(86 days)
The SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear 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 SAUFLON CLARITI TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters.
The SAUFLON CLARITI MULTIFOCAL (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may require a reading addition of +4.00 Diopters or less.
The SAUFLON CLARITI MULTIFOCAL TORIC (somofilcon A) Soft (hydrophilic) Contact Lens with UV blocker and handling tint is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes that may exhibit astigmatism up to 10.00 Diopters and that may require a reading addition of +4.00 Diopters or less.
The lenses may be prescribed for daily wear for up to one month with removal for cleaning and disinfection (chemical, not heat) prior to reinsertion as recommended by the eye care professional.
Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact lens with UV blocker and handling tint helps protect against transmission of harmful UV radiation to the cornea and into the eye. The lens has a tint added to make the lens more visible for handling.
The Sauflon Clariti (somofilcon A) Soft (Silicone Hydrogel) Contact Lens with UV Blocker and handling tint is available as a single vision, toric and multifocal lens. The lens material (somofilcon A) is a hydrophilic co-polymer of silicone containing monomers and hydrophilic monomers which is cross-linked with Alkyl bis methacrylate. 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 to block UV radiation. A D&C Green 6 tint is also included in the composition of the lens for ease of handling and visibility.
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 Sauflon Clariti (somofilcon A) Soft (hydrophilic) Contact Lens with UV Blocker and Handling Tint is spherical flexible shell, which covers the cornea and a portion of the adjacent sclera, with the following dimensions:
• Chord Diameter: 13.0 to 18.0mm
• Centre Thickness: 0.03 to 0.70mm
• Base Curve: 7.5 to 9.5mm
• Powers: -30.00 DS to +30.00 DS
• Toric cylinder options: Between -0.75 and -9.75
• Toric Axis options: 10° to 180° (5° steps)
• Multifocal ADD: Add power of up to +4.00, labelled with indicative add strength to be read in conjunction with the fitting guide.
The physical/optical properties of the lenses are:
· Refractive Index: 1.4008
· %Transmittance @ 590nm: 98.30%
. %Transmittance @ 280-315nm: 0.71 .
. %Transmittance @ 316-380nm: 20.62
. Surface Character: Hydrophilic
Water Content: . 56%
60 x 10-11 (cm2/sec) (ml O2/ml x mmHg) Oxygen Permeability (DK): . at 35°C (Fatt Method for determination of oxygen permeability).
1.17 Specific Gravity:
The provided document is a 510(k) summary for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets distinct acceptance criteria through a standalone study with a defined ground truth.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the format of defined numerical thresholds that the new device must meet independently. Instead, it relies on demonstrating that the physical, optical, and chemical properties of the subject device are substantially equivalent to its predicate devices. The reported device performance is presented through a comparison table outlining these properties for the subject device and the predicates.
| Property | Subject Device Performance (Sauflon Clariti (somofilcon A) with UV Blocker and Handling Tint) | Predicate Device 1 (Sauflon Clariti with UV Blocker, K130342) | Predicate Device 2 (Air Optix Aqua, K033919/K073459) |
|---|---|---|---|
| Material | Somofilcon A Silicone Hydrogel | Somofilcon A Silicone Hydrogel | Lotrafilcon B Silicone Hydrogel |
| Indications for Use | Daily wear monthly replacement | Daily wear monthly replacement | Daily wear monthly replacement |
| Manufacturing Process | Cast Moulding | Cast Moulding | Cast Moulding |
| Water Content | 56% | 56% | 33% |
| Refractive Index | 1.40 | 1.40 | 1.42 |
| Light Transmittance | ≥96% | ≥96% | ≥96% |
| Dk @35°C (Edge Corrected) | 60 (polarographic method) | 60 (polarographic method) | 110 (Coulometric method) |
| Color/Tint | Blue Visibility Tint (D&C Green 6) | No Visibility Tint | Blue Visibility Tint (Copper phthalocyanine) |
| UV Blocker | Benzophenone | Benzophenone | None |
| Modulus (MPa) | 0.55 | 0.55 | 0.92 |
| Tensile Strength (MPa) | 1.05 | 1.05 | 0.9 |
| Elongation at Break % | 163 | 163 | 205 |
| Packaging Materials | Injected molded polypropylene blisters or Sabic PP PCGH19 covered by aluminium foil laminate and blister strips are packed into printed cartons | Injected molded polypropylene blisters or Sabic PP PCGH19 covered by aluminium foil laminate and blister strips are packed into printed cartons | Injected molded polypropylene blisters covered by aluminium foil laminate and blister strips are packed into printed cartons |
| Packaging Solution | Borate buffered saline solution containing 0.005% poloxamer 407. | Borate buffered saline solution containing 0.005% poloxamer 407. | Phosphate buffered saline solution |
| Packaging Method | Hermetically sealed blister pack | Hermetically sealed blister pack | Hermetically sealed blister pack |
Summary of Device Performance against "Acceptance Criteria" (Substantial Equivalence): The document claims "substantial equivalence" based on these comparisons. For most properties, the subject device directly matches one of the predicate devices. Where differences exist (e.g., tint, water content, Dk, UV blocker, Modulus, Tensile Strength, Elongation at Break, packaging materials, packaging solution), the differences are argued to not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "A clinical study was conducted to evaluate the safety and efficacy of SAUFLON CLARITI (somofilcon A) Soft (hydrophilic) with UV Blocker and handling tint by comparison with Air Optix Aqua hydrophilic contact lenses (Ciba Vision Inc.)."
- Sample Size for Test Set: The specific number of subjects in this clinical study (test set) is not provided in the summary.
- Data Provenance: The study involved a comparison with Air Optix Aqua lenses. The summary does not explicitly state the country of origin for the data or whether it was retrospective or prospective, but clinical trials for regulatory submissions are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of information is usually relevant for studies involving human interpretation (e.g., image analysis). For a contact lens clinical study evaluating safety and efficacy, the "ground truth" is generally derived from direct clinical observations (e.g., visual acuity, adverse events, fit) performed by qualified clinicians (optometrists, ophthalmologists). The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method (such as 2+1, 3+1, or none) for the clinical study. This is less common to report for contact lens clinical studies compared to, for example, studies involving subjective image interpretation where expert discrepancies need resolution.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not conducted as described in the provided text. MRMC studies are typically used to assess the performance of diagnostic devices interpreted by multiple human readers, often with and without AI assistance, which is not applicable to a contact lens evaluation in this context. The clinical study was a direct comparison of the subject contact lens to a predicate contact lens.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a physical contact lens, not an algorithm or AI system. The "standalone performance" of the contact lens is assessed through its physical, optical, chemical properties, and human clinical trials (with humans wearing the device, not interacting with an algorithm).
7. The Type of Ground Truth Used
For the clinical study:
- Derived from: Clinical observations (e.g., visual acuity, comfort, lens fit, adverse events) as measured during the study by clinical investigators. This is a form of outcomes data and expert clinical assessment.
- For the physicochemical studies: Laboratory measurements of defined properties (e.g., water content, Dk, transmittance, modulus, tensile strength).
8. The Sample Size for the Training Set
This question is not applicable. The document describes a physical medical device (contact lens), not an AI/algorithm-based device that requires a training set. The manufacturing process for contact lenses (cast moulding) does not involve a "training" phase in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
This question 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.