The UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) 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 are presbyopic. The lens may be worn by persons who may exhibit astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

Device Description

The Ultra Vue/P, Ultra Vue/C (hioxifilcon B) Soft (Multifocal) 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 cornes and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon 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 appear somewhat wareed: 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.

AI/ML Overview

This submission is a 510(k) summary for the UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens. It asserts substantial equivalence to predicate devices and focuses on material properties and manufacturing processes rather than a detailed clinical study demonstrating specific performance against acceptance criteria for a new clinical endpoint. Therefore, much of the requested information about clinical acceptance criteria and a study proving device performance against them is not explicitly available in the provided text.

Based on the provided text, the "acceptance criteria" are implied by the claim of substantial equivalence to existing predicate devices. The study proving the device meets these "acceptance criteria" is the demonstration of similar characteristics to those predicate devices.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As specific performance "acceptance criteria" (e.g., visual acuity targets, comfort scores, etc.) are not presented in a quantitative manner in this substantial equivalence submission, the table below will reflect the comparison of physical and material characteristics to predicate devices, which serve as the implicit "acceptance criteria" for substantial equivalence.

Characteristic	Acceptance Criteria (Implied by Predicate Devices)	Reported Device Performance (UltraVue/P, UltraVue/C Multifocal)
Material	Hydrophilic Polymer (Similar to Predicates)	Hydrophilic Polymer
Production Method	Lathe-Cut	Lathe-Cut
Lens Function	Refractive medium for distance, intermediate, near focusing; compensates for refractive error (Same as Predicates)	Refractive medium for near, intermediate, distant focusing; compensates for refractive error
Water Content	Similar to 8.4%, 8.0%, 18.1%, 11.3% in predicates	48%
Polymer Content	Similar to predicates	52%
Polymer Type	polymacon, tafilcon, ocufilcon, hetilcon	hioxifilcon B
DK Value	Similar to 8.4, 8.0, 18.1, 11.3	15
Refractive Index	Similar to predicates	1.404 (hydrated)
Specific Gravity	Similar to predicates	1.136 (hydrated)
Light Transmission	Greater than 95% T	Greater than 95% T

Note: The "acceptance criteria" in this context are not quantitative performance thresholds from a clinical trial, but rather the demonstration that the new device's characteristics are sufficiently similar to those of legally marketed predicate devices to establish substantial equivalence.

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

The provided document describes a 510(k) premarket notification for substantial equivalence, not a clinical study with a "test set" in the sense of patient data. The "testing" referred to is primarily focused on material properties and manufacturing process equivalence, and pre-clinical toxicology.

Sample Size for Test Set: Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical and chemical properties of the lens material itself, which would be tested on material samples, not a patient cohort. No specific numbers of samples for these material tests are given.
Data Provenance: The document is a regulatory submission from a Canadian company (Opti-Center Laboratories) to the US FDA. The "pre-clinical toxicology and manufacturing/chemistry data" mentioned in the "Substantial Equivalence" section would originate from internal company testing or contract laboratories. The specific country of origin for these raw data is not stated, but the submission is for US market approval. The data is pre-marketing, so it would be considered prospective in relation to the submission date, but not "retrospective" clinical data.

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)

This information is not applicable and not provided in the document. This is a 510(k) submission for contact lenses, which relies on demonstrating equivalence through material science and design specifications, not expert-adjudicated clinical "ground truth" data for, for example, image interpretation or disease diagnosis.

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

This information is not applicable and not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used in clinical trials, especially those involving expert interpretation of medical images or outcomes, to establish a consensus "ground truth." This document is a regulatory filing focused on substantial equivalence of a physical medical device.

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

This information is not applicable and not provided in the document. MRMC studies, especially those involving "AI assistance," are relevant for diagnostic imaging devices where human readers interpret medical images. This document is for soft contact lenses, which do not involve AI-assisted diagnostics or human 'readers' in that context.

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

This information is not applicable and not provided in the document. A standalone algorithm performance study is relevant for AI/ML-based diagnostic devices. This device is a contact lens.

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

The "ground truth" implicitly used for this device's "study" (i.e., the demonstration of substantial equivalence) is derived from established scientific understanding of material properties, manufacturing processes, and the performance of currently marketed predicate contact lenses.

The "ground truth" for material properties (e.g., water content, DK value, refractive index) is based on standard scientific measurement techniques.
The comparison to predicate devices serves as the "ground truth" for what constitutes "safe and effective" performance within this product category for the purpose of a 510(k). The regulatory assumption is that if the new device is sufficiently similar to a legally marketed predicate device, it shares its safety and effectiveness profile.

8. The sample size for the training set

This information is not applicable and not provided in the document. A "training set" refers to data used to train an algorithm, typically in machine learning or AI. This document pertains to a physical medical device (contact lens) and not an algorithmic system.

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

This information is not applicable and not provided in the document, as it relates to training data for algorithms, not a physical medical device.

Summary

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510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS K974599

This summary of 510(k) safety and effectiveness information is being submitted in accordance I with the requirements of SMDA 1990 and 21 CFR 807.92.

MAR - 2 1998

The assigned 510(k) number is:

K974599

Applicant information:

ﻟﻴﺴﻴﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Date Prepared:

November 28, 1997

Name: Address Opti-Center Laboratories 4375 Ouimet Street Sherbrooke (Quebec) Canada JIL 1X5

Robert Mercure Contact Person: (819) 564-8114 Phone number:

Martin Dalsing USA Consultant: (970) 243-5490 Phone number

Device Information:

Device Classification:	Class II
Classification Number:	LPL
Classification Name:	Lenses, Soft Contact, Daily Wear
Trade Name:	UltraVue/P, UltraVue/C (hioxifilcon B) Soft(Multifocal) Daily Wear Contact Lens (Clear & BlueVisibility Tint, Lathe-cut from Lens Blank)

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Equivalent Devices:

The UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens is substantially equivalent to the following prodicate devices in terms of intended use and design. Prodicate devices include: the Bi-Soft manufactured by Lombart Lenses, the LifeStyle 4-Vue and LifeStyle Xtra manufactured by The LifeStyle Co., the Horizon 55 Bicon manufactured by Westcon, the Ocu-Flex-53 manufactured by Ocu-Ease Optical, the SimulVue manufactured by Unilens Corp and the BENZ-G 3X manufactured by BENZ Research and Development Corp.

Device Description:

In the hydrated state, the lens conforms to the curvature of the eye covering the cornes and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifileon 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 appear somewhat wareed: 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).

Intended Use:

The UltraVue/P, UltraVue/C (hioxifileon B) Soft (Multifocal) 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 are presbyopic. The lens may be worn by persons who may exhibit astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

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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 Les Laboratories Opti-Center Inc. The established safety profile (pre-clinical 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 that the production method, lens function and material of the UltraVueP, UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens (Clear & Blue Visibility Tim, Lathe-cut from Lens Blank), are substantially equivalent to the predicate devices. In addition, the water content, polymer, DK value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate devices.

	Characteristic	UltraVue/P Multifocal	UltraVue/C Multifocal	PREDICATE DEVICES
1.)	PRODUCTION METHOD	Lathe-Cut	Lathe-Cut	SAME
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.	SAME
3.)	MATERIAL	Hydrophilic Polymer	Hydrophilic Polymer	SAME
a.	Water Content	48%	48%	Similar
b.	Polymer Content	52%	52%	Similar
c.	Polymer	hioxifilcon B	hioxifilcon B	polymacon, tafilcon,ocufilcon, hetilcon
d.	DK Value	15	15	8.4, 8.0, 18.1, 11.3
e.	Refractive Index	1.404 (hydrated)	1.404 (hydrated)	Similar
f.	Specific Gravity	1.136 (hydrated)	1.136 (hydrated)	Similar
g.	Light Transmission	greater than 95% T	greater than 95% T	Similar

Substantial Equivalence Matrix

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 2 1998

Mr. Martin J. Dalsing Official Correspondent and US Consultant for Opti-Center Laboratories, Inc. 623 Glacier Drive Grand Junction, CO 81503

Re: K974599

Trade Name: UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lens (Clear & Blue Visability Tint, Lathe-cut from Lens Blank) Regulatory Class: II Product Code: 86 LPL Dated: November 28, 1997 Received: December 9, 1997

Dear Mr. Dalsing:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are 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 these devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices 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 devices 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 J. Dalsing

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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 devices, 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

UltraVue/P, UltraVue/C (hioxifilicon B) Soft (Multifocal) Daily Wear Contact Device Name: Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)

INDICATIONS FOR USE:

The UltraVue/P, UltraVue/C (hioxifilcon B) Soft (Multifical) Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lens may be worn by persons who exhibit astigmatism of .75 diopters or less where the astigmatism does not interfere with visual scuity.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Daniel W. C. Brown Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K974599

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.