(147 days)
Not Found
PMA P830037/S31
No
The summary describes a physical contact lens with specific material properties and manufacturing processes. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No
The stated intended use is for the correction of vision, which is a prosthetic function, not a therapeutic one.
No
This device is a contact lens intended for correcting vision, not for diagnosing conditions.
No
The device description clearly outlines physical dimensions and material composition of contact lenses, which are hardware components.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that these are contact lenses intended for the correction of vision in the eye. They are placed on the surface of the eye and do not involve the analysis of bodily specimens.
- Intended Use: The intended use is solely for correcting refractive errors (myopia, hyperopia, astigmatism) and improving visual acuity.
Therefore, the DuraSoft 3 UV contact lenses are medical devices, but they fall under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.
The DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses as indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.
The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.
Product codes
Not Found
Device Description
The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:
DuraSoft 3 UV Optifit Toric
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.07 to 0.56 mm (varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters
DuraSoft 3 UV Spherical Lenses
Chord Diameter: 12.0 to 15.0 mm
Center Thickness: 0.05 to 0.56 mm (varies with power)
Base Curves: 7.80 to 9.00 mm
Powers: -20.00 Diopters to +20.00 Diopters
The lens material (phemfilcon A) is a hydrophilic copolymer of 2hydroxyethyl methylcrylate and 2-ethoxyethyl methacrylate. The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by adding the UV absorber to the polymerized rods. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configurations.
The physical properties of the lenses are:
Specific Gravity: 1.152
Refractive Index: 1.412
Light Transmittance:
LiteTint: 95% minimum
Colors: 97% minimum
Surface Characteristics: Hydrophilic
Water Content: 55%
Optical Zone: (Colors): 5 mm
(LiteTint) : 5 mm to 9 mm (varies with power)
Oxygen Transmissibility: Dk/L = 32.2 x 10-9 ml O2 cm at 35°C sec ml mm Hg
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Test data demonstrates the mouring processes and that the processes have no affect on the physical, optical or chemical properties of the finished lenses, and that the final finished specifications of the lenses are not adversely affected.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
PMA P830037/S31
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo for Wesley Jessen. The logo consists of a black circle with the letters "WJ" in white inside the circle. Below the circle, the words "WESLEY JESSEN" are written in a stylized font.
MAY 1 4 1997
SUMMARY OF SAFETY AND EFFECTIVENESS
K 965052
General Information
| A. Device Generic Name: | DuraSoft 3 UV (phemfilcon A) hydrophilic contact lens |
|---|---|
| B. Device Trade Name: | DURASOFT® 3 Spherical: Clear, LiteTint™, Colors, Colors Complements DURASOFT® 3 OptiFit® Toric: Clear, LiteTint™, Colors, Colors Complements DURASOFT® 3 UV Spherical: Clear, LiteTint™, Colors, Colors Complements DURASOFT® 3 UV OptiFit®: Clear, LiteTint™, Colors, Colors Complements |
| C. Manufacturer's Name: | Wesley Jessen Corporation 333 East Howard Avenue Des Plaines, IL 60018 |
| D. Contact Person: | Mr. Richard Main Regulatory Affairs Phone: 847 294-3342 Fax: 847 294-3434 |
| E. Device Common Name: | contact lens for daily wear |
Indications for Use
The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear in the correction of vision in aphakic and/or not-aphakic persons with non-diseased eyes that are of myopic (nearsighted) or hyperopic (farsighted) and for the correction of astigmatism from 0.75 to 6.00 diopters. The lens ranges in power from -20.00 to +20.00 diopters.
The DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses as indicated for daily wear in the correction of visual acuity in aphakic and/or not-aphakic persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit astigmatism of 2.00 diopters (D) or less that does not interfere with visual acuity. The lens ranges in power from -20.00 to +20.00 diopters.
The lenses indicated are for Daily Wear. The eye care practitioner may prescribe the lenses for daily use with routine daily cleaning, rinsing and disinfection. The lenses may be disinfected using a chemical disinfection system.
1
Substantial Equivalence
Substantial equivalence is being claimed for the addition of the UV absorber into the D3 Optifit Toric and D3 Spherical Soft lenses on the absorber inco and be prior approval of D3 FreshLook LiteTint UV lenses. The primary change occurring with the daily wear versions is that the UV absorber is being added to polymerized rods for lathed cut lenses while the previous approval was for the addition of the same UV absorber in the molding process as an in-molding process. Test data demonstrates the mouring processes and that the processes have no affect on the physical, optical or chemical properties of the finished lenses, and that the final finished specifications of the lenses are not adversely affected.
The process of incorporating the UV absorber into the polymer rods has been adjusted as an additive before polymerization which differs little from the previously approved in-process molding technique for molding lenses.
The sponsor will add appropriate UV absorption curves and standard claims statements to its labeling, and will continue to extend the current shelf life expiration date of two years, based on a reference to an approved shelf life protocol under the sponsor's PMA P830037/S31 approved March 5, 1990.
Device Description
The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are hemispherical shells of the following dimensions:
DuraSoft 3 UV Optifit Toric
| Chord Diameter: | 12.0 to 15.0 mm |
|---|---|
| Center Thickness: | 0.07 to 0.56 mm (varies with power) |
| Base Curves: | 7.80 to 9.00 mm |
| Powers: | -20.00 Diopters to +20.00 Diopters |
DuraSoft 3 UV Spherical Lenses
| Chord Diameter: | 12.0 to 15.0 mm |
|---|---|
| Center Thickness: | 0.05 to 0.56 mm (varies with power) |
| Base Curves: | 7.80 to 9.00 mm |
| Powers: | -20.00 Diopters to +20.00 Diopters |
The lens material (phemfilcon A) is a hydrophilic copolymer of 2hydroxyethyl methylcrylate and 2-ethoxyethyl methacrylate. The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are made by adding the UV absorber to the polymerized rods. Once cured the rods are cut to buttons and then lathed to the proper correction for toric or spherical configurations.
2
The physical properties of the lenses are:
| Specific Gravity: | 1.152 |
|---|---|
| Refractive Index: | 1.412 |
| Light Transmittance: | |
| LiteTint: | 95% minimum |
| Colors: | 97% minimum |
| Surface Characteristics: | Hydrophilic |
| Water Content: | 55% |
| Optical Zone: (Colors): | 5 mm |
| (LiteTint) : | 5 mm to 9 mm (varies with power) |
| Oxygen Transmissibility: | Dk/L = 32.2 x 10-9 ml O2 cm at 35°C |
| sec ml mm Hg |
General Use Instructions
The DuraSoft 3 UV Optifit Toric (phemfilcon A) Soft (hydrophilic) Contact Lenses and the DuraSoft 3 UV Spherical (phemfilcon A) Soft (hydrophilic) Contact Lenses are available as astigmatic or spherical lenses, concacc - Learing schedule may be prescribed for daily use at the direction of the eye care practitioner.