The COLORSOFT PROSTHETIC 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 lens for cosmetic management of conditions such as comeal, iris or lens abnormalities. The lens may also be prescribed for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical disinfection system only.

Device Description

The COLORSOFT PROSTHETIC Tinted Soft Contact Lens are lens that have been previously prescribed for a specific patient. They have been supplied to Colorsoft Laboratories to be modified by a tinting process using 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 reactive color additive on that portion of the anterior (front) surface of the lens that corresponds to the iris. The COLORSOFT PROSTHETIC contact lenses 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 black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 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.

AI/ML Overview

This 510(k) submission describes a new device, the COLORSOFT PROSTHETIC Tinted Soft Contact lens, and compares it to a predicate device, the Alden Classic Prosthetic Tinted Soft Contact Lens, to establish substantial equivalence. The document does not describe a study with acceptance criteria and device performance; instead, it outlines the device's characteristics and its intended use, asserting its equivalence to an existing product. Therefore, I cannot extract information about acceptance criteria, study sizes, expert qualifications, or ground truth details from this document.

The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel clinical trial data with specific acceptance criteria and detailed performance metrics.

Specifically, the document does not contain:

A table of acceptance criteria and reported device performance.
Information on sample sizes, data provenance, or details of a test set.
Information on the number or qualifications of experts to establish ground truth.
Details of an adjudication method.
Results of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study.
Results of a standalone algorithm performance study.
Information on the type of ground truth used in a study.
Sample size for a training set.
How ground truth for a training set was established.

The document primarily focuses on:

Device Identification: Name, applicant, classification.
Substantial Equivalence Claim: Stating equivalence to predicate devices ("Alden Classic Prosthetic Tinted Soft Contact Lens" and "Colorsoft Laboratories COLORSOFT Color Enhanced Tinted Soft Contact Lens").
Device Descriptive Characteristics: Materials, tinting process, available tint patterns.
Indications for Use: Cosmetic management of conditions like corneal, iris, or lens abnormalities, and occlusive therapy.
Comparison Table (Table #1 - Substantial Equivalence): This table directly compares characteristics of the COLORSOFT PROSTHETIC with the ALDEN CLASSIC PROSTHETIC and another Colorsoft product, highlighting similarities in intended use, indications, listed colored additives, and uses/restrictions. This comparison serves as the "study" for substantial equivalence, rather than a performance study against acceptance criteria.

The 510(k) clearance process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical performance studies with predefined acceptance criteria for a novel technology.

Summary

{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.

K992339 The assigned 510(k) number is:

Applicant information:

Date Prepared:	July 12, 1999
Name:	Colorsoft Laboratories
Address	623 Glacier DriveGrand Junction, CO 81503
Contact Persons:	Mrs. Deanna Werber
Phone Number:	(970) 248-9445
USA Consultant:	Martin Dalsing,Med-Vice Consulting, Inc.Consultant for Colorsoft Laboratories, Inc623 Glacier DriveGrand Junction, CO 81503(970) 243-5490Fax #: (970) 243-5501E-mail: mdalsing@gj.net

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Trade Name:	COLORSOFT PROSTHETICTinted Soft Contact lens
Classification Name:	Lenses, Soft Contact, Daily Wear

{1}------------------------------------------------

Substantially Equivalent Devices:

The "COLORSOFT PROSTHETIC" Tinted Soft Contact Lens is substantially equivalent to the "Alden Classic Prosthetic Tinted Soft Contact Lens" and the Colorsoft Laboratories "COLORSOFT Color Enhanced Tinted Soft Contact Lens", the predicate devices.

Device Descriptive Characteristics:

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 black 5, reactive blue 19, reactive blue 19, reactive blue 4, reactive blue 163. reactive red 11. reactive red 180. reactive vellow 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:

1. Clear lens with Black Pupil. Pupil sizes available in 2.0 mm to 12.5 mm.
1. Black Occluder Lens. A Central Black area that occludes light. Available to full lens diameter in 0.5 mm increments.
1. 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.
1. Tinted lens with Black Pupil. Uses the Colorsoft Color Enhanced tinted contact lens with black pupil. Pupil sizes available in 2.0 mm to 12.5 mm diameter.

{2}------------------------------------------------

INDICATIONS FOR USE:

The COLORSOFT PROSTHETIC 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 lens for cosmetic management of conditions such as corneal, iris or lens abnormalities. The lens may also be prescribed for occlusive therapy for conditions such as diplopia, amblyopia or extreme photophobia. The lens may be disinfected using a chemical disinfection system only.

The following table summarizes Colorsoft Laboratories claim of substantial equivalency in terms of safety and efficacy to the predicate devices previously mentioned.

	Characteristic	COLORSOFT PROSTHETIC(Colorsoft Laboratories)	ALDEN CLASSIC PROSTHETIC(Predicate Device)
1.)	INTENDEDUSE	Cosmetic Management of conditions such ascorneal, iris, or lens abnormalities.	Cosmetic Management of conditions such ascorneal, iris, or lens abnormalities.
2.)	INDICATION	The CANTOR & SILVER 5XPROSTHETIC Tinted Soft Contact Lens areindicated for daily wear to enhance or alterthe apparent eye color, including ocularmasking, either in sighted or non-sightedeyes that require a prosthetic contact lensfor cosmetic management of conditions suchas corneal, iris or lens abnormalities. Thelens may also be prescribed for thecorrection of refractive ametropia (myopia,hyperopia and astigmatism) in aphakic andnot aphakic persons or for occlusive therapyfor conditions such as diplopia, amblyopiaor extreme photophobia. The lens aredisinfected using a hydrogen peroxide lenscare system only and are available in afrequent replacement program .	The ALDEN CLASSIC PROSTHETIC(polymacon) Tinted, Soft Contact Lens isindicated for daily wear to enhance or alterthe apparent eye color, including ocularmasking, either in sighted or non-sightedeyes that require a prosthetic contact lensesfor cosmetic management of conditions suchas corneal, iris or lens abnormalities. Thelens may also be prescribed for thecorrection of refractive ametropia (myopia,hyperopia and astigmatism) in aphakic andnot aphakic persons or for occlusive therapyfor conditions such as diplopia, amblyopiaor extreme photophobia. The lens may bedisinfected with either a chemical or a heatdisinfection system.
3.)	FDA "listed"colored additives	The reactive colored additives consist ofreactive black 5, reactive blue 4, reactiveblue 19, reactive 21, reactive blue 163,reactive yellow 15, reactive yellow 86,reactive orange 78, reactive red 11 andreactive red 180.	Vat Green 1, Vat Brown 1,Vat Blue 6,
4.)	Uses andrestrictions.	The color additives listed above may be usedto color contact lenses in amounts not toexceed the minimum reasonably required toaccomplish the intended prosthetic effect.	The color additives listed above may be usedto color contact lenses in amounts not toexceed the minimum reasonably required toaccomplish the intended prosthetic effect.
5.)	Color AdditiveCharacteristics	The color additives used are not removed bylens handling and approvedcleaning/disinfecting procedures. Theoptical and perform ance characteristics arenot altered by the lens coloring process.	The color additives used are not removed bylens handling and approvedcleaning/disinfecting procedures. Theoptical and performance characteristics arenot altered by the lens coloring process.

Table #1 - Substantial Equivalence

{3}------------------------------------------------

Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 16 1999

Colorsoft Laboratories Corporation c/o Mr. Martin Dalsing 623 Glacier Drive Grand Junction, CO 81503

Re: K992339 Trade Name: COLORSOFT PROSTHETIC Tinted Soft Contact lens Regulatory Class: II Product Code: 86 LPL Dated: July 12, 1999 Received: July 13, 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:

COLORSOFT PROSTHETIC Tinted Soft Contact lens

INDICATIONS FOR USE:

い

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

t. Daniel W.C. Brown, PH.D

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K992339

$\$

Prescription Use X (Per 21 CFR 801.109) Or

Over-The-Counter Use

(Optional Format 1-2-96)

Regulation Number and Section

§ 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.