The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system.

Device Description

The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured using the cast molding method. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from polymacon, which is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution. The polymacon name has been adopted by the United States Adopted Names Council (USAN).

The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are available clear, tinted for visibility, or tinted to enhance or alter the apparent color of the eye. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Iron Oxide, C.I. Reactive Blue No.4, Reactive Black 5, Titanium Dioxide.

When producing the color lenses, the manufacturing process changes the specifications to the clear contact lens by pad-printing the color pigment(s)-entrapping the colorants in the interpenetrating network of the contact lens material in a location that corresponds to the iris. The color pigments used are not removed by lens handling and 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. The tinting pattern has a clear pupil diameter of 6.0 mm. The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280nm - 315mm), and >50% in the UVA range (316nm - 380nm).

The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are manufactured in an aspheric design configuration.

AI/ML Overview

This document does not describe a study involving an AI/ML powered device. Instead, it is a 510(k) summary for a medical device called "TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)," which are traditional contact lenses, not an AI or algorithm-driven product.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies proving an AI device meets them, as the provided text does not contain that type of content. The document focuses on the substantial equivalence of the contact lenses to predicate devices based on material properties, manufacturing, indications for use, and non-clinical performance data (toxicology, shelf life, physicochemical & mechanical properties). It explicitly states that "Clinical testing is not required."

Summary

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August 5, 2022

DK Medivision Co., Ltd. % Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, OR 97068

Re: K220045

Trade/Device Name: TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 28, 2022 Received: July 1, 2022

Dear Bret Andre:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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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): medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K220045

Device Name

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Indications for Use (Describe)

The eye care professionals may prescribe the lens for single use daily wear in a frequent replacement program. As prescribed for planned replacement, the lens should be dising a chemical or hydrogen peroxide disinfecting system.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510 (k) SUMMARY

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: K220045

I. SUBMITTER

Date Prepared:	June 25th, 2022
Name:Address:	DK Medivision Co., Ltd.23 Busong 1-gil, jiksan-eup,Seobuk-gu Cheonan-si, Chungcheongnam-do,KOREA
Contact Person:	Henry HongQ.A manager
Phone number:	(82)415810100
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted Color)
Common Name:	Contact Lens, Daily Wear
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Regulatory Class:	Class II
Product Code:	LPL; MVN

Purpose of 510(k) Submission:

~ New Device ~

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III. PREDICATE DEVICE

The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are substantially equivalent to the following predicate device(s):

"Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens" By YUNG SHENG OPTICAL 510(k) number; K132854 Primary Predicate
"ChicView (Polymacon) Daily Wear Soft (Hydrophilic) Contact Lenses (Tinted/Color)" By JOOWON INNOVATION CO., LTD. 510(k) number: K161098 Reference Predicate

IV. DEVICE DESCRIPTION

Color Additive	Listing
Iron Oxide	21 CFR § 73.3125
C.I. Reactive Blue No.4	21 CFR § 73.3121
Reactive Black 5	21 CFR § 73.3127
Titanium Dioxide	21 CFR § 73.3126

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The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are

manufactured in an aspheric design configuration. The material properties and available parameters of the finished lenses are as follows:

Parameter	Range	Tolerance*
Chord Diameter	11.00 mm to 15.00 mm	±0.20 mm
Center Thickness	0.05 mm to 0.15 mm	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Base Curve	7.00 mm to 10.0 mm	±0.20 mm
Back Vertex Power (F'v)(in 0.25D steps)	-0.50 D to -12.00D	When 0.00 < F'v ≤ 10.00 D → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D → ±0.50 D
Surface Appearance	-	Lenses should be clear with no surface defect
Oxygen Permeability(x 10-11(cm²/sec)(mlO2)/(mlx mmHg))	11.12	±20%
Light Transmission - Tinted(@ 380-780nm)	95%	±5%
Ultraviolet RadiationTransmittance	< 5 % TUVB< 50 % TUVA	TUVB (280 to 315 nm) < 0.05TVTUVA (316 to 380 nm) < 0.50TV
Water Content	38%	±2%
Refractive Index	1.440 (hydrated)	±0.005

ISO 18369-2:2017 Ophthalmic optics - Contact lenses - Part 2: Tolerances

V. INDICATIONS FOR USE

The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with nondiseased eyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are substantially equivalent to the predicate devices identified (K132854 and K161098) in terms of the following:

USAN contact lens material (polymacon)
FDA Group 1 (<50% H2O, non-ionic polymer)
FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
트 Intended use - daily wear contact lenses
Actions
Indications for use
트 UV absorber
Cast molded production method
Pad-printing contact lens tinting method (reference predicate K161098)

The following matrix illustrates the production method, lens function and material characteristics of the TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color), as well as the predicate devices.

	DK MedivisionTREVUES(Subject Device)	Yung Sheng OpticalEyesecret 38 UV(K132854)	Joowon InnovationChicView(K161098)
Actions	The contact lenses act as arefractive medium that focuslight rays from near and distantobjects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina	The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina
FDA Classification	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)
FDA Group	FDA Group 1(<50% H2O, non-ionicpolymer)	FDA Group 1(<50% H2O, non-ionicpolymer)	FDA Group 1(<50% H2O, non-ionicpolymer)
Production Method	Fully molded	Fully molded	Fully molded
USAN name	polymacon	polymacon	polymacon
Water Content (%)	38±2%	38±2%	38±2%
Oxygen Permeabilityx 10-11 (cm2/sec)(mlO2)/(ml x mmHg(@ 35°C)) (revised Fatt method)	11.12	13.35	11.15
Refractive Index(hydrated)	1.440	1.440	1.435
UV Blocker	Yes	Yes	No
Pad-Printed Tinting	Yes	No	Yes
Sterilization Process	Steam sterilization	Steam sterilization	Steam sterilization
Packaging	Blister	Blister	Blister

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	Indications for Use
DK MedivisionTREVUES(SubjectDevice)	The TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are indicated for thecorrection of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseasedeyes. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters where theastigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be usedto enhance or alter the apparent color of the eye.The eye care professionals may prescribe the lens for single use daily disposable or daily wear in aFrequent Replacement Program. As prescribed for planned replacement, the lens should be disinfectedusing a chemical or hydrogen peroxide disinfecting system.
Yung ShengOpticalEyesecret 38UV(K132854)	The Eye Secret 38 UV Apsheric (polymacon) Soft (hydrophilic) Contact Lenses for Daily WearWear are indicated for the correction of ametropia (myopia) in aphakic and not-aphakicpersons with non-diseased eyes. The lenses may be worn by persons who exhibitastigmatism of 2.00 diopters or less that does not interfere with visual acuity.
JoowonInnovationChicView(K161098)	The ChicView (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for thecorrection of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia orhyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters orless where the astigmatism does not interfere with visual acuity. The lens is available clear or tintedand may be used to enhance or alter the apparent color of the eye.Daily wear replacement schedules may vary from patient to patient and should be decided by eyecarepractitioners in consultation with their patients.Frequent/Planned Replacement Wear: Eyecare practitioners may prescribe any of the above lenses forfrequent/planned replacement wear, with cleaning disinfection and scheduled replacement. Whenprescribed for frequent/planned replacement wear, the lens may be disinfected using a chemicaldisinfecting system.Disposable Wear: Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear.When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfectingsystems as they are to be discarded after a single use.

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PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Non-clinical Testing

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the TREVUES (polymacon) finished contact lenses. The results support the claim that the TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.

Toxicology:

All non-clinical toxicology tests were conducted in accordance with the GLP regulation.

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses and packaging materials are non-toxic.
· Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic.
· Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation for the finished lenses and packaging materials.

Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the TREVUES (polymacon) finished contact lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate devices.

Physicochemical & Mechanical Properties:

The following tests were completed to verify substantial equivalence to predicate devices: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistency of the material properties between the TREVUES (polymacon) contact lenses and the predicate devices.

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Clinical Testing

Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from polymacon materials has been demonstrated previously.

VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories conducted biocompatiblity, microbiology, and shelf-life stability studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this Premarket Notification establishes that the TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) are as safe and effective as the predicate device when used in accordance with the labeled directions for the proposed indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.

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.