(122 days)
The CVue Advanced HydraVUE Irregular Cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.
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 CVue Advanced HydraVUE (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel contact lenses for daily wear are fabricated from efrofilcon 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 lathe-cut and made to order for individual prescriptions. Each lens consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. 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 lenses will be manufactured in spherical, toric, multifocal toric and irregular cornea configurations. The lens is supplied sterile in vials containing a buffered saline solution.
This 510(k) summary describes the CVue Advanced HydraVUE Irregular Cornea (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel contact lenses for daily wear. The device is being submitted for an expanded indication to include the management of irregular corneal conditions like keratoconus and post-graft fitting, in addition to the correction of visual acuity in aphakic and non-aphakic persons with myopia or hyperopia.
The submission claims substantial equivalence to three predicate devices: IntelliWave3, Metro Soft, and CVue Advanced Definitive, all of which are efrofilcon A silicone hydrogel contact lenses for daily wear.
Here's a breakdown of the requested 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 numerical or threshold format for clinical efficacy. Instead, it relies on the established performance of the predicate devices and the material properties. The acceptance is implied by demonstrating substantial equivalence in material, manufacturing, and intended use as the predicates that have already met regulatory requirements.
| Characteristic | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (CVue Advanced HydraVUE) |
|---|---|---|
| Intended Use | Same as predicate devices for irregular cornea management and ametropia correction | Indicated for correction of ametropia and management of irregular corneal conditions (keratoconus, post-graft fitting) |
| Material | efrofilcon A | efrofilcon A |
| Manufacturing Process | Lathe-cut, custom manufactured | Lathe-cut, made to order for individual prescriptions |
| Water Content | 74% | 74% |
| Oxygen Permeability | 60 x 10⁻¹¹ (cm²/sec)(ml O₂/ml x mm Hg@35 °C) | 60 x 10⁻¹¹ (cm²/sec)(ml O₂/ml x mm Hg@35 °C) (Note: reported as 59.8 x 10⁻¹¹ in description) |
| Specific Gravity | 1.130 (predicate table) | 1.048 (hydrated) (description), 1.130 (predicate table) |
| Sterility | Sterile for indicated shelf-life | Lenses supplied in glass vials are sterile for the indicated shelf-life |
| Physical/Material Properties | Consistent with marketed lenses | Lens physical and material properties are consistent with currently marketed lenses |
| Clinical Performance | Previously established for efrofilcon A material | Clinical performance of efrofilcon A lens material has been previously established |
| Biocompatibility | Previously established | Preclinical toxicology and biocompatibility were previously established |
| Shelf-life Stability | Follows scientific protocols | Shelf-life stability studies followed scientific protocols, data scientifically valid |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a specific "test set" or clinical study with patient sample sizes for the CVue Advanced HydraVUE Irregular Cornea lenses itself. Instead, it relies on substantial equivalence to predicate devices, whose clinical performance and material properties were previously established.
Therefore, no new clinical study was conducted for this specific 510(k) submission to demonstrate performance based on a new test set. The data provenance for the previously established clinical performance and material data related to efrofilcon A is not detailed in this document. It references Master File MAF #1708 for the efrofilcon A material.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable, as no new clinical study (test set) was performed for this 510(k) submission. Clinical performance was established through previous submissions for the efrofilcon A material itself.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical study (test set) was performed for this 510(k) submission.
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
Not applicable. This device is a contact lens, not an AI-powered diagnostic or assistive technology. No MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens. No algorithm-only or standalone performance study was done.
7. The Type of Ground Truth Used
For the safety and effectiveness of the efrofilcon A material, the "ground truth" was established through:
- Preclinical toxicology and biocompatibility studies: These tests assess the material's interaction with biological systems.
- Clinical performance data for the efrofilcon A lens material: This would involve patient studies from previous submissions to demonstrate the material's safety and effectiveness in-vivo. The document references Master File MAF #1708 for this data.
- Physical and material property testing: Laboratory measurements of water content, oxygen permeability, light transmission, etc., with established benchmarks for safe and effective contact lenses.
- Sterility and shelf-life stability studies: Laboratory validation that the product remains sterile and effective over its shelf life.
8. The Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI model.
9. How the Ground Truth for the Training Set was Established
Not applicable. This device is a contact lens, not an AI model.
§ 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.