The C-Vue's Toric Multifocal Contact Lens is 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.

Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

Device Description

The C-Vue's Tonc (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens is a front surface asphere consisting of multiple aspheric zones with an eccentric lenticulation for ballast and axis stabilization. The base curve has a toroidal posterior optic zone and a flattened peripheral curve which approximates the curvature of the sclera. The most plus power is in the center of the lens, with the power progressively becoming more minus towards the periphery. The lens material, (methafilcon A), is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid, crosslinked with ethyleneglycol dimethacrylate.

The C-Vue35 Toric Multifocal Contact Lens is a hemispherical shell of the following dimensions:

Chord diameters: 14.0 to 15.0mm
Center thickness: 0.10 to 0.60mm; varies with power
Base curves: 8.4 to 9.3mm
Powers: -20.00 to +20.00 diopters
Add powers: Up to +3.00 diopters
Cylinder: Up to 4.00 diopters
Axis: 1° to 180° in 1° steps
Optical zone diameters: 5.0 to 10.0mm

The physical/optical properties of the lens are:

specific gravity: 1.09
refractive index (wet): 1.415
light transmittance (clear and tint): greater than 90% in the visible light region
water content: 55%
oxygen transmissibility: 18.83 x 10^-11 (cm²/sec)(ml O2/ml x mm Hg)*

as measured by Schema Versatae Model 920 connected to a polargraphic cell

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the C-Vue35 Toric (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens, based on the provided 510(k) summary:

This device is a medical device, and the provided document is a 510(k) summary for premarket notification to the FDA. For such devices, particularly contact lenses, "acceptance criteria" usually refer to meeting established safety and effectiveness standards, often demonstrated through comparison to a legally marketed predicate device rather than complex performance metrics against a specific numerical threshold. Clinical studies for contact lenses primarily focus on demonstrating comparable safety and effectiveness, including patient comfort, vision correction, and lack of adverse events.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list distinct "acceptance criteria" in the format of numerical targets. Instead, the demonstration of substantial equivalence to a predicate device serves as the primary "acceptance criterion" for marketing approval. The document asserts that the device meets the safety and effectiveness profile of its predicate.

Acceptance Criterion Type	Description of Criterion	Reported Device Performance (as implied by the 510(k))
Material Properties	Similar or equivalent physical/optical properties to established, safe contact lens materials, ensuring biocompatibility, oxygen supply, and optical clarity.	The device utilizes "methafilcon A," a copolymer with established safety. Specific properties like water content (55%), oxygen transmissibility ($18.83 \times 10^{-11}$), refractive index (1.415), specific gravity (1.09), and light transmittance (>90%) are reported and are presumed to be within acceptable ranges.
Intended Use	Capability to correct refractive ametropia (myopia and hyperopia), presbyopia, and astigmatism up to 4.00 diopters in aphakic and/or non-aphakic persons with non-diseased eyes for daily wear in a Planned Replacement Program, and to be disinfected chemically.	The device's design (aspheric zones, eccentric lenticulation, toroidal posterior optic zone) directly supports its intended use for multifocal and toric correction. The 510(k) states the device is indicated for these uses.
Safety Data	Comparable safety profile (pre-clinical toxicology and manufacturing/chemistry data) to a legally marketed predicate device. This implies demonstrating non-toxicity, appropriate material stability, and lack of adverse biological reactions.	The device is stated to have an "established safety profile (pre-clinical toxicology and manufacturing/chemistry data) ... equivalent to the BENZ-MF (methafilcon A), 510(k) K003861" (which is also listed as a legally marketed device).
Manufacturing/Quality	Manufactured according to specified process controls and a quality management system. The manufacturing, packaging, and sterilization procedures must be similar to those of currently marketed devices.	The device "will be manufactured according to specified process controls and a quality management system currently in place." It will undergo "manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Unilens Corp., USA."
Substantial Equivalence	The device must not raise different questions of safety and effectiveness than a legally marketed predicate device (LifeStyle MV2™ Toric (polymacon) Soft (hydrophilic) Multifocal Contact Lens). This is the overarching regulatory "acceptance criterion."	The 510(k) directly states the device is "substantially equivalent to the predicate device identified below in terms of intended use and design." It further confirms this by adding, "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 device identified above."

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

The provided 510(k) summary does not explicitly mention a specific clinical test set, its sample size, or data provenance (country, retrospective/prospective). For 510(k) submissions of contact lenses, particularly when demonstrating substantial equivalence, clinical data might be leveraged from the predicate device or a previous similar device, or new limited clinical trials might be conducted. However, this summary only refers to "pre-clinical toxicology and manufacturing/chemistry data" and states equivalence to an existing 510(k) device (BENZ-MF, K003861). It implies that the type of material has an established track record.

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

Given the lack of explicit clinical trial data in this summary, there's no information provided on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method for the Test Set

Again, due to the absence of detailed clinical trial data, no adjudication method is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in this document. This type of study is more common for diagnostic imaging AI devices, rather than contact lenses, where the primary focus is on direct vision correction and ocular health as opposed to interpretive accuracy.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a physical contact lens, not a software algorithm. Therefore, "standalone performance" in the context of AI algorithms is not relevant.

7. Type of Ground Truth Used

For the purpose of substantial equivalence in a 510(k) for contact lenses, the "ground truth" is largely established by:

Established Material Properties and Biocompatibility: The known safety and performance of the methafilcon A material itself, as demonstrated in prior approvals (like K003861).
Clinical Performance of Predicate Device: The safety and effectiveness of the predicate device (LifeStyle MV2™ Toric), implying that a device with similar design and materials should yield similar clinical outcomes.
Manufacturing and Quality Control Data: Internal testing to ensure the lens meets its physical and optical specifications.

There's no mention of pathology or outcomes data from a specific de novo clinical study in this summary.

8. Sample Size for the Training Set

Not applicable. As a physical medical device (contact lens) and not an AI algorithm, there is no "training set."

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

Not applicable. As there is no training set mentioned, there is no information on how its ground truth would have been established.

Summary

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K041608

510(k) Summary

Applicant Information

JUL - 7 2004

Date prepared:	June 1, 2004
Name:	Unilens Corp., USA
Address:	10431 72nd Street, NorthLargo, FL 33777
Contact person:	Josepha Bruno, Director 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-Vue55 Toric (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens

Equivalent device

The C-Vue's Toric (methafilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate device: LifeStyle MV2™ Toric (polymacon) Soft (hydrophilic) Multifocal Contact Lens

Device description

The C-Vue35 Toric Multifocal Contact Lens is a hemispherical shell of the following dimensions:

Chord diameters	14.0 to 15.0mm
Center thickness	0.10 to 0.60mm; varies with power
Base curves	8.4 to 9.3mm
Powers	-20.00 to +20.00 diopters
Add powers	Up to +3.00 diopters
Cylinder	Up to 4.00 diopters
Axis	1° to 180° in 1° steps
Optical zone diameters	5.0 to 10.0mm

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The physical/optical properties of the lens are:

specific gravity	1.09
refractive index (wet)	1.415
light transmittance (clear and tint)	greater than 90% in the visible light region
water content	55%
oxygen transmissibility	$18.83 \times 10^{-11}$ (cm²/sec)(ml O2/ml x mm Hg)*

as measured by Schema Versatae Model 920 connected to a polargraphic cell

Intended use

The C-Vue33 Toric Multifocal Contact Lens is 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.

Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

Substantial equivalence

The new device 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 distributed by Unilens Corp., USA. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-MF (methafilcon A), 510(k) K003861. 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 device identified above.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL - 7 2004

Unilens Corp., USA c/o Ms. Josepha Bruno Director, Quality Assurance 10431 72nd Street North Largo, FL 33777

Re: K041608

Trade/Device Name: C-Vue35 Toric Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens for Daily Wear

Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: June 9, 2004 Received: June 15, 2004

Dear Ms. Bruno:

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.

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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Page 2 - Ms. Josepha Bruno

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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Akeryl Rosenthal

A. Ralph Rosenthal, M.D. 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

510(k) Number (if known): _ KO4-1608 _________________________________________________________________________________________________________________________________________

Device Name: C-Vue's Toric Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens

Indications for Use:

Eyecare practitioners may prescribe the lens for daily wear in a Planned Replacement Program. The lens may be disinfected using a chemical disinfection system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINE ON ANOTHER PAGE IF NEEDED)

(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number	K041608
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Prescription Use(Part 21 CFR 801 Subpart D)
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AND/OR

Over-The-Counter-Use(Part 21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of Device Evaluation (ODE)

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.