(165 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 (polyvinyl 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.
Focus® DAILIES®, Focus® DAILIES® Toric, Focus® DAILIES® Progressives One-Day contact lenses include spherical, toric, and multifocal lens designs in the following parameter ranges:
- Power Range: -20.00D to +20.00D .
- 0.010 mm for -3.00D spherical (varies with power) Center Thickness: .
Lenses have the following properties:
- 1.38 Refractive index: .
- 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 CIBA VISION marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blisterpack 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). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CIBA VISION Nelfilcon A Daily Wear Soft Contact Lenses:
1. Table of Acceptance Criteria and Reported Device Performance
This product is a contact lens seeking substantial equivalence through a 510(k) submission. For such devices, acceptance criteria are typically met by demonstrating that the device is as safe and effective as a legally marketed predicate device. The primary "performance" metric here is the demonstration of substantial equivalence.
| Feature / Criteria | Predicate Devices (K050065, K050213) | Modified Device (Focus DAILIES Family) | Acceptance Met? |
|---|---|---|---|
| Material: | nelfilcon A | nelfilcon A | Yes |
| Material Class: | FDA Group 2 (>50% H2O, nonionic polymer) | FDA Group 2 (>50% H2O, nonionic polymer) | Yes |
| Water Content: | 69% | 69% | Yes |
| Power Range: | +20.00 to -20.00D | +20.00 to -20.00D | Yes |
| Visibility Tint: | With or without copper phthalocyanine | With or without copper phthalocyanine | Yes |
| Manuf. Method: | Lightstream Technology™: Full mold cast (K050065), Full mold cast, integrated print step (K050213) | Lightstream Technology™: Full mold cast, integrated print step | Yes (consistent with one or both predicates) |
| Lens Designs: | Spherical, toric, multifocal | Spherical, toric, multifocal | Yes |
| Sterilization: | Steam sterilization, validated autoclave | Steam sterilization, validated autoclave | Yes |
| Packaging: | Blister pack | Blister pack | Yes |
| Package Storage Saline: | Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108 | Phosphate-acetate buffered saline with up to 0.02% Poloxamer 108 | Yes |
| Indications for Use: | Daily wear for optical correction of refractive ametropia (myopia, hyperopia, astigmatism) in non-aphakic, non-diseased eyes; Progressives for presbyopia with specific additions/astigmatism | Daily wear for optical correction of refractive ametropia (myopia, hyperopia, astigmatism) in non-aphakic, non-diseased eyes; Progressives for presbyopia with specific additions/astigmatism | Yes (explicitly stated as substantially equivalent) |
| Safety and Effectiveness: | Demonstrated by predicate devices | Demonstrated by substantial equivalence to predicates | Yes |
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."
Therefore:
- Sample Size for Test Set: Not applicable, as no new clinical testing was performed for this 510(k) submission.
- Data Provenance: Not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new clinical (test set) data was generated or evaluated for this 510(k) submission. The basis for substantial equivalence relies on the established safety and effectiveness of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical (test set) data requiring adjudication was generated.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size.
No. This is a medical device (contact lens) and not an AI/software device that would typically undergo MRMC studies. The approval pathway is 510(k) where "substantial equivalence" to a predicate is the primary criterion.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No. This is a contact lens, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" in this context is the safety and effectiveness established for the predicate devices. This would have been determined through:
- Clinical Performance: Data from human clinical trials (implied to have been conducted for the original predicates).
- Physical and Chemical Properties: Bench testing data comparing material characteristics.
- Toxicological Testing: Data supporting biocompatibility.
- Stability Testing: Data demonstrating shelf life and sterility maintenance.
For the current submission, the ground truth is essentially the established regulatory status and performance of the predicate lenses.
8. The Sample Size for the Training Set
Not applicable, as no machine learning algorithm was involved. If "training set" refers to the data used to initially establish the safety and effectiveness of the predicate devices, that information is not provided in this 510(k) summary.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as this is a contact lens and not an AI/software device with a "training set." The safety and effectiveness of the predicate devices were established through a combination of non-clinical (material properties, sterilization, packaging integrity, stability) and clinical testing, as is standard for contact lenses. The present submission leverages that established "ground truth" of the predicate devices to demonstrate substantial equivalence for the modified device.
§ 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.