eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K

K181579 · E&E Optics, Inc. · HQD · Jul 26, 2018 · Ophthalmic

Device Facts

• Record ID: K181579
• Device Name: eLens Rigid Gas Permeable Contact Lens for Daily Wear, eLens Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K
• Applicant: E&E Optics, Inc.
• Product Code: HQD · Ophthalmic
• Decision Date: Jul 26, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 886.5916
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected using a chemical disinfection system only. The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is 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. The lenses may be disinfected using a chemical disinfection system only.

Device Story

Lathe-cut rigid gas permeable (RGP) contact lenses; fabricated from hydrophobic fluoro-silicone acrylate materials (hexafocon A, hexafocon B, or oprifocon A). Lenses act as refractive medium to focus light on retina; orthokeratology lenses temporarily reshape cornea to reduce myopia. Prescribed by eye care professionals for daily wear. Patients use chemical disinfection systems. Benefits include vision correction and management of irregular corneal conditions; risks consistent with standard RGP lens wear.

Clinical Evidence

No clinical data provided; safety and effectiveness established by reference to predicate devices.

Technological Characteristics

Lathe-cut rigid gas permeable contact lenses; materials: hexafocon A, hexafocon B, or oprifocon A (FDA Group #3 fluoro-silicone acrylate); water content <1%; oxygen permeability (Dk) ranges 85-161 x 10^-11; includes color additives (D&C Green No. 6, C.I. Solvent Yellow No. 18, D&C Violet No. 2, FD&C Red No. 17); chemical disinfection required.

Indications for Use

Indicated for correction of refractive ametropia (myopia, hyperopia, astigmatism, presbyopia) in aphakic/non-aphakic persons with non-diseased eyes; management of irregular corneal conditions (keratoconus, pellucid marginal degeneration, post-penetrating keratoplasty, post-refractive surgery); and temporary reduction of myopia up to 5.00D via orthokeratology 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 XO (hexafocon A) Contact Lens for Daily Wear Orthokeratology (K001960)
• Boston Equalens II (oprifocon A) Contact Lens for Daily Wear Orthokeratology (K003933)
• Boston XO2 (hexafocon B) Contact Lens for Daily Wear (Orthokeratology) (K071266)
• Boston XO (Hexafocon A) Rigid Gas Permeable Contact Lens (K071043)
• Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens (K170001)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 26, 2018

E&E Optics Inc. % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K181579

Trade/Device Name: eLens (hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lens for Daily Wear. eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lens for Daily Wear Ortho-K Regulation Number: 21 CFR 886.5916 Regulation Name: Rigid Gas Permeable Contact Lens Regulatory Class: Class II Product Code: HOD. MUW Dated: June 13, 2018 Received: June 15, 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.html; 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 mediation-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) K181579

### Device Name

eLens (hexafocon A. hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear; eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K

### Indications for Use (Describe)

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected using a chemical disinfection system only.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is 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. The lenses may be disinfected using a chemical disinfection system only.

Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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

| <span style="font-size: 10pt;">☑ Recreation Use (Part 91 CFR 201.5(b))</span> |
|-------------------------------------------------------------------------------|
| <span style="font-size: 10pt;">☐ On-The-Spot Use (91 CFR 201.5(c))</span> |

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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# 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: K181579

#### I. SUBMITTER

- July 11th, 2018 Date Prepared:
- Name: E&E Optics Inc. Address: 1795 E. Holt Blvd, Unit 104 Ontario, CA 91761 United States Contact Person: Bonnie Wan President [phone] Phone number: Consultant: Bret Andre EyeReg Consulting, Inc. 6119 Canter Ln.

West Linn, OR 97068 Phone number: [phone]

#### II. DEVICE

| Trade Name: | eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable<br>Contact Lenses for Daily Wear;<br>eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable<br>Contact Lenses for Daily Wear Ortho-K | |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Common<br>Name: | Daily wear rigid gas permeable (hydrophobic) contact lens;<br>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: | HQD; MUW | |

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#### III. PREDICATE DEVICE

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are substantially equivalent to the following predicate devices:

- . "Boston XO (hexafocon A) Contact Lens for Daily Wear Orthokeratology" By Bausch + Lomb Inc. 510(k) number; K001960
- . "Boston Equalens II (oprifocon A) Contact Lens for Daily Wear Orthokeratology" By Bausch + Lomb Inc. 510(k) number: K003933
- . "Boston XO2 (hexafocon B) Contact Lens for Daily Wear (Orthokeratology)" By Bausch + Lomb Inc. 510(k) number: K071266
- 트 "Boston XO (Hexafocon A) Rigid Gas Permeable Contact Lens" By Bausch + Lomb Inc. 510(k) number; K071043
- . "Acuity 85 (Oprifocon A) Rigid Gas Permeable Contact Lens" By Acuity Polymers Inc. 510(k) number; K170001

#### DEVICE DESCRIPTION IV.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are lathe cut from one of the following hydrophobic. FDA Group #3 fluoro-silicone acrylate materials: hexafocon A, hexafocon B, or oprifocon A-with the following properties:

| | HEXAFOCON A | HEXAFOCON B | OPRIFOCON A |
|----------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|------------------------------------------------------------------|
| Refractive Index | 1.414 | 1.424 | 1.423 |
| Water Content | <1% | <1% | <1% |
| Specific Gravity | 1.266 | 1.19 | 1.24 |
| Wetting Angle | 49° | 38° | 30° |
| Oxygen Permeability<br>(Dk) ISO/FATT Method<br>(cm2/sec) (ml O2/ml x mm Hg @ 35°C) | $100 \times 10^{-11}$ | $141 \times 10^{-11}$ (edge corrected)<br>$161 \times 10^{-11}$ (non-edge<br>corrected) | $85 \times 10^{-11}$ |
| Contain one or more of the following color<br>additives conforming to:<br>21 CFR Part 73 & 74, Subpart D | D&C Green No. 6, C.I. Solvent<br>Yellow No. 18, and D&C Violet<br>No. 2 | D&C Green No. 6, C.I. Solvent<br>Yellow No. 18, and D&C Violet<br>No. 2 | D & C Green No. 6, FD & C Red<br>No. 17,<br>CI Solvent Yellow 18 |

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The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are available in the following lens parameters:

| Parameter | Range | Tolerance |
|-------------------|------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| Base Curve | 4.00mm to 9.00mm | ± 0.05 mm |
| Center Thickness | 0.20mm to 0.50mm | ± 0.02 mm |
| Diameter | 7.00mm to 21.00mm | ± 0.10mm |
| Spherical Power | -20.00 D to +20.00 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) |
| Cylindrical Power | Up to -9.00 D<br>(in 0.25 D steps) | ± 0.25 (0 to = 2D)<br ± 0.37 (2 to = 4D)<br ± 0.50 (over 4D) |
| Cylindrical Axis | 1° to 180° (in 1º steps) | ± 5° |
| Multifocal Power | +1.00 D to 3.75 D<br>(in 0.25 D steps) | ± 0.25D |

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K 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 0.30mm (low minus lens)<br>0.20mm to 0.70mm (plus lens) | ± 0.02 mm |
| Diameter | 6.50mm to 11.50mm | ± 0.10mm |
| 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 |
| Spherical Power | -10.00 D to +30.00 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) |
| Aspheric Lens Eccentricity | -1.5 to 1.5 (oblate, prolate, or<br>tangent conic) | |

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#### V. INDICATIONS FOR USE

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear are indicated for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic and not aphakic persons with non-diseased eyes. Also, the lenses may be prescribed in otherwise non-diseased eyes that require a gas permeable 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 lenses may be disinfected using a chemical disinfection system only.

The eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K is 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. The lens may be disinfected using a chemical disinfection system only.

Note: To maintain the orthokeratology effect of myopia reduction, lens wear must be continued on a prescribed wearing schedule.

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

The following matrix illustrates the production method, intended use and materials of the eLens (hexafocon A. hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K, as well as the predicate device.

| | eLens RGP<br>Contact Lenses | Boston XO RGP<br>Contact Lens | Boston XO2 RGP<br>Contact Lens | Boston Equalens II<br>RGP Contact Lens |
|----------------------|-----------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|---------------------------------------------------------------------------|
| | Subject Device | Predicate Device<br>(K001960) | Predicate Device<br>(K071266) | Predicate Device<br>(K003933) |
| Classification | Same as predicate | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>21 CFR 886.5916 | Class II<br>Lenses, Rigid Gas Permeable,<br>Daily Wear<br>21 CFR 886.5916 |
| Product Code | Same as predicate | HQD; MUW | HQD; MUW | HQD; MUW |
| FDA Group # | Same as predicate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate | Group # 3 Fluoro<br>Silicone Acrylate |
| USAN | Same as predicate | hexafocon A | hexafocon B | oprifocon A |
| Production<br>Method | Same as predicate | Lathe-Cut | Lathe-Cut | Lathe-Cut |

# Substantial Equivalence Matrix

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| Actions | Same as predicate | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina. (orthokeratology) | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina. (orthokeratology) | The contact lenses act as a<br>refractive medium that<br>focus light rays from near<br>and distant objects on the<br>retina. (orthokeratology) |
|--------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Same as predicate | Daily Wear | Daily Wear | Daily Wear |
| Indication for Use | Same as predicate | Indicated for the correction of<br>refractive ametropia (myopia,<br>hyperopia, astigmatism and<br>presbyopia) in aphakic and not<br>aphakic persons with non-<br>diseased eyes. Also, the lenses<br>may be prescribed in otherwise<br>non-diseased eyes that require<br>a gas permeable contact lens<br>for the management of<br>irregular corneal conditions<br>such as keratoconus, pellucid<br>marginal degeneration, or<br>following penetrating<br>keratoplasty or refractive (e.g.,<br>LASIK) surgery. Also,<br>indicated for daily wear in an<br>orthokeratology fitting<br>program for the temporary<br>reduction of myopia of up to<br>5.00 diopters in non-diseased<br>eyes. | Indicated for the correction of<br>refractive ametropia (myopia,<br>hyperopia, astigmatism and<br>presbyopia) in aphakic and<br>not aphakic persons with non-<br>diseased eyes. Also, the<br>lenses may be prescribed in<br>otherwise non-diseased eyes<br>that require a gas permeable<br>contact lens for the<br>management of irregular<br>corneal conditions such as<br>keratoconus, pellucid<br>marginal degeneration, or<br>following penetrating<br>keratoplasty or refractive<br>(e.g., LASIK) surgery. Also.<br>indicated for daily wear in an<br>orthokeratology fitting<br>program for the temporary<br>reduction of myopia of up to<br>5.00 diopters in non-diseased<br>eyes. | Indicated for the correction of<br>refractive ametropia (myopia,<br>hyperopia, astigmatism and<br>presbyopia) in aphakic and<br>not aphakic persons with non-<br>diseased eyes. Also, the<br>lenses may be prescribed in<br>otherwise non-diseased eyes<br>that require a gas permeable<br>contact lens for the<br>management of irregular<br>corneal conditions such as<br>keratoconus, pellucid<br>marginal degeneration, or<br>following penetrating<br>keratoplasty or refractive<br>(e.g., LASIK) surgery. Also,<br>indicated for daily wear in an<br>orthokeratology fitting<br>program for the temporary<br>reduction of myopia of up to<br>5.00 diopters in non-diseased<br>eyes. |

#### VII. PERFORMANCE DATA

## ~ Non-Clinical Studies ~

The non-clinical performance data to establish the safety and effectiveness of contact lenses manufactured from hexafocon A, hexafocon B, and oprifocon A 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 hexafocon A. hexafocon B. and oprifocon A has been addressed in previous applications.

# VIII. CONCLUSIONS

### Substantial Equivalence

Information presented in this Premarket Notification establishes that eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear and eLens (hexafocon A, hexafocon B and oprifocon A) Rigid Gas Permeable Contact Lenses for Daily Wear Ortho-K are as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

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# 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.