CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS

K080632 · Clearlab SG Pte, Ltd. · MVN · Oct 15, 2008 · Ophthalmic

Device Facts

• Record ID: K080632
• Device Name: CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS
• Applicant: Clearlab SG Pte, Ltd.
• Product Code: MVN · Ophthalmic
• Decision Date: Oct 15, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

Device Story

Clear1-day® is a daily disposable, soft (hydrophilic) contact lens; functions as a refractive medium to focus light on the retina. Manufactured via a spun-cast process using hioxifilcon A, a non-ionic copolymer of 2-HEMA and GMA. Lens is 58% water by weight when hydrated; includes a pale blue visibility tint. Intended for daily wear by patients with refractive ametropia; lens is discarded after each use. Provides optical correction for myopia and hyperopia in phakic or aphakic eyes. Device is prescribed by eye care professionals.

Clinical Evidence

Bench testing only. Physical properties reported include refractive index (1.4011), light transmission (>95%), water content (59.77%), and oxygen permeability (25.38 x 10-11 (cm2/sec)(ml O2/ml x mm Hg)).

Technological Characteristics

Material: hioxifilcon A (42% polymer, 58% water). Non-ionic copolymer of 2-hydroxyethyl methacrylate and 2,3-dihydroxypropyl methacrylate cross-linked with ethylene glycol dimethacrylate. Spun-cast production. Visibility tint: Reactive Blue #4 (21 CFR 73.3121). Oxygen permeability: 25.38 x 10-11 (cm2/sec)(ml O2/ml x mm Hg). Refractive index: 1.4011 (wet).

Indications for Use

Indicated for daily wear, single-use optical correction of myopia and hyperopia in phakic or aphakic patients with non-diseased eyes and ≤1.00D of astigmatism.

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

• Extreme H2O (hioxifilcon A) (K992692)
• Clear All Day (hioxifilcon A) (K052290)

Submission Summary (Full Text)

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# OCT 1 5 2008

## 510(k) SUMMARY

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

(65)-6282 3953

The assigned 510 (k) number is: K080632

Applicant information:

Fax number:

| Initial Date Prepared: | 29 February 2008 |
|--------------------------------------------|----------------------------------------|
| Name: | Clearlab SG Pte Ltd |
| Address: | 139, Joo Seng Road<br>Singapore 368362 |
| Contact Person/<br>Official Correspondent: | Tan Hwee Ee |
| Phone number: | (65)-63801-347 |

| FDA US Agent/ | Medvice Consulting, Inc |
|-----------------|-------------------------|
| Contact Person: | Martin Dalsing |
| Phone number: | [phone] |
| Fax number: | [phone] |

.

Device Information:

| Device Classification: | Class II |
|------------------------|-------------------------------------------------------------------|
| Classification number: | LPL |
| Classification name: | Lenses, Soft Contact, Daily Disposable |
| Trade name: | Clear1-day® (hioxifilcon A) Daily Disposable Soft Contact<br>Lens |

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#### Equivalent Predicate Devices:

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate devices:

- 1. Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp.
- 2. Clear All Day (hioxifilcon A), K052290, Manufactured by Clearlab SG Pte Ltd.

### Device Description:

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibilityhandling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name,

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a coloriess, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. 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 58% water by weight. The physical properties of the lens are:

Refractive Index at 21ºC: Light Transmission: Surface Character: Water Content at 21ºC: Specific Gravity at 21ºC: Oxygen Permeability at 34-36°C: 1.4011(wet) > 95% Hydrophilic 59.77 % 1.086(wet) 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).

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#### Intended Use:

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

#### Technological Characteristics:

The technological characteristics of the Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens as compared to the technological characteristics of the predicate devices are illustrated in the following table.

1

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| Pre-Clinical<br>equivalency/Device | Clear1-day®<br>(hioxifilcon A)<br>New Device | Clear All Day<br>(hioxifilcon A)<br>Predicate Device | Extreme H2O<br>(hioxifilcon A)<br>Predicate Device |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Indicated for daily<br>wear for the<br>correction of visual<br>acuity in non-<br>aphakic persons<br>with non-diseased<br>eyes with myopia or<br>hyperopia. | Indicated for daily<br>wear for the<br>correction of visual<br>acuity in aphakic<br>and non-aphakic<br>persons with non-<br>diseased eyes with<br>myopia or<br>hyperopia. | Indicated for daily<br>wear for the<br>correction of visual<br>acuity in aphakic<br>and non-aphakic<br>persons with non-<br>diseased eyes with<br>myopia or<br>hyperopia. |
| Functionality | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. | The contact lenses<br>act as a refractive<br>medium that focus<br>light rays from near<br>and distant objects<br>on the retina. |
| Indications | Daily Disposable,<br>Soft (hydrophilic)<br>contact lens | Daily Wear, Soft<br>(hydrophilic)<br>contact lens | Daily Wear, Soft<br>(hydrophilic)<br>contact lens |
| Production Method | Spun-Cast | Cast-molded | Cast-molded |
| FDA Group # | Group #2 >50%<br>Water, non-ionic<br>Polymer | Group #2 >50%<br>Water, non-ionic<br>Polymer | Group #2 >50%<br>Water, non-ionic<br>Polymer |
| USAN name | Hioxifilcon A | Hioxifilcon A | Hioxifilcon A |
| Water Uptake (%) | 59.77% | 56.47% | 60.24% |
| Oxygen<br>Permeability (Dk) | 25.38 x 10-11<br>(cm2/sec) (ml<br>O2/ml x mm Hg) | 25.29 x 10-11<br>(cm2/sec) (ml<br>O2/ml x mm Hg) | 28.91 x 10-11<br>(cm2/sec) (ml<br>O2/ml x mm Hg) |
| Specific Gravity<br>(wet) (g/cm3) | 1.086 | 1.113 | 1.088 |

. . . . . . . .

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle figure in the center.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clearlab SG Pte. Ltd. c/o Martin Dalsing, Official Correspondent Medvice Consulting, Inc. 806 Kimball Ave. Grand Junction, CO 81501

Re: K080632

Trade/Device Name: Clear 1-Day Daily Disposable Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: MVN, LPL Dated: September 8, 2008 Received: September 12, 2008

Dear Mr. Dalsing:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA mav publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M. B. Egerkins, mD

Malvina B. Eydelman, M.D Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# INDICATIONS FOR USE STATEMENT

#### Device Name: Clear1-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses

## INDICATIONS FOR USE:

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phalic anglaalic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

or

Over-The-Counter Use

(Optional Format 1-2-96)

Myna Smith

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

**510(k) Number** K080632