OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES

K013445 · Florida Optical Engineering, Inc. · LPL · Dec 26, 2001 · Ophthalmic

Device Facts

• Record ID: K013445
• Device Name: OSPREY SPHERICAL AND TORIC MULTIFOCAL SOFT CONTACT LENSES
• Applicant: Florida Optical Engineering, Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 26, 2001
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity. The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less. Eye care practitioners may prescribe the lenses for planned replacement wear with cleaning, disinfection and scheduled replacement (See WEARING SCHEDULE). When prescribed for planned replacement wear, the lenses may be disinfected using either a heat or chemical disinfection system.

Device Story

OSPREY Spherical and Toric Multifocal Soft Contact Lenses are center-distance, simultaneous-focus, progressive-addition lenses. Manufactured via lathe-cutting hioxifilcon B polymer blanks. Toric versions feature superior/inferior front surface flanges (slab-off) for axis stabilization. Prescribed by eye care practitioners for daily wear; patient-maintained via cleaning/disinfection. Lenses correct visual acuity in presbyopic patients with myopia or hyperopia, with or without astigmatism. Benefit: provides simultaneous distance and near vision correction in a soft lens format.

Clinical Evidence

No clinical data provided; substantial equivalence based on physicochemical properties and design comparison to predicate.

Technological Characteristics

Material: hioxifilcon B (non-ionic polymer). Water content: 48%. Refractive index: 1.515 (dry), 1.425 (hydrated). Oxygen permeability: 15 x 10^-11 (cm²/sec)(ml O2/ml x mm Hg@35°C). Design: Center-distance, simultaneous-focus, progressive-addition. Toric stabilization: slab-off flanges. Manufacturing: Lathe-cut. Disinfection: Heat or chemical.

Indications for Use

Indicated for daily wear correction of visual acuity in aphakic/non-aphakic persons with non-diseased eyes, myopia or hyperopia, and presbyopia. Spherical lenses indicated for astigmatism ≤ 1.50D. Toric lenses indicated for astigmatism ≤ 4.50D.

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

• UltraVue/P and UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact Lenses

Submission Summary (Full Text)

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FLORIDA OPTICAL ENGINEERING, Inc.

510(k) Premarket Notification

# 510(k) PREMARKET NOTIFICATION

## Summary of Safety and Effectiveness

September 22, 2000

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

#### The Assigned 510(k) Number: K013445

#### Applicant Information

Date Prepared:

Name:

Registration Number:

Address:

13709 Progress Boulevard, Box 14 Alachua, Florida 32615

Richard A. Griffin, O.D., President

Florida Optical Engineering, Inc.(FLOE)

Contact Person:

Phone Number: Fax Number: e-mail Address:

[phone] [phone] [e-mail]

### Manufacturing and Sterilization

Euclid Systems Corporation 2810 Towerview Road Herndon, VA 2017

George E. Glady, VP Operations

Contact Person: Phone Number:

800-447-9396 E-mail Address: [e-mail]

#### Device Information

Device Classification:

Classification Number:

Classification Name:

Trade/Proprietary Name:

eorge@Bacha.

Class II

LPL

Soft Contact Lenses, Daily Wear

OSPREYTM Spherical (hioxifilcon B) Multifocal Soft Daily Wear Contact Lenses

and

OSPREY"M Toric (hioxifilcon B) Multifocal Soft Daily Wear Contact Lenses

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Image /page/1/Picture/0 description: The image shows the logo for Florida Optical Engineering. The logo consists of a dark oval shape at the top, with the words "FLORIDA OPTICAL ENGINEERING" written in a bold, slanted font below it. The text is also dark and appears to be slightly distorted, giving it a dynamic look.

The material, Benz-G 5X (hioxifilcon A), may be disinfected using a chemical (nonthermal) disinfection system.

- UltraVue/P and UltraVue/C (hioxifilcon B) Soft (Multifocal) Daily Wear Contact 3. Lenses (Clear and Blue Visibility Tint, Lathe-cut from Lens Blanks) is the predicate device because it is manufactured from:
- (a) the same polymer (hioxifilcon B), the polymer which already has FDA clearance,
- (b) using similar multifocal lens designs and
- (c) using lathe-cutting equipment.

UltraVue/P and UltraVue/C (hioxifilcon B) soft contact lenses made from clear and a blue visibility tint BENZ-G 3X lens blanks are intended for daily wear for correction of visual acuity of aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The Lenses may be worn by people who may exhibit astigmatism of 0.75 Diopters or less where astigmatism does not interfere with visual acuity.

The material, Benz-G 3X (hioxifilcon B), is non-ionic polymer that may be disinfected using either the heat (thermal) or chemical (non-thermal) disinfection system.

The physical properties of the lens blanks made from Benz-G 3X (hioxifilcon B) lens polymer material, which are used to manufacture predicate devices number 1 and 3 are listed in Table 4.

| Refractive Index | 1.515 (dry) and 1.425 (hydrated) |
|-----------------------------|---------------------------------------------|
| Color Pigment Name | Phthalocyanine Blue |
| Light Transmission (Clear) | greater then 95% T |
| Light Transmission (Tinted) | greater then 95% T |
| Water Content | 48% by weight |
| Specific Gravity | 1.308 (dry) and 1.136 (hydrated |
| Oxygen Permeability | 15 x 10-11 (cm²/sec)(ml O2/ml x mm Hg@35°C) |

## Table 4. Physicochemical Properties(*) of Benz-G 3X (hioxifilcon B) Lens Blanks Polymer Material.

(*) NOTE: Data Taken from Technical Manual, Benz Research and Development, Inc. (April 1999)

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510(k) Premarket Notification

#### INTENDED USE

The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less.

Eye care practitioners may prescribe the lenses for planned replacement wear with cleaning, disinfection and scheduled replacement (See WEARING SCHEDULE). When prescribed for planned replacement wear, the lenses may be disinfected using either a heat or chemical disinfection system.

### DESCRIPTION OF DEVICE

OSPREY™ Spherical or Toric (hioxifilcon B) Multifocal Soft Daily Wear Contact Lenses (Clear and Blue Visibility Tint, Lathe-cut from Lens Blanks) are made from clear and a blue visibility tint BENZ-G 3X (hioxifilcon B) lens blanks intended for daily wear for correction of visual acuity of aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia and are presbyopic. The lenses are manufactured by lathe-cutting of lens blanks in dry (i.e. non-hydrated) state into hemispherical shell which can be polished when desired. The toric contact lens have a Toric Base Curve.

Osprey™ Multifocal Soft Contact Lens is a center-distance, simultaneous-focus, progressive-addition lens. Focal power within the central power zone is generated on the front surface, beginning at the central distance power, and increasing radially outward. Labeled Add Power is that Add Power which is occurring at the pupillary zone diameter of 3.5 mm. The back surface may be either spherical or toric for correcting astigmatism. The toric lens is held on axis by the superior and inferior front surface flanges, formed by slab-off. The lenses are available in clear and with a blue visibility tint as supplied by the manufacturer of lens blanks.

Side-by-side comparison of the key physical/chemical/optical properties of the Osprey™ Multifocal Contact Lens compared with the lenses to which substantial equivalence is sought is given in Table 5. As can be seen from this table, the Present Device, that is, OSPREY™ Multifocal Soft Contact Lens satisfies the requirements for substantial equivalency determination. Only difference is in the shape of lens curvature, which defines the optics, all other aspects are the same for this lens and predicate devices.

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Image /page/3/Picture/2 description: The image is a black and white circular logo. The logo features a stylized depiction of an eagle or bird with three curved lines forming its body and wings. The bird is facing to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged along the circumference of the circle.

DEC 2 6 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Richard Griffin, O.D. Florida Optical Engineering, Inc. (FLOE) 13709 Progress Boulevard, Box 14 Alachua, FL 32615

Re: K013445

Trade/Device Name: Osprey (hioxifilcon B) Spherical and Toric Multifocal Lens for Daily Wear. Regulation Number: 21 CFR 886.5925 Regulation Name: Soft Contact Lens, Daily Wear Regulatory Class: Class II Product Code: LPL Dated: October 17, 2001 Received: October 17, 2001

Dear Dr. Griffin:

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 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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This letter will allow you to begin marketing your device as described in your Section 510(k) I his ictier will and in your to ough finding of substantial equivalence of your device to a legally prematication. "The suits 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 If you desire specific acriso for in vitro diagnostic devices), please contact the Office of additionally 21 CFT Fur 05-1. Additionally, for questions on the promotion and advertising of Compliance at [phone]. 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 international 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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FLORIDA OPTICAL ENGINEERING, Inc.

510(k) Premarket Notification

# INDICATIONS FOR USE STATEMENT

K013445 510(k) Number:

OSPREY™ Spherical or Toric (hioxifilcon B) Multifocal Soft Device Name: Daily Wear Contact Lenses (Clear and Blue Visibility Tint, Lathe-cut from Lens Blanks).

Indications for Use:

The OSPREY Spherical (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia. The lenses may be worn by persons with astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

The OSPREY Toric (hioxifilcon B) Multifocal Soft Contact Lenses are indicated for daily wear for the correction of visual acuity in aphakic and not-aphakic persons with non-diseased eyes that are myopic or hyperopic with presbyopia and astigmatism of 4.5 diopters or less.

Sarcia

(Division Sign-Off)

Division of Ophthalitnic Ear Nose and Throat Devises

510(k) Number N(0)344

Prescription Use
(Per 21 CFR 801.109)