AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES

K123973 · Pegavision Corporation · LPL · Apr 23, 2013 · Ophthalmic

Device Facts

• Record ID: K123973
• Device Name: AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
• Applicant: Pegavision Corporation
• Product Code: LPL · Ophthalmic
• Decision Date: Apr 23, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5925
• Device Class: Class 2

Intended Use

Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or notaphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only. Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Story

Aquamax contact lenses are soft (hydrophilic) daily wear lenses manufactured via cast molding. Material is polymacon (HEMA crosslinked with EGDMA) with 38% water content. Lenses are tinted blue for visibility and contain a benzotriazole UV-absorbing monomer. Intended for vision correction in patients with refractive ametropia. Prescribed by eye care practitioners for frequent/planned replacement; requires chemical (non-heat) disinfection. Lenses provide UV protection. Clinical benefit includes vision correction and protection against harmful UV radiation transmission to the cornea.

Clinical Evidence

No clinical data provided. Safety and effectiveness established via non-clinical bench testing, including biocompatibility (cytotoxicity, sensitization, ocular irritation), microbiology (sterilization validation), and leachability studies. Predicate devices are widely used with well-documented safety profiles.

Technological Characteristics

Material: Polymacon (HEMA crosslinked with EGDMA). Water content: 38%. Refractive index: 1.43. Oxygen permeability: 12.1 x 10^-11 (cm²/sec)(mL O2/mL-mmHg). Manufacturing: Cast molding. Tint: C.I. reactive blue 19. UV blocker: Benzotriazole monomer. Sterilization: Steam sterilization (SAL 10^-6). FDA Group I (non-ionic, <50% water).

Indications for Use

Indicated for daily wear vision correction of refractive ametropia (myopia/hyperopia) in aphakic or non-aphakic persons with non-diseased eyes. Suitable for patients with refractive astigmatism ≤ 2.00 D. Prescription range +20.00D to -20.00D.

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

• Soflens Multifocal (Polymacon) Visibility Tinted Contact lens (K020927)
• Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens (K042824)

Submission Summary (Full Text)

{0}------------------------------------------------

# KI23973

## 1.4 510(k) SUMMARY

APR 2 3 2013

The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).

### Submitter Information

| Company: | PEGAVISION CORPORATION |
|-----------------|-----------------------------------------------------------|
| | 2F-1 No.5, Shing Yeh St. Shan Ding Vil. Kwei Shan Hsiang, |
| | Taoyuan Hsien 333, Taiwan |
| Contact Person: | Mr. Tony Hsu, President |
| Phone: | 886-3-329-8808 |
| Fax: | 886-3-329-8897 |
| E-Mail: | [e-mail] |
| Date Prepared: | Dec. 17, 2012 |

## Identification of Device

| Trade Name: | Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic)<br>Contact Lenses<br>Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic)<br>Contact Lenses |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | Soft (hydrophilic) Contact Lenses (daily wear) |
| Classification Name: | Lenses, Soft Contact, Daily Wear 21CFR. 886.5925,<br>Product Code LPL<br>Lenses, Soft Contact (Disposable), 21CFR. 886.5925,<br>Product Code MVN |
| FDA Classification: | Class II |

## Indication for use

Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or not-aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be

{1}------------------------------------------------

## K123973

prescribed in spherical powers ranging from +20.00D to -20.00D.

- Eye Care Practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.
Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

#### Description of Device

Aquamax (Polymacon) Ouarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are available as spherical lenses manufactured by cast molding method. The model illuminated with water content of 38%. These hydrogel lens materials are homo-polymer of 2-hydroxyethyl methacrylate (HEMA) crosslinked with ethylene glycol dimethacrylate (EGDMA) via photo-polymerization. These lenses are tinted blue using C.I. reactive blue 19 to make them more visible for handling. These lenses contain UV blocker, a benzotriazole UV absorbing monomer to block UV radiation. The average transmittance characteristics of theses lenses are less than 5 % in the UV range of 280-315 nm and less than 50% in the UVA range of 316-380nm. Lenses are supplied sterile in sealed blister package containing sterile isotonic borate buffered saline solution.

#### Summary of Clinical Study

Polymacon lenses have been used widely. Its safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by two lenses cleared by FDA

- Soflens Multifocal (Polymacon) Visibility Tinted Contact lens, K 020927 . Submitted by Bausch & Lomb Inc.
- Frequency 38 (Polymacon) Soft (hydrophilic) Contact Lens, K 042824, . submitted by Cooper Vision Inc.

Clinical studies for Aquamx (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are not required for the premarket notification as the USAN name and process are the same as the above mentioned predicate devices.

l - 1 1

{2}------------------------------------------------

### Non-clinical Study

All tests were conducted in accordance with the May 1994 FDA guideline title Premarket Notification 510(K) Guidance Document for Class IV Contact Lenses.

The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses and establish substantial equivalence to predicate lenses Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens (K020927); and Frequency 38 (Polymacon) Soft (Hydrophilic) Contact Lens (K042824). The evidence of substantial equivalence to the predicate lenses is described below.

#### a) Technological characteristics studies

The technological characteristics of Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses are illustrated in the following Table.

| Characteristics | Aquamax<br>(Polymacon)<br>Quarterly<br>Disposable Soft<br>(Hydrophilic)<br>Contact Lens | Aquamax<br>(Polymacon)<br>Monthly<br>Disposable Soft<br>(Hydrophilic)<br>Contact Lens | Soflens Multifocal<br>(Polymacon)<br>Visibility Tinted<br>Contact Lens | Frequency 38<br>(Polymacon) Soft<br>(hydrophilic)<br>Contact Lens |
|-------------------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------------------------------------------------------------------|-------------------------------------------------------------------|
| FDA Group | Group I<br>< 50 % water, non-<br>ionic polymer | Group I<br>< 50 % water, non-<br>ionic polymer | Group I<br>< 50 % water<br>non-ionic polymer | Group I<br><50 % water<br>Non-ionic polymer |
| USAN Name | Polymacon | Polymacon | Polymacon | Polymacon |
| Production Method | Cast molding | Cast molding | Cast molding | Cast molding |
| Water content | 38 % | 38 % | 38 % | 38 % |
| Refractive Index | 1.43 | 1.43 | 1.43 | 1.43 |
| Oxygen<br>permeability (edge<br>corrected)) @35<br>°C | $12.1 x 10^{-11}$<br>(cm²/sec)(mL<br>O2/mL-mmHg) | $12.1 x 10^{-11}$<br>(cm²/sec)(mL<br>O2/mL-mmHg) | $10.3 x 10^{-11}$<br>(cm²/sec)(mL<br>O2/mL-mmHg) | $8.0 x 10^{-11}$<br>(cm²/sec)(mL<br>O2/mL-mmHg) |

1-12

{3}------------------------------------------------

## K123973

| Characteristic | Aquamax<br>(Polymacon)<br>Quarterly<br>Disposable Soft<br>(Hydrophilic)<br>Contact Lenses | Aquamax<br>(Polymacon)<br>Monthly<br>Disposable Soft<br>(Hydrophilic)<br>Contact Lenses | Soflens Multifocal<br>(Polymacon)<br>Visibility Tinted<br>Contact Lens<br>(K020927) | Frequency 38<br>(Polymacon) Soft<br>(hydrophilic)<br>Contact Lens<br>(K042824) |
|-------------------|-------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------|
| Power(Diopter) | +20.00 to -20.00 D | +20.00 to -20.00 D | + 20.00 to -20.00D | + 20.00 to -20.00D |
| % T at 593 nm | > 95 % | > 95 % | > 96 % | > 97 % |
| % T at 380-316 nm | < 50 % | < 50 % | - | - |
| % T at 315-280 nm | < 5 % | < 5 % | - | - |

The oxygen permeability data for predicate Frequency 38 lenses were copied from 510(K) summary of respective lens. Actual measurement of oxygen permeability for Soflens Multifocal gave substantially equivalent value within error of measurement.

#### b) Biocompatibility

The standard cytotoxicity, maximization sensitization and ocular irritation tests were carried out for both Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses and negative responses were recorded for all tests. The validity of blister package for lenses was demonstrated by passing the standard extraction tests.

#### c) Microbiology

Steam sterilization process had been validated to deliver a minimum SAL of 10°, thereby complying with the requirement of FDA group IV. There is shelf-life stability supporting that these lenses remain sterile through the expiration date claimed for the product.

#### d) Bacteriostatic Validation

The steam sterilizer was tested for effectiveness by measuring and demonstrating the uniformity of temperature at different location inside the sterilizer over test period. Tested microorganisms were killed under tested conditions as compared to control.

Lenses remained sterilized and there was no microbial growth for a period of 5

{4}------------------------------------------------

years tested under accelerated condition. Seal of lens packages remained tight for a period of 5 years as demonstrated by the constant peeling strength tested under accelerated condition.

#### e) Leachability

Studies were conducted to determine the leachable materials from the finished lenses. The results show that, at the levels of the detection reported, there are no leachable monomers and additive residues.

### Substantial Equivalence Statement

In conclusion, it is PEGAVISION's conviction that data submitted in this 510(K) to validate the claim of substantial equivalency, substantiates our ability to manufacture soft contact lenses, the Aquamax (Polymacon) Quarterly Disposable Soft (Hydrophilic) Contact Lenses and Aquamax (Polymacon) Monthly Disposable Soft (Hydrophilic) Contact Lenses, with the same established safety profile and effectiveness as the predicate devices -Soflens Multifocal (Polymacon) Visibility Tinted Contact Lens via K020927 and Frequeny 38 (Polymacon) Soft (Hydrophilic) Contact Lens via K042824.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird-like figure.

Public Health Service

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

April 23, 2013

Pegavision Corporation % Mr. Tony Hsu President 2F-A No. 5 Shing Yeh St. Shan Ding Vil. Taoyuan, Kwei Shan Hsiang China (Taiwan) 33341

Re: K123973

Trade/Device Name: Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lens; Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925

Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: March 18, 2013 Received: March 19, 2013

Dear Mr. Hsu:

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.

{6}------------------------------------------------

Page 2 - Mr. Tony Hsu

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/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/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Deborah Falls -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

{7}------------------------------------------------

## K123973

## Indications for Use

510(k) Number (if known): K123973

Device Name: Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses. Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses

Indications for Use:

Aquamax (polymacon) Quarterly Disposable Soft (hydrophilic) Contact Lenses and Aquamax (polymacon) Monthly Disposable Soft (hydrophilic) Contact Lenses are indicated for daily wear for vision correction of refractive ametropia in aphakic or notaphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who exhibit refractive astigmatism of 2.00 diopters (D) or less where the astigmatism does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00 D to -20.00 D. Eye practitioners may prescribe the lens for frequent/planned replacement wear with cleaning, rinsing, disinfection and scheduled replacement as prescribed by the eye care professional. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical (not heat) lens care system only.

Lenses help protect against transmission of harmful UV radiation to the cornea and into the eve.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| Joseph C. Hutter |
|-----------------------------|
| 2013.04.18 14:15:15 -04'00' |

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

510(k) Number K123973