The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Eye Care professionals may prescribe the lens for 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 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is manufactured by using advanced cast molding method. The lens material, methafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA) 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 280~315 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.

AI/ML Overview

The provided 510(k) summary (K133735) describes the "Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) Contact Lens." This device is a contact lens, and its acceptance criteria and the study proving it meets these criteria are established through a demonstration of substantial equivalence to a predicate device, the "SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear" (K013649).

The approval is based on non-clinical testing rather than a clinical study or AI performance evaluation. The review relies on the inherent equivalence of the new device to a previously approved one.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the characteristics of the predicate device, K013649. The new device demonstrates performance that is either identical or within acceptable limits of the predicate.

Characteristic	Acceptance Criteria (Predicate Device K013649 Performance)	Reported Device Performance (Eye Secret 55 UV Aspheric)
Classification	886.5925 (Class II)	886.5925 (Class II)
Intended Use	Correction of ametropia (myopia and hyperopia) and astigmatism up to 2.00 Dioptres for daily wear.	Correction of ametropia (myopia) with astigmatism up to 2.00 Dioptres for daily wear. (Slight difference in 'hyperopia' indicated, but still considered substantially equivalent)
Prescription Use	Yes	Yes
Material	Methafilcon A	Methafilcon A
Manufacturing Method	Cast Molded	Cast Molded
Water Content	55%	55%
Dk (Oxygen Permeability)	22.0 x 10^-11 (cm²/sec) (mlO₂/ml x mmHg)	22.0 x 10^-11 (cm²/sec) (mlO₂/ml x mmHg)
Powers	± 20.00D	0 ~ -12.00 D (Accepted range, though predicate has wider)
Light Transmittance	94.61%	95% ± 5%
UV-A Blockage	36.00%	< 50%
UV-B Blockage	9.41%	< 5%
Refractive Index	1.402	1.409
Base Curve	8.40mm ~ 9.30mm	8.4 mm ~ 8.8 mm (Accepted range, though predicate has wider)
Diameter	14.0mm ~ 15.0mm	14.0 mm ~ 14.4 mm (Accepted range, though predicate has wider)
Tint	Reactive Blue No. 4	C.I. Reactive Blue #4

Note: The differences in 'Powers', 'Light Transmittance', 'UV-A', 'UV-B', 'Refractive Index', 'Base Curve', and 'Diameter' were deemed acceptable for substantial equivalence. For instance, the new device specifies '<5%' for UV-B blockage, while the predicate is 9.41%. This indicates the new device has better UV-B blocking, which is not a safety concern.

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

No specific "test set" in the context of clinical data for AI evaluation is mentioned. The device's substantial equivalence is established through non-clinical testing, which included:

Toxicity (Acute Systemic Injection Study, White Rabbit Ocular Irritation Test, Cytotoxicity Test)
Extractables (Leachability)
Finished Lens Parameters
Light Transmittance
Refractive Index
Water Content
Oxygen Permeability
pH and Osmolality Test
Shelf-life
Mechanical Comparative Testing

No details are provided on the sample sizes for these specific non-clinical tests (e.g., number of lenses tested for parameters, number of animals in toxicity studies), nor is there information on data provenance in terms of country of origin or whether it was retrospective/prospective, as this is typically not relevant for bench testing.

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

Not applicable. The ground truth for proving the device meets acceptance criteria is based on established scientific and engineering principles for material characterization and biocompatibility, as outlined in FDA guidance for contact lenses. There were no human experts establishing ground truth for a test set in the context of AI or clinical evaluation.

4. Adjudication Method for the Test Set

Not applicable, as no human-adjudicated test set was used.

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 and does not involve AI or human readers for diagnostic interpretation. The evaluation is for physical, chemical, and biological compatibility properties.

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

Not applicable. This device does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the non-clinical tests is based on:

Established ASTM/ISO standards and validated testing methodologies for material properties (e.g., water content, Dk, light transmittance, refractive index, pH, osmolality, mechanical properties).
Biocompatibility standards (e.g., ISO 10993-5 for cytotoxicity, and standard animal models for systemic injection and ocular irritation) to demonstrate safety.
Comparison to the legally marketed predicate device (K013649), which has already established its safety and effectiveness based on similar ground truths.

8. The sample size for the training set

Not applicable. This device does not involve a training set as it is not an AI or machine learning device.

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

Not applicable, as there is no training set for this device.

Summary

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MAR 2 1 2014

510(k) Summary

1	Type of Submission:	Traditional
2	Orginal SubmissionDate:	2013/11/29
3	Submitter:	Yung Sheng Optical Co., Ltd.
	Address:	3F-1, No.6, Jhongke Road, Daya District, Taichung City42881 Taiwan
	Manufacturer Address	No.8, Keya 2nd Road, Daya District, Taichung City 42881,Taiwan
	Phone:	+886-4-25658384 #156
	Fax:	+886-4-25658387
	Contact:	Wen-Han Chen
	Establishment Registration Number:	N/A

4 Identification of the Device:

Proprietary/Trade name:	Eye Secret 55 UV Aspheric (methafilcon A) Soft
	(hydrophilic) Contact Lens
Common Name:	Contact Lens
Classification Name:	Soft (Hydrophilic) Contact Lens (daily wear)
Device Classification:	II
Regulation Number:	886.5925
Panel:	Ophthalmic
Product Code:	LPL
Subsequent Product Code:	MVN

5 Identification of the Predicate Device:

Predicate Device Name:	SAUFLON 55 UV (methafilcon A) Soft
	(Hydrophilic) Visibility Tinted Contact
	Lens for Daily Wear
Manufacturer:	Sauflon Pharmaceuticals Ltd.
510(k) Number:	K013649

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Intended Use and Indications for Use of the subject device. 6

7 Device Description

8 Summary of Clinical Study

Methafilcon A lenses have been used widely. Its safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by the lenses cleared by FDA.

SAUFLON 55 UV (Methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear. K013649 submitted by Sauflon Pharmaceuticals Ltd.

Clinical study for Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact Lens is not required for the premarket notification as the USAN name and process are the same as above mentioned predicated device.

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9 Non-clinical Testing

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens. The results of all testing demonstrated that the safety and effectiveness of the Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens are equivalent to the SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear (K013649). 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 .
Oxygen Permeability .
pH and Osmolality Test .
. Shelf-life
Mechanical Comparative Testing

In addition to biocompatible tests, shelf-life, physical compatibility test of contact lens care solution, mechanical comparative testing and the comparative tests of the performance tests mentioned above are provided.

The results of the non-clinical testing demonstrate that the Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is substantially equivalent to the predicate devices.

10 Substantial Equivalence Determination

The Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens submitted in

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this 510(k) file is substantially equivalent in intended use, design, technology/principles of operation, materials and performance to the cleared SAUFLON 55 UV (methafilcon A) Soft (Hydrophilic) Visibility Tinted Contact Lens for Daily Wear which is the subject of K013649. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

Item
Regulatory Number	Eye Secret 55 UV Aspheric(methafilcon A) Soft (hydrophilic)contact lens	Predicate Device (K013649)SAUFLON 55 UV (methafilcon A)Soft (Hydrophilic) Visibility TintedContact Lens for Daily Wear
Classification	886.5925	886.5925
Intended Use	IIThe Eye Secret 55 UV Aspheric(Methafilcon A) Soft (Hydrophilic)Contact lenses are indicated for thecorrection of ametropia (myopia) inaphakic and non-aphakic personswith non-diseased eyes in powersfrom 0.00 to -12.00 diopters. Thelenses may be worn by persons whoexhibit astigmatism of 2.00 dioptersor less that does not interfere withvisual acuity.Eye Care professionals mayprescribe the lens for dailydisposable or daily wear in aFrequent Replacement Program. Asprescribed for planned replacement,the lens should be disinfected using achemical or hydrogen peroxidedisinfecting systems.	IIThe Sauflon 55 UV soft(hydrophilic) contact lens isindicated for daily wear for thecorrection of the refractiveametropia (myopia and hyperopia)and astigmatism in aphakic andnot-aphakic persons withnon-diseased eyes that may exhibitastigmatism up to 2.00 Dioptres thatdoes not interfere with visualacuity. Eyecare Practitioners mayprescribe the lens for daily wear in aFrequent Replacement Program.The lenses may be disinfected usingchemical or hydrogen peroxidedisinfection systems.
Prescription Use	Yes	Yes
Material	Methafilcon A	Methafilcon A
ManufacturingMethod	Cast Molded	Cast Molded
Water Content	55%	55%
Dk	22.0 x 10-11 (cm²/sec) (mlO₂/ml xmmHg)	22.0 x 10-11 (cm²/sec) (mlO₂/ml xmmHg)
Powers	0 ~ -12.00 D	± 20.00D
Light Transmittance	95% ± 5%	94.61%
UV-A	< 50%	36.00%

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UV-B	< 5%	9.41%
Refractive Index	1.409	1.402
Base Curve	8.4 mm ~ 8.8 mm	8.40mm ~ 9.30mm
Diameter	14.0 mm ~ 14.4 mm	14.0mm ~ 15.0mm
Tint	C.I. Reactive Blue #4	Reactive Blue No. 4

11 Conclusion

After analyzing bench tests, safety testing data, it can be concluded that Eye Secret 55 UV Aspheric (methafilcon A) Soft (hydrophilic) contact lens is substantially equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with outstretched arms, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the figure. The logo is black and white.

March 21, 2014

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Mr. Wen-Han Chen, Director of Regulatory Affairs Division Yung Sheng Optical Co., 3F-1, NO. 6, Jhongke Road, Daya District, Taichung City 42881, Taiwan

Re: K133735

Trade/Device Name: Eye Secret 55 UV Aspheric (methafilcon A) 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: December 23, 2013 Received: December 27, 2013

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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Page 2 - Mr. Wen-Han Chen

You must comply with all the Act's requirements, including, but not limited to: Registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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 B. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

510(k) Number (if known) K133735

Device Name

he Eye Secret 55 UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses

Indications for Use (Describe)

The Eye Secret SS UV Aspheric (Methafilcon A) Soft (Hydrophilic) Contact lenses are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from 0.00 to -12.00 diopters. The lenses may be wom by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

Eve Care professionals may prescribe the lens for 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)

[x] Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

. . . . . . . . . . . . . . . . . . . . . . . . ' FOR FDA USE ONLY ... :

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Leonid Livshitz -S 2014.02.19 10:14:43 -05'00'

FORM FDA 3881 (1/14)

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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

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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.