SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS

K964696 · Sunsoft Corp. · LPL · Feb 20, 1997 · Ophthalmic

Device Facts

• Record ID: K964696
• Device Name: SUNSOFT (METHAFILCON A) SOFT (HYDROPHILIC) DAILY WEAR CONTACT LENS
• Applicant: Sunsoft Corp.
• Product Code: LPL · Ophthalmic
• Decision Date: Feb 20, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

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.

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.

Indications for Use

Indicated for correction of visual acuity in patients requiring contact lenses.

Regulatory Classification

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)

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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

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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 $C_{\mathrm{pk}}$ 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.


Executive Officer,
Regulatory Affairs & Compliance
November 21, 1996