REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT

K080512 · Metro Optics of Austin, Inc. · LPL · Jul 23, 2008 · Ophthalmic

Device Facts

• Record ID: K080512
• Device Name: REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT
• Applicant: Metro Optics of Austin, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 23, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery. 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.

Device Story

RevitalEyes is a lathe-cut, soft (hydrophilic) contact lens made of Hioxifilcon B; intended for daily wear to correct ametropia in post-surgical corneas. The lens is supplied in a dry state and becomes soft/pliable when hydrated in an aqueous solution. It functions as a refractive medium, focusing light onto the retina. The device is prescribed by eyecare practitioners for frequent/planned replacement; patients perform daily cleaning and disinfection using chemical (non-heat) systems. The lens provides a transparent optical surface that conforms to the corneal curvature. By correcting vision in surgically altered eyes, the device benefits patients by improving visual acuity following refractive procedures.

Clinical Evidence

No clinical data provided; substantial equivalence is based on bench testing, material characterization, and comparison of physical properties (water content, oxygen permeability, refractive index) to predicate devices.

Technological Characteristics

Material: Hioxifilcon B (hydrophilic polymer). Water content: 49% (hydrated). Oxygen permeability: 16.40 x 10^-11 (cm^2/sec)(ml O2/ml x hPa @ 35°C). Refractive index: 1.51 (dry), 1.42 (hydrated). Form factor: Lathe-cut soft contact lens. Sterilization: Not specified.

Indications for Use

Indicated for daily wear in non-diseased eyes requiring soft contact lenses for management of surgically altered corneas following LASIK, PRK, or RK surgery.

Regulatory Classification

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.

Predicate Devices

• Metro-G 3X (K964902)
• FlexLens Post Refractive Surgery (K961943)

Submission Summary (Full Text)

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# JUL 2 3 2008 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:

K080Sız

# Applicant information:

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| Date Prepared: | June 9, 2008 |
|-----------------|----------------------------------------------------------------------------------------------|
| Name: | Metro Optics of Austin, Inc. |
| Address | 15802 Vision Drive<br>Pflugerville, TX 78660 |
| Contact Person: | Steve Webb |
| Phone number: | [phone] |
| | President |
| Consultant: | Martin Dalsing<br>Medvice Consulting, Inc.<br>806 Kimball Avenue<br>Grand Junction, CO 81501 |
| Phone number | [phone] |

Device Information:

| Device Classification: | Class II |
|------------------------|------------------------------------------------------------------------------------------------------------|
| Classification Number: | LPL |
| Classification Name: | Lenses, Soft Contact, Daily Wear |
| Trade Name: | RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens<br>(Hioxifilcon B) clear and blue visibility tint. |

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## Equivalent Devices:

The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint are substantially equivalent to the following predicate devices in terms of contact lens material, intended use and design.

Predicate devices include:

| Metro-G 3X, manufactured by Metro Optics of Austin, | K964902 |
|-------------------------------------------------------------|---------|
| FlexLens Post Refractive Surgery, manufactured by FlexLens, | K961943 |

# Device Description:

The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, which in the dry (unhydrated) state may be machined and polished to by cloud and prophilic nature of these materials allows the lens to become soft and pliable when immersed in an aqueous solution.

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 (hioxifileon B) soft hydrophilis 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 appar somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 49% water by weight. The physical properties of the lens are:

(Hioxifilcon B)

| Refractive Index | 1.51 (dry) 1.42 (hydrated) |
|---------------------|-------------------------------------------------------------------------------|
| Light Transmission | greater than 94% |
| Surface Character | hydrophilic |
| Water Content | 49 % |
| Specific Gravity | 1.137 (hydrated) |
| Oxygen Permeability | $16.40 X 10^{-11} (cm^2/sec) (ml O_2/ml x hPa @ 35°C), (revised Fatt method)$ |

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### Intended Use:

The RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint may be prescribed for the corrective ametropia (myopia, hyperopia, and astigmatism) in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.

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.

### Substantial Equivalence:

The device will be manufactured according to specified process controls and a quality assurance program. The established safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry of the device is equivalent to the BENZ-G 3X. Being similar with respect to indications for use, materials, plysical construction and safety & effectiveness to the predicate devices, this meets the requirements per six(r) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness, than the predicate devices identified above.

The following matrix illustrates the production method, lens function and material characteristics of the RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint, as well as the predicate devices.

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# Substantial Equivalence Matrix

| | RevitalEyes<br>New Device | Flexlens Post Refractive<br>Surgery (hefilcon A)<br>predicate device | METRO-G<br>(hioxifilcon B)<br>predicate device |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily wear and may be<br>prescribed in other wise non-diseased<br>eyes that require a soft contact lens for<br>the management of surgically altered<br>corneas following LASIK, PRK or RK<br>surgery. | Indicated for daily wear and may be<br>prescribed in other wise non-diseased<br>eyes that require a soft contact lens for<br>the management of surgically altered<br>corneas following refractive surgery. | Indicated for daily wear for the<br>correction of visual acuity in aphakic<br>and not aphakic persons with non-<br>diseased eyes with myopia or<br>hyperopia. |
| Functionality | same as<br>predicate device | After machining from the optical<br>blank, the contact lenses act as a<br>refractive medium that focus light rays<br>from near and distant objects on the<br>retina. | After machining from the optical<br>blank, the contact lenses act as a<br>refractive medium that focus light rays<br>from near and distant objects on the<br>retina. |
| Indications | same as<br>predicate device | Daily wear, Soft (hydrophilic) contact<br>lens | Daily wear, Soft (hydrophilic) contact<br>lens |
| Production<br>Method | same as<br>predicate device | Lathe-cut | Lathe-cut |
| FDA Group # | same as<br>predicate device | Group # 1 < 50% Water, Nonionic<br>Polymers | Group # 1 < 50% Water, Nonionic<br>Polymers |
| USAN name | Hioxifilcon B | Hefilcon A | Hioxifilcon B |
| Water<br>Content | 48% | 45.0% | 48.0% |
| Oxygen<br>Permeability | $16.40 X 10-11 (cm2/sec)(ml 02/ml x mm Hg @ 35 degrees C)(revised Fatt method).$ | $13.2 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degrees C)(revised Fatt method).$ | $16.40 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degrees C)(revised Fatt method).$ |
| Specific<br>Gravity | 1.137 | 1.142 | 1.137 |

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2008

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

Re: K080512

> Trade/Device Name: RevitalEyes Post-Surgical Soft Daily Wear Contact Lens (hioxifilcon B) clear and blue visibility tint Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: June 9, 2008 Received: June 18, 2008

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.

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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

M. B. Egerthans, m.d.

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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# METRO OPTICS of Austin

510(K) Premarket Notification

# INDICATIONS FOR USE STATEMENT

#### Device Name: RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens (Hioxifilcon B) clear and blue visibility tint.

#### INDICATIONS FOR USE:

The RevitalEyes, Post-Surgical (Hioxifilcon B) Soft Contact Lenses for daily wear may be prescribed in other wise non-diseased eyes that require a soft contact lens for the management of surgically altered corneas following LASIK, PRK or RK surgery.

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.

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

| | | Concurrence of CDRH Office of Device Evaluation (ODE) | |
|---------------------------------------|-----------------------------|-------------------------------------------------------|--|
| | Division Sign-Off | | |
| | Division of Ophthalmic Ear, | | |
| | Nose and Throat Devices | | |
| Prescription Use (Per 21 CFR 801.109) | <div>X</div> | | |
| 510(k) Number | K080512 or | Over-The-Counter Use | |
| | (Optional Format 1-2-96) | | |