SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON

K090806 · Safilens, S.R.L. · LPL · Dec 18, 2009 · Ophthalmic

Device Facts

• Record ID: K090806
• Device Name: SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON
• Applicant: Safilens, S.R.L.
• Product Code: LPL · Ophthalmic
• Decision Date: Dec 18, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The Safi-gel Daily Disposable (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic and/or not aphakic persons with non-diseased eyes. The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.

Device Story

Safi-gel Daily Disposable lenses are soft, hydrophilic contact lenses made of methafilcon A (55% water content). Lenses function as refractive elements to focus light on the retina. Available in sphere, toric, and multifocal designs. Toric lenses feature a bi-curve reduced optic front surface to maintain axis stability. Multifocal lenses utilize an aspherical design. Lenses are tinted with Pigment Blue 15 (copper phthalocyanine) and incorporate a UV-absorbing compound (RUVA-93). Prescribed by eye care professionals for single-use daily wear; discarded after each removal. Benefits include vision correction for ametropia and presbyopia.

Clinical Evidence

No clinical data. Substantial equivalence was established via bench testing of physicochemical properties and toxicological assessment of lens extracts. Microbiological testing was not required as manufacturing and packaging are identical to the predicate device.

Technological Characteristics

Material: methafilcon A (hydrophilic polymer of 2-hydroxyethyl methacrylate crosslinked with ethylene glycol dimethacrylate). Water content: 55%. Tint: Pigment Blue 15. UV absorber: RUVA-93. Refractive index: 1.410 (wet). Light transmittance: 90.3%. UV transmittance: 9.3%. Designs: sphere, toric (cylinder -0.50D to -2.50D), and aspherical multifocal. Diameter: 14.0-15.0 mm. Base curve: 8.40-9.30 mm.

Indications for Use

Indicated for daily disposable wear for correction of refractive ametropia (myopia, hyperopia, presbyopia, and astigmatism up to 2.00D) in aphakic or 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

• 55 UV (methafilcon A) Soft (hydrophilic) Lens for Daily Wear (K051095)
• 55 UV Multifocal (methafilcon A) Soft (hydrophilic) Lens for Daily Wear (K051095)
• 55 UV Toric (methafilcon A) Soft (hydrophilic) Lens for Daily Wear (K051095)

Submission Summary (Full Text)

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K090806

## SUMMARY FOR FOI

17

. .

## Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens
Carles (1) Sales (method motherfilcon A) Soft (hydrophilic) Le Safi-gel Daily Disposable (filethannoni (2) Soft (hydrophilic) Lens
Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Contact Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Extrans
Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens

| 1. | Submitted by: | Safilens, S.r.L.<br>Via Grazia Deledda, 5<br>34079 Staranzano (GO)<br>Italy |
|----|-----------------|--------------------------------------------------------------------------------------------|
| | Contact: | John M. Szabocsik, Ph.D. |
| | Official agent: | Szabocsik and Associates<br>203 N. Wabash, Ste 1200<br>Chicago, IL 60601<br>[phone] |

DEC 1 8 2009

| 2. | Date prepared: | May 22, 2009 |
|----|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 3. | Device: | |
| | Common Name: | Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens<br>Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens<br>Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens |
| | Trade Name: | Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens<br>Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens<br>Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens |
| 4. | Classification: | Code LPL, Class II (Performance Standards)<br>21 CFR 886.5925<br>Soft (hydrophilic) contact lens |
| 5. | Substantial equivalence: | This product is substantially equivalent to the 55 UV (methafilcon A) Soft (hydrophilic) Lens for Daily Wear, the 55 UV Multifocal (methafilcon A) Soft (hydrophilic) Lens for Daily Wear, and the 55 UV Toric (methafilcon A) Soft (hydrophilic) Lens for Daily Wear, cleared for market in K051095. |

K090806 response Page 19 of 26

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Device

Device
description: The lens material (methafilcon A) is a hydrophilic polymer of 2-The lens material (methanton) A) is a nyalopadic acid crosslinked with hydroxyethyl methactylate(11EMIA), niethydrated lens contains 55%
ethylene glycol dimethacrylate (45%). The HV obserbing compound ethylene glycon diffieldiacrylate (4576). The IIJ absorbing compound water by weight with fiyaluropolymer. The lens is tinted using (RUVA-93) incorporated into the folls polyment
Pigment Blue 15 (copper phthalocyanine). The lens acts as a refracting I ightent Difocus light rays on the retina.

> The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) The Sail-gel Daily Disposable "(incens, which incorporates a
> Lens is available as a single vision lens, which incorporates a Lens is available as a single vision rent, arve reduced optic front tangential back surface edge int and of our result.
> surface. The peripheral curve is tangential at the back optic zone.

The Safi-gel Daily Disposable Toric (methafilcon A) Soft The Safi-gel Daily Disposable "Forre (includer and base curve, and
(hydrophilic) Lens design incorporates a cylinder and back surface (hydrophilic) Leils design incorporates a of any the back surface. the peripheral curve is tangential will coge mo on an and and off of
From the bi-curve reduced optic front surface has beth aides thicker at From the bi-curve reduced optic non This makes both sides thicker at
the upper and lower half of the lens. This have the suis stable the upper and lower han of the front surface to keep the axis stable.
the horizontal level on the front surface to keep the axis stable.

The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft The San-gel Daily Disposable Multiroous (1)
(Hydrophilic) Contact Lens is available as an aspherical multifocal lens.

The Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens is a hemispheric
e (method in the finalisations The Saff-ger Daily of the following dimensions:

| Diameter: | 14.2 mm |
|-------------------|-------------------------------------|
| Center Thickness: | 0.08 mm (-3.00D) dry |
| Base Curves: | 8.70 mm and 8.30 mm |
| Powers: | +4.00D to -6.00D (in 0.25D steps) |
| | + 4.50D to +12.00D (in 0.50D steps) |
| | -6.50D to -20.00D (in 0.50D steps) |

The Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens is a
reas and Carlos and Callering dimensions: ine Sall-ger Daily Dispossable of the following dimensions:

| Diameter:<br>Center Thickness:<br>Base Curves:<br>Powers: | 14.5 mm<br>0.08 mm (-3.00D) dry<br>8.70 mm<br>+4.00D to -6.00D (in 0.25D steps)<br>+4.50D to +12.00D (in 0.50D steps)<br>-6.50D to -20.00D (in 0.50D steps) |
|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cylinder Power: | -0.50DC to -2.50D |
| Axis: | Full circle (in 10°steps) |

The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact
ed the Same of the Savil including hell which covers the cornea and a portion of the adja The Safi-gel Daily Disposable Multifocal (methanicon A) Jost (n. Jur.) 1977)
Lens is a hemispherical flexible shell which covers the cornea and a portion of the adjacent Lens is a nothe following dimensions:

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6.

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14.0mm to 15.0mm Diameter: 0.06mm to 0.40mm Center Thickness: 8.40mm to 9.30mm Base Curve: +12.00 Diopters to -20.00 Diopters Powers: Powers: Continuous add power to +3.25 1.5, 1.9 mm Zone Sizes: The physical/optical properties of the lens are: 1.410 (wet) Refractive Index: Light Transmittance: 90.3% UV Transmittance 9.3% 55% Water Content: Water Content: Intended use: The Safi-gel Daily Disposable (methafilcon A) Soft The Safi-gel Daily Disposabile (Includines). Ily disposable wear for
(hydrophilic)Contact Lens is indicated for daily disposable wear for (hydrophilic)Contact Lens is including to rems)
correction of refractive ametropia, hyperopia, hyperopia) in aphakic of
correction of refractive ametropia, hyperopia, hyperop correction of refractive ametropia (if your diseased eyes that may exhibit refractive
not-aphakic persons with non-diseased eyes that may exhibit refractive not-aphakic persons with non-diseased eyes that hay ender interfere
and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity. The Safi-gel Daily Disposable Toric (methafilcon A) Soft The Safi-gel Daily Disposable 1011 (Micated for daily disposable wear for (hydrophilic) Contact Lens is indicated for Golf 2017 - 11:4 correction of refractive anietropia (info@play of proposity)
in aphakic or not-aphakic persons with non-diseased eyes.
In aphakic or not-aphakic persons with non-diseased eye The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft The Safi-gel Daily Disposable Minicated for daily disposable wear for
(Hydrophilic) Contact Lens is indicated for daily disposable wear for (Hydrophilic) Contact Lens is intication in tamily hoperopia) and
the correction of refractive ametropia (myopia and hyperopia) and the correction of refractive ametropla (informatiseased eyes
presbyopia in aphakic or not-aphakic persons with non-diseased eyes
some of research and and and assismatism up t presbyopia in aphakic or not-aphake persons was astigmatism up to 2.00
that may exhibit refractive and/or comeal astigmatism up to 2.00
acuity. that may exhibit refractive and of ve The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable in
terest and the station abole for seeb removal The Sail-gel Daily Disposuble in and removal.
wear, and are to be discarded after each removal. was a moduct was shown to be substantially equivalent to the predicate device in The product was shown to be substantially equivalent to the products of the most
physicochemical testing of water content, oxygen transmissibility, light transmission (visibl and UV) and refractive index. Toxicological testing of extracts of the Safi-gel Daily Disposable (methafilcon A)
Toxicological to Incondemansmanested that the lenses were non-cytotoxic, showed Toxicological testing of extracts of the Sali-gel Daily Disposable (institution of the Sales)
Soft (hydrophilic) Contact Lens demonstrated that the lenses were non-cytotoxic, Soft (hydrophinc) Contact Lens comes
no systemic toxicity, and showed no ocular irritation.

entire team of "
Microbiological testing was not required because the manufacture and packaging in the 1005. Microbiological testing was not required been below in K051095.
are the same as that for the predicate device, cleared in K051095.

Clinical testing was not required because the physical/chemical properties are the light Clinical testing was not req-

Labeling was submitted as part of the application.

K090806 response Page 21 of 26

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Safilens, S.r.L. c/o John M. Szabocsik, Ph.D. Szabocsik and Associates 203 North Wabash Avenue Suite 1200 Chicago, IL 60601

DEC 1-8-2009

Re: K090806

Trade Name: Safilens Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Contact Lens (sphere, toric and multifocal) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 30, 2009 Received: December 3, 2009

Dear Dr. Szabocsik:

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. Iisting 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 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 may 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803),-please-go-to-http://www.fda.gov/cdrh/mdr/-for-the-CDRH's-Office.of_ Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Kenia Alexandr for

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

Enclosure

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## Safi-gel Daily Disposable (methafilcon A) Soft (hydrophilic) Lens DEVICE NAME: Safi-gel Daily Disposable Toric (methafilcon A) Soft (hydrophilic) Lens Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (hydrophilic) Contact Lens

## INDICATIONS FOR USE

The Safi-gel Daily Disposable (methafilcon A) Soft (Hydrophilic) Contact Lens is indicated for daily disposable wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes that may exhibit fryperopia) in aphants of astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Safi-gel Daily Disposable Multifocal (methafilcon A) Soft (Hydrophilic) Contact I he Ban' get Daily disposable wear for the correction of refractive ametropia (myopia Lens is mercated to daily and in aphakic and not-aphakic persons with non-diseased eyes and may exhibit refractive and/or corneal astigmatism up to 2.00 diopters that does not interfere with visual acuity.

The Safi-gel Daily Disposable Toric (methafilcon A) Soft (Hydrophilic) Contact Lens is I he San gol Daily disposable wear for the correction of refractive ametropia (myopia, manouted for dasty enoptism) in aphakic and/or not aphakic persons with non diseased eyes.

The Safi-gel Daily Disposable Lenses are to be prescribed for single-use disposable wear, and are to be discarded after each removal.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

ﻤﻤﺎ Prescription Use OR (Optional Format 1-2-96)

Over-The-Counter Use _____(Per 21 CFR 801.109)

s

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

510(k) Number K090806

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