(74 days)
The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.
The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity.
The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Leases are available with in monomer tint (Vat Blue 9) and with ultraviolet absorbing additive (benzophenone based):
- in the power range of -20.00 to +10.00 diopters for sphere,
- +0.25 to +3.00 diopters for addition
- with center thickness from 0.025mm to.40mm .
- with base curves of 8.00mm to 9.20mm ●
- with diameter of 12.00mm to 15.00mm .
The lens material is the same as the one BIOMEDICS® UV (ocufilcon D) described in submission PMA890023/S4 and S7 ,K984046.
The Biomedics® UV Multifocal (ocufilton D) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes that are presbyopic, with ar without associated ametropia, allowing for the correction of up to +3.00 diopters of add, with refractive astigmatism of no more than 0.75 diopters that does not interfere with visual acuity. The multifocal lens is a aspheric center near design.
The medical device in question is the BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lens.
Here's an analysis of the acceptance criteria and the study proving it:
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" and "reported device performance" are primarily demonstrated through substantial equivalence to predicate devices. The submission indicates that clinical studies were not necessary because the subject device was proven equivalent in material, physicochemical characteristics, parameters, and design to already approved devices. Therefore, the "performance" is implicitly deemed acceptable if it matches the established performance of the predicate devices.
| Acceptance Criteria Category | Specific Criteria/Comparison Point | Predicate Device Performance | Subject Device Performance (BIOMEDICS® UV Multifocal) |
|---|---|---|---|
| Material Equivalence | Production Method | Cast molded process | Cast molded process |
| Material Type | ocufilcon D (Group IV) | ocufilcon D (Group IV) | |
| Color Additive | Vat Blue 6 Dye | Vat Blue 6 Dye | |
| UV Additive | Yes | Yes | |
| Water Content % @ 20°C | 55 | 55 | |
| Refractive Index @ 20°C | 1.41 | 1.41 | |
| Dk (Oxygen Permeability) | 19.6 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg) @ 35°C | 19.6 x 10^-11 (cm²/sec) (ml O₂/ml x mm Hg) @ 35°C | |
| Light Transmittance (Tv, %) | 97% | 97% | |
| Intended Use Equivalence | General Indication | Daily wear, correction of ametropia | Daily wear, correction of ametropia and presbyopia |
| Multifocal Correction | Not applicable to spherical predicate | Up to +3.00 diopters addition, refractive astigmatism |
§ 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.