(25 days)
MyDay (stenfilcon A) ASPHERE Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuty.
MyDay (stenfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
MyDay (stenfilcon A) MULTIFOCAL Soft Contact lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity.
MyDay (stenfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optical correction of distance and near vision in presbyopic phakic persons with non-diseased eyes who may have -10.00 diopters of astigmatism or less.
AVAIRA VITALITY SPHERE and ASPHERE (fanfilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
A VAIRA VITALITY (fanfilcon A) TORIC Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eves in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL Soft lenses are indicated for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with nondiseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.
AVAIRA VITALITY (fanfilcon A) MULTIFOCAL TORIC Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters.
Eye Care Practitioners may prescribe the Avaira Vitality (fanfilcon A) Soft Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, the Avaira Vitality (fanfilcon A) Soft Contact lens is to be discarded after each removal.
MyDay Contact Lenses are available as Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The MyDay material, stenfilcon A, is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the MyDay Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
Avaira Vitality Contact Lenses are available as Sphere, Asphere, Toric, Multifocal, and Multifocal Toric lens designs. The Avaira Vitality material, fanfilcon A. is primarily a random copolymer of polydimethylsiloxane methacrylate and vinylmethyl acetamide. The lenses have a blue tint which is added to make the lens more visible for handling. The lenses also contain a UV absorbing monomer, benzotriazolyl methacrylate, which is used to block UV radiation. When placed on the cornea in its hydrated state, the Avaira Vitality Soft (Hydrophilic) Contact Lens acts as a refracting medium to focus light rays on the retina.
The provided text describes a 510(k) premarket notification for two soft contact lenses: MyDay (stenfilcon A) and Avaira Vitality (fanfilcon A). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices, primarily due to a manufacturing process change and a change to the purity specification.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail format with specific targets. Instead, it refers to "performance testing" conducted according to established standards. The reported device performance is presented as the results of these tests, which presumably align with the expectations of the referenced standards for substantial equivalence.
| Performance Test | Standard(s) | Reported Device Performance |
|---|---|---|
| Contact Angle | ANSI Z80.20-2016 | Testing performed, assumed to meet standard requirements for substantial equivalence. |
| Water Content | BS EN ISO 18369-2:2017, BS EN ISO 18369-4:2017 | Testing performed, assumed to meet standard requirements for substantial equivalence. |
| Mechanical Properties | ANSI Z80.20-2016, ASTM D1708-02a | Testing performed, assumed to meet standard requirements for substantial equivalence. |
| Total Extractables | ANSI Z80.20-2016, BS EN ISO 18369-4:2017 | Testing performed, assumed to meet standard requirements for substantial equivalence. |
| Dimensional/Optical Parameters | BS EN ISO 18369-2:2017, BS EN ISO 18369-3:2017 | Testing performed, assumed to meet standard requirements for substantial equivalence. |
| Biocompatibility | ISO 10993-18:2020 | Not required. Equivalency demonstrated through chemical profiling between modified and unmodified lenses. |
2. Sample Size Used for the Test Set and Data Provenance
The document states that "non-clinical studies were provided in support of the substantial equivalence determination." However, it does not specify the sample sizes used for the test set for any of the performance tests.
Regarding data provenance, the studies were "conducted in accordance with the GLP regulation (21 CFR Part 58) or according to valid scientific protocols." This indicates that the data is from prospective studies designed to meet regulatory standards. The country of origin of the data is not specified, but given it's a US FDA submission, it's typically assumed to be generated in compliance with US regulatory frameworks.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to the type of device and study described. The performance tests for contact lenses (contact angle, water content, mechanical properties, etc.) involve objective measurements rather than subjective expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
This information is not applicable as the studies are focused on objective physical and chemical properties of the contact lenses, which do not involve subjective interpretation or adjudication by multiple readers to establish ground truth.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret images, and AI might assist in that interpretation. For contact lenses, the evaluation focuses on physical, chemical, and biological properties, not human interpretation of medical images.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "algorithm only" performance to evaluate.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests on contact lenses is established through objective, standardized measurements according to the specified ANSI, ISO, and ASTM standards. For example, water content is measured using a defined gravimetric method, and mechanical properties are determined through tensile testing. For biocompatibility, chemical profiling (against ISO 10993-18:2020) was used to establish equivalence to the unmodified lenses (which presumably had established biocompatibility).
8. The Sample Size for the Training Set
This information is not applicable. The device is not an AI/ML algorithm that requires a training set. The studies described are traditional non-clinical performance and material characterization tests.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this 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.