HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable soft contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who exhibit refractive astigmatism of 1.00D or less where the astigmatism does not interfere with visual acuity.

Device Description

The HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens is made of hydrogel material, hioxifilcon A, with UV blocker available as spherical lens. The composition of the lens is 43% hioxifilcon A and 57% water. A light blue color tinted with "reactive Blue19" listed in 21 CFR Part 73.3121 is for handling visibility purpose. The UV transmission (the thinnest lens measured by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm. Lenses are supplied sterile in sealed blister packs containing MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) with isotonic buffered saline solution.

AI/ML Overview

The provided text is a 510(k) Summary for the HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens. It outlines the device's characteristics and its comparison to predicate devices to demonstrate substantial equivalence, but it explicitly states that no clinical study was conducted to prove the device meets acceptance criteria. Therefore, most of the requested information regarding a study, sample sizes, experts, adjudication, MRMC, and standalone performance cannot be provided as they are not applicable to this submission.

However, based on the provided "Technological characteristic" and "Performance Data" sections, we can infer some aspects of what would typically be considered "acceptance criteria" for a contact lens and how its performance was assessed non-clinically.

Here's a breakdown of the requested information, adapted to what is available in the text:

1. Table of acceptance criteria and the reported device performance:

Since no clinical study was performed with explicit acceptance criteria and corresponding performance metrics from that study, I will extract relevant technical specifications of the HydroSens A lens from the "Technological characteristic" and "Performance Data" sections, along with performance from non-clinical physiochemical studies. These values represent the device's intended performance.

Criterion (Inferred from Technological Characteristics & Performance Data)	Acceptance Criteria (Implied / Design Specification)	Reported Device Performance (from Non-Clinical Tests)
Dimensional Characteristics:
Diameter Range	13.0 to 15.0 mm, ±0.2mm	Stated as design specification
Base Curve	8.0 to 9.2 mm, ±0.2mm	Stated as design specification
Center Thickness (-3.00D)	0.08 mm, ± [0.010 mm + 0.10 tc]	Stated as design specification
Power Range (for	FL	≤ 10.00 D)
Power Range (for 10.00 D <	FL	≤ 20.00 D)
Material Properties:
Water Content	57%	57%
Light Transmittance	95%	95%
Refractive Index (hydrated)	N/A (compared to 1.404 for predicates)	1.402
Oxygen Permeability (Dk, 35°C)	N/A (compared to 18x10-11 for predicates)	22x10-11
Specific Gravity (hydrated)	N/A (compared to 1.136 for predicates)	1.1300
Modulus	N/A (compared to 0.34 Mpa for predicate)	0.38 Mpa
Tensile Strength	N/A (compared to 36 gf/mm² for predicate)	35.0 gf/mm²
Elongation at Break	N/A (compared to 128% for predicate)	108%
Toughness	N/A (compared to 0.215 J/m3 for predicate)	0.210 J/m3
UV Protection:
UV-A Transmission (315-380 nm)	Less than 50%	Less than 50%
UV-B Transmission (280-315 nm)	Less than 5%	Less than 5%
Sterilization & Biocompatibility:
Sterility	Sterile in sealed blister packs	Demonstrated through testing against ISO17665-1/2
Biocompatibility	Non-toxic and biocompatible	Demonstrated through testing against ISO 10993 series

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not applicable. No clinical study was performed. Non-clinical tests would have used various sample sizes per test (e.g., a batch of lenses for physical property testing, materials for biocompatibility), but specific numbers are not provided.
Data Provenance: Not applicable for a clinical test set. Non-clinical tests were conducted by the manufacturer (Visco Vision Inc., Taiwan).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No clinical study for which experts would establish ground truth was conducted.

4. Adjudication method for the test set:

Not applicable. No clinical study with adjudication was performed.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is a contact lens, not an AI-powered diagnostic device, and no clinical study was conducted.

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.

7. The type of ground truth used:

Not applicable for a clinical study. For non-clinical performance, the "ground truth" is based on established scientific and engineering standards and validated test methods (e.g., ISO 18369 for ophthalmic optics, ISO 10993 for biocompatibility) that define the acceptable range for physical, chemical, and biological properties of contact lenses.

8. The sample size for the training set:

Not applicable. No machine learning algorithm requiring a training set was used.

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

Not applicable. No machine learning algorithm requiring a training set was used.

In summary: The submission for the HydroSens A contact lens relies on demonstration of substantial equivalence to legally marketed predicate devices through comparison of indications for use, technological characteristics, and non-clinical performance testing (biocompatibility, sterilization, stability, and physiochemical properties) to established standards, rather than a clinical study with acceptance criteria for patient outcomes.

Summary

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December 7, 2020

Visco Vision Inc Evan Huang Director of Global QA No. 1. Xingye St., Guishan Dist., Taoyuan City, 33341 Taiwan

Re: K200618

Trade/Device Name: HydroSens A (hioxifilcon A) Spherical 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: October 28, 2020 Received: November 2, 2020

Dear Evan Huang:

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. 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 located 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

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/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. 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, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K200618

Device Name

HydroSens A (hioxifilcon A) Spherical Hydrogel Soft 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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Image /page/3/Picture/0 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is simple and clean, with a focus on the company name and its expertise in silicone hydrogels. The overall impression is professional and informative.

510(k) Summary

1. Establishment Information:

Company Name	Visco Vision Inc
Company Address	No. 1, Xingye St., Guishan Dist., Taoyuan City, 33341, TAIWAN
Telephone:	+886-3-359-6868
Fax:	+886-3-359-6868

2. Contact Person:

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

3. Preparation Date:

2020/03/04

4. Device Identification:

Common or usual name	Hydrogel Soft Contact Lens
Classification Name	Soft (hydrophilic) contact lens
Regulation Number	886.5925
Product Code	LPL,MVN
Device Class	Class 2
Panel	Ophthalmic
Device Name	HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens
Trade Name:	HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens

5. Predicate Device:

◆ K040303, 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint)
◆ K992692, 59% extreme H2O® soft contact lens

6. Device Description

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K200618

Image /page/4/Picture/1 description: The image shows the logo for VISCO. The word "VISCO" is written in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font.

by spectrophotometry as stated in ISO 18369) is less than 50% in the UVA range of 315 - 380 nm and less than 5% in the range of UVB range of 280-315 nm.

Lenses are supplied sterile in sealed blister packs containing MPC polymer (2-(Methacryloyloxy) ethyl 2-(trimethylammonio) ethyl phosphate-n-butyl methacrylate copolymer) with isotonic buffered saline solution. The compatibility and package integrity of the blister pack packaging system has been demonstrated and successfully used for other marketed lens products, and packaged lenses are effectively steam sterilized in a validated autoclave. Blister pack containers are labeled with the lens parameters, lot number and product expiration date. The expiration date has been established through stability studies that have assessed the chemical stability of the lens and package integrity (ability to maintain sterility). Shelf-life studies are ongoing to establish and extend the labeled expiration date.

7. Intended Use:

The HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens are daily disposable 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.

8. Technological characteristic

8.1 HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens characteristics:

. Diameter Range : 13.0 to 15.0 mm, ±0.2mm
. Base Curve : 8.0 to 9.2 mm, ±0.2mm
Center Thickness : 0.08 mm for -3.00D (varies with power), ± [0.010 mm + 0.10 tc] .
+8.00 to -12.00 D (JF L| ≤ 10,00 D: ±0.25D; 10,00 D < |F L| ≤ Power : .

20.00 D: ±0.50D)

9. Substantial Equivalence Comparison

All comparison table for applied devices are as following, and the substantial equivalence determination is based on the 510(k) Substantial Equivalence Decision-Making Process Flowchart which includes the comparison and discussion of indications for use, technology, and performance specifications.

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Image /page/5/Picture/0 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is aligned to the left and the background is white.

Category	HydroSens A(hioxifilcon A)Hydrogel Soft ContacLens	59% extreme H2O®soft contact lens(K992692)	59% Extreme H2O(hioxifilcon A) SoftContact Lens forDaily Wear(cast-molded, with avisibility tint)(K040303)	Result ofComparison
Indications for use	HydroSens A(hioxifilcon A)Spherical HydrogelSoft Contact Lens aredaily disposable softcontact lens indicatedfor the correction ofrefractive ametropia(myopia andhyperopia) in phakic oraphakic persons withnon-diseased eyes whoexhibit refractiveastigmatism of 1.00Dor less where theastigmatism does notinterfere with visualacuity.	59% extreme H2O®soft contact lens fordaily Wear areindicated for correctionof visual acuity inaphakic ornot-aphakic personswith non-diseasedeyes that are myopicor hyperopic. The lensmay be worn bypersons who exhibitrefractive astigmatismof 0.75 Diopters or lessthat does not interferewith visual acuity. Thelens are available clearand with a bluevisibility handling tint.Eyecare practitionersmay prescribe the lensfor frequent/plannedreplacement wear, withcleaning disinfectionand scheduledreplacement. Whenprescribed forfrequent/plannedreplacement wear, thelens may be disinfected	The 59% Extreme H 20(hioxifilcon A) toricsoft contact lens fordaily wear is indicatedfor the correction ofvisual acuity in aphakicor not-aphakic personswith non-diseasedeyes that are myopic orhyperopic. The lensmay be worn bypersons who exhibitastigmatism of 10.00Diopters or less. Eyecare practitioners mayprescribe the lens forfrequent/plannedreplacement wear, withcleaning disinfectionand scheduledreplacement. Whenprescribed forfrequent/plannedreplacement wear, thelens may be disinfectedusing a chemicaldisinfection system.	The mainindicationare same,the minordifferencedoes notinterferewith theeffectiveness orsafety oflens
		using either a heat andchemical disinfectionsystem.
Applicant	Visco Vision Inc	Benz Research andDevelopment INC.	Hydrogel VisionCorporation	Different
Classification	Class II	Class II	Class II	Same
Regulationnumber	886.5925	886.5925	886.5925	Same
Product code	LPL,MVN	LPL	LPL	Different
Intended use	Myopia, Hyperopia,	Myopia, Hyperopia	Myopia, Hyperopia,astigmatism	Different
ReplacementSchedule	Daily Disposable	Daily Wear	Daily Wear	Different
USAN Name	hioxifilcon A	hioxifilcon A	hioxifilcon A	Same
FDA Category(Group)	Group #2 >50%Water, non-ionicPolymer	Group #2 >50%Water, non-ionicPolymer	Group #2 >50%Water, non-ionicPolymer	Same
ManufacturingMethod	Cast Molded	Cast Molded	Cast Molded	Same
Lens Design	Spherical	Spherical	Spherical,Toric	Different
Water Content	57%	59%	59%	Different
LightTransmittance	95%	95%	95%	Same
RefractiveIndex	1.402 (hydrated)	1.404 (hydrated)	1.404 (hydrated)	Different
OxygenPermeability(DK, 35°C)	22x10-11 (cm2/sec)(mlO2/ml x mmHg @35°C)	18x10-11 (cm2/sec)(mlO2/ml x mmHg @35°C)	18x10-11 (cm2/sec)(mlO2/ml x mmHg @35°C)	Different
Specific Gravity	1.1300(hydrated)	1.136 (hydrated)	1.136 (hydrated)	Different
Sterilization	Steam Sterilization	Steam Sterilization	Steam Sterilization	Same
Modulus	0.38 Mpa	-	0.34 Mpa	Different
Tensile strength	35.0 gf/mm²	-	36 gf/mm²	Different
Elongation atbreak	108%	-	128%	Different

Toughness	0.210 J/m3	-	0.215 J/m3	Different

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Image /page/6/Picture/0 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The image is simple and clean, with a focus on the company name and its expertise in silicone hydrogel.

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Image /page/7/Picture/1 description: The image contains the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, gray font. The text is horizontally aligned and centered.

10. Non-clinical tests

10.1 Biocompatibility

The safety tests, such as biocompatibility have been performed in accordance with Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994 and GLP regulation (21 CFR part 58) and relevant ISO 10993 series biocompatibility standard. The biocompatibility report indicates that each test article (lens extracts from the final sterilized blister packaging , packaging buffer solution, extracts of packaging material (Al foil and PP blister)) does not negatively impact the safety of the devices and all of them are non-toxic and biocompatible.

These tests include: cytotoxicity, acute systemic toxicity, ocular irritation and skin sensitization testing. Biocompatibility testing performed includes the following referenced standards

· ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
· ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization
· ISO 10993-11:2017 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
10.2 Sterilization and Stability Testing
- � ISO17665-2 sterilization Of Health Care Products Moist Heat Part 2: Guidance on the Application of ISO 17665-1. (Sterility)
- · ISO17665-1 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
- · ISO 11987 Ophthalmic optics-Contact lenses-Determination of shelf-life.
10.3 Performance Data

Physiochemical studies were conducted according to ISO 18369 Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.

. ISO18369-3 Ophthalmic optics Contact lenses Part 3: Measurement Methods
· ISO18369-4 Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials
◆ ISO18369-2 Ophthalmic optics Contact lenses Part 2: Tolerances

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Image /page/8/Picture/1 description: The image shows the word "VISCO" in large, bold, blue letters. Below the word "VISCO" is the phrase "The Silicone Hydrogel Expert" in a smaller, lighter font. The text is aligned to the left and the background is white.

11. Clinical study

This 510(k) submission does not utilize clinical study for establishing substantial equivalence therefore this section does not apply.

12. Conclusions:

HydroSens A (hioxifilcon A) Hydrogel Soft Contact Lens and 59% extreme H2O® soft contact lens, 59% Extreme H2O (hioxifilcon A) Soft Contact Lens for Daily Wear (cast-molded, with a visibility tint) have the same manufacturing process, operating principles, sterilization and materials as the above predicate devices. Being similar with respect to the physical, optical, mechanical property and performance characteristic to the predicated deice, this meets the Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses,May 1994, the information provided herein supports the claim of substantial equivalence. it shows that "HydroSens A (hioxifilcon A) 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.