(78 days)
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No
The summary describes standard soft contact lenses for vision correction and does not mention any AI or ML components in its design, function, or intended use.
No
The device is indicated for correcting refractive errors (myopia, hyperopia, presbyopia, and astigmatism), which are optical conditions, not diseases or therapeutic treatments. It functions as a vision correction aid rather than a device designed to cure, treat, or prevent a disease.
No
The devices described (contact lenses) are for correction of refractive errors, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of polymerized material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states that these are contact lenses designed to be placed on the corneal surface of the eye to correct refractive errors (myopia, hyperopia, presbyopia, astigmatism). They are a physical device for vision correction, not a tool for analyzing biological samples.
- Intended Use: The intended use is for correcting vision problems, not for diagnosing a disease or condition through the analysis of a sample.
The information provided aligns with the description of a Class II medical device (contact lens) used for vision correction, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Device Name: Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear(clear and tinted)
The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfaction systems.
Device Name: Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted)
The Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems,
Product codes
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Device Description
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eve including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of alding in lens centration and comfort.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
corneal surface of the eye
Indicated Patient Age Range
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Intended User / Care Setting
Eyecare practitioners
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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
NOV 20 1996
510 (k) Summary
K 963488
SUBMITTER:
Submitted on behalf of:
| Company Name: | Specialty UltraVision, Inc. |
|---|---|
| Address: | 307 Orchard City Drive |
| Campbell, CA 95008 | |
| Phone: | (408) 341-0700 |
| Fax: | (408) 341-0717 |
CONTACT PERSON: Dr. Garold Edwards
DATE SUMMARY PREPARED: October 8, 1996
- TRADE NAME: Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Wear (clear and tinted) and Specialty Choice (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted)
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Waar (clear and tinted) and Specialty Choice 48 (methafiicon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Waar (clear and tinted) are equivalent to The LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted) currently marketed in the U.S and the LifeStyle 55 (methafilcon A) Single Vision Soft (Hydrophilic) Contact Lens for Daily Wear (clear and tinted) .
The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Wear (clear and tinted) and Specialty Choice® (methafficon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted) are substantially equivalent to the indication for use of the LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft Contact Lens for Daily Wear (clear and tinted) marketed for use in the U.S. and the LifeStyle 55 (methafilcon A) Single Vision Soft Contact Lens for Daily Wear (clear and tinted). Specialty UltraVision, Inc. has received from the manufacturer of the predicate device all manufacturing information including; but not limited to, formulation, manufacturing processes (including polymerization conditions, tinting process, lens parameter tolerances, sterilization and packaging, quality control/quality assurance, established shelf life data, shelf life
1
protocol), and labeling; necessary to manufacture the devices, which are the subject of K963488. In addition, Specialty UltraVision, Inc. will manufacture these devices at the same manufacturing location as the predicate devices.
This lens is in Group 4 ionic, high water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses. Revised Edition May 1994. The physical, optical, and chemical properties of the Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lenses for Daily Wear (clear and tinted) and the Specialty Choice (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear(clear and tinted) are equivalent to those of the LifeStyle FREQUENCY PROGRESSIVE (methafilcon A) Multifocal Soft Contact Lens for Daily Wear(clear and tinted) and the Lifestyle 55 (methafilcon a) Single Vision Soft Contact Lens for Daily Wear(clear and tinted).
DESCRIPTION of the DEVICE:
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients crosslinked with EGDMA and other components which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eve including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of alding in lens centration and comfort.
INDICATIONS FOR USE:
Device Name: Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens for Daily Wear(clear and tinted)
The Specialty Progressive (methafilcon A) Soft (Hydrophilic) Multifocal Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfaction systems.
2
Device Name: Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lenses for Daily Wear (clear and tinted)
The Specialty Choice® (methafilcon A) Soft (Hydrophilic) Single Vision Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.
Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using chemical or hydrogen peroxide disinfection systems,
PARAMETERS AVAILABLE:
Specialty Progressive (methafilcon A)
| Powers: | +4.00 to -5.00D |
|---|---|
| Center Thickness: | .17 mm |
| Diameter: | 14.5 mm |
| Base Curve: | 8.4 mm (Minus lenses) |
| 8.6 mm(Plus Lenses) |
Specialty Choice AB (methafilcon A)
| Powers: | +20.00 to -20.00D |
|---|---|
| Center Thickness: | .07 mm |
| Diameter: | 14.3 mm |
| Base Curve: | 8.60 mm |