The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design and indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program.

FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.

DISPOSABLE WEAR
When prescribed for Disposable Wear, the lens is to be discarded after each removal.

Device Description

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The lenses are clear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4. Each finished lens is supplied in a plastic blister container with A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.

AI/ML Overview

This document is a 510(k) Pre-Market Notification for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through novel studies. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not applicable in the way they would be for an AI/ML medical device.

However, I can extract information related to the device's characteristics and the non-clinical tests performed to demonstrate its safety and effectiveness relative to established standards and predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a numerical or target performance manner as one might expect for a diagnostic or AI device. Instead, it compares the subject device's characteristics to those of its predicate devices, implying that similarity or equivalence to the predicate's performance across these characteristics is the "acceptance criterion" for substantial equivalence.

Characteristic	Acceptance Criterion (Implied: Similar to Predicate)	Reported Subject Device Performance	Predicate Device 1 (K150630) Performance	Predicate Device 2 (K211448) Performance
Material USAN Name	Polymacon (same as Predicate 1)	Polymacon	Polymacon	Etafilcon A
Manufacturing Method	Cast Molded (same as Predicate 1 & 2)	Cast Molded	Same	Same
Sterilization	Moist Heat (Steam) in Validated Autoclave (same as Predicate 1 & 2)	Moist Heat (Steam) in Validated Autoclave	Same	Same
Packaging	Blister pack (same as Predicate 1 & 2)	Blister pack	Same	Same
Water Content	38 % (same as Predicate 1)	38 %	38 %	58%
Tint	C.I. Reactive Blue #4 (same as Predicate 1)	C.I. Reactive Blue #4	Same	Reactive Blue 19
Packaging Solution	Similar to predicate packaging solutions or established safe solutions.	A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.	Phosphate buffered saline solution containing sodium hyaluronate and trehalose.	Sterile isotonic borate buffered saline solution with Tween 80, Sodium Hyaluronate, Polyethylene Glycol, and Cyanocobalamin.
Base Curve	Range of 7.50 ~ 9.00 mm (similar to Predicate 1, or appropriate for contact lenses)	7.85 ~ 10.00 mm	7.50 ~ 9.00 mm	N/A (Predicate 2 provides a wider range of lens types, base curve is not explicitly listed in table for this predicate)
Diameter	Range of 12.0 ~ 15.0 mm (similar to Predicate 1)	12.0 ~ 15.0 mm	Same	N/A (Predicate 2 provides a wider range of lens types, diameter is not explicitly listed in table for this predicate)
Center Thickness (Eye Secret 38 UV lens)	0.04 ~ 0.14 mm (similar to Predicate 1)	0.06 ~ 0.13 mm	0.04 ~ 0.14 mm	N/A
Center Thickness (Air Light 38 UV lens)	Not explicitly compared but within acceptable range for contact lenses.	0.03 mm	N/A	N/A
Refractive Index	1.440 ± 0.005 $n_d$ (same as Predicate 1)	1.440 ± 0.005 $n_d$	Same	1.402 $n_d$
Oxygen Permeability (Dk)	13.5 x 10-11 (cm2/sec)(ml O2/ml x mmHg) (same as Predicate 1)	13.5 x 10-11 (cm2/sec)(ml O2/ml x mmHg)	Same	19.73 x 10-11 (cm2/sec)(ml O2/ml x mmHg)
Light Transmittance	95 ± 5 % (similar to Predicate 1 and >95% for Predicate 2)	95 ± 5 %	Same	> 95%
UV-A Transmittance (Eye Secret 38 UV lens)	< 50 % (same as Predicate 1)	< 50 %	Same	Same (for applicable UV-blocking lenses of Predicate 2)
UV-A Transmittance (Air Light 38 UV lens)	< 70 % (implied acceptable for UV-blocking lenses)	< 70 %	N/A	N/A
UV-B Transmittance (Eye Secret 38 UV lens)	< 5 % (same as Predicate 1)	< 5 %	Same	Same (for applicable UV-blocking lenses of Predicate 2)
UV-B Transmittance (Air Light 38 UV lens)	< 40 % (implied acceptable for UV-blocking lenses)	< 40 %	N/A	N/A
Powers (Eye Secret 38 UV lens)	-0.50 ~ -20.00 D (similar to Predicate 1 and within typical contact lens range)	-20.00 ~ +20.00 D	-0.50 ~ -20.00 D	-12.00 ~ +6.00 D (for spherical and aspheric lenses of Predicate 2)
Powers (Air Light 38 UV lens)	0.00 ~ -10.00 D (within typical contact lens range)	0.00 ~ -10.00 D	N/A	N/A
Cytotoxicity Test	Pass (non-toxic)	Passed (reported as non-toxic and biocompatible)	N/A (implicitly passed as legally marketed)	N/A (implicitly passed as legally marketed)
Ocular Irritation Test	Pass (non-irritating)	Passed	N/A	N/A
Acute Systemic Toxicity Test	Pass (non-toxic)	Passed	N/A	N/A

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

The document describes non-clinical testing, meaning these are laboratory-based tests on the device materials and finished products, not human subject trials.

Sample Size: Not explicitly stated for each specific physical/chemical test (e.g., how many lenses were tested for water content). However, testing was conducted according to ISO standards, which would include appropriate sample sizes for reproducibility and statistical confidence.
Data Provenance: The tests are performed by the manufacturer, Yung Sheng Optical Co., Ltd. The document does not specify a country of origin for the data beyond that implied by the manufacturer's location (Taiwan). These are prospective tests performed on the subject device to demonstrate its properties.

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

Not applicable. For non-clinical tests of contact lens physical and chemical properties, "ground truth" is established by direct measurement using validated scientific methods and instrumentation, often against international standards (e.g., ISO 18369). Expert consensus is not typically used to establish these types of truths.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or assessment of imaging data where expert disagreement might occur. For objective physical and chemical tests, the results are typically quantitative and directly measured.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a contact lens, not an AI-assisted diagnostic or imaging system. The concept of "human readers" improving with AI assistance does not apply.

6. Standalone (Algorithm Only) Performance

Not applicable. This is a physical medical device (contact lens), not a standalone algorithm.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on:

Material specifications: The chemical composition of the lens material.
Physical and optical measurements: Direct measurements of properties like water content, refractive index, light transmittance, oxygen permeability, base curve, diameter, and center thickness, conforming to ISO standards (ISO 18369-3:2017 and ISO 18369-4:2017).
Biological safety standards: Compliance with ISO 10993 series for toxicology (e.g., cytotoxicity, ocular irritation, acute systemic toxicity).

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that uses a training set.

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

Not applicable. This is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 16, 2024

Yung Sheng Optical Co., Ltd. Wen-Han Chen RA Manager No. 8, Keya 2nd Road, Daya District Taichung City, 42881 Taiwan

Re: K232839

Trade/Device Name: Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Air Light 38 UV Aspheric (polymacon) 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. MVN Dated: November 15, 2024 Received: November 15, 2024

Dear Wen-Han Chen:

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/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 -S

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) K232839

Device Name

Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use (Describe)

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is available as aspheric lens design and indicated for the correction of refractive ametropia (myopia or hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuty. The eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program.

FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned Replacement Wear, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting system each time it is removed and should be discarded per the eye care practitioner's guidance.

DISPOSABLE WEAR When prescribed for Disposable Wear, the lens is to be discarded after each removal.

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) Notification for Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K232839)

510(k) Summary

1. Type of Submission: Traditional 510(k) 510(k) number: K232839
1. Submitter: Yung Sheng Optical Co., Ltd. Address: No.8, Keya 2nd Rd., Daya District, Taichung City 42881, Taiwan Establishment Registration Number: 3004021238 Date prepared: May 26, 2023 Contact Person 1

Name: Mr. Wen-Han, Chen / RA manager Phone number: +886-4-25658384 #3509 E-mail: wenhanchen@hydron.com.tw

Contact Person 2

Name: Mr. James Chang / RA specialist Phone number: +886-4-25658384 #3514 E-mail: jameschang@hydron.com.tw

3. Identification of the Device

Device name:	Eye Secret 38 UV Aspheric (polymacon) Soft(hydrophilic) Contact Lens for Daily Wear,Air Light 38 UV Aspheric (polymacon) Soft(hydrophilic) Contact Lens for Daily Wear
Common Name:	Contact Lens
Classification Name:	Lenses, Soft Contact, Daily Wear
Device Classification:	II
Regulation Number:	886.5925
Panel:	Ophthalmic
Product Code:	LPL for Lenses, Soft Contact, Daily WearMVN for Lens, Contact, (Disposable)

4. Identification of the Predicate Device

Predicate Device Name:	Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear
Manufacturer:	Yung Sheng Optical Co., Ltd.
Product Code:	LPL for Lenses, Soft Contact, Daily WearMVN for Lens, Contact, (Disposable)
510(k) Number:	K150630

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Predicate DeviceName:	Aquamax (Etafilcon A) Daily Disposable Soft(Hydrophilic) Contact Lenses,Aquamax (Etafilcon A) Soft (Hydrophilic) ContactLenses
Manufacturer:	Pegavision Corporation
Product Code:	LPL, MVN
510(k) Number:	K211448

5. Intended Use and Indications for Use of the subject device

FREQUENT/PLANNED REPLACEMENT WEAR

DISPOSABLE WEAR

When prescribed for Disposable Wear, the lens is to be discarded after each removal.

6. Device Description

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(HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). The lenses contain a benzophenone UV-absorbing monomer which has been incorporated into the polymer matrix of the lens to absorb ultraviolet (UV) light. The lenses are clear or tinted from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4. Each finished lens is supplied in a plastic blister container with A) Standard Saline Solution, or B) Sodium Hyaluronate Packaging Solution, or C) PMB Packaging Solution, or D) Cyanocobalamin Packaging Solution.

The purpose of this 510(k) Notification is to notify the FDA of a new device, intended for commercial distribution by Yung Sheng Optical Co., Ltd. under the trade name of Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear containing 4 different type of packaging solution.

7. Characteristics of Substantial Equivalence

Material and Process Comparison Table

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510|k) Notification for Eye Seret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K232839)

	Subject Device	Predicate device
Device Name	Eye Secret 38 UV Aspheric (polymacon)Soft (hydrophilic) Contact Lens for DailyWear/Air Light 38 UV Aspheric(polymacon) Soft (hydrophilic) ContactLens for Daily Wear	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic)Contact Lens for Daily Wear	Aquamax (Etafilcon A) Daily Disposable Soft(Hydrophilic) Contact Lenses, Aquamax (Etafilcon A)Soft (Hydrophilic) Contact Lenses
Manufacturer	Yung Sheng Optical Co., ltd	Same	Pegavision Corporation
510(k) Number	K232839	K150630	K211448
Classification	Class II	Same	Same
Product Code	LPL and MVN	Same	Same
Intended Use	The Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic) ContactLens for Daily Wear/Air Light 38 UVAspheric (polymacon) Soft (hydrophilic)Contact Lens for Daily Wear is available asaspheric lens design and indicated for thecorrection of refractive ametropia (myopiaor hyperopia) in aphakic and not-aphakicpersons with non-diseased eyes. The lensmay be worn by person who exhibitastigmatism of 2.00 diopters or less thatdoes not interfere with visual acuity. Theeye care professionals may prescribe thelens for single use daily disposable or dailywear in a Frequent Replacement Program.FREQUENT/PLANNED REPLACEMENTWEARWhen prescribed for Frequent/PlannedReplacement Wear, the lens should bedisinfected using a chemical or hydrogenperoxide disinfecting system each time it is	The Eye Secret 38 UV isindicated for the correction ofrefractive ametropia (myopia)in aphakic and not-aphakicpersons with non-diseasedeyes. The lenses may be wornby person who exhibitastigmatism of 2.00 diopters orless that does not interferewith visual acuity. The EyeSecret 38 UV helps protectagainst transmission of harmfulUV radiation to the cornea andinto the eye. The eye careprofessionals may prescribethe lens for single use dailydisposable or daily wear in aFrequent ReplacementProgram. As prescribed forplanned replacement, the lensshould be disinfected using achemical or hydrogen peroxide	Spherical and AsphericalAquamax (Etafilcon A) SPHERE and ASPHERE Soft(Hydrophilic) Contact Lenses are indicated for dailywear for the correction of ametropia (myopia andhyperopia) in aphakic and/or non-aphakic persons withnon-diseases eyes in powers from +6.00 to -12.00diopters. The lenses may be worn by persons whoexhibit astigmatism of 2.00 diopters or less that doesnot interfere with visual acuity.ToricAquamax (Etafilcon A) Toric Soft (Hydrophilic) ContactLenses are indicated for daily wear for the correction ofametropia (myopia or hyperopia with astigmatism) inaphakic and/or non-aphakic persons with non-diseasedeyes in powers from +6.00 to -12.25 diopters andastigmatic corrections from -0.25 to -3.50 diopters.MultifocalAquamax (Etafilcon A) Multifocal Soft (Hydrophilic)Contact Lenses are indicated for daily wear for thecorrection of refractive ametropia (myopia andhyperopia) and presbyopia in aphakic and/ornon-aphakic persons with non-diseased eyes in powers
	Subject Device	Predicate device
Device Name	Eye Secret 38 UV Aspheric (polymacon)Soft (hydrophilic) Contact Lens for DailyWear/Air Light 38 UV Aspheric(polymacon) Soft (hydrophilic) ContactLens for Daily Wear	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic)Contact Lens for Daily Wear	Aquamax (Etafilcon A) Daily Disposable Soft(Hydrophilic) Contact Lenses, Aquamax (Etafilcon A)Soft (Hydrophilic) Contact Lenses
	removed and should be discarded per theeye care practitioner's guidance.DISPOSABLE WEARWhen prescribed for Disposable Wear, thelens is to be discarded after each removal.	disinfecting systems.	from +6.00 to -12.25 diopters and with non-diseasedeyes who may require a reading addition from +0.25Dto +3.00D. The lenses may be worn by persons whoexhibit astigmatism of 2.00 diopters or less that doesnot interfere with visual acuity.The lenses are intended for frequent/plannedreplacement wear with cleaning, rinsing, disinfectionand scheduled replacement as prescribed by the eyecare professional. When prescribed forfrequent/planned replacement wear, the lens maybedisinfected using a chemical (not heat) lens caresystem only.
MaterialUSAN Name	Polymacon	Same	Etafilcon A
ManufacturingMethod	Cast Molded	Same	Same
Sterilization	Moist Heat (Steam) in Validated Autoclave	Same	Same
Packaging	Blister pack	Same	Same
Water Content	38 %	Same	58%
Tint	C.I. Reactive Blue #4	Same	Reactive Blue 19
Packaging solution	A) Standard Saline Solution, or B) SodiumHyaluronate Packaging Solution, or C) PMBPackaging Solution, or D) CyanocobalaminPackaging Solution.	Phosphate buffered salinesolution containing sodiumhyaluronate and trehalose.	Sterile isotonic borate buffered saline solution withTween 80, Sodium Hyaluronate, Polyethylene Glycol,and Cyanocobalamin.

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510|k) Notification for Eye Seret 38 UV Aspheric (polymoco) Soft (hydrophilic) Contact Lens for Daily Wear and Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K232839)

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510|k) Notification for Eye Seret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K232839)

	Subject Device			Predicate device

Device Name	Eye Secret 38 UV Aspheric (polymacon) Soft(hydrophilic) Contact Lens for Daily Wear/Air Light 38UV Aspheric (polymacon) Soft (hydrophilic) ContactLens for Daily Wear		Eye Secret 38 UV Aspheric(polymacon) Soft(hydrophilic) Contact Lensfor Daily Wear	Aquamax (Etafilcon A) Daily Disposable Soft(Hydrophilic) Contact Lenses, Aquamax(Etafilcon A) Soft (Hydrophilic) ContactLenses
Base Curve	7.85 ~ 10.00 mm		7.50 ~ 9.00 mm	N/A
Diameter	12.0 ~ 15.0 mm		Same	N/A
Center Thickness	Eye Secret 38 UV lens	0.06 ~ 0.13 mm	0.04 ~ 0.14 mm	N/A
	Air Light 38 UV lens	0.03 mm
Refractive Index	1.440 ± 0.005 $n_d$		Same	1.402 $n_d$
	13.5 x 10-11			19.73 x 10-11
Oxygen Permeability (Dk)	(cm2/sec)(ml O2/ml x mmHg)		Same	(cm2/sec)(ml O2/ml x mmHg)
Light Transmittance	95 ± 5 %		Same	> 95%
UV-A Transmittance	Eye Secret 38 UV lens	< 50 %	Same	Same
	Air Light 38 UV lens	< 70%
UV-B Transmittance	Eye Secret 38 UV lens	< 5 %	Same	Same
	Air Light 38 UV lens	< 40%
Powers	Eye Secret 38 UV lens	-20.00 ~ +20.00 D	-0.50 ~ -20.00 D	-12.00 ~ +6.00
	Air Light 38 UV lens	0.00 ~ -10.00 D

● Technological Characteristics Comparison Table

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8. Non-Clinical Testing

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear.

Physiochemical Studies
The physiochemical studies were conducted according to ISO 18369-4:2017 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2017 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses. The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994:
. Finished Lens Parameters
. Refractive Index
Light Transmittance
Water Content
. Extractables (Leachability)
1 Oxygen Permeability
. Mechanical Properties Testing
. Physical Compatibility Test with Packaging Solution
Shelf-life .
Toxicology Studies

Toxicology studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.

Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear

Cytotoxicity Test (ISO 10993-5)
Ocular Irritation Test (ISO 10993-10, ISO 9394)
Acute Systemic Toxicity Test (ISO 10993-11)

Packaging Solution

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Cytotoxicity Test (ISO 10993-5)
Ocular Irritation Test (ISO 10993-10)
Acute Systemic Toxicity Test (ISO 10993-11)

PP blister and aluminum foil [identical to K150630]

Cytotoxicity Test (ISO 10993-5) ●
Ocular Irritation Test (ISO 10993-10)
Acute Systemic Toxicity Test (ISO 10993-11)

The biocompatibility tests were conducted on test articles representative of the primary packaging solution options. The results of the non-clinical testing, including physiochemical studies and toxicology studies, demonstrated that the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear met all the specifications and is concluded substantially equivalent to the predicate device.

9. Summary of Clinical Study

technological characteristics, formulation, manufacturing and The sterilization processes are the same as the predicate devices. Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

10. Conclusion

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear/Air Light 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate devices, Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (510K number K150630) and Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses (510K number K211448) in term of optical property, physiochemical and pre-clinical toxicology. They are produced from the same or similar material, have the same functional and scientific technology, lens characteristics as well as the intended uses are identical. It is

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concluded that the lenses are as safe, as effective and perform as well as the both predicate devices.

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.