(84 days)
The Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens is indicated as daily wear and single use soft contact lens for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with nondiseased eyes who exhibit refractive astigmatism of 1.00 D or less here the astigmatism does not interfere with visual acuity.
The Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with nondiseased eyes and whose powers are from -12.00 to +8.00 D and astigmatism corrections are from -0.75 to -2.25 D.
The Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lenses are indicated as daily wear and single use for the correction of ametropia (myperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -12.00 to +8.00 D with add powers from +0.25 to +2.75 D. The lenses may be worn by persons who exhibit astigmatism of 1.00 D or less where the astigmatism does not interfere with visual acuity.
Evecare practitioners prescribe the lens for single-use disposable wear.
The Daily Breeze B (olifilcon B) Silicone Hydrogel Soft Contact Lens is made of hydrogel material, olifilcon B, with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 53% olifilcon B, which is a copolymer of 1-vinyl-2-pyrrolidinone (NVP) and Siloxane macromer, and 47% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.
Lenses are supplied sterile in sealed blister packs containing isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.
The provided text is a 510(k) summary for a contact lens device, not an AI/ML medical device. Therefore, it does not contain the information requested regarding acceptance criteria and study details for an AI/ML device.
Specifically, the document states:
"This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply." (Page 7, Section 11. Clinical study)
The information requested regarding AI/ML device performance, such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, and standalone performance, is not present in this document.
The document focuses on the physicochemical properties, manufacturing process, and comparison to a predicate contact lens device to demonstrate substantial equivalence, which is typical for a contact lens submission.
§ 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.