(110 days)
The Benz-G 4X 54% (Hioxifilcon D) Multifocal Lathed soft contact lens for daily wear is indicated for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. The spherical lens may be worn by persons who exhibit astigmatism of 0.75 Diopter or less that does not interfere with visual acuity. The toric lens may be worn by persons who exhibit astigmatism of up to 10 Diopters.
Eye care practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system.
The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lenses are hemispherical shells and are available as multifocal lens designs. The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is fabricated from Hioxifilcon D, which is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2,3-, Dihydroxypropyl Methacrylate (Glycerol Methacrylate, GMA) and cross-linkned with ethylene glycol dimethacrylate (EGDMA). It consists of 46% Hioxifilcon Datod 54% water by weight when immersed in normal buffered saline solution buffered. The lens is available with a blue visibility handling tint, phthalocyanato (2) - (copper).
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, rransparent 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.
The Benz-G 4X (Hioxifilcon D) Multifocal Lathed soft contact lens is substantially equivalent to the predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens cleared under 510(k) K062854. The submission does not describe a study to prove acceptance criteria in the traditional sense of a clinical trial with a test set, ground truth, or statistical analysis. Instead, it relies on substantial equivalence to a previously cleared device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the new device are implicitly established by demonstrating that its characteristics are substantially equivalent to those of the predicate device (Benz-G 4X Lathed Lens, K062854). The relevant "performance criteria" are the physical, chemical, and intended use specifications, which are compared side-by-side.
| Characteristic | Acceptance Criteria (Predicate Device K062854) | Reported Device Performance (New Device) |
|---|---|---|
| Intended Use | Correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes that are myopic or hyperopic. Spherical lens for astigmatism ≤ 0.75 Diopters; Toric lens for astigmatism up to 10.0 Diopters. For daily wear, frequent/planned replacement. | Correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are myopic, hyperopic, possess astigmatism of 10.0 diopters or less and are presbyopic. Spherical lens for astigmatism ≤ 0.75 Diopters; Toric lens for astigmatism up to 10.0 Diopters. For daily wear, frequent/planned replacement. (Addition of presbyopic correction) |
| USAN Name | Hioxifilcon D | Hioxifilcon D |
| Classification Number | LPL | LPL |
| Classification Name | Soft (hydrophilic) contact lens, daily wear | Soft (hydrophilic) contact lens, daily wear |
| Material Classification | FDA Group 2 (> 50% H2O, non-ionic polymer) | FDA Group 2 (> 50% H2O, non-ionic polymer) |
| Production Method | Lathe-Cut | Lathe-Cut |
| Water Content | 54% ± 2 | 54% ± 2 |
| Specific Gravity | 1.299 (dry) | 1.299 (dry) |
| Expansion | 1.35 | 1.35 |
| Refractive Index | 1.408 hydrated | 1.408 hydrated |
| Light Transmission | Greater than 95% T | Greater than 95% T |
| Tint | Blue Phthalocyanato (2) - (copper) | Blue Phthalocyanato (2) - (copper) |
| Oxygen Permeability | 18 x 10-11 Fatt Dk units (Fatt method) / 23 x 10-11 Fatt Dk units (ANSI Z80:2004 polarographic method) | 18 x 10-11 Fatt Dk units (Fatt method) / 23 x 10-11 Fatt Dk units (ANSI Z80:2004 polarographic method) |
| Optical Zone | Optic Zone: 7.971 | Optic Zone: 8.0 (OZ1: 1.8 - 6.2, OZ2: 6.2 - 1.8) (Difference in design due to multifocal nature) |
| Breaking Force | 57 gms | 57 gms |
| Tensile Strength | 25 g/sq.mm | 25 g/sq.mm |
| Modulus | 21 g/sq.mm | 21 g/sq.mm |
| Elongation | 186% | 186% |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The submission states, "It was determined that clinical studies were not necessary to establish the safety and effectiveness of the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses." Therefore, there was no separate test set of subjects/data used for clinical evaluation of the new device. The data provenance would be inherent in the predicate device's original clearance.
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, as no new clinical study with a test set was conducted for the new device. The ground truth for the predicate device would have been established at the time of its clearance (K062854).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical study with a test set was conducted for the new device.
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-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a contact lens, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable for a new clinical study. The basis of equivalence is the identical physical and chemical properties and manufacturing process to the predicate device, with an expanded intended use to include presbyopia.
8. The sample size for the training set
Not applicable, as no new clinical study was conducted.
9. How the ground truth for the training set was established
Not applicable, as no new clinical study was conducted.
Study Proving Acceptance Criteria:
The study proving the acceptance criteria for the Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses is based on a side-by-side comparison testing with its predicate device, the Benz-G 4X (Hioxifilcon D) Lathed Lens (K062854).
The document explicitly states:
- "Side by side comparison testing was conducted on the Benz-G 4X (Hioxifilcon D) Lathed Lens already cleared under 510(k) K062854, and Multifocal Lenses manufactured by Benz Research & Development from Hioxifilcon D material."
- "This Benz-G 4X (Hioxifilcon D) material is identical to the previously cleared Benz-G 4X (Hioxifilcon D) under K062854."
- "The Benz-G 4X (Hioxifilcon D) Multifocal Lathed lenses have the identical manufacturing process (lathe-cut versus lathed-cut) as the marketed lens Benz-G 4X (Hioxifilcon D) Lathed."
The conclusion drawn from this comparison is that the new device is substantially equivalent to the predicate device in terms of:
- Intended use (with the addition of presbyopia correction)
- Materials
- Toxicological properties
- Physicochemical properties
The primary difference, an additional optical zone for multifocal correction, is presented as an enhancement to visual acuity correction rather than a fundamental change requiring new extensive clinical testing, given the identical base material and manufacturing process. The FDA's August 9, 2010 letter confirms this determination of substantial equivalence.
§ 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.