Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

K162223 · Supervision Optimax Sdn Bhd · LPL · Jan 4, 2017 · Ophthalmic

Device Facts

• Record ID: K162223
• Device Name: Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)
• Applicant: Supervision Optimax Sdn Bhd
• Product Code: LPL · Ophthalmic
• Decision Date: Jan 4, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.

Device Story

Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are single-use, daily disposable corneal lenses; manufactured from HEMA-MPC copolymer material; MPC improves biocompatibility. Lenses feature aspheric front curve, spherical base curve, and blue handling tint (Reactive Blue Dye 246). Lenses are hydrophilic (58% water content), supplied sterile in blister packs with phosphate-buffered saline. Intended for daily wear by patients to correct myopia or hyperopia with minor astigmatism. Prescribed by eye care professionals; patient self-applied. Device functions by resting on the cornea to correct refractive errors, improving visual acuity. No software or electronic components.

Clinical Evidence

No clinical data. Safety and effectiveness demonstrated via non-clinical physiochemical studies (ISO 18369-3:2006, ISO 18369-4:2006) and toxicology testing (ISO 10993-5, -10, -11), including cytotoxicity, ocular irritation, skin sensitization, and acute systemic toxicity tests. All tests passed.

Technological Characteristics

Material: HEMA-MPC copolymer (omafilcon A). FDA Category: Group II (non-ionic, high water). Water content: 59% ± 2%. Manufacturing: Cast molded. Curing: Thermal. Sterilization: Moist heat (steam) in validated autoclave. Design: Aspheric front curve, tri-curve, spherical base curve. Connectivity: None. Software: None.

Indications for Use

Indicated for daily wear for correction of visual acuity in non-aphakic persons with non-diseased eyes, myopic or hyperopic, with astigmatism of 1.00D or less.

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

• Proclear (omafilcon A) Soft Contact Lenses (K112302)
• Proclear XC (omafilcon A) and Proclear 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear (K061948)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized graphic of three human profiles facing right, stacked on top of each other. The graphic is black and white. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.

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

January 4, 2017

Supervision Optimax Sdn Bhd Ms. Yap Peak Geeh Regulatory Affairs Manager Lot 38, Putra Industrial Park, Bukit Rahman Putra 40160 Sungai Buloh Selangor Darul Ehsan, Malaysia

Re: K162223

Trade/Device Name: Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: November 25, 2016 Received: November 28, 2016

Dear Ms. Geeh:

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 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.

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Page 2 - Ms. Yap Geeh

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 devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Denise L. Hampton -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

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# Indications for Use

510(k) Number (if known) K162223

Device Name Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses

Indications for Use (Describe)

Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.

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

| <div> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------|
| <div> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# Preparation Date: 4th January 2017

#### 1.0 Submitter:

| Name | : Supervision Optimax Sdn Bhd |
|----------------|---------------------------------------------------------------------------------------------------|
| Address | : Lot 38, Putra Industrial Park,<br>Bukit Rahman Putra,<br>40160 Sungai Buloh, Selangor, Malaysia |
| Phone No. | : 603-6145 2328 |
| Fax No. | : 603-6156 2191 |
| Contact Person | : Yap Peak Geeh |
| Email Address | : [e-mail] |

## 2.0 Device Identification:

| Proprietary Name | : Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact<br>Lens |
|---------------------|--------------------------------------------------------------------------|
| Common Name | : Soft (Hydrophilic) Contact Lens |
| Classification Name | : Soft (Hydrophilic) Contact Lens<br>(21 CFR 886.5925, Product Code LPL) |
| Classification | : Class II |

# 3.0 Identification Of The Legally Marketed Devices that equivalency is claimed:

| | Predicate Device | |
|-------------------|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Manufacturer | CooperVision, Inc | CooperVision, Inc |
| Device Name | Proclear (omafilcon A)<br>Soft Contact Lenses | Proclear XC (omafilcon A) and Proclear 1 day<br>(omafilcon A) Hydrophilic<br>Contact Lenses for Daily<br>Wear |
| 510(k) Number | K112302 | K061948 |
| Regulation Number | 21 CFR 886.5925 | 21CFR 886.5925 |
| Regulatory Name | Soft (hydrophilic) contact<br>lens | Soft (hydrophilic) contact<br>lens |
| Regulatory Class | II | II |
| Product Code | LPL and MVN | LPL and MVN |

# 4.0 Description of the Device:

The Aveo (omafilcon A) 1-DaY Aspheric Soft (Hydrophilic) Contact Lenses are single use daily disposable soft contact lens produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)

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where molecules are found naturally in human cell membranes that improves the lens biocompatibility.

The contact lenses contain 58% water by weight and is sold in the blister package immersed in phosphate buffered packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens.

The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).

The contact lenses are hydrophilic, soft and it is supplied in sterile state.

#### 5.0 Intended Use of the Device:

Aveo (omafilcon A)1-Day Aspheric Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with nondiseased eyes that are myopic or hyperopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity. The contact lenses are intended for daily wear, single use and are to be discarded at the end of the day.

#### 6.0 Summary of the Technological Characteristics of the Device:

Below is the summary of the technological characteristics of the Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses as compared to the predicate device.

| Technological Characteristics | | | |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Product Name | Aveo (omafilcon A)1-Day<br>Aspheric Soft (Hydrophilic)<br>Contact Lenses | Proclear Asphere | Proclear 1 day |
| Manufacturer | Supervision Optimax Sdn<br>Bhd | CooperVision, Inc. | CooperVision, Inc. |
| 510(K) Number | This submission | K112302 | K061948 |
| Intended Use | Aveo (omafilcon A) 1-Day<br>Aspheric Soft (Hydrophilic)<br>Contact Lenses are<br>indicated for daily wear for<br>the correction of visual<br>acuity in not aphakic<br>persons with non-diseased<br>eyes that are myopic or | Proclear Asphere<br>(omafilcon A) Soft<br>Contact lenses are<br>indicated for daily wear<br>for the correction of<br>visual acuity in non-<br>aphakic persons with<br>non-diseased eyes that | Sphere and aspheric<br>(omafilcon A) Soft<br>(hydrophilic) contact<br>lenses are indicated<br>for daily wear for the<br>correction of visual<br>acuity in not aphakic<br>persons with non- |

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| | hyperopic and exhibit<br>astigmatism of 1.00D or less<br>that does not interfere with<br>visual acuity. The contact<br>lenses are intended for<br>daily wear, single use and<br>are to be discarded at the<br>end of the day. | are myopic or hyperopic<br>and exhibit astigmatism<br>of 2.00D or less that<br>does not interfere with<br>visual acuity. | diseased eyes that<br>are myopic or<br>hyperopic and exhibit<br>astigmatism of 2.00D<br>or less that does not<br>interfere with visual<br>acuity. |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| Modality | Daily Wear | Daily Wear | Daily Wear |
| Lens Design | Aspherical | Aspherical | Aspheric |
| USAN<br>Material<br>Name | omafilcon A | omafilcon A | omafilcon A |
| FDA<br>Category | Group II | Group II | Group II |
| (Group) | Non-ionic, High water | Non-ionic, High water | Non-ionic, High water |
| Manufacturing | Cast Molded | Finished Inside<br>Polymerization System II | Cast Molded |
| Method | | | |
| Curing | Thermal Cure | Thermal Cure | Thermal Cure |
| Sterilization | Moist Heat (Steam) in<br>Validated Autoclave | Moist Heat (Steam) in<br>Validated Autoclave | Steam: Validated<br>Autoclave |
| Packaging | Blister Pack | Blister Pack | Blister Pack |
| Visibility Tint | Reactive Blue Dye 246 | VAT Blue 6 | Vat Blue 6 |
| Water Content | 59% ± 2% | 59% ± 2% | 60% ± 2% |
| Package Saline | Phosphate Buffered Saline | Phosphate Buffers<br>PEG200 and Tween 80 | Not Stated |
| Refractive Index | 1.4002 | 1.395 ± 0.005 | 1.40 |
| Oxygen<br>Permeability (Dk) x<br>$10-11$ | 25.68 | 21.05 | 21 |
| Light Transmission | 98% | >90% | >90% |
| Base Curve | 8.4mm to 8.8mm | 8.0mm to 9.3mm | 8.00mm to 9.50mm |
| Diameter ⌀T | 14.0mm to 14.4mm | 13.6mm to 15.2mm | 13.0mm to 15.5mm |
| Power | -10.00 to +6.00 | -20.00 to +20.00 | -20.00 to +20.00 |

# 7.0 Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

### Physiochemical Studies

The physiochemical studies were conducted according to ISO 18369-4:2006 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2006 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses.

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# Toxicology Studies

Toxicology (in-vivo and in-vitro) studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.

| Test | Performance of Subject<br>Device | Result |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------|
| Cytotoxicity Test<br>ISO 10993-5: 2009(E): Biological<br>Evaluation of Medical Devices-Part 5:<br>Tests for in vitro Cytotoxicity. | Non-cytotoxic. | Pass |
| Ocular Irritation Study in New Zealand<br>White Rabbit<br>ISO 10993-10: 2010(E): Biological<br>Evaluation of Medical Devices-Part 10:<br>Tests for Irritation and Skin Sensitization. | Non-irritant to eyes of<br>rabbits. | Pass |
| Skin Sensitization Study in Guinea Pigs<br>ISO 10993-10: 2010(E): Biological<br>Evaluation of Medical Devices-Part 10:<br>Tests for Irritation and Skin Sensitization. | Non-sensitizer | Pass |
| Acute Systemic Toxicity Study in Swiss<br>Albino Mice<br>ISO 10993-11: 2006(E): Biological<br>Evaluation of Medical Devices-Part 11:<br>Tests for in Systemic Toxicity. | Animals treated with the<br>extract of the subject<br>device did not show any<br>systemic toxicity. | Pass |

## 8.0 Clinical Test

The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device, Proclear Asphere (K112302) and Proclear 1 day (K061948). Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

## 9.0 Conclusion

The Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses are substantially equivalent to the predicate device, Proclear Asphere (K112302) and Proclear 1 day (K061948) in term of optical property, Physiochemical and pre-clinical toxicology. They are produced from the same material (omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.