(28 days)
SPHERICAL
Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters that does not interfere with visual acuity.
TORIC
Biomedics 52 (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 10.00 diopters.
The lens may be prescribed for Daily Wear in not-aphakic persons. The eyecare practitioner may prescribe the contact lens for either single-use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for single-use disposable wear the lens is to be discarded after each removal. When prescribed for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.
The Biomedics (ocufilcon B) Soft (Hydrophilic) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Biomedics 52 (ocufilcon B) soft contact lens is a Group IV, daily wear silicone hydrogel contact lens that is not surface treated and is characterized by a high oxygen permeability (Dk). The lens material, ocufilcon B. is composed of polymerized material of HEMA and cross linked with other monomers, incorporating phthalocyanine blue as an integrated, handling tint. A UV blocker is added to reduce the amount of ultraviolet light transmitted into the eye. The lenses are manufactured in spherical and toric configurations. The Biomedics 52 (ocufilcon B) Soft (hydrophilic) contact lenses are a hemispherical shell. The physical properties and available dimensions are unchanged from predicate 510(k)s.
The provided 510(k) summary (K113267) for the CooperVision Biomedics 52 contact lenses explicitly states that no clinical studies were required for this submission. The basis for this is that the technical characteristics, formulation, manufacturing, and sterilization processes of the lens materials are not changing and are considered equivalent to currently marketed ocufilcon B soft contact lenses by Cooper Vision.
Therefore, the submission does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective. The submission focuses on demonstrating substantial equivalence to predicate devices based on non-clinical aspects, primarily the unchanged nature of the device itself and modifications to a shelf-life protocol (which did not affect the device's physicochemical or toxicological properties).
Given this, I cannot provide the requested table and details because the information is not present in the provided text. The document clearly states:
- "Results from physical, optical and chemical properties were not required as support for this modification to shelf life protocol. Change will not affect physicochemical properties of the lenses." (Section 9)
- "Results from in-vivo and in-vitro studies were not required as support for this modification to shelf life protocol. Change will not affect lenses ability to remain non-toxic and biocompatible with the ocular environment." (Section 10)
- "The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are not changing and therefore are equivalent to ocufilcon B soft contact lenses currently marketed by Cooper Vision, therefore no clinical data is required." (Section 12)
The approval is based on substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device, without requiring new clinical performance data for the specific changes addressed in this 510(k).
§ 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.