(26 days)
Not Found
No
The device description focuses on the physical and chemical properties of the contact lens material and design, with no mention of software, algorithms, or data processing that would suggest the use of AI/ML. The performance studies are related to toxicology and material properties, not algorithmic performance.
No.
The device is indicated for correcting refractive ametropia (myopia and hyperopia) and astigmatism, and for enhancing or altering eye color, which are not considered therapeutic uses. It corrects an existing condition rather than treating a disease or illness.
No
The device is a contact lens used for correction of refractive ametropia (myopia and hyperopia) and for cosmetic purposes (altering eye color), not for diagnosing medical 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 tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description clearly states that this device is a contact lens designed to be placed on the corneal surface of the eye for the correction of refractive errors (myopia, hyperopia, astigmatism) and to alter eye color. It is a physical device used directly on the body, not a test performed on a sample taken from the body.
- Lack of IVD Characteristics: The text does not mention any analysis of biological samples, detection of biomarkers, or diagnostic testing procedures, which are hallmarks of IVDs.
Therefore, this device is a medical device, specifically a contact lens, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) 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. These lenses may be used to enhance or alter the apparent color of the eye.
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 (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. The lenses are made by modifying the uncolored methafilcon A cast molded lens by affixing a colored pigment on that the unoolorod from hamsee that corresponds to the iris. The colored pigments consist of portion on the from oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine phinalobyanino groom, we . 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 that 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 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
Aphakic and not-aphakic persons
Intended User / Care Setting
Eyecare 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)
Performance Testing of Contact Lens:
Lenses were loaded with the following eleven pigments (i.e., listed color additives): Carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide black, phthalocyanine blue and titanium dioxide. The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic. Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color or significant levels of residual monomers.
The physical optical, and chemical properties of the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)) are equivalent to those of the FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd.
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
982774
2 1998 SEP
510 (k) Summary
SUBMITTER:
Submitted on behalf of:
Manufacturer:
CL-TINTERS
Address:
Hoylaamotie 7 Fin-00380 Helsinki Finland
Phone:
358 9340 5066
CONTACT PERSON:
Martin S. Knopf
DATE SUMMARY PREPARED: August 1, 1998
TRADE NAME:
ﻤﺴﺎ
)
ﻨﺔ .
FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic AND CRAZ I - (motile) Wear (clear and tinted)
contact lens COMMON NAME:
SUBSTANTIALLY EQUIVALENT TO:
FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methall.con A )
Creating Children for Drile)Wass (alsos and tipted) are equivalent to Aspect FANTASY, NATURAL, BRILLIANCE, SOLAMOON NAD Of See equivalent to Aspect
Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent Lens for I Hydrophilic Contact Lens for Daily Wear (clear and timed) are ogeneral (1984)
Vision Care, Ltd.'s FREQUENCY 55 (methafilcon A) Hydrophilic Contact Lens for Daily
1991 - Std. Vision Care, Ltd. 3 FREQUENCY 35 (REQUENT) . Wear (clear and tinted) .
FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A)
Claimed Children (cu Deile:W/gor (cloar and tipted) are substantially equili FANTASY, NATURAL, BRILLIANCE, GLAMOUN Alined) are substantially equivalent to
Hydrophilic Contact Lens for Daily Wear (clear and tinted) are substantially equivality of A Hydrophilic Contact Lens for Daily Weal (clear and times) UENCY 55 (methafilcon A)
the indications for use of Aspect Vision Care, Ltd.'s FREQUENCY 55 (methant to K971164. In the indications for use of Aspect Vision Cale, Ltd. 3 intedburns and to K971164. In
Hydrophilic Contact Lens for Daily Wear (clear and tinted) pursuant to K971164. In Hydrophilic Contact Lens for Daily villa (cuea and intod) parsual lenses at the same
addition, Aspect Vision Care, Ltd. will produce the dry cast molded lenses are subsequent addition, Aspect Vision Care, Ltd. Will produce the are subsequently manufacturing location as the predicate devices. "Those tones" is a listed color additives) to produce their unique tinting patterns.
This lens is in Group 4, lonic, high water content polymers as established by the FDA and This lens is in Group 4, lonic, high water content Lenses, Revised Edition May
located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May located in the Guidance Document for bally virosties of the FANTASY, NATURAL.
1994. The physical, optical, and chemical properties of the FANTASY, NATURAL 1994. The physical, optical, and chemican propriated A) Hydrophilic Contact Lens for Daily
BRILLIANCE, GLAMOUR AND CRAZY (methafilicon A) Hydrophilic Care, Ud BRILLIANCE, GLAMOOK AND OF OLE I Those of the Aspect Vision Care, Ltd.
Wear (clear and tinted) are equivalent to those of the Aspect Vision and Wear (clear and tinted) are equivalent to those of the Abpoor Holly Wear (clear and tinted).
FREQUENCY 55 (methafilcon A) Soft Contact Lens for Daily Wear (clear and tinted).
1
DESCRIPTION of the DEVICE:
Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. The lenses are made by modifying the uncolored methafilcon A cast molded lens by affixing a colored pigment on that the unoolorod from hamsee that corresponds to the iris. The colored pigments consist of portion on the from oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide brown, iron oxide black, phthalocyanine phinalobyanino groom, we . 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 that 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 aiding in lens centration and comfort.
INDICATIONS FOR USE:
Device Name: FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)
The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A ) Hydrophilic Contact Lens (clear and tinted ) 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. These lenses may be used to enhance or alter the apparent color of the eye.
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.
Performance Testing of Contact Lens
Lenses were loaded with the following eleven pigments (i.e., listed color additives):
Carbazole violet, chromium oxide green, dihydrodinaphto brown, dihydrodioxo yellow, phthalocyanine green, iron oxide red, iron oxide black, phthalocyanine blue and titanium dioxide.
The results of toxicology testing (cytotoxicity, acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic. Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color or significant levels of residual monomers.
The physical optical, and chemical properties of the FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methafilcon A) Hydrophilic Contact Lens for
2
Daily Wear (clear and tinted)) are equivalent to those of the FREQUENCY 55
Cally Wear Air Hotel webilia Centret Lens for Daily Wear (clear and tinted) from th Daily Wear (clear and tinted) are equivalent to those or the Prezent inted) from Aspect
(methafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) from Aspect (methafilcon A) Hydrophilic Contact Lens for Daily Vveal (cical under) (and the mail.
Vision Care, Ltd. since this lens is provided to CL-TINTERS by Aspect Vision Care, Ltd.
PARAMETERS AVAILABLE:
The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY™ (methafilcon A )
Creative Collection of Jacand tipted) Hydrophilic Contact Lens (clear and tinted) +8.00 to -8.00D Powers: Center Thickness: 0.12 mm 14.2 mm Diameter: 8.8 mm Base Curve:
ڊ
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
2 1998 SEP
CL- TINTERS c/o Martin S. Knopf President and CEO Knopf Associates, Inc. 84 West Main Street Freehold, New Jersey 07728
Re: K982774
Trade Name: FANTASY, NATURAL, BRILLANCE, GLAMOUR AND CRAZY (methalfilcon A) Hydrophilic Contact Lens for Daily Wear (clear, tinted and cast molded) Regulatory Class: II Product Code: 86 LPL Dated: August 1, 1998 Received: August 7, 1998
Dear Mr. Knopf:
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 used 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 for childling the Current Good
Medical Devices: Concept on the in (91 GETT 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 - Martin S. Knopf
This letter will allow you to begin marketing your device as described in your 510(k) I mis letter will anow you to begin indine of substantial equivalence of your device to a premarket notification. The I Dri midnig of vasitication 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 OFF 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 Compliance at (001) 591 1815 - 12011-11-27) - 11-11-2017 - 11-11-2017 - 11-21-2017 - 11-21-2017 - 11-21-2017 - 11-21-2017 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 (2) Cr (6) ... ). 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
Rosenthal, M.D. A. Ralph Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS STATEMENT
Device Name: FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY
Clear and Children Child Contact Lean for Daily Wear (clear and tighted) Device Name: FANTAST, NATORAL, BRIZEMTOD, Septact Clear and tinted)
The FANTASY, NATURAL, BRILLIANCE, GLAMOUR AND CRAZY (methalitoon A) The FANTASY, NATURAL, BRICLIANCE, SEAMOUNT for Casily wear for the comection Hydrophilic Contact Lens (clear and thile) is included for and nor-aphakic persons with
of refractive ametropia (myopia and hyperopia) in aphakic and not and of refractive ametropia (myopla and nyporopian up to 2.00 Diopters that does not
non-diseased eyes that may exhibit astigment on used to replance or alter the app non-diseased eyes that may exhibit asigniatism up to 2.05 bigpler that the apparent color of the eye.
Eyecare practitioners may proscribe the lens for daily waar in a Frequent Replacement Eyecare practilioners may prescribe the fens for using would in the reach as a conside disinfection systems.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Over the Counter Use
Concurrence of CDRH, Office of Device Evaluation (ODE)
Proscription Use______________________________________________________________________________________________________________________________________________________________
Samuel W.C. Brown, Ph.D
OR
Division of Ophthalmic Devices
(Division Sign-Off)
510(k) Number
(Optional Format 1-2-86)
178