FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

K980634 · Aspect Vision Care, Ltd. · LPL · Apr 22, 1998 · Ophthalmic

Device Facts

• Record ID: K980634
• Device Name: FREQUENCY UV (ETAFILCON A) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
• Applicant: Aspect Vision Care, Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and aqua visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism 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 chemical or hydrogen peroxide disinfection systems.

Device Story

FREQUENCY UV is a hydrophilic contact lens (etafilcon A) for daily wear; functions as a flexible hemispherical shell covering cornea and portion of sclera; corrects refractive ametropia (myopia, hyperopia, astigmatism). Lens material consists of HEMA and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate; contains benzotriazole UV-absorbing monomer to block UV radiation. Available in clear and aqua visibility tint (Reactive Blue Dye No. 4 and Reactive Yellow Dye #86). Prescribed by eyecare practitioners for daily wear, including frequent replacement programs; disinfected via chemical or hydrogen peroxide systems. Benefits patient by providing vision correction and UV protection.

Clinical Evidence

Bench testing only. Toxicology testing (cytotoxicity, acute systemic toxicity, acute ocular irritation) demonstrated non-toxicity. Residual monomer and color leachability testing confirmed no leachable color or significant residual monomers. Physical, optical, and chemical properties compared to predicate.

Technological Characteristics

Material: etafilcon A (HEMA/methacrylic acid copolymer); 58% water content. Form: hemispherical flexible shell, 14.0-15.0mm diameter, 0.03-0.40mm center thickness. UV-blocking via benzotriazole monomer. Manufacturing: cast molding. Sterilization: parametric release. Connectivity: N/A.

Indications for Use

Indicated for daily wear correction of myopia, hyperopia, and astigmatism (up to 2.00 D) in aphakic and non-aphakic persons with non-diseased eyes.

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

• Acuvue (etafilcon A) Hydrophilic Contact Lens for Daily Wear (K962804)

Submission Summary (Full Text)

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K980634

APR 22 1998

# 510 (k) Summary

SUBMITTER:

Submitted on behalf of:

| Company Name: | Aspect Vision Care, Ltd. |
|---------------|---------------------------------------------------------------|
| Address: | South Point, Hamble<br>Southampton S031 4RF<br>United Kingdom |

Phone: Fax:

011 44 1703 455 567 011 44 1703 455 523

CONTACT PERSON:

Martin S. Knopf

DATE SUMMARY PREPARED: February 16, 1998

TRADE NAME: FREQUENCY UV™ (etaflicon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

COMMON NAME: contact lens

SUBSTANTIALLY EQUIVALENT TO:

FREQUENCY UV (etafilcon A ) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are substantially equivalent to Acuvue (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted with UV Blocker) that received marketing clearance pursuant to K962804, currently marketed in the U.S. A comparison of properties is found in the chart below.

#### Preclinical Testing

The results of toxicology testing (cytotoxicity. Acute systemic toxicity and acute ocular irritation) have demonstrated that the subject lens is non toxic. Furthermore, the results of residual monomer and color leachability testing demonstrate that the respective extracts did not contain leachable color nor significant levels of residual monomers.

The physical optical, and chemical properties of the FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)) are equivalent to those of the Acuvus (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted with UV Blocker) from Vistakon, Inc.

This lens is in Group 4. Ionic, high 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 UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted) are equivalent to those of the Acuvue (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted with UV Blocker).

The lens will be sterilized and packaged in the same manner as previously cleared in K971164. This lens will also be sterility released by parametric release, as cleared in 1971164.

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## COMPARISON OF PHYSICAL/OPTICAL PROPERTIES:

| PARAMETER | FREQUENCY UV™<br>Hydrophilic Contact<br>Lens for Daily Wear<br>(clear and tinted) | Acuvue (etafilcon A)<br>Hydrophilic Contact Lens<br>for Daily Wear (clear and<br>tinted with UV Blocker) |
|-------------------------------|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| | | |
| material | etafilcon A | Etafilcon A |
| indication for use | myopia, hyperopia and<br>astigmatism | myopia, hyperopia and<br>astigmatism |
| water content | 58% | 58% |
| % transmittance @ 593nm | 93.91% | 96.42% |
| % transmittance @ 280-315 nin | 9.5 | 2.4 |
| % transmittance @ 316-380 nm | 7.86 | 15.55 |
| Dk (35 °C) (Edge Corrected) | 15.62 X 10" | 15.09 X 10" |
| powers | -20.00 to+20.00 D | -20.00 to+20.00 D |
| color | clear and aqua visibility | clear and blue visibility |
| specific gravity | 0.98-1.12 | 0.98-1.12 |
| refractive index | 1.39 | 1.4 |
| tensile strength | 1.12 | 0.64 |
| Modulus | 0.35 | 0.22 |
| Elongation at Break | 249 | 228 |
| Toughness | 1.12 | 0.74 |
| manufacturing method | Cast Molding | Cast Molding |

### DESCRIPTION of the DEVICE:

D

The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens is available as a spherical lens in both clear and an aqua visibility tint. The lens material (etafilcon A ) is a hydrophilic polymer of 2hydroxyethyl methacrylate (HEMA) and methacrylic acid which is cross-linked with 1,1,1trimethylol propane trimethacrylate and ethyleneglycol dimethacrylate. When hydrated, the lens consists of 42.0% HEMA and 58.0% water by weight when immersed in normal saline. The lens is visibility tinted aqua with Reactive Blue Dye No. 4 and Reactive Yellow Dye # 86. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 10% in the UVB range of 280 to 315 nm and less than 10% in the UVA range of 315 to 380 nm. The FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear is a hemispherical flexible shell which cover the cornea and a portion of the adjacent sclera with the following dimensions:

- Chord Diameter: . 14.0mm to 15.0mm
- 0.03mm to 0.40mm Center Thickness: ●
- Base Curve: 8.40mm to 9.30mm
- Spherical Powers: -20.00 Diopters to +20.00 Diopters .

The physical/optical properties of the lens are:

- 1.39 Refractive Index: .
- % Transmittance @593nm: >90% .
- % Transmittance @ 280-315nm <10% ●
- % Transmittance @ 316-380nm <10% t
- 0.98-1.12 Specific Gravity (calculated): t
- Surface Character: clear .

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- 58% Water Content: .
- Oxygen Permeabllity (Dk)" : .

*[Fatt Method for determination of oxygen permeability, edge corrected]

## INDICATIONS FOR USE:

## Device Nams: FREQUENCY UV (etafilcon A) Hydrophilic Contact Lens for Daily Wear (clear and tinted)

The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and tinted ) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism in aphakic and not-aphakic persons with non-diseased eyes.

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

## PARAMETERS AVAILABLE:

The FREQUENCY UV™ (etafilcon A) Hydrophilic Contact Lens (clear and tinted)

| Powers: | +10.00 to -10.00D |
|-------------------|-----------------------------------------------------|
| Center Thickness: | 0.07 mm |
| Diameter: | 14.2 mm |
| Base Curve: | 8.6, 8.9 mm (minus lenses) and 8.8 mm (plus lenses) |

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - U.S." is arranged in a circular pattern around the caduceus symbol. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 2 1998

Aspect Vision Care, Ltd. c/o Mr. Martin S. Knopf Associates, Inc. 90 West Main Street Freehold, NJ 07728

Re: K980634

Trade Name: Frequency UV (Etafilcon A) Soft (hydrophilic) Daily Wear Contact Lens, Clear and Aqua Visibility tinted with UV Blocker (Sperical and Cast-Molded) Regulatory Class: Class II Product Code: 86 LPL Dated: February 16, 1998 Received: February 19,1998

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 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 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 [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 STATEMENT

# Device Name: FREQUENCY™ UV (etafilcon A) (Hydrophilic Contact Lens for Daily Wear (clear and aqua visibility tinted)

The FREQUENCY™ UV (etafilcon A) Hydrophilic Contact Lens (clear and aqua visibility tinted) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and astigmatism 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 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 | <div style="display:inline-block; vertical-align:middle;"> <img src="data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAAUAAAAFCAYAAACNbyblAAAAHElEQVQI12P4//8/AxMDAwMDAwMDwwMDw8MDAwMDAwEAN0wCB9yJzQAAAAAElFTkSuQmCC" style="width: 10px; height: 10px;"/> </div> | OR | Over-the-Counter Use | |
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| (Division Sign-Off) | |
|--------------------------------|---------|
| Division of Ophthalmic Devices | |
| 510(k) Number | K980634 |

(Optional Format 1-2-96)