Except for decreased light transmittance due to the tint intensity, the pretinted 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 Description

The CRYSTAL TINTED SOFT CONTACT LENSES are available in Aqua, Amber, Roval Blue, Sky Blue, Sapphire Blue, Emerald Green, Mint Green, Green, Light Yellow, Dark Yellow, Light Red, Dark Red, Brown, Black and Orange. They are available with or without tinted centers (pupillary area). The practitioner may also choose tint intensity and custom mix colors (via consultation with CRII).

CRYSTAL TINTED SOFT CONTACT LENSES are color enhanced soft contact lenses that have been previously prescribed for a specific patient. They have been supplied to CRII by a certified supplier to be modified by a tinting process. This process uses color additives that have been supplied by a certified supplier and listed as safe for contact lenses containing hydroxyl groups in accordance with FDA 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 reactive additive on that portion of the anterior (front) surface of the lens that corresponds to the iris.

CRYSTAL TINTED SOFT CONTACT LENSES are tinted using certified Reactive dyes listed by the FDA as approved for use with contact lenses. The lens material is modified by permanently fixing tints to the polymer using the following color additives, either alone or in combination: Reactive Blue 19, Reactive Blue 21, Reactive Yellow 86, Reactive Black 5, Reactive Red 11, Reactive Blue 163, Reactive Orange 78, Reactive Yellow 15, and Reactive Red 180.

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 and appear somewhat warped; however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

Based on the provided 510(k) notification summary for the "Crystal Tinted Soft Contact Lenses," here's a breakdown of the acceptance criteria and the supporting study information:

This device (Crystal Tinted Soft Contact Lenses) is a medical device, but not one that typically relies on AI or complex algorithms requiring extensive performance studies as seen in imaging or diagnostic AI. Instead, the "study" for this type of device focuses on demonstrating safety and substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Safety:
a. Absence of significant microbial contamination (Bioburden)	Bioburden testing showed less than 4 CFU's recoverable for any sample, passing NAMSA testing standards. (Section 2)
b. Non-toxic, non-irritating to the eye and body	All mixed dyes applied to lenses subjected to: - ISO Ocular Irritation Study in the Rabbit: Negative - ISO Acute Systemic Toxicity Study in the Mouse: Negative - Cytotoxicity Using the ISO Elution Method: Negative (Section 2)
c. Color additives used are safe and within regulatory limits.	Color additives are FDA-listed Reactive Dyes, used in amounts "not to exceed the minimum reasonably required to accomplish the intended coloring effect." Lenses are thoroughly washed to remove unbound reactive color additives. (Section 1 & 5)
Effectiveness/Substantial Equivalence:
a. Indications for Use consistency with predicate	"Daily wear to enhance and/or alter the apparent eye color." (Same as predicate) (Section 3 & 5)
b. Intended Use consistency with predicate	"Daily wear to enhance and/or alter the apparent eye color." (Same as predicate) (Section 3 & 5)
c. Lens Function consistency with predicate	"Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error." (Same as predicate) (Section 5)
d. Material (Polymer, Additives) consistency with predicate	Polymer: Hydrophilic (Same as predicate) Additives: FDA Listed Reactive Dyes (Same as predicate) (Section 5)
e. Manufacturing process results in similar characteristics after tinting	Reactive Dye molecules permanently fixed to the polymer. "The color additives are not removed by lens handling and cleaning/disinfecting procedures. The optical performance characteristics are not altered by the lens tinting process." (Section 1 & 5)
f. Compatibility with disinfection methods (chemical disinfection)	"The lens may be disinfected using a chemical disinfection system only." (This implies compatibility was confirmed, though specific data isn't detailed in the provided text beyond this statement.) (Section 3 & 8)
g. Optical parameters remain the same as originally prescribed (except for decreased light transmittance due to tint intensity).	"Except for decreased light transmittance due to the tint intensity, the pretinted lens optical parameters remain the same as originally prescribed for the user prior to tinting." (This is a claim supporting equivalence, implying testing or analysis confirmed this property.) (Section 3 & 8)

2. Sample Size Used for the Test Set and Data Provenance

Bioburden Testing: Ten samples were tested for microorganisms. (Section 2)
Toxicity Studies: "All dyes to be used in the custom tinting process were mixed together and applied to (hydrophilic) soft contact lenses. The contact lenses were then subjected to the following three Toxicity Studies..." While the exact number of lenses or animals used in each specific toxicity study (Ocular Irritation, Systemic Toxicity, Cytotoxicity) is not explicitly stated in the provided text, the standard ISO protocols for these tests would involve specific sample sizes (e.g., rabbits for ocular irritation, mice for systemic toxicity, in-vitro samples for cytotoxicity). However, the document doesn't provide the specifics beyond "the contact lenses were then subjected to..."
Data Provenance: The Bioburden testing was performed at NAMSA in Northwood, Ohio. The Toxicity Studies were performed by North American Science Associates Incorporated. This indicates the testing was done by certified labs. The submission date (Oct 14, 1999) suggests the data is retrospective relative to the submission, but the tests themselves would have been conducted prospectively by the labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

There were no human "experts" establishing ground truth in the conventional sense (e.g., radiologists interpreting images) for this device's performance assessment. The "ground truth" for contact lenses is established through standardized laboratory testing (bioburden, toxicity) and material characterization, guided by FDA regulations and ISO standards. The expertise comes from the certified laboratories (NAMSA, North American Science Associates) conducting these specific tests and interpreting the results against established pass/fail criteria.

4. Adjudication Method for the Test Set

Not applicable for this type of device. The evaluation relied on objective laboratory test results against predefined standards (e.g., "<4 CFUs," "Negative" for toxicity).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a tinted contact lens, not an AI or diagnostic imaging device.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm.

7. The Type of Ground Truth Used

The ground truth used for this device's safety and effectiveness assessment was based on:

Objective laboratory test results: Bioburden counts, toxicological endpoints (ocular irritation, systemic toxicity, cytotoxicity results).
Compliance with regulatory standards: Adherence to FDA color additive regulations, and (implicitly) ISO standards for toxicity testing.
Comparison to a legally marketed predicate device: Demonstrating that the new device shares fundamental scientific technology, materials, indications, and performance characteristics with an already approved device.

8. The Sample Size for the Training Set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as point 8.

Summary

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K 993489

510(k) NOTIFICATION SUMMARY

Summary Prepared: 10/12/99 Application Date: 10/14/99

Applicant/Manufacturing and Packaging:

Crystal Reflections, Int., Inc. 170 N. La Canada, Ste. 80 Green Valley, AZ 85614

(800)807-8722

Jack Carter, President

Contact Person (Submission Correspondent):

Robert Breece, O.D. BioMed Devices Corporation 1325 Progress Drive Front Royal, VA 22630

(540) 636-7976 Fax (540) 635-8846

Trade Name: Crystal Tinted Soft Contact Lenses

Classification Name: Lenses, Soft Contact, Daily Wear

Soft Contact Lens Common Name:

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Description of CRYSTAL TINTED SOFT CONTACT LENSES:

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Bioburden/Toxicology Testing:

Bioburden testing was performed at NAMSA in Northwood, Ohio in February, 2000. Ten samples were tested for two types of microorganisms: aerobic bacteria and fungi. There were less than 4 CFU's recoverable for any sample, passing according to NAMSA testing standards.

All dyes to be used in the custom tinting process were mixed together and applied to (hydrophilic) soft contact lenses. The contact lenses were then subjected to the following three Toxicity Studies by the North American Sclence Associates Incorporated: ISQ Ocular Irritation Study In the Rabbit, ISO Acute Systemic Toxicity Study in the Mouse, and Cytotoxicity Using the ISO Elution Method. All results were negative.

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"Statement of Indications for Use"

Device Name:

Crystal Tinted Soft Contact Lens

INDICATIONS FOR USE:

The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color.

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CRII claims the CRYSTAL TINTED CONTACT LENS that it custom tints from contact lenses that were previously prescribed for each individual patient by his/her personal eye care professional, is substantially equivalent to the following "legally marketed predicate device":

PREDICATE DEVICE:

Manufacturer: Adventures in Colors, Inc.

Adventure Tints, Color Enhanced Soft Contact Device names: Lens (K984098)

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	Characteristic	CRYSTAL TINTED SOFTCONTACT LENS	PREDICATEDEVICE
1.)	INDICATION	Daily Wear, Soft (hydrophilic) contactlens	SAME
2.)	INTENDED USE	The CRYSTAL TINTED SOFTCONTACT LENS is indicated for dailywear to enhance and/or alter theapparent eye color.	SAME
3.)	LENS FUNCTION	Refractive medium that focuses lightrays from near and distant objects onthe retina, while compensating forrefractive error.	SAME
4.)	MATERIALS
a.	Polymer	Hydrophilic	SAME
b.	Additives	FDA Listed Reactive Dyes	SAME
5.)	FDA "LISTED"COLORADDITIVES	The reactive color additives are asfollows: Reactive Blue 19, ReactiveBlue 21, Reactive Yellow 86, ReactiveBlack 5, Reactive Red 11, ReactiveBlue 163, Reactive Orange 78,Reactive Yellow 15 and Reactive Red180.	SAME
a.	Uses andRestrictions	The color additives listed above may beused to color soft contact lenses inamounts not to exceed the minimumreasonably required to accomplish theintended effect.	SAME
b.	Color AdditiveCharacteristics	The color additives are not removed bylens handling and cleaning/disinfectingprocedures. The optical performancecharacteristics are not altered by thelens tinting process.	SAME
c.	Colors Offered	Aqua, Amber, Royal Blue, Sky blue,Sapphire Blue, Emerald Green, MintGreen, Green, Light Yellow, DarkYellow, Light Red, Dark Red, Brown,Black and Orange	Blue, Green, Aqua,Yellow, Lavender,Brown, Ultra Violet (hotpink) and Amber
6.)	PRODUCTIONMETHOD	FDA Listed Reactive Dye moleculesreplace Hydroxyl (polymer) ions	SAME

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Image /page/6/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 symbol that resembles a stylized caduceus or a bird-like figure with three wing-like shapes.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 1 4 2000

Crystal Reflections, Int., Inc. c/o Robert Breece, O.D. BioMed Devices Corporation 1325 Progress Drive Front Royal, VA 22630

Re: K993489 Trade Name: CRYSTAL TINTED SOFT CONTACT LENS For Daily Wear (tinted with Reactive Dyes) Regulatory Class: II Product Code: 86 LPL Dated: April 3, 2000 Received: April 4, 2000

Dear Dr. Breece:

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 .

{7}------------------------------------------------

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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,
A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic, Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

. Enclosure

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"Statement of Indications for Use"

Device Name:

Crystal Tinted Soft Contact Lens

INDICATIONS FOR USE:

The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color.

E.j. C, PhD.

(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number. K 993489

Prescription Use
(Per 21 CFR 801.109)

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.