Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

K180985 · Supervision Optimax Sdn Bhd · LPL · Jun 8, 2018 · Ophthalmic

Device Facts

• Record ID: K180985
• Device Name: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses
• Applicant: Supervision Optimax Sdn Bhd
• Product Code: LPL · Ophthalmic
• Decision Date: Jun 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Aveo (omafilcon A) 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. Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the 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 between 0.50D and 2.50D or less that does not interfere with visual acuity. Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients. Frequent Planned Replacement Wear When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system. Disposable Wear When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

Device Story

Aveo (omafilcon A) soft contact lenses; daily wear; indicated for visual acuity correction in non-aphakic, non-diseased eyes with myopia, hyperopia, and astigmatism. Material: HEMA-MPC copolymer; 58% water content; includes RB 246 pigment for handling tint and RUVA-93 UV absorber. Aspheric front curve (tri-curve) and spherical base curve (aspheric model); multi-radius base curve (toric model). Supplied sterile in blister packs with phosphate-buffered saline. Prescribed by eyecare practitioners; worn by patients. Frequent planned replacement (cleaned/disinfected) or daily disposable (discarded after removal). Benefits: biocompatibility via MPC (phospholipid-like) material; vision correction.

Clinical Evidence

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

Technological Characteristics

Material: HEMA-MPC copolymer (Group II, non-ionic, high water). Water content: 59% ± 2%. Oxygen permeability (Dk): 25.68. Refractive index: 1.4002. Manufacturing: Cast molded, thermal cure. Sterilization: Moist heat (steam) autoclave. Packaging: Blister pack, phosphate-buffered saline. Visibility tint: Reactive Blue Dye 246. UV absorber: RUVA-93.

Indications for Use

Indicated for daily wear correction of visual acuity in non-aphakic, non-diseased eyes. Aspheric lenses for myopia/hyperopia with astigmatism ≤1.00D. Toric lenses for myopia/hyperopia with astigmatism 0.50D to 2.50D.

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)
• Aveo (omafilcon A) 1-day Aspheric Soft (Hydrophilic) Contact Lens (K162223)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right is written in blue and white. The text is arranged in three lines, with "FDA" on the top line, "U.S. FOOD & DRUG" on the second line, and "ADMINISTRATION" on the third line.

June 8, 2018

Supervision Optimax SDN BHD Yap Peak Geeh Regulatory Affairs Manager Lot 38. Putra Industrial Park. Bukit Rahman Putra 40160 Sungai Buloh, Selangor Dural Ehsan, Malaysia

Re: K180985

Trade/Device Name: Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 30, 2018 Received: April 13, 2018

Dear Yap Peak 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.

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

J Angelo Green -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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## Indications for Use

510(k) Number (if known) K180985

#### Device Name

Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses

#### Indications for Use (Describe)

Aveo (omafilcon A) 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 and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.

Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of between 0.50D and 2.50D or less that does not interfere with visual acuity.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

#### Frequent Planned Replacement Wear

When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and time they are removed from the patients' eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

Disposable Wear When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size:16px">☒</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <span style="font-size:16px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(K) Summary K180985

### Preparation Date: 05th June 2018

#### 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) Soft (Hydrophilic) Contact Lenses Common Name : Soft (Hydrophilic) Contact Lenses Classification Name: Lenses, Soft Contact, Daily Wear (21 CFR 886.5925, Product Code LPL) Lenses, Soft Contact, (Disposable) (21 CFR 886.5925, Product Code MVN) Classification : Class II

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

| | Predicate Device | |
|-------------------|--------------------------------------------|-------------------------------------------------------------------|
| Manufacturer | CooperVision, Inc | Supervision Optimax Sdn Bhd |
| Device Name | Proclear (omafilcon A) Soft Contact Lenses | Aveo (omafilcon A) 1-day Aspheric Soft (Hydrophilic) Contact Lens |
| 510(k) Number | K112302 | K162223 |
| Regulation Number | 21 CFR 886.5925 | 21CFR 886.5925 |
| Regulatory Name | Soft (hydrophilic) contact lens | Soft (hydrophilic) contact lens |
| Regulatory Class | II | II |
| Product Code | LPL and MVN | LPL and MVN |

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### 4.0 Description of the Device:

The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are daily wear soft contact lenses produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine) where molecules are found naturally in human cell membranes that improves the lens biocompatibility.

The contact lenses contain 58% water by weight and are 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. Reactive ultraviolet absorber RUVA-93 is used to block UV radiation.

The device is a corneal contact lens having a total diameter less than the visible iris diameter and is designed to be worn in its entirety on the cornea.

Aveo (Omafilcon A) Aspheric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).

Aveo (Omafilcon A) Toric Soft (Hydrophilic) Contact Lenses have an aspheric front curve (external curve) which is tri-curve for the sphere power and multi-radius base curve for the cylinder power (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) 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.

Aveo ( omafilcon A) Toric Soft ( Hydrophilic) Contact Lenses are indicated the 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 between 0.50D and 2.50D or less that does not interfere with visual acuity.

Daily wear replacement schedules may vary from patient to patient and should be decided by eyecare practitioners in consultation with their patients.

#### Frequent Planned Replacement Wear

When prescribed for frequent planned replacement wear the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patients' eve and discarded after the recommended wearing period prescribed by the eye care practitioner. The lenses may be disinfected using a chemical disinfection system.

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## Disposable Wear

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

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

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

| Technological Characteristics | | | |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristic | Subject Device | Predicate Device | Predicate Device |
| Product Name | Aveo | Proclear Asphere | Aveo |
| Manufacturer | Supervision Optimax Sdn<br>Bhd | CooperVision, Inc. | Supervision Optimax<br>Sdn Bhd |
| 510(K) Number | K180985 | K112302 | K162223 |
| Intended Use | Aveo (omafilcon A)<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<br>hyperopic and exhibit<br>astigmatism of 1.00D or less<br>that does not interfere with<br>visual acuity.<br><br>Aveo (omafilcon A) Toric<br>Soft (Hydrophilic) Contact<br>Lenses are indicated the<br>daily wear for the<br>correction of visual acuity in<br>not aphakic persons with<br>non-diseased eyes that are<br>myopic or hyperopic and<br>exhibit astigmatism of<br>between 0.50D and 2.50D<br>or less that does not<br>interfere with visual acuity. | 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<br>are myopic or hyperopic<br>and exhibit astigmatism<br>of 2.00D or less that<br>does not interfere with<br>visual acuity.<br><br>Proclear Toric<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<br>are myopia or hyperopic.<br>The lens may be worn by<br>persons who have<br>astigmatism of 5.00D or<br>less . | Aveo (omafilcon A)1-<br>Day Aspheric 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-<br>diseased eyes that<br>are myopic or<br>hyperopic and exhibit<br>astigmatism of 1.00D<br>or less that does not<br>interfere with visual<br>acuity. The contact<br>lenses are intended<br>for daily wear, single<br>use and are to be<br>discarded at the end<br>of the day. |
| Modality | Daily Wear | Daily Wear | Daily Wear |
| Lens Design | Aspherical | Aspherical | Aspherical |
| Material | Omafilcon A | Omafilcon A | Omafilcon A |
| Name | | | |
| FDA<br>(Group) | Group II<br>Non-ionic, High water | Group II<br>Non-ionic, High water | Group II<br>Non-ionic, High water |
| Manufacturing<br>Method | Cast Molded | Finished Inside<br>Polymerization System II | Cast Molded |
| Curing | Thermal Cure | Thermal Cure | Thermal Cure |
| Sterilization | Moist Heat (Steam) in<br>Validated Autoclave | Moist Heat (Steam) in<br>Validated Autoclave | Moist Heat (Steam) in<br>Validated Autoclave |
| Packaging | Blister Pack | Blister Pack | Blister Pack |
| Visibility Tint | Reactive Blue Dye 246 | VAT Blue 6 | Reactive Blue Dye 246 |
| Water Content | 59% ± 2% | 59% ± 2% | 59% ± 2% |
| Package Saline | Phosphate Buffered Saline | Phosphate Buffers<br>PEG200 and Tween 80 | Phosphate Buffered Saline |
| Refractive Index | 1.4002 | $1.395 \pm 0.005$ | 1.4002 |
| Oxygen<br>Permeability (Dk) x<br>10-11 | 25.68 | 21.05 | 25.68 |
| Light Transmission | 98% | >90% | 98% |
| Base Curve | 8.4mm to 8.8mm | 8.0mm to 9.3mm | 8.4mm to 8.8mm |
| Diameter Øт | 14.0mm to 14.7mm | 13.6mm to 15.2mm | 14.0mm to 14.4mm |
| Power | -10.00 to +6.00 | -20.00 to +20.00 | -10.00 to +6.00 |

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## 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.

#### Toxicology Studies

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

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| 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, therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

#### 9.0 Conclusion

The Aveo (Omafilcon A) Soft (Hydrophilic) Contact Lenses are substantially equivalent to the predicate device as they are produced from the same material (Omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical.