The EZvue UV (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity.

The EZvue Colors (ocufilcon D) Spherical Soft Contact Lenses for daily wear are indicated for the correction of refractive error in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

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

Frequent/Planned Replacement Wear:

Eyecare 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.

Disposable Wear:

Eyecare 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 EZvue UV soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the contact lens material to block UV radiation. EZvue UV lenses are available clear and visibility tinted (for handling) using C.I. Reactive Blue Dye #19.

The EZvue Colors soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. EZvue Colors lenses are tinted to enhance or alter the apparent color of the eye. Lenses are tinted with a combination of one or more of the following 'listed' color additives: C.I. Reactive Blue 19, C.I. Pigment Green 7, Iron oxides, C.I. Reactive Yellow 86, C.I. Reactive Black 5, C.I. Pigment Violet 23, Titanium dioxide. The imprinted color pattern is surrounded on both sides by layers of contact lens material (ocufilcon D). The tinting pattern has a Clear Pupil diameter of 5.5 to 9.0 mm.

In the hydrated state, both lenses conform to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) soft hydrophilic contact lens has a spherical back surface.

AI/ML Overview

This document describes the 510(k) premarket notification for EZvue UV and EZvue Colors Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices, thus avoiding the need for extensive new clinical studies.

Here's an analysis based on your questions:

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

The document does not explicitly state "acceptance criteria" in the typical sense of quantitative benchmarks for device performance in a clinical study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through physical properties, material composition, and intended use. The "reported device performance" refers to these physical characteristics and the results of non-clinical testing.

Characteristic	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (EZvue UV/Colors)
Material	Ocufilcon D (same as primary predicate)	Ocufilcon D (hydrophilic co-polymer of 2-HEMA, methacrylic acid, EGDMA, initiator)
Water Content	55±2%	55±2%
Oxygen Permeability	16 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C))	16 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)
Refractive Index	Not explicitly stated for predicate in comparison table	1.410
Light Transmission (clear/UV)	>93%	>93%
Light Transmission (color)	>93% (clear region corresponding to pupil)	>93% (clear region corresponding to pupil)
Surface Character	Hydrophilic	Hydrophilic
Specific Gravity	1.05 (hydrated)	1.05 (hydrated)
UV Transmittance (EZvue UV)	<5% UVB (280-315nm); <50% UVA (316-380nm)	<5% UVB (280-315nm); <50% UVA (316-380nm)
Sterility	Sterile for shelf-life	Lenses supplied in blister packages are sterile for the indicated shelf-life
Biocompatibility	Non-toxic, non-irritating	Packaging material and extracts are not toxic and not irritating

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

The document primarily relies on non-clinical testing and the established performance of the ocufilcon D lens material of the predicate device (K082879).

Non-clinical Testing: Conducted "in vitro and in vivo." Specific sample sizes for these tests (e.g., how many lenses tested for sterility, how many animals for biocompatibility) are not provided.
Country of Origin: The applicant is "I-SEE VISION TECHNOLOGY INC." from Hsinchu, TAIWAN, R.O.C. The non-clinical toxicology tests were conducted "under Good Laboratory Practice regulations," but the specific location of these labs is not mentioned.
Retrospective or Prospective: These non-clinical tests are prospective, meaning they were performed specifically for this submission. The reliance on the "previously established" clinical performance of the (polymacon - this appears to be a typo and likely refers to ocufilcon D based on the context) lens material is retrospective, as it refers to data gathered for the predicate.

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. This submission does not involve a clinical study requiring expert assessment for ground truth. The "ground truth" for non-clinical tests is based on objective laboratory measurements and standardized protocols (e.g., sterility tests, toxicity assays).

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

Not applicable. There was no clinical test set requiring human 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 device is a contact lens, not an AI-powered diagnostic tool. MRMC studies are for evaluating diagnostic efficacy.

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

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

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

For the non-clinical tests, the "ground truth" is based on:

Objective Laboratory Measurements: e.g., chemical composition analysis, water content measurements, oxygen permeability, UV transmittance.
Standardized Biological Assays: For sterility and biocompatibility, these would follow established protocols for detecting microbial growth or toxic responses.
Reference Standards: For performance metrics compared against the predicate device.

For the clinical performance, the ground truth is based on the previously established "clinical performance" of the predicate lens material, which would have involved outcomes data from clinical trials.

8. The sample size for the training set

Not applicable. This is not an AI device requiring a training set. The "training" for the device's development would be analogous to product development and formulation.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 of three human profiles facing right, arranged in a cascading manner.

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

April 15, 2015

EyeReg Consulting, Inc. I-SEE VISION TECHNOLOGY Inc. Mr. Bret Andre Official Correspondent 474 NE 61st PL Hillsboro, OR 97124

Re: K150293

Trade/Device Name: Ezvue Uv, Soft Daily Wear Contact Lenses (ocufilcon D), Ezvue Colors, Soft Daily Wear Contact Lenses (oculfilcon D) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: February 3, 2015 Received: February 6, 2015

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. 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 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 contact the Division of Industry and Consumer Education 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. 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

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 Industry and Consumer Education 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.

Sincerely yours,

Kesia Y. Alexander -A

for Malvina B. Eydelman, 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K150293

Device Name EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D)

EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)

Indications for Use (Describe)

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

Frequent/Planned Replacement Wear:

Disposable Wear:

Eyecare 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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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:	K150293
Applicant information:
Date Prepared:	03/30/2015
Name:	I-SEE VISION TECHNOLOGY INC.1F, No.45, Lane 2, Sec. 2,Kuang-Fu Road, Hsinchu 30071,Taiwan, R.O.C.
Contact Person:	Isaac HuangSpecial Assistant to President
Phone number:	+886-3-5752822
Consultant:	Bret J AndreEyeReg Consulting, Inc.474 NE 61st PlHillsboro, OR 97124United States
Phone number:	(503) 372-5226
Device Information:
Device Classification:	Class II
Product Code:	LPL; MVN
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	EZvue UV, Soft Daily Wear Contact Lenses(ocufilcon D)EZvue Colors, Soft Daily Wear Contact Lenses(ocufilcon D)

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Equivalent Devices:

The EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses are substantially equivalent to the following predicate devices:

Predicate devices:

"EZyue (ocufilcon D)" . By I-See Vision Technology Inc. 510(k) number: K082879 Primary Predicate
"42 UV (hefilcon A)" . By Optical Connection, Inc. 510(k) number: K040900 Reference Predicate
"Frequency Colors (methafilcon A)" . By Coopervision, Inc. 510(k) number: K001090 Reference Predicate

EZvue UV(ocufilcon D) Device Description:

The EZvue UV soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

The nonionic lens material (ocufilcon D) is a hydrophilic co-polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and methacrylic acid, cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 45% ocufilcon D and 55% water by weight when immersed in saline solution. The (ocufilcon D) name has been adopted by the United States Adopted Names Council (USAN).

A UV absorbing monomer-2-(Benzoyl-3-hydroxyphenoxy)ethyl acrylate-is incorporated in the contact lens material to block UV radiation. The UV blocking for EZvue UV averages >95% in the UVB range of 280nm - 315nm and >50% in the UVA range of 316nm - 380mm.

EZvue UV lenses are available clear and visibility tinted (for handling) using C.I. Reactive Blue Dye #19. In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) 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.

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EZvue Colors (ocufilcon D) Device Description:

The EZvue Colors soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces.

EZvue Colors lenses are tinted to enhance or alter the apparent color of the eye. Lenses are tinted with a combination of one or more of the following 'listed' color additives:

Name of Colorant	Listing
C.I. Reactive Blue 19	21 CFR § 73.3127
C.I. Pigment Green 7	21 CFR § 73.3124
Iron oxides	21 CFR § 73.3125
C.I. Reactive Yellow 86	21 CFR § 73.3121
C.I. Reactive Black 5	21 CFR § 73.3127
C.I. Pigment Violet 23	21 CFR § 73.3107
Titanium dioxide	21 CFR § 73.3126

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by imprinting a listed color additive(s) on the non-optical zone area of the lens, which corresponds to the location of the iris. The imprinted color pattern is surrounded on both sides by layers of contact lens material (ocufilcon D). As part of the manufacturing process, the lenses containing the color additives are thoroughly washed to remove any excess color additives. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens in the location that corresponds to the iris, the coloring process does not alter the original characteristics of the pre-tinted lens. The tinting pattern has a Clear Pupil diameter of 5.5 to 9.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (ocufilcon D) 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.

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The physical properties of the EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D). Soft Daily Wear Contact Lenses are:

Refractive Index	1.410
Light Transmission (clear/UV)	greater than 93%
Light Transmission (color)	greater than 93% (clear region corresponding to pupil)
Surface Character	hydrophilic
Water Content	55±2%
Specific Gravity	1.05 (hydrated)
Oxygen Permeability	16 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 55% water by weight. The lenses will be manufactured in the spherical design configuration with the following features and properties:

Chord Diameter:	13.60 mm to 15.00 mm
Center Thickness:	0.060 mm to 0.200 mm
Base Curve:	8.40 mm to 9.10 mm
Power Range
- Sphere Power:	-12.00D to +8.00D in 0.25D steps

Intended Use:

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

Frequent/Planned Replacement Wear:

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K150293

Disposable Wear:

Eyecare 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.

Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses packaged in blister packages. 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 EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses demonstrate that:
. Lenses supplied in blister packages are sterile for the indicated shelf-life,
. The packaging material and extracts are not toxic and not irritating,
Clinical Data The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k).

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 EZvue UV (ocufilcon D) and EZvue Colors (ocufilcon D), Soft Daily Wear Contact Lenses 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 daily wear soft contact lenses. The benefits to the patient are the same as those for other daily wear soft contact lenses.

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Substantial Equivalence:

The EZvue UV/ EZvue Colors Soft Contact Lens will be manufactured according to specified process controls and a cGMP quality assurance program currently in place.

The final packaging and sterilization of the lenses will be carried out in accordance with the currently established procedures for EZvue (K082879), the predicate device.

The established safety profile of the EZvue UV/ EZvue Colors contact lens material is equivalent to the predicate devices identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, 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.

The following matrix illustrates the equivalencies of the EZvue UV(ocufilcon D) / EZvue Colors (ocufilcon D) Soft Contact Lenses for Daily Wear, as well as the substantial equivalent predicate devices.

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Substantial Equivalence Matrix

	I-See VisionTechnology Inc.EZvue UV(Subject Device)	I-See VisionTechnology Inc.EZvue Colors(Subject Device)	I-See VisionTechnology Inc.EZvue(Primary PredicateDevice)	OpticalConnection, Inc.42 UV(ReferencePredicate Device)	Coopervision,Inc.FrequencyColors(Reference PredicateDevice)
Intended Use	Soft Contact Lenses fordaily wear are indicatedfor the correction ofrefractive error inaphakic and not aphakicpersons with non-diseased eyes withmyopia or hyperopiaand/or possessesrefractive astigmatismnot exceeding 2.00Diopters, and/or arepresbyopic.	Soft Contact Lenses fordaily wear are indicatedfor the correction ofrefractive error inaphakic and not aphakicpersons with non-diseased eyes withmyopia or hyperopiaand/or possessesrefractive astigmatismnot exceeding 2.00Diopters, and/or arepresbyopic. The lensmay be used to enhanceor alter the apparentcolor of the eye.	Soft Contact Lensesfor daily wear areindicated for thecorrection ofrefractive error inaphakic and notaphakic persons withnon-diseased eyeswith myopia orhyperopia and/orpossesses refractiveastigmatism notexceeding 2.00Diopters, and/or arepresbyopic.	Soft Contact Lensesfor daily wear areindicated for thecorrection ofrefractive error inaphakic and notaphakic persons withnon-diseased eyeswith myopia orhyperopia and/orpossesses refractiveastigmatism notexceeding 2.00Diopters, and/or arepresbyopic.	Soft Contact Lensesfor daily wear toenhance or alter theapparent color ofthe eye, includingocular masking, ineither sighted ornon-sighted eyesthat requireprosthetic contactlens for themanagement ofconditions such ascorneal, iris, or lensabnormalities.
Functionality	Same as predicatedevice	Same as predicatedevice	The contactlenses act as arefractivemedium thatfocus light raysfrom near anddistant objectson the retina	The contactlenses act as arefractivemedium thatfocus light raysfrom near anddistant objects onthe retina	The contactlenses act as arefractivemedium thatfocus light raysfrom near anddistant objectson the retina
Indications	Daily Wear, Soft(hydrophilic)Contact Lens	Daily Wear, Soft(hydrophilic)Contact Lens	Daily Wear, Soft(hydrophilic)Contact Lens	Daily Wear, Soft(hydrophilic)Contact Lens	Daily Wear, Soft(hydrophilic)Contact Lens
ProductionMethod	Fully-molded	Fully-molded	Fully-molded	Fully-molded	Fully-molded
USAN name	ocufilcon D	ocufilcon D	ocufilcon D	hefilcon A	methafilcon A
Water Content(%)	55±2%	55±2%	55±2%	42±2%	55±2%
OxygenPermeability	$16 x 10^{-11}$(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C))(revised Fatt method)	$16 x 10^{-11}$(cm²/sec)(mlO₂)/(ml xmmHg @ 35°C))(revised Fatt method)	$16 x 10^{-11}$(cm²/sec)(mlO₂)/(mlx mmHg @ 35°C))(revised Fatt method)		$15.04 x 10^{-11}$(cm²/sec)(mlO₂)/(mlx mmHg @ 35°C))
UVTransmittance	<5% UVB(280nm - 315nm)<50% UVA(316nm - 380nm)			< 10% UVB
Specific Gravity	1.05 (hydrated)	1.05 (hydrated)	1.05 (hydrated)	1.039 (hydrated)

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.