The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is indicated for daily wear for persons requiring Keratoconus management with otherwise nondiseased eyes. The lens may be prescribed for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and not-aphakic persons. The lens may be disinfected with a chemical or heat disinfection system.

Device Description

The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a hydrophilic polymer of 2-hydroxyethyl-methacrylate crosslinked with ethylene glycol dimethacrylate. When fully hydrated in a 0.9% sodium chloride solution, the lens is 38% water and 62% polymacon by weight. In that fully hydrated state the lens is soft and readily wet by saline and aqueous solution. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a spherical conic lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens design begins with a spherical 5.0mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then flattens into the base curve, which is considered the fitting curve of the lens. The cone curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with a peripheral curve to maintain alignment and comfort.

AI/ML Overview

The provided document is a 510(k) summary for the Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens for Daily Wear. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish independent safety and effectiveness.

Therefore, the document does not contain information regarding:

Acceptance criteria and a study proving the device meets those criteria.
Sample sizes for a test set, data provenance, or details about training sets.
Number and qualifications of experts for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
Standalone (algorithm only) performance studies.
Specific types of ground truth used in novel studies (e.g., pathology, outcomes data).

Instead, the submission demonstrates substantial equivalence by comparing the Ocu-Flex-38 lens to a predicate device (Harrison Keratoconus Lens PMA #N17976 (hefilcon A) Manufactured By: Paragon Vision Sciences Flexlens Products) based on:

Intended Use: The intended use of the Ocu-Flex-38 is for daily wear for persons requiring Keratoconus management with otherwise non-diseased eyes, for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and non-aphakic persons, and allows for chemical or heat disinfection. This is compared to the intended use of the Flexlens Harrison Keratoconus Lens.
Technological Characteristics: Evaluation of manufacturing method, lens function, and material properties.

Here's a table summarizing the comparison, which serves as the basis for demonstrating "acceptance" of substantial equivalence:

Characteristic	Ocu-Flex-38 (polymacon) Soft Keratoconus Contact lens	Predicate Device: Flexlens Harrison Keratoconus Lens	Assessment of Equivalence (Implicit Acceptance Criteria)
PRODUCTION METHOD	Lathe-cut	Lathe-cut	Equivalent
LENS FUNCTION	Keratoconus management. Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism)	Keratoconus management. Refractive medium that focuses light rays from near and distant objects on the retina, while compensating for refractive error, including (astigmatism)	Equivalent
MATERIAL	Soft Contact Lens - Group 1, Low Water, Non-ionic polymer	Soft Contact Lens - Group 1, Low Water, Non-ionic polymer	Equivalent Classification
a. Water Content	38%	45%	Considered Substantially Equivalent in context of overall material group/performance
b. Polymer	(polymacon)	(hefilcon A)	Different polymers, but both classified as Group 1, Low Water, Non-ionic
c. Oxygen Permeability	8.41 x 10⁻¹¹ at 35°C	16 x 10⁻¹¹ at 35°C	Considered Substantially Equivalent despite numerical difference
d. Refractive Index	1.41	1.43	Considered Substantially Equivalent
e. Specific Gravity	1.18	1.09	Considered Substantially Equivalent
f. Light Transmission	96%T	96%T	Equivalent

Study to Prove Acceptance Criteria:

The "study" to prove acceptance criteria in a 510(k) submission is primarily the comparison table and the narrative argument for substantial equivalence. The manufacturer asserts that the new device will be manufactured under specified process controls and a Quality Management System (CGMP guidelines), and that its established safety profile (preclinical toxicology and manufacturing/chemistry data) is equivalent to the predicate device.

The FDA's review and subsequent clearance (K992466) signifies their agreement that the Ocu-Flex-38 is "substantially equivalent" to the predicate device and does not raise different questions of safety and effectiveness. This is the "proof" the device meets the regulatory acceptance criteria for market clearance under the 510(k) pathway. No new clinical safety or effectiveness data from human trials are presented in this summary beyond the comparison to the predicate device's known safety and effectiveness profile.

Summary

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K992466

Image /page/0/Picture/21 description: The image shows the logo for Ocu-Ease Optical Products, Inc. The logo consists of the letters "OE" in a stylized font, with the words "Ocu-Ease" above a line and the words "Optical Products, Inc." below the line. The text is in black and the background is white. The logo is simple and professional.

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.

Assigned 510(k) Number:
-------------------------	--

Applicant Information:

Date Prepared:

Name: Address: July 20, 1999

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

Contact Person:	Charles R. Vermette
	President
Phone/Fax Number:	Phone: (510)724-0384 Fax: (510)724-4842

Establishment Registration No .: 2916547

Device Information:

Regulatory Classification: Class II LPL Product Code:

Device Trade Name:

Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens for Daily Wear (Clear and Tinted, lathe-cut)

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SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

Classification Name:	Lenses, Contact (other material), DailyWear
Classification Number:	886.5925
Panel:	Ophthalmic

Equivalent Devices:

The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens for Daily Wear is substantially equivalent to the predicate device identified below in terms of intended use and design.

Predicate Device:

Harrison Keratoconus Lens PMA #N17976 (hefilcon A) Manufactured By: Paragon Vision Sciences Flexlens Products

Device Description:

The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens is a spherical conic lens. It is designed to provide optimum comfort and visual acuity to the keratoconus patient. The Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens design begins with a spherical 5.0mm optic zone that fits the peak of the cone and provides for good visual acuity. The lens then flattens into the base curve, which is considered the fitting curve of the lens. The cone curve will vary in rate of change depending on how far the keratoconus has advanced and creates optimal corneal alignment. The design finishes with a peripheral curve to maintain alignment and comfort.

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SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

The physical properties of the lens are:

Refractive Index	1.43
Light Transmission	96% of visible light
Specific Gravity	1.18
Water Content	38%
Color Pigment Names	[phthalocyaninato(2-)] copper
Oxygen Permeability	8.41 x 10-11 (cm³ O2 cm)/sec cm² mm Hg@35°C(Fatt Method)

Intended Use:

Substantial Equivalence:

The new device will be manufactured according to specified process controls and a Quality Management System certified to CGMP guidelines. The new device will undergo manufacturing, packaging and other process procedures similar to soft contact lens devices currently marketed and distributed by Ocu-Ease Optical Products, Inc. in the USA. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the Harrison Keratoconus Lens (soft lens). PMA #N17976 (Hefilcon A). Being similar with respect to indications for use, materials, physical construction and safety and effectiveness to the predicate device, 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 device identified above.

The following matrix illustrates that the production method, lens function and material of the Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens 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:	(Illegible)
	Charles R. Vermette, President
Date:	07/20/1999

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Summary of Safety and Effectiveness

Substantial Equivalence Matrix

	Characteristic	Ocu-Flex-38 (polymacon)Soft Keratoconus Contactlens	Predicate Device:Flexlens HarrisonKeratoconus Lens
1.)	PRODUCTIONMETHOD	Lathe-cut	Lathe-cut
2.)	LENS FUNCTION	Keratoconus management.Refractive medium thatfocuses light rays from nearand distant objects on theretina, while compensating forrefractive error, including(astigmatism)	Keratoconus management.Refractive medium thatfocuses light rays from nearand distant objects on theretina, while compensating forrefractive error, including(astigmatism)
3.)	MATERIAL	Soft Contact Lens - Group 1,Low Water, Non-ionicpolymer	Soft Contact Lens - Group 1,Low Water, Non-ionic polymer
a.	Water Content	38%	45%
b.	Polymer	(polymacon)	(hefilcon A)
c.	OxygenPermeability	8.41 x $10^{-11}$ at 35C	16X $10^{-11}$ at 35C
d.	Refractive Index	1.41	1.43
e.	Specific Gravity	1.18	1.09
f.	Light Transmission	96%T	96%T

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Image /page/4/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized design of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird-like figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 4 1999

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

Re: K992466 Trade Name: Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens for Daily Wear Regulatory Class: II Product Code: LPL Dated: July 20, 1999 Received: July 23, 1999

Dear Mr. Vermette:

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 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). 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 (Premaket 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. 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 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

Page 1 of 1

510(k) Number (if known):

Device Name: Ocu-Flex-38 Keratoconus (polymacon) Soft Contact Lens

Indications of Use:

(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

(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number. K 992466

Prescription Use
(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.