(74 days)
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No
The description focuses on the chemical and physical process of tinting contact lenses and does not mention any computational or algorithmic processes related to AI or ML.
No.
Explanation: The device is indicated for enhancing or altering eye color, which is a cosmetic purpose, not a therapeutic one to treat or mitigate a disease.
No
The device description indicates that it is a colored contact lens used to change eye color for cosmetic purposes, not to diagnose any medical condition.
No
The device is a physical contact lens that is tinted using a chemical process and tinting system, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "enhance and/or alter the apparent eye color" and provide "ease of patient handling." This is a cosmetic and functional purpose related to vision correction and appearance, not for diagnosing a disease or condition based on in vitro examination of specimens.
- Device Description: The description focuses on the physical characteristics of the contact lens, the tinting process, and the chemical components used for tinting. It does not describe any components or processes related to analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens (like blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic results.
In summary, the SOFTCHROME TINTS are contact lenses designed to change eye color and aid in handling, which falls under the category of medical devices for vision correction and cosmetic purposes, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The SOFTCHROME TINTS. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MZD
Device Description
SOFTCHROME TINTS Transparent Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. The lenses are tinted with utilization of the patented "In-Office Tinting System for Soft Contact Lenses". The tinting system consists of various tinting fixtures, calibrated mixing vessels, pre-mixed color additives, activator solution, neutralizer solution, tinting instructions, tips and recipes. The lens tinting process uses color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. 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 lenses 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 color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The In-Office Tinting System for Soft Contact Lenses offers a variety of colors and intensity levels. The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is also available in a variety of colors for visibility-handling tint.
The 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 black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 86. or reactive orange 78. The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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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.
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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.
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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).
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§ 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:
Applicant information:
| Date Prepared: | 11 June, 1999 | |
|---|---|---|
| Name: | Softchrome, Inc. | |
| Address | 2551 San Ramon Valley Blvd., Suite #105 | |
| San Ramon, CA 94583 | ||
| Contact Person: | Mrs. Karen L. Johnson | |
| Phone Number: | (925) 743-1285 | |
| U.S. Consultant: | Martin Dalsing | |
| Med-Vice Consulting, Inc. | ||
| Official Correspondent Softchrome, 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, MZD |
| Trade Name: | SOFTCHROME TINTS |
| Transparent Tinted Soft Contact Lens | |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
1
Substantially Equivalent Devices:
The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is substantially equivalent to the Adventure Tints Color Enhanced Soft Contact Lens, the predicate device.
INDICATIONS FOR USE:
The SOFTCHROME TINTS. Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.
Device Descriptive Characteristics:
SOFTCHROME TINTS Transparent Tinted Soft Contact Lens are color enhanced soft contact lenses that have been previously prescribed for a specific patient. The lenses are tinted with utilization of the patented "In-Office Tinting System for Soft Contact Lenses". The tinting system consists of various tinting fixtures, calibrated mixing vessels, pre-mixed color additives, activator solution, neutralizer solution, tinting instructions, tips and recipes. The lens tinting process uses color additives that have been listed as safe for contact lenses in accordance with the FDA's color additive regulations. 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 lenses 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 color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The In-Office Tinting System for Soft Contact Lenses offers a variety of colors and intensity levels. The SOFTCHROME TINTS Transparent Tinted Soft Contact Lens is also available in a variety of colors for visibility-handling tint.
The 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 black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 86. or reactive orange 78. The color additives used are not removed by lens handling and approved cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens.
2
The following table summarizes Softchrome Inc. claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.
| | Characteristic | Softchrome Tints
(Softchrome Inc.) | Adventure Tints
(Predicate Device) |
|-----|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1.) | INTENDED USE | Daily wear, Soft (hydrophilic) contact
lens | Daily wear, Soft (hydrophilic) contact
lens |
| 2.) | INDICATION | The SOFTCHROME TINTS,
Transparent Tinted Soft Contact Lens is
indicated for daily wear to enhance
and/or alter the apparent eye color. The
SOFTCHROME TINTS visitint
provides for ease of patient handling and
does not affect iris color. Except for
decreased light transmittance due to the
tint intensity, the pre-tinted lens optical
parameters remain the same as originally
prescribed for the user prior to tinting.
The lens may be disinfected using a
chemical disinfection system only. | The ADVENTURE TINTS Color
Enhanced Soft Contact Lens is indicated
for daily wear to enhance and/or alter
the apparent eye color. The
ADVENTURE TINTS visitint provides
for ease of patient handling and does not
affect iris color. Except for decreased
light transmittance due to the tint
intensity, the pre-tinted lens optical
parameters remain the same as originally
prescribed for the user prior to tinting.
The lens may be disinfected using a
chemical disinfection system only. |
| 3.) | ACTIONS | In its hydrated state, when placed on the
cornea, the lenses act as a refracting
medium to focus light rays on the retina. | In its hydrated state, when placed on the
cornea, the lenses act as a refracting
medium to focus light rays on the retina. |
| 4.) | 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. | 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. |
| 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 accompish the intended
coloring effect. | The color additives listed above may be
used to color contact lenses in amounts
not to exceed the minimum reasonably
required to accompish the intended
coloring effect. |
| 5.) | Color Additive
Characteristics | The color additives used are not
removed by lens handling and
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
cleaning/disinfecting procedures. The
optical and performance characteristics
are not altered by the lens coloring
process. |
| 6.) | Colors Offered | Aqua, Blue, Sky Blue, Green, Brown,
Black, Green, Yellow, Amber and Red | Blue, Green, Aqua, Yellow, Lavender,
Brown, Ultra Violet (hot pink) and
Amber |
Table - Substantial Equivalence
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles or faces, stacked on top of each other, with flowing lines suggesting movement or connection.
Public Health Service
AUG 27 1999
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Softchrome, Inc. c/o Mr. Martin Dalsing Med-Vice Consulting, Inc. 623 Glacier Drive Grand Junction, CO 81503
Re: K991995
Trade Name: SOFTCHROME TINTS, Transparent Tinted Soft Contact lens (tinted with the "In-Office Tinting System for Soft Contact Lenses") Regulatory Class: II
Product Code: 86 MZD Dated: June 11, 1999 Received: June 14, 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:
SOFTCHROME TINTS Transparent Tinted Soft Contact lens
INDICATIONS FOR USE:
The SOFTCHROME TINTS, Color Enhanced Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color. The SOFTCHROME TINTS visibility tinted lens provides for ease of patient handling and does not affect iris color.
Except for decreased light transmittance due to the tint intensity, the pre-tinted lens optical parameters remain the same as originally prescribed for the user prior to tinting. The lens may be disinfected using a chemical disinfection system only.
(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR 801.109) OL
Over-The-Counter Use
(Optional Format 1-2-96)
Hanel W.C. Brown
(Division Sign-Off)
Division of Ophthalmic Devices 510(k) NumberK991995
$\mathcal{f}$
SOFTCHROME TINTS, Transparent Tinted Soft Contact Lens for Daily Wear
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