FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

K971049 · Aspect Vision Care, Ltd. · LPL · May 21, 1997 · Ophthalmic

Device Facts

• Record ID: K971049
• Device Name: FREQUENCY 38 (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
• Applicant: Aspect Vision Care, Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: May 21, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity. Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

Device Story

Hemispherical soft contact lens; manufactured from polymerized HEMA crosslinked with EGDMA; designed to fit over corneal surface. Corrects refractive ametropia (myopia, hyperopia, astigmatism) by providing corrective power corresponding to eye's refractive needs. Features base curve, optical zone (>6mm), secondary/tertiary curves, and beveled edges for centration and comfort. Prescribed by eyecare practitioners for daily wear, including frequent replacement programs. Patient self-maintains via heat, chemical, or hydrogen peroxide disinfection. Benefits include improved visual acuity for patients with refractive errors.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on identical material, formulation, and manufacturing processes to the predicate device.

Technological Characteristics

Material: Polymacon (HEMA crosslinked with EGDMA). Group 1, non-ionic, low water content polymer. Form factor: Hemispherical shell, 14.0 mm diameter, 8.6 mm base curve, 0.07 mm center thickness. Power range: +20.00 to -20.00D. Sterilization: Not specified (manufacturing process referenced from predicate).

Indications for Use

Indicated for daily wear correction of myopia and hyperopia in aphakic and non-aphakic persons with non-diseased eyes; includes astigmatism up to 2.00 Diopters.

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

• LifeStyle 4 Vue (polymacon) Hydrophilic Contact Lens (K950283, K963001)

Submission Summary (Full Text)

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FROM: Panasonic FAX SYSTEM
MAY 21 1997

# 510 (k) Summary K971049

## SUBMITTER:

Submitted on behalf of:

| Company Name: | Aspect Vision Care, Ltd. |
| --- | --- |
| Address: | South Point, Hamble
Southampton SO31 4RF
United Kingdom |
| Phone: | 011 44 1703 455 567 |
| Fax: | 011 44 1703 455 523 |

## CONTACT PERSON:

Martin S. Knopf

## DATE SUMMARY PREPARED:

April 16, 1997

## TRADE NAME:

FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

## COMMON NAME:

contact lens

## SUBSTANTIALLY EQUIVALENT TO:

FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to The LifeStyle 4 Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) currently marketed in the U.S.

The FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) is substantially equivalent to the LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted) manufactured by The LifeStyle Company, Inc. Aspect Vision Care, Ltd. has received from the manufacturer of the LifeStyle 4-Vue (polymacon) Hydrophilic Contact Lens for Daily Wear all manufacturing information including; but not limited to, formulation, manufacturing processes (including polymerization conditions, tinting process, lens parameter tolerances, sterilization and packaging, quality control/quality assurance, established shelf life data, shelf life protocol) necessary to manufacture the devices, which are the subject of K963001 and K950283. Aspect Vision Care, Ltd. has also received from The LifeStyle Company, Inc. the right to reference its premarket notifications, K950283 and K963001. In addition, Aspect Vision Care, Ltd. will manufacture these devices at the same manufacturing location as the predicate devices.

This lens is in Group 1, non-ionic, low water content polymers as established by the FDA and located in the Guidance Document for Daily Wear Contact Lenses, Revised Edition May 1994. The physical, optical, and chemical properties of the FREQUENCY 38 (polymacon) Hydrophilic

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FROM : Panasonic FAX SYSTEM
PHONE NO. :
Apr. 16 1997 10:23AM P4

Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the LifeStyle 4 Vue (polymacon) Soft Contact Lens for Daily Wear (clear and tinted).

## DESCRIPTION of the DEVICE:

Soft contact lenses are hemispherical shells manufactured of polymerized material of HEMA crosslinked with EGDMA which yield the appearance of lenses which are designed to fit over the corneal surface of the eye. These lenses are designed with varying base curves which conform to the shape of the radius of the cornea and center over the apex of the cornea to provide corrective refraction for functional conditions of the eye including myopia (nearsightedness), hyperopia (farsightedness) and astigmatism (multiple foci). Each lens provides corrective power which is to correspond to the refractive power of the eye to which it is being treated. Each lens is designed with a base curve on the internal side of the lens and an optical zone in the center of the lens which is generally of a diameter greater than 6mm. Secondary and tertiary curves as well as beveled edge configurations are built into the lens for the purpose of aiding in lens centration and comfort.

## INDICATIONS FOR USE:

**Device Name:** FREQUENCY 38 (polymacon) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

## PARAMETERS AVAILABLE:

The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted)

| Powers: | +20.00 to -20.00D |
| --- | --- |
| Center Thickness: | 0.07 mm |
| Diameter: | 14.0 mm |
| Base Curve: | 8.6 mm |

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

MAY 21 1997

Aspect Vision Care, Ltd.
c/o Mr. Martin S. Knopf
President and CEO of Knopf
Associates, Inc.
84 West Main Street
Freehold, NJ 07728

Re: K971049
Trade Name: Frequency™ 38 (Polymacon) Soft (Hydrophilic) Daily Wear
Contact Lens (Clear and Visibility tint, Spherical and Cast-
molded)
Regulatory Class: II
Product Code: 86 LPL
Dated: March 20, 1997
Received: March 21, 1997

Dear Mr. Knopf:

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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation
(21 CFR Part 820) and that, through periodic GMP 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 S. Knopf

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 at [phone].

Sincerely yours,


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 STATEMENT

Device Name: FREQUENCY 38™ (polymacon) (Hydrophilic Contact Lens for Daily Wear (clear and tinted)

The FREQUENCY 38™ (polymacon) Hydrophilic Contact Lens (clear and tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 Diopters that does not interfere with visual acuity.

Eyecare practitioners may prescribe the lens for daily wear in a Frequent Replacement Program. The lenses may be disinfected using heat, chemical or hydrogen peroxide disinfection systems.

(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

5.2.① 5/14/97
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K971049

(Optional Format 1-2-96)

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