K Number

Device Name

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Manufacturer

Yung Sheng Optical Co., Ltd

Date Cleared

2022-09-02

(256 days)

Product Code

LPL MVN

Regulation Number

886.5925

Intended Use

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia) in aphakic and not-aphakic persons with nondiseased 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. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Device Description

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is hydrophilic available with aspheric design manufactured by using Cast Molding method. The soft contact lens material, Omafilcon A, is a random copolymer of 2-hydroxyethyl methacrylate (HEMA) and 2-Methacryloyloxyethyl phosphoryIcholine (MPC) crosslinked with ethylene glycol dimethacrylate (EDGMA), and has 59% water by weight. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. Thus, the lens helps protect against the transmission of harmful UV radiation to the cornea and into the eye. The transmittance characteristics are less than 5 % in the UVB range of 280 nm to 315 nm and less than 50 % in the UVA range of 316 nm to 380 nm. The lenses are tinted from edge to edge for visibility purposes with the color additive Reactive Blue 246. The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye. 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 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K061948, K162223

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a physical contact lens and its material properties, with no mention of software, algorithms, or AI/ML capabilities.

Therapeutic

No
This device is primarily indicated for correcting refractive errors (myopia or hyperopia) and blocking UV radiation, not for treating a disease or therapeutic condition.

Diagnostic

This device is a soft (hydrophilic) contact lens indicated for daily wear to correct refractive ametropia (myopia or hyperopia), not for diagnosing medical conditions.

SaMD (Software as a Medical Device)

The device is a physical contact lens made of a specific material, not a software program. The description details its physical properties, manufacturing method, and testing related to material characteristics and biocompatibility.

IVD (In Vitro Diagnostic)

Based on the provided text, the Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear is not an In Vitro Diagnostic (IVD) device.

Here's why:

Intended Use: The intended use is for the correction of refractive ametropia (myopia or hyperopia) and protection against UV radiation. This is a therapeutic and protective function, not a diagnostic one.
Device Description: The description focuses on the physical properties of the contact lens material and its design for vision correction and UV blocking. It does not describe any components or functions related to testing or analyzing samples from the human body.
Lack of Diagnostic Function: The device does not perform any tests on biological samples (like blood, urine, or tissue) to diagnose a disease or condition. It is a medical device used to alter the optical properties of the eye and provide UV protection.

IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This contact lens does not fit that definition.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The eye care professionals may prescribe the lens for single use daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

Product codes (comma separated list FDA assigned to the subject device)

LPL, MVN

Device Description

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

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 2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butylmethacrylate copolymer (PMB) wetting agent.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyes, cornea

Indicated Patient Age Range

Not Found

Intended User / Care Setting

eye care professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

A series of preclinical testing were performed to demonstrate the safety and effectiveness of the Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear.

Physiochemical Studies: Conducted according to ISO 18369-4:2017 and ISO 18369-3:2017. Tests include Finished Lens Parameters, Refractive Index, Light Transmittance, Water Content, Extractables (Leachability), Oxygen Permeability.
Mechanical Properties Testing.
Physical Compatibility Test with Packaging Solution.
Shelf-life.
Toxicology Studies: Reports show lenses are non-toxic and biocompatible. Tests include Cytotoxicity Test (ISO 10993-5), Ocular Irritation Test (ISO 10993-10), Acute Systemic Toxicity Test (ISO 10993-11), Skin Sensitization Test (ISO 10993-10) for the lens and packaging solution.
The results of the non-clinical testing demonstrated that the device met all specifications and is substantially equivalent to the safety and effectiveness of both predicate devices. No clinical studies were required.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K061948, K162223

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of the square.

September 2, 2022

Yung Sheng Optical Co., Ltd Wen-Han Chen RA Manager No. 8, Keya 2nd Road, Daya District Taichung City, 428 Taiwan

Re: K213983

Trade/Device Name: Eye Secret 59 UV Aspheric (Omafilcon A) 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: July 26, 2022 Received: July 26, 2022

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 (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 located 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.

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

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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-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, 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

Indications for Use

510(k) Number (if known) K213983

Device Name

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

510(k) Summary

1. Type of Submission: Traditional 510(k)

2. Submitter:	Yung Sheng Optical Co., Ltd.
Address:	No.8, Keya 2nd Rd., Daya District, Taichung City
	42881, Taiwan
Phone:	+886-4-25658384 Ext.3509
Fax:	+886-4-25658387
Contact:	Wen-Han Chen
Date prepared:	November 24, 2021
Establishment Registration Number:	3004021238

3. Identification of the Device

Proprietary/Trade name:	Eye Secret 59 UV Aspheric (Omafilcon A) 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)
510(k) Number:	K213983

4. ldentification of the Predicate Device

Predicate Device Name:	Proclear (omafilcon A) Daily Disposable/Daily Wear Soft Contact Lens
Manufacturer:	CooperVision Inc.
Product Code:	LPL for Lenses, Soft Contact, Daily Wear
MVN for Lens, Contact, (Disposable)
510(k) Number:	K061948
Predicate Device Name:	Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses
Manufacturer:	Supervision Optimax Sdn Bhd
Product Code:	LPL for Lenses, Soft Contact, Daily Wear
MVN for Lens, Contact, (Disposable)
510(k) Number:	K162223

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

The eye care professionals may prescribe the lens for single use daily disposable or daily wear in a Frequent Replacement Program. When prescribed for frequent/planned replacement, the lens should be disinfected using a chemical or hydrogen peroxide disinfecting systems.

6. Device Description

The Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

7. Characteristics of Substantial Equivalence

Material and Process comparison table
	Subject Device	Predicate device	Predicate device
Device Name	Eye Secret 59 UV Aspheric
(Omafilcon A) Soft (hydrophilic)
Contact Lens for Daily Wear	Proclear (omafilcon A) Daily
Disposable/Daily Wear Soft
Contact Lens	Aveo (omafilcon A) 1-Day
Aspheric Soft (Hydrophilic)
Contact Lenses
Manufacturer	Yung Sheng Optical Co., ltd	CooperVision, Inc.	Supervision Optimax Sdn Bhd
510(k) Number	This submission	K061948	K162223
FDA Category	Group II
Non-ionic
High water content	Group II
Non-ionic
High water content	Group II
Non-ionic
High water content
Product Code	LPL and MVN	LPL and MVN	LPL and MVN
Intended Use	The Eye Secret 59 UV Aspheric
(Omafilcon A) Soft (hydrophilic)
Contact Lens for Daily Wear is
indicated for daily wear 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.	Proclear (omafilcon A) Daily
Disposable/Daily Wear Soft
Contact Lens are indicated
for daily wear for the
correction of visual acuity in
not aphakic persons with
non-diseased eyes that are
myopic or hyperopic and
exhibit astigmatism of 2.00D
or less that does not
interfere with visual acuity.	Aveo (omafilcon A)1-Day
Aspheric Soft (Hydrophilic)
Contact Lenses are indicated
for daily wear for the
correction of visual acuity in
not aphakic persons with
non-diseased eyes that are
myopic orhyperopic and
exhibit astigmatism of 1.00D
or less that does not interfere
with visual acuity. The
contact lenses are intended
for daily wear, single use and
are to be discarded at the
end of the day.
Material
USAN Name	Omafilcon A	Omafilcon A	Omafilcon A
Manufacturing
Method	Cast Molded	Cast Molded	Cast Molded
Sterilization	Moist Heat (Steam) in Validated
Autoclave	Moist Heat (Steam) in
Validated Autoclave	Moist Heat (Steam) in
Validated Autoclave
Packaging	Blister pack	Blister pack	Blister pack
Water Content	$59 \pm 2$ %	$60 \pm 2$ %	$59 \pm 2$ %
Tint	Reactive Blue 246	Vat Blue 6	Reactive Blue 246
Packaging
solution	Phosphate buffered saline
solution containing 2-
(Methacryloyloxy) ethyl 2-
(trimethylammonio) ethyl
phosphate-n-
butylmethacrylate copolymer
wetting agent	Not Stated	Phosphate Buffered Saline

Material and Process Comparison Table
● Technological Characteristics Comparison Table

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

	Subject Device	Predicate device	Predicate device
Device Name	Eye Secret 59 UV Aspheric
(Omafilcon A) Soft (hydrophilic)
Contact Lens for Daily Wear	Proclear (omafilcon A) Daily
Disposable/Daily Wear Soft
Contact Lens	Aveo (omafilcon A) 1-Day
Aspheric Soft (Hydrophilic)
Contact Lenses
Base Curve	7.50 ~ 9.00 ± 0.20 mm	8.00 ~ 9.50 ± 0.20 mm	8.40 ~ 8.80 ± 0.20 mm
Diameter	12.0 ~ 15.0 ± 0.20 mm	13.0 ~ 15.5 ± 0.20 mm	14.0 ~ 14.4 ± 0.20 mm
Center Thickness	0.030 ~ 0.200 mm	0.035 ~ 0.960 mm	Not Stated
Refractive Index	1.390 ± 0.005 nd	1.400 ± 0.005 nd	1.4002 ± 0.005 nd
Oxygen
Permeability (Dk)
x 10-11 (cm²/sec) (ml
O2/ml x mmHg)	25 ± 20%	21.00 ± 20 %	25.68 ± 20 %
Light
Transmittance	95 ± 5 %	> 90%	98 %
UV-A