(175 days)
The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves 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 (Toric) (hioxifilcon B) 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 45 (Spherical) and Ultra Gel (Toric) (hioxifileon B) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon B, 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 eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) 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 48% water by weight. The physical properties of the lens are:
Refractive Index: 1.515 (dry) 1.404 (hydrated)
Color Pigment Name: Phthalocyanine Blue
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Water Content: 48 % ±2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).
The provided summary for the Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lenses does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria.
This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.
Therefore, many of the requested sections below cannot be populated from the provided text.
Here's an attempt to address the points based on the available information:
Acceptance Criteria and Device Performance Study (Information Not Provided)
The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific acceptance criteria and the results of a study designed to prove the device meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| (Not specified in the document) | (Not specified in the document) | (Not specified in the document) |
2. Sample size used for the test set and data provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified. The submission relies on demonstrating similarity to predicate devices rather than presenting a performance study with a distinct test set.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
- Number of experts: Not applicable, as a test set with expert-established ground truth is not described.
- Qualifications: Not applicable.
4. Adjudication method for the test set:
- Not applicable, as a test set requiring adjudication is not described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
- No MRMC comparative effectiveness study is mentioned in the provided text. The document is a 510(k) summary for a contact lens, which typically does not involve such studies for regulatory clearance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a contact lens and does not involve an algorithm.
7. The type of ground truth used:
- Not applicable, as no specific performance study with ground truth is detailed. The submission relies on the established safety and effectiveness profile of the predicate devices.
8. The sample size for the training set:
- Not applicable, as this device is a contact lens and does not involve a "training set" in the context of an algorithm.
9. How the ground truth for the training set was established:
- Not applicable.
Summary of Approach in the Document:
The provided document, a 510(k) summary, demonstrates substantial equivalence by comparing the new device (Resolution 45 and Ultra Gel contact lenses) to legally marketed predicate devices ("Horizon 55 Spherical & Westhin Toric" and "BENZ-G 3X"). This equivalence is established based on:
- Intended Use: The indications for use are similar.
- Design and Materials: The materials (hioxifilcon B, hydrophilic polymer), production method (lathe-cut), and physical properties (water content, polymer content, DK value, refractive index, specific gravity, light transmission) are compared and found to be similar or within acceptable ranges.
- Safety and Effectiveness Profile: The submission states that the established safety profile (preclinical toxicology and manufacturing/chemistry data) of the new device is equivalent to the BENZ-G 3X predicate.
Instead of a new performance study with defined acceptance criteria, the regulatory pathway relies on the known safety and effectiveness of the equivalent predicate devices.
§ 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.