The OxyAqua (olifilcon D) Spherical Silicone Hydrogel soft (hydrophilic) contact lenses are daily wear single use soft contact lens indicated for the corrective ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft (hydrophilic) Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft (hydrophilic) Contact lenses are indicated as daily wear for the correction of ametropia (myopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

Device Description

The OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens is made of silicone hydrogel material with UV blocker available as spherical lens, toric lens and multifocal lens. The composition of the lens is 42% olifilcon D and 58 % water. A light blue color tinted with "reactive Blue19" is for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.4% (< 5%) in the UVB range of 280-315nm and 13.7% (< 50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

AI/ML Overview

The document describes the premarket notification for a new soft contact lens, the "OxyAqua (olifilcon D) silicone hydrogel soft contact lens," seeking substantial equivalence to a predicate device. Here's an analysis of the acceptance criteria and supporting study:

The provided document does not explicitly present a table of acceptance criteria with corresponding device performance metrics in a way that is typically found in a clinical trial report for software. However, the regulatory submission for the OxyAqua contact lenses implicitly relies on demonstrating that the device is "as safe, as effective, and performs as well as the predicate device."

Here's an interpretation of the implied acceptance criteria and reported device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance (OxyAqua - Olifilcon D)
Safety
Biocompatibility (non-toxic in ocular environment)	Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.
Absence of new or increased adverse reactions	Clinical study found no significant adverse reactions reported or Grade 3 or Grade 4 slit lamp findings. No significant differences in slit-lamp findings were found between groups (OxyAqua vs. Predicate).
Acceptable Slit Lamp Findings	No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups.
Effectiveness/Performance
Visual Acuity correction (for ametropia/presbyopia)	Mean VA for both lenses (OxyAqua and Predicate) was similar at each visit. Visual acuity could be corrected to 0.1 (log MAR) or better in the clinical study.
Lens Wearing Time (acceptable daily wear)	Clinical study included lens wearing time as a parameter, and participants wore the lenses on a daily wear basis, demonstrating acceptable wearing time (though specific duration not explicitly stated as a result).
Physiochemical properties within established specifications	Physiochemical studies were conducted according to ISO 18369. The physical, optical, and chemical properties of the lens are within established specifications for the lenses.
Substantial Equivalence to Predicate
Overall similarity "as safe" and "as effective" as predicate	"Comparison to the predicate device for chemical composition, physical and optical properties, it shows that 'OxyAqua silicone hydrogel soft contact lens' is as safe, as effective and performs as well as the predicate device."
Matching Indications for Use	The indications for use for OxyAqua (Spherical, Toric, Multifocal) are clearly defined for correction of ametropia, astigmatism, and presbyopia in non-diseased eyes, for daily wear and single use, aligning with the type of conditions typically addressed by soft contact lenses and, by implication, those addressed by the predicate.
Similar Technological Characteristics (despite material change)	Despite material difference (Olifilcon D vs B, 58% vs 47% water content, Dk 85 vs 120), other characteristics like diameter, base curve, center thickness, powers, refractive index, light transmittance, handling tint, and manufacturing method are presented as similar or within acceptable ranges for substantial equivalence. The predicate device shared the same manufacturer and product code (MVN), implying a similar regulatory and safety profile as a daily disposable soft contact lens.

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

Sample Size: "At least 30 evaluable subjects were participated."
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, the description of "a three-month clinical study" strongly suggests it was a prospective study conducted to specifically support this submission. The manufacturer is based in Taiwan.

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

This type of information is generally not applicable for contact lens clinical trials in the same way it is for AI/computer vision devices. Ground truth for contact lenses is established through direct clinical observations and measurements by eye care professionals (e.g., ophthalmologists, optometrists) during the study visits. The document does not specify the number or qualifications of these clinical professionals, but it can be inferred that appropriately qualified clinicians would have performed the evaluations as part of a "clinical study."

4. Adjudication Method for the Test Set

Not specified. Clinical studies for contact lenses typically involve direct observation and measurement by qualified eye care practitioners. There is no mention of a separate adjudication process by experts, as common in AI device evaluations where multiple readers interpret images.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, an MRMC study was not done. MRMC studies are typically performed to evaluate the diagnostic performance of a new system (often AI-based) by comparing reader interpretations with and without the system's aid. This study compared two contact lenses (OxyAqua vs. an existing predicate) in a clinical trial setting.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not applicable. The device is a physical medical device (contact lens), not an AI algorithm. Its performance is inherent to the lens itself when worn by a human.

7. The Type of Ground Truth Used

The ground truth was established through clinical observations and measurements (e.g., visual acuity, slit-lamp findings, adverse event reporting) by clinicians during a prospective clinical study directly on human subjects. This is considered direct clinical evidence.

8. The Sample Size for the Training Set

This question is not applicable. The device is a manufactured physical product (contact lens), not a machine learning model that requires a training set. The "study" refers to the clinical trial conducted for regulatory submission, not machine learning model development.

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

This question is not applicable for the same reason as above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

April 3, 2018

Visco Vision, Inc. % Jennifer Ting Manager Jens Medical Consulting, Ltd. 6F, No. 39 Jixian Rd., Luzhou Dist. New Taipei City, TW 247

Re: K173958

Trade/Device Name: OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: December 24, 2017 Received: February 5, 2018

Dear Jennifer Ting:

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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

Denise L. Hampton -S

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) K173958

Device Name

OxyAqua (olifilcon D) Silicone Hydrogel Soft (hydrophilic) Contact Lens

Indications for Use (Describe)

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

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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K173958 510 (k) Summary

Preparation Date: March 20, 2018

5.1 Establishment Information:

Name	Visco Vision Inc.
Address	No. 1, Xingye St., Guishan Dist., Taoyuan City 33341 Taiwan
Contact	Ted TT Huang
Phone No.	886-3-3490202
Fax No.	886-3-3596868

5.2 Contact Person:

Name	Evan Huang
Phone No	886-3-3490202
Fax No	886-3-3596868
e-mail:	evan.huang@viscovision.com.tw

5.3 Device Identification:

Proprietary Name	OxyAqua (olifilcon D) Silicone Hydrogel Soft Contact Lens
Common Name	Soft (hydrophilic) Contact Lenses
Classification Name	Lenses, Soft Contact, Daily Wear,(21 CFR 886.5925, Product Code LPL)Lenses, Soft Contact, Daily Wear (Disposable),(21 CFR 886.5925, Product Code MVN)

Classification II

5.4 Legally Marketed Equivalent Device:

Predicate Device Name	Si-Hy (olifilcon B) Silicone Hydrogel Soft Contact Lens
Manufacturer	Visco Vision Inc.
510(k) Number	K160344
Product Code	MVN

5.5 Device Description

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absorbing monomer is used to block UV radiation. The transmittance characteristics are 2.4% (< 5%) in the UVB range of 280-315nm and 13.7% (< 50%) in the UVA range of 316-380nm. It is supplied in a sterile state packaged in a buffered saline solution.

5.6 Indication for Use:

The OxyAqua (olifilcon D) Spherical Silicone Hydrogel soft contact lenses are daily wear single use soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

The OxyAqua (olifilcon D) Toric Silicone Hydrogel Soft Contact Lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) with astigmatism in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters and astigmatic corrections are from -0.75 to -2.25 diopters.

The OxyAqua (olifilcon D) Multifocal Silicone Hydrogel Soft Contact lenses are indicated as daily wear for the correction of ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes and whose powers are from -20.00 to +20.00 diopters with add powers from +0.75 to +2.75 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less where the astigmatism does not interfere with visual acuity.

Eye care practitioners may prescribe the lens for daily wear disposable use (single use). The lenses are to be discarded upon removal. Therefore, no cleaning or disinfecting is required.

5.7 Technological characteristic

OxyAqua SPHERICAL Soft Contact Lenses characteristics:

Diameter Range: 13.0 to 15.0 mm .
Base Curve:8.0 to 9.2 mm .
Center Thickness : 0.08 mm for -3.00D (varies with power) .
. Power:+20.00 to -20.00 D

OxyAqua TORIC Soft Contact Lenses characteristics:

Diameter Range: 13.0 to 15.0 mm .

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Base Curve:8.0 to 9.2 mm •
Center Thickness:0.08 mm for -3.00D (varies with power) •
Power:+20.00 to -20.00 D •
Cylinder: -0.75D ~ -2.25D .
Axis: 10° to 180° (in 10° increments) •

OxyAqua MULTIFOCAL Soft Contact Lenses characteristics:

Diameter Range:13.0 to 15.0 mm
. Base Curve:8.0 to 9.2 mm
Center Thickness:0.08 mm for -3.00D (varies with power) .
Power:+20.00 to -20.00 D .
Additional Powers: +0.75D ~ +1.25D (LOW) .
- +1.50D ~ +2.00D (MID)
- +2.25D ~ +2.75D (HIGH)

5.8 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

Similarities and differences
Item	Device	Predicate (K160344)
Product Name	OxyAqua (olifilcon D)Silicone Hydrogel softcontact lens	Si-Hy (olifilcon B) SiliconeHydrogel soft contact lens
Manufacturer	VISCO VISION Inc.	VISCO VISION Inc.
Intended Use	Myopia, Hyperopia	Myopia, Hyperopia,astigmatism, Presbyopia
Lens Design	Spherical, toric, ormultifocal	Spherical, toric, ormultifocal
Replacement Schedule	Daily Disposable (Singleuse)	Daily Disposable (Singleuse)
Chemical composition	Olifilcon D	Olifilcon B
Classification	Group II(High water, nonionic)	Group I (Nonionic, Lowwater)
Water Content	58 %	47 % (<50%),
Oxygen Permeability(DK, 35°C)	85(Fatt method)	120(Fatt method)

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Base Curve Range (mm)	8.2~9.0	8.0~9.2
Diameter (mm)	13.8~14.4	13.0~15.0
Center Thickness	Varies with design and power(0.08 mm at -3.00D)	Varies with design and power (0.08 mm at -3.00D)
Powers	-20.00D to +20.00D in 0.25 steps	-20.00D to +20.00D
Refractive Index	1.394	1.410
Light Transmittance	94%	94%
Blue handling tint	Reactive Blue19	Reactive Blue19
Method of Manufacture	Molded	Molded

5.9 Nonclinical Tests Performed

5.9.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
5.9.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

5.10 Clinical Studies

A three-month clinical study was conducted to demonstrate the safety and effectiveness of the OxyAqua (olifilcon D) silicone hydrogel soft contact lens by comparison with Si-Hy (olifilcon B) silicone hydrogel soft contact lens when worn on a daily wear basis. At least 30 evaluable subjects were participated. Parameters measured include visual acuities, adverse reactions, symptom, problem and complaints, slit lamp findings, as well as lens wearing time. It was found that the mean VA for both lenses was similar at each visit. The visual acuity could be corrected to 0.1 (log MAR) or better. No significant slit lamp findings (i.e. Grade 3 or Grade 4) were noted. No significant differences in slit-lamp findings were found between groups.

The clinical study provided data to establish substantial equivalence with the predicate, control lens, Si-Hy (olifilcon B) silicone hydrogel soft contact lens, Visco Vision Inc. (K160344), with respect to the safety and effectiveness.

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5.11 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "OxyAqua silicone hydrogel soft contact lens" is as safe, as effective and performs as well as the predicate device.

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.