The C.VUE Advanced Definitive, sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 10 diopters.

The C.VUE Advanced Definitive, multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The C.VUE Advanced Definitive, multifocal toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Device Description

The C.VUE Advanced Definitive Silicone Hydrogel Soft Contact Lenses are fabricated from efrofileon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates D&C Green 6 as an integrated handling tint. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

The document describes the acceptance criteria and the study conducted for the C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list "acceptance criteria" in a quantitative manner for specific performance metrics that would be compared to reported device performance. Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on material properties, intended use, and manufacturing process.

However, we can infer some key device properties and compare them across the new device and predicate devices.

Property	Acceptance Criteria (Inferred from Predicate "IntelliWave" which the new device is identical to)	Reported Device Performance (C.VUE Advanced Definitive)
USAN Name	efrofilcon A	efrofilcon A
Water Content	74%	74%
Oxygen Permeability	60 x 10^-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method)	59.8 x 10^-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method)
Specific Gravity	1.139 (hydrated)	1.048 (hydrated) (Note: Discrepancy observed between page 2 and page 5 for specific gravity, with 1.048 on page 2 and 1.139 on page 5)
Production Method	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured
Intended Use & Indications	Daily wear for correction of ametropia, including astigmatism and presbyopia	Matches the predicate IntelliWave indications

Note on Specific Gravity: There is a discrepancy in the reported Specific Gravity for the C.VUE Advanced Definitive. On page 2, it states "1.048 (hydrated)", while in the table on page 5, it lists "1.139" and identifies it as "same as IntellliWave³". This suggests a potential transcription error or an oversight in the consistency of data presentation within the document. Given the claim of being identical to IntelliWave³, the value of 1.139 from the equivalence table might be the intended point of comparison for acceptance.

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

The document states: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." It explicitly mentions that the C.VUE Advanced Definitive is identical in material and manufacturing process to the cleared Intelliwave³ (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens (K100221).

Therefore, no new clinical test set (sample size or provenance) was used for this specific 510(k) submission. The reliance is on the prior establishment of clinical performance for the efrofilcon A material through the predicate device. The document does not provide details about the sample size or provenance of the original clinical studies for the Intelliwave³ lens that established the performance of the efrofilcon A material.

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

As no new clinical studies were conducted for this submission, there were no experts specifically used to establish ground truth for a new test set for the C.VUE Advanced Definitive lens.

4. Adjudication Method for the Test Set

Since no new clinical studies were conducted, there was no adjudication method applied to a new test set for this submission.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission did not involve new clinical trials comparing human readers with and without AI assistance or any other form of MRMC study, as the device is a contact lens and not an AI-driven diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, no standalone algorithm performance study was conducted.

7. The Type of Ground Truth Used

The "ground truth" for the safety and effectiveness of the efrofilcon A material was established through previous clinical performance data (presumably clinical trials, expert evaluations, and outcomes data) for the predicate Intelliwave³ lens, which used the same material. The current submission relies on the established safety and effectiveness of this material and manufacturing process.

Additionally, non-clinical testing on the C.VUE Advanced Definitive lenses contributed to the evidence, including:

In vivo preclinical toxicology and biocompatibility tests
Sterility testing
Packaging material and extract toxicity/irritation tests
Physical and material property consistency tests

These non-clinical tests were conducted according to GLP regulations and valid scientific protocols to confirm the device's properties.

8. The Sample Size for the Training Set

This question is not applicable. The device is a contact lens and does not involve an AI algorithm that requires a training set.

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

This question is not applicable, as there is no training set for an AI algorithm.

Summary

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PAGE 1 OF 6

OCT 2 8 2010

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.

K100456 The assigned 510(k) number is:

Applicant information:

Date Prepared:

September 22, 2010

Name: Address Unilens CORP USA 10431 72nd Street North Largo, FL 33777

Mr. Michael Pecora

President

(727) 544-2531

Contact Person:

Phone number:

Consultant:

Martin Dalsing Medvice Consulting, Inc. 806 Kimball Avenue Grand Junction, CO 81501

(970) 243-5490 Phone number

Device Information:

Device Classification: Class II

Classification Number: LPL

Lenses, Soft Contact, Daily Wear Classification Name:

Trade Name:

C·VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

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K100456
PAGE 2 OF 6

Equivalent Devices:

The C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lenses (efrofilcon A) are substantially equivalent to the following predicate devices:

Predicate devices:

"IntelliWave", Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" by Art Optical Contact Lens, Inc. 510(k) number: K100221

"C.VUE Advanced (hioxifilcon D)" by Unilens CORP USA 510(k) number; K082393

"Biofinity (comfilcon A)" by Coopervision, Inc. 510(k) number; K052560

"ActiFresh 400 (lidofilcon A)" By Hydron Ltd. 510(k) number: K983637

Device Description:

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The Physical properties of the lens are:

Refractive Index	1.38
Light Transmission	greater than 97%
Surface Character	hydrophilic
Water Content	74 %
Specific Gravity	1.048 (hydrated)
Oxygen Permeability	59.8 x 10-11 (cm2/sec) (ml O2/ml x hPa @ 35°C), (revised Fatt method).

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, toric, multifocal and multifocal toric configurations with the following features and properties.

• Chord Diameter	12.0 mm to 16.00 mm
• Center Thickness	0.01 mm to 0.50 mm
• Base Curve	8.0 mm to 9.5 mm
• Power Range	-20.00D to +20.00D in 0.25 steps
• Cylinder Power (Toric)	-0.25D to -10.00D
• Cylinder Power (Multifocal Toric)	-0.25D to -4.00D
• Add Power (Multifocal)	+0.50D to +3.00D

The lens is supplied sterile in glass vials containing a bution. The vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

Intended Use:

The C.VUE Advanced Definitive, toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 10 diopters.

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Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning. disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Testing:

Non-clinical Testing A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the C.VUE Advanced Definitive (efrofilcon A) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinical toxicology tests were conducted in accordance with the GLP regulation, All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the C.VUE Advanced Definitive (efrofilcon A) Silicone Hydrogel Soft Contact Lenses demonstrate that: � Lenses supplied in glass vials are sterile for the indicated shelf-life, The packaging material and extracts are not toxic and not irritating, and . Lens physical and material properties are consistent with currently marketed . lenses. Clinical Data The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k). The C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is identical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K100221. The C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenses have the identical manufacturing process (lathe-cut versus lathe-cut) as the marketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, cleared under K 100221.

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Substantial Equivalence:

The following matrix illustrates the production method, lens function and material characteristics of the C.VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens, as well as the predicate devices.

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, Microbiology, chemistry, shelf-life stability studies and followed 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 C VUE Advanced Definitive, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of Silicone Hydrogel, Daily Wear Soft Contact Lens. The benefits to the patient are the same as those for other Silicone Hydrogel contact lenses.

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	C-VUE Advanced Definitive,Silicone Hydrogel(efrofilcon A)New Device	IntelliWave³, SiliconeHydrogel (efrofilcon A)predicate device	Unilens C-VUE Multifocal(hioxifilcon D)predicate device	CooperVision Biofinity(comfilcon A)predicate device	Hydron Ltd. ActiFresh 400(lidofilcon A)predicate device
Intended Use	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia. The lens may also beprescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia. The lens may also beprescribed for management ofirregular corneal conditions such askeratoconus and post graft fitting.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia, posses refractiveastigmatism and/or are Presbyopic.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia.	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia.
Functionality	same aspredicate device	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina.	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina.	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina.	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina.
Indications	Daily wear, Silicone Hydrogel Soft(hydrophilic) contact lens	Daily wear, Silicone Hydrogel Soft(hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contactlens	Daily wear, Silicone Hydrogel Soft(hydrophilic) contact lens	Daily wear, Soft (hydrophilic) contactlens
Production Method	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured	Lathe-Cut, custom manufactured	Cast Molded, mass produced	Lathe-Cut, custom manufactured
USAN name	efrofilcon A	efrofilcon A	hioxifilcon D	comfilcon A	lidofilcon A
Water Content	74%	74%	54%	48.0%	74.0%
Oxygen Permeability	$60 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$60 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$23.00 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$128 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$	$28 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35 degrees C), (revised Fatt method).$
Specific Gravity	1.139	1.139	1.142	1.142	1.060

K100456
PAGE 6 OF 6

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle or bird with outstretched wings. The bird is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in all capital letters.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room ~WO66-G609 Silver Spring, MD 20993-0002

Unilens Corp USA c/o Medvice Consulting, Inc. Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501

OCT 2 8 2010

Re: K100456

Trade/Device Name: C-VUE Advanced Definitive Silicone Hydrogel Daily Wear Soft

Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: September 22, 2010 Received: September 24, 2010

Dear Mr. Dalsing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm.

Sincerely yours,

Deborah falls

Malvina B. Evdelman, M.D. Director Division of Ophthalmic. Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Device Name: C.VUE Advanced Definitive, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

INDICATIONS FOR USE:

OCT 2 8 2010

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the Iens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801.109) or

(Division Sign-Off) (Optional Format 1-2-96)

Over The Counter Use
Marc Polloy

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K100456

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.