BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for daily wear to enhance or alter the apparent color of the eye. The eye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Biomedics® UV Colors Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with ultraviolet absorbing additive (benzophenone based) and marketed in four colors: Blue, Green, Hazel and Grey in the power range of -20.00 to +10.00 diopters for sphere, with center thickness from 0.025mm to.40mm, with base curves of 8.00mm to 9.20mm, with diameter of 12.00mm to 15.00mm.

The lenses are made by affixing a color pigment on the front surface of the lens, which corresponds to the iris. The colored pigments consist of Iron Oxide (Black, Russet & Yellow), Titanium Dioxide (White), Cartozole The colored piginents consist of from Onle (Green), Chromium Oxide (Green). All colored additives used are listed in 21 CFR 73 subpart D and 74 subpart D.

This lens material, packaging, manufacturing and sterilization process is equivalent to BIOMEDICS®UV (ocufilcon D) described in submission PMA890023/S4 and S7, 510(K) K984046.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. As such, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the traditional sense of a performance study for a new medical device.

Instead, the submission aims to show that the new device (BIOMEDICS® UV Colors) is as safe and effective as already legally marketed devices. This is done by comparing its characteristics and performance to those of the predicate devices.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC study, effect size) are not applicable or not explicitly detailed in the provided document, as a head-to-head clinical performance study against pre-defined acceptance criteria for a novel device is not the primary objective of this type of submission.

However, I can extract information related to the comparisons made to establish substantial equivalence, which serves a similar purpose to demonstrating "meeting acceptance criteria" in the context of a 510(k).

Here's a breakdown based on the provided text, addressing the applicable points:

1. Table of "Acceptance Criteria" (Predicate Device Metrics) and Reported Device Performance

In the context of a 510(k) for substantial equivalence, the "acceptance criteria" are effectively the characteristics and performance of the predicate devices. The "reported device performance" is how the new device compares to these predicates.

Characteristic Comparison	Predicate Device: BIOMEDICS® UV Sphere (ocufilcon D) (Where applicable)	Predicate Device: FRESHLOOK Colorblends (phere (Hydrophilic) (Where applicable for colored lens aspects)	Subject Device: BIOMEDICS® UV Colors (ocufilcon D)
Material	ocufilcon D (Group IV)	Phemfilcon A	ocufilcon D (Group IV)
Production Method	Cast molded process	Cast molded	Cast molded process
Intended Use	Extended and Daily wear, Correction of ametropia	Extended and Daily Wear	Daily wear, Correction of ametropia, Enhance/alter eye color, UV protection
Color Additive	Vat Blue 6 Dye (for tint)	Iron Oxides, Titanium Dioxide, Copper Phthalocyanine Blue/Green, Chrome Oxide, Carbazole Violet	Iron Oxides, Titanium Dioxide, Copper Phthalocyanine Blue/Green, Chrome Oxide, Carbazole Violet
UV Additive	Yes	Not specified, but UV blocking for predicate BIOMEDICS® UV	Yes
Water Content % @ 20°C (Labeled)	55	Not specified	55
Water Content % @ 20°C (Measured)	54.1	Not specified	53.8
Refractive Index @ 20°C (Labeled)	1.41	Not specified	1.41
Refractive Index @ 20°C (Measured)	1.405	Not specified	1.405
Dk permeability, ISO 9913-1 @ 35°C x 10-11 (cm²/sec) (ml O₂/ml x mm Hg) (Labeled)	19.6	Not specified	19.6
Dk permeability, ISO 9913-1 @ 35°C x 10-11 (cm²/sec) (ml O₂/ml x mm Hg) (Measured)	17.4	Not specified	17.4
Elongation at break, % @ 20°C (Measured)	80	Not specified	80
Mechanical strength, Mpa @ 20°C (Measured)	0.52	Not specified	0.52
Light transmittance, Tv, % @ 20°C (Labeled)	97%	Not specified	97%
Light transmittance, Tv, % @ 20°C (Measured)	97.4	Not specified	97.8
Base Curve, mm (-7.00D) (Labeled)	8.60	Not specified	8.60
Base Curve, mm (-7.00D) (Measured)	8.55 ± 0.021	Not specified	8.49 ± 0.027
Diameter, mm (-7.00D) (Labeled)	14.20	Not specified	14.20
Diameter, mm (-7.00D) (Measured)	14.13 ± 0.03	Not specified	14.20 ± 0.008
Power, D (-7.00D) (Labeled)	-7.00	Not specified	-7.00
Power, D (-7.00D) (Measured)	-7.48 ± 0.087	Not specified	-7.34 ± 0.123
Tint Process	Not specified for base BIOMEDICS® UV	Pad Printing	Pad Printing
Print Zone	Not applicable	corresponds to the iris	corresponds to the iris
Location of print	Not applicable	Front surface	Front surface

2. Sample size used for the test set and the data provenance

Material properties and physical characteristics (Tables 1 & 2): The measurements for "Characteristics comparison, -7.00 D" state "40 lenses" for both predicate and subject devices for Base Curve, Diameter, and Power. Other material properties likely involved similar or different sample sizes, but it's not explicitly stated for each property.
Data Provenance: The document does not specify the country of origin of the data. It implies laboratory testing rather than human subject testing for these physical properties. The studies are "Non-clinical studies."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable. The submission focuses on comparing physical, chemical, and design characteristics of the subject device to predicate devices, and conducting non-clinical toxicology and materials testing. There is no "ground truth" established by experts in the context of diagnostic accuracy or clinical judgment, as would be relevant for an AI/CADe device.

4. Adjudication method for the test set

Not applicable as there is no "test set" requiring adjudication in the context of clinical judgment or diagnostic accuracy.

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 is not an AI/CADe device, and no MRMC study was conducted. The submission specifically states: "It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Biomedics® UV Colored lenses."

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

Not applicable. This is a contact lens, not an algorithm/AI.

7. The type of ground truth used

For material properties and physical characteristics (Tables 1 & 2): The "ground truth" is measured physical and chemical properties and specifications, comparing the subject device's adherence to its own specifications and its similarity to predicate device specifications/measurements.
For toxicology studies: Standardized ISO guidelines for biological evaluation (e.g., cytotoxicity, acute systemic injection, ocular irritation) are used. The "ground truth" are the established biological safety endpoints defined by these standards (e.g., absence of cytotoxicity, no systemic toxicity, no irritation).
For chemistry studies (residual monomers, color extraction, shelf life): The "ground truth" is established analytical chemistry detection limits and stability protocols.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable.

Summary of the Overall Study/Demonstration:

The submission demonstrates substantial equivalence through a series of non-clinical studies and comparisons to predicate devices.

Chemical and Physical Property Comparisons: The subject device's material properties (e.g., water content, refractive index, Dk, mechanical strength, light transmittance) and physical parameters (base curve, diameter, power) were measured and compared to those of the predicate BIOMEDICS® UV Sphere lenses. The results showed "substantial equivalence."
Toxicology Studies:
- Cytotoxicity Test: Conducted according to ISO 10993: Part 5. Result: "test articles were not cytotoxic."
- Acute Systemic Injection Test: In mice, according to ISO 10993: Part 11. Result: "Each test article met the test requirements" (i.e., no systemic toxicity).
- Ocular Eye Irritation Test: In rabbits, according to ISO 10993: Part 10. Result: "the test article extracts are not considered irritants to the ocular tissue of rabbits."
- The "worst case scenario" of Blue and Red Printed lenses were used for these toxicology studies.
Chemistry Studies:
- Material property data were generated and found "substantially equivalent."
- Residual monomer levels were determined and found "substantially equivalent" to the predicate.
- A color extraction study was conducted, and pigments were not detected in saline extracts above detection limits, indicating color fastness.
- Shelf life stability protocols were included.
Solution Compatibility: Tested with Allergan Complete and Essilor (OSL) Concerto, finding no adverse interaction.
Design and Intended Use Comparison (Colored Lenses): The colored lens design aspects (pigments, tint process, print zone, location of print, manufacturing method) were compared to the FRESHLOOK Colorblends predicate device and found to be "equivalent."

The conclusion drawn from these studies is that the BIOMEDICS® UV Colors lenses are equivalent in optical, chemical, and physical properties to the predicate devices and do not raise new questions of safety or effectiveness.

Summary

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510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

OCDC55 Reference Section : 3 Version : I Page : I / 6

0. APPLICANT'S NAME AND ADDRESS

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

Contact Person

Richard Lippman, OD FAAO Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 Telephone: (301) 770-9590 (301) 770-9584 Fax:

1. IDENTIFICATION OF DEVICE

Common Name: Trade Name: Classification: Device classification:

Soft Contact Lens BIOMEDICS®UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens Daily Wear Soft (hydrophilic) Contact Lens Class II (21 CFR 886.5925 (b) (1))

2. DESCRIPTION OF DEVICE

The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lenses are available with ultraviolet absorbing additive (benzophenone based) and marketed in four colors:

Blue, Green, Hazel and Grey ●
in the power range of -20.00 to +10.00 diopters for sphere, .
with center thickness from 0.025mm to.40mm .
with base curves of 8.00mm to 9.20mm .
with diameter of 12.00mm to 15.00mm .

This lens material, packaging, manufacturing and sterilization process is equivalent to BIOMEDICS®UV (ocufilcon D) described in submission PMA890023/S4 and S7, 510(K) K984046.

K013377

DEC 2 0 2001

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3. INTENDED USE

The Biomedics® UV Colors Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

4. PREDICATE DEVICES

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

Lens material, spherical lens design and intended use:

BIOMEDICS® UV (ocufilcon D) Sphere Hydrophilic Contact Lenses, FDA Group IV, high water content, ionic soft contact lenses for daily wear marketed internationally by OCULAR SCIENCES Inc. under PMA 890023/57 and K984046.

Opaque colored lens:

FRESHLOOK Colorblends (phere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603.

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5. CHARACTERISTICS

CHARACTERISTICS Biomedics® UV sphere in the following table.

TABLE 1

Material comparison
Predicate device		Subject device
BIOMEDICS® UV Sphere		BIOMEDICS® UV Colors
PRODUCTION METHOD	Cast molded process		Cast molded process
INTENDED USE	Extended and daily wearCorrection of ametropia		Daily wearCorrection of ametropia
MATERIAL	ocufilcon D		ocufilcon D
Type	Group IV		Group IV
Color additive	Vat Blue 6 Dye21 CFR 73.3119CAS #130-20-1		Iron Oxides	21 CFR 73.3125
			Titanium Dioxide	21 CFR 73.3126
			Carbazole Violet	21 CFR 73.3107
			Copper Phthalocyanine Blue	21 CFR 74.3045
			Copper Phthalocyanine Green	21 CFR 73.3124
			Chrome Oxide	21 CFR 73.3111
UV additive	Yes		Yes
Characteristics comparison	Measured	Labeled	Measured	Labeled
Water Content % @ 20°C	54.1	55	53.8	55
Refractive Index @ 20°C	1.405	1.41	1.405	1.41
Dk permeability, ISO 9913-1Polarimetric method with edgecorrection @ 35°Cx 10-11 (cm²/sec) (ml O₂/ml x mm Hg)	17.4	19.6	17.4	19.6
Elongation at break, % @ 20°C	80	NA	80	NA
Mechanical strength, Mpa @ 20°C	0.52	NA	0.52	NA
Light transmittance	Tv, % @ 20°CIlluminant A with a 2° observer(between 380 and 780 nm)	(between 400 and 800 nm)	Tv, % @ 20°CIlluminant A with a 2°observer (between 380 and780 nm)	Tv, % @ 20°CIlluminant A with a 2°observer (between 380and 780 nm)
	97.4	97%	97.8	97%

TABLE 2

Parameter comparison
	Predicate deviceBIOMEDICS® UV		Subject deviceBIOMEDICS® UV Colors
Characteristics comparison, -7.00 D40 lenses	Labeled	Measured	Labeled	Measured
Base Curve, mm	8.60	$8.55 \pm 0.021$	8.60	$8.49 \pm 0.027$
Diameter, mm	14.20	$14.13 \pm 0.03$	14.20	$14.20 \pm 0.008$
Power, D	-7.00	$-7.48 \pm 0.087$	-7.00	$-7.34 \pm 0.123$

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510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

TABLE 3

Opaque (Colors) lens comparison
	Predicate device	Subject device
	FRESHLOOK COLORBLENDS	BIOMEDICS®UV Colors
Indications	Extended and Daily Wear	Daily Wear
Pigments	Iron Oxides 21 CFR 73.3125Titanium Dioxide 21 CFR 73.3126Copper Phthalocyanine Blue 21 CFR 74.3045Copper Phthalocyanine Green 21 CFR 73.3124Chrome Oxide 21 CFR 73.3111Carbazole Violet 21 CFR 73.3107	Iron Oxides 21 CFR 73.3125Titanium Dioxide 21 CFR 73.3126Copper Phthalocyanine Blue 21 CFR 74.3045Copper Phthalocyanine Green 21 CFR 73.3124Chrome Oxide 21 CFR 73.3111Carbazole Violet 21 CFR 73.3107
Tint Process	Pad Printing	Pad Printing
Print Zone	corresponds to the iris	corresponds to the iris
Location of print	Front surface	Front surface
Manufacturing method	Cast molded	Cast molded

6. NON CLINICAL STUDIES

Non-clinical studies are summarized below:

Chemistry

Material property data were generated on the BIOMEDICS® UV sphere and the BIOMEDICS® UV™Colors . lenses. The material properties were substantially equivalent.
The lens care product manufacturers have previously shown compatibility of Group IV lenses with their . products.
. The shelf life stability for BIOMEDICS® UV Colors lenses is based upon stability protocols included with this notification.
. Studies were conducted to determine the residual monomers on the subject device and on the predicate device. The levels of residual monomers were substantially equivalent. HEMA, MA, EDGMA and UV Blocker.
. Color extraction study was conducted to assess the color fastness of the pigments used to print the Colors lens. The pigments were not detected in the saline extracts above the detection limit for each of the pigments in any of the samples.

Toxicology, lenses materials

In accordance with the May 1994 Guidance Document for Daily Wear contact lenses, toxicology studies have been conducted on the BIOMEDICS® UV Colors containing UV blocker. Blue and Red Printed lenses (worst case scenario) were used in the studies. The results are summarized below:

● Cytotoxicity Test:

A Cytotoxicity Test has been conducted on the subject device according to ISO 10993: Biological Evaluation of Medical Devices, Part 5: Tests for Cytotoxicity: In vitro Methods guidelines, was conducted on the test articles, to determine the potential for Cytotoxicity.

The negative controls and the positive controls performed as anticipated. Under the conditions of the study, the test articles were not cytotoxic.

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510(K) PREMARKET NOTIFICATION

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Reference	OCDC55
Section	3
Version	1
Page	5 / 6

Acute Systemic Injection Test in the mouse: .

· Acute Systemic Injection Lest in the mouse.
An evaluation of the test articles for systemic toxicity in mice after and Medical Prolection of Madical intraperitoneal administration has been conducted according to the ISO 1093: Biological Evaluation of Medical Devices, Part 11: Tests for Systemic Toxicity.

Devices, Fari II. Tests for Systems from the test article extracts. Each test article met the test requirements.

Ocular Eye Irritation Test in the rabbit: .

· Octuar Eye Irritation of 0.9% NaCl and conomics of the subject atticle after a single after a single instillation in the rabbit has been conding to ISO 10993: Biological Evaluation of Medical devices, Part 10: Tests for the Irritation and Sensitization.

Patt 10. Tests for the firmation and belief the rest article extracts are not considered irritants to the ocular tissue of rabbits.

Solution Compatibility

Solution Companibility efficacy of their care products with lens groups for which they are approved.

Solution compatibility was performed using Allergan Complete and Essilor (OSL) Concerto. Solution companists was personics assig rinersity between any of the colored printed lenses, with or without cleaning.

Non-clinical studies and manufacturing information provided by reference PMA890023 S4/S7 and K984046

Cast molded manufacturing process .
Packaging process .
Toxicology packaging materials ●
Microbiology and sterilization .

7. CLINICAL DATA

It was determined that Clinical Studies were not necessary to establish the safety and efficacy of the Biomedics® UV Colored lenses. This determination was based on the following:

Colorodics® UV Colors lenses were proven to be substantial equivalent to the predicate Biomedics® UV . Sphere lenses (PMA890023/54 and S7 and K984046). Showed substantial equivalence in physiochemical characteristics and parameters.
The Biomedics® UV Colors lens design was proven to be equivalent to the predicate device: FRESHLOOK Colorblends (phemfilcon A) Sphere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603.

8. CONCLUSIONS DRAWN FROM STUDIES

Validity of Scientific Data:

A contract laboratory using Good Laboratory Practices conducted the Toxicology and Color Extraction studies. Chemistry leachables studies were conducted in-house.

Substantial Equivalence:

Information provided in this 510K establishes that the Biomedics® UV Colors lenses are equivalent in optical, chevical and physical properties of the predicate devices and do not raise any questions of safety and Therefore, the device is substantially equivalent to the predicate devices, Biomedics® UV effectiveness. (ocufilcon D) Soft (Hydrophilic) Spherical and FRESHLOOK Colorblends (phemfilcon A) Sphere (Hydrophilic) Contact lenses marketed internationally by Wesley Jessen under PMA 830037 S33/S39 and K954603. Risk and Benefits:

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The risks of the subject device are the same as those normally attributed to the wearing of soft (hydrophilic) The risks of the subject device are the same as those normally and the same as those for other soft (hydrophilic) contact lenses.

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

FIGURE 1

BIOMEDICS® UV Colors

Image /page/5/Figure/8 description: This image is a flowchart that describes the process for determining whether a new medical device is substantially equivalent to a predicate device. The flowchart starts with a 510(k) submission and then asks a series of questions to determine whether the new device is substantially equivalent. The questions include whether the device is clear, whether it uses listed colors, and whether it is an FDA-approved care regimen. The flowchart also considers whether the device has the same USAN with the same suffix, the same USAN with a different suffix, or a new USAN.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized eagle with three lines representing its wings, and 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

DEC 2 0 2001

Ocular Sciences Inc. c/o Richard Lippman, OD FAAO Senior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852

Re: K013377

Trade/Device Name: BIOMEDICS®UV Colors (ocufilcon D) Soft (Hydrophilic) Contact lens Regulation Number: 21 CFR 886.5925 Regulation Name: Daily Wear Soft (hydrophilic) Contact Lens Regulatory Class: II Product Code: LPL Dated: October 11, 2001 Received: October 12, 2001

Dear Dr. Lippman:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your we determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 to bears in 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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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 and additionally 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. 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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INDICATION FOR USE STATEMENT

510(k) Number (if known)

Device Name:

Indications for Use:

BIOMEDICS® UV Colors spherical lenses are indicated for the correction of visual acuity in not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn not-apilance persons with how alsoused of and the may of 2.00 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Colors (ocufilcon D) Soft (Hydrophilic) Contact Lens are indicated for The DROMLDICOS OF OF Offer the apparent color of the eye. The eye care practitioner may daily wear to chiance or after single use disposable wear and for frequent replacement prescribed the ocheast for frequent replacement/planned replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The Biomedics® UV Colors 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

Over-the -counter-use

Lianiel W. Brown, Ph.D.

Division of Ophthalmic Devices

510(k) Number_K013377

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.