Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

• K Number: K151586
• Device Name: Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens
• Manufacturer: YUNG SHENG OPTICAL CO., LTD.
• Date Cleared: 2015-08-10 ( 60 days)
• Product Code: LPL MVN
• Regulation Number: 886.5925

Intended Use

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using 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 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.

Predicate Devices

K133735

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard contact lens and its physical properties and testing, with no mention of AI or ML.

Therapeutic

No
The device is indicated for the correction of refractive ametropia (myopia) and protection against UV radiation, which are not considered therapeutic purposes.

Diagnostic

No

This device is a contact lens designed to correct refractive ametropia and protect against UV radiation. Its primary function is therapeutic/corrective, not diagnostic, as it does not gather or analyze data to identify a medical condition.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a physical contact lens made of Methafilcon A, a material, and is manufactured using a cast molding method. It is a tangible, physical medical device, not software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
• Device Function: The Eye Secret 55 UV Aspheric Contact Lens is a device that is placed on the eye (in vivo) to correct vision and provide UV protection. It does not perform any diagnostic tests on bodily samples.

The provided text clearly describes a contact lens intended for vision correction and UV protection, which falls under the category of medical devices but not specifically In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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.

Product codes

LPL, MVN

Device Description

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using 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 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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Cornea and into the eye

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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens. The results of all testing demonstrated that the safety and effectiveness of the subject device are equivalent to the predicate device, Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K133735). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994:

• · Toxicity
  • 1. Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
  • 2. White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
  • 3. 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 .
• . Physical Compatibility Test with Contact Lens Care Solution and Packaging Solution

The results of the non-clinical testing demonstrated that the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate device.

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

Not Found

Predicate Device(s)

K133735

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

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

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

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

August 10, 2015

Yung Sheng Optical Co., Ltd. Mr. Wen-Han Chen RA Supervisor 3f-1, No. 6, Jhongke Road, Daya District Taichung City, TW 42881

Re: K151586

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: June 9, 2015 Received: June 11, 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.

1

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 801and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Kesia Y. Alexander -A

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

2

Indications for Use

510(k) Number (if known)

K151586

Device Name

Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens

Indications for Use (Describe)

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 disintected 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)

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510(k) Summary

• Traditional 510(k) 1. Type of Submission:

2.	Submitter:	Yung Sheng Optical Co., Ltd.
	Address:	3F-1, No.6, Jhongke Road, Daya District, Taichung
City 42881 Taiwan
	Manufacturing
facility:	No.8, Keya 2nd Road, Daya District, Taichung City
42881, Taiwan
	Phone:	[phone] #156 、 191
	Fax:	[phone]
	Contact:	Wen-Han Chen / Che-Yu Shen
	Date prepared:	May 29, 2015
	Establishment Registration Number:	3004021238

3. Identification of the Device

| Proprietary/Trade
name: | Eye Secret 55 UV Aspheric (Methafilcon A)
Soft (hydrophilic) Contact Lens | |
|----------------------------|------------------------------------------------------------------------------|--|
| 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 Name: | Eye Secret 55 UV Aspheric (Methafilcon A) Soft
(hydrophilic) Contact Lens |
|-----------------------------------------|------------------------------------------------------------------------------|
| Manufacturer: | Yung Sheng Optical Co., Ltd. |
| 510(k) Number or Clearance Information: | K133735 |

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

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

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens 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.

6. Device Description

The Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is manufactured by using 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 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.

7. Summary of Clinical Study

Methafilcon A lenses have been used widely. Their safety and effectiveness have been well documented and cleared by FDA "Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K133735)" submitted by Yung Sheng Optical Co., Ltd. is an example.

5

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

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 device.

8. 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 subject device are equivalent to the predicate device, Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (K133735). The following tests were conducted as recommended by the FDA Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, 1994:

• · Toxicity
  • 1. Acute Systemic Injection Study: The lens material meets the requirements of the systemic injection test and is considered non-toxic.
  • 2. White Rabbit Ocular Irritation Test: Ocular irritation test was performed and produced no ocular irritation.
  • 3. 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 .
• . Physical Compatibility Test with Contact Lens Care Solution and Packaging Solution

The results of the non-clinical testing demonstrated that the Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens is substantially equivalent to the predicate device.

6

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

9. Substantial Equivalence Determination

The information presented in this submission establishes the substantial equivalence of the subject device "Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens" to the predicate device. The following table summarized the substantial equivalence comparison information.

	Subject Device	K133735
Device Name	Eye Secret 55 UV Aspheric
(Methafilcon A) Soft (hydrophilic)
Contact Lens	Eye Secret 55 UV Aspheric
(Methafilcon A) Soft (hydrophilic)
Contact Lens
Intended Use	The Eye Secret 55 UV Aspheric
(Methafilcon A) Soft (hydrophilic)
Contact Lens 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 55 UV
Aspheric (Methafilcon A) Soft
(hydrophilic) Contact Lens 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.	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.
Material	Methafilcon A	Methafilcon A
Manufacturing
Method	Cast Molded	Cast Molded
Water Content	55 %	55 %
	Subject Device	K133735
Device Name	Eye Secret 55 UV Aspheric
(Methafilcon A) Soft (hydrophilic)
Contact Lens	Eye Secret 55 UV Aspheric
(Methafilcon A) Soft (hydrophilic)
Contact Lens
Powers	-0.50 D ~ -20.00 D	-0.00 ~ -12.00 D
Light
Transmittance	95 % (± 5 %)	95 % (± 5 %)
UV-A