The Metro Soft, 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 nondiseased 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 Metro Soft, 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 nondiseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The Metro Soft, multifocal (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 .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Metro Soft, 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 non-aphakic persons with non-diseased eves and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add nower of up to +4.00 diopters.

The Metro Soft, irregular cornea (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 and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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 Metro Soft Silicone Hydrogel Soft Contact Lenses are fabricated from efrofilcon 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 bevond 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 provided text describes a 510(k) summary submission for a medical device, the Metro Soft Silicone Hydrogel Daily Wear Soft Contact Lens. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than establishing entirely new safety and effectiveness through extensive standalone clinical trials.

Therefore, the requested information about acceptance criteria, a study proving device meets acceptance criteria, sample sizes for test/training sets, number/qualifications of experts, adjudication methods, MRMC studies, or specific ground truth for an AI/algorithm-based device is not applicable to this document. This document details a regulatory submission for a contact lens, which is a physical device, and not an AI or algorithm.

Instead, the document outlines the following:

1. Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" in this context are the characteristics of the device that demonstrate its substantial equivalence to predicate devices. The performance is reported by direct comparison of its physical properties and intended use.

Characteristic	Metro Soft (efrofilcon A) - New Device	Predicate (IntelliWave3, efrofilcon A)	Predicate (Metro Optics RevitalEyes, hioxifilcon B)	Predicate (Coopervision Biofinity, comfilcon A)	Predicate (Hydron Ltd. ActiFresh 400, lidofilcon A)
Intended Use	Daily wear for correction of ametropia, management of irregular corneal conditions.	Same as new device	Same as new device	Daily wear for correction of ametropia.	Daily wear for correction of ametropia.
Functionality	Same as predicate device	Focus light rays on retina	Focus light rays on retina	Focus light rays on retina	Focus light rays on retina
Indications	Daily wear, Silicone Hydrogel Soft	Daily wear, Silicone Hydrogel Soft	Daily wear, Soft	Daily wear, Silicone Hydrogel Soft	Daily wear, Soft
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 B	comfilcon A	lidofilcon A
Water Content	74%	74%	48%	48.0%	74.0%
Oxygen Permeability	60 x 10-11 cm2/sec	60 x 10-11 cm2/sec	15.89 x 10-11 cm2/sec	128 x 10-11 cm2/sec	28 x 10-11 cm2/sec
Specific Gravity	1.139	1.139	1.142	1.142	1.060

2. Study Proving Device Meets Acceptance Criteria:

The study that "proves the device meets the acceptance criteria" in this context is the comparison demonstrating substantial equivalence to legally marketed predicate devices. The document explicitly states:

Clinical Data: "The clinical performance of the (efrofilcon A) lens material has been previously established, and therefore was not required for this 510(k)." This indicates that clinical studies were performed for the material in a prior submission (likely K100221 for IntelliWave3).
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 Metro Soft (efrofilcon A) Silicone Hydrogel Soft Contact Lenses... All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols."
Key Finding for Substantial Equivalence: "The Metro Soft, (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." And "The Metro Soft, (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 K100221."

No specific sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, or training set details are provided because this is a 510(k) submission for a physical medical device, not an AI/ML algorithm requiring such specific performance validation methods. The "ground truth" for this submission relies on established safety and performance data of the predicate devices and general standards for biocompatibility and material properties of contact lenses.

Summary

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PAGE 1 of 6

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

UCT 2 8 2010

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:	K100244
Applicant information:
Date Prepared:	September 20, 2010
Name:Address	Metro Optics of Austin, Inc.15802 Vision DrivePflugerville, TX 78660
Contact Person:	Steve WebbPresident
Phone number:	(512) 251-2382
Consultant:	Martin DalsingMedvice Consulting, Inc.806 Kimball AvenueGrand Junction, CO 81501
Phone number	(970) 243-5490
Device Information:
Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens(efrofilcon A)

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100244 PAGE 2 of 6

Equivalent Devices:

The Metro Soft, 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

"RevitalEyes, Post-Surgical (hioxifilcon B) by Metro Optics of Austin, Inc. 510(k) number: K080512

"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, multifocal toric and irregular Cornea 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 -12.00D
• Cylinder Power (Multifocal Toric)	-0.25D to -4.00D
• Add Power (Multifocal)	+0.50D to +4.00D

The lens is supplied sterile in vials containing a buffered saline solution. 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 Metro Soft, 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 nondiseased eves. 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.

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K100244
PAGE 4 OF 6

The Metro Soft, 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 non-aphakic 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.

Testing:

Non-clinical Testing	A series of in vitro and in vivo preclinical toxicology and biocompatibility testswere performed to assess the safety and effectiveness of the Metro Soft (efrofilconA) Silicone Hydrogel Soft Contact Lenses packaged in glass vials. All non-clinicaltoxicology tests were conducted in accordance with the GLP regulation. All othertesting was conducted according to valid scientific protocols.
	Test results of the non-clinical testing on the Metro Soft (efrofilcon A) SiliconeHydrogel 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 previouslyestablished, and therefore was not required for this 510(k).
	The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lens isidentical to the cleared Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily WearSoft Contact Lens, cleared under K100221.
	The Metro Soft, (efrofilcon A) Silicone Hydrogel Daily Wear Soft Contact Lenseshave the identical manufacturing process (lathe-cut versus lathe-cut) as themarketed Intelliwave3 (efrofilcon A) Silicone Hydrogel Daily Wear Soft ContactLens, cleared under K100221.

Substantial Equivalence:

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The following matrix illustrates the production method, lens function and material characteristics of the Metro Soft, (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 Metro Soft, (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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	Metro Soft, SiliconeHydrogel (efrofilcon A)New Device	IntelliWave3, SiliconeHydrogel (efrofilcon A)predicate device	Metro Optics, RevitalEyes(hioxifilcon B)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. 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.	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 B	comfilcon A	lidofilcon A
Water Content	74%	74%	48%	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).	15.89 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

人100244 PAGE 6 OF 6

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

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

Metro Optics of Austin Inc. c/o Medvice Consulting, Inc. Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501

OCT 2 8 2010

Re: K100244

Trade/Device Name: Metro Soft 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 20, 2010 Received: September 22, 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.

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: Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

INDICATIONS FOR USE:

Evecare 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.

(PLEASE DO NOT 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)

(Optional Format 1-2-96)

Over-The-Counter Use

OCT 2 8 2010

Marc Robert

(Division Sign-Off) (Division Sign-On)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

K100244
Number

510(k) Number

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.