The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are nearsighted (myopic) or farsighted (hyperopic) and may exhibit astigmatism of 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are myopic, or hyperopic, and/or presbyopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The lens may be disinfected with chemical (not heat) disinfection system.

Device Description

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are fabricated from methafilcon 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 eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical 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 ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2-hydroxyethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution.

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses are available as a spherical, toric, aspheric and toric aspheric design.

The physical properties of the lens are:
Refractive Index 1.4153
Light Transmission greater than 95% T
Specific Gravity 1.090 g/cc
Water Content 55%
Color Pigment Name Phthalocyanine Blue
Oxygen Permeability Dk=18x10-11 @ 35°C

AI/ML Overview

This 510(k) premarket notification is for contact lenses, which are regulated as medical devices. The submission focuses on demonstrating "substantial equivalence" to a predicate device already on the market, rather than conducting a de novo clinical study with specific acceptance criteria and performance metrics in the way an AI/ML device would. Therefore, many of the requested fields are not applicable.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

For contact lenses seeking 510(k) clearance via substantial equivalence, the "acceptance criteria" are not reported as specific performance metrics derived from a clinical trial, but rather as demonstrating equivalence in critical characteristics to a predicate device. The "performance" is implicitly deemed acceptable if these characteristics are substantially equivalent.

Characteristic	Acceptance Criteria (Predicate Device Value)	Reported Device Performance (Ocu-Flex 55)
Material	Hydrophilic (methafilcon A)	Hydrophilic (methafilcon A)
Water Content	55%	55%
Dk Value	$18 \times 10^{-11}$ @ 35°C	$18 \times 10^{-11}$ @ 35°C
Production Method	Lathe-cut	Lathe-cut
Lens Function	Refractive medium for vision correction	Refractive medium for vision correction
Indication	Correction of refractive ametropia	Correction of refractive ametropia
Refractive Index	Not explicitly stated for predicate but stated as "substantially equivalent"	1.4153
Light Transmission	Not explicitly stated for predicate but stated as "substantially equivalent"	> 95% T
Specific Gravity	Not explicitly stated for predicate but stated as "substantially equivalent"	1.090 g/cc

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" is a comparative analysis demonstrating substantial equivalence to a legally marketed predicate device (Horizon 55). This is explicitly stated: "The following matrix illustrates that the production method, lens function and material of the Ocu-Flex 55... is substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

Not applicable for this type of 510(k) submission. There was no "test set" in the context of an AI/ML or a new clinical performance study. The data provenance is a comparison of product specifications and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. Ground truth in the context of clinical expert consensus for a test set is not relevant for a substantial equivalence submission of a contact lens based on material and design specifications.

4. Adjudication Method 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 device is a contact lens, not an AI/ML diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of the predicate device, Horizon 55, and other similar methafilcon A lenses (BENZ - MF). The manufacturer is demonstrating that the Ocu-Flex 55 matches the characteristics that have already been deemed safe and effective by the FDA through the predicate's prior clearance. This includes:

Manufacturing/Chemistry Data: The production method (lathe-cut), material (methafilcon A), water content, Dk value, refractive index, specific gravity, and light transmission are all compared to the predicate.
Intended Use Compatibility: The indications for use are aligned with the predicate device.
Safety Profile: The submission references the established safety profile (pre-clinical toxicology) of BENZ - MF (methafilcon A), noting equivalence.

8. The Sample Size for the Training Set

Not applicable. There is no concept of a "training set" for this type of device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable.

Summary

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510(k) Premarket Notification Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

cu-Lase ptical Products, Inc.

629 Tennent Avenue Pinole, California 94564 Telephone: 510-724-0384 (NAT'L) 800-521-8984 Facsimile: 800-OCU-EASE · e-mail: custom@ocuease.com visit us on the web: www.ocuease.com

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.

Assianed 510(k) Number:

K011577

Applicant Information: Date Prepared:

Name: Address:

Contact Person:

Phone/Fax Number:

Device Information:

Device Classification:

Classification Number:

Classification Name:

Device Trade Name:

May 10, 2001

Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, CA. 94564

Charles R. Vermette President OR Kelli Wayne

Phone: (510)724-0384 Fax: (510)724-4842

Class II

LPL

Lenses, Soft Contact, Daily Wear

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (Clear and Tinted, lathe-cut)

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Equivalent Devices:

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lens for Daily Wear is substantially equivalent to the predicate device(s) identified below in terms of intended use and design.

Predicate Device:

Horizon 55 (methafilcon A) Sphere, Toric, Progressive, Progressive Toric 510(k) #K992010 Manufactured By: Westcon Contact Lens

Device Description:

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly bevond the limbus forming a colorless, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. 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 ionic lens material (methafilcon A) is a hydrophilic co-polymer of 2hydroxvethyl methacrylate and methacrylic acid crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 55% water by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution.

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

The physical properties of the lens are:

Refractive Index Light Transmission Specific Gravity Water Content Color Pigment Name Oxygen Permeability

1.4153 greater than 95% T 1.090 g/cc ર્ રેજી Phthalocyanine Blue Dk=18x10-11 @ 35°C

Intended Use:

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or notaphakic persons with non-diseased eyes that are myopic or hyperopic and is intended to correct astigmatism of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eves that are mvopic, or hyperopic, and/or presbyopic, and which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear (clear or tinted)

SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

The lens may be disinfected with chemical (not heat) disinfection system.

Substantial Equivalence:

The new device will be manufactured according to specified process controls and a Quality Management System certified to CGMP guidelines currently in place. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently manufactured, marketed and distributed by Ocu-Ease Optical Products, Inc. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ - MF (methafilcon A), 510k #K980418 and K003861. Being similar with respect to indications for use, materials, physical construction and safety and 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 Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone Toric Aspherical (methafilcon A) Soft Contact Lenses for Daily Wear is substantially equivalent to the predicate device. In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device.

Signed: Charles R. Vermette, President Date: 05/10/2001

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510(k) Premarket Notification

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin Zone 5 Spherical, Torio, Tim Lono 10) Soft Contact Lenses for Daily Wear

(clear or tinted)

SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Substantial Equivalence Matrix

	Characteristic	Ocu-Flex 55 Spherical,Toric, Thin Zone Toric,Aspherical, ToricAspherical and Thin ZoneToric Aspherical(methafilcon A) SoftContact Lenses	Predicate Device:Westcon Horizon 55 (methafilconA) Soft Contact Lens
1.)	PRODUCTIONMETHOD	Lathe-cut	Lathe-cut
2.)	LENS FUNCTION	Refractive medium thatfocuses light rays from nearand distant objects on theretina, while compensatingfor refractive error	Refractive medium that focuseslight rays from near and distantobjects on the retina, whilecompensating for refractive error
3.)	INDICATION	Correction of visual acuity inaphakic and not-aphakicpersons with non-diseasedeyes with myopia, hyperopiaand astigmatism	Correction of visual acuity inaphakic and not-aphakic personswith non-diseased eyes withmyopia, hyperopia and astigmatism
3.)	MATERIAL	hydrophilic (methafilcon A)	hydrophilic (methafilcon A)
4.)	WATER CONTENT	55%	55%
5.)	Dk Value	$Dk=18x10^{-11}$ @ 35°C	$Dk=18x10^{-11}$ @ 35°C

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Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or connection. The profiles are stacked on top of each other, creating a sense of unity and collaboration.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2001

Mr. Charles R. Vermette President Ocu-Ease Optical Products, Inc. 629 Tennent Avenue Pinole, California 94564

Re: K011577

Ne: Your Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical, Toric Aspherical and Thin Zone Toric Asperhical (methafilcon A) Soft Contact Lenses (Clear & Tinted, Lathe-cut from Lens Blank) Regulation Number: 886.5925 Regulatory Class: II Product Code: LPL Dated: May 10, 2001 Received: May 22, 2001

Dear Mr. Vermette:

We have reviewed your Section 510(k) notification of intent to market the device referenced we nave reviewed your occared he 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 the cliactified 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 (Itch). Tou may, thereford mailier in of the Act include requirements for annual registration, I to: - 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 ( Femailtons 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 periodic Q inspections, and 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

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Page 2 - Mr. Charles R. Vermette

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 nodication. The I DA miding of various 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 IT you desire specific active ror your stic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please 574-6415. Additionally, for questions on (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information Misoranding of reletence to premarket in an obtained from the Division of Small Manufacturers on your responsibilités under the 1123 -2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
A. Ralph Rosenthal

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

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Ocu-Ease Optical Products, Inc. 510(k) Premarket Notification Ocu-Flex 55 Spherical, Toric, Tronic, Aspherical, Toric Aspherical and Thin Zone 15 Sphencal, 1 one, 1 the filtion A) Soft Contact Lenses for Daily Wear (clear or tinted)

INDICATIONS FOR USE STATEMENT

Page 1 of 1

Device Name:

Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical, d-riex 35 Spherical (methafilcon A) Soft Contact Lenses (Clear & Tinted, Lathe-cut from Lens Blank)

INDICATIONS FOR USE:

The Ocu-Flex 55 Spherical, Toric, Thin Zone Toric, Aspherical, Toric Aspherical and Thin The Ocu-Flex 55 Sphencal, Tonc, Thin Lond Lenses are indicated for daily wear for the Zone Tone Asphencal (methallion) A) Ook Oonliae Lendo are Massan Property.
correction of refractive ametropia (myopia, hyperopia and astigmatism) in not-aphakic persons with non-diseased eyes.

The Ocu-Flex 55 Spherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual aculty in aprakte of not-apilanc with the may with the contribution of 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric and Thin Zone Toric (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic persons with indicated for daily wear for the correction of visual douly in application of 4.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Aspherical (methafilcon A) Soft Contact Lens is indicated for daily wear for the correction of visual aculty in aphake of not uphants poleone which may exhibit astigmatism of up to 1.50D or less that does not interfere with visual acuity.

The Ocu-Flex 55 Toric Aspherical and Thin Zone Toric Aspherical (methaticon A) Soft The Ocu-Flex 35 Tollo Asphencal and Thin London in the Contrity in aphakic or not-aphakic on not-aphakic Contact Lens is indicated for daily wear for the one one and/or presbyopic and is intended persons will non-diseased eyes that are infopted of types in therfere with visual acuity.

The lens may be disinfected with a chemical (not heat) disinfection system.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Division of Ophthalmic Devices

Prescription Use_ (Per 21 CFR 801.109) OR

Over-The-Counter Use_

Daniel W. C. Brown, Ph.D.

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Numberional Format 1-2-96) K011577

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.