The CVUE ADVANCED (hioxifilcon D) Single Vision and Multifocal Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.

The CVUE ADVANCED (hioxifilcon D) Toric and Multifocal Toric Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia), presbyopia and astigmatism up to 4.00 diopters in aphakic and/or not-aphakic persons with non-diseased eyes.

Eye care practitioners may prescribe the lens 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 disinfection system.

Device Description

CVUE ADVANCED (hioxifilcon D) soft contact lenses are semi-scleral flexible shells which cover the cornea and may cover a portion of the adjacent sclera and are available as aspheric single vision, multifocal, toric multifocal designs. Torics have a toroidal posterior optic zone, and multifocals have the most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. All lenses share a base curve with a flattened peripheral curve which approximates the curvature of the sclera. The lens material, (hioxifilcon D), is a non-ionic copolymer of 2-hydroxyethyl methacrylate (2-HEMA) and 2, 3dihydroxypropyl methacrylate (Glycerol Methacrylate, GMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA). It consists of 46% hioxifilcon D and 54% water by weight when immersed in normal buffered saline solution. The lens is available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).

The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:

Chord diameter: 12.5 to 17.0mm
Center thickness: 0.13 to 0.73; varies with power
Base curve: 7.0 to 10.5mm
Powers: -20.00 to +20.00 diopters
ADD powers (multifocal): Up to +3.00 diopters
Cylinder (toric): Up to 4.00 diopters
Axis (toric): 0° to 180° in 1° steps
Optical zone diameters: 5.0 to 10.0mm

The physical/ootical properties of the lens are:

Refractive Index 1.408 (hydrated)
Light Transmission - tinted greater than 90%
Water Content 54%
Specific Gravity 1.299 (dry)
Oxygen Permeability (Dk Value) 23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects

AI/ML Overview

The provided text is a 510(k) summary for the C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens. It does not contain information about specific acceptance criteria or a study proving the device meets those criteria in the context of performance metrics like sensitivity, specificity, or accuracy that would typically be associated with AI/ML medical devices.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a contact lens. The "study" mentioned is the established safety profile and manufacturing/chemistry data, which were deemed equivalent to the predicate device.

Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies) are not applicable to this type of submission.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance

No explicit acceptance criteria in terms of accuracy, sensitivity, or specificity are provided for this medical device submission. The substantial equivalence argument relies on the inherent properties of the contact lens material and design being comparable to already approved devices.

The "performance" is implicitly demonstrated through the device's physical/optical properties and the claim of substantial equivalence.

Characteristic	Reported Performance (C-VUE® Advanced™)
Refractive Index	1.408 (hydrated)
Light Transmission - tinted	greater than 90%
Water Content	54%
Specific Gravity	1.299 (dry)
Oxygen Permeability (Dk Value)	23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This submission relies on substantial equivalence to predicate devices, not a new clinical performance study with a test set in the conventional AI/ML sense. The "safety profile (pre-clinical toxicology and manufacturing/chemistry data)" of the device is stated to be equivalent to the predicate device (BENZ-G 4X (hioxifilcon D), 510(k) K062854). This implies that previous data collected for the predicate device forms the basis of comparison, but specific sample sizes and data provenance for that data are not detailed in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth establishment with experts is not relevant for this type of substantial equivalence submission for a contact lens.

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

Not applicable. This is not a study requiring adjudication of expert opinions.

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. An MRMC study is not relevant for a contact lens submission focused on substantial equivalence. There is no AI component mentioned.

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

Not applicable. This device is a physical contact lens, not an algorithm.

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

Not applicable. The concept of "ground truth" as typically applied to performance studies (like for AI/ML devices) is not directly addressed here. The "truth" is established by the known physical, chemical, and optical properties of the material and the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of an AI/ML device.

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

Not applicable. There is no "training set" or "ground truth for a training set" in this context.

Summary

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K082393

Special 510(k) hioxifilcon D contact lenses Unilens Corp., USA 10431 7210 Street North, Largo, FL 33777 USA

Registration No. 1034196

510(k) Summary

Applicant Information

SEP 1 1 2008

Date prepared:	18 August 2008
Name:	Unilens Corp., USA
Address:	10431 72nd Street, NorthLargo, FL 33777
Contact person:	Alan J. FrazerDirector of Quality Assurance
Phone number:	(727) 544-2531
Fax number:	(727) 545-1883

Device Information

Device classification:	Class II
Classification number:	LPL
Classification name:	Lenses, Soft Contact, Daily Wear
Trade name:	C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic)Contact Lens

Equivalent device

The C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device:

C-VUE® Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens; and Benz-G 4X 54% (hioxifilcon D) Lathed Sphere and Toric Lenses

Device description

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available with or without a blue visibility handling tint, phthalocyanato (2) -(copper).

The CVUE ADVANCED (hioxifilcon D) soft contact lens is a hemispherical shell of the following dimensions:

Chord diameter:	12.5 to 17.0mm
Center thickness:	0.13 to 0.73; varies with power
Base curve:	7.0 to 10.5mm
Powers:	-20.00 to +20.00 diopters
ADD powers (multifocal):	Up to +3.00 diopters
Cylinder (toric):	Up to 4.00 diopters
Axis (toric):	0° to 180° in 1° steps
Optical zone diameters:	5.0 to 10.0mm

The physical/ootical properties of the lens are:

Refractive Index	1.408 (hydrated)
Light Transmission - tinted	greater than 90%
Water Content	54%
Specific Gravity	1.299 (dry)
Oxygen Permeability (Dk Value)	23 x 10-11 Fatt Units (cm2/sec) (ml O2/ml x mm Hg @ 35°C), ANSI Z80.20:2004 upgraded polarographic method corrected for boundary-layer and edge effects

Intended Use (Indications)

The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased eyes. The lens may be worn by persons who require up to 3.00 Diopters of add and who exhibit astigmatism of up to 0.75 Diopters that does not interfere with visual acuity.

Substantial equivalence

The CVUE ADVANCED (hioxifilcon D) Single Vision Contact Lenses will be manufactured according to specified process controls and a quality management system currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and

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Special 510(k) hioxifilcon D contact lenses Unilens Corp., USA 10431 72™ Street North, Largo, FL 33777 USA

distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 4X (hioxifilcon D), 510(k) K062854. Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

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Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling an eagle or bird with its wings spread.

SEP 1 1 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Unilens Corp.,USA Alan J. Frazer Director of Quality Assurance 10431 72nd Street, North Largo FL 33777

Re: K082393

Trade/Device Name: C-VUE® Advanced™ (hioxifilcon D) Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: August 18, 2008 Received: August 19, 2008

Dear Mr. Frazer:

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. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements. including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Marlina B. Egleston, M.D.

Malvina B. Eydelman, M.I 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

Ko82393 510(k) Number (if known):

Device Name: C-Vue® Advanced™ (hioxifiocon D) soft (hydrophilic) contact lenses

Indications for Use:

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Att

Nose and Throat Devis

510(k) Number K082343

Page _ of _

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.