The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for the correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into 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 systems.

Device Description

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is manufactured by using cast molding method. The lens material, polymacon, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 50% in the UVA range of 316 to 380 nm. The lenses are tinted blue for visibility purposes with the color additives, C.I. Reactive Blue No.4.

The lenses are available as aspheric lenses. Each finished lens is supplied in a plastic blister container with a sterile isotonic phosphate buffered saline solution containing sodium hyaluronate and trehalose wetting agents.

AI/ML Overview

The provided document describes the predicate device "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" (K143052) and the new device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear." The acceptance criteria are based on demonstrating substantial equivalence to the predicate device through non-clinical testing.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison to the predicate device, serving as the de-facto acceptance criteria. The subject device must match or perform equivalently to the predicate device across various parameters.

Parameter	Acceptance Criteria (Predicate Device K143052)	Reported Device Performance (Subject Device)
Intended Use	Correction of ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. Lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program, disinfected using chemical or hydrogen peroxide systems.	Correction of refractive ametropia (myopia) in aphakic and not-aphakic persons with non-diseased eyes. Lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Helps protect against transmission of harmful UV radiation. Prescribed for single use daily disposable or daily wear in a Frequent Replacement Program, disinfected using chemical or hydrogen peroxide systems.
Material	Polymacon	Polymacon
Manufacturing Method	Cast Molded	Cast Molded
Water Content	38 %	38 %
Powers	-0.00 ~ -20.00 D	-0.50 D ~ -20.00 D
Light Transmittance	95 % (± 5 %)	95 % (± 5 %)
UV-A	< 50 %	< 50 %
UV-B	< 5 %	< 5 %
Refractive Index	1.440 (± 0.005 nd)	1.440 (± 0.005 nd)
Base Curve	8.60 (± 0.20 mm)	7.85 ~ 10.00 (± 0.2 mm)
Diameter	14.00 (± 0.20 mm)	12.00 ~ 15.00 (± 0.2 mm)
Tint	C.I. Reactive Blue #4 for handling purpose and printed with an intermittent coating a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10.	C.I. Reactive Blue #4 for handling purpose
Packaging Solution	Phosphate buffered saline solution containing sodium hyaluronate and trehalose	Phosphate buffered saline solution containing sodium hyaluronate and trehalose
Toxicity (Acute Systemic Injection)	Meets requirements of systemic injection test, non-toxic.	Meets requirements of systemic injection test, non-toxic.
Toxicity (White Rabbit Ocular Irritation)	No ocular irritation.	No ocular irritation.
Toxicity (Cytotoxicity)	Meets requirements of ISO 10993-5.	Meets requirements of ISO 10993-5.
Extractables (Leachability)	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate.
Finished Lens Parameters	Demonstrated equivalence to predicate. (Specific parameters like Base Curve and Diameter have differences as noted above, which are considered within acceptable limits for substantial equivalence.)	Testing performed, results demonstrated safety and effectiveness equivalent to predicate.
Light Transmittance	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate. (Specific values for UV-A, UV-B, and Light Transmittance are identical to predicate.)
Refractive Index	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate. (Specific value identical to predicate.)
Water Content	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate. (Specific value identical to predicate.)
Shelf-life	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate.
Mechanical Properties Comparative Testing	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate.
Specific Gravity Comparative Testing	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate.
Physical Compatibility Test with Contact Lens Care Solution and Packaging Solution	Demonstrated equivalence to predicate.	Testing performed, results demonstrated safety and effectiveness equivalent to predicate.

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

The document does not specify a distinct "test set" in the context of clinical trials or data for algorithm evaluation. Instead, it refers to non-clinical testing to demonstrate equivalence. For these non-clinical tests (e.g., toxicity, extractables, finished lens parameters), the sample sizes are not explicitly mentioned.

The data provenance for most tests is implied to be from the manufacturer, Yung Sheng Optical Co., Ltd., based in Taiwan. The tests are described as preclinical testing performed to demonstrate the safety and effectiveness. These are laboratory-based tests rather than data collected from human subjects.

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

Not applicable. The evaluation is based on non-clinical laboratory testing and comparison to an existing predicate device, not on expert-adjudicated images or clinical outcomes requiring ground truth establishment by experts in that manner.

4. Adjudication Method for the Test Set

Not applicable. There's no adjudication process described as the safety and effectiveness are determined by laboratory test results against established compliance standards (e.g., ISO 10993-5) and direct comparison to the predicate device's characteristics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This is not an AI/software device. It is a soft contact lens, and its evaluation does not involve human readers or AI assistance.

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

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

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and performance characteristics of legally marketed predicate devices, along with compliance with international standards for medical device materials and product characteristics (e.g., ISO 10993-5 for cytotoxicity, FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses). The subject device demonstrates equivalence to these benchmarks through specific laboratory tests.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/software device and therefore does not have a "training set."

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

Not applicable. There is no training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized design of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The seal is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 15, 2015

Yung Sheng Optical Co., Ltd. Wen-Han Chen, Regulatory Affairs Supervisor 3F-1, No.6, Jhongke Road, Daya District, Taichung City, 42881 Taiwan

Re: K150630

Trade/Device Name: Eye Secret 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: April 10, 2015 Received: April 16, 2015

Dear Mr. 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 (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. 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.

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.

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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 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"

(21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina 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

510(k) Number (if known) K150630

Device Name

Eye Secret 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 is indicated for the correction of refractive ametropia (myopia) in aphakic persons with non-diseased eyes. The lenses may be worn by person who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

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.

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

1. Type of Submission: Traditional 510(k)

2.	Submitter:	Yung Sheng Optical Co., Ltd.
	Address:	3F-1, No.6, Jhongke Road, Daya District, Taichung
		City 42881 Taiwan
	Manufacturingfacility:	No.8, Keya 2nd Road, Daya District, Taichung City42881, Taiwan
	Phone:	(04) 25658384 #156 、157
	Fax:	(04) 25658387
	Contact:	Wen-Han Chen / Tsung-Jen Yeh
	Date prepared:	April 10, 2015
	Establishment Registration Number:	3004021238

3. Identification of the Device

Proprietary/Trade name:	Eye Secret 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 Wear	MVN for Lens, Contact, (Disposable)

4. Identification of the Predicate Device

Predicate Device	Eye Secret 38 UV Aspheric Color (polymacon)
Name:	Soft (hydrophilic) Contact Lens for Daily Wear;
Manufacturer:	Yung Sheng Optical Co., Ltd.
510(k) Number or Clearance Information:	K143052

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

The Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

6. Device Description

7. Summary of Clinical Study

Polymacon lenses have been used widely. Their safety and effectiveness have been well documented and cleared by FDA "Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear; Eye Secret 38 UV Aspheric Color (Polymacon) 1-Day Soft(Hydrophilic) Contact Lens (K143052)" submitted by Yung Sheng Optical Co., Ltd. are examples.

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Clinical study for the subject device is not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.

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. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear are equivalent to the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K143052). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, February 27, 1997:

· Toxicity
- 1. Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
- 1. White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
- 1. Cytotoxicity Test: The test article meets the requirements of ISO 10993-5.
Extractables (Leachability) .
. Finished Lens Parameters
Light Transmittance .
. Refractive Index
. Water Content
Shelf-life .
. Mechanical Properties Comparative Testing
Specific Gravity Comparative Testing
Physical Compatibility Test with Contact Lens Care Solution and Packaging . Solution

The results of the non-clinical testing demonstrated that the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device.

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9. Substantial Equivalence Determination

The information presented in this submission establishes the substantial equivalence of the subject device "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear" to predicate devices. The following table summarized the substantial equivalence comparison information.

	Subject Device	K143052		Subject Device	K143052
Device Name	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic)Contact Lens for Daily Wear	Eye Secret 38 UV Aspheric Color(polymacon) Soft (hydrophilic) ContactLens for Daily Wear	Device Name	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilic)Contact Lens for Daily Wear	Eye Secret 38 UV Aspheric Color(polymacon) Soft (hydrophilic) ContactLens for Daily Wear
Intended Use	The Eye Secret 38 UV is indicatedfor the correction of refractiveametropia (myopia) in aphakic andnot-aphakic persons withnon-diseased eyes. The lenses maybe worn by person who exhibitastigmatism of 2.00 diopters or lessthat does not interfere with visualacuity. The Eye Secret 38 UV helpsprotect against transmission ofharmful UV radiation to the corneaand into the eye. The eye careprofessionals may prescribe thelens for single use daily disposableor daily wear in a FrequentReplacement Program. Asprescribed for plannedreplacement, the lens should bedisinfected using a chemical orhydrogen peroxide disinfectingsystems.	The Eye Secret 38 UV Color is indicatedfor the correction of ametropia(myopia) in aphakic and not-aphakicpersons with non-diseased eyes. Thelenses may be worn by persons whoexhibit astigmatism of 2.00 diopters orless that does not interfere with visualacuity. Eye Secret 38 UV Color helpsprotect against transmission ofharmful UV radiation to the corneaand into the eye. For Eye Secret 38 UVColor, the eye care professionals mayprescribe the lens for single use dailydisposable or daily wear in a FrequentReplacement Program. As prescribedfor planned replacement, the lensshould be disinfected using a chemicalor hydrogen peroxide disinfectingsystems.	UV-A	< 50 %	< 50 %
Material	Polymacon	Polymacon	UV-B	< 5 %	< 5 %
ManufacturingMethod	Cast Molded	Cast Molded	RefractiveIndex	1.440 (± 0.005 nd)	1.440 (± 0.005 nd)
Water Content	38 %	38 %	Base Curve	7.85 ~ 10.00 (± 0.2 mm)	8.60 (± 0.20 mm)
Powers	-0.50 D ~ -20.00 D	-0.00 ~ -20.00 D	Diameter	12.00 ~ 15.00 (± 0.2 mm)	14.00 (± 0.20 mm)
LightTransmittance	95 % (± 5 %)	95 % (± 5 %)	Tint	C.I. Reactive Blue #4 for handlingpurpose	C.I. Reactive Blue #4 for handlingpurpose and printed with anintermittent coating a combination ofthe following approved pigments:Copper Phthalocyanine, Reactive Black5, Iron Oxide, Titanium Dioxide,Carbazole Violet and D&C Yellow No.10.
Packagingsolution	Phosphate buffered saline solutioncontaining sodium hyaluronate andtrehalose	Phosphate buffered saline solutioncontaining sodium hyaluronate andtrehalose

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

10. Conclusion

After analyzing the bench tests and safety testing data, it can be concluded that the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device.

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.