(146 days)
The CLARITI 1 DAY (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
The CLARITI 1 DAY TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The CLARITI 1 DAY MULTIFOCAL (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may require a reading addition of +3.00 Diopters or less and may exhibit astigmatism up to 1.50 Diopters or less.
The CLARITI 1 DAY MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV blocker is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and require a reading addition of +3.00 Diopters or less.
The Clarti 1 Day (somofilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfection is required.
The Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker is available as sphere lens, toric lens, multifocal lens, and multifocal toric lens.
In its hydrated state, Clariti 1 day (somofilcon A) Soft (hydrophilic) Daily Disposable Contact Lens with UV Blocker when placed on the cornea acts as a refracting media to focus light rays on the retina.
Clariti 1 day (somofilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear Single Use are a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with tetraethyleneglycol dimethacrylate and di-functional methacryloxypropyl-terminated poly(dimethylsiloxane).
When hydrated the lens consists of 44.0% somofilcon A and 56.0% water by weight of saline immersed in normal saline. A benzophenone UV absorbing monomer is used in the contact lens to help protect against transmission of harmful UV radiation and Clariti 1 day (somofilcon A) Soft contact lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The average transmittance characteristics are less than 5% in the UVB range of 280 to 315nm and less than 50% in the UVA range of 316-380nm.
The lens has a hemispherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
- Chord Diameter: 13.0mm to 15.5mm
- Centre Thickness: 0.03mm to 0.50mm
- Base Curve: 7.5mm to 9.30mm
- Powers: -20.00 DS to +20.00 DS
- Toric Cylinder options: -0.75, -1.25, -1.75 and -2.25
- Toric Axis options: 10° to 180° (10° steps)
- Multifocal Add: Lens "LOW" = "low" for spectacle near ADD lens (Max +2.25 ADD) Lens "HIGH" = "high" for spectacle near ADD lens (+2.50 ADD or greater)
Here's a summary of the acceptance criteria and study information for the Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance & Device Description
The document states that the performance specifications/parameters for both the subject and predicate device are identical. Therefore, the acceptance criteria are implicitly those listed under "Performance Specifications/Parameters Comparison" in the Predicate Device column, and the reported device performance for the subject device is stated as "Same" for each parameter.
| Performance Specifications/Parameters | Predicate Device (Clariti 1 day, K130331) | Subject Device (Clariti 1 day, K181920) |
|---|---|---|
| Water Content (%) | 56 | Same |
| Refractive Index | 1.401 | Same |
| Oxygen Permeability (Dk @ 35°C) | 60 x 10^-11 [(cm²/sec) x (ml O2)/(ml x mm Hg)] | Same |
| Base Curve (mm) | 8.6 | Same |
| Diameter (mm) | 14.0 | Same |
| Light Transmittance (%) | >95 | Same |
| Modulus (MPa) | ≥0.3 | Same |
| Tensile Strength (MPa) | ≥0.4 | Same |
| Elongation to Break (%) | ≥100 | Same |
| Surface Treatment | No | Same |
| Center Thickness (mm) | Varies with power | Same |
| Power Range (D) | -20.00 to +20.00 | Same |
| Additional Device Description Information (not acceptance criteria but important characteristics): | ||
| Chord Diameter: | 13.0mm to 15.5mm | Same (implied, as device description is identical) |
| Centre Thickness: | 0.03mm to 0.50mm | Same (implied) |
| Base Curve: | 7.5mm to 9.30mm | Same (implied) |
| Powers: | -20.00 DS to +20.00 DS | Same (implied) |
| Toric Cylinder options: | -0.75, -1.25, -1.75 and -2.25 | Same (implied) |
| Toric Axis options: | 10° to 180° (10° steps) | Same (implied) |
| Multifocal Add: | "LOW" (Max +2.25 ADD), "HIGH" (+2.50 ADD or greater) | Same (implied) |
| %Transmittance @ 590nm: | 98.13 | Same (implied) |
| %Transmittance @ 280-315nm: | 0.71 | Same (implied) |
| %Transmittance @ 316-380nm: | 20.62 | Same (implied) |
| Surface Character: | Hydrophilic | Same (implied) |
| Specific Gravity: | 1.17 | Same (implied) |
Key Differences Between Subject and Predicate Device:
There were two technological differences between the subject device (K181920) and the predicate device (K130331) that required performance data:
- Addition of 4,4'-Diallyoxyl benzophenone (DAB): The subject device includes both UV416 and DAB as UV blockers, whereas the predicate only had UV416.
- Change from borate to phosphate buffered packaging solution: The subject device uses Phosphate Buffered Saline Solution containing 0.020% w/v Poloxamer 407, while the predicate used Borate Buffered Saline Solution containing 0.005% w/v Poloxamer 407.
2. Sample Size Used for the Test Set and Data Provenance
The document states that "Conclusive evidence was provided to demonstrate that the subject device lens material is equivalent to the currently marketed predicate device lens material through the statistical analysis of the physiochemical properties, especially water content, oxygen permeability, modulus, and toughness of the lens."
For the performance testing (bench testing), the document mentions that "Each test was conducted according to the ANSI, ISO, and/or ASTM standard indicated." However, specific sample sizes for the test set are not provided in the given text.
The data provenance is not explicitly stated as country of origin, but the testing was conducted in accordance with international standards (ISO, ANSI, ASTM) and FDA guidance documents (e.g., Use of International Standard ISO 10993-1, Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses). This implies that standard laboratory testing was performed, likely at the manufacturer's or a contract research organization's facilities. The studies appear to be prospective in nature, as they were conducted to support the substantial equivalence claim for the subject device.
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 this submission. The "ground truth" in this context refers to the defined physical, chemical, and optical properties of the contact lenses, as measured by standardized bench tests, and biocompatibility evaluations. These measurements do not rely on expert interpretation in the way that image-based diagnostic devices might.
4. Adjudication Method for the Test Set
This is not applicable. The performance testing involves direct physical, chemical, and optical measurements against established standards, not subjective assessments requiring adjudication.
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
An MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images. This submission is for a medical device (contact lens) where performance is assessed through bench and biocompatibility testing, not human interpretation of data. The document explicitly states: "clinical performance data was not required to be submitted in this 510(k)."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an algorithm or AI-powered device. The device's performance is assessed through its physical characteristics and biological safety.
7. The Type of Ground Truth Used
The "ground truth" for the performance criteria was established through:
- Bench Testing: Measurements of physical, chemical, and optical properties (e.g., water content, oxygen permeability, refractive index, mechanical properties, light transmittance, specific gravity, contact angle, total extractables, non-polymeric residuals) using established ANSI, ISO, and ASTM standards.
- Biocompatibility Testing: Evaluation according to ISO 10993 series for cytotoxicity, irritation, systemic toxicity, and sensitization.
- Comparison to Predicate: The key ground truth was the established performance of the legally marketed predicate device (Clariti 1 day, K130331), demonstrating that the subject device's performance was "Same" or equivalent across all measured parameters despite minor material and packaging solution changes.
8. The Sample Size for the Training Set
This is not applicable. This submission is for a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This is not applicable for the reasons stated 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.