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 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 to the power of -11 (cm squared/sec) (ml O sub 2/ml x hPa @ 35 degrees C), (revised Fatt method)

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device, specifically a soft contact lens. The purpose of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. This process does not involve extensive clinical trials with acceptance criteria, ground truth, or statistical analyses in the same way a PMA (Premarket Approval) would.

Therefore, the requested information regarding acceptance criteria, study details (sample sizes for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable to this type of submission.

Instead, the submission focuses on demonstrating substantial equivalence based on material properties, intended use, and design similarity to existing predicate devices.

Here's what the document does provide, structured to address relevant aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, it compares the new device's properties to existing, legally marketed predicate devices to establish substantial equivalence.

Characteristic	Acceptance Criteria (Predicate Device Values)	RevitalEyes (New Device) Reported Performance
Intended Use	Corrective ametropia in non-diseased eyes; management of surgically altered corneas (FlexLens), or correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes with myopia or hyperopia (METRO-G).	Indicated for daily wear and may be prescribed in non-diseased eyes that require soft contact lens for management of surgically altered corneas following LASIK, PRK or RK surgery.
Functionality	Act as a refractive medium to focus light rays on the retina.	Same as predicate device.
Indications	Daily wear, soft (hydrophilic) contact lens.	Same as predicate device.
Production Method	Lathe-cut.	Same as predicate device (Lathe-cut).
FDA Group #	Group # 1 < 50% Water, Nonionic Polymers.	Same as predicate device (Group # 1 < 50% Water, Nonionic Polymers).
USAN Name	Hefilcon A (FlexLens), Hioxifilcon B (METRO-G).	Hioxifilcon B.
Water Content	45.0% (FlexLens), 48.0% (METRO-G).	49% (Device Description), 48% (Substantial Equivalence Matrix).
Oxygen Permeability	$13.2 X 10^{-11}$ (FlexLens), $16.40 X 10^{-11}$ (METRO-G).	$16.40 X 10^{-11} (cm^2/sec)(ml O_2/ml x hPa @ 35°C), (revised Fatt method)$.
Specific Gravity	1.142 (FlexLens), 1.137 (METRO-G).	1.137.

2. Sample size used for the test set and the data provenance:

Not applicable. This submission is a 510(k), which relies on demonstrating substantial equivalence to predicate devices, not on a new clinical study with a "test set" in the context of device performance evaluation against specific metrics. The "study" mentioned refers to the pre-clinical toxicology and clinical study data of the predicate device, BENZ-G 3X, which is leveraged to establish the safety profile of the new device.
Data Provenance: The document states that the safety profile (pre-clinical toxicology, clinical study data, manufacturing/chemistry) of the new device is "equivalent to the BENZ-G 3X." This implies that the safety and effectiveness data for the predicate device, BENZ-G 3X, is being referenced, but no details of that specific predicate study are provided here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. No such "ground truth" establishment by experts for a specific test set is described or required for this type of 510(k) submission.

4. Adjudication method for the test set:

Not applicable. No adjudication method is described as there isn't a "test set" in the context of a new performance study.

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 or assistive technology for human readers.

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:

Not applicable. There is no "ground truth" in the context of a new clinical performance study for this 510(k). The basis for FDA clearance is substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as the predicate.

8. The sample size for the training set:

Not applicable. No "training set" in the context of device development or performance evaluation is mentioned or required for this 510(k) submission.

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

Not applicable.

Summary

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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:

い

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Date Prepared:	June 9, 2008
Name:	Metro Optics of Austin, Inc.
Address	15802 Vision DrivePflugerville, TX 78660
Contact Person:	Steve Webb
Phone number:	(512) 251-2382
	President
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:	RevitalEyes, Post-Surgical Soft Daily Wear Contact Lens(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 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:

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

	RevitalEyesNew Device	Flexlens Post RefractiveSurgery (hefilcon A)predicate device	METRO-G(hioxifilcon B)predicate device
Intended Use	Indicated for daily wear and may beprescribed in other wise non-diseasedeyes that require a soft contact lens forthe management of surgically alteredcorneas following LASIK, PRK or RKsurgery.	Indicated for daily wear and may beprescribed in other wise non-diseasedeyes that require a soft contact lens forthe management of surgically alteredcorneas following refractive surgery.	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	After machining from the opticalblank, the contact lenses act as arefractive medium that focus light raysfrom near and distant objects on theretina.	After machining from the opticalblank, the contact lenses act as arefractive medium that focus light raysfrom near and distant objects on theretina.
Indications	same aspredicate device	Daily wear, Soft (hydrophilic) contactlens	Daily wear, Soft (hydrophilic) contactlens
ProductionMethod	same aspredicate device	Lathe-cut	Lathe-cut
FDA Group #	same aspredicate device	Group # 1 < 50% Water, NonionicPolymers	Group # 1 < 50% Water, NonionicPolymers
USAN name	Hioxifilcon B	Hefilcon A	Hioxifilcon B
WaterContent	48%	45.0%	48.0%
OxygenPermeability	$16.40 X 10-11 (cm2/sec)(ml 02/ml x mm Hg @ 35 degrees C)(revised Fatt method).$	$13.2 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degrees C)(revised Fatt method).$	$16.40 X 10-11 (cm2/sec)(ml O2/ml x mm Hg @ 35 degrees C)(revised Fatt method).$
SpecificGravity	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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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.

(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)	X
510(k) Number	K080512 or	Over-The-Counter Use
	(Optional Format 1-2-96)

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.