Biomedics® 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

Toric:

The lenses may be prescribed for Daily Wear in not-aphakic persons. The eye care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA and other monomeric ingredients including a proprietary ultraviolet absorber, crosslinked with EDGMA and other components which vield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Biomedics 60 (ocufilcon "F") UV Blocking Daily Wear soft (Hydrophilic) Contact Lens, based on the provided 510(k) summary:

The entire submission is focused on demonstrating substantial equivalence to a previously cleared device, not on meeting specific acceptance criteria through a de novo clinical study for this specific device.

Because this is a 510(k) submission based on substantial equivalence, there isn't a traditional "acceptance criteria" table with numerical performance targets and reported device performance from a new clinical study for this specific device. Instead, the acceptance criteria are implicitly that the new device's physical, optical, and chemical properties, as well as its indications for use, are substantially equivalent to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Biomedics 60)
Material Properties:
- Water content	60%
- Oxygen Permeability	25.3 x 10⁻¹¹ (cm³/sec)(mL x mm Hg)
- Refractive Index	1.4041
- Light Transmittance	97.7%
- UV-A Transmittance (thinnest lenses)	23.4%
- UV-B Transmittance (thinnest lenses)	5.8%
- Material Composition	HEMA and other monomeric ingredients (ocufilcon "F"), proprietary UV absorber, crosslinked with EDGMA
- Chemical Residuals (Monomers, UV Additive)	Extremely low levels for product monomers, undetectable for UV additive
- Category (FDA Guidance for Daily Wear Contact Lenses)	Category IV (high water, ionic)
Device Characteristics:
- Geometry (Base Curves, Diameters, Powers, Center Thickness)	Equivalent to predicate devices
- Tint	Blue Visibility Tint
- Compatibility with cleaning/disinfecting solutions	Compatible with all soft contact lens solutions
Safety:
- Toxicological analyses (Ocular Irritation, Cytotoxicity, Systemic Toxicity)	Non-toxic in animal tests
Indications for Use:
- Correction of Myopia/Hyperopia with Astigmatism	Spherical: up to 2.00 diopters astigmatism; Toric: up to 10.00 diopters astigmatism
- Daily Wear use in not-aphakic persons	Yes
- UV Blocking claims	Yes

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

Test Set Sample Size: Not applicable. No dedicated clinical "test set" was used for this device. The submission relies on preclinical data and the established safety and efficacy of predicate devices.
Data Provenance: Preclinical data (toxicology) was likely generated internally or through contract labs. The "proof" of substantial equivalence comes from comparing the physical and chemical properties of the Biomedics 60 to already cleared devices.

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

Number of Experts & Qualifications: Not applicable. There was no clinical trial for this specific device, and thus no "ground truth" established by experts for a test set. The FDA review process involves their own internal experts (e.g., A. Ralph Rosenthal, M.D., Director, Division of Ophthalmic Devices).

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. No test set requiring expert adjudication was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission specifically states: "There was no clinical investigation of this lens as the characteristics of the device are substantially equivalent to the device from which the lens was modified."

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

Standalone Performance: Not applicable. This is a contact lens, not an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For the preclinical evaluations mentioned (toxicology), the "ground truth" would be the observed biological responses in the animal models, interpreted by scientists/toxicologists. For the substantial equivalence argument, the "ground truth" refers to the established safety and effectiveness of the predicate devices based on their prior clinical evaluations and market history.

8. The Sample Size for the Training Set

Training Set Sample Size: Not applicable. This is not an AI/machine learning device. The "training" in this context refers to the accumulated knowledge and clinical data from the predicate devices that form the basis for the substantial equivalence claim.

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

Ground Truth for Training Set: Not applicable in the AI sense. However, the basis for the claim of safety and efficacy (analogous to "ground truth") for the predicate devices was established through:
- Prior clinical evaluations (clinical trials) conducted for those specific predicate devices (e.g., P890023/S26, K984046, K972303, K942214).
- Regulatory clearance processes for those predicate devices, which would have involved FDA review of clinical data, preclinical data, and manufacturing information.
- "Performance data available on the predicate device(s) through product testing, literature review, and/or clinical experience." (implied by the substantial equivalence argument).

Summary

{0}------------------------------------------------

NOV 2 4 1999

Image /page/0/Picture/1 description: The image shows a logo with the words "OCULAR SCIENCES" in bold, uppercase letters on a black rectangle. Below the rectangle is a circle with a crosshair inside of it, next to the words "AMERICAN HYDRON" in bold, uppercase letters. The logo is black and white and appears to be for a company in the ocular science or eye care industry.

K 992264

510(k) Summary

SUBMITTER:

Submitted on behalf of:

Company Name: Address:

Phone: Fax:

CONTACT PERSON:

Ocular Sciences, Inc. 475 Eccles Av. South San Francisco, CA 95014 (415) 583-1400 (415) 583-1108

Richard E. Lippman, O.D., F.A.A.O. Official Representative and Correspondent C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852

DATE SUMMARY PREPARED:

November 1, 1999

BIOMEDICS 60 (ocufilcon "F") UV Blocking In TRADE NAME: Monomer Tint Visibility Daily Wear soft (Hydrophilic) Contact Lens

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO:

The BIOMEDICS 60 (ocufilcon "F") UV Blocking Daily Wear Contact Lens with In-Monomer Tint is equivalent to the daily wear lens of the same material but of a modified water content, as cleared in K984046, K942214 and K972303 for daily wear, and P890023/S26, P890023/S4 P890023/S7 for extended wear, currently marketed by Ocular Sciences, Inc.

The BIOMEDICS® 60 (ocufilcon "F") UV Blocking Daily Wear contact lens is substantially equivalent to the indication for use of the BIOMEDICS® 55 (ocufilcon D) In Monomer Tint ocufilcon D cast molded contact lens marketed for use in the U.S. by Ocular Sciences, Inc.

{1}------------------------------------------------

cleared under K984046 and K972303. Additionally, the subject contact lens is equivalent and has similar and equivalent characteristics and properties as the clear BIOMEDICS® 55 (ocufilcon D) cast molded contact lens, cleared under K942214, and P890023/S26. The cast molding process was approved under P890023/S4. This lens is in the Lens Group IV high water ionic group as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses. Revised Edition May 1994. The physical, and chemical properties of the BIOMEDICS 60 (ocufilcon "F") UV visibility tint cast molded Ocular Sciences, Inc.contact lens are substantially equivalent to both the clear and tinted versions of the BIOMEDICS 55 (ocufilcon D) cast molded contact lenses.

DESCRIPTION of the DEVICE:

INDICATIONS FOR USE:

Spherical:

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses are indicated for the correction of visual acuity in persons with non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism up to 2.00 diopters that does not interfere with visual acuity.

Toric:

The lenses may be prescribed for Daily Wear in not-aphakic persons. The eve care practitioner may prescribe the contact lens for either single use disposable wear or for frequent replacement wear, with cleaning, disinfection, and scheduled replacement (SEE WEARING SCHEDULE). When prescribing for frequent replacement wear, the contact lens may be disinfected using a chemical (not heat) disinfecting system.

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye

{2}------------------------------------------------

PARAMETERS AVAILABLE:

6.50 mm to 10.8 mm Base Curves: 12.5 mm to 18.0 mm Diameters: -6.00 to +10.00 Diopters sphere Powers: -00.25 to -10.00 Diopters Cylinder Power: 0.025 mm to 0.27 mm depending on power Center Thickness: Tint: Blue Visibility tint

ULTRAVIOLET TRANSMITTANCE CURVES

The following graph represents the transmittance of ultraviolet light in the UVA and UVB range as well as light transmittance through the visual spectrum, as compared to the human cornea and crystalline lens:

Figure L Transmittance Curves

Image /page/2/Figure/5 description: The image is a graph that shows the percentage of transmission of light through different types of lenses. The x-axis represents the wavelength of light in nanometers, ranging from 200 to 750. The y-axis represents the percentage of transmission, ranging from 0 to 100. There are three lines on the graph, representing the Oculicon 60% water contact lens, the human cornea (24 year old person), and the human crystalline lens (25 year old person).

at . 2,50 0 Ocurilcon 50% Water Concent Hydropoulle Canta

The average ultraviolet transmittance in terms of percent for the thinnest lenses (0.07mm includes lenses from -2.25D to -6.00D) are UV-A (23.4%) and UV-B (5.8%).

PRECLINICAL INFORMATION

A battery of preclinical tests including toxicological analyses of Ocular Irritation, Cytotoxicity, and Systemic Toxicity were conducted on the material in animals. The results of these tests indicated that the finished materials or extracts of the finished materials were non-toxic to the tissues of the animals which were tested. Residuals of chemical monomers and the UV additive

{3}------------------------------------------------

were evaluated and found to be of extremely low levels for the product monomers, and undetectable for the UV additive, to the sensitivity of the instrumentation used to calculate such residuals.

The physical, optical and chemical properties of the lens indicate that the device is substantially equivalent to the parent device of the marketed lens (ocufilcon D) material. The oxygen permeability of the material is 25.3 X 10-11 (cm³/sec)(mL x mm Hg); a water content of 60%, a refractive index of 1.4041; light transmittance of 97.7%.

Other physical characteristics of the device were equivalent to the company's prior marketed lenses to which this lens is compared.

The lens characteristics place it in Category IV (high water, ionic) and the device is compatible with all soft contact lens solutions available on the market for cleaning, rinsing and disinfection.

There was no clinical investigation of this lens as the characteristics of the device are substantially equivalent to the device from which the lens was modified. The safety information provided and physical, optical and chemical parameters of the lens are substantially equivalent to lenses already having had clinical evaluation.

LABELING

The Biometrics 60 (ocufilcon "F") UV Blocking IMT Visibility Tint Contact Lens for Daily Wear is provided to the user with a Package Insert, Patient Instruction Booklet for either Daily Disposable or Scheduled Replacement, and a Practitioner Fitting Guide. These materials are also available from the company. The address is as follows:

Ocular Sciences, Inc. 475 Eccles Ave. South San Francisco, CA 94080 (650) 583-1400

4

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three lines extending from its head, representing health, services, and human aspects. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Nov 2 4 1999

Ocular Science, Inc. c/o Richard E. Lippman, O.D. Senior Consultant CL MCINTOSH 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852

Re: K992264

Trade Name: Biomedics® 60 (ocufilcon F) UV Blocking Contact Lens for Daily Wear (Spherical and Toric, Visibility Tint with or without UV Blocker, cast molded) Regulatory Class: II Product Code: 86 LPL, MVN Dated: November 15, 1999 Received: November 15, 1999

Dear Dr. Lippman:

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

{5}------------------------------------------------

Page 2 - Dr. Richard E. Lippman, O.D.

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

{6}------------------------------------------------

Indications Statement

510(k) Number (if known) K992264

Device Name:_ Biomedics® 60 (ocufilcon "F") UV Blocking Daily Wear Contact Lens

Indications for Use:

Spherical:

Toric:

Biomedics 60 (ocufilcon F) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Additional Claims:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Presription Use
-----------------	--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

Over-The-Counter Use
----------------------	--

	Ezio (Division Sign-Off)
	Division of Ophthalmic Devices
510(k) Number	K 992264

(Oprtional Format 1-2-96)
000005

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.