The Resolution 45 (Spherical) (hioxifilcon B) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eves 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 (Toric) (hioxifilcon B) 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 45 (Spherical) and Ultra Gel (Toric) (hioxifileon B) Soft Daily Wear Contact Lenses are fabricated from hioxifilcon B, 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 eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) 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 48% water by weight. The physical properties of the lens are:

Refractive Index: 1.515 (dry) 1.404 (hydrated)
Color Pigment Name: Phthalocyanine Blue
Light Transmission (clear): greater than 95% T
Light Transmission (tinted): greater than 95% T
Water Content: 48 % ±2%
Specific Gravity: 1.308 (dry) 1.136 (hydrated)
Oxygen Permeability: 15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fatt method).

AI/ML Overview

The provided summary for the Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lenses does not contain information about acceptance criteria or a study that specifically proves the device meets those criteria.

This document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

Therefore, many of the requested sections below cannot be populated from the provided text.

Here's an attempt to address the points based on the available information:

Acceptance Criteria and Device Performance Study (Information Not Provided)

The provided 510(k) summary focuses on demonstrating substantial equivalence to predicate devices rather than presenting specific acceptance criteria and the results of a study designed to prove the device meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Metric	Acceptance Criteria	Reported Device Performance
(Not specified in the document)	(Not specified in the document)	(Not specified in the document)

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

Sample Size: Not specified.
Data Provenance: Not specified. The submission relies on demonstrating similarity to predicate devices rather than presenting a performance study with a distinct test set.

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

Number of experts: Not applicable, as a test set with expert-established ground truth is not described.
Qualifications: Not applicable.

4. Adjudication method for the test set:

Not applicable, as a test set requiring adjudication is not described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

No MRMC comparative effectiveness study is mentioned in the provided text. The document is a 510(k) summary for a contact lens, which typically does not involve such studies for regulatory clearance.

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

Not applicable. This device is a contact lens and does not involve an algorithm.

7. The type of ground truth used:

Not applicable, as no specific performance study with ground truth is detailed. The submission relies on the established safety and effectiveness profile of the predicate devices.

8. The sample size for the training set:

Not applicable, as this device is a contact lens and does not involve a "training set" in the context of an algorithm.

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

Not applicable.

Summary of Approach in the Document:

The provided document, a 510(k) summary, demonstrates substantial equivalence by comparing the new device (Resolution 45 and Ultra Gel contact lenses) to legally marketed predicate devices ("Horizon 55 Spherical & Westhin Toric" and "BENZ-G 3X"). This equivalence is established based on:

Intended Use: The indications for use are similar.
Design and Materials: The materials (hioxifilcon B, hydrophilic polymer), production method (lathe-cut), and physical properties (water content, polymer content, DK value, refractive index, specific gravity, light transmission) are compared and found to be similar or within acceptable ranges.
Safety and Effectiveness Profile: The submission states that the established safety profile (preclinical toxicology and manufacturing/chemistry data) of the new device is equivalent to the BENZ-G 3X predicate.

Instead of a new performance study with defined acceptance criteria, the regulatory pathway relies on the known safety and effectiveness of the equivalent predicate devices.

Summary

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3/29/99

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.

Applicant information:

Date Prepared:

October 1, 1998

Name:	Opti-Center Laboratories Inc.
Address	4375 Ouimet Street
	Sherbrooke (Quebec) Canada JIL 1X5
Contact Person:	Robert Mercure
Phone number:	(819) 564-8114

USA Consultant:	Med-Vice Consulting, Inc.
	Martin Dalsing
Phone number	(970) 243-5490

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	Resolution 45 (Spherical) and Ultra Gel (Toric)(hioxifilcon B) Soft Daily Wear contact Lens, (Clear & BlueVisibility Tint, Lathe-cut from Lens Blank)

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Equivalent Devices:

The Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lenses are substantially equivalent to the following predicate devices in terms of intended use and design. Predicate devices include: "Horizon 55 Spherical & Westhin Toric" manufactured by Westcon Contact Lens, and the "BENZ-G 3X" 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 48% water by weight. The physical properties of the lens are:

Refractive Index	1.515 (dry) 1.404 (hydrated)
Color Pigment Name	Phthalocyanine Blue
Light Transmission (clear)	greater than 95% T
Light Transmission (tinted)	greater than 95% T
Water Content	48 % ±2%
Specific Gravity	1.308 (dry) 1.136 (hydrated)
Oxygen Permeability	15 X 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C), (revised Fattmethod).

Intended Use:

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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 (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X, 510(k) #K964528. 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 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank), as well as the predicate devices.

	Characteristic	Resolution 45(Spherical)	Ultra Gel (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	48%	48%	55%, 48%
b.	Polymer Content	52%	52%	45%, 52%
c.	Polymer	hioxifilcon B	hioxifilcon B	methafilcon A,hioxifilcon B
d.	DK Value	15	15	18.2, 15
e.	Refractive Index	1.404 (hydrated)	1.404 (hydrated)	1.408, 1.404
f.	Specific Gravity	1.136 (hydrated)	1.136 (hydrated)	1.090, 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 shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three horizontal lines above them, resembling a bird in flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 9 1999

Mr. Martin Dalsing Official FDA Correspondent Opti-Center Laboratories 623 Glacier Drive Grand Junction, CO 81503

Re: K983496

Trade Name: Resolution 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank) Regulatory Class: II Product Code: 86 LPL Dated: January 20, 1999 Received: January 26, 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. Roeyl. 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 45 (Spherical) and Ultra Gel (Toric) (hioxifilcon B) Soft Daily Wear Device Name: Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)

INDICATIONS FOR USE:

The Resolution 45 (Spherical) (hioxifilcon B) 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 (Toric) (hioxifileon B) 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.

(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 K983496

Prescription Use
(Per 21 CFR 801.109)
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.