(69 days)
Not Found
No
The document describes a physical contact lens and its material properties and intended uses. There is no mention of any software, algorithms, or data processing that would involve AI or ML.
Yes
The device is indicated for "occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia," which are therapeutic applications.
No
The device is a contact lens used to alter eye color, correct refractive ametropia, or for occlusive therapy. It does not perform any diagnostic functions.
No
The device is a physical contact lens made from hioxifilcon B material with added tints. It is a tangible medical device, 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, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The OXYLENS PROSTHETIC and OXYLENS TINTED contact lenses are placed on the eye for cosmetic purposes (altering eye color, masking abnormalities) and/or for correcting vision (myopia, hyperopia, astigmatism, occlusive therapy). They do not analyze any biological samples taken from the body.
The device description and intended use clearly indicate that these are medical devices for external use on the eye, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Toric Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Contact Lens is fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tint mixture containing; Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17 -Dimethoxydinaphtho [1.2.3 -cd:3'.2'.1' -lm] pervlene-5,10-dione, and Brown 16,23 -Dihydrodinaphtho [2,3-a.2 ] 3 ' -i] napth [2',3' ; 6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.
The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Tint Patterns Available:
- Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
- Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
- Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
- Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
The OXYLENS TINTED may contain a single listed color additive, or may contain a combination of color additives in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The color additives are added to the contact lens for enhancing and/or altering the apparent color of the eve.
In the hydrated state, the OXYLENS TINTED, PROSTHETIC lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a color altering optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are:
Refractive Index: 1.515 (dry) 1.404 (hydrated)
Light Transmission: greater than 70% T *
Water Content: 48 %
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Color additives: Vat Brown 1, Vat Blue 6, Vat Green 1, Vat Yellow3, Vat Orange 1
Oxygen Permeability: 15 X 10-11 Fatt Units (cm2/sec)(ml O2/ml x mm Hg @ 35°C), (revised Fatt method)
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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): 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
510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is: K983278
Applicant information:
| Date Prepared: | September 14, 1998 |
|---|---|
| Name: | Alden Optical Laboratories |
| Address | 13295 Broadway |
| Alden, New York 14004 | |
| Contact Person: | Charles H. Creighton |
| Phone Number: | 800.253.3669 |
| USA Consultant: | MedVice Consulting, Inc. |
| Phone Number: | Martin Dalsing |
| (970) 243-5490 |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Trade Name: | OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft |
| Daily Wear Contact Lens, Tinted (lathe-cut) | |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
Substantially Equivalent Devices:
The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Daily Wear Contact Lens, Tinted (lathecut) is substantially equivalent to the "ALDEN CLASSIC PROSTHETIC" (polymacon) Tinted, Soft Contact lens (lathe-cut) and the BENZ-G 3X (hioxifilcon B) Soft (Spherical and Toric) Daily Wear Contact Lens, the predicate devices.
1
Device Descriptive Characteristics:
The OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Contact Lens is fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. A tint mixture containing; Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17 -Dimethoxydinaphtho [1.2.3 -cd:3'.2'.1' -lm] pervlene-5,10-dione, and Brown 16,23 -Dihydrodinaphtho [2,3-a.2 ] 3 ' -i] napth [2',3' ; 6,7] indolo [2,3-c] carbazole-5,10,15,17,22,24-hexone is added to the lens.
The tint mixture (BLACK) is processed into the contact lens to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Tint Patterns Available:
-
- Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
-
- Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
-
- Black Annular with clear pupil. Black Annular diameter range 7.5 mm to full lens diameter in 0.5 mm increments. Clear Pupil diameter range 2.0 mm to 7.5 mm in 0.5 mm increments.
-
- Tinted lens with Black Pupil. Uses the Alden Classic Tinted (polymacon 38%) contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
The OXYLENS TINTED may contain a single listed color additive, or may contain a combination of color additives in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. The color additives are added to the contact lens for enhancing and/or altering the apparent color of the eve.
In the hydrated state, the OXYLENS TINTED, PROSTHETIC lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a color altering optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
2
The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are:
| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|---|---|
| Light Transmission: | greater than 70% T * |
| Water Content | 48 % |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Color additives | Vat Brown 1, Vat Blue 6, Vat Green 1, Vat Yellow3, Vat Orange 1 |
| Oxygen Permeability | 15 X 10-11 Fatt Units (cm2/sec)(ml O2/ml x mm Hg @ 35°C), (revised Fatt method) |
-
- Patients may experience a reduction in visibility while wearing a dark shade of lens in conditions of low illumination.
Intended Uses:
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eve color, including ocular masking, either in sighted or non-sighted eyes that require a prosthetic contact lenses for cosmetic management of conditions such as corneal, in's or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Toric Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eves with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.
The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.
3
Substantial Equivalence:
The devices will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Alden Optical Laboratories. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the devices is equivalent to the Alden Classic Tinted (polymacon) 510(k) #K980554, the Oxylens (hioxifilcon B) 510(k) # K981252 and the Benz-G 3X (hioxifilcon B) 510(k) # K964528. Being similar with respect to materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.
The following matrix illustrates the production methods, lens functions and material characteristics of the OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Daily Wear Contact Lens (lathe-cut), as well as the predicate devices.
4
Substantial Equivalence Matrix
| | Characteristic | OXYLENS
PROSTHETIC | OXYLENS TINTED | PREDICATE
DEVICE(S) |
|-----|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION
METHOD | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| 2.) | LENS FUNCTION | Enhance or alter the
apparent eye color,
including ocular masking,
either in sighted or non-
sighted eyes that require a
prosthetic contact lenses for
cosmetic management of
conditions such as corneal,
iris or lens abnormalities.
The lens may also be
prescribed for the correction
of refractive ametropia
(myopia, hyperopia and
astigmatism) in aphakic and
not aphakic persons or for
occlusive therapy for
conditions such as diplopia,
amblyopia or extreme
photophobia. | Refractive medium that
focuses light rays from near
and distant objects on the
retina, while compensating
for refractive error,
including (astigmatism),
including enhancing and/or
altering the apparent eye
color. | Enhance or alter the
apparent eye color,
including ocular masking,
either in sighted or non-
sighted eyes that require a
prosthetic contact lenses for
cosmetic management of
conditions such as corneal,
iris or lens abnormalities.
The lens may also be
prescribed for the correction
of refractive ametropia
(myopia, hyperopia and
astigmatism) in aphakic and
not aphakic persons or for
occlusive therapy for
conditions such as diplopia,
amblyopia or extreme
photophobia. |
| 3.) | MATERIAL | Hydrophilic Polymer | Hydrophilic Polymer | Hydrophilic Polymer |
| a. | Water Content | 48% | 48% | 38%, 48% |
| b | Polymer Content | 52% | 52% | 62%, 52% |
| C | Polymer | hioxifilcon B | hioxifilcon B | Polymacon, hioxifilcon B |
| d. | DK Value | 15 | 15 | 9, 15 |
| e | Refractive Index | 1.404 (hydrated) | 1.404 (hydrated) | 1.430, 1.404 (hydrated) |
| f | Specific Gravity | 1.136 (hydrated) | 1.136 (hydrated) | 1.18, 1.136 (hydrated) |
| g | Light Transmission | greater than 70 % T
(N/A
for non-sighted eyes) | greater than 70 % T | greater than 70 % T |
| h. | Color Additives | Vat Green 1, Green (21
CFR 73.3120) CI# 59825 | Vat Green 1, Green (21
CFR 73.3120) CI# 59825 | Vat Blue 6, Blue (21 CFR
73.3119) CI# 69825 |
| | | Vat Brown 1, Brown (21
CFR 73.3117) CI# 70800 | Vat Brown 1, Brown (21
CFR 73.3117) CI# 70800 | Not Applicable for Clear
Contact Lens |
| | | Vat Blue 6, Blue (21 CFR
73.3119) CI# 69825 | Vat Yellow 3, Yellow (21
CFR 73.3118) CI# 61725 | |
| | | | Vat Orange 1, Orange (21
CFR 73.3112) CI# 59105 | |
| | | | Vat Blue 6, Blue (21 CFR
73.3119) CI# 69825 | |
5
Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol consists of four stylized human profiles facing right, arranged in a stacked formation, with the top profile being the most prominent and the others gradually diminishing in size.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 25 1998
Alden Optical Laboratories, Inc. c/o Mr. Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503
Re: K983278
Trade Name: OXYLENS TINTED PROSTHETIC (hioxifilcon B) Tinted Soft Daily Wear Contact Lens (lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: September 14, 1998 Received: September 17, 1998
Dear Mr. Dalsing :
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 .
6
Page 2 - Mr. Martin Dalsing
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,
ARoey L. Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
INDICATIONS FOR USE STATEMENT
OXYLENS TINTED, PROSTHETIC (hioxifilcon B), Soft Daily Wear Device Name: Contact Lens, Tinted (lathe cut).
INDICATIONS FOR USE:
The OXYLENS PROSTHETIC (hioxifilcon B), Tinted Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or non-sighted eyes that require a prostheric contact leases for cosmetic management of conditions such as comeal, ins or lens abnormalities. The lens may also be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not aphakic persons or for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifilcon B) Spherical Soft Contact Lenses for daily wear, are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The lens may be disinfected with either a chemical or a heat disinfection system.
The OXYLENS TINTED (hioxifileon B) Toric Soft Contact Leases for daily wear, are indicated for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters. The lens may be disinfected with either a chemical or a heat disinfection system.
The leases are available within a planned replacement program with frequency of replacement determined by the practitioner.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| (Division Sign-Off) | ||
| Division of Ophthalmic Devices | ||
| Prescription Use (Per 21 CFR 801.109) | X | |
| 510(k) Number | K983278 | |
| or | ||
| Over-The-Counter Use ____ |
(Optional Format 1-2-96)
OXYLENS TINTED, PROSTHETIC (hionifiloon B), Soft Deily Wear Corned Lans, Ticked (latho ask)
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