(136 days)
Not Found
No
The document describes a standard contact lens with different designs (single vision, toric, multifocal) and color options. There is no mention of any computational or analytical functions that would typically involve AI/ML. The testing described is standard for contact lenses and does not involve performance metrics related to AI/ML.
Yes
The device aids in the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which are medical conditions affecting vision, thus performing a therapeutic function.
No
The device is a contact lens indicated for the correction of refractive ametropia and to alter the apparent color of the eye. It is for therapeutic/corrective use, not to diagnose a condition.
No
The device is a contact lens, which is a physical medical device made of a hydrophilic polymer. The description details the material composition and physical properties of the lens, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Saview-Colors 42 UV contact lenses are placed directly on the eye to correct vision (refractive ametropia and presbyopia) and alter eye color. They do not analyze any biological specimens from the body.
- Intended Use: The intended use clearly states the correction of refractive errors and altering eye color, not the diagnosis or monitoring of a disease through the analysis of a specimen.
- Device Description: The description focuses on the lens material, design, and manufacturing process, not on any components or processes related to analyzing biological samples.
Therefore, the Saview-Colors 42 UV contact lens is a medical device, but it falls under a different classification than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors 42 UV lens also acts to enhance or alter the apparent color of the eye.
Eve care practitioners may prescribe the lenses for single use disposable wear or frequent replacement. When prescribed for a Disposable Wearing Schedule, the lenses are not intended to be cleaned or disinfected and should be discarded after a single use. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
The Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA), and using azobisisobutyronitrile (AIBN) as the initiator. A compound 22-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] UV absorbing ethvl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74.
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
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 practitioners / Not Specified
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.
- Stability Testing
- . Toxicology Testing
- Cytotoxicity i
- Ocular Irritation 8
- Acute Systemic Injection
- Physical/Chemical Testing C
Clinical Testing:
Clinical data is not required for this submission.
Key Results:
Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of Results of acute systemic injection, ocular irritation and in vitro cvrotoxicity tests showed the Saview-Colors 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
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
K123484 Page 1 of 5
Page 1 of 3
MAR 2 9 2013
510(k) Summary
Submitter Information:
| Address: | St. Shine Optical Co., Ltd. |
|---|---|
| 4,5F No. 276-2, Sec. 1, Ta Tung Rd. | |
| Hsi Chih Dist., 221, New Taipei City | |
| Taiwan R.O.C. | |
| Registration No.: | 9617499 |
| Contact Person: | Ella Lee |
| Project Manager, R&D Div. | |
| Telephone: | 886-2-2647-9356 |
| Fax: | 886-2-8691-6776 |
| Date Prepared: | Mar. 12, 2013 |
Device:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Name: | Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens |
| Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens | |
| Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens | |
| Classification Name: | Soft (Hydrophilic) Contact Lens (daily wear) |
| Device Classification: | Class II (21 CFR 886.5925) |
| Product Code: | LPL, MVN |
| Panel: | Ophthalmic |
Predicate Devices:
The predicate devices are S 42 UV Single Vision (hefilcon A) Soft (hydrophilic) Lens, T 42 UV Toric (hefilcon A) Soft (hydrophilic) Lens and M 42 UV Multifocal (hefilcon A) Soft (hydrophilic) Lens covered under 510(k) K040900 and FreshLook ", Freshlook® Toric and FreshLook® Progressive (nelfilcon A) One Day Color Contact Lens covered under 510(k) K050213.
Description of Devices:
1
The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA), and using azobisisobutyronitrile (AIBN) as the initiator. A compound 22-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] UV absorbing ethvl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74.
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is available as a single vision lens.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.
Indication for Use:
The Saview-Colors 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.
The Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and
2
hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters. The Saview-Colors 42 UV lens also acts to enhance or alter the apparent color of the eye.
Eve care practitioners may prescribe the lenses for single use disposable wear or frequent replacement. When prescribed for a Disposable Wearing Schedule, the lenses are not intended to be cleaned or disinfected and should be discarded after a single use. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.
The Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Non-Clinical Testing:
The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.
- Stability Testing
- . Toxicology Testing
- Cytotoxicity i
- Ocular Irritation 8
- Acute Systemic Injection
- Physical/Chemical Testing C
Clinical Testing:
Clinical data is not required for this submission.
Description of Safety and Substantial Equivalence:
Information submitted in the 510(k) cstablishes that the Savicw-Colors 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Results of Results of acute systemic injection, ocular irritation and in vitro cvrotoxicity tests showed the Saview-Colors 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.
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| | | S 42 UV Single Vision,
T 42 UV Toric and M
42 UV Multifocal
(hefilcon A) Soft
(hydrophilic) Lens -
K040900 | FreshLook®
(nelfilcon A) One
Day Color Contact
Lens - K050213 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Device | Saview-Colors 42 UV,
Saview-Colors 42 UV Toric,
and Saview-Colors 42 UV
Multifocal (hefilcon A) Soft
(Hydrophilic) Contact Lens | | |
| Material
(Classification) | hefilcon A
(Group 1) | hefilcon A
(Group 1) | nelfilcon A
(Group 2) |
| Indication for use | myopia, hyperopia, presbyopia
and astigmatism | myopia, hyperopia,
presbyopia and
astigmatism | myopia, hyperopia,
presbyopia and
astigmatism |
| Water content | 42 % | 42 % | 69 % |
| Visible light
transmittance | 97.06 % | 90.3 % | Clear≥97 %
Vistint 96 % |
| UV Transmittance | UVA : 0.49 %
UVB : 9.22 % |