(90 days)
The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline. It is indicated for the correction of visual acuity.
The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline.
This document is a 510(K) summary for a contact lens and does not contain the information required to populate the fields of "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of AI/ML device performance. This document describes the biocompatibility, physical/optical characteristics, and manufacturing process validation of a contact lens, comparing a new manufacturing method to an existing one. It is not about the performance of a device that uses an algorithm or AI.
Therefore, I cannot provide the requested information from the given text.
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Image /page/0/Picture/0 description: The image shows the word "Sunsoft" in a bold, sans-serif font. Below the word "Sunsoft" is the phrase "A Member of the Essilor Group" in a smaller, serif font. The text is black and the background is white. The image appears to be a logo or branding element.
GBO Academy Parkway West Y Albuquerque. \ M. 87109-4405 707-345-7967
l nited States/Canada: 800-526-2020 Consultation/Administration: 800-648-2015 FAX Orders: 505-344-3087
FEB 20 1997
510(K) SUMMARY K 9646 96
Trade Name
Sunsoft (methafilcon A) Soft (Hydrophilic) DW Contact Lens
Generic Name:
Soft Contact Lens
Equivalent Device:
Sunsoft (methafilcon A) Soft (Hydrophilic) Contact Lens
Description and Intended Use:
The Sunsoft (methafilcon A) Soft ( Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmetharcylate and methacrylic acid. When hydrated, the lens consists of 45% methafilcon A and 55% water by weight when immersed in normal saline. It is indicated for the correction of visual acuity.
Assessment Of Equivalence:
Biocompatibility
Cytotoxicity, acute systemic toxicity and ocular irritation studies were conducted with samples of tinted lenses produced with the proposed static molding and lathing process. Test results showed no evidence of cellular or systemic toxicity, or ocular irritation.
Physical/Optical Characteristics
Light transmittance, refractive index, linear expansion, oxygen permeability and tensile strength were determined in samples of tinted lenses produced by static and centrifugal molding. Lenses were of similar thickness and power. comparison of the data from this study showed that the lenses were equivalent in physical and optical characteristics.
Manufacturing Process Validation
Two replicate production batches of three lens designs, that is, toric, asphere and sphere, were produced using the proposed production method. Thirty samples per batch were evaluated for axis and cylinder power (toric) base curve (sphere and
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asphere), diameter, lens thickness and dioptric power. All measurements were within specification. Evaluation of process capability for dioptric power resulted in Cok values of 1.2 or greater for all batches.
Conclusions
Biocompatibility studies of tinted lenses produced with the proposed manufacturing process showed no evidence of cellular or systemic toxicity, or ocular irritation. A comparative evaluation of this lens with lenses manufactured using the approved centrifugally molded/back lathed process showed that the two methods of production result in lenses that are equivalent in physical and optical characteristics. The static molding process is highly capable, as evidenced by a process validation study in which the manufacture of sphere and toric lens designs met all specifications of lenses manufactured by currently approved molding technology.
James B. Williams
Executive Officer, Regulatory Affairs & Compliance November 21, 1996
§ 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.