(70 days)
No
The summary describes a standard contact lens and its material properties, with no mention of AI or ML technology.
No.
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia, which are refractive errors, not diseases or therapeutic conditions.
No
Explanation: The device is a contact lens used for vision correction (refractive ametropia), not for diagnosing medical conditions. Its function is to correct existing vision problems, not to identify or detect them.
No
The device description clearly states that the device is a physical contact lens made of a hydrophilic polymer, not software.
Based on the provided text, 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 Description and Intended Use: The description clearly states that these are contact lenses intended to be worn on the eye (cornea and sclera) for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia). They are a physical device applied to the body, not used to analyze samples taken from the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, diagnostic testing, or any of the typical characteristics of an IVD.
Therefore, these contact lenses fall under the category of medical devices, but not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The S 42 UV Single Vision (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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.
The T 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 and/or not aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 5.00 Diopters.
The M 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.
The lenses may be disinfected using chemical (not heat) or hydrogen peroxide disinfecting systems. Eyecare practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical (not heat), or hydrogen peroxide disinfecting systems.
Product codes
LPL
Device Description
S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes, cornea, and a portion of the adjacent sclera.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eyecare practitioners, daily wear
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)
A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.
Results of Systemic Injection, Primary Ocular Irritation and Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. 42 UV lenses were extracted and evaluated for presence of the UV blocking compound. Results showed no evidence of unsafe amounts of this compound in the extracts. Physicochemical testing of 42 UV lenses demonstrated equivalency to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Optical Connection Inc.
510(k) Summary
Submitter Information:
Optical Connection, Inc. a subsidiary of St. Shine Optical Co., Ltd. 3315 Almaden Expressway, Suite 25 San Jose, CA, 95125
| Contact Person: | Garold L. Edwards, O.D., F.A.A.C
Regulatory Consultant |
|-----------------|-----------------------------------------------------------|
| Telephone: | (408) 221-3860 |
| Fax: | (831) 335-0166 |
- Date Prepared: March 23, 2004
Device Name:
| Common Name: | Soft (Hydrophilic) Contact Lens |
|---|---|
| Trade/Proprietary Names: | S 42 UV Single Vision (hefilcon A) Soft |
| (Hydrophilic) Contact Lens for Daily Wear | |
| T 42 UV Toric (hefilcon A) Soft (Hydrophilic) | |
| Contact Lens for Daily Wear | |
| M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) | |
| Contact Lens for Daily Wear | |
| Classification Name: | Soft (Hydrophilic) Contact Lens |
| Device Classification: | Class II (21 CFR 886.5925) |
1
Predicate Devices:
The molded Specialty 42 UV, Specialty 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lenses and Saview 55 Multifocal (methafilcon A) Soft (Hydrophilic Contact Lens were selected as the predicate devices.
Specialty 42 UV, Specialty 42 UV Toric (hefilcon A) and Saview 55 Multifocal (methafilcon A) devices are manufactured in the same facility, under the same quality system, using the same molding, tinting, packaging and sterilization processes.
Description of Devices:
S 42 UV Single Vision, T 42 UV Toric, and M 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical flexible shells that cover the cornea and a portion of the adjacent sclera. The 42 UV Contact Lens is available in a single vision lens design, the 42 UV Toric Contact Lens is available in a back surface design, and the 42 UV Multifocal lens is available in an aspheric lens design. The lens material (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) cross-linked with ethyleneglycol dimethacrylate (EGDMA), using AIBN as the initiator. The lens contains 42% water by weight. 42 UV, 42 UV Toric, and 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear are tinted using Piqment Blue 15, ([Phthalocyaninato(2-)] copper) which is approved for coloring contact lenses under 21 CFR 5 74.3045 and a UV absorbing compound, 2-(benzoyl-3-hydroxyphenoxy)ethyl acrylate, has been incorporated into the lens polymer.
2
Comparison to Predicate Devices
| Lens type
Predicate
device 510(k) | S 42 UV Single
Vision, T 42 UV
Toric and
M 42 UV Multifocal
(hefilcon A) Soft
(Hydrophilic)
Contact Lenses for
Daily Wear
(molded) | S 42 UV Single
Vision, T 42 UV
Toric and
M 42 UV Multifocal
(hefilcon A) Soft
(Hydrophilic)
Contact Lenses for
Daily Wear
(lathe-cut) | Specialty 42 and
Specialty 42 Toric
(hefilcon A) Soft
(Hydrophilic)
Contact Lenses for
Daily Wear | Specialty 42 UV and
Specialty 42 UV
Toric (hefilcon A)
Soft (Hydrophilic)
Contact Lenses for
Daily Wear | Saview 55
Multifocal
(methafilcon A) Soft
(Hydrophilic)
Contact Lens for
Daily Wear |
|-----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|
| | | | K000376 | K011089 | |
| | | | | | K030548 |
| Material | hefilcon A | hefilcon A | hefilcon A | hefilcon A | methafilcon A |
| Material
classification | Hydrophilic Lens
Group 1 | Hydrophilic Lens
Group 1 | Hydrophilic Lens Group
1 | Hydrophilic Lens Group
1 | Hydrophilic Lens Group
4 |
| Indication for
use | myopia, hyperopia,
astigmatism, and
presbyopia | myopia, hyperopia,
astigmatism, and
presbyopia | myopia, hyperopia and
astigmatism | myopia, hyperopia and
astigmatism | myopia, hyperopia and
presbyopia |
| Water
content | 42% | 42% | 42% | 42% | 55% |
| Visible light
transmittance | 98% | 98% | 98% | 98% | 97.6% |
| UV
transmittance |