The Saview 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Saview 58 UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. Saview 58 UV Toric lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or non-aphakic persons with non-disease eyes that may exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Saview 58 UV Multifocal lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacement. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems.

Device Description

The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses are available as a spherical lens for single vision. astigmatic (toric) lens and aspherical multifocal lens respectively. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate, initiated by Azobisisobutyronitrile. A UV absorbing compound 2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl]ethyl methacrylate is incorporated into the lens polymer. The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses with visible tint are tinted blue using Pigment Blue 15 to make the lens more visible for handling.

AI/ML Overview

This 510(k) summary describes a series of pre-clinical tests performed to demonstrate the safety and effectiveness of the Saview 58 UV contact lenses and to establish substantial equivalence to predicate devices. It does not contain information about a study based on human subjects or clinical data in the traditional sense of a device performance study.

Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts, adjudication method, MRMC studies, standalone performance, and training set information) are not applicable or cannot be extracted from this document, as they relate to clinical performance evaluation, which was not the primary method of demonstrating substantial equivalence here.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for safety and effectiveness were primarily demonstrated through physicochemical equivalency and pre-clinical safety tests. The specific "acceptance criteria" are implied by the comparison to predicate device parameters and the successful completion of safety tests.

PARAMETER	Saview 58 UV, Saview 58 UV Toric, and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear (Reported Device Performance)	Predicate Device (ACUVUE - etafilcon A) Key Performance/Composition	Predicate Device (55 UV series - methafilcon A) Key Performance/Composition
Material	etafilcon A	etafilcon A	methafilcon A
Material Classification	Group 4	Group 4	Group 4
Indication for Use	myopia, hyperopia, astigmatism, and presbyopia	myopia, hyperopia, astigmatism, and presbyopia	myopia, hyperopia, presbyopia and astigmatism
Water Content	58%	58%	55%
Visible Light Transmittance	91.752%	88.592%	90.3%
UV Transmittance	UVB 2.016%, UVA 14.937%	UVB 0.831%, UVA 11.894%	UVB 2.435%, UVA 15.816%
Dk (35°C)	26.3 x 10^-11	28 x 10^-11	18.9 x 10^-11
Powers	+12.00 ~ -12.00D	+20.00 ~ -20.00D	+4.00 ~ -20.00D
Color	Blue visibility, Pigment Blue 15	Blue visibility, Reactive Blue #4	Blue visibility, Pigment Blue 15
Refractive Index	1.3992	1.3988	1.415
Method of Manufacture	Moulded	Moulded	Moulded
Acute Systemic Injection	Non-toxic	(Implied safe, as predicate)	(Implied safe, as predicate)
Ocular Irritation	Non-irritating	(Implied safe, as predicate)	(Implied safe, as predicate)
In Vitro Cytotoxicity	Non-toxic	(Implied safe, as predicate)	(Implied safe, as predicate)
Residue Evaluation	No evidence of unsafe amounts of residue	(Implied safe, as predicate)	(Implied safe, as predicate)
Shelf Life Testing	Lenses remain sterile and properties do not change before expiration date	(Implied stable, as predicate)	(Implied stable, as predicate)

Study Proving Device Meets Acceptance Criteria:

A series of "pre-clinical tests" were performed. These tests focused on:

Biocompatibility and Safety: Acute Systemic Injection, Ocular Irritation, and In Vitro Cytotoxicity Tests.
Material Characterization: Physicochemical testing to compare properties like water content, UV transmittance, Dk, refractive index, etc., to the predicate devices.
Residue Analysis: Evaluation for the presence of residue.
Shelf Life Testing: To ensure sterility and property stability over time.

The conclusion states that the information submitted establishes that the Saview 58 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. This comparison to legally marketed predicate devices forms the basis of the "substantial equivalence" determination, not a standalone clinical performance study on the device's ability to correct vision.

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

Sample Size for Test Set: Not specified. The document mentions "a series of pre-clinical tests" and "physicochemical testing" but does not detail the number of lenses or test articles used for each test.
Data Provenance: The device manufacturer is St. Shine Optical Co., Ltd. in Taiwan. The pre-clinical tests and physicochemical evaluations would have been conducted by or for them, likely in a laboratory setting. The data is thus from laboratory testing, not a human clinical study with specific country of origin or retrospective/prospective designations.

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

Not applicable. This document describes pre-clinical and physicochemical testing, not a clinical trial requiring human expert ground truth for diagnostic accuracy, for example.

4. Adjudication Method:

Not applicable for the type of pre-clinical and physicochemical testing described.

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 not an AI-assisted diagnostic device, nor is an MRMC study mentioned.

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

Not applicable. This is a contact lens, not an algorithm. The device's "standalone" performance is assessed via its physical and chemical properties and biocompatibility as described in the pre-clinical tests.

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

The "ground truth" for these tests is based on established scientific methods and industry standards for material characterization, biocompatibility testing, and comparison against the known properties of the predicate devices. For example, specific analytical techniques provide data on water content, UV transmittance, Dk, etc., which are then compared to the predicate's values. Biocompatibility tests have their own endpoints (e.g., cell viability in cytotoxicity, absence of irritation in ocular irritation).

8. The sample size for the training set:

Not applicable. There is no machine learning or AI component requiring a training set described in this document.

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

Not applicable. No training set is involved.

Summary

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K092852

VI. 510(k) Summary

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ﺐ •

In response to the requirements of the safe Medical Devices Act of 1990, a summary of the safety and effectiveness information upon which the substantial equivalence determination is based is included in this submission.

. . . .

510(k) Summary

Submitter Information:

St. Shine Optical Co., Ltd. 4,5F No, 276-2, Sec. 1, Ta Tung Rd. Hsi Chih City, 221 Taipei County Taiwan R.O.C. Registration No. 9617499

Contact Person:	Brian LaiManager, Regulatory Affairs
Telephone:	886-2-2647-9356
Fax:	886-2-8691-7785
Date Prepared:	September 15, 2009
Device Name:
Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Name:	Saview 58 UV (etafilcon A) Soft(Hydrophilic) Contact Lens for Daily WearSaview 58 UV Toric (etafilcon A) Soft(Hydrophilic) Contact Lens for Daily WearSaview 58 UV Multifocal (etafilcon A) Soft(Hydrophilic) Contact Lens for Daily Wear
Classification Name:	Soft (Hydrophilic) Contact Lens
Device Classification:	Class II (21 CFR 886.5925)

Predicate Devices:

ACUVUE (etafilcon A) Contact Lens clear and visibility tint with UV blocker, 55 UV (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear, 55 UV Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear and 55 UV Toric (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear are selected as the predicate devices.

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The ACUVUE lenses were cleared under 510(k) K962804, and are manufactured by a molding process that uses the etafilcon A material. The dye tinting is different; the lenses are tinted with Reactive Blue #4, where the Saview 58 UV lenses are tinted with Pigment Blue 15.

The 55 UV, 55 UV Toric, 55 UV Multifocal Soft Contact Lenses are cleared under 510(k) K051095, and are selected as predicate devices because although they are molded from a different material, they are tinted with the same dye, using the same UV blocker and the same lens designs, and produced in the same facility, under the same quality system, using the same molding, in-monomer tinting, packaging and sterilization processes as the Saview 58 UV, Saview 58 UV Toric, Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses.

Description of Devices:

2-[3-(2H-Benzotriazol-2yl)-4-hydroxyphenyl]ethyl methacrylate is incorporated into the lens polymer. The Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal (etafilcon A) Soft (hydrophilic) Contact Lenses with visible tint are tinted blue using Pigment Blue 15 to make the lens more visible for handling.

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PARAMETER	Saview 58 UV, Saview 58 UV Toricand Saview 58 UV Multifocal(etafilcon A) Soft (hydrophilic)Contact Lenses for Daily Wear	ACUVUE (etafilcon A) Contact Lensclear and visibility tint with UVblocker	55 UV, 55 UV Toric, 55 UVMultifocal (methafilcon A) Soft(Hydrophilic) Contact Lenses forDaily Wear
Submissionnumber	N/A	K962804	K051095
Material	etafilcon A	etafilcon A	methafilcon A
MaterialClassification	Group 4	Group 4	Group 4
Indication for use	myopia, hyperopia, astigmatism, andpresbyopia	myopia, hyperopia, astigmatism, andpresbyopia	myopia, hyperopia, presbyopia andastigmatism
Water content	58%	58%	55%
Visible lighttransmittance	91.752%	88.592%	90.3%
UV transmittance@280-315 mm@316-380 mm	UVB 2.016%UVA 14.937%	UVB 0.831%UVA 11.894%	UVB 2.435%UVA 15.816%
Dk (35°C)	$26.3 x 10^{-11}$	$28 x 10^{-11}$	$18.9 x 10^{-11}$
Powers	+12.00 ~ -12.00D	+20.00 ~ -20.00D	+4.00 ~ -20.00D
Color	Blue visibilityPigment Blue 15	Blue visibilityReactive Blue #4	Blue visibilityPigment Blue 15
Refractive index	1.3992	1.3988	1.415
Method ofmanufacture	Moulded	Moulded	Moulded

021

. . . . . . .

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Indication for Use:

Description of Safety and Substantial Equivalence:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview 58 UV, the Saview 58 UV Toric, and the Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear, and to establish substantial equivalence to the predicate devices.

Results of Acute Systemic Injection, Ocular Irritation and In Vitro Cytoticity Tests show the lenses to be non-toxic and non-irritating. The Saview 58 UV lenses were extracted and evaluated for presence of residue. Results showed no evidence of unsafe amounts of residue in the extracts. Physicochemical testing of the Saview 58 UV lenses demonstrated equivalency to the predicate devices.

Conclusion:

Information submitted in the 510(k) establishes that the Saview 58 UV, Saview 58 UV Toric and Saview 58 UV Multifocal Contact Lenses (etafilcon A) have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the expiration date. Therefore, the devices are substantially equivalent to the predicate devices.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features an eagle with its wings spread, symbolizing protection and vigilance. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

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

MAR 1 1 2010

St. Shine Optical Co., Ltd. c/o Mr. Brian Lai Manager, Regulatory Affairs 4,5F No, 276-2, Sec. 1, Ta Tung Rd. Hsi Chih City, 221 Taipei County Taiwan R.O.C.

Re: K092852

Trade/Device Name: Saview 58UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily

Wear

Saview 58UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear

Saview 58UV Multifocal (etafilcon 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: February 6, 2010

Received: February 12, 2010

Dear Mr. Lai:

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, Dr u 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, intering 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 truthu and not misleding.

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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Page 2 - Mr. Brian Lai

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); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 vours.

Kesia Alexander Jr

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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INDICATIONS STATEMENT

Device Names:

Saview 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear Saview 58 UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens for Dally Wear

Indications for Use:

The Saview 58 UV (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-disease eves that may exhibit refractive and/or Corneal astigmatism up to 1.00 diopters that does not interfere with visual acuity. Savieve 58 UV lenses help protect against transmission of harmful UV radiation to the comea and into the eye.

The Saview 58 UV Toric (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic or non-aphakic persons with non-diseased eyes. Saview 58 UV Tonc lenses help protect against transmission of harmful UV radiation to the comea and into the eye.

The Saview 58 UV Multifocal (etafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and Sybirity of and presbyopia in aphakic or non-aphakic persons with non-disease eyes that may Exhibit refractive and/or corneal astigmatism up to 1.00 diopters that does not interfere with Visual acuity. Saview 58 UV Multifocal lenses help protect against transmission of harmil UV radiation to the cornea and into the eye.

The lenses may be disinfected using chemical or hydrogen peroxide disinfecting systems. Eye care practitioners may prescribe the lenses for daily wear and/or frequent replacment. When prescribed for a Frequent Replacement Program, the lenses may be disinfected using Chemical or hydrogen peroxide disinfection systems.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR Over-the-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Houdinhika Virani

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

510(k) Number K092852

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.