The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are indicated for the correction of 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 that does not interfere with visual acuity.

For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, 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 Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are 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 from edge to edge for visibility purposes with the color additive C.I. Reactive Blue No. 4 and printed with an intermittent coating containing a combination of the following approved pigments: Copper Phthalocyanine, Reactive Black 5, Iron Oxide, Titanium Dioxide, Carbazole Violet and D&C Yellow No. 10. 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 provided text details a 510(k) premarket notification for new contact lenses, asserting their substantial equivalence to a legally marketed predicate device. This type of submission focuses on demonstrating equivalence rather than establishing de novo safety and effectiveness through extensive clinical trials. Therefore, the information typically requested in your prompt regarding acceptance criteria, study details, expert involvement, and specific performance metrics like sensitivity, specificity, and reader studies is not explicitly available in this document.

However, I can extract the closest available information related to the device's characteristics and the non-clinical testing performed to support its substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly based on demonstrating similar performance and characteristics to the predicate device (Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, K132854). The "reported device performance" are the characteristics of the new devices.

Characteristic	Acceptance Criteria (Implied: Similar to predicate K132854)	Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear Performance	Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens Performance
Regulatory Number	886.5925	886.5925	886.5925
Classification	II	II	II
Intended Use	Same as predicate	The same	The same
Prescription Use	Yes	Yes	Yes
Material	polymacon	polymacon	polymacon
Manufacturing Method	Cast Molded	Cast Molded	Cast Molded
Water Content	38 %	38 %	38 %
Powers	-0.50 D ~ -12.00 D (predicate)	-0.00 D ~ -20.00 D	-0.00 D ~ -20.00 D
Light Transmittance	95 % ± 5 %	95 % ± 5 %	95 % ± 5 %
UV-A	< 50 %	< 50 %	< 50 %
UV-B	< 5 %	< 5 %	< 5 %
Refractive Index	1.440 ± 0.005 nd	1.440 ± 0.005 nd	1.440 ± 0.005 nd
Base Curve	8.6 ± 0.2mm (predicate)	8.6 ± 0.2 mm	8.7 ± 0.2 mm
Diameter	14.0 ± 0.2mm	14.0 ± 0.2 mm	14.0 ± 0.2 mm
Center Thickness	0.08 mm to 0.11 mm (predicate, varies with power)	0.06 mm to 0.11 mm (varies with power)	0.06 ± 0.02 mm
Toxicity	Non-toxic	Meets requirements; non-toxic	Meets requirements; non-toxic
Ocular Irritation	No ocular irritation	Produced no ocular irritation	Produced no ocular irritation
Cytotoxicity	Meets ISO 10993-5	Meets ISO 10993-5	Meets ISO 10993-5

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical or AI performance evaluation. The "testing" referred to is primarily non-clinical bench testing. For these tests:

Sample size: Not explicitly stated for each non-clinical test (e.g., how many lenses were used for extractables or mechanical properties).
Data provenance: Taiwan (Yung Sheng Optical Co., Ltd., based in Taichung City, Taiwan). The tests were conducted to demonstrate equivalence to a predicate device already cleared by FDA, suggesting the data originates from the manufacturer's testing facilities or contracted labs. These are likely retrospective in the sense that they are conducted on manufactured samples, not as part of a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The submission is for contact lenses, and the "ground truth" for non-clinical tests (e.g., material properties, toxicity) is established by standard scientific and regulatory methods, not by expert consensus in a diagnostic sense.

4. Adjudication method for the test set

Not applicable. There is no diagnostic "test set" requiring adjudication by experts.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a contact lens, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used

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

Standardized methods and accepted thresholds: For tests like toxicity (systemic injection, ocular irritation, cytotoxicity based on ISO 10993-5), accepted biological responses or lack thereof served as the ground truth.
Physical and chemical specifications: For parameters like water content, refractive index, light transmittance, and dimensions, the ground truth is the measured value and its adherence to pre-defined specifications (often mirroring the predicate device's specifications).

8. The sample size for the training set

Not applicable. There is no AI component requiring a training set.

9. How the ground truth for the training set was established

Not applicable.

Summary

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

December 16, 2014

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: K143052

Trade/Device Name: 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 Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: October 15, 2014 Received: October 23, 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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) K143052

Device Name

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

Indications for Use (Describe)

For Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, 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 disinfected using a chemical or hydrogen peroxide disinfecting systems.

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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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

510(k) Summary

5.1 Type of Submission: Traditional

5.2	Submitter:	Yung Sheng Optical Co., Ltd.
	Address:	3F-1, No.6, Jhongke Road, Daya District, TaichungCity 42881 Taiwan
	Manufacturer	No.8, Keya 2nd Road, Daya District, Taichung City
	Address	42881, Taiwan
	Phone:	(04) 25658384 #156g157
	Fax:	(04) 25658387
	Contact:	Wen-Han Chen / Tsung-Jen Yeh
	Establishment Registration Number:	N/A
	Date Prepared	November 17, 2014

Identification of the Device: 5.3

Proprietary/Tradename:	Eye Secret 38 UV Aspheric Color (polymaconSoft (hydrophilic) Contact Lens for Daily WearEye Secret 38 UV Aspheric Color (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 Lens, 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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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

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

5.6 Device Description

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are 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.

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5.7 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 (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear (K132854) submitted by Yung Sheng Optical Co., Ltd. is an example.

Clinical studies for the Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are 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 Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (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 Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (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:

No 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.

Ni Extractables

Ni Finished Lens Parameters

Ng Light Transmittance

Ni Refractive Index

Ni Water Content

Ng Shelf-life

Ng Mechanical Properties Comparative Testing

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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

No Specific Gravity Comparative Testing

Ni 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 Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens are substantially equivalent to the predicate device.

5.9 Substantial Equivalence Determination

The Eye Secret 38 UV Aspheric Color (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear and Eye Secret 38 UV Aspheric Color (polymacon) 1-Day Soft (hydrophilic) Contact Lens submitted in this 510(k) file are substantially equivalent in intended use, 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.

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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

Comparison Table
Item	Eye Secret 38 Color	Eye Secret 38 Color 1-Day	Predicate Device (K132854)
Product Name	Eye Secret 38 UV AsphericColor (polymacon) Soft(hydrophilic) Contact Lens forDaily Wear	Eye Secret 38 UV AsphericColor (polymacon) 1-Day Soft(hydrophilic) Contact Lens	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilicContact Lens for Daily Wear
Regulatory Number	886.5925	886.5925	886.5925
Classification	II	II	II
Intended Use	The same	The same	Eye Secret 38 UV Aspheric(polymacon) Soft (hydrophilicContact Lens for Daily Wear isindicated for daily wear forthe correction of refractiveametropia (myopia) in aphakicand not-aphakic persons withnon-diseased eyes. The lensesmay be worn by person whoexhibit astigmatism of 2.00diopters or less that does notinterfere with visual acuity.
Prescription Use	Yes	Yes	Yes
Material	polymacon	polymacon	polymacon
ManufacturingMethod	Cast Molded	Cast Molded	Cast Molded
Water Content	38 %	38 %	38 %
Powers	-0.00 D ~ -20.00 D	-0.00 D ~ -20.00 D	-0.50 D ~ -12.00 D
Light Transmittance	95 % ± 5 %	95 % ± 5 %	95 % ± 5 %
UV-A	< 50 %	< 50 %	< 50 %
UV-B	< 5 %	< 5 %	< 5 %
Refractive Index	1.440 ± 0.005 nd	1.440 ± 0.005 nd	1.440 ± 0.005 nd
Base Curve	8.6 ± 0.2 mm	8.7 ± 0.2 mm	8.6 ± 0.2mm
Diameter	14.0 ± 0.2 mm	14.0 ± 0.2 mm	14.0 ± 0.2mm
Center Thickness	0.06 mm to 0.11 mm(varies with power)	0.06 ± 0.02 mm	0.08 mm to 0.11 mm(varies with power)

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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

5.10 Conclusion

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