristics or safety/effectiveness of the contact lens. The document states: "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."
- Reported Device Performance: The "performance" here refers to maintaining the inherent properties and safety profile of the contact lenses. The comparison table (Table 1: Substantial Equivalence Comparison) on pages 5-6 effectively serves as the "reported device performance" against the predicate. It shows that key attributes like intended use, material, water content, power range, visibility tint, manufacturing method, sterilization, packaging, and storage saline solution are either identical or considered equivalent after the modification.
- Modified Device: DAILIES® AquaComfort Plus® Family (nelfilcon A)
- Predicate Device: DAILIES® AquaComfort Plus® Family (nelfilcon A) (K123994)
| Characteristic | Modified Device | Predicate Device | Outcome / Meeting Criteria |
|---|---|---|---|
| 510(k) number: | TBD | K123994 | (For the new submission) |
| Intended Use: | Daily Wear, Daily Disposable | Daily Wear, Daily Disposable | Meets (Identical) |
| Material Classification: | FDA Group 2 (>50% H2O, nonionic polymer) | FDA Group 2 (>50% H2O, nonionic polymer) | Meets (Identical) |
| Lens Material: | nelfilcon A | nelfilcon A | Meets (Identical) |
| Water Content: | 69% | 69% | Meets (Identical) |
| Power Range: | +20.00 to -20.00 D | +20.00 to -20.00 D | Meets (Identical) |
| Visibility Tint: | With or without copper phthalocyanine | With or without copper phthalocyanine | Meets (Identical) |
| Manufacturing Method: | Lightstream® Technology: Full mold cast, integrated print step | Lightstream® Technology: Full mold cast, integrated print step | Meets (Identical in general "Lightstream® Technology: Full mold cast, integrated print step" description, with explicit statement regarding the specific print technology being part of this established process for predicate and other Alcon lenses.) |
| Lens Designs: | Spherical, toric, multifocal | Spherical, toric, multifocal | Meets (Identical) |
| Sterilization: | Steam sterilization, validated autoclave | Steam sterilization, validated autoclave | Meets (Identical) |
| Packaging: | Blister pack | Blister pack | Meets (Identical) |
| Package Storage Saline Solution: | Phosphate-acetate buffered saline with up to 0.5% Poloxamer 108. Contains PEG and HPMC. | Phosphate-acetate buffered saline with up to 0.5% Poloxamer 108. Contains PEG and HPMC. | Meets (Identical) |
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- This document refers to "process validation" and "non-clinical testing" rather than clinical test sets in the context of an AI/ML device. The "test set" here would refer to the samples used in the non-clinical process validation, which are not specified in terms of number or provenance. There are no descriptions of patient data, as this is a physical medical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
- Not applicable. There is no "ground truth" to establish in the context of an AI/ML output. Performance is demonstrated through manufacturing controls and the comparison to the existing predicate.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There is no human interpretation or adjudication of AI output.
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-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this submission is the established safety and effectiveness of the predicate device, against which the modified device's characteristics are compared through non-clinical validation.
8. The sample size for the training set:
- Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "Non-clinical Testing: 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."
This indicates that the manufacturer conducted internal testing and validation of their manufacturing process for the modified contact lenses. The acceptance criteria were met because these non-clinical tests confirmed that the modified lenses, despite the change in print technology, maintained all the critical physical and chemical properties as well as safety aspects of the predicate device. The detailed comparison table serves as the evidence for this equivalence. The FDA letter confirms that "FDA's issuance of a substantial equivalence determination" means they have reviewed the submission and find the device substantially equivalent based on the provided information, thus accepting the manufacturer's evidence.
§ 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.