(253 days)
The C.VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.
The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 10 diopters.
The C.VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.
The C.VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.
Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
The C.VUE Advanced Definitive Silicone Hydrogel Soft Contact Lenses are fabricated from efrofileon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).
In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The document describes the acceptance criteria and the study conducted for the C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics that would be compared to reported device performance. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on material properties, intended use, and manufacturing process.
However, we can infer some key device properties and compare them across the new device and predicate devices.
| Property | Acceptance Criteria (Inferred from Predicate "IntelliWave" which the new device is identical to) | Reported Device Performance (C.VUE Advanced Definitive) |
|---|---|---|
| USAN Name | efrofilcon A | efrofilcon A |
| Water Content | 74% | 74% |
| Oxygen Permeability | 60 x 10^-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method) | 59.8 x 10^-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method) |
| Specific Gravity | 1.139 (hydrated) | 1.048 (hydrated) (Note: Discrepancy observed between page 2 and page 5 for specific gravity, with 1.048 on page 2 and 1.139 on page 5) |
| Production Method | Lathe-Cut, custom manufactured | Lathe-Cut, custom manufactured |
| Intended Use & Indications | Daily wear for correction of ametropia, including astigmatism and presbyopia | Matches the predicate IntelliWave indications |
Note on Specific Gravity: There is a discrepancy in the reported Specific Gravity for the C.VUE Advanced Definitive. On page 2, it states "1.048 (hydrated)", while in the table on page 5, it lists "1.139" and identifies it as "same as IntellliWave³". This suggests a potential transcription error or an oversight in the consistency of data presentation within the document. Given the claim of being identical to IntelliWave³, the value of 1.139 from the equivalence table might be the intended point of comparison for acceptance.
2. Sample Size Used for the Test Set and Data Provenance
The document states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." It explicitly mentions that the C.VUE Advanced Definitive is identical in material and manufacturing process to the cleared Intelliwave³ (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens (K100221).
Therefore, no new clinical test set (sample size or provenance) was used for this specific 510(k) submission. The reliance is on the prior establishment of clinical performance for the efrofilcon A material through the predicate device. The document does not provide details about the sample size or provenance of the original clinical studies for the Intelliwave³ lens that established the performance of the efrofilcon A material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As no new clinical studies were conducted for this submission, there were no experts specifically used to establish ground truth for a new test set for the C.VUE Advanced Definitive lens.
4. Adjudication Method for the Test Set
Since no new clinical studies were conducted, there was no adjudication method applied to a new test set for this submission.
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. The submission did not involve new clinical trials comparing human readers with and without AI assistance or any other form of MRMC study, as the device is a contact lens and not an AI-driven diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, no standalone algorithm performance study was conducted.
7. The Type of Ground Truth Used
The "ground truth" for the safety and effectiveness of the efrofilcon A material was established through previous clinical performance data (presumably clinical trials, expert evaluations, and outcomes data) for the predicate Intelliwave³ lens, which used the same material. The current submission relies on the established safety and effectiveness of this material and manufacturing process.
Additionally, non-clinical testing on the C.VUE Advanced Definitive lenses contributed to the evidence, including:
- In vivo preclinical toxicology and biocompatibility tests
- Sterility testing
- Packaging material and extract toxicity/irritation tests
- Physical and material property consistency tests
These non-clinical tests were conducted according to GLP regulations and valid scientific protocols to confirm the device's properties.
8. The Sample Size for the Training Set
This question is not applicable. The device is a contact lens and does not involve an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for an AI algorithm.
§ 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.