← Product Code [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL) · K964696 # SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS (K964696) _Sunsoft Corp. · LPL · Feb 20, 1997 · Ophthalmic · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K964696 ## Device Facts - **Applicant:** Sunsoft Corp. - **Product Code:** [LPL](/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL.md) - **Decision Date:** Feb 20, 1997 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 886.5925 - **Device Class:** Class 2 - **Review Panel:** Ophthalmic ## Indications for Use The Sunsoft (methafilcon A) Soft (Hydrophilic) Contact Lens is a random copolymer of 2-hydroxyethylmethacrylate 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. ## Device Story Sunsoft (methafilcon A) soft hydrophilic contact lens; random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid; 45% polymer/55% water content. Used for visual acuity correction. Manufactured via static molding and lathing process. Evaluated for biocompatibility (cytotoxicity, systemic toxicity, ocular irritation) and physical/optical properties (light transmittance, refractive index, oxygen permeability, tensile strength). Process validation confirmed consistency across toric, asphere, and sphere designs with Cpk values ≥ 1.2. Clinician-prescribed device. ## Clinical Evidence Bench testing only. Biocompatibility studies (cytotoxicity, acute systemic toxicity, ocular irritation) showed no adverse effects. Physical/optical characterization (transmittance, refractive index, oxygen permeability, tensile strength) and process validation (axis, cylinder, base curve, diameter, thickness, dioptric power) confirmed equivalence to approved manufacturing methods. ## Technological Characteristics Material: methafilcon A (random copolymer of 2-hydroxyethylmethacrylate and methacrylic acid). Hydrated state: 45% polymer, 55% water. Designs: toric, asphere, sphere. Manufacturing: static molding and lathing. Properties: light transmittance, refractive index, oxygen permeability, tensile strength. ## Regulatory 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. ## Predicate Devices - Sunsoft (methafilcon A) Soft (Hydrophilic) Contact Lens ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} Sunsoft A Member of the Essilor Group 6005 Academy Parkway West N.E. Albuquerque, NM 87109-4405 505-345-7967 United States/Canada: 800-526-2020 Consultation/Administration: 800-648-2015 FAX Orders: 505-344-3087 FEB 20 1997 510(k) SUMMARY K964696 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-hydroxyethylmethacrylate 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. A 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 {1} asphere), diameter, lens thickness and dioptric power. All measurements were within specification. Evaluation of process capability for dioptric power resulted in $C_{\mathrm{pk}}$ 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, asphere and toric lens designs met all specifications of lenses manufactured by currently approved molding technology. ![img-0.jpeg](img-0.jpeg) Executive Officer, Regulatory Affairs & Compliance November 21, 1996 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K964696](https://fda.innolitics.com/submissions/OP/subpart-f%E2%80%94therapeutic-devices/LPL/K964696) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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