HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The HYDROGENIC® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. The eye care practitioner may prescribe the contact lenses for either single use disposable wear or for frequent replacement wear. When prescribed for frequent replacement the lenses may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):

+10.00 D to -10.00 D Asphere
with center thickness from 0.025mm to 0.40mm
. with base curves of 8.00mm to 9.20mm
. with diameter of 12.00mm to 18.00mm

The lens material for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same as the Biomedics® 60 UV (ocufileon F) lens in spherical design as described in submission K992264 cleared on November 24, 1999.

The aspheric lens design for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same design construct as the BIOMEDICS® UV ASPHERE (ocufilcon D) as cleared in K020193 on February 28, 2002.

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens has a spherical posterior surface. The anterior (convex) surface is constructed in lenticular form to provide optimum edge thickness and contour. This front optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes and has been aspherized to control longitudinal spherical aberration of the lens across the power range.

AI/ML Overview

This document is a 510(k) Premarket Notification for a contact lens, indicating that clinical studies were not deemed necessary to establish safety and efficacy because the device was determined to be substantially equivalent to previously cleared predicate devices. Therefore, the information provided does not contain details about specific acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, or ground truth establishment in the context of a new clinical performance study.

Here's an analysis based on the provided text, addressing the points where information is available or noting its absence:

1. A table of acceptance criteria and the reported device performance

The document compares the subject device, HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens, to predicate devices, primarily HYDROGENICS® 60 UV Sphere and BIOMEDICS® 55 UV Asphere, to demonstrate substantial equivalence. The "acceptance criteria" are implied by the characteristics of the predicate devices which the new device must match or be equivalent to.

Characteristic	Predicate Device (HYDROGENICS® 60 UV Sphere/BIOMEDICS® 55 UV Asphere)	Subject Device (HYDROGENICS® 2.0 60 UV ASPHERE)	Acceptance/Equivalence Indication
Production Method	Cast molded process	Cast molded process	Equivalent
Intended Use	Daily wear, Correction of ametropia	Daily wear, Correction of ametropia	Equivalent
Material (ocufilcon F)	60%	60%	Equivalent
Material Type	Group IV	Group IV	Equivalent
Color additive	Vat Blue 6 Dye	Vat Blue 6 Dye	Equivalent
UV additive	Yes	Yes	Equivalent
Dk permeability (x $10^{-11}$)	25.3	25.3	Equivalent
Light transmittance (Tv, % @ 20°C)	97.7% (between 380-780 nm)	>95% (between 400-800 nm)	Comparable (with slight range difference)
Base Curve, mm (-2.00 D)	Labeled: 8.6, Measured: 8.4 (for BIOMEDICS® 55 UV Asphere)	Labeled: 8.5, Measured: 8.5	Comparable
Diameter, mm (-2.00 D)	Labeled: 14.2, Measured: 14.1 (for BIOMEDICS® 55 UV Asphere)	Labeled: 14.1, Measured: 14.08	Comparable
Power, D (-2.00 D)	Labeled: -2.00, Measured: 2.13 (for BIOMEDICS® 55 UV Asphere)	Labeled: -2.00, Measured: -1.97	Comparable

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

Clinical studies were not performed for this device submission as stated in Section 7: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the HYDROGENICS®2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses". Therefore, there is no test set sample size or data provenance from a new clinical study. The submission relies on equivalence to predicate devices, whose data provenance is not specified in this document.

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)

Not applicable, as no new clinical studies were conducted that required expert-established ground truth.

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

Not applicable, as no new clinical studies were conducted requiring adjudication.

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-assisted diagnostic tool.

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

Not applicable. This is not an AI algorithm.

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

Not applicable for a new clinical study. The "ground truth" for the device's characteristics and safety/efficacy is established by the successful marketing and clearance of its predicate devices and the physical/chemical properties demonstrating equivalence.

8. The sample size for the training set

Not applicable, as no new clinical trials were conducted. For the manufacturing information and finished lens parameters comparison, sample sizes for quality control testing are implied but not specified in this summary.

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

Not applicable, as no new clinical trials were conducted that would involve a "training set" in the context of device performance evaluation. The "ground truth" for the predicate devices' safety and efficacy would have been established through their respective clearance processes, likely including clinical trials and performance testing, but details are not provided in this document.

Summary

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JUL 1 8 2003

510(K) PREMARKET NOTIFICATION

SUMMARY

Reference	OSLA60
Section	3
Version	1
Page	1 / 5

(ocufilcon F) soft (hydrophilic) contact lens

SECTION 3:

510(K) SUMMARY

APPLICANT'S NAME AND ADDRESS

Ocular Sciences Inc. 1855 Gateway Blvd. Suite 700 Concord, CA 94520 USA

Richard Lippman, OD FAAO Vice President Ophthalmic Regulatory Medical Products R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road Suite 30 Rockville, Maryland 20850 Telephone: (240) 683-3738 (240)683-9236 Fax:

1. IDENTIFICATION OF DEVICE

Common Name: Trade Name:

Contact Person

Classification: Device classification: Hydrophilic Soft Contact Lens HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens Daily Wear Soft (hydrophilic) Contact Lens Class II (21 CFR 886.5925)

2. DESCRIPTION OF DEVICE

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are available with in monomer tint (Vat Blue 6) and with ultraviolet absorbing additive (benzophenone based):

+10.00 D to -10.00 D Asphere
with center thickness from 0.025mm to 0.40mm
. with base curves of 8.00mm to 9.20mm
. with diameter of 12.00mm to 18.00mm

The aspheric lens design for the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) is the same design construct as the BIOMEDICS® UV ASPHERE (ocufilcon D) as cleared in K020193 on February 28, 2002.

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3. INTENDED USE

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

4. PREDICATE DEVICES

The following predicate lenses were selected to address material (FDA Group IV: high water, ionic polymer), intended use (daily wear) and lens designs (Asphere).

Lens material, spherical lens design and intended use:

BIOMEDICS® UV 60 (ocufilcon F) Hydrophilic Contact Lenses for Daily Wear, FDA Group IV, high water content, ionic soft contact lenses are marketed nationally by OCULAR SCIENCES Inc. under PMA K992264 cleared for marketing on November 24, 1999.

Asphere lens design:

BIOMEDICS® UV ASPHERE (ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear, FDA Group IV, high water content, ionic soft contact lenses are marketed nationally and internationally by OCULAR SCIENCES Inc. under K020193 cleared for marketing on February 28, 2002.

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Ocular Sciences	510(K) PREMARKET NOTIFICATION	Reference : OSLA60
	SUMMARY	Section : 3
(ocufilcon F) soft (hydrophilic) contact lens		Version : 1
		Page : 3 / 5

5. CHARACTERISTICS

The characteristics of the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are compared to the characteristics of the predicate device HYDROGENICS 60 UV Sphere in the following table.

TABLE I

Material Comparison
	Predicate DeviceHYDROGENICS® 60UV Sphere and Toric(K992264)	Subject deviceHYDROGENICS® 2.0 60UV Asphere
PRODUCTION METHOD	Cast molded process	Cast molded process
INTENDED USE	Daily wearCorrection of ametropia	Daily wearCorrection of ametropia
MATERIAL	ocufilcon F60%	ocufilcon F60%
Type	Group IV	Group IV
Color additive	Vat Blue 6 DyeCFR 130-20-1	Vat Blue 6 DyeCFR 130-20-1
UV additive	Yes	Yes
Dk permeability, ISO 9913-1 Polarimetric methodwith edge correction @ 35°Cx $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg)	$25.3 x 10^{-11}$	$25.3 x 10^{-11}$
Light transmittance	Tv, % @ 20°CIlluminant Awith a 2°observer(between 380and 780 nm)97.7%	(between 400 and800 nm)>95%
	Tv, % @ 20°CIlluminant Awith a 2°observer(between 380and 780 nm)97.7%	(between 400 and800 nm)>95%

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510(K) PREMARKET NOTIFICATION

SUMMARY

(ocufilcon F) soft (hydrophilic) contact lens

TABLE 2

	Lenses design comparison
	Subject DeviceHYDROGENICS® 2.0 60 UV ASPHERE(ocufilcon F)		Predicate DeviceBIOMEDICS® 55 UV Asphere(ocufilcon D)K020193
Characteristics comparison,-2.00 D	Measured	Labeled	Measured	Labeled
Base Curve, mm	8.5	8.5	8.4	8.6
Diameter, mm	14.08	14.1	14.1	14.2
Power, D	-1.97	-2.00	2.13	-2.00

6. NON CLINICAL STUDIES

In support to this application we are providing

Additional Manufacturing information .
Finished Lens Parameters comparison with the predicate device ●
Labeling Information ●

By reference: K992264, K020193 and K984046 data can be found concerning:

Predicate Device ●
. Chemistry
Manufacturing process .
Toxicology: lens and packaging materials
Residual (leachables) Monomer
Shelf life data
Microbiology .
. Packaging

7. CLINICAL DATA

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the HYDROGENICS®2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses, This determination was based on the following:

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses were . demonstrated to be substantial equivalent to the predicate BIOMEDICS/HYDROGENICS® UV Sphere lenses (K99264 and K984046). All demonstrated substantial equivalence in parameters.
. The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lens design was demonstrated to be equivalent to the predicate Asphere lenses: BIOMEDICS® UV Asphere (ocuffilcon D) approved under K020193.

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Ocular	Sciences
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510(K) PREMARKET NOTIFICATION

(ocufilcon F) soft (hydrophilic) contact lens

8. CONCLUSIONS DRAWN FROM STUDIES

Substantial Equivalence:

The information provided in this 510(k) establishes that the HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses are equivalent in optical, chemical and physical properties of the predicate devices and do not raise any questions of safety and effectiveness. Therefore the device is substantially equivalent to the predicate device.

Risk and Benefits:

The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear base. The patient are the same as those for other soft (hydrophilic) contact lenses.

9. ROUTE CHOSEN IN THE FLOW CHART FOR 510 (K) DAILY WEAR CONTACT LENS

FIGURE 1

HYDROGENICS® 2.0 60 UV ASPHERE

Image /page/4/Figure/13 description: This image is a flowchart that outlines a decision-making process. It starts with "510(k)" and branches out based on questions like "Clear?" and "FDA Approved Care Regimen?". The flowchart then leads to different categories such as "Same USAN with Same Suffix", "Same USAN with Different Suffix", and "New USAN", each requiring specific data like Physicochemical Properties, Toxicology, Microbiology, and Clinical Performance Data to determine if it is SE or NSE.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol resembling three abstract human figures or birds in flight, arranged in a layered, overlapping manner.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ocular Sciences, Inc.

c/o Richard E. Lippman, O.D., F.A.A.O. R.P. Chiacchierini & Associates, LLC 15825 Shady Grove Road, Suite 30 Rockville, MD 20850

Re: K031477

Trade/Device Name: Hydrogenics® 2.0 60 UV Asphere (ocufilcon F) Soft (hydrophilic) Contact Lenses indicated for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL; MVN Dated: May 9, 2003 Received: May 9, 2003

JUL 1 8 2003

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Richard E. Lippman, O.D., F.A.A.O.

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A. Reipi 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

Enclosure

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INDICATION FOR USE STATEMENT

SECTION 2: INDICATION FOR USE STATEMENT

KC31477 510(k) Number (if known)

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses Device Name:

Indications for Use:

HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact lenses are indicated for the correction of visual acuity in persons with not-aphakic, non-diseased eyes that are myopic (nearsighted) or hyperopic (farsighted) and may exhibit refractive astigmatism 2.00 diopters or less that does not interfere with visual acuity.

The HYDROGENICS® 2.0 60 UV ASPHERE (ocufilcon F) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use OR Over-the-counter-use

(Division Sign-off)
Division of Ophthalmic Devices

510(k) Number K031477

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.