OCuSOFT® AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT® AMENITY™ (linofilcon A) TORIC DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

OCuSOFT® AMENITY™ (linofilcon A) MULTIFOCAL DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by people who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

Device Description

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are a hemispherical shells with molded base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from linofilcon A, which is a random co-polymer of silicone containing monomers and hydrophilic monomers. The lens consists of 62.0% linofilcon A and 38.0% water by weight when immersed in saline solution with added lubricants. The linofilcon A name has been adopted by the United States Adopted Names Council (USAN).

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ incorporate a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lenses block >95% in the UVB range (280mm - 315nm), and >70% in the UVA range (316nm - 380nm).

AI/ML Overview

The provided text is a 510(k) summary for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. It details the similarity of the device to predicate devices rather than providing a standalone clinical study with specific acceptance criteria and performance results for the new device.

Therefore, much of the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, and ground truth establishment for a standalone study is not explicitly present in the provided document. The document refers back to predicate device studies (K213216, K191929, K213119) for clinical and non-clinical data.

However, I can extract the material properties and their tolerances which act as performance criteria for the device itself.

Acceptance Criteria and Reported Device Performance

The provided document lists material properties and tolerances (acting as acceptance criteria) for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™. Since this is a 510(k) summary demonstrating substantial equivalence to predicate devices, the performance is generally asserted to meet these specified ranges, implying the device does meet these criteria. The table below presents these:

Parameter	Acceptance Criteria (Range/Tolerance)	Reported Device Performance (Implied adherence to these ranges)
Chord Diameter	13.00 mm to 15.00 mm, ±0.20 mm	Meets specified range
Center Thickness	0.080 mm @ -3.00 D; When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5%	Meets specified range
Base Curve	8.00 mm to 9.50 mm, ±0.20 mm	Meets specified range
Back Vertex Power (F'v)	+20.00D to -20.00D; When 0.00 < F'v ≤ 10.00 D → ±0.25 D; When 10.00 < F'v ≤ 20.00 D → ±0.50 D	Meets specified range
Cylinder Power (F'c)	-0.25 D to -2.25 D (in 0.25 D steps); When 0.00 < F'c ≤ 2.00 D → ±0.25 D; When 2.00 < F'c ≤4.00 D→±0.37 D	Meets specified range
Cylinder Axis	5° to 180° in 5° steps; When 0.00 < F'c ≤ 1.50 D → ± 8°; When F'c > 1.50 D→± 5°	Meets specified range
Multifocal Power	+0.25 D to +4.00 D (in 0.25 D steps), ±0.25D	Meets specified range
Surface Appearance	Lenses should be clear with no surface defect	Meets specified criterion
Oxygen Permeability (x 10-11(cm²/sec)(mlO2)/(ml x mmHg))	100, ±20%	Meets specified range (100 edge-corrected)
Light Transmittance - Tinted (@ 380-780nm)	95%, ±5%	Meets specified range (implied to be ≥ 95%)
Ultraviolet Radiation Transmittance	< 5% TUVB; < 30% TUVA	Meets specified criteria (< 0.05TV for TUVB, < 0.50TV for TUVA)
Water Content	38%, ±2%	Meets specified range (38±2%)
Refractive Index	1.415 (hydrated), ±0.005	Meets specified range (1.415 hydrated)

Study Information (Based on provided document)

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

Test Set Sample Size: Not explicitly stated for the device in this document. The document refers to "Non-clinical performance tests were performed to demonstrate the safety and effectiveness of the linofilcon A finished contact lenses in K213216." and "A clinical study was performed to demonstrate the safety and effectiveness of the linofficon A finished contact lenses in K213216." This implies the testing relevant to safety and effectiveness, including clinical performance, was primarily conducted for the predicate device K213216.
Data Provenance: The manufacturing facility is in Hsinchu Science Park, Baoshan Township, Hsinchu County, Hsinchu – District, TAIWAN. The specific country of origin for clinical data (if separate from manufacturing) is not detailed. The non-clinical studies followed GLP regulations.

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

Not applicable as the document does not describe a study involving expert assessment for ground truth establishment in the context of AI or diagnostic imaging. This device is a medical device (contact lens), not an AI diagnostic tool.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable for a contact lens safety and effectiveness study as described.

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

Not applicable. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an algorithm. The device "OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™" is a physical contact lens. The "Non-Clinical Performance Testing" and "Bench Testing - Manufacturing Verification Testing" sections describe standalone testing of the physical properties and biocompatibility of the contact lenses.

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

For the non-clinical and bench testing, the ground truth would be based on established scientific measurement methodologies (e.g., ISO standards for biocompatibility, ANSI Z80.20 for contact lens parameters).
For clinical studies (referenced to K213216), the ground truth for safety and effectiveness would likely involve clinical assessments by ophthalmologists/optometrists based on established clinical endpoints, patient reported outcomes, and adverse event monitoring.

7. The sample size for the training set:

Not applicable. This is not an adaptive algorithm or AI, so there is no "training set."

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

July 12, 2024

Unicon Optical Co., Ltd. Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K241707

Trade/Device Name: OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™; OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™: OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEALTM

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: May 21, 2024 Received: June 13, 2024

Dear Bret Andre:

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.

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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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "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 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/postmarketing-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-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 -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

510(k) Number (if known) K241707

Device Name

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™; OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™; OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™

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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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SPECIAL 510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: K241707

I. SUBMITTER

Date Prepared: July 1, 2024

Name:	UNICON OPTICAL CO., LTD.
Address:	No.16, Gongye E. 9th Rd.Hsinchu Science Park, Baoshan TownshipHsinchu County Hsinchu – District,TAIWAN 30075

Contact Person:	Nick LiaoDirector
Phone number:	+886-4-23551233
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSESwith HYDRASEAL™;OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACTLENSES with HYDRASEAL™;OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLECONTACT LENSES with HYDRASEAL™
CommonName:	Contact Lens, Daily Wear (Disposable)
ClassificationName:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
RegulatoryClass:	Class II
Product Code:	LPL; MVN

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III. PREDICATE DEVICE

The OCuSOFT AMENITY™ (linofilcon A) CONTACT LENSES with HYDRASEAL™ are substantially equivalent to the following predicate device(s):

I "Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens" By Unicon Optical Co., Ltd. 510(k) number; K213216 Primary Predicate
I "Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens" By Unicon Optical Co., Ltd. 510(k) number; K191929 Reference Predicate
I "Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens" By Innova Vision Inc. 510(k) number; K213119 Reference Predicate

IV. DEVICE DESCRIPTION

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ contain C.I. Reactive Blue No. 19 (21 CFR Part 73.3127) for visibility and handling.

The following table lists the material properties and available parameters for the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™:

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Parameter	Range	Tolerance*
Chord Diameter	13.00 mm to 15.00 mm	±0.20 mm
Center Thickness	0.080 mm @ -3.00 D	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Base Curve	8.00 mm to 9.50 mm	±0.20 mm
Back Vertex Power (F'v)	+20.00D to -20.00D	When 0.00 < F'v ≤ 10.00 D → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D → ±0.50 D
Cylinder Power (F'c)	-0.25 D to -2.25 D(in 0.25 D steps)	When 0.00 < F'c ≤ 2.00 D → ±0.25 DWhen 2.00 < F'c ≤4.00 D→±0.37 D
Cylinder Axis	5° to 180° in 5° steps	When 0.00 < F'c ≤ 1.50 D → ± 8°When F'c > 1.50 D→± 5°
Multifocal Power	+0.25 D to +4.00 D(in 0.25 D steps)	±0.25D
Surface Appearance	-	Lenses should be clear with no surface defect
Oxygen Permeability(x 10-11(cm²/sec)(mlO2)/(ml x mmHg))	100	±20%
Light Transmittance - Tinted(@ 380-780nm)	95%	±5%
Ultraviolet Radiation Transmittance	< 5% TUVB< 30% TUVA	TUVB (280 to 315 nm) < 0.05TVTUVA (316 to 380 nm) < 0.50TV
Water Content	38%	±2%
Refractive Index	1.415 (hydrated)	±0.005

ANSI Z80.20. Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements and Physicochemical Properties (2016)

V. INDICATIONS FOR USE

OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuitv.

OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with

HYDRASEAL™ is substantially equivalent to the primary predicate device identified (K213216) regarding the following features:

FDA category - Group V
FDA classification Soft (hydrophilic) Contact Lens (21 CFR 886.5925) ■
Contact lens USAN material (linofilcon A)
트 Intended use - daily wear contact lenses
트 Actions
Indications for use (single vision)
Same manufacturing facility and cast molded production method ■
트 Injection molded polypropylene blister packaging

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with

HYDRASEAL™ is substantially equivalent to the reference predicate device identified (K191929) regarding the following features:

트 FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Intended use daily wear contact lenses I
Actions
트 Indications for use (single vision, toric)
트 Same manufacturing facility and cast molded production method
I Injection molded polypropylene blister packaging
Packaging solution composition ■

The OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ is substantially equivalent to the reference predicate device identified (K213119) regarding the following features:

트 FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
트 Intended use - daily wear contact lenses
트 Actions
Indications for use (single vision, toric, multifocal)
트 Same manufacturing production method (cast molded)
I Injection molded polypropylene blister packaging

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The following matrix illustrates the production method, lens function and material characteristics of the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with
HYDRASEAL™, as well as the predicate devices.

	OCuSOFTAMENITYTM(Subject Device)	UniconQualis(K213216)	UniconHydrogel(K191929)	Innova Vision Inc.Innova Vision Hydrogel(K213119)		Indications for Use
Intended Use	Daily wear,Soft (hydrophilic) contactlens	Daily wear,Soft (hydrophilic) contact lens	Daily wear,Soft (hydrophilic) contact lens	Daily wear,Soft (hydrophilic) contact lens	OCuSOFTAMENITY™(SubjectDevice)	OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic personswith non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons whoexhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.
Actions	In its hydrated state, thecontact lens, when placed onthe cornea, acts as arefracting medium to focuslight rays on the retina	In its hydrated state, thecontact lens, when placed onthe cornea, acts as a refractingmedium to focus light rays onthe retina	In its hydrated state, thecontact lens, when placed onthe cornea, acts as a refractingmedium to focus light rays onthe retina	In its hydrated state, thecontact lens, when placed onthe cornea, acts as a refractingmedium to focus light rays onthe retina		OCuSOFT AMENITY™ Toric (linofilcon A) DAILY DISPOSABLE CONTACT LENSES withHYDRASEAL™ are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) inaphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters andastigmatic corrections from -0.25 to -2.25 diopters.
FDAClassification	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)		OCuSOFT AMENITY™ Multifocal (linofilcon A) DAILY DISPOSABLE CONTACT LENSES withHYDRASEAL™ are indicated for the correction of refractive ametropia (myopia and hyperopia) andpresbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibitastigmatism of 1.00 diopters or less that does not interfere with visual acuity.
FDA Group	FDA Group V	FDA Group V	FDA Group II	FDA Group II		OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™are to be prescribed for single use, daily disposable wear. The lenses are not intended to be cleaned ordisinfected and should be discarded after a single use.
ProductionMethod	Fully molded	Fully molded	Fully molded	Fully molded	UniconQualis(K213216)	The Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens is indicated for the correction ofametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 1.00diopter (D) or less of astigmatism.
USAN name	linofilcon A	linofilcon A	hioxifilcon A	hioxifilcon A		Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/plannedreplacement wear with cleaning, disinfection and scheduled replacement. When prescribed for dailydisposable wear, the lens is to be discarded after each removal. When prescribed for frequent/plannedreplacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Water Content(%)	38±2%	38±2%	59±2%	59±2%	UniconHydrogel(K191929)	The Unicon Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is indicated for the correction ofametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and 6.00diopters (D) or less of astigmatism.
OxygenPermeabilityx 10-11 (cm2/sec)(mlO2)/(mlx mmHg @ 35°C)) (revisedFatt method)	100 (edge-corrected)	100 (edge-corrected)	25	25		Eye Care Professionals may prescribe the lenses either for single-use disposable wear or frequent/plannedreplacement wear with cleaning, disinfection and scheduled replacement. When prescribed for dailydisposable wear, the lens is to be discarded after each removal. When prescribed for frequent/plannedreplacement wear, the lens may be cleaned and disinfected using a chemical disinfection system only.
Refractive Index(hydrated)	1.415	1.415	1.404	1.400	Innova VisionInc.Innova VisionHydrogel(K213119)	Sphere/AsphereInnova Vision Sphere and Asphere (Hioxifilcon A) Soft Contact lenses are indicated for the correction ofametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powersfrom -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 dioptersor less that does not interfere with visual acuity.ToricInnova Vision Toric (Hioxifilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopiaor hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters.MultifocalInnova Vision Multifocal (Hioxifilcon A) Soft Contact lenses are indicated for the correction of refractiveametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes.
UV Blocker	Yes - benzotriazole	Yes - benzotriazole	Yes - benzotriazole	Yes - benzotriazole
Manufacturing	Cast-Molded	Cast-Molded	Cast-Molded	Cast-Molded
Color	Blue Handling TintC.I. Reactive Blue No. 19	Blue Handling TintC.I. Reactive Blue No. 19	Blue Handling TintReactive Blue Dye #4	Blue Handling TintC.I. Reactive Blue No. 19

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The following matrix compares the indications for use of the OCuSOFT AMENITY™ (linofilcon A) DAIL Y DISPOSABLE CONTACT LENSES with HYDRASEAL™ with the predicate device.

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non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 2.00 diopters or less that does not interfere with visual acuity. Multifocal Toric Innova Vision Multifocal Toric (Hioxifilcon A) Soft Contact lenses are indicated for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -10.00 diopters. Eye Care Practitioners may prescribe the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement or for single-use disposable wear. When prescribed for frequent/planned replacement, the Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eve Care Professional. When prescribed for frequent/planned replacement wear. the lenses may be disinfected using a chemical disinfection only. When prescribed for single-use disposable wear, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Performance Testing

Non-clinical performance tests were performed to demonstrate the safety and effectiveness of the linofilcon A finished contact lenses in K213216. Additional testing performed on the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ include:

Toxicology:

All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed on extracts of the finished contact lenses and the contact lens storage solution in accordance with ISO 10993-5 with results indicating that the contact lens extracts and packaging solution is non-cytotoxic.
· Systemic Toxicity: Acute systemic toxicity was performed on the extracts of the finished contact lenses in accordance with ISO 10993-11 and no acute systemic toxicity was found.
· Acute Ocular Irritation: Acute ocular irritation testing was performed on extracts of the finished contact lens and the contact lens storage solution in accordance with ISO 10993-23 and resulted in no ocular irritation.

Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the OCuSOFT AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

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Bench Testing - Manufacturing Verification Testing:

Manufacturing verification testing was conducted to demonstrate the ability of our facility to manufacture lenses in the available design configurations to a variety of prescribed parameters on a repeatable basis. All lenses were manufactured to pre-determined finished product specifications within the ANSI Z80.20 tolerance.

Clinical Testing

A clinical study was performed to demonstrate the safety and effectiveness of the linofficon A finished contact lenses in K213216.

VIII. CONCLUSIONS

Validity of Scientific Data

Pursuant to Good Laboratory Practice regulations, laboratories conducted non-clinical studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this Premarket Notification establishes that the AMENITY™ (linofilcon A) DAILY DISPOSABLE CONTACT LENSES with HYDRASEAL™ is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft (hydrophilic) daily wear contact lenses.

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.