(24 days)
The Resolution 5X (Spherical) (hioxifilcon A) 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 Ultra Gel 5X (Toric) (hioxifilcon A) 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/or possesses refractive astigmatism not exceeding 10 diopters.
The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon 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.
In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon 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 hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight.
This document is a 510(k) summary for the Resolution 5X (Spherical) and Ultra Gel 5X (Toric) Hioxifilcon A Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices rather than providing a study that establishes de novo acceptance criteria and demonstrates the device meets them.
Therefore, the following information is not applicable or not present in the provided text:
- Acceptance criteria table and reported device performance directly addressing those criteria.
- Sample sizes used for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size information.
- Standalone (algorithm-only) performance study.
- Type of ground truth used for a testing evaluation.
- Sample size for a training set.
- How ground truth for a training set was established.
This is a traditional 510(k) submission, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary evaluation here is a comparison to predicate devices, not a clinical trial establishing new performance criteria.
Here's a breakdown of the information that is present and relevant to the concept of demonstrating safety and effectiveness through substantial equivalence:
1. A table of acceptance criteria and the reported device performance:
This specific table, as would be expected for a de novo submission or a clinical trial report, is not present. Instead, the document provides a "Substantial Equivalence Matrix" comparing the new device's characteristics to its predicate devices. The "acceptance criteria" are implicitly met if the new device's characteristics are similar enough to the predicate devices such that it does not raise new questions of safety and effectiveness.
Substantial Equivalence Matrix (Implicit "Acceptance Criteria" based on Predicate Devices):
| Characteristic | Resolution 5X (Spherical) | Ultra Gel 5X (Toric) | PREDICATE DEVICES |
|---|---|---|---|
| PRODUCTION METHOD | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| LENS FUNCTION | Refractive medium that focuses light rays from distant, intermediate and near objects on the retina, while compensating for refractive error. | Refractive medium that focuses light rays from near, intermediate and distant objects on the retina, while compensating for refractive error. | Refractive medium that focuses light rays from near, intermediate and distant objects on the retina, while compensating for refractive error. |
| MATERIAL | Hydrophilic Polymer | Hydrophilic Polymer | Hydrophilic Polymer |
| a. Water Content | 58% | 58% | 58%, 48% |
| b. Polymer Content | 42% | 42% | 42%, 52% |
| c. Polymer | hioxifilcon A | hioxifilcon A | hioxifilcon A, hioxifilcon B |
| d. DK Value | 20 | 20 | 20, 15 |
| e. Refractive Index | 1.404 (hydrated) | 1.404 (hydrated) | 1.404, 1.404 |
| f. Specific Gravity | 1.136 (hydrated) | 1.136 (hydrated) | 1.136, 1.136 |
| g. Light Transmission | greater than 95% T | greater than 95% T | greater than 95% T |
Device Performance (from Device Description):
| Physical Property | Value |
|---|---|
| Refractive Index (dry) | 1.515 |
| Refractive Index (hydrated) | 1.404 |
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Water Content | 58% ± 2% |
| Specific Gravity (dry) | 1.308 |
| Specific Gravity (hydrated) | 1.136 |
| Oxygen Permeability (DK value) | $20 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) (revised Fatt method). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No separate "test set" for performance evaluation in the context of a new acceptance criterion is described, as this is a substantial equivalence submission. The pre-clinical toxicology and manufacturing/chemistry data were deemed equivalent to the predicate device (BENZ-G 5X, K952620), but details on those specific tests are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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 is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. Safety and effectiveness are demonstrated by substantial equivalence to predicate devices, drawing from their established safety profiles.
8. The sample size for the training set:
Not applicable.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.