(65 days)
The AQUASOFT (ocufilcon D) Spherical 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. 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 lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT (ocufilcon D) Toric 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 have astigmatism of 7.00D of astigmatism or less. The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AOUASOFT (ocufilcon D) Multifocal 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 are presbyopic. The lens may be worn by persons who exhibit no more than 2.00 D of astigmatism and can obtain satisfactory visual acuity in a power range of +4.00D to -5.00D and have near add requirements up to 3.00D.
The lens may be cleaned and disinfected using a chemical (not heat) lens care system.
Eyecare practitioners may prescribe the lenses for daily wear for disposal after removal in a disposable lens program or for cleaning, disinfection and scheduled replacement in a frequent replacement program. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.
The AQUASOFT (ocufilcon D) Soft (hydrophilic) Contact Lens is available as a single vision spherical lens, aspherical multifocal lens and as a back surface astigmatic (toric) lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.
The ionic lens material. (ocufilcon D) is a co-polymer of 2-Hydroxyethylmethacrylate (2-HEMA) and Methacrylic Acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution. The lens polymer contains a UV absorbing compound and is available clear or with a blue visibility-handling tint, color additive 'Reactive Blue 19', 21 CFR part 73.2121. The ocufilcon D name has been adopted by the United States Adopted Names Council (USAN).
In the AQUASOFT Contact Lens with UV Blocker, a Benzophenone UV absorbing monomer is used to block UV radiation. The UV blocking for AQUASOFT averages > 99% in the UVB range of 280nm -315nm and 83% in the UVA range of 316 - 380mm.
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 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 55% water by weight.
The provided 510(k) summary describes the AQUASOFT (ocufilcon D) Daily Wear Contact Lens. This document indicates that no clinical studies were required or performed to demonstrate substantial equivalence for this device. Instead, the submission relies on non-clinical performance data and a comparison of technological characteristics to a predicate device.
Therefore, the following information is not present in the document:
- Acceptance criteria in the context of a clinical study
- Study proving device meets acceptance criteria (as no clinical study was done)
- Sample size for the test set
- Data provenance
- Number of experts used to establish ground truth
- Qualifications of experts
- Adjudication method
- MRMC comparative effectiveness study or effect size
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
However, I can provide the technological characteristics comparison table which serves as the "performance" data for demonstrating substantial equivalence based on pre-clinical information.
1. Table of Key Technological Characteristics (Acceptance Criteria are inferred from equivalence to predicate device)
The device demonstrates substantial equivalence by matching or being comparable to the predicate device across these characteristics. Any significant deviation would require further justification or clinical data.
| Pre-Clinical Equivalency / Device | AQUASOFT (ocufilcon D) New Device Performance | BIOMEDICS 55 (ocufilcon D) Predicate Device ("Acceptance Criteria") |
|---|---|---|
| Submission number | New Device | K982947 |
| Intended Use | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. | Indicated for daily wear for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. |
| Functionality | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. | The contact lenses act as a refractive medium that focus light rays from near and distant objects on the retina. |
| Indications | Daily wear, Soft (hydrophilic) contact lens | Daily wear, Soft (hydrophilic) contact lens |
| Production Method | Cast-molded | Cast-molded |
| FDA Group # | Group # 4 >50% Water, Ionic Polymers | Group # 4 >50% Water, Ionic Polymers |
| USAN name | ocufilcon D | ocufilcon D |
| Water Uptake (%) | 55.0% | 55.0% |
| Oxygen Permeability | 19.7 x 10^-11^ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). | 19.7 x 10^-11^ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method). |
| Specific Gravity | 1.062 | 1.141 |
Summary of the Study (Demonstration of Substantial Equivalence):
The "study" in this context is a pre-clinical comparison of the AQUASOFT lens to a legally marketed predicate device (BIOMEDICS 55) to demonstrate substantial equivalence, rather than a clinical trial with specific acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable, as no clinical test set was used. The evaluation was based on a comparison of device characteristics and non-clinical laboratory testing.
- Data provenance: Not explicitly stated for specific test data, but the submission is from ClearLab PTE, Ltd. (Singapore) and 1800 CONTACTS, Inc. (USA). The non-clinical tests were conducted as recommended by the FDA guidance document for Daily Wear Contact Lenses.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical test set requiring expert ground truth was performed or discussed in this summary.
4. Adjudication method for the test set:
- Not applicable, as no clinical test set was used.
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, as this is a contact lens device (not an AI medical imaging device) and no clinical studies were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable, as this is a contact lens device (not an AI algorithm).
7. The type of ground truth used:
- Not applicable directly to a clinical test set. For the non-clinical tests (e.g., toxicology, physiochemical properties), the "ground truth" would be established by industry standards, validated laboratory methods, and regulatory guidelines for contact lens materials.
8. The sample size for the training set:
- Not applicable, as there is no "training set" in the context of an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable.
Conclusion from the document:
The submission concludes that the AQUASOFT Soft Contact Lens is substantially equivalent to the predicate device(s) based on the presented technological characteristics and non-clinical testing, and "does not raise different questions of safety and effectiveness than that of the predicate devices." No clinical data was required or submitted for this 510(k) premarket notification.
§ 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.