ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS

K141280 · Seinoh Optical Co. , Ltd. · LPL · Jul 18, 2014 · Ophthalmic

Device Facts

• Record ID: K141280
• Device Name: ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
• Applicant: Seinoh Optical Co. , Ltd.
• Product Code: LPL · Ophthalmic
• Decision Date: Jul 18, 2014
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

The iLens® (ocufileon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be wom by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. As prescribed for single use daily dispossble wear, patients are instructed to dispose of the lens at each removal. The iLens® Daily Wear Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

iLens is a spherical, hydrogel soft contact lens made of ocufilcon D (45%) and water (55%). Features UV-blocking benzotriazole monomer; light blue tint (reactive Blue19) for handling. Supplied sterile in buffered saline. Prescribed by eye care practitioners for daily wear; patients use for single-use disposable or scheduled replacement (chemical/hydrogen peroxide disinfection). Lens corrects refractive ametropia (myopia/hyperopia) and provides UV protection. Benefits include vision correction and reduced UV transmission to the cornea.

Clinical Evidence

No clinical data provided. Substantial equivalence established via physiochemical bench testing (ISO 18369) and comparison of material, formulation, and manufacturing processes to the predicate device.

Technological Characteristics

Material: HEMA hydrogel (ocufilcon D). Water content: 55%. Refractive index: 1.405. Oxygen permeability: 20 x 10-11 (Fatt method). UV blocker: benzotriazole monomer. Manufacturing: cast-molded. Dimensions: 13-15mm diameter, 8.2-9.2mm base curve. Sterilization: steam.

Indications for Use

Indicated for daily wear correction of myopia and hyperopia in aphakic/non-aphakic persons with non-diseased eyes; power range -20.00D to +20.00D; astigmatism ≤ 2.0D. Suitable for single-use disposable or frequent replacement wear.

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

• Biomedics® 55 (ocufilcon D) (K091339)

Reference Devices

• Sauflon 55 UV (methafilcon A) (K013649)
• Frequency 55 (K000384)

Submission Summary (Full Text)

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# K141280 510(K) SUMMARY

Date of the summary prepared: June 10, 2014

# 1 Establishment Information:

| Name | Seinoh Optical Co. Ltd. |
|----------|--------------------------------------------------------------------------------------|
| Address | 3F, No. 14, Wucyuan 3rd Rd., Sinjhuang Dist., New<br>Taipei City 242, Taiwan, R.O.C. |
| Phone No | 886-2-2298-8255 |
| Fax No. | 886-2-2298-8335 |

# 2 Owner:

| Company | Seinoh Optical Co. Ltd |
|-----------|-----------------------------------------------|
| Name | Vicent Hu |
| Address | 3F, No. 14, Wucyuan 3rd Rd., Sinjhuang Dist., |
| | New Taipei City 242, Taiwan, R.O.C. |
| Phone No | 886-2- 2298-8255 ext: 8858 |
| Fax No. . | 886-2 —2298-8335 |
| | |

#### 3 US Agent:

| Company | ABAND INC. |
|----------|---------------------------------------------------|
| Address | 5581 Daniels Street, Unit A, Chino, CA 91710, USA |
| Phone No | (866)-886-8888 (Toll free) |
| Fax No | (909)-627-6207 |

# 4 Contact Person:

| Name | Jennifer TING |
|----------|---------------------------|
| Phone No | 886-2-82823192 |
| Fax No | 886-2-82867686 |
| e-mail: | [e-mail] |

# 5 Device Identification:

| Proprietary Name | iLens ® (ocufilcon D) Daily Wear Soft (Hydrophilic)<br>Contact Lens |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Soft (hydrophilic) Contact Lenses |
| Classification Name | Lenses, Soft Contact, Daily Wear (21 CFR 886.5925,<br>Product Code LPL)<br>Lenses, Soft Contact, Daily Wear (Disposable),<br>(21 CFR 886.5925, Product Code MVN) |
| Classification | II |

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#### 6 Legally Marketed Equivalent Device:

| Predicate Device Name | Biomedics® 55 (ocufilcon D) |
|-----------------------|-----------------------------|
| Manufacturer | CooperVision, Inc. |
| 510(k) Number | K091339 |
| Product Code | LPL, MVN |

#### 7 Device Description

- The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is a . spherical lens with UV blocker.
- The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is . available in hemispherical shell.
- The lenses are made of HEMA hydrogel. The composition is 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution.
- The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose.
- A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
- The lens is supplied in a sterile state, packaged in a buffered saline solution. -

#### 8 Indication for Use:

The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be worn by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. The eye care practitioner may prescribe the lens for either single-use disposable wear or for scheduled replacement wear. When prescribed for scheduled replacement, the lens may be disinfected using a chemical (no heat) or hydrogen peroxide disinfecting system. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.

#### 9 Technological characteristics

The spherical lens design specification:

- · Diameter 13 mm to 15 mm

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- Center Thickness 0.08mm @ -3.00D ●
- (Varies with Power) Base Curve 8.2 mm to 9.2 mm ● . Power -20.00D to +20.00D -6.00D to +6.00D (0.25D increments) +20.00D to +6.50D, -6.50D to -20.00D (0.50D increments)

The physical properties of the lenses are:

- . Refractive index: 1.405 (hydrated)
- Light transmittance: > 95%
- Water content: 55% by weight in normal saline .
- 20 x 10-11 (Fatt method) Oxygen permeability ●

# 10 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

| Similarities | | |
|------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Item | Device | Predicate (K091339) |
| Product Name | iLens ® (ocufilcon D) Daily<br>Wear Soft (Hydrophilic)<br>Contact Lens | BIOMEDICS UV SPHERE<br>Soft Contact Lenses |
| Manufacturer | Seinoh Optical Co. Ltd | CooperVision, Inc |
| Intended Use | Daily Wear for<br>Frequent/Planned Replacement<br>Wear or for Daily disposable<br>Wear | Daily Wear for<br>Frequent/Planned<br>Replacement Wear or for<br>Daily disposable Wear |
| USAN Name | Ocufilcon D | Ocufilcon D |
| Material | Hydrogel | The same |
| Lens Design | Spherical | Spheric, aspheric, toric or<br>multifocal |
| Classification | Class II, | The same |
| Type | Group IV Ionic High Water | The same |
| Water Content | 55% | 55 % |
| Oxygen Permeability<br>(DK, 35 °C) | 20<br>(Fatt method) | 19.6<br>(Fatt method) |

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| Base Curve Range | 8.2 mm to 9.2 mm | 6.50 mm to 10.8 mm |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------|
| Diameter (mm) | 13 to 15 | 12.5 ~ 18.0 |
| Center Thickness | 0.08mm @ -3.00D<br>(Varies with power) | Varies with power (0.025 mm to 0.40 mm) |
| Powers | -20.00D to +20.00D<br>-6.00D to +6.00D<br>(0.25D increments)<br>+20.00D to +6.50D, -6.50D to -20.00D<br>(0.50D increments) | -20.00 D to +20.00 D<br>Add powers: +0.25 D to +3.00 D |
| Replacement Schedule | Disposable or Daily wear | Disposable or Daily wear |
| Refractive Index | 1.405 | 1.41 |
| Light Transmittance | >95% | >95% |
| Method of<br>Manufacture | Cast-Molded | The same |
| Surfactant in the final<br>Product Saline | None | Yes |
| Sterilization | steam | The same |
| Packaging | Blister pack | The same |
| Blue handling tint | Yes, reactive Blue19 | Yes, Entrapment Dye |

| Mechanical Strength | Device | Predicate<br>(K013649) | Predicate<br>(K000384) |
|-------------------------|-----------|----------------------------------|------------------------|
| Product Name | iLens | Sauflon 55 UV<br>(methafilcon A) | Frequency 55 |
| Tensile strength (Mpa) | 0.43 | 1.47 | 0.66 |
| Modulus (Mpa) | 0.57 | 0.52 | 0.48 |
| Elongation at break (%) | 55.8 | 280 | 179 |
| toughness (J/m³) | 0.21 | 1.39 | 0.38 |
| Manufacturing method | Cast Mold | Cast Mold | Cast Mold |

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#### 11 Nonclinical Tests Performed

- 11.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
- 11.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

### 12 Clinical Studies

The technical characteristics, formulation, manufacturing, and sterilization processes of the subject device are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.

### 13 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "iLens" (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens" is as safe, as effective and perform as well as the predicate device.

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Public Health Service

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

July 18, 2014

Seinoh Optical Co. Ltd. c/o Jennifer Ting Jens Medical Consulting 6F No. 39 Ln. 224. Jixian Road Luzhou Distr. 247. New Taipei City Taiwan ROC

Re: K141280

Trade/Device Name: iLens (ocufileon D) Daily Wear Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: LPL, MVN Dated: May 20, 2014 Received: May 22, 2014

Dear Ms. Ting:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into cither 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.

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Page 2 - Ms. Jennifer Ting

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 (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.

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/ucm 115809.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/MedicalDevices/Safety/ReportalProblem/default.htm 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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Kesia Y. Alexander -S

for 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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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

#### Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k) Number (if known) K141280

Device Name

iLens (neufilean D) Daily Wear Soft (Hydrophilic) Contact Lens

#### Indications for Use (Describe)

The iLens® (ocufileon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be wom by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. As prescribed for single use daily dispossble wear, patients are instructed to dispose of the lens at each removal. The iLens® Daily Wear Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

# Joseph C. Hutter -S 2014.07.15 16:00:24 -04'00'

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