Saview SH 38 UV (Senofilcon 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 who may have 1.00D of astigmatism or less does not interfere with visual acuitv.

Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH 38 UV multifocal (Senofilcon 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 who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear or frequent replacement wear. Eye care practitioners may prescribe the lens for daily disposable wear, or for frequent replacement wear.

For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).

Device Description

Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:

The lens designs include spherical, toric and multifocal lenses.
UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is stated and explicitly noting what is not provided.

Understanding the Device:
The device in question is a Soft (Hydrophilic) Contact Lens (Saview SH 38 UV, Saview SH 38 UV toric, and Saview SH 38 UV multifocal) made of Senofilcon A, which is visibility tinted. It's classified as a Class II medical device.

Key Point: This document is a 510(k) premarket notification decision letter, which means the manufacturer is asserting substantial equivalence to already legally marketed predicate devices, rather than proving efficacy from scratch through entirely novel clinical trials. The focus here is on demonstrating that the new device is as safe and effective as the predicate devices, primarily through non-clinical performance data and material comparisons. Therefore, many of the typical "AI/ML validation" questions (like number of experts, adjudication, MRMC studies, training set details) will likely not apply directly to this type of device submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally based on meeting various ISO standards and FDA guidance documents for contact lenses. The comparison table provides specific performance data points of the subject device against its predicate devices.

Property / Acceptance Criteria (Derived from Standards/Predicate)	Reported Device Performance (Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal)
Intended Use	Matches predicate devices (K042275 & K051095) for correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic or not-aphakic persons with non-diseased eyes.
Material (USAN Name)	Senofilcon A (Matches Predicate K042275)
Material (Classification)	Group 5C (Silicone hydrogel: low water subgroup) (Matches Predicate K042275)
Water Content	38% (Matches Predicate K042275, lower than K051095's 55%)
Visible Light Transmittance	≥90% (Meets/Exceeds both predicates: K042275 at ≥78%, K051095 at 90.3%)
UV Transmittance	UVB < 5%, UVA < 50% (Compared to K042275: UVB<1%, UVA<10%; K051095 UVB: 2.435%, UVA: 15.816%. This shows different UV filtering properties but presumably accepted as safe and effective for the stated UV protection claim of "UV absorbing monomer is used" and being "Visibility Tinted Soft").
Dk (35°C) non-edge corrected	$122 \times 10^{-11}$ (Matches Predicate K042275, significantly higher than K051095's $18.9 \times 10^{-11}$)
Dk (35°C) boundary layer and edge corrected	$103 \times 10^{-11}$ (Matches Predicate K042275)
Power Range (Spherical)	+20.00 to -20.00D (Similar to K042275's +20.00 to -20.00D and K051095's +4.00 to -20.00D)
Power Range (Toric Cylinder)	-0.50 to -3.00D (for toric only) (Range similar to K051095's 0.50D to -2.50D, but higher maximum cylinder power than K051095)
Power Range (Multifocal Add)	Continuous add power to +3.00D (for multifocal only) (Similar to K051095's continuous add power to +3.25D)
Color	Tint: [Phthalocyaninato(2-)] copper
Refractive Index	1.42 (Matches Predicate K042275, similar to K051095's 1.410)
Method of Manufacture	Moulded (Matches both predicates)
Packaging Materials	PP (Polypropylene) blister and Aluminum foil (Matches Predicate K051095)
Package Storage Saline Solution	Saline solution (Matches Predicate K051095)
Biocompatibility	Complies with ISO 10993-5:2009 (Cytotoxicity), ISO 10993-23:2021 (Ocular Irritation), ISO 10993-11:2017 (Acute Systemic Injection). Also leverages biocompatibility testing of packaging solution and material from K051095.
Physicochemical Properties	Complies with ISO 11981:2017, ISO 18369-2:2017, ISO 18369-3:2017, 18369-4:2017, and FDA Guidance (2006/05) for Color Additives. Tests include: Physical Compatibility of Contact Lens Care Products, Extractables, Finished Lens Parameters, Transmittance, Refractive Index, Water Content, Oxygen Permeability, Mechanical Properties, Leachable Additives, Specific Gravity.
Sterilization & Shelf Life	Complies with ISO 17665-1:2006, USP<71>, ISO 11737-1:2018, ISO 11737-2:2019, USP<61>, ISO 11987:2012, ISO 18369-1:2017, ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017, ISO 14644-1:2015, ISO 14644-3:2019, NEBB: 2009. Tests include: Stability Test, Autoclave Validation, Sterilization Efficacy of BI, Sterility Test, Bioburden test, Clean Environment Test Controls Report.

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

Sample Size for Test Set: Not explicitly stated as a "test set" in the context of a separate, clinical performance study. The data provided refers to non-clinical testing of the device itself (e.g., physical, chemical, mechanical properties, biocompatibility, sterilization validation). These tests are typically performed on representative batches of the manufactured device according to established protocols and standards, but the specific number of lenses or samples tested for each property is not detailed in this summary.
Data Provenance: The manufacturer is St. Shine Optical Co., Ltd. from New Taipei City, Taiwan. The non-clinical testing appears to have been conducted by the manufacturer or their designated labs. The information provided does not specify if any data for this device was from other countries, though the predicate device K051095's ownership was transferred to St. Shine Optical. The studies are non-clinical (laboratory/in-vitro) as opposed to retrospective or prospective patient studies.

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

Not applicable / Not provided. This information is typically relevant for studies involving human interpretation (e.g., AI in radiology). For a contact lens 510(k) submission, "ground truth" and expert consensus would refer to established scientific and engineering principles, and validated test methods (e.g., ISO standards) for measuring physical, chemical, and biological properties, not human interpretative tasks. The "experts" involved are the individuals performing and overseeing the technical and scientific tests (e.g., chemists, material scientists, microbiologists), and the regulatory bodies (FDA) that review the compliance with standards.

4. Adjudication Method for the Test Set

Not applicable / Not provided. Adjudication is relevant when multiple human readers/reviewers provide subjective opinions that need to be reconciled, particularly in imaging or clinical diagnostic studies. The non-clinical testing described here relies on objective measurements and standardized test methods, where results are compared against predetermined specifications and ISO standards, not subject to human adjudication in the same way.

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, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant to its regulatory pathway.

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 or AI. It is a physical medical device (contact lens).

7. The Type of Ground Truth Used

The "ground truth" for this submission are the established physical, chemical, and biological performance specifications and safety profiles for contact lenses, as defined by:
- Relevant ISO standards (e.g., ISO 11981, ISO 18369 series, ISO 17665-1, ISO 10993 series for biocompatibility).
- FDA guidance documents (e.g., 1994 FDA Guidance Document for Daily Wear Contact Lenses, FDA Guidance for Color Additives).
- Performance characteristics of the predicate devices (K042275 and K051095), which the subject device aims to be substantially equivalent to.
- GLP regulations (21 CFR Part 58) for biocompatibility tests.

8. The Sample Size for the Training Set

Not applicable / Not provided. There is no "training set" in the context of AI/machine learning for this device. The manufacturing process and quality control would involve internal development and validation data, but this is not a "training set" like in AI.

9. How the Ground Truth for the Training Set Was Established

Not applicable / Not provided. Since there is no "training set," this question does not apply. The "ground truth" for demonstrating safety and effectiveness relies on standard testing methodologies and comparison to known safe and effective predicate devices and regulatory standards, as described in point 7.

Summary

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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 logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

July 1, 2024

St. shine Optical Co., Ltd. Mina Lee R&D assistant person 4,5F No. 276-2, Sec. 1, Ta Tung Rd.,Hsi Chih Dist. New Taipei City, 22146 Taiwan

Re: K240477

Trade/Device Name: Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted 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: May 20, 2024 Received: May 20, 2024

Dear Mina Lee:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents titled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-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.

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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 -S

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

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Indications for Use

Submission Number (if known)

K240477

Device Name

Indications for Use (Describe)

For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Submitter Information:

Address:	St. Shine Optical Co., Ltd.4,5F No. 276-2, Sec. 1, Ta Tung Rd. Hsi Chih Dist., 22146, New Taipei City Taiwan R.O.C.
Registration No.:	9617499
Contact Person:	Mina LeeAssistant, R&D Div.
E-mail:	s7034@stshine.com.tw Telephone:
Telephone:	886-2-2641-7543#228
Fax:	886-8691-6776
Date Prepared:	February 05, 2024

Device:

Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Name:	Saview SH 38 UV (Senofilcon A) Visibility TintedSoft (Hydrophilic) Contact LensSaview SH 38 UV toric (Senofilcon A) VisibilityTinted Soft (Hydrophilic) Contact LensSaview SH 38 UV multifocal (Senofilcon 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, MVN
Panel:	Ophthalmic

Predicate Devices:

. VISTAKON (SENOFILCON A) SOFT CONTACT LENS - K042275
55 UV, 55 UV Multifocal, and the 55 UV Toric (methafilcon A) Soft (Hydrophilic) ● Daily Wear Contact Lenses - K051095

Description of Devices:

Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens:

The lens designs include spherical, toric and multifocal lenses. .

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UV absorbing monomer is used. The transmittance are less than 5% in the . UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR . Part 74 for use in medical device is used.
The lens contains 38% water by weight and each lens is supplied sterile in a blister . container in saline solution.

Indication for Use:

Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

Saview SH 38 UV multifocal (Senofilcon 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 nondiseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multifocal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

For a daily disposable wear lens, the lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

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For a frequent replacement wear lens, the lens may be cleaned or disinfected using chemicals disinfecting systems (hydrogen peroxide disinfecting systems are not included).

Comparison of technological characteristics with the predicate device

	Subject Device	Predicate Device	Predicate Device
Device	Saview SH 38 UV,Saview SH 38 UV toric,Saview SH 38 UVmultifocal (Senofilcon A)Visibility Tinted Soft(Hydrophilic) Contact Lens	VISTAKON(SENOFILCON A) SOFTCONTACT LENS(K042275)	The 55 UV, 55 UVMultifocal, 55 UV Toric(methafilcon A) Soft(Hydrophilic) Daily WearContact Lens (K051095)
Intended Use	Sphere:Daily wear for the correctionof refractive ametropia(myopia, hyperopia) inaphakic or not-aphakicpersons with non-diseasedeyes who may have 1.00D ofastigmatism or less does notinterfere with visual acuity.	Sphere:Daily wear for the correctionof refractive ametropia(myopia and hyperopia) inphakic or aphakic personswith non-diseased eyes whomay have 1.00D ofastigmatism or less.	Sphere:Daily wear for the correctionof refractive ametropia(myopia, hyperopia) inaphakic or not-aphakicpersons with non-diseasedeyes that may exhibitrefractive and/or cornealastigmatism up to 2.00diopters that does notinterfere with visual acuity.
	Toric:Daily wear for the correctionof refractive ametropia(myopia, hyperopia, andastigmatism) in aphakic ornot-aphakic persons withnon-diseased eyes. The toriclens is specified for up to3.00 diopters of astigmatism.The highest cylinder poweris -3.00D.	Toric:Daily wear for the correctionof visual acuity in phakic oraphakic persons with non-diseased eyes that arehyperopic or myopic andmay have 10.00D ofastigmatism or less.	Toric:Daily wear for the correctionof refractive ametropia(myopia, hyperopia, andastigmatism) in aphakic ornot-aphakic persons withnon-diseased eyes. The toriclens is specified for up to2.50 diopters of astigmatism.Cylinder power is 0.50 D to-2.50 D
	Multifocal:Daily wear for the correctionof refractive ametropia(myopia and hyperopia) andpresbyopia in aphakic or not-aphakic persons with non-diseased eyes who may have0.75D of astigmatism or lessdoes not interfere with visualacuity. The multifocal lens isspecified for up to +3.00diopters of add power. Thehighest add power is+3.00D.	Multifocal:Daily wear for the correctionof distance and near vision inpresbyopic, phakic oraphakic persons with non-diseased eyes who may have0.75D of astigmatism or less.	Multifocal:Daily wear for the correctiorof refractive ametropia(myopia and hyperopia) andpresbyopia inaphakic or not-aphakic person with non-diseased eyes that mayexhibit refractive and/orcorneal astigmatism up to2.00 diopters that does notinterfere with visual acuity.Continuous add power to+3.25D
Modality	Daily disposable andfrequent replacement wear	Daily disposable andfrequent replacement wear	Daily disposable andfrequent replacement wear
Material(Classification)	Group 5C(Silicone hydrogel: lowwater subgroup)	Group 5C(Silicone hydrogel: lowwater subgroup)	Group 4methafilcon A
USAN Name	Senofilcon A	Senofilcon A	methafilcon A
Indication foruse	Myopia, hyperopia,presbyopia, astigmatism	Myopia, hyperopia,presbyopia, astigmatisn	Myopia, hyperopia,presbyopia, astigmatisn
Water content	38%	38%	55%
Visible lighttransmittance	≥90%	≥78%	90.3%
UVtransmittance	UVB <5%UVA <50%	UVB<1%UVA <10%	UVB: 2.435%UVA: 15.816%
Dk(35°C)non-edgecorrected	$122 x 10^{-11}$	$122 x 10^{-11}$	$18.9 x 10^{-11}$
Dk(35°C)boundary layerand edgecorrected	$103 x 10^{-11}$	$103 x 10^{-11}$	N/A

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	+20.00 to -20.00D		+4.00 to -20.00D
Power	Cylinder power:-0.50 to -3.00D (for toriconly)	N/A	Cylinder power:0.50 to -2.50D (for toriconly)
	Continuous add power to+3.00D (for multifocal only)		Continuous add power to+3.25D (for multifocal only)
Color	Tint:[Phthalocyaninato(2-)]copper	Tint:Reactive Blue Dye #4	Tint:Pigment 15
Refractiveindex	1.42	1.42	1.410
Method ofmanufacture	Moulded	Moulded	Moulded
Packagingmaterials	PP (Polypropylene) blisterand Aluminum foil	N/A	PP (Polypropylene) blisterand Aluminum foil
Package storagesaline solution	Saline solution	0.005% methyl ethercellulose	Saline solution

Summary of Non-clinical Performance Data

All tests were performed to assess the properties and safety and effectiveness of the contact lens following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. Biocompatibility tests were conducted in accordance with the GLP regulation (21 CFR Part 58). All other testing was conducted according to scientific methods. Non-Clinical testing performed includes:

Physicochemical Properties:

Physical Compatibility of Contact Lens Care Products with Contact Physical

Compatibility of Contact Lens Care Products with Contact

-Extractables

-Finished Lens Parameters
-Transmittance
ーRefractive Index
-Water Content
-Oxygen Permeability

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-Mechanical Properties (Modulus, Tensile strength, Elongation, Toughness)

-Leachable Additives

-Specific Gravity

Test results demonstrated that subject device complies with ISO 11981:2017, ISO 18369-2:2017, ISO 18369-3:2017, 18369-4:2017, FDA Guidance- Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses (2006/05) requirements.

Sterilization validation and Shelf life:

-Stability Test

ーAutoclave Validation

-Report of Evaluation for the Sterilization Efficacy of BI Inside and Outside of the

Package

-Sterility Test Report

-Bioburden test

-Clean Environment Test Controls Report

Test results demonstrated that subject device complies with ISO 17665-1:2006, USP<71>, ISO 11737-1:2018, ISO 11737-2:2019, USP<61>, ISO 11987:2012, ISO 18369-1:2017, ISO 18369-2:2017, ISO 18369-3:2017, ISO 18369-4:2017, ISO 14644-1:2015, ISO 14644-3:2019, NEBB: 2009 requirements.

Biocompatibility:

For lens:

-Cytotoxicity (ISO 10993-5:2009)

-Ocular Irritation (ISO 10993-23:2021)

-Acute Systemic Injection (ISO10993-11:2017)

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For packaging solution:

The ownership of K051095 was transferred from Optical Connection, Inc. to our firm, St. Shine Optical Co., Ltd.. The biocompatibility testing for packaging solution referenced in K051095 is held by our firm as well. Therefore, the material of packaging solution, saline solution, is identical to that of K051095.

For packaging material:

The ownership of K051095 was transferred from Optical Connection, Inc. to our firm, St. Shine Optical Co., Ltd.. The biocompatibility testing for packaging material referenced in K051095 is held by our firm as well. The material of blister package comprises a base and a cover. The base material is homo PP (Polypropylene) and the cover is a laminate of Aluminum foil. Therefore, the packaging materials are identical to that of K051095.

The testing performed on Saview SH 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview SH 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens, Saview SH 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens demonstrated that the device functions in a safe and effective manner. Performance tests included conformance to specifications, functional test results verify that the device performs as expected and are equivalent to the predicate device without creating additional risk to the user.

Summarv of Clinical Performance Data

No clinical test data was used to support the decision of substantial equivalence. The safety and effectiveness of finished contact lenses have been established through previous non-clinical performance testing. Safety and effectiveness of the Senofilcon A lens material is identical to that of K042275. Safety and effectiveness of packaging material and package storage saline solution is identical to that of K051095.

Substantial Equivalence Conclusion:

The information submitted in the 510(k) establishes that the Saview SH 38 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness. Method of manufacture Shelf life testing has shown the lenses remain sterile and that lens properties do not change before the

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expiration date. Results of cytotoxicity, ocular irritation and acute systemic injection tests showed substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview SH 38 UV, Saview SH 38 UV toric, Saview SH 38 UV multifocal (Senofilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.

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.