(182 days)
The Crystal Tinted Soft Contact Lens is indicated for daily wear to enhance and/or alter the apparent eye color.
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.
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.
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., "
§ 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.