The Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction of refractive ametropia (myperopia) 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-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with nondiseased eyes that may exhibit refractive astigmatism up to 2.50 diopters that does not interfere with visual acuity. The Saview-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit refractive and/or corneal 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-Colors Aqua 42 UV lens also acts to enhance or alter the apparent color of the eye.

Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal 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 (hefilcon A) is a hydrophilic polymer of 2-hydroxyethyl methacrylate (HEMA) and n-vinyl-2-pyrrolidone (NVP) crosslinked with ethylene glycol dimethacrylate (EGDMA). A UV absorbing compound 2-[3-(2H-Benzotriazol-2y1)-4-hydroxyphenyl] ethyl methacrylate is incorporated into the lens polymer. The lens contains 42% water by weight and each lens is supplied sterile in a blister container containing hyaluronic acid polymer in saline solution. The lenses are printed with an intermittent coating containing a combination of the following approved pigments: iron oxides, titanium dioxide, phthalocyanine green and carbazole violet listed in 21 CFR Part 73 and [phthalocyaninato (2-)] copper list in 21 CFR Part 74. The lens designs include spherical, toric and multifocal lenses.

AI/ML Overview

This document pertains to a 510(k) premarket notification for Saview-Colors Aqua 42 UV (hefilcon A) Soft (hydrophilic) contact lenses. The submission aims to demonstrate substantial equivalence to predicate devices, not necessarily to prove specific performance criteria of an AI/ML powered medical device. Therefore, many of the requested categories related to medical device performance and AI/ML studies are not applicable to this document.

However, I can extract information related to the non-clinical testing performed and the comparison to predicate devices, which serves a similar purpose of demonstrating safety and effectiveness based on established criteria for contact lenses.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Parameters):

Acceptance Criteria Category/Test	Reported Device Performance (Saview-Colors Aqua 42 UV)	Predicate Device 1 (Saview-Colors 42 UV, K123484)	Predicate Device 2 (Saview-Aqua 55 UV, K121201)
Material (Classification)	hefilcon A (Group 1)	hefilcon A (Group 1)	methafilcon A (Group 4)
Indication for Use	myopia, hyperopia, presbyopia and astigmatism	myopia, hyperopia, presbyopia and astigmatism	myopia, hyperopia, presbyopia and astigmatism
Water Content	42%	42%	55%
Visible Light Transmittance	97.06%	97.06%	96.78%
UV-A Transmittance	9.22%	9.22%	12.370%
UV-B Transmittance	0.49%	0.49%	1.025%
Dk (35° C)	$10.89 \times 10^{-11}$	$10.89 \times 10^{-11}$	$21.4 \times 10^{-11}$
Powers	+12.00D to -20.00D	+12.00D to -20.00D	+12.00D to -20.00D
Refractive Index	1.4347 (wet)	1.4347 (wet)	1.404 (wet)
Method of Manufacture	Moulded	Moulded	Moulded
Packaging	PP Blister Pack	PP Blister Pack	PP Blister Pack
Colorants	Iron oxides, Titanium dioxide, [Phthalocyaninato (2-)] copper, Phthalocyanine green, Carbazole violet	Iron oxides, Titanium dioxide, [Phthalocyaninato (2-)] copper, Phthalocyanine green, Carbazole violet	Copper phthalocyanine (visibility tinted)
Package Storage (Saline Solution)	Saline solution containing hyaluronic acid polymer	Saline solution containing hyaluronic acid polymer	Saline solution
Stability Testing	Performed, lenses remain sterile and properties do not change before expiration date.	Not explicitly detailed but implied for predicate.	Not explicitly detailed but implied for predicate.
Toxicology Testing	Cytotoxicity: showed substantial equivalence. Ocular Irritation: showed substantial equivalence. Acute Systemic Injection: showed substantial equivalence.	Not explicitly detailed but implied for predicate.	Not explicitly detailed but implied for predicate.
Physical/Chemical Testing	Performed (results summarized above in comparison table).	Not explicitly detailed but implied for predicate.	Not explicitly detailed but implied for predicate.

Information not applicable or not found in the provided document, based on the nature of this 510(k) submission for contact lenses:

Sample sized used for the test set and the data provenance: This document describes non-clinical and physical/chemical testing, not a "test set" in the context of an AI/ML model. The specific sample sizes for tests like stability, cytotoxicity, etc., are not provided in this summary. Data provenance (country of origin, retrospective/prospective) is not mentioned for these tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as this is not an AI/ML device requiring expert ground truth for a diagnostic outcome.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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, as this is not an AI/ML powered device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML powered device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of an AI/ML device. For the contact lens, the "ground truth" for non-clinical tests would be established by validated test methodologies and specifications for safety and performance (e.g., ISO standards for biocompatibility, physical properties for contact lenses).
The sample size for the training set: Not applicable, as this is not an AI/ML powered device.
How the ground truth for the training set was established: Not applicable, as this is not an AI/ML powered device.

Summary of Device Meeting Acceptance Criteria:

The document explicitly states that "Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses have comparable physicochemical properties to the predicate devices and do not raise questions of safety and effectiveness." It further concludes that the results of stability testing, acute systemic injection, ocular irritation, and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility.

The acceptance criteria are implied to be the established safety and performance profiles, including physical characteristics and biocompatibility, demonstrated by the legally marketed predicate devices. The study proving the device meets these criteria involved a series of non-clinical tests as recommended by the "Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994." These tests focused on:

Stability Testing: To ensure lenses remain sterile and properties do not change before the expiration date.
Toxicology Testing: Including Cytotoxicity, Ocular Irritation, and Acute Systemic Injection to confirm biocompatibility.
Physical/Chemical Testing: To characterize properties like water content, transmittance, Dk, powers, refractive index, etc., and compare them to predicate devices.

Clinical testing was explicitly stated as NOT required for this submission, indicating that the non-clinical data and comparison to predicate devices were sufficient to demonstrate substantial equivalence for the specified indications for use.

Summary

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

October 21, 2016

St. Shine Optical Co., Ltd. Ms. Ella Lee Project Manager, R&D Div. 4,5F No. 276-2, Sec. 1, Ta Tung Rd., Hsi Chih Dist. New Taipei City, TW 22146

Re: K162317

Trade/Device Name: Saview-Colors Aqua 42 UV (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon 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: August 15, 2016 Received: September 2, 2016

Dear Ms. 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 (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.

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 contact the Division of Industry and Consumer Education 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. 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely,

Kesia Alexander

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

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Indications for Use

510(k) Number (if known) K162317

Device Name

Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens

Indications for Use (Describe)

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)

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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:	Ella Lee
	Project Manager, R&D Div.
Telephone:	886-2-2647-9356
Fax:	886-2-8691-6776
Date Prepared:	Aug.10, 2016

Device:

Common Name:	Soft (Hydrophilic) Contact Lens
Trade/Proprietary Name:	Saview-Colors Aqua 42 UV (hefilcon A) Soft(Hydrophilic) Contact LensSaview-Colors Aqua 42 UV Toric (hefilcon A) Soft(Hydrophilic) Contact LensSaview-Colors Aqua 42 UV Multifocal (hefilcon A) 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:

The predicate devices are Saview-Colors 42 UV, Saview-Colors 42 UV Toric, and Saview-Colors 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K123484 and Saview-Aqua 55 UV, Saview-Aqua 55 UV Toric, and Saview-Aqua 55 UV Multifocal(methafilcon A) Soft (Hydrophilic) Contact Lens covered under 510(k) K121201.

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Description of Devices:

Indication for Use:

The Saview-Colors Aqua 42 UV (hefilcon A) 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-Colors Aqua 42 UV also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Toric (hefilcon A) 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-Colors Aqua 42 UV Toric lens also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV Multifocal (hefilcon A) 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 and/or corneal 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-Colors Aqua 42 UV Multifocal lens also acts to enhance or alter the apparent color of the eye.

The Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric and Saview-Colors Aqua 42 UV Multifocal 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.

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Non-Clinical Testing:

The following tests were conducted as recommended by the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, revised May 1994.

Stability Testing
Toxicology Testing
- Cytotoxicity ■
- Ocular Irritation ■
- Acute Systemic Injection ■
Physical/Chemical Testing

Clinical Testing:

Clinical data is not required for this submission.

Description of Safety and Substantial Equivalence:

Information submitted in the 510(k) establishes that the Saview-Colors Aqua 42 UV lenses 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. Results of acute systemic injection, ocular irritation and in vitro cytotoxicity tests showed the Saview-Colors Aqua 42 UV lenses are substantially equivalent to the predicate device in safety and biocompatibility. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens are substantially equivalent to the predicate devices.

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	Saview-Colors Aqua 42UV, Saview-Colors Aqua42 UV Toric, andSaview-Colors Aqua 42UV Multifocal (hefilconA) Soft (Hydrophilic)Contact Lens	Saview-Colors 42 UV,Saview-Colors 42 UVToric, andSaview-Colors 42 UVMultifocal (hefilcon A)Soft (Hydrophilic)Contact Lens (K123484)	Saview-Aqua 55 UV,Saview-Aqua 55 UVToric, andSaview-Aqua 55 UVMultifocal Soft(Hydrophilic) ContactLens (K121201)
Material(Classification)	hefilcon A(Group 1)	hefilcon A(Group 1)	methafilcon A(Group 4)
Indication foruse	myopia, hyperopia,presbyopia andastigmatism	myopia, hyperopia,presbyopia andastigmatism	myopia, hyperopia,presbyopia andastigmatism
Water content	42 %	42 %	55 %
Visible lighttransmittance	97.06 %	97.06 %	96.78 %
UVTransmittance	UVA : 9.22 %UVB : 0.49 %	UVA : 9.22 %UVB : 0.49 %	UVA : 12.370 %UVB : 1.025 %
Dk (35° C)	$10.89×10^{-11}$	$10.89×10^{-11}$	$21.4x10^{-11}$
Powers	+12.00D to -20.00D;	+12.00D to -20.00D;	+12.00D to -20.00D
Refractive index	1.4347 (wet)	1.4347 (wet)	1.404 (wet)
Method ofmanufacture	Moulded	Moulded	Moulded
Packaging	PP Blister Pack	PP Blister Pack	PP Blister Pack
Colorants	Iron oxidesTitanium dioxide[Phthalocyaninato (2-)]copperPhthalocyanine greenCarbazole violet	Iron oxidesTitanium dioxide[Phthalocyaninato (2-)]copperPhthalocyanine greenCarbazole violet	Copper phthalocyanine(visibility tinted)
	Package Storagesaline solution	Saline solution containinghyaluronic acid polymer	Saline solution	Saline solutioncontaining hyaluronicacid polymer

Table 1 Comparison Chart

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Conclusion:

A series of pre-clinical tests were performed to demonstrate the safety and effectiveness of the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens and to establish substantial equivalence to the predicate devices. Information submitted in the 510(k) also establishes that the Saview-Colors Aqua 42 UV lenses do not raise questions of safety and effectiveness. Therefore, the Saview-Colors Aqua 42 UV, Saview-Colors Aqua 42 UV Toric, and Saview-Colors Aqua 42 UV Multifocal (hefilcon 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.