(133 days)
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Not Found
No
The device description focuses on the physical properties and manufacturing process of a contact lens, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a contact lens intended for correcting refractive errors (myopia, hyperopia, and astigmatism), which is a corrective function, not a therapeutic one that treats a disease or condition.
No
The device is a contact lens designed to correct refractive errors (myopia, hyperopia, astigmatism) and does not diagnose any conditions.
No
The device description clearly describes a physical contact lens made of polymerized material, not software.
Based on the provided text, 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 this device is a contact lens. Its purpose is to be placed on the eye to correct refractive errors (myopia, hyperopia, astigmatism). It does not perform any tests on bodily samples.
- Intended Use: The intended use is for the correction of refractive ametropia, which is a functional correction of vision, not a diagnostic test.
Therefore, this device falls under the category of a medical device, but specifically a contact lens for vision correction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Specialty T (ocufilicon A) Soft (hydrophilic) Toric Contact Lons is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2,50 diopters,
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
Product codes (comma separated list FDA assigned to the subject device)
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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 conter over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eve 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 7mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mold to provide consistent optics. Orientation marks are molded into the front surface as part ofd the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort, Axis stabilization is achieved by the action of the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.
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
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.
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).
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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
510 (k) Summary for K963764
SUBMITTER:
JAN 30 1997
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: December 13, 1996
TRADE NAME: Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear
COMMON NAME: contact lens
SUBSTANTIALLY EQUIVALENT TO:
Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is equivalent to Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear.
Specialty T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear is substantially equivalent to the indication for use of the Hydron Ultra T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear marketed for use in the US. This lens is in Group 3 ionic, low 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 T (ocufilcon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear are equivalent to those of the Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear. The subject device utilizes the same formulation, manufacturing and sterilization processes. packaging, Quality Control/Quality Assurance Procedures and established shelf life as the predicate device, the Ocular Sciences/American Hydron Ultra T (ocufilcon A) Toric Soft (Hydrophilic) Contact Lens for Daily Wear. A side by side comparison of the physical, optical and mechanical properties clearly establish the equivalency of these two contact lens products.
1
Comparison of physical/mechanical properties of Ultra T lenses Vs. Specialty T Lenses
| PARAMETER | Ocular Sciences/Am. Hydron
Ultra T (ocufilcon A) Toric | | | | Specialty T (ocufilcon A) Toric | | | |
|------------------------------------|-----------------------------------------------------------|-------|----------|----|---------------------------------|-------|----------|----|
| | units | mean | st. dev. | n | units | mean | st. dev. | n |
| refractive index | | 1.427 | 0.002 | 30 | | 1.427 | 0.001 | 30 |
| specific gravity | | 1.16" | | | | 1.16* | | |
| water content | % | 43.7 | 0.45 | 29 | % | 44.1 | 0.37 | 30 |
| oxygen permeability
Dk (@35° C) | Dk** | 10.2 | 1.41 | 20 | Dk** | 11.3 | 1.43 | 20 |
| light transmittance
(@590 Nm) | % | 98.31 | 1.27 | 10 | % | 98.51 | 0.82 | 10 |
| Mechanical Properties | | | | | | | | |
| modulus | N/mm² | 0.37 | 0.048 | 21 | N/mm² | 0.36 | 0.051 | 18 |
| tensile strength | N/mm² | 0.37 | 0.048 | 21 | N/mm² | 0.34 | 0.136 | 18 |
| Elongation @
break | % | 148 | 53 | 21 | % | 165 | 69 | 18 |
Notes:
All products are produced by a spin casting process, consequently, only hydrated lenses are available for testing.
- Measured using 10 lenses for a single measurement. The range was 1.15 to 1.17 ** (cm2 x ml O2) / (sec x ml x mmHg) x 10 -11
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 conter over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eve 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 7mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort. The lens is manufactured by spin casting and has a front toric surface which is determined by the shape of the mold to provide consistent optics. Orientation marks are molded into the front surface as part ofd the spin casting process. The lens is a prism ballasted, non-truncated toric, with an inferior slab off to help maintain patient comfort, Axis stabilization is achieved by the action of the differential thickness profile (prism) of the lens squeezing the thicker portion of the lens to the bottom.
2
INDICATIONS FOR USE:
Device Name: Specialty T (ocufileon A) Soft (Hydrophilic) Toric Contact Lens for Daily Wear
The Specialty T (ocufilicon A) Soft (hydrophilic) Toric Contact Lons is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2,50 diopters,
Eyecare practitioners may prescribe the lens for frequent/planned replacement wear, with cleaning, disinfection and replacement. The lens may be disinfected using either a heat, chemical or hydrogen peroxide disinfection system.
PARAMETERS AVAILABLE:
Specialty T( ocufilcon A)
| Powers: | plano to -6.00 diopters (in 0.25 diopter steps) |
|---|---|
| Cylinder Powers: | -1.00, -1.50, -2.00 diopters |
| Axis: | 10o to 180o in 10o steps |
| Center Thickness: | 0.15 mm |
| Diameter: | 14.5 mm |
| Base Curve: | Varies with power |