(50 days)
No
The device description focuses on the material properties, manufacturing process, and physical characteristics of a contact lens, with no mention of AI or ML.
Yes
The device is indicated for "correction of refractive ametropia (myopia, hyperopia and astigmatism)" and "occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia," which are therapeutic applications.
No
The device is a prosthetic contact lens indicated for cosmetic management, correction of refractive ametropia, and occlusive therapy; it does not perform any diagnostic function.
No
The device description clearly indicates it is a physical contact lens made from polymacon, a material used in soft contact lenses. It describes the physical properties, tinting process, and available patterns of the lens itself, which is a hardware medical device.
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 ALDEN CLASSIC PROSTHETIC contact lens is a device that is placed on the eye. Its function is to alter the appearance of the eye, correct vision, or provide occlusive therapy. It does not perform any tests on biological samples to diagnose or monitor a medical condition.
- Intended Use: The intended use clearly describes cosmetic management, vision correction, and occlusive therapy, none of which fall under the definition of in vitro diagnostics.
Therefore, this device is a medical device, but specifically an ophthalmic device, not an IVD.
N/A
Intended Use / Indications for Use
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted 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.
Product codes
LPL
Device Description
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is fabricated from polymacon, 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 stunt mixture containing: Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17-Dimethoxydinaphtho [1,2,3 -> 1' - Im] perylene-5,10-dione, and Brown 16,23 -Dibydrodinaphtho [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 leas 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 occhisive 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.
In the hydrated state, the leas conforms to the curvature of the eye covering the cornes and extending sightly beyond the limbus forming a color altering optical surface. The (polymacon) soft hydrophilic contact leas 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 leas dries out, it will become hard and 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 38% water by weight. The physical properties of the lens are:
Refractive Index: 1.52 (dry) 1.43 (hydrated)
Light Transmission: greater than 70% T
Water Content: 38 %
Specific Gravity: 1.28 (dry) 1.18 (hydrated)
Color additives: Vat Brown 1, Vat Blue 6, Vat Green 1
Oxygen Permeability: 9 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)
WESLEY-JESSEN PROSTHETIC (phemfilcon A) Soft Contact Leas, BENZ-38 (polymacon) Soft Contact Lens
Reference Device(s)
Alden Classic, K973967, Alden Classic Tinted (polymacon), K980554
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
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:
K983053
Applicant information:
| Date Prepared: | August 28, 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: | ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, |
| Soft Contact Lens (lathe-cut). | |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
1
Substantially Equivalent Devices:
The ALDEN CLASSIC PROSTHETIC (polymacon) Tipted, Soft Contact Lens is substantially equivalent to the "WESLEY-JESSEN PROSTHETIC" (phemfilcon A) Soft Contact Leas and the BENZ-38 (polymacon) Soft Contact Lens, the predicate devices.
Device Descriptive Characteristics:
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas is fabricated from polymacon, 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 tunt mixture containing: Blue 7,16-Dichloro-6, 15-dihydro-5,9,14,18-anthrazinetetrone, Green 16,17-Dimethoxydinaphtho [1,2,3 -> 1' - Im] perylene-5,10-dione, and Brown 16,23 -Dibydrodinaphtho [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 leas 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 occhisive therapy for conditions such as diplopia, amblyopia or extreme photophobia.
Tim 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.
In the hydrated state, the leas conforms to the curvature of the eye covering the cornes and extending sightly beyond the limbus forming a color altering optical surface. The (polymacon) soft hydrophilic contact leas 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 leas dries out, it will become hard and 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 38% water by weight. The physical properties of the lens are:
| Refractive Index | 1.52 (dry) 1.43 (hydrated) |
|---|---|
| Light Transmission: | greater than 70% T |
| Water Content | 38 % |
| Specific Gravity | 1.28 (dry) 1.18 (hydrated) |
| Color additives | Vat Brown 1, Vat Blue 6, Vat Green 1 |
| Oxygen Permeability | 9 X $10^{-11}$ Fatt Units (cm²/sec)(ml O₂/ml x mm Hg @ 35°C), (revised Fatt |
| method) |
Intended Use:
The ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens is indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted or nonsighted 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.
Substantial Equivalence:
The device 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 (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Alden Classic, and Alden Classic Tinted (polymacon), 510(k)'s #K973967 and #K980554. Being similar with respect to materials, physical construction and safety & effectiveness to the predicate device, 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.
3
The following mattix illustrates the production methods, leas functions and material characteristics of the ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Leas as well as the predicate device.
Substantial Equivalence Matrix
| | Characteristic | ALDEN CLASSIC
PROSTHETIC | WESLEY-JESSEN
PROSTHETIC |
|-----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | PRODUCTION
METHOD | 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. | 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 |
| a. | Polymer | Polymacon | phemfilcon A |
| b. | Water Content | 38% | 38% |
| c. | Polymer Content | 62% | 62% |
| d. | DK Value | 9 | 12.9 |
| e. | Refractive Index | 1.43 (hydrated) | 1.440 (hydrated) |
| f. | Specific Gravity | 1.18 (hydrated) | 1.17 (hydrated) |
| g. | Light Transmission | Varies depending on prosthetic lens
design | Varies depending on prosthetic lens
design |
| h. | Color Additives | Vat Green 1,
Vat Brown 1,
Vat Blue 6, | Iron oxides, chromium oxide greens,
titanium dioxide, [phthalocyaninato
(2)] copper, carbazole violet and
phthalocyanine green. |
4
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and head. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 21 1998
Alden Optical Laboratories, Inc. c/o Mr. Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503
Re: K983053
Trade Name: ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Daily Wear Contact Lens (lathe-cut) Regulatory Class: II Product Code: 86 LPL Dated: August 28, 1998 Received: September 1, 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 .
5
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,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
INDICATIONS FOR USE STATEMENT
Device Name:
ALDEN CLASSIC PROSTHETIC (polymacon) Tinted, Soft Contact Lens (Lathe cut).
INDICATIONS FOR USE:
The ALDEN CLASSIC PROSTHETIC (polymacon) Tiated, Soft Contact Leas (Lathe-cut) 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, 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.
(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 | |
| 510(k) Number | K983053 |
or
| Prescription Use | X | Over-The-Counter Use | |
|---|---|---|---|
| (Per 21 CFR 801.109) | (Optional Format 1-2-96) |
ALDEN CLASSIC PROSTHETIC (Polyanson) Trated, Soll Carned Lathousel)
… 15