BIOMEDICS UV MULTIFOCAL

K012425 · Ocular Sciences Puerto Rico, Inc. · LPL · Oct 12, 2001 · Ophthalmic

Device Facts

• Record ID: K012425
• Device Name: BIOMEDICS UV MULTIFOCAL
• Applicant: Ocular Sciences Puerto Rico, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Oct 12, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear. 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 the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems. The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are presbyopic, with or without associated ametropia. The lens may be worn by persons who require up to +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity. The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

Biomedics UV Multifocal is a soft (hydrophilic) contact lens made of ocufilcon D; features aspheric center-near design for presbyopia correction. Lens is cast-molded; contains Vat Blue 6 dye and benzophenone-based UV-absorbing additive. Prescribed by eye care practitioners for daily wear; available for single-use or frequent replacement schedules. Patients use lens to correct visual acuity and protect against UV radiation. Clinical benefit includes improved near vision for presbyopic patients while maintaining standard soft lens comfort and safety profile.

Clinical Evidence

No clinical data. Substantial equivalence established via physiochemical characterization and comparison of lens parameters and design to predicate devices.

Technological Characteristics

Material: ocufilcon D (FDA Group IV, high water, ionic). Water content: 55%. Refractive index: 1.41. Dk: 19.6 x 10^-11. Design: Aspheric center-near multifocal. Additive: Benzophenone-based UV absorber. Tint: Vat Blue 6. Manufacturing: Cast molded. Sterilization: Chemical or hydrogen peroxide systems.

Indications for Use

Indicated for daily wear in non-aphakic, non-diseased, presbyopic patients with or without ametropia. Corrects up to +3.00 diopters of addition and refractive astigmatism of 0.75 diopters or less. Provides UV radiation protection.

Regulatory Classification

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.

Predicate Devices

• BIOMEDICS® UV (ocufilcon D) Sphere Hydrophilic Contact Lenses (PMA 890023/S7, K984046)
• Rythmic® UV (surfilcon A) Hydrophilic Contact Lenses (K003170)

Submission Summary (Full Text)

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# OCT 1 2 2001

K012425

#### Ocular Sciences

(ocufilcon D) soft (hydrophlic) contact lens

### 510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE Reference : OCDM55 : 3 Section Version : 3 Page :114

### 0. APPLICANT'S NAME AND ADDRESS

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

Contact Person

Richard Lippman, OD FAAO Schior Consultant C.L. McIntosh & Associates, Inc. 12300 Twinbrook Parkway, Suite 625 Rockville, Maryland 20852 Telephone: [phone] Fax: [phone]

#### 1. IDENTIFICATION OF DEVICE

| Common Name: | Hydrophilic Soft Contact Lens |
|------------------------|------------------------------------------------------------------------|
| Trade Name: | Biomedics ® UV Multifocal (ocufilcon D) Soft(Hydrophilic) contact lens |
| Classification: | Daily Wear Soft (hydrophilic) Contact Lens |
| Device classification: | Class II (21 CFR 886.5925 (b) (1)) |

#### 2. DESCRIPTION OF DEVICE

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Leases are available with in monomer tint

(Vat Blue 9) and with ultraviolet absorbing additive (benzophenone based):

- in the power range of -20.00 to +10.00 diopters for sphere,
- +0.25 to +3.00 diopters for addition
- 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 lens material is the same as the one BIOMEDICS® UV (ocufilcon D) described in submission PMA890023/S4 and S7 ,K984046.

The Biomedics® UV Multifocal (ocufilton D) 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 optical surface allows for correction of visual acuity in non-aphakic persons with non-diseased eyes that are presbyopic, with ar without associated ametropia, allowing for the correction of up to +3.00 diopters of add, with refractive astigmatism of no more than 0.75 diopters that does not interfere with visual acuity. The multifocal lens is a aspheric center near design.

#### 3. INTENDED USE

.

The BIOMEDICS® UV Multifocal (ocufileon D) Soft (Hydrophilic) Contact Lenses are indicated for daily wear The cye care practitioner may prescribe the contact lens for either single use disposable wear and for frequent replacement wear. When prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting systems.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the correction of visual acuity in not-aphakic persons with non-discosed cyes that are wildoul

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Ocular Sciences

(ocufilcon D) soft (hydrophilic) contact lens

### 510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE Reference : OCDM55 Section : 3 Version : 3 Page :214

associated ametropia. The lens may be worn by persons who require up 10 +3.00 diopters of addition and who exhibit refractive astigmatism of 0.75 diopters or less that does not interfere with visual acuity.

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) 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 imended use:

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

#### Multifocal lens design:

Rythmic® UV (surfilcon A) Hydrophilic Contact Lenses, FDA Group II, high water content, non ionic soft contact lenses for daily wear marketed internationally by OCULAR SCIENCES Inc under K003170

### 5. CHARACTERISTICS

The characteristics of the Biomedics® UV Multifocal (ocufilcon D) Soft(Hydrophilic) contact lens arc compared to the characteristics of the prodicate device Biomedics® UV sphere in the following table.

#### TABLE I

| Material comparison | | |
|------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|--------------------------------------------------------------------------|
| | Predicate device | Subject device |
| | BIOMEDICS® UV Sphere | BIOMEDICS® UV Multifocal |
| PRODUCTION METHOD | Cast molded process | Cast molded process |
| INTENDED USE | Extended and daily wear<br>Correction of ametropia | Daily wear<br>Correction of ametropia and presbyopia |
| MATERIAL | ocufilcon D | ocufilcon D |
| Type | Group IV | Group IV |
| Color additive | Vat Blue 6 Dye<br>CFR 130-20-1 | Vat Blue 6 Dye<br>CFR 130-20-1 |
| UV additive | Yes | Yes |
| Characteristics comparison | Labeled | Labeled |
| Water Content % @ 20°C | 55 | 55 |
| Refractive Index @ 20°C | 1.41 | 1.41 |
| Dk, Polarimetric method with edge<br>correction @ 35°C<br>x 10-11 (cm²/sec) (ml O₂/ml x mm Hg) | 19.6 | 19.6 |
| Elongation at break, % @ 20°C | NA | NA |
| Mechanical strength, Mpa @ 20°C | NA | NA |
| Light transmittance | Tv, % @ 20°C<br>Illuminant A with a 2° observer (between 380 and 780 nm) | Tv, % @ 20°C<br>Illuminant A with a 2° observer (between 380 and 780 nm) |
| | 97% | 97% |

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### Ocular Sciences

### 510(K) PREMARKET NOTIFICATION

(ocufilcon D) soft (hydrophilic) contact lens

### SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE

Reference : OCDM55 : 3 Section : 3 Version : 3 / 4 Page

#### TABLE 2

| | Lenses design comparison | |
|-------------------------------------|-------------------------------------------------------|-------------------------------------------------------|
| | Predicate spherical device<br>BIOMEDICS® UV Sphere | Subject spherical device<br>BIOMEDICS® UV Multifocal |
| Characteristics comparison, -3.00 D | Labeled | Labeled |
| 30 lenses | | |
| Base Curve, mm | 8.60 | 8.60 |
| Diameter, mm | 14.20 | 14.20 |
| Power, D | -3.00 | -3.00 |
| | Predicate multifocal device<br>RYTHMIC® UV Multifocal | Subject multifocal device<br>BIOMEDICS® UV Multifocal |
| Characteristics comparison, -3.00 D | Labeled | Labeled |
| 30 lenses | | |
| Power, D | -3.00 | -3.00 |

### 6. NON CLINICAL STUDIES

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

- Chemistry ●
- Cast molded manufacturing process ●
- Toxicology data: lens and packaging materials ●
- Residual (leachables) Monomer .
- Shelf life data ◆
- Microbiology and sterilization .
- Packaging ●

### 7. CLINICAL DATA

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

- The Biomedics® UV Multifocal (ocufileon D) Soft(Hydrophilic) contact lens were proven to be substantial . I in: blomedics® OF Maniboon (Overale 1-2014) 1-2 (PMA890023/S4 and S7 and K984046). Showed substantial equivalence in physiochemical characteristics and parameters.
- The Biomedics® UV Multilocal (ocufileon D) Soft(Hydrophilic) contact lens design was proven to be . equivalent to the predicate multifocal lenses: Rythmic® UV Multifocal lenses from Ocular Sciences( K003170).

### 8. CONCLUSIONS DRAWN FROM STUDIES

#### Substantial Equivalence:

The information provided in this 510K establishes that the Biomedical® UV Multifocal (ocufileon D) soft The mich provided in this 970x columnical, chemical and physical properties of the predicated covices and do not raise any questions of safety and effectiveness. There for the device is substantially equivalent to the predicate device.

### Risk und Benefits:

The risks of the subject device are the same as those normally attributed to the see (fordershillian THE TISS of the Subject device are the patient are the same as those for other soft (tydrophilic) contact lenses.

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| Ocular Sciences |
|-----------------|
|-----------------|

(ocufilcon D) soft (hydrophilic) contact lens

## 510(K) PREMARKET NOTIFICATION

SUMMARY OF SAFETY AND SUBSTANTIAL EQUIVALENCE Reference : OCDM55 Section :3 Version : 3 : 4 / 4 Page

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

### FIGURE 1

Biomedics® UV Multifocal

Image /page/3/Figure/8 description: The image is a flowchart that describes a process. The flowchart starts with a 610(k) and then asks if it is clear. If it is not clear, it asks if it is a listed color, and if not, it is refused to accept. If it is clear, it asks if it is an FDA-approved care regimen, and if not, it is a non-substantial equivalent. If it is an FDA-approved care regimen, it goes to UGAN, and then it branches out to same UBAN with same suffix, same USAN with different suffix, and new UBAN.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows a black and white logo of the U.S. Department of Health & Human Services. The logo features a stylized eagle with three curved lines representing its wings. The eagle is positioned within a circular border that contains the text "U.S. Department of Health & Human Services" around the perimeter.

**9200 Co**
**Rockvil**

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ocular Sciences, Inc. c/o Richard E. Lippman, O.D., F.A.A.O. CL McIntosh & Associates, Inc. 12300 Twinbrook Parkway Suite 625 Rockville, MD 20852

Re: K012425

Trade/Device Name: Biomedics® UV Multifocal (ocufilcon D) Soft (hydrophilic) Contact Lens for Daily Wear (visibility tint, cast molded) Regulation Number: 21 CFR 886.5925 (b) (1) Regulation Name: Soft (hydrophilic) Contact Lens for Daily Wear Regulatory Class: Class II Product Code: LPL Dated: July 24, 2001 Received: July 30, 2001

OCT 1 2 2001

Dear Mr. Lippman:

We have reviewed your Section 510(k) notification of intent to market the device referenced above w I 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 the 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, with 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 provident of the 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 11 your as the reas be subject to such additional controls. Existing major regulations affecting your I spice can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A as no vall vequivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: Fraction 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 Drug ! lanninouance ( = 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 - 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) This letter will and w you've FDA finding of substantial equivalence of your device to a legally promatics notification - 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 11 you desire specific acrison. 10 for in vitro diagnostic devices), please contact the Office of additionally at [phone]. Additionally, for questions on the promotion and advertising of Compinatee at (301) 97 - the Office of Compliance at [phone]. 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 Other general informational and Consumer Assistance at its toll-free number [phone] or [phone] 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) | K012425 |
|--------------------------|---------|
|--------------------------|---------|

BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lens Device Name:

#### Indications for Use:

The BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for daily The BIOMEDICS" OV Munitional (ocuribed) D) box (1) 2707 either single use disposable wear and or wear. The eye care practitions thay prescribed for frequent replacement the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system.

BIOMEDICS® UV Multifocal (ocufilcon D) Soft (Hydrophilic) Contact Lenses are indicated for the BIOMEDICS OV Multilocal (cedificou D) Ont (x) Loop-diseased eyes that are presty of the or correction of visual aculty in not-aplaatic persons who require up to +3.00 diopters of without associated alletitions. The felis may of world of persons that does not interfere with visual acuity .

The BIOMEDICS® UV Multifocal (ocufilcon D) 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)

| Presription Use | | OR | Over -The-Counter Use |
|-----------------|--|----|--------------------------|
| | | | (Optional Format 1-2-96) |

Ming-Chuen Shih

(Division Sign-off)

Division of Ophthalmic Devices

| 510(k) Number | K012425 |
|---------------|---------|
|---------------|---------|

000007