The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wcar for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive am etropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.

The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) the correction of refractive ametropia Contact Lens is indicated for daily wear for (myopia and hyperopia) and presbyopia in aphakic or or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.

The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye. The lenses are to be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The lens material (methafilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate, and using azobisisobutyronitrile (AIBN) as the initiator. A UV absorbing monomer, 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl] ethyl methacrylate, is incorporated into the lens polymer and used to block UV radiation. The UV blocker for Saview-Aqua 55 UV (methafilcon A) Visibility tinted Soft (Hydrophilic) Contact Lens averages 87.630 in the UVA range of 316 nm to 380 nm and 98.975 % in the UVB range of 315 % nm to 280 nm. The lens contains 55% water by weight and each lens is supplied sterile in a blister container containing 0.2 % hyaluronic acid polymer in saline solution. The lens is visibility tinted using Pigment Blue 15(Copper phthalocyanine) to make the lens more visible for handling.

The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.

The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available in a double slab-off back surface design. The lens design incorporates a cylinder and base curve. From the bi-curve reduced optic front surface, there exists a slab-off of the upper and lower half of the lens. This makes both sides thicker at the horizontal level on the front surface to keep the axis stable.

The Savicw-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Saview-Aqua 55 UV contact lenses:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily demonstrates substantial equivalence to predicate devices rather than establishing specific, new acceptance criteria for the Saview-Aqua 55 UV lenses against numerical targets. Instead, the "acceptance criteria" are implicitly understood to be meeting or exceeding the performance characteristics of the predicate devices. The study compares key physicochemical properties.

Characteristic	Acceptance Criteria (Implied: Comparable/Better than Predicate K051095 and K090806)	Saview-Aqua 55 UV Reported Performance	Predicate K051095 Performance	Predicate K090806 Performance
Material	methafilcon A (Group 4)	methafilcon A (Group 4)	methafilcon A (Group 4)	methafilcon A (Group 4)
Indication for use	myopia, hyperopia, presbyopia, astigmatism	myopia, hyperopia, presbyopia, astigmatism	myopia, hyperopia, presbyopia, astigmatism	myopia, hyperopia, presbyopia, astigmatism
Water content	55%	55%	55%	55%
Visible light transmittance (381 nm ~ 780 nm)	≥ 90.3% (from predicates)	96.78%	90.3%	90.30%
UV Transmittance	≤ 9.1% (from predicate K051095)	6.7%	9.1%	9.3%
UVA (316 nm ~ 380 nm)	≤ 15.816% (from predicate K051095)	12.370%	15.816%	(Not specified)
UVB (280 nm ~ 315 nm)	≤ 2.435% (from predicate K051095)	1.025%	2.435%	(Not specified)
Dk (35°C)	≥ 18.9 x 10^-11 (from predicates)	21.4 x 10^-11	18.9 x 10^-11	18.9 x 10^-11
Powers	Comparable range to predicates	+12.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal)	+4.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal)	+4.00D to -20.00D (single vision); Cylinder -0.50D to -2.50D (Toric); Add to +3.25 (Multifocal)
Color	Pigment blue 15	Pigment blue 15	Pigment blue 15	Pigment blue 15
Refractive index (wet)	Comparable to predicates	1.404	1.410	1.410
Method of manufacture	Moulded	Moulded	Moulded	Moulded
Package Storage saline solution	Saline solution (some may contain hyaluronic acid polymer)	Saline solution containing hyaluronic acid polymer	Saline solution	Saline solution with hyaluropolymer

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

The document describes "pre-clinical tests" and "physicochemical testing" but does not specify numerical sample sizes for these tests. It indicates the data comes from tests performed by St. Shine Optical Co., Ltd. in Taiwan, R.O.C. (the submitter). The data is generated prospectively for the purpose of this submission, but not in the context of a clinical trial on human subjects for device performance. It focuses on material properties and safety.

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

This information is not applicable and not provided. The "ground truth" for these tests relates to the inherent physical and chemical properties of the lenses and their biological safety as tested in vitro or in animal models, not human diagnostic interpretation.

4. Adjudication Method for the Test Set:

Not applicable. There is no human interpretation or adjudication process described for the physicochemical and biocompatibility testing.

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 is a contact lens submission, not an AI-powered diagnostic device.

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

Not applicable. This is a contact lens submission, not an algorithm.

7. The Type of Ground Truth Used:

The ground truth used for this type of submission is based on:

Physicochemical Measurements: Standardized laboratory tests to determine properties like water content, transmittance, Dk, refractive index, etc.
Biocompatibility Standards: Results from tests showing non-toxicity, non-irritation, and absence of unsafe residues, typically assessed against established biological safety standards for medical devices (ISO 10993 series, though not explicitly cited, is standard practice).
Sterility Testing: Ensuring the product remains sterile until the expiration date.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this device.

Summary

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K121201

OCT 2 6 2012

05 Summary of 510(k) Submission

Submitter Information:

Address:

St. Shine Optical Co., Ltd. 4,5F No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 221, New Taipei City Taiwan R.O.C.

Registration No .: 9617499

Contact Person:	Thomas Kuo,
	Manager, R&D Div.
Telephone:	886-2-2647-9356
Fax:	886-2-8691-6776
Date Prepared:	11. Oct., 2012

Device:

Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Name:	Saview-Aqua 55 UV (methafilcon A) Visibility TintedSoft (Hydrophilic) Contact Lens
	Saview-Aqua 55 UV Toric (methafilcon A) VisibilityTinted Soft (Hydrophilic) Contact Lens
	Saview-Aqua 55 UV Multifocal (methafilcon A)Visibility Tinted Soft (Hydrophilic) Contact Lens
Classification Name:	Soft (Hydrophilic) Contact Lens (daily wear)
Device Classification:	Class II (21 CFR 886.5925)
Product Code:	LPL
Panel:	Ophthalmic

Predicate Devices:

The predicate devices are Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens, Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens, and Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens covered under 510(k) K090806 and 55 UV (mcthafilcon A) Soft (hydrophilic) Contact Lens, 55 UV Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens and 55 UV Toric (methafilcon A) Soft (hydrophilic) Contact Lens covered under 510(k) K051095.

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Description of Devices:

The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as a single vision lens.

The Savicw-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is available as an aspherical multifocal lens.

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K121201

Table 1 Comparison Chart

: : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : : :

	Saview-Aqua 55 UV,Saview-Aqua 55 UV Toric, andSaview-Aqua 55 UV Multifocal Soft(Hydrophilic) Contact Lens	55 UV, 55UVMultifocal, and 55 UVToric Soft(Hydrophilic) ContactLens - K051095	Safi-gel, Safi-gel Toricand Safi-gel MultifocalSoft (Hydrophilic)Contact Lens - K090806
Device
Material(Classification)	methafilcon A(Group 4)	methafilcon A(Group 4)	methafilcon A(Group 4)
Indication for use	myopia, hyperopia,presbyopia andastigmatism	myopia, hyperopia,presbyopia andastigmatism	myopia, hyperopia,presbyopia andastigmatism
Water content	55 %	55%	55 %
Visible lighttransmittance(381 nm ~ 780 nm)	96.78 %	90.3%	90.30 %
UV Transmittance	6.7%	9.1 %	9.3 %
UVA(316 nm ~ 380 nm)	12.370 %	15.816 %
UVB(280 nm ~ 315 nm)	1.025 %	2.435 %
Dk (35° C)	$21.4x10^{-11}$	$18.9 x 10^{-11}$	$18.9 x 10^{-11}$
Powers	+12.00D to -20.00D;Cylinder powers -0.50Dto -2.50D (Saview-Aqua55 UV Toric only);Continuous add power to+3.25 (Saview-Aqua55 Multifocal only)	+4.00 D to -20.00 D;Cylinder powers 0.50 Dto -2.50 D (55 UV Toriconly);Continuous add powerto +3.25 (55UVMultifocal only)	+4.00D to -20.00D;Cylinder powers -0.50Dto -2.50D (Safi-gel Toriconly);+12.00 D to -20.00 DContinuous add power to+3.25 (Safi-gelMultifocal only)
Color	Pigment blue 15	Pigment blue 15	Pigment blue 15
Refractive index	1.404 (wet)	1.410 (wet)	1.410 (wet)
Method of manufacture	Moulded	Moulded	Moulded
Package Storage salinesolution	Saline solutioncontaining hyaluronicacid polymer	Saline solution	Saline solution withhyaluropolymer

05-3

・

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Indication for Use:

The Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity.

The Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity and require add power of up to +3.25 diopters.

The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric and Saview-Aqua 55 UV Multifocal lenses are to be prescribed for single-use daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Description of Safety and Substantial Equivalence:

A scries of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, and to establish substantial equivalence to the predicate devices.

Results of Acute Systemic Injection, Ocular Irritation and In Vitro Cytotoxicity Tests show the lenses to be non-toxic and non-irritating. The Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the

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extracts. Moreover, results of Oral Toxicity, Acute Ocular Irritation and In Vitro Cytotoxicity Tests show the packaging or the storage solution to be non-toxic and non-irritating as well. Physicochemical testing of the Saview-Aqua 55 UV Lenses demonstrated equivalency to the predicate devices.

Conclusion:

· Information submitted in the 510(k) establishes that the Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown our products remain sterile and the properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

St. Shine Optical Co., Ltd. Mr. Thomas Kuo Manager, R&D Division 4,5F No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 221 New Taipei City Taiwan R.O.C.

OCT.26 2002

Re: K121201

Trade/Device Name: Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Codes: LPL, MVN Dated: September 24, 2012 Received: October 1, 2012

Dear Mr. Kuo:

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, de needs mat hat (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 I ou may, arones 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean I lease of advised that I Drivised by a levice complies with other requirements of the Act that I Dri has intact a are regulations administered by other Federal agencies. You must or any I cutar statues and registents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI'N I all 607), labeling (21 OFR 803); good manufacturing practice requirements as set de rice-related daverse overals) (21 CER Part 820); and if applicable, the electronic form in the quant on 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 11 you desire specific ad 170 bout FDA/Centers Offices/CDRHOffices/ucm115809.htm for go to mtp.//www.idai.gov.il Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regulation onations 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 I ou may of amel generational 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Dubral Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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KI2I20I

04 Indications for Use Statement

510(k) Number (if known):___K121201

Device Name:

Saview-Aqua 55 UV (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Toric (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview-Aqua 55 UV Multifocal (methafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Indications for Use:

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marc Robley

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K121201

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.