(23 days)
Alden Classic Prosthetic Tinted Soft Contact Lens, CANTOR & SILVER 5X Tinted
Not Found
No
The device description focuses on the physical properties, manufacturing process, and available tint patterns of a prosthetic contact lens. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes.
The "Intended Use / Indications for Use" section states that the device can be used for "occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia," which are therapeutic applications.
No
The device is a contact lens designed to alter eye color, correct refractive errors, or for occlusive therapy. It does not perform any diagnostic function to identify or characterize a disease or condition.
No
The device is a physical contact lens, which is a hardware medical device, not software. The description details the materials, manufacturing process, and physical characteristics of the lens.
No, 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, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens is a medical device that is placed directly on the eye. Its function is to:
- Enhance or alter the apparent eye color for cosmetic purposes.
- Mask ocular abnormalities.
- Correct refractive errors (myopia, hyperopia, astigmatism).
- Provide occlusive therapy for conditions like diplopia or amblyopia.
- No Specimen Analysis: The device does not analyze any biological specimens from the patient. It interacts directly with the eye for therapeutic and cosmetic purposes.
Therefore, based on the provided information, the CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens is a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens 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 are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted to the eyecare professional instructions.
The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 19, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
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 CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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.
Alden Classic Prosthetic Tinted Soft Contact Lens, CANTOR & SILVER 5X Tinted
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: | K992500 |
|---|---|
| Applicant information: | |
| Date Prepared: | July 23, 1999 |
| Name: | Cantor & Silver Limited |
| Address | Manor Road, Brackley |
| Northamptonshire | |
| England NN13 6ED | |
| Contact Person: | Mr. David Cantor |
| Managing Director/President | |
| Phone Number: | 011 44 1280 702002 |
| Fax: | 011 44 1280 703003 |
| USA Consultant: | Martin Dalsing, |
| Med-Vice Consulting, Inc. | |
| Consultant for Cantor & Silver, Inc. | |
| 623 Glacier Drive | |
| Grand Junction, CO 81503 | |
| (970) 243-5490 | |
| Fax #: (970) 243-5501 | |
| E-mail: mdalsing@gj.net |
Device Information:
| Device Classification: | Class II |
|---|---|
| Classification Number: | LPL |
| Trade Name: | Cantor and Silver 5X Prosthetic Tinted |
| (hioxifilcon A) Soft Daily Wear Contact Lens | |
| Classification Name: | Lens, Soft Contact, Daily Wear |
1
Substantially Equivalent Devices:
The "CANTOR & SILVER 5X PROSTHETIC" Tinted Soft Contact Lens is substantially equivalent to the "Alden Classic Prosthetic Tinted Soft Contact Lens" and the Cantor & Silver "CANTOR & SILVER 5X Tinted", the predicate devices.
Device Descriptive Characteristics:
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted with FDA "listed" color additives. The color additives are used in amounts not to exceed the minimum reasonably required to accomplish the intended coloring effect. As part of the manufacturing process, the lens containing the color additives are thoroughly washed to remove unbound reactive color additives. The manufacturing process alters and/or changes the specifications to the clear version of a contact lens by affixing a listed reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are tinted to the eyecare professional instructions.
The prosthetic color additive effect is formed by reacting one or more of the reactive color additives listed in this paragraph with (poly hydroxyethyl methacrylate). The reactive color additives that may be used either alone or in combination are: reactive blue 21, reactive blue 19, reactive blue 19, reactive blue 4. reactive blue 163, reactive red 11, reactive red 180, reactive yellow 15, reactive yellow 86, or reactive orange 78. The color additives used are not removed by lens handling or approved cleaning/disinfecting procedures. The prosthetic lens tinting process does not alter the optical and/or performance characteristics of the finished tinted soft contact lens.
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 CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.
2
INDICATIONS FOR USE:
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens 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 are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
The following table summarizes Cantor & Silver Limited claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.
| Characteristic | CANTOR & SILVER 5X
PROSTHETIC
(Cantor & Silver) | ALDEN CLASSIC PROSTHETIC
(Predicate Device) | |
|----------------|-------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INTENDED
USE | Cosmetic Management of conditions such as
corneal, iris, or lens abnormalities | Cosmetic Management of conditions such as
corneal, iris, or lens abnormalities. |
| 2.) | INDICATION | The CANTOR & SILVER 5X
PROSTHETIC Tinted Soft Contact Lens are
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 lens
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 are
disinfected using a hydrogen peroxide lens
care system only and are available in a
frequent replacement program. | 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 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. |
| 3.) | FDA "listed"
colored additives | The reactive colored additives consist of
reactive black 5, reactive blue 4, reactive
blue 19, reactive 21, reactive blue 163,
reactive yellow 15, reactive yellow 86,
reactive orange 78, reactive red 11 and
reactive red 180. | Vat Green 1, Vat Brown 1,
Vat Blue 6, |
| 4.) | Uses and
restrictions | The color additives listed above may be used
to color contact lenses in amounts not to
exceed the minimum reasonably required to
accomplish the intended prosthetic effect. | The color additives listed above may be used
to color contact lenses in amounts not to
exceed the minimum reasonably required to
accomplish the intended prosthetic effect. |
| 5.) | Color Additive
Characteristics | The color additives used are not removed by
lens handling and approved
cleaning/disinfecting procedures. The
optical and performance characteristics are
not altered by the lens coloring process. | The color additives used are not removed by
lens handling and approved
cleaning/disinfecting procedures. The
optical and performance characteristics are
not altered by the lens coloring process. |
Table #1 - Substantial Equivalence
3
Image /page/3/Picture/1 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 an abstract image of an eagle or bird-like figure with stylized wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 8 1999
Cantor Silver Limited c/o Mr. Martin Dalsing MED-VICE CONSULTING, INC. 623 Glacier Drive Grand Junction, CO 81503
Re: K992500
Trade Name: CANTOR & SILVER 5X Prosthetic Tinted (hioxifilcon A) Soft Daily Wear Contact Lens
Regulatory Class: II Product Code: 86 LPL Dated: July 23, 1999 Received: July 26, 1999
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 .
4
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
5
INDICATIONS FOR USE STATEMENT
Device Name:
CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact lens
INDICATIONS FOR USE:
The CANTOR & SILVER 5X PROSTHETIC Tinted Soft Contact Lens are indicated for daily wear to enhance or alter the apparent eye color, including ocular masking, either in sighted eyes that require a prosthetic contact lens 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 are disinfected using a hydrogen peroxide lens care system only and are available in a frequent replacement program.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel W. C. Brown, Ph.D.
(Division Sign Off)
Division Sign-Off) Division of Ophthalmic Devices K992500 510(k) Number .
Prescription Use X (Per 21 CFR 801.109)
or
Over-The-Counter Use __
(Optional Format 1-2-96)