OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)

K981252 · Alden Optical Labs., Inc. · LPL · Jun 23, 1998 · Ophthalmic

Device Facts

• Record ID: K981252
• Device Name: OXYLENS (HIOXIFILCON B) SOFT (SPHERICAL & TORIC) DAILY WEAR CONTACT LENSS (CLEAR & BLUE VISIBILITY TINTED, LATHE-CUT FR)
• Applicant: Alden Optical Labs., Inc.
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity. The OXYLENS (hioxifilcon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters. The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

Device Story

OxyLens is a daily wear, lathe-cut, hydrophilic soft contact lens made of hioxifilcon B. In hydrated state, lens conforms to corneal curvature to correct refractive errors (myopia, hyperopia, astigmatism). Lens requires maintenance in compatible aqueous solution; rehydrates if dried. Used by patients under practitioner guidance for planned replacement. Provides refractive medium to focus light on retina. Benefits include vision correction for aphakic and non-aphakic patients.

Clinical Evidence

No clinical data provided; substantial equivalence based on bench testing and comparison of physical/chemical properties to predicate devices.

Technological Characteristics

Material: hioxifilcon B (hydrophilic polymer). Water content: 48% ± 2%. Oxygen permeability (Dk): 15 x 10^-11 (cm2/sec)(ml O2/ml x mmHg @ 35°C). Refractive index: 1.404 (hydrated). Lathe-cut manufacturing. Clear or Phthalocyanine Blue tint. Daily wear modality.

Indications for Use

Indicated for correction of visual acuity in aphakic and non-aphakic persons with non-diseased eyes with myopia or hyperopia. Spherical lenses for astigmatism ≤ 1.50D; Toric lenses for astigmatism ≤ 10D.

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

• Alden Classic series (spherical and toric lens)
• Satureyes and Satureyes Toric (Metro Optics)
• BENZ-G 3X (K964528)

Submission Summary (Full Text)

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## JUN 2 3 1998

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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 is:

98i2j2

#### Applicant information:

Date Prepared:

April 2, 1998

Name: Address: Alden Optical Laboratories 13295 Broadway Alden, New York 14004

Mr. Charles H. Creighton Contact Person: 800.253.3669 Phone Number:

US Consultant:

Phone Number:

Fax Number:

Mr. Martin Dalsing 623 Glacier Grand Junction, CO 81503 970.243.5490 970 243.5501

Med-Vice Consulting, Inc.

### Device Information:

Regulatory Classification: Class II

86 LPL Product Code:

OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Trade Name: Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)

Lenses, Soft Contact, Daily Wear Classification Name:

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#### Equivalent Devices:

The OXYLENS (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens is substantially equivalent to predicate devices in terms of intended use and design. Predicate devices include our own "Alden Classic" series (spherical and toric lens) manufactured by Alden Optical Labs, "Satureyes" and "Satureyes Toric" manufactured by Metro Optics and the "BENZ-G 3X" manufactured by Benz Research and Development.

#### Device Description:

The OXYLENS (bioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact lenses are fabricated from hioxifilcon B, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (hioxifilcon B) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eve. If the lens dries out, it will become hard and appear somewhat warped, however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 48% water by weight. The physical properties of the lens are.

| Refractive Index | 1.515 (dry) 1.404 (hydrated) |
|-----------------------------|-----------------------------------------------------------------------|
| Light Transmission (clear) | greater than 95% T |
| Light Transmission (tinted) | greater than 95% T |
| Color Pigment Name | Phthalocyanine Blue |
| Water Content | 48 % ± 2% |
| Specific Gravity | 1.308 (dry) 1.136 (hydrated) |
| Oxygen Permeability | 15 X 10-11 (cm2/sec) (ml O₂/ml x mm Hg @ 35°C), (revised Fatt method) |

#### Intended Use:

The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters or less where the astigmatism does not interfere with visual acuity.

The OXYLENS (hioxifilcon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism.

The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

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## Substantial Equivalence:

The device will be manufactured according to specified process controls and a quality assurance program. The device will undergo manufacturing, packaging and sterilization procedures similar to devices currently marketed and distributed by Alden Optical Laboratories. The established safety profile (preclinical toxicology and manufacturing/chemistry data) of the device is equivalent to the BENZ-G 3X (hioxifilcon B), 510(k) #K964528. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate devices identified above.

The following matrix illustrates that the production method, lens function and material of the OxyLens (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathecut from Lens Blank), are substantially equivalent to the predicate device(s). In addition, the water content, polymer, Dk value, refractive index, specific gravity, and light transmission are as well substantially equivalent to the predicate device.

| | Characteristic | OXYLENS (bioxifilcon B) | PREDICATE<br>DEVICES |
|-----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| 1.) | PRODUCTION<br>METHOD | Lathe-Cut | SAME |
| 2.) | LENS FUNCTION | Refractive medium that focuses light<br>rays from near and distant objects on<br>the retina, while compensating for<br>refractive error, including<br>(astigmatism) | SAME |
| 3.) | MATERIAL | Hydrophilic Polymer | SAME |
| a. | Water Content | 48% | SAME/SIMILAR |
| b. | Polymer Content | 52% | SAME/SIMILAR |
| c. | Polymer | bioxifilcon B | SAME/SIMILAR |
| d. | DK Value | 15 | SAME/SIMILAR |
| e. | Refractive Index | 1.404 (hydrated) | SAME/SIMILAR |
| f. | Specific Gravity | 1.136 (hydrated) | SAME/SIMILAR |
| g. | Light Transmission | greater than 95 % T | SAME/SIMILAR |

## SUMMARY OF SAFETY AND EFFECTIVENESS Substantial Equivalence Matrix

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 1998

Alden Optical Laboratories, Inc. C/O Martin J. Dalsing 623 Glacier Drive Grand Junction, CO 81503

Re: K981252

Trade Name: Oxylens (hioxifilcon B) Soft (Sperical & Toric) Daily Wear Contact Lens (Clear & Blue Visibility Tint, Lathe-cut from Lens Blank)

Regulatory Class: II Product Code: 86 LPL Dated: April 2, 1998 Received: April 6, 1998

Dear Mr. Dalsing:

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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Page 2 - Mr. Martin J. Dalsing

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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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## INDICATIONS FOR USE STATEMENT

#### OXYLENS (hioxifilcon B) Soft (Spherical & Toric) Daily Wear Contact Lens Device Name: (Clear & Blue Visibility Tint, Lath-cut from Lens Blank)

#### INDICATIONS FOR USE:

The OXYLENS (hioxifilcon B) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or byperopia. The lens may be worn by persons who exhibit refractive astigmatism of 1.50 diopters of less where the astigmatism does not interfere with visual acuity.

The OXYLENS (hioxifileon B) Toric Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia and/or possesses refractive astigmatism not exceeding 10 Diopters.

The lenses are available within a planned replacement program with frequency of replacement determined by the practitioner.

(PLEASE DO OT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use 12 (Per 21 CFR 801.109)

or

Over-The-Counter Use 0

(Optional Format 1-2-96)

Mig-Churen. Shi

(Division Sign-Off) Division of Ophthalmic Devices

510(k) Number

< 78/2.