The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only 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 care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens 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 0.01 % sodium hyaluronate and 0.1 % trehalose wetting agents.

AI/ML Overview

The document provided describes the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens and its substantial equivalence to a predicate device, K132854. The submission focuses on non-clinical testing to demonstrate safety and effectiveness.

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 "Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens" are established by demonstrating equivalence to the predicate device, "Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854)." Performance is shown through comparative testing against the predicate's established characteristics.

Test Item / Characteristic	Acceptance Criteria (Predicate Device K132854)	Reported Device Performance (Eye Secret 38 UV 1-Day)
Material	Polymacon	Polymacon
Manufacturing Method	Cast molding	Cast molding
Water Content	38 %	38 %
Powers	-0.50 D ~ -12.00 D	-0.50 D ~ -20.00 D
Light Transmittance (Overall)	95 ± 5 %	95 ± 5 %
UV-A Transmittance	< 50 %	< 50 %
UV-B Transmittance	< 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 ± 0.20 mm
Diameter	14.00 ± 0.20 mm	12.00 ~ 15.00 ± 0.20 mm
Center Thickness	0.044 ~ 0.131 mm (varies with power)	0.060 ± 0.020 mm
Tint	C.I. Reactive Blue No. 4	C.I. Reactive Blue No. 4
Toxicity (Acute Systemic Injection)	Meets requirements of systemic injection test (non-toxic)	Meets requirements of the systemic injection test and is considered non-toxic.
Toxicity (White Rabbit Ocular Irritation)	No ocular irritation	Produced no ocular irritation.
Toxicity (Cytotoxicity)	Meets requirements of ISO 10993-5	Meets the requirements of ISO 10993-5.
Extractables (Leachability)	- (Tested to demonstrate safety)	Performed (demonstrated safety)
Finished Lens Parameters	- (Tested to demonstrate safety/effectiveness)	Performed (demonstrated safety/effectiveness)
Shelf-life	- (Tested to demonstrate safety/effectiveness)	Performed (demonstrated safety/effectiveness)
Mechanical Properties	- (Comparative testing performed)	Performed (demonstrated equivalence)
Specific Gravity	- (Comparative testing performed)	Performed (demonstrated equivalence)
Physical Compatibility with Solutions	- (Tested to demonstrate safety/effectiveness)	Performed (demonstrated safety/effectiveness)

Note: For the test items without specific numerical acceptance criteria in the predicate column, the acceptance criterion is that the new device's performance is demonstrated to be equivalent or safe and effective, as required for a 510(k) submission.

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

The document does not specify exact sample sizes for each non-clinical test. It states that "A series of preclinical testing were performed" and lists the types of tests. These tests are generally conducted on a representative sample of the devices.

The data provenance is Taiwan, as the manufacturer is based in Taichung City, Taiwan, and the tests were performed to support the 510(k) submission for the US market. The study is considered prospective for the new device's testing, as samples of the new device were specifically tested according to recommended FDA guidelines.

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

This information is not provided in the document. The studies performed are non-clinical (bench testing and biological safety tests) and do not typically involve human experts establishing a "ground truth" in the same way clinical studies for AI models do. Compliance with standards and regulatory requirements is typically assessed by designated test personnel and internal/external auditors.

4. Adjudication Method for the Test Set

This information is not applicable as the studies are non-clinical tests measuring physical parameters and biological responses, not expert review or diagnostic performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This document describes the submission of a contact lens, which is a physical medical device, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is a contact lens and does not involve an algorithm or AI. All the testing performed can be considered "standalone" in the sense that it's the performance of the device itself being measured, without human-in-the-loop interaction in the context of an AI system.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is established by:

Established Test Methods and Standards: e.g., ISO 10993-5 for cytotoxicity.
Predicate Device Specifications: physical parameters are compared directly to the known specifications of the legally marketed predicate device.
Regulatory Guidance: The tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical contact lens, not an AI model, so there is no concept of a "training set" in this context.

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

This question is not applicable for the same reasons as #8.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is an abstract image of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the most prominent.

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

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

Re: K143190

Trade/Device Name: Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 17, 2014 Received: November 19, 2014

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. 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

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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/ResourcesforYou/Industry/default.htm. 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

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 -S

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) K143190

Device Name

Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens

Indications for Use (Describe)

The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is indicated for daily wear single use only for the corrective 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 care professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal: Therefore no cleaning or disinfecting is required. The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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

× Prescription Use (Part 21 CFR 801 Subpart D)

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

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Yung Sheng Optical Co., Ltd. 510(k) Notification

Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens

510(k) Summary

K143190

5.1 Type of Submission: Traditional

	5.2 Submitter:	Yung Sheng Optical Co., Ltd.
	Address:	3F-1, No.6, Jhongke Road, Daya District, Taichung
		City 42881 Taiwan
	Manufacturer	No.8, Keya 2nd Road, Daya District, Taichung City
	Address	42881, Taiwan
	Phone:	(04) 25658384 #156 / 157
	Fax:	(04) 25658387
Contact:		Wen-Han Chen / Tsung-Jen Yeh
	Establishment Registration Number:	N/A
	Date Prepared	December 05, 2014

5.3 Identification of the Device:

Proprietary/Trade name:	Eye Secret 38 UV Aspheric (polymacon)1-Day Soft (hydrophilic) Contact Lens
Common Name:	Contact Lens
Classification Name:	Lenses, Soft Contact, Daily Wear
Device Classification:	II
Regulation Number:	21 CFR 886.5925 (b) (1)
Panel:	Ophthalmic
Product Code:	LPL for Lenses, Soft Contact, Daily WearMVN for Lenses, Soft Contact (Disposable)

5.4 Identification of the Predicate Device:

Predicate Device Name:	Eye Secret 38 UV Aspheric (polymacon)Soft (hydrophilic) Contact Lens for DailyWear
Manufacturer:	Yung Sheng Optical Co., Ltd.
510(k) Number or Clearance Information:	K132854

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

5.6 Device Description

The purpose of this 510(k) Notification is to notify the FDA of the new device, intended for commercial distribution by Yung Sheng Optical Co., Ltd. under the trade name of Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens.

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5.7 Summary of Clinical Study

Polymacon lenses have been used widely. Its safety and effectiveness have been well documented and cleared by FDA. Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854) submitted by Yung Sheng Optical Co., Ltd. is an example.

Clinical study for Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens is not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.

5.8 Non-clinical Testing

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens are equivalent to the Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854). 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

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Yung Sheng Optical Co., Ltd. 510(k) Notification

. 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) 1-Day Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate device.

5.9 Substantial Equivalence Determination

The Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens submitted in this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear which is the subject of K132854. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Comparison Table
Eye Secret 38 UV 1-Dayltem		Predicated Device (K132854)
	EyeSecret38UVAspheric	SecretအရှUVAsphericEye
Product Name	(polymacon) 1-Day Soft (hydrophilic)	Soft(polymacon)(hydrophilic)
	Contact Lens	Contact Lens for Daily Wear
Regulatory
Number	886.5925	886.5925
Classification	ll	ll
	Eye Secret 38 UV AsphericThe	The Eye Secret 38 UV Aspheric
	(polymacon) 1-Day Soft (hydrophilic)	(polymacon)Soft(hydrophilic)
	Contact Lens is indicated for daily	Contact Lensfor DailyWear is
	use only for thewear single	indicated fordaily wear for the
	correction of refractive ametropia	correction of refractive ametropia
Intended Use	(myopia) in aphakic and not-aphakic	(myopia) in aphakic and not-aphakic
	persons with non-diseased eyes.	persons with non-diseased eyes.
	The lenses may be worn by person	The lenses may be worn by person
	who exhibit astigmatism of 2.00	who exhibit astigmatism of 2.00
	diopters or less that does not	diopters or less that does not
	interfere with visual acuity.	interfere with visual acuity.

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Yung Sheng Optical Co., Ltd. 510(k) Notification

Comparison Table
Item	Eye Secret 38 UV 1-Day	Predicated Device (K132854)
Prescription Use	Yes	Yes
Material	Polymacon	Polymacon
ManufacturingMethod	Cast molding	Cast molding
Water Content	38 %	38 %
Powers	-0.50 D ~ -20.00 D	-0.50 D ~ -12.00 D
LightTransmittance	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	7.85 ~ 10.00 ± 0.20 mm	8.60 ± 0.20 mm
Diameter	12.00 ~ 15.00 ± 0.20 mm	14.00 ± 0.20 mm
Center Thickness	0.060 ± 0.020 mm	0.044 ~ 0.131 mm(varies with power)
Tint	C.I. Reactive Blue No. 4	C.I. Reactive Blue No. 4

5.10 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that the Eye Secret 38 UV Aspheric (polymacon) 1-Day Soft (hydrophilic) Contact Lens 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.