Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens

K180988 · Acuity Polymers, Inc. · HQD · Jun 8, 2018 · Ophthalmic

Device Facts

• Record ID: K180988
• Device Name: Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lens, Acuity 58 (enflufocon B) Rigid Gas Permeable Contact Lens, Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens, Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens
• Applicant: Acuity Polymers, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Jun 8, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only. The lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.

Device Story

Rigid gas permeable (RGP) contact lenses composed of fluoro-silicon acrylate copolymers; designed for daily wear correction of refractive errors and management of irregular corneal conditions. Lenses are wet-shipped and stored in compatible multipurpose solutions (BOSTON SIMPLUS or Menicon Unique pH) for up to 30 days. Prescribed by eye care professionals; patient self-administered. Output is physical lens providing optical correction. Benefits include vision improvement and management of corneal irregularities. Device functions as a passive optical corrective element.

Clinical Evidence

No clinical data presented. Substantial equivalence established via bench testing, including biocompatibility studies per ISO 10993-1, solution compatibility studies, and bioburden studies confirming no CFUs found during 30-day wet storage/shipping simulation.

Technological Characteristics

Materials: Fluoro-silicon acrylate copolymers. Form factor: Rigid gas permeable contact lens. Connectivity: None. Sterilization: Not specified (bioburden monitored). Standards: ISO 13485 (Quality Management), ISO 11737 (Microbiological methods).

Indications for Use

Indicated for daily wear correction of refractive error (myopia, hyperopia, presbyopia, astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. Also indicated for management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, or post-refractive surgery) in non-diseased eyes.

Regulatory Classification

Identification

A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.

Predicate Devices

• BOSTON RGP Lenses Wet Shipped in Boston Advance Comfort Formula Conditioning Solution and Stored for Up to 30 Days (K073184)

Reference Devices

• Acuity 100 (hexafocon A) (K162005)
• Acuity 18 (enflufocon A) (K163254)
• Acuity 85 (oprifocon A) (K170001)
• Acuity 58 (enflufocon B) (K170007)
• BOSTON SIMPLUS (K024289)
• Menicon Unique pH (K130805)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 8, 2018

Acuity Polymers, Inc. James A. Bonafini, Jr. President & COO 1667 Lake Avenue, Suite 354 Rochester, NY 14615

Re: K180988

Trade/Device Name: The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: April 13, 2018 Received: April 16, 2018

Dear James Bonafini:

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

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

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 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

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

# Indications for Use

#### 510(k) Number (if known) K180988

#### Device Name

The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses

#### Indications for Use (Describe)

The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D tor daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only. The lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.

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

| <input checked="true" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) |
|--------------------------------------------------------------------------------------|
| <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

# 510(k) SUMMARY

| 1. Date Prepared | February 19, 2018 |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. Applicant's Name: and Address: | Acuity Polymers, Inc.<br>1667 Lake Avenue, Suite 354<br>Rochester, NY 14615<br>[phone] |
| 3. Contact Person: | James A. Bonafini, Jr. President (submitter)<br>Telephone: [phone]<br>E-Mail: [e-mail] |
| 4. Identification of Device: | |
| Common Name: | Daily Wear Contact Lens |
| Proprietary Name: | The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A),<br>Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid<br>Gas Permeable Contact Lenses |
| Device Classification: | Lenses, Rigid Gas Permeable, Daily Wear Contact Lens;<br>Class II (21 CFR 886.5916) |
| Device Product Code: | HQD |
| 5. Premarket Notification Number | K180988 |
| 6. Establishment Registration Number: | 3012228452 |

- 7. Description of the New Device
- a. The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Boston SIMPLUS Multi-Action Solution.

BOSTON SIMPLUS Multi-Action Solution, a sterile, aqueous, buffered solution that contains poloxamine, hydroxyalky phosphonate, boric acid, sodium borate, sodium chloride, hydroxypropylmethyl cellulose, Glucam and preserved with polyaminopropyl biguanide (0.0005%), chlorhexidine gluconate (0.003%).

- b. The Acuity Polymers Rigid Gas Permeable Contact Lenses are daily wear rigid gas permeable contact lenses comprised of fluoro-silicon acrylate copolymers wet shipped in Menicon Unique pH Multi-purpose solution.
Menicon Unique-pH multi-purpose solution is a proprietary sterile, aqueous solution buffered to approximate the pH and tonicity of the eye. It contains hydroxypropyl guar,

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

a proprietary wetting/conditioning polymer system, polyethylene glycol, Tetronic 1304, boric acid, propylene glycol, and is preserved with polyquad (polyquaternium-1) (0.0011%), and edetate disodium (0.01%)

#### 8. Intended Use

The Acuity 100 (hexafocon A), Acuity 85 (oprifocon A), Acuity 58 (enflufocon B) and Acuity 18 (enflufocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric powers ranging from -20.00 D to +20.00 D for daily wear. The lenses may be prescribed for daily wear in otherwise non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery. The lens may be disinfected using a chemical disinfection system only. The lenses may be stored in a multipurpose solution (BOSTON SIMPLUS or Menicon Unique pH) solution up to 30 days.

#### 9. Predicate Devices:

Boston RGP Lenses Wet Shipped in Boston SIMPLUS Multi-Action Solution as described in K073184 has been selected as the predicate device.

#### 10. Substantial Equivalence

Substantial equivalence is based on:

| Device Description | 510(k) | Clearance Date |
|--------------------------------------------------------------------------------------------------------------------------|---------|----------------|
| BOSTON RGP Lenses Wet Shipped in Boston<br>Advance Comfort Formula Conditioning<br>Solution and Stored for Up to 30 Days | K073184 | 02/21/2008 |

Acuity Polymers Rigid Gas Permeable Contact Lenses Wet Shipped in Multipurpose Solution and Stored up to 30 Days is substantially equivalent to that cleared under K073184.

# 11. Clinical Studies

Clinical data is not necessary as the products, both RGP lenses and multi-purpose disinfection solutions are cleared for use as indicated.

The gas permeable lens materials manufactured by Acuity Polymers, Inc. have been tested and found to meet the biocompatibility requirements listed in the FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 10993-1 (2009) for a surface device, limited contact.

These materials have been cleared under the following 510(k)s which include solution compatibility studies, showing stable lens parameters when using either Boston SIMPLUS Multi-Action Solution or Menicon Unique pH Multi-purpose Solutions:

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

# RGP Lens Materials:

| Device Description | 510(k) | Clearance Date |
|--------------------------|---------|----------------|
| Acuity 100 (hexafocon A) | K162005 | 12/8/2016 |
| Acuity 18 (enflufocon A) | K163254 | 01/18/2017 |
| Acuity 85 (oprifocon A) | K170001 | 06/02/2017 |
| Acuity 58 (enflufocon B) | K170007 | 05/31/2017 |

Multi-action Solutions:

| Storage Solution | 510(k) | Clearance Date |
|-------------------|---------|----------------|
| BOSTON SIMPLUS | K024289 | 05/03/2003 |
| Menicon Unique pH | K130805 | 07/03/2013 |

# 12. Relationship to Special Controls (Guidance)

This submission requires reliance upon a guidance document to describe the change and its relevance to current guidance. The FDA Daily Wear Contact Lens Guidance Document, May 1994. is the relevant document to which this submission is based. Clinical performance data is not necessary since the material and optical design of the stated lenses is cleared under the 510(k) process and the solutions are deemed compatible and also cleared under the 510(k) process.

# 13. Manufacturing & Packaging:

Finished Product Manufacturing, Inspection, Packaging and Distribution: Acuity Polymers, Inc. (Est. Regis: #3012228452) 1667 Lake Avenue, Suite 354 Rochester, NY 14615 [phone]

# 14. Action Taken to Comply with FDA Special Controls:

The submission is for a daily wear contact lens, Class II subject to Special Controls. The Special Control is the FDA Daily Wear Contact Lens Guidance Document, May 1994 to which this submission is applied. All testing listed in this 510(k) submission is in accordance with that document.

# 15. Conformance to Standards

Acuity Polymers' quality system conforms and is certified to ISO Standard 13484 (2003). Medical Devices: Quality Management Systems: Requirements for regulatory purposes.

In accordance by ISO 11737 Sterilization of medical devices - Microbiological methods -Part 1: Determination of a population of microorganisms on products, Acuity Polymers conducts bioburden studies to monitor lens manufacturing for evidence of microorganisms.

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

Normally performed on non-sterile dry lenses, the testing was extended to evaluate wet storage (up to 30-days) and shipping of RGP lenses as part of the manufacturing process. It was determined that no CFUs were found at any test point during the 30-day period.

#### 16. Conclusion

The Acuity Polymers Rigid Gas Permeable Contact Lenses Wet Shipped in Multipurpose Solution and Stored up to 30 Days is substantially equivalent to that described under K073184: "BOSTON RGP Contact Lenses Wet Shipped in BOSTON SIMPLUS Multi-Action Solution and stored up to 30 days".

Since both the RGP lenses and multi-purpose disinfection solutions are cleared and no change in indications for use is expected. it is seen that the application is equivalent to that described in K073184.

Acuity Polymers quality management system complies with The FDA Daily Wear Contact Lens Guidance Document, May 1994 and ISO 13485 (2003) Medical Devices: Quality Management Systems: Requirements for regulatory purposes.