Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

K203571 · Acuity Polymers, Inc. · HQD · Apr 9, 2021 · Ophthalmic

Device Facts

• Record ID: K203571
• Device Name: Acuity 200 (fluoroxyfocon A) Rigid Gas Permeable Contact Lens
• Applicant: Acuity Polymers, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Apr 9, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2

Intended Use

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

Acuity 200™ is a lathe-cut, rigid gas permeable (RGP) contact lens made of siloxanyl fluoromethacrylate copolymer; available in spherical, toric, multifocal, scleral, and aspheric designs. Used by eye care practitioners to manage refractive errors and irregular corneal conditions. Lens provides oxygen permeability (Dk 200) and is tinted for visibility; optional UV absorber. Patient wears lenses daily; cleaned/disinfected via chemical systems. Output is corrected vision for patients with corneal irregularities or refractive errors. Benefits include improved visual acuity and management of corneal surface distortions.

Clinical Evidence

Retrospective chart review of 41 patients (66 eyes) with irregular corneal conditions managed with Acuity 200 lenses. Results showed stable or improved vision and corneal condition across 13,760 total days of wear with no serious adverse reactions reported.

Technological Characteristics

Material: siloxanyl fluoromethacrylate copolymer (fluoroxyfocon A); Dk: 200 x 10^-11; Modulus: 1194 MPa; Hardness: 78 Shore D; Refractive Index: 1.430; Specific Gravity: 1.18. Production: lathe-cut. Designs: spherical, toric, multifocal, scleral, aspheric. Connectivity: N/A. Sterilization: chemical disinfection.

Indications for Use

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

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

• Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens (K201194)
• BostonSight PD Prosthetic Device (K161461)
• Ampleye Scleral RGP Lens (K172314)

Submission Summary (Full Text)

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April 9, 2021

Acuity Polymers, Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn. OR 97068

## Re: K203571

Trade/Device Name: Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HQD Dated: March 1, 2021 Received: March 8, 2021

## Dear Bret Andre:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone [phone] or 301-796-7100).

Sincerely.

# J Angelo Green -S

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic. Anesthesia. Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K203571

Device Name

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens

Indications for Use (Describe)

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and non-aphakic persons with nondiseased eyes. 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 510 (k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

### The assigned 510(k) number is:

#### I. SUBMITTER

| Date Prepared: | April 7th, 2021 |
|----------------------------------|----------------------------------------------------------------------------------------------|
| Name:<br>Address: | Acuity Polymers, Inc.<br>1667 Lake Avenue, Suite 354<br>Rochester, NY 14615<br>United States |
| Contact Person:<br>Phone number: | James A. Bonafini, Jr<br>President<br>[phone] |
| Consultant: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068 |
| Phone number: | [phone] |

#### II. DEVICE

| Trade Name: | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
|-------------------------|----------------------------------------------------------------|
| Common<br>Name: | Daily wear rigid gas permeable contact lens |
| Classification<br>Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory<br>Class: | Class II |
| Product Code: | HQD |
| ~Reason for Submission~ | New Indications for Use |

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#### III. PREDICATE DEVICE

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is substantially equivalent to the following predicate devices:

- "Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens" ■ By Acuity Polymers, Inc. 510(k) number; K201194
- 트 "BostonSight PD Prosthetic Device" Manufactured by Boston Foundation for Sight 510(k) number; K161461
- I "Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)" By Art Optical Contact Lens, Inc. 510(k) number; K172314

#### IV. DEVICE DESCRIPTION

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is manufactured from a machine latheable rigid gas permeable material composed of siloxanyl fluoromethacrylate copolymer that is tinted for visibility and available with or without an ultraviolet (UV) light absorber.

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is made available in spherical, toric, multifocal, scleral and aspheric designs in the following lens parameters:

| Parameter | Range | Tolerance |
|--------------------|--------------------|------------------------------------------------------------------------------------------------------------------|
| Base Curve | 4.00mm to 11.5mm | ± 0.05 mm |
| Center Thickness | 0.08mm to 0.75mm | ± 0.02 mm |
| Diameter | 7.0mm to 21.0mm | ±0.10mm |
| Spherical Power | -20.00D to +20.00D | ± 0.12 (0 to = 5D)<br ± 0.18 (5 to = 10.0D)<br ± 0.25 (10 to = 15D)<br ± 0.37 (15 to = 20D)<br ± 0.50 (over 20D) |
| Cylindrical Power | Up to 9.00D | ± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D) |
| Multifocal Power | +1.00D to 4.00D | ± 0.25D |
| Surface Appearance | | Lenses should be clear with no surface<br>defect |

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The following table depicts the physical properties of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens:

| | Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens |
|-----------------------------|--------------------------------------------------------------------------------|
| Refractive Index | 1.430 |
| Modulus (MPa) | 1194 |
| Hardness (Shore D) | 78 |
| Specific Gravity | 1.18 |
| Oxygen Permeability<br>(Dk) | $200 \times 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35 °C) |
| Color Additives | Visibility Tints – D&C Green #6, D&C Violet #2, Solvent Yellow 18, D&C Red #17 |

#### V. INDICATIONS FOR USE

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is 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 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 Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and disinfected using a chemical (not heat) lens care system.

#### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is substantially equivalent to the predicate devices (cleared under K201194, K161461, and K172314) in terms of the following:

- Intended use daily wear contact lenses 트
- 트 Indications for use
- o Management of Irregular Corneal Conditions
- Correction of Refractive Error o
- 트 Actions
- Classification - Lenses, Rigid Gas Permeable, Daily Wear (21 CFR 886.5916)
- 트 FDA material group - group # 3 fluoro silicone acrylate
- USAN material (fluoroxyfocon A)
- 트 Production method - lathe cut
- 트 Final packaging and shipping

The following matrix illustrates the production method. lens function and material characteristics of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens, as well as the predicate device.

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| | Acuity 200TM<br>(fluoroxyfocon A)<br>Rigid Gas<br>Permeable<br>Contact Lens | Acuity 200TM<br>(fluoroxyfocon<br>A) Rigid Gas<br>Permeable<br>Contact Lens | BostonSight PD<br>Prosthetic<br>Device | Ampleye Scleral RGP<br>Lens (roflufocon D,<br>roflufocon E,<br>hexafocon A,<br>paflufocon D) |
|--------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device<br>(K201194) | Predicate<br>Device<br>(K161461) | Predicate Device<br>(K172314) |
| Classification | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily<br>Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily<br>Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid<br>Gas Permeable,<br>Daily Wear<br>21 CFR<br>886.5916 | Class II<br>Lenses, Rigid Gas<br>Permeable, Daily Wear<br>21 CFR 886.5916 |
| Product Code | HQD | HQD | HQD | HQD |
| FDA Group # | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3<br>Fluoro Silicone<br>Acrylate | Group # 3 Fluoro<br>Silicone Acrylate |
| Material (USAN) | fluoroxyfocon A | fluoroxyfocon A | roflufocon D,<br>roflufocon E,<br>oprifocon A,<br>and hexafocon<br>B | roflufocon D,<br>roflufocon E,<br>hexafocon A,<br>paflufocon D |
| Production<br>Method | Lathe-Cut | Lathe-Cut | Lathe-Cut | Lathe-Cut |
| Intended Use | Daily Wear | Daily Wear | Daily Wear | Daily Wear |
| Water Content<br>(%) | <1% | <1% | <1% | <1% |
| UV Absorber<br>Available | Yes | Yes | Yes | Yes |

# Substantial Equivalence Matrix

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| | Indications for Use |
|--------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Acuity 200TM<br>(fluoroxyfocon<br>A) Rigid Gas<br>Permeable<br>Contact Lens<br>(Subject Device) | The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens is indicated for daily wear for<br>the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and<br>non-aphakic persons with non-diseased eyes. The lenses may be prescribed for daily wear in otherwise<br>non-diseased eyes that require a rigid contact lens for the management of irregular corneal conditions<br>such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive<br>(e.g., LASIK) surgery.<br>The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lens may be cleaned and<br>disinfected using a chemical (not heat) lens care system. |
| Acuity 200TM<br>(fluoroxyfocon<br>A) Rigid Gas<br>Permeable<br>Contact Lens<br>(K201194) | The Acuity 200TM (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses are indicated for daily wear<br>for the correction of refractive error (myopia, hyperopia, presbyopia and/or astigmatism) in aphakic and<br>non-aphakic persons with non-diseased eyes. The lens may be prescribed in spherical and aspheric<br>powers ranging from -20.00 D to +20.00 D for daily wear. |
| BostonSight PD<br>Prosthetic Device<br>(K161461) | The Boston Sight PD Prosthetic Device for daily wear is indicated for therapeutic use for the<br>management of a distorted corneal surface that:<br>1. precludes satisfactory spectacle lens correction<br>2. demonstrates significant improved rigid contact lens corrected vision<br>3. is incapable of wearing traditional corneal lenses because of the inability to achieve adequate<br>lens centration/stability and/or tolerance to physical contact with a lens<br>Causes of corneal distortion include corneal degeneration (e.g. keratoconus, keratoglobus, pellucid<br>marginal degeneration, Salzmann's nodular degeneration), corneal dystrophy (e.g, lattice dystrophy,<br>Reis-Bucklers dystrophy), and scarring from surgery (e.g. corneal transplant, LASIK, radial<br>keratotomy), infection, or trauma.<br>The BostonSight PD Prosthetic Device for daily wear is also indicated for therapeutic use in eyes with<br>ocular surface disease from dry eye (e.g. ocular Graft-versus-Host disease, Sjögren's syndrome, dry eye<br>syndrome), limbal stem cell deficiency (e.g.Stevens-Johnson syndrome, chemical and thermal burns,<br>radiation), disorders of the skin (e.g. atopy, ectodermal dysplasia), neurotrophic keratitis (e.g. Herpes<br>simplex, Herpes zoster, Familial Dysautonomia), and corneal exposure (e.g. anatomic, paralytic) that<br>might benefit from the presence of an expanded tear reservoir and protection against an adverse<br>environment. When prescribed for therapeutic use for distorted cornea or ocular surface disease, the<br>BostonSight PD Prosthetic Device may incidentally provide correction of refractive error.<br>The BostonSight PD Prosthetic Device may be cleaned and disinfected using a chemical (not heat)<br>care system. |
| Ampleye Scleral<br>RGP Lens<br>(roflufocon D,<br>roflufocon E,<br>hexafocon A,<br>paflufocon D)<br>(K172314) | The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) for daily<br>wear is indicated for use for the management of irregular astigmatism, corneal degeneration or<br>dystrophy caused by keratoconus, keratoglobus, pellucid marginal degeneration (PMD), post corneal<br>trauma/scaring, post keratoplasty, post K-Pro, post RK, post PRK, post LASIK, Salzmann's nodular<br>degeneration, Cogan's dystrophy, granular corneal dystrophy, lattice corneal dystrophy or Reis-Bucklers<br>dystrophy.<br><br>The Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is also<br>indicated for therapeutic management of ocular surface disease from dry eye including ocular<br>pemphigoid, Stevens-Johnson syndrome, symblepharon formation, graft vs host disease, persistent<br>epithelial defect, exposure keratitis, neurotrophic keratopathy( herpes simplex, herpes zoster, familial<br>dysautonomia), Sjögren's syndrome, filamentary keratitis, limbal stem cell deficiency, atopy,<br>ectodermal dysplasia. When prescribed for therapeutic use for irregular astigmatism or ocular surface<br>diseases, the Ampleye Scleral RGP Lens may also provide correction of refractive error including<br>myopia, hyperopia, presbyopia and regular astigmatism.<br><br>Eye care practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning,<br>disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the<br>lens may be cleaned and disinfected using a chemical (not heat) lens care system. |

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#### VII. PERFORMANCE DATA

### ~ Non-Clinical Studies ~

Non-clinical testing to demonstrate the safety and effectiveness of the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens has been addressed through previously cleared 510(k) premarket notifications.

### ~ Clinical Studies ~

Four (4) independent practitioners retrospectively reviewed medical charts of 41 patients (66 total eyes) presenting with irregular corneal conditions that were managed using contact lenses manufactured from Acuity 200 (fluoroxyfocon A) material. For all patients, the irregular corneal conditions and vision remained stable or improved during treatment with the Acuity 200 (fluoroxyfocon A) contact lenses. The successful fitting of 66 eyes over a total of 13,760 days without any serious adverse reaction reported demonstrate the Acuity 200 (fluoroxyfocon A ) contact lenses are safe and effective for the management of irregular corneal conditions such as keratoconus, pellucid marginal degeneration, or following penetrating keratoplasty or refractive (e.g., LASIK) surgery.

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## VIII. CONCLUSIONS

### Substantial Equivalence

Information presented in this premarket notification establishes that the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens for daily wear is as safe and effective as the predicate devices when used in accordance with the labeled directions for use and for the proposed indications.

## Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of rigid gas permeable (RGP) daily wear contact lenses. The benefits to the patient are the same as those for other RGP contact lenses.