Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The eye care practitioner may prescribe the contact lens for frequent replacement wear, with cleaning, rinsing and disinfection and scheduled replacement as prescribed by the eyecare professional. The contact lens may be disinfected using chemical (not heat) disinfection system.

Device Description

Calaview Colors Soft (hydrophilic) Contact Lens are available as non-spherical lenses manufactured by spin-casting method. The model illuminated with high water content (58 ± 1%). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with 1,1,1-trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo- polymerization. The Calaview Colors Contact lens contains pigments around the non-optic area that will mask or enhance the color of the natural iris without blocking the light transmittance. The lens is colored with one or more of the FDA-approval color additives: iron oxides, titanium dioxide, phthalocyaninato copper, phtalocyanine green, vat orange 1. The Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens is available in the following opaque colors: Blue, green, violet, gray, hazel, white, yellow, gold, orange red and black. Lenses are supplied sterile in sealed blister packers containing sterile isotonic phosphate buffered saline solution.

AI/ML Overview

The provided text describes the safety and effectiveness of Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear. This is a premarket notification (510(k)) submission, which aims to demonstrate that a device is substantially equivalent to a legally marketed predicate device. Therefore, the "acceptance criteria" are implied by the characteristics and performance of the predicate devices.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens are implicitly set by the characteristics and performance of its predicate devices: ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114) and Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129). The study demonstrates substantial equivalence to these predicates rather than explicitly stating acceptance criteria for each metric.

Characteristic	Acceptance Criteria (Predicate Range/Values)	Reported Device Performance (Calaview Colors)
%Water content	57 to 59 (Discon) / 58 (Acuvue Colors)	57 to 59
Refractive index	1.407 (Discon) / 1.40 (Acuvue Colors)	1.407
Specific Gravity	1.05 (Discon & Acuvue Colors)	1.05
Oxygen permeability (edged corrected) @ 35°C	24 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] (Discon) / 22.4 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)] (Acuvue Colors)	24 x 10^-11 [(cm²/sec)(ml O₂/ml-mmHg)]
%Light Transmission	>93 (Discon) / >85 (Acuvue Colors)	>93
Base Curve Radius, mm	8.00~~9.00 (Discon) / 7.85~~10.00 (Acuvue Colors)	8.00~9.00
Diameter, mm	13.8~~14.2 (Discon) / 12.0~~15.0 (Acuvue Colors)	13.8~14.2
Center Thickness, mm	0.08~~0.20 (Discon) / 0.06~~1.00 (Acuvue Colors)	0.08~0.20
Power, Diopters	+6.0D~-20.0D (Discon) / +20.0D~-20.0D (Acuvue Colors)	+6.0D~-20.0D
Biocompatibility	Non-toxic, non-irritating, non-cytotoxic (based on predicate standards)	Irritation test in rabbit eye: non-irritated. Systemic toxicity: non-toxic. Cytotoxicity: not cytotoxic.
Sterilization	Minimum SAL of 10⁻⁶ (based on FDA Group IV requirement)	Steam sterilization validated to deliver minimum SAL of 10⁻⁶
Leachability	No leachable monomers and addictive residues at detection levels (based on predicate standards)	No leachable monomers and addictive residues
Clinical performance	"Good and safe" with corrected vision and satisfaction (from predicate experience)	Nearly 100% vision corrected, nearly all satisfied, generally stable condition without severe complication.

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

The clinical study involved a test set of 65 human eyes.
The data provenance mentions "Calaview Colors lenses have been wide-used around the world, including Taiwan. China, Europe, etc." and implies the study participants were part of this usage. The study appears to be retrospective in the sense that the lenses "have been wide-used" and observed, although the "65 human eyes ... within 6 months" could also indicate a prospective observational study. Without further details, it's difficult to definitively classify. The country of origin for the 65 human eyes is not explicitly stated within the document for the specific clinical study, but the submitter is based in Taiwan.

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

The document does not provide information on the number or qualifications of experts used to establish a "ground truth" for the test set in the clinical study. The assessment of "vision corrected," "satisfied with the lens wearing," and "stable condition without severe complication" likely comes from the "eye care practitioner" mentioned, but no specifics are given.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the clinical study's test set.

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

No MRMC comparative effectiveness study was done. This device is a contact lens; therefore, it's not an AI-assisted diagnostic tool for which an MRMC study would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. Again, this is a physical medical device (contact lens), not an algorithm.

7. The Type of Ground Truth Used

For the clinical study, the "ground truth" was based on clinical observation and patient reported outcomes (e.g., visual acuity correction, patient satisfaction, lack of adverse events/complications). For the technical characteristics, the "ground truth" was established by laboratory measurements against defined standards or measurements from predicate devices.

8. The Sample Size for the Training Set

This submission is for a physical medical device (contact lens); it does not involve a "training set" in the context of machine learning algorithms. The manufacturing process and material properties are developed and validated through engineering and scientific principles, not machine learning training.

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

As there is no training set in the machine learning sense, this question is not applicable. The device's design and manufacturing rely on well-established principles of polymer chemistry and optics, and its safety and effectiveness are confirmed through non-clinical laboratory testing and clinical observation against predicate devices and regulatory requirements.

Summary

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K062541

SUMMARY OF SAFETY AND EFFECTIVENESS FOR Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

	Submitter Information:
Company:	INNOVA VISION INC.No. 231-1, Wen-Te Road, Chiung-lin Village,Hsin-Chu County, Taiwan.	JUN - 7 2006
Contact Person:	Mr. Michael w. Hsu,Executive Vice President
Phone:	886-3-592-7299
FAX:	886-3-592-6213
E-Mail:	mikehsu@innovavision.com.tw
Date Prepared	July. 25, 2006

ldentification of Device:

Classification Name:	Soft hydrophilic contact lens, per 21 CFR. 886.5925
Trade Name:	Calaview Colors (Etafilcon A) Soft (hydrophilic)Contact Lens for Daily Wear
Common or usual Name:	Soft (hydrophilic) Contact lens (daily wear)
FDA Classification:	Class II

Predicate Device:

ACUVUE 2 colours Brand(Etafilcon A) Contact Lens clearedvia K010114 Johnson & Johnson Co. USA.	Discon (Etafilcon A) Soft (hydrophilic)Contact Lens for Daily Wear clearedvia K051129 from Innova Vision Inc., Taiwan.
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Indications for Use

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Description of Device

Summary of Clinical Study

The Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens were tested in 65 human eyes separately within 6 months. Nearly a hundred percent of the participants' vision was corrected and nearly all were satisfied with the lens wearing and care of lenses. In general, these products are good and safe for customers.

Calaview Colors lenses have been wide-used around the world, including Taiwan. China, Europe, etc. Among the users being daily worn the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens, all the procedures were in generally stable condition without severe complication. There are no significant side effects and complaints to be observed.

Nonclinical Studies

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens, and establish substantial equivalence to predicate lenses-Discon Lens (K051129); ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114). All testing was conducted in accordance with the May 1994 FDA guideline titled Premarket Notification 510(K) Guidance Document for Class IV Contact lenses, and in conformance to applicable device regulations. The evidence of substantial equivalent to the predicate lens described as follow:

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a) Technological characteristics studies

There characterizations of Calaview Colors (Etafilcon A) Soft (hydrophilic) Contact Lens are equivalent and comparable to those of predicate lenses.

Characteristic	Calaview Colors	AcuvueColors	Discon
%Water content	57 to 59	58	57 to 59
Refractive index	1.407	1.40	1.407
Specific Gravity	1.05	1.05	1.05
Oxygen permeability (edgedcorrected) @ 35°C	$24\times10^{-11}$[(cm2/sec)(mlO2/ml-mmHg)]	$22.4\times10^{-11}$[(cm2/sec)(mlO2/ml-mmHg)]	$24\times10^{-11}$[(cm2/sec)(mlO2/ml-mmHg)]
%Light Transmission	>93	>85	>93
Base Curve Radius, mm	8.00~9.00	7.85~10.00	8.00~9.00
Diameter, mm	13.8~14.2	12.0~15.0	13.8~14.2
Center Thickness, mm	0.08~0.20	0.06~1.00	0.08~0.20
Power, Diopters	+6.0D~-20.0D	+20.0D~-20.0D	+6.0D~-20.0D

b) Biocompatibility

In accordance with the May 1994 Guidance Document for daily wear contact lenses, toxicity studies have been conducted on the model: Calaview Colors (Efafilcon A) Soft (hydrophilic) Contact Lens. The Irritation test in the rabbit eye and Systemic toxicity studies indicate the extracts would be considered as non-toxic and nor The Cytotoxicity testing demonstrates the lens is not cytotoxic under the irritated. conditions of the study.

c) Microbiology

Steam sterilization process has been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA Group IV. There is shelf-life stability data supporting that the lens remains sterile through the expiration date claimed for the product.

d) Leachability

Studies were conducted to determine the leachable materials from the finished lens. The results show that, at the levels of the detection reported, there are no leachable monomers and addictive residues.

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Substantial equivalence Statement

Testing performed on the Calaview Colors Soft (hydrophilic) Contact Lens for Daily Wear indicated that it can support the efficiency and security use as well as the predicate devices-Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129) & ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114), when used in accordance with the instructions for use. It is due to the facts that the risks and benefits of the subject device are the same as soft contact lenses for to the daily wear.

In conclusion, it is Innova's conviction that data submitted in this 510(k) to validate the claim of substantial equivalency, substantiates our ability to manufacture a soft contact lens, the Calaview Colors Soft (hydrophilic) Contact Lens, with the same established safety profile and effectiveness as the predicate device-- Discon (Etafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear (K051129) & ACUVUE 2 colours Brand (Etafilcon A) Contact Lens (K010114).

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Image /page/4/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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a series of human profiles, rendered in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Innova Vision, Inc. c/o Ms. Jennifer Reich Harvest Consulting Corp. 2904 N. Boldt Dr. Flagstaff AZ 86001

JUN - 7 2007

Re: K062541

Trade/Device Name: Calaview Colors (etafilcon A) Soft Hydrophilic Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: May 25, 2007 Received: May 30, 2007

Dear Ms. Reich:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eichelman S.M.D

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number:

Device Name: Calaview Colors Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devices
510(k) Number	K062541

Prescription Use:
or Over the Counter Use

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.