(87 days)
Not Found
No
The device description focuses on the physical properties and manufacturing of soft contact lenses for refractive correction. There is no mention of AI, ML, image processing, or any data-driven algorithms used in the device's function or design.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which are refractive errors, not diseases or therapeutic conditions.
No
The device is a contact lens used for correction of refractive ametropia (myopia, hyperopia, and astigmatism), not for diagnosing medical conditions.
No
The device description clearly states it is a physical soft contact lens made of a copolymer, designed to fit over the corneal surface of the eye. This is a hardware device, 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 tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this device is a contact lens designed to be placed on the surface of the eye to correct refractive errors (myopia, hyperopia, astigmatism). It is a physical device for vision correction, not a test performed on a biological sample.
- Intended Use: The intended use is for correcting refractive ametropia, which is a functional condition of the eye, not for diagnosing a disease or condition through analysis of a biological sample.
Therefore, this device falls under the category of a medical device, specifically a contact lens, and not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are 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.
Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
Product codes
86 LPL
Device Description
Soft contact lenses are hemispherical shells manufactured of a copolymer of 2hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolldone (NVP), 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 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 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 6 mm. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
corneal surface of the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care practitioners
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Flexlens (hefilcon A) Hydrophilic Contact Lens for Daily Wear, Paragon Vision Sciences, Flexlens Toric (hefilcon A) Hydrophilic Contact Lens for Daily Wear, Paragon Vision Sciences
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
NOV 2 0 1997 K973192
510 (k) Summary
SUBMITTER:
- Company: Specialty UltraVision, Inc. 307 Orchard City Drive Suite 100 Campbell, CA 95008
Contact Person: Ivalee Cohen Director, Regulatory and Clinical Affairs
Telephone: 408-341-0700 408-341-0717 FAX:
- Date Prepared: November 17, 1997
DEVICE NAME:
| Common Name: | Soft Contact Lens |
|---|---|
| Trade Names: | Specialty 42 (hefilcon A) Hydrophilic Contact Lens for |
| Daily Wear (clear and visibility tinted) | |
| Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens | |
| for Daily Wear (clear and visibility tinted) |
FDA Classification: Class II
SUBSTANTIALLY EQUIVALENT TO:
Flexlens (hefilcon A) Hydrophilic Contact Lens for Daily Wear, Paragon Vision Sciences Flexlens Toric (hefilcon A) Hydrophilic Contact Lens for Daily Wear, Paragon Vision Sciences
Specialty 42 (hefilcon A) Hydrophilic Contact Lens for Daily Wear and tinted) and Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens for Daily Wear (clear and visibility tinted) are substantially equivalent in physical, optical and chemical properties, as well as material of manufacture, indications for use and method of manufacture to Paragon Vision Sciences' Flexlens (hefilcon A) Hydrophilic Contact Lens for Daily Wear and Flexlens Toric (hefilcon A). Flexiens lenses received marketing approval pursuant to N17-976. Specialty UltraVision, Inc. has received from the manufacturer of the hefilcon A contact lens buttons, BENZ Research and Development Corp., the right to reference their master file (MAF 872) and 510(k) K972807 regarding the manufacture and distribution of this material.
1
The hefilcon A lens material has been placed in Group 1, low water, and non-ionic polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition, May, 1994.
DESCRIPTION OF THE DEVICE:
Soft contact lenses are hemispherical shells manufactured of a copolymer of 2hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolldone (NVP), 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 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 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 6 mm. 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.
| PARAMETER | Specialty 42 Hydrophilic
Contact Lens for Daily Wear
(clear and visibility tinted) | Flexlens Hydrophilic
Contact Lens for Daily Wear |
|--------------------------|------------------------------------------------------------------------------------------|-----------------------------------------------------|
| material | hefilcon A | hefilcon A |
| indication for use | myopia and hyperopia | myopia, hyperopia and
astigmatism |
| water content | 42% | 42% |
| light transmittance | >95% | >95% |
| Dk (35° C) | 13.25 X 10-11 | 13.13 X 10-11 |
| powers | +20.00 to -20.00 Diopters | +20.00 to -20.00 Diopters |
| color | clear and blue visibility | clear |
| specific gravity | 1.031 | 1.044 |
| refractive index | 1.417 | 1.413 |
| Method of
manufacture | Lathe cut | Lathe cut |
SIMILARITIES AND DIFFERENCES
INDICATIONS FOR USE:
The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are 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.
Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
2
PARAMETERS AVAILABLE:
i
. . . . .
:
Specialty 42 (hefilcon A) Hydrophilic Contact Lens (clear and visibility tinted)
| Powers: | +20.00 to -20.00 Diopters |
|---|---|
| Diameter: | 14.3 mm |
| Base Curve: | 8.6 mm |
Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens (clear and visibility tinted)
| Powers: | +1.00 to -7.00 Diopters |
|---|---|
| Diameter: | 14.5 mm |
| Base Curve: | 8.3 mm, 8.6 mm. And 8.9 mm |
| Cylinder powers: | -0.75, -1.25, -1.75, -2.25, -2.75, -3.25 Diopters |
| Axes: | 10°, 20°, 80°, 100°, 160°, 170°, 180° |
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, forming a single abstract shape.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 20 1997
Ms. Ivalee Cohen Director of regulatory and Clinical Affairs Specialty Ultra Vision, Inc. 84 West Main Street Freehold, NJ 07728
Re: K973192
Trade Name: Specialty 42 (hefilcon A) Hydrophilic Contact Lens for Daily Wear and Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens for Daily Wear (clear and visibility tinted, lathe cut) -------------
Regulatory Class: II Product Code: 86 LPL Dated: August 18, 1997 Received: August 25, 1997
Dear Ms. Cohen:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. -----------------------------
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
4
Page 2 - Ms. Ivalee Cohen
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS STATEMENT
510(k) Numbør: K973192
Device Name:
Specialty 42 (hefilcon A) Hydrophilic Contact Lens for Daily Wear (clear and visibility tinted)
Specialty T-42 (hefilcon A) Hydrophilic Toric Contact Lens for Daily Wear (clear and visibility tinted)
Indications For Use:
The Specialty 42 and the Specialty T-42 Toric (hefilcon A) Hydrophilic Contact Lenses (clear and visibility tinted) are 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.
Eye care practitioners may prescribe the lenses for daily wear in a Frequent Replacement program with scheduled replacement. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-GONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use_
Daniel W. C. Brown, Ph.D. 8
(Optional Format 1-2-96)
(Division Sign-Off) Division of Ophthalmic Devices K973192 510(k) Number.