The Resolution 5X (Spherical) (hioxifilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity 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 .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Ultra Gel 5X (Toric) (hioxifilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 diopters.

Device Description

The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon 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.

In the hydrated state, the lens conforms to the curvature of the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon 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.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight.

AI/ML Overview

This document is a 510(k) summary for the Resolution 5X (Spherical) and Ultra Gel 5X (Toric) Hioxifilcon A Soft Daily Wear Contact Lenses. The submission asserts substantial equivalence to predicate devices rather than providing a study that establishes de novo acceptance criteria and demonstrates the device meets them.

Therefore, the following information is not applicable or not present in the provided text:

Acceptance criteria table and reported device performance directly addressing those criteria.
Sample sizes used for a test set, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size information.
Standalone (algorithm-only) performance study.
Type of ground truth used for a testing evaluation.
Sample size for a training set.
How ground truth for a training set was established.

This is a traditional 510(k) submission, which relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary evaluation here is a comparison to predicate devices, not a clinical trial establishing new performance criteria.

Here's a breakdown of the information that is present and relevant to the concept of demonstrating safety and effectiveness through substantial equivalence:

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

This specific table, as would be expected for a de novo submission or a clinical trial report, is not present. Instead, the document provides a "Substantial Equivalence Matrix" comparing the new device's characteristics to its predicate devices. The "acceptance criteria" are implicitly met if the new device's characteristics are similar enough to the predicate devices such that it does not raise new questions of safety and effectiveness.

Substantial Equivalence Matrix (Implicit "Acceptance Criteria" based on Predicate Devices):

Characteristic	Resolution 5X (Spherical)	Ultra Gel 5X (Toric)	PREDICATE DEVICES
PRODUCTION METHOD	Lathe-Cut	Lathe-Cut	Lathe-Cut
LENS FUNCTION	Refractive medium that focuses light rays from distant, intermediate and near objects on the retina, while compensating for refractive error.	Refractive medium that focuses light rays from near, intermediate and distant objects on the retina, while compensating for refractive error.	Refractive medium that focuses light rays from near, intermediate and distant objects on the retina, while compensating for refractive error.
MATERIAL	Hydrophilic Polymer	Hydrophilic Polymer	Hydrophilic Polymer
a. Water Content	58%	58%	58%, 48%
b. Polymer Content	42%	42%	42%, 52%
c. Polymer	hioxifilcon A	hioxifilcon A	hioxifilcon A, hioxifilcon B
d. DK Value	20	20	20, 15
e. Refractive Index	1.404 (hydrated)	1.404 (hydrated)	1.404, 1.404
f. Specific Gravity	1.136 (hydrated)	1.136 (hydrated)	1.136, 1.136
g. Light Transmission	greater than 95% T	greater than 95% T	greater than 95% T

Device Performance (from Device Description):

Physical Property	Value
Refractive Index (dry)	1.515
Refractive Index (hydrated)	1.404
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	58% ± 2%
Specific Gravity (dry)	1.308
Specific Gravity (hydrated)	1.136
Oxygen Permeability (DK value)	$20 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) (revised Fatt method).

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

Not applicable. No separate "test set" for performance evaluation in the context of a new acceptance criterion is described, as this is a substantial equivalence submission. The pre-clinical toxicology and manufacturing/chemistry data were deemed equivalent to the predicate device (BENZ-G 5X, K952620), but details on those specific tests are not provided in this summary.

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.

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

Not applicable.

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 is not an AI-assisted device.

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

Not applicable. This is not an algorithmic device.

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

Not applicable. Safety and effectiveness are demonstrated by substantial equivalence to predicate devices, drawing from their established safety profiles.

8. The sample size for the training set:

Not applicable.

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

Not applicable.

Summary

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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:	K992589
Applicant information:
Date Prepared:	July 28, 1999
Name:Address	Opti-Center Laboratories Inc.4375 Ouimet StreetSherbrooke (Quebec) Canada J1L 1X5
Contact Person:Phone number:	Robert Mercure(819) 564-8114
USA Consultant:	Med-Vice Consulting, Inc.Martin Dalsing
Phone number	(970) 243-5490

Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	Resolution 5X (Spherical) and Ultra Gel 5X (Toric)(Hioxifilcon A) Soft Daily Wear Contact Lens, (Clear &Blue Visibility Tint, Lathe-cut from Lens Blank)

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Equivalent Devices:

The Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lenses are substantially equivalent to the following predicate devices in terms of intended use and design. Predicate devices include: "Resolution 45 (Spherical) and Ultra Gel (Toric)" manufactured by Opti-Center Laboratories Inc., and the "BENZ-G 5X" manufactured by Benz Research and Development.

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:

Refractive Index	1.515 (dry) 1.404 (hydrated)
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	58% ±2%
Specific Gravity	1.308 (dry) 1.136 (hydrated)
Oxygen Permeability	$20 X 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method).

Intended Use:

The Resolution SX (Spherical) (hioxifilcon A) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity 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 .75 diopters or less where the astigmatism does not interfere with visual acuity.

The Resolution 5X (Spherical), Ultra Gel 5X (Toric) (Dioxiflicon A) Soft Dally Wear Contact Lens (Clear & Blue Visibility Tint, Inthe-cut from Lens Blank) .

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510(k) Premarket Notification

Substantial Equivalence:

The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Opti-Center Laboratories, Inc. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 5X, 510(k) #K952620. 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 devices identified above.

The following matrix illustrates the production method, lens function and material characteristics of the Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank), as well as the predicate devices.

	Characteristic	Resolution 5X(Spherical)	Ultra Gel 5X (Toric)	PREDICATEDEVICES
1.)	PRODUCTIONMETHOD	Lathe-Cut	Lathe-Cut	Lathe-Cut
2.)	LENS FUNCTION	Refractive medium thatfocuses light rays fromdistant, intermediate andnear objects on theretina, whilecompensating forrefractive error.	Refractive medium thatfocuses light rays fromnear, intermediate anddistant objects on theretina, whilecompensating forrefractive error.	Refractive medium thatfocuses light rays fromnear, intermediate anddistant objects on theretina, whilecompensating forrefractive error.
3.)	MATERIAL	Hydrophilic Polymer	Hydrophilic Polymer	Hydrophilic Polymer
a.	Water Content	58%	58%	58%, 48%
b.	Polymer Content	42%	42%	42%, 52%
c.	Polymer	hioxifilcon A	hioxifilcon A	hioxifilcon A,hioxifilcon B
d.	DK Value	20	20	20, 15
e.	Refractive Index	1.404 (hydrated)	1.404 (hydrated)	1.404, 1.404
f.	Specific Gravity	1.136 (hydrated)	1.136 (hydrated)	1.136, 1.136
g.	Light Transmission	greater than 95% T	greater than 95% T	greater than 95% T

Substantial Equivalence Matrix

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Image /page/3/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with its wings spread, with three human profiles visible within the eagle's body.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 26 1999

Opti- Center Laboratories, Inc. c/o Mr. Martin Dalsing MED-VICE CONSULTING, INC. 623 Glacier Drive Grand Junction, CO 81503

Re: K992589

Trade Name: Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (Hioxifilcon A) Soft Daily Wear Contact Lens, (Clear & Blue Visibility Tint, Lathe-cut from Lens Bank) Regulatory Class: II Product Code: 86 LPL Dated: July 28, 1999 Received: August 2, 1999

Dear Mr. Dalsing:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .

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Page 2 - Mr. Martin Dalsing

· This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on.the.promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Resolution 5X (Spherical) and Ultra Gel 5X (Toric) (hioxifilcon A) Soft Daily Device Name: Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)

INDICATIONS FOR USE:

. .

(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 Devices

510(k) Number	K992589
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Prescription Use	x
(Per 21 CFR 801.109)

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.