iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

K183200 · C&E GP Specialist, Inc. · MUW · Jan 9, 2019 · Ophthalmic

Device Facts

• Record ID: K183200
• Device Name: iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
• Applicant: C&E GP Specialist, Inc.
• Product Code: MUW · Ophthalmic
• Decision Date: Jan 9, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

Device Story

iSee contact lenses are lathe-cut, rigid gas permeable (RGP) lenses manufactured from fluoro-silicone acrylate materials (roflufocon D or E). Lenses act as refractive medium to focus light on retina; used in orthokeratology fitting programs for temporary myopia reduction. Prescribed by eyecare practitioners for daily wear; requires chemical cleaning/disinfection. Patient benefits include temporary vision correction without daytime glasses/contacts. Device is non-implantable, external ocular prosthetic.

Clinical Evidence

No clinical data presented in this submission; safety and effectiveness addressed by reference to predicate devices.

Technological Characteristics

Rigid gas permeable contact lens; materials: roflufocon D or roflufocon E (FDA Group #3 fluoro-silicone acrylate). Oxygen permeability (Dk): 100-125 x 10^-11 (cm²/sec)(ml O₂/ml x mm Hg @ 35°C). Production: lathe-cut. Dimensions: 6.50-11.50mm diameter, 6.50-11.00mm base curve. Connectivity: none. Sterilization: chemical (non-heat) lens care system.

Indications for Use

Indicated for daily wear in orthokeratology fitting program for temporary reduction of myopia up to 5.00 diopters in non-diseased eyes. Requires continued wear on prescribed schedule to maintain effect. Contraindicated in 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

• OPTIMUM GP OK Daily Wear Contact Lens (Roflufocon D & E) (K160859)

Submission Summary (Full Text)

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510(K) Premarket Notification

# 510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS

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: K183200

#### I. SUBMITTER

| Date Prepared: | November 15th, 2018 |
|-------------------|-------------------------------------------------------------------------------------------------|
| Name:<br>Address: | C&E GP Specialists, Inc.<br>15970 Bernardo Center Drive<br>San Diego, CA 92127<br>United States |
| Contact Person: | Steve Wagner<br>President |
| Phone number: | [phone] |
| Consultant: | Bret Andre<br>EyeReg Consulting, Inc.<br>6119 Canter Ln.<br>West Linn, OR 97068 |
| Phone number: | [phone] |

#### II. DEVICE

| Trade Name: | iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact<br>Lenses |
|-------------------------|--------------------------------------------------------------------------------|
| Common<br>Name: | Daily wear rigid gas permeable (hydrophobic) contact lens (Orthokeratology) ) |
| Classification<br>Name: | Rigid gas permeable contact lens. (21 CFR 886.5916) |
| Regulatory<br>Class: | Class II |
| Product Code: | MUW |

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#### III. PREDICATE DEVICE

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are substantially equivalent to the following predicate devices:

- . "OPTIMUM GP OK Daily Wear Contact Lens (Roflufocon D & E)" By Contamac, Ltd. 510(k) number; K160859
#### DEVICE DESCRIPTION IV.

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are are lathe cut from one of the following hydrophobic, FDA Group #3 fluoro-silicone acrylate materials: roflufocon D or roflufocon E-with the following properties:

| | ROFLUFOCON D | ROFLUFOCON E |
|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|
| Refractive Index | 1.4333 | 1.4332 |
| Light Transmission (clear) | >97% | >97% |
| Light Transmission (tinted) | >90% | >90% |
| Wetting Angle (Dynamic contact<br>receding angle) | 3° | 6° |
| Specific Gravity | 1.166 | 1.155 |
| Oxygen Permeability<br>(Dk)<br>ISO/FATT Method | 100 x $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @<br>35°C) | 125 x $10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @<br>35°C) |
| Visitint lenses contain one or more of<br>the following color additives conforming<br>to: 21 CFR Part 73 & 74, Subpart D | D & C Green No. 6, FD & C Red No.<br>17, CI Solvent Yellow 18 | D & C Green No. 6, FD & C Red No.<br>17, CI Solvent Yellow 18 |

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are available in the following lens parameters:

| Parameter | Range | Tolerance |
|------------------|-----------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Base Curve | 6.50mm to 11.00mm | ± 0.05 mm |
| Center Thickness | 0.10mm to 0.70mm | ± 0.02 mm |
| Diameter | 6.50mm to 11.50mm | ± 0.10mm |
| Spherical Power | -10.00 D to +3.00 D<br>(in 0.25D steps) | ± 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) |

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# C&E GP Specialists, Inc.

510(K) Premarket Notification

| Secondary Curves | 0.10mm to 2.00mm (flatter or<br>steeper than base curve) | ± 0.10mm |
|-------------------|----------------------------------------------------------|----------|
| Peripheral Curves | 0.10mm to 2.00mm (flatter or<br>steeper than base curve) | ± 0.10mm |
| Multifocal Power | +1.00 D to 3.75 D<br>(in 0.25 D steps) | ± 0.25D |

#### V. INDICATIONS FOR USE

The iSee (roffufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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

The following matrix illustrates the production method, intended use and materials of iSee (rofflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses, as well as the predicate device.

| | iSee Daily OK Contact Lens | Optimum GP OK Contact Lens |
|--------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Subject Device | Predicate Device (K160859) |
| Classification | Same as predicate | Class II<br>Lenses, Rigid Gas Permeable, Daily Wear<br>21 CFR 886.5916 |
| Product Code | Same as predicate | MUW |
| FDA Group # | Same as predicate | Group # 3 Fluoro Silicone Acrylate |
| USAN | Same as predicate | Roflufocon D.<br>Roflufocon E |
| Production Method | Same as predicate | Lathe-Cut |
| Actions | Same as predicate | The contact lenses act as a refractive medium that<br>focus light rays from near and distant objects on<br>the retina. (orthokeratology) |
| Intended Use | Same as predicate | Daily Wear (orthokeratology) |
| Indication for Use | Same as predicate | Indicated for daily wear in an orthokeratology fitting<br>program for the temporary reduction of myopia of up to<br>5.00 diopters in non-diseased eyes. |

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#### PERFORMANCE DATA VII.

## ~ Non-Clinical Studies ~

The non-clinical performance data to establish the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E has been addressed by reference to the predicate devices.

## ~ Clinical Studies ~

Clinical performance data to demonstrate the safety and effectiveness of contact lenses manufactured from roflufocon D and roflufocon E have been addressed in previous applications.

## VIII. CONCLUSIONS

## Substantial Equivalence

Information presented in this Premarket Notification establishes that iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

## 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.

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Image /page/4/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.

January 9, 2019

C&E GP Specialist % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Lane West Linn, OR 97068

Re: K183200

Trade/Device Name: iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: MUW Dated: November 15, 2018 Received: November 19, 2018

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 yours,

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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### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K183200

Device Name

iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses

## Indications for Use (Describe)

The iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses are indicated for daily wear in an orthokeratology fitting program for the temporary reduction of myopia of up to 5.00 diopters in non-diseased eyes. To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system.

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