The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.

The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not-aphakic persons with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The Legacy ( ocufilcon D) Performance-Tinted MUL TIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic persons with nondiseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

Device Description

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The hydrophilic characteristics allow aqueous solutions to enter the lens. The lenses are fabricated from ocufilcon D, which is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid (MAA), cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufiocon D and 55% water by weight when immersed in saline solution. The (ocufiocon D) name has been adopted by the United States Adopted Names Council (USAN).

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are subsequently tinted to achieve different colors using permanently listed color additives that conform to 21 CFR Part 73.3121. The lenses are processed to incorporate the 'listed' color additives and contain only the amount of the additive needed to accomplish the intended coloring effect. The lenses contain one or a combination of one or more of the following 'listed' color additives: Reactive Black 5, Reactive yellow 15, Reactive orange 78, Reactive red 180.

The Legacy (ocufilcon D) Performance-Tinted Contact Lenses are designed to aid visual performance in athletic settings. Legacy (ocufilcon D) Performance Tinted Contact Lenses enhance contrast in a wide range of outdoor light conditions. This enables the wearer to see a ball or selected objects with greater clarity than with the naked eye.

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses incorporate a UV absorbing monomer. The lenses block >95% in the UVB range (280mm - 315nm), and >50% in the UVA range (316nm - 380nm).

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured in the sphere, toric, and multifocal design configurations.

AI/ML Overview

The Legacy (Ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses underwent a series of non-clinical tests to demonstrate their safety and effectiveness. Clinical testing was not required as the performance of ocufilcon D materials has been previously established.

1. Table of Acceptance Criteria and Reported Device Performance:

The following table summarizes the performance data for the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, compared against established standards or general expectations for contact lenses.

Parameter	Acceptance Criteria (or Standard)	Reported Device Performance
Toxicology
In-Vitro Cytotoxicity	Non-toxic (in accordance with ISO 10993-5)	Non-toxic
Systemic Toxicity	Non-toxic (meets ISO 10993-11 requirements for systemic injection)	Non-toxic
Acute Ocular Irritation	No ocular irritation (in accordance with ISO 10993-10)	No ocular irritation
Compatibility
Solution Compatibility	Compatible with chemical disinfection systems currently marketed for soft (hydrophilic) contact lenses	Compatible with chemical disinfection systems
Shelf Life	Stable, sterile, and package integrity maintained over labeled expiration date	Stability, sterility, and package integrity maintained over labeled expiration date
Physicochemical & Mechanical Properties	Consistent with predicate device and established standards (e.g., ANSI Z80.20)	Consistent with predicate device and established standards
Chord Diameter	±0.20 mm	Meets tolerance (range: 11.00 mm to 15.00 mm)
Center Thickness	When ≤ 0.10 mm → ±0.010 mm + 10%; When > 0.10 mm → ±0.015 mm + 5%	Meets tolerance (range: 0.05 mm to 0.15 mm)
Base Curve	±0.20 mm	Meets tolerance (range: 7.00 mm to 10.0 mm)
Back Vertex Power (F'v)	When 0.00 < F'v ≤ 10.00 D → ±0.25 D; When 10.00 < F'v ≤ 20.00 D → ±0.50 D	Meets tolerance (range: +20.00D to -20.00D)
Cylinder Power (F'c)	When 0.00 < F'c ≤ 2.00 D → ±0.25 D; When 2.00 < F'c ≤ 4.00 D → ±0.37 D	Meets tolerance (range: -0.25D to -4.00D)
Cylinder Axis	When 0.00 < F'c ≤ 1.50 D → ± 8°; When F'c > 1.50 D → ± 5°	Meets tolerance (range: 10° to 180°)
Multifocal Add Power	±0.37 D	Meets tolerance (range: +0.25D to +4.00D)
Surface Appearance	Lenses should be clear with no surface defect	Clear with no surface defect
Oxygen Permeability (x 10⁻¹¹ (cm²/sec)(mlO2)/(ml x mmHg))	±20% of 19.6	19.6
Light Transmission - Tinted (@ 380-780nm)	> 38%	> 38% (reported with ±5% tolerance)
Ultraviolet Radiation Transmittance (TUVB: 280-315 nm; TUVA: 316-380 nm)	< 5 % TUVB; < 50 % TUVA (Specifically: < 0.05Tv TUVB; < 0.50Tv TUVA)	< 5 % TUVB; < 50 % TUVA
Water Content	±2% of 55%	55%
Refractive Index (hydrated)	±0.005 of 1.410	1.410

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

The document does not explicitly state a specific sample size for each non-clinical test. However, it indicates that "A series of preclinical testing was performed." The provenance for the non-clinical toxicology tests is that they were conducted "in accordance with the GLP regulation." The data is thus scientifically valid under 21 CFR 860.7. No specific country of origin is mentioned for the test data, beyond the general adherence to international standards (ISO). The nature of the testing is non-clinical (laboratory-based), rather than retrospective or prospective patient data.

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

Not applicable. This device is a contact lens and its performance criteria are based on objective physical, chemical, and biological compatibility measurements, not on expert interpretations of medical images or conditions. The "ground truth" is established by adherence to recognized international standards (e.g., ISO, ANSI) and regulatory guidelines.

4. Adjudication method for the test set:

Not applicable. The tests performed are objective, quantitative measurements (e.g., cytotoxicity, oxygen permeability, refractive index) rather than human-interpreted assessments requiring adjudication.

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-assisted diagnostic or imaging device. Therefore, MRMC studies and AI assistance are not relevant.

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

Not applicable. As noted above, this is a physical medical device, not a software algorithm.

7. The type of ground truth used:

The "ground truth" for the non-clinical tests was established by objective standards and regulatory guidelines. This includes:

International Standards: ISO 10993-5 (In-Vitro Cytotoxicity), ISO 10993-11 (Systemic Toxicity), ISO 10993-10 (Acute Ocular Irritation), and ANSI Z80.20 (Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties).
Regulatory Compliance: Adherence to GLP (Good Laboratory Practice) regulations and 21 CFR 73.3121 for color additives.
Predicate Device Comparison: The physicochemical and mechanical properties were also compared for "consistent material properties" with the primary predicate device (ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses, K182247).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

Not applicable. As this device does not use machine learning, no training set or its associated ground truth was established.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 9, 2019

VizionFocus, Inc. Mr. Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

Re: K192225

Trade/Device Name: Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 1, 2019 Received: November 4, 2019

Dear Mr. 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 (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) K192225

Device Name

Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses

Indications for Use (Describe)

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

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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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: K192225

SUBMITTER I.

Date Prepared:	December 6th, 2019
Name:	VIZIONFOCUS INC.
Address:	No.66, Youyi Rd., Zhunan TownshipMiaoli County 350,Taiwan (R.O.C.)
Contact Person:	Angus ShihGeneral Manager
Phone number:	037-582900
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily WearContact Lenses
CommonName:	Contact Lens, Daily Wear
ClassificationName:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
RegulatoryClass:	Class II
Product Code:	LPL; MVN

Purpose of 510(k) Submission:

~ New Device ~

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III. PREDICATE DEVICE

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the following predicate device(s):

ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)" . By Vizionfocus, Inc. 510(k) number; K182247 Primary predicate . MAXSIGHT (polymacon) Sport-Tinted Contact Lens
By Bausch & Lomb, Inc. 510(k) number: K050157 Reference predicate

IV. DEVICE DESCRIPTION

Color Additive	CAS Reg. No	Listing
Reactive Black 5	17095-24-8	21 CFR § 73.3121
Reactive yellow 15	60958-41-0	21 CFR § 73.3121
Reactive orange 78	68189-39-9	21 CFR § 73.3121
Reactive red 180	98114-32-0	21 CFR § 73.3121

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The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured in the sphere, toric, and multifocal design configurations. The material properties and available parameters of the finished lenses are as follows:

Parameter	Range	Tolerance*
Chord Diameter	11.00 mm to 15.00 mm	±0.20 mm
Center Thickness	0.05 mm to 0.15 mm	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Base Curve	7.00 mm to 10.0 mm	±0.20 mm
Back Vertex Power (F'v)	+20.00D to -20.00D(in 0.25D steps)	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)	-0.25D to -4.00D(in 0.25D steps)	When 0.00 < F'c ≤ 2.00 D → ±0.25 DWhen 2.00 < F'c ≤ 4.00 D → ±0.37 D
Cylinder Axis	10° to 180°(in 10° steps)	When 0.00 < F'c ≤ 1.50 D → ± 8°When F'c > 1.50 D → ± 5°
Multifocal Add Power	+0.25D to +4.00D (0.50D steps)	±0.37 D
Surface Appearance	-	Lenses should be clear with no surface defect
Oxygen Permeability(x 10-11(cm²/sec)(mlO2)/(mlx mmHg))	19.6	±20%
Light Transmission - Tinted(@ 380-780nm)	> 38%	±5%
Ultraviolet RadiationTransmittance	< 5 % TUVB< 50 %TUVA	TUVB (280 to 315 nm) < 0.05TvTUVA (316 to 380 nm) < 0.50Tv
Water Content	55%	±2%
Refractive Index	1.410 (hydrated)	±0.005

*ANSI Z80.20, Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements And Physicochemical Properties (2010)

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V. INDICATIONS FOR USE

The Legacy (ocufilcon D) Performance-Tinted SPHERICAL contact lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic or notaphakic persons with non-diseased that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.

The Legacy (ocufilcon D) Performance-Tinted TORIC Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 5.00 diopters.

The Legacy (ocufilcon D) Performance-Tinted MULTIFOCAL Soft Contact Lenses for daily wear are indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.0 diopters that does not interfere with visual acuity.

Daily wear replacement schedules may vary from patient and should be decided by eye care practitioners in consultation with their patients.

Eye care practitioners may prescribe any of the above lenses for frequent/planned replacement wear. with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Eye care practitioners may prescribe any of the above lenses for single use daily disposable wear. When prescribed for daily disposable wear the lens is to be discarded after each removal.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE VI. DEVICE

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the predicate devices identified (K182247 and K050157) in terms of the following:

USAN contact lens material (ocufilcon D) .
트 FDA Group 4 (>50% H2O, ionic polymer)
FDA classification Soft (hydrophilic) Contact Lens (21 CFR 886.5925) .
. Intended use - daily wear contact lenses
" Actions
트 Indications for use
Design configurations available (spherical, toric, multifocal) 트
. UV absorber
I Cast molded production method

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The following matrix illustrates the production method, lens function and material characteristics of the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses, as well as the predicate devices.

	VizionfocusLegacy Performance-Tinted(Subject Device)	VizionfocusILICON 55 UV(Predicate Device)(K182247)	Bausch & Lomb,Maxsight sport-tinted(Predicate Device)(K050157)
Indications for Use	Indicated for daily wearfor the correction ofrefractive error inaphakic and not aphakicpersons with non-diseased eyes withmyopia or hyperopiaand/or presbyopia.	Indicated for daily wearfor the correction ofrefractive error inaphakic and not aphakicpersons with non-diseased eyes withmyopia or hyperopia.	For the correction of visualacuity in not aphakicpersons with non-diseasedeyes with myopia orhyperopia and mayexhibited refractiveastigmatism up to 2.00diopters that does notinterfere with visual acuity.
Actions	The contact lenses act asa refractive medium thatfocus light rays fromnear and distant objectson the retina	The contact lenses act asa refractive medium thatfocus light rays fromnear and distant objectson the retina	The contact lenses act as arefractive medium thatfocus light rays from nearand distant objects on theretina
FDA Classification	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic)Contact Lens (21 CFR886.5925)	Soft (hydrophilic) ContactLens (21 CFR 886.5925)
FDA Group	FDA Group 4(>50% H2O, ionicpolymer)	FDA Group 4(>50% H2O, ionicpolymer)	FDA Group 1(<50% H2O, non-ionicpolymer)
Production Method	Fully molded	Fully molded	Fully molded
USAN name	ocufilcon D	ocufilcon D	polymacon
Water Content (%)	55±2%	55±2%	38.6±2%
Oxygen Permeabilityx 10-11 (cm²/sec)(mlO2)/(ml xmmHg @ 35°C)) (revised Fattmethod)	19.6	19.6	8.4
Refractive Index(hydrated)	1.410	1.410	1.43
Modulus (MPa)	0.49	0.49	-
UV Blocker	Yes	Yes	No

Substantial Equivalence Matrix

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VII. PERFORMANCE DATA

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

Non-clinical Testing

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the finished contact lenses. The results support the claim that the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are substantially equivalent to the currently marketed predicate devices. A summary of the results from the preclinical studies is presented below.

Toxicology:

All non-clinical toxicology tests were conducted in accordance with the GLP regulation.

· In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses and packaging materials are non-toxic.
· Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and are considered non-toxic.
Acute Ocular Irritation: Acute ocular irritation test was performed in accordance with ISO 10993-10 and produced no ocular irritation for the finished lenses and packaging materials.

Solution Compatibility:

The Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are manufactured from ocufilcon D (USAN), which is compatible with chemical disinfection systems currently marketed in the US for use with soft (hydrophilic) contact lenses.

Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses over the duration of the labeled expiration date. The data presented supports substantial equivalence of the contact lenses to the already marketed predicate devices.

Physicochemical & Mechanical Properties:

The following tests were completed to verify substantial equivalence with the primary predicate device: refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity and polymerization residuals.

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Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses and the predicate devices.

Clinical Testing

Clinical testing is not required. The clinical performance of soft (hydrophilic) contact lenses manufactured from ocufilcon D materials has been demonstrated previously.

VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology, microbiology, and shelf-life stability 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 Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses are 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 tinted soft (hydrophilic) daily wear contact lenses. In addition to the benefits from other tinted soft (hydrophilic) daily wear contact lenses, Legacy (ocufilcon D) Performance-Tinted Soft (Hydrophilic) Daily Wear Contact Lenses aid visual performance in athletic settings.

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.