K Number
K230824
Device Name
IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)
Date Cleared
2023-09-06

(166 days)

Product Code
Regulation Number
886.5925
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity. The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The IntelliWave3 multifocal (efrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eves that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. 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 or hydrogen peroxide disinfection systems.
Device Description
The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to became soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
More Information

Not Found

No
The summary describes a contact lens made from a specific material and its intended uses and manufacturing process. There is no mention of any computational or analytical capabilities that would suggest the use of AI or ML.

No.
The device is indicated for the correction of ametropia, which is a refractive error, not a disease or injury that requires therapy. While it provides a functional correction, it does not treat or cure an underlying medical condition.

No

The device is a contact lens intended for the correction of vision (ametropia), not for diagnosing medical conditions. Its function is to modify the optical properties of the eye, not to provide information about the presence or absence of a disease or condition.

No

The device is a physical contact lens made of efrofilcon A, not a software application. The description details the material composition, manufacturing process, and physical properties of the lens.

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The IntelliWave3 contact lenses are medical devices intended for the correction of vision problems (ametropia, astigmatism, presbyopia) by being placed directly on the eye. They do not analyze samples from the body to provide diagnostic information.
  • Intended Use: The intended use clearly states the lenses are for "correction of ametropia" and management of "irregular corneal conditions," which are therapeutic and corrective functions, not diagnostic ones.
  • Device Description: The description focuses on the material properties and physical characteristics of the contact lens itself.
  • Performance Studies: The studies described are bench testing, shelf life, toxicology, preservative uptake/release, and solution compatibility, all related to the safety and performance of the lens as a physical device. There are no studies related to analyzing biological samples for diagnostic purposes.

Therefore, the IntelliWave3 contact lens is a medical device, but it falls under the category of a therapeutic or corrective device, not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The IntelliWave3 multifocal (efrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eves that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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 or hydrogen peroxide disinfection systems.

Product codes (comma separated list FDA assigned to the subject device)

LPL

Device Description

The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to became soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal toric and irregular cornea configurations with the following features and properties .:

The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

eyes

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Eyecare practitioners

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Studies:
Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Performance Testing-The following bench tests were completed: refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity and quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the efrofilcon A. Silicone Hydrogel Daily Wear Soft Contact Lenses and the predicate device.

Shelf Life-Testing was performed to evaluate the stability, sterility, and package integrity of the IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

Toxicology-All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.

  • In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO 10993-5 with results indicating that the finished lenses are not cytotoxic.
  • Systemic Toxicity: The finished lenses meet the requirements of the systemic . injection test in accordance with ISO 10993-11 and are considered not acutely systemically toxic.
  • Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-10, and the extracts from finished lenses produced no ocular irritation.
  • Skin Sensitization Study (Maximization Test): The skin sensitization study was . conducted on the finished lenses in accordance with ISO 10993-10, and the contact lens extracts did not produce skin sensitization.
  • 22-Day Ocular Irritation: The 22-day ocular irritation test was conducted in accordance with ISO 9394 on the finished lenses, and the finished contact lenses produced no ocular irritation.

Preservative Uptake and Release—efrofilcon A. Silicone Hydrogel Daily Wear Soft Contact Lenses were analyzed for uptake and release of preservatives found in lens care products. Testing was conducted according to ISO 11986:2017, Ophthalmic optics -Contact lenses and contact lens care products - Determination of preservative uptake and release. Uptake and release profiles of efrofilcon A contact lenses for the preservatives tested demonstrate sub-detection limit amounts of release at each time point evaluated.

Solution Compatibility-The physical compatibility of efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses with commonly available cleaning and disinfection solutions (peroxide and MPDS) was confirmed following the methodology described in ISO 11981:2017, Ophthalmic optics - Contact lenses and contact lens care products -Determination of physical compatibility of contact lens care products with contact lenses.

Clinical Studies-Clinical testing was not necessary for this application.

Conclusions Drawn from Testing-Results from testing presented in this premarket notification for the IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses demonstrate no relevant differences from the predicate devices and supports the substantial equivalence claim.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K100221

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 886.5925 Soft (hydrophilic) contact lens.

(a)
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.(b)
Classification. (1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
(c)
Date PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the act is required before a device described in paragraph (b)(2) of this section may be commercially distributed. See § 886.3.

0

September 6, 2023

Image /page/0/Picture/1 description: The image contains two logos. The logo on the left is the Department of Health & Human Services-USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.

Art Optical Contact Lens, Inc. % Bret Andre Principal Consultant EyeReg Consulting Inc. 6119 Canter Lane West Linn, Oregon 97068

Re: K230824

Trade/Device Name: IntelliWave3. Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: August 1, 2023 Received: August 2, 2023

Dear Mr. 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.

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

1

801); medical device 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-safety-reportingcombination-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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 (1-800-638-2041 or 301-796-7100).

Sincerely,

Elvin Y. Ng -S

for 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 Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known) K230824

Device Name

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

Indications for Use (Describe)

The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The IntelliWave3 multifocal (efrofilcone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eves that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

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 or hydrogen peroxide disinfection systems.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

3

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4

510 (k) SUMMARY

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

The assigned 510(k) number is:K230824
I. SUBMITTER
Date Prepared:August 31st, 2023
Name:Art Optical Contact Lens, Inc.
Address3175 3 Mile Rd NW
Grand Rapids, MI 49534
Contact Person:Jill Anastor
President
Phone number:(630) 530-9700
Consultant/
Correspondent:EyeReg Consulting, Inc.
Bret Andre
6119 Canter Lane
West Linn, OR 97068
Phone number(503) 372-5226
II. DEVICE

| Trade Name: | IntelliWave³, Silicone Hydrogel Daily Wear Soft Contact
Lens (efrofilcon A) |
|----------------------|--------------------------------------------------------------------------------|
| Common Name: | Soft, daily wear contact lens |
| Classification Name: | Soft (hydrophilic) contact lens.
(21 CFR 886.5925) |
| Regulatory Class: | Class II |
| Product Code: | LPL |

5

III. PREDICATE DEVICE

The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are substantially equivalent to the following predicate device:

  • "IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" Manufactured by Art Optical Contact Lens, Inc. 510(k) number; K100221

IV. DEVICE DESCRIPTION

The IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are fabricated from efrofilcon A, which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to became soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a group 2, daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers. The lenses are made by lathe-cut for custom RX. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN).

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

| | IntelliWave³, Silicone Hydrogel Daily Wear Soft
Contact Lenses |
|------------------------------------------------|-------------------------------------------------------------------|
| Refractive Index (wet) | 1.3770 |
| Visible light transmission (%) @ 380-780nm | 94.4% |
| Specific Gravity (wet) | 1.049 |
| Water Content | 74±2% |
| Oxygen Permeability
(Dk)
ISO/FATT Method | $56 x 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C) |

The physical properties of the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are as follows:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 74% water by weight. The lenses will be manufactured in spherical, aspherical, toric, multifocal toric and irregular cornea configurations with the following features and properties .:

6

ParameterRangeTolerance
Base Curve7.4mm to 9.5mm± 0.20mm
Center Thickness0.01mm to 0.60mmWhen ≤ 0.10 mm → ±0.010 mm + 10%
When > 0.10 mm → ±0.015 mm + 5%
Diameter12.00mm to 16.00mm± 0.20mm
Spherical Power-23.50 D to +23.50 D
(in .25D steps)When 0.00 $ 4.00 D → ±1.00 D
Cylindrical Power (Multifocal Toric)-0.25 D to -4.00 DWhen 0.00 $ 4.00 D → ±1.00 D
Cylindrical Axis1° to 180° (in 1° steps)± 5°
Add Power (Multifocal)+0.50 D to +4.00 D± 0.25D

The lens is supplied sterile in vials containing a buffered saline solution. Vial labeling is printed with appropriate lot numbering, expiration dating and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

V. INDICATIONS FOR USE

The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not interfere with visual acuity.

The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters.

The IntelliWave3 multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and nonaphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting.

7

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 or hydrogen peroxide disinfection systems.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses are substantially equivalent to the IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (predicate device -K100221) in the following areas:

  • USAN Material (efrofilcon A) ●
  • Manufacturing facility, procedures and controls ●
  • Product code (LPL)
  • Classification (Class II) - Soft (hydrophilic) contact lens. (21 CFR 886.5925)
  • FDA material group - group V silicone hydrogel
  • Lathe cut manufacturing process
  • Lens designs (spherical, aspherical, toric, multifocal, multifocal toric and irregular ● cornea)
  • Actions and intended use ●

The following table depicts the classification and technical characteristics of the IntelliWave2 Silicone Hydrogel Daily Wear Soft Contact Lenses in comparison with the predicate devices.

| | IntelliWave3, Silicone Hydrogel Daily Wear
Soft Contact Lenses | IntelliWave3 Silicone Hydrogel Daily Wear Soft
Contact Lenses |
|-----------------------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------|
| | Subject Device | Predicate Device |
| 510(k) Number | | K100221 |
| Intended Use | Daily Wear | Daily Wear |
| Device and
Classification | Class II
Soft (hydrophilic) contact lens. (21 CFR
886.5925) | Class II
Soft (hydrophilic) contact lens. (21 CFR
886.5925) |
| Product Code | LPL | LPL |
| Production Method | Lathe-cut | Lathe-cut |
| Material (USAN) | Efrofilcon A | Efrofilcon A |
| FDA Group # | Group # V Silicone Hydrogel | Group # V Silicone Hydrogel |
| Refractive Index (wet) | 1.3770 | 1.3762 |
| Visible light transmission (%) @
380-780nm | 94.4% | 97.4% |
| Specific Gravity (wet) | 1.049 | 1.048 |
| Water Content | 74±2% | 74±2% |
| Oxygen Permeability
(Dk) ISO/FATT Method | $56.0 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$ | $59.8 x 10^{-11} (cm^2/sec) (ml O_2/ml x mm Hg @ 35°C)$ |
| Refractive Index (wet) | 1.3770 | 1.3762 |

8

Indications for Use
IntelliWave3, Silicone
Hydrogel Daily Wear
Soft Contact Lenses
(Subject Device)The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the
correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens
may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not
interfere with visual acuity.
The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the
correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or
possesses refractive astigmatism not exceeding 12 diopters.
The IntelliWave3 multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for
the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes
and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to
+4.00 diopters.
The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated
for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes
and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to
+4.00 diopters.
The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are
indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be
prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal
conditions such as keratoconus and post graft fitting.
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 or hydrogen peroxide disinfection systems.
IntelliWave3 Silicone
Hydrogel Daily Wear
Soft Contact Lenses
(Predicate Device:
K100221)The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the
correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lens
may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does not
interfere with visual acuity.
The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for the
correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or
possesses refractive astigmatism not exceeding 12 diopters.
The IntelliWave3 multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for
the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes
and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add power of up to
+4.00 diopters.
The IntelliWave3 multifocal-toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated
for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes
and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to
+4.00 diopters.
The IntelliWave3 irregular cornea (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are
indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may be
prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal
conditions such as keratoconus and post graft fitting.
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 or hydrogen peroxide disinfection systems.

9

VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

Following non-clinical testing was performed on IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lenses:

Bench Testing-manufacturing verification testing was conducted to demonstrate the ability of Art Optical Contact Lens, Inc. to manufacture IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses, on a repeatable basis, from supplied lens blanks to a variety of prescribed parameters. All lenses were manufactured to established finished product specifications within the ANSI Z80.20 tolerance.

Performance Testing-The following bench tests were completed: refractive index, water content, Dk, % transmission, tensile strength, modulus, % elongation to break, specific gravity and quantification of polymerization residuals. Results of physicochemical and mechanical property testing demonstrate consistent material properties between the efrofilcon A. Silicone Hydrogel Daily Wear Soft Contact Lenses and the predicate device.

Shelf Life-Testing was performed to evaluate the stability, sterility, and package integrity of the IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

Toxicology-All biocompatibility/toxicology tests were conducted in accordance with the GLP regulation.

  • In-Vitro Cytotoxicity: Cytotoxicity testing was performed in accordance with ISO ● 10993-5 with results indicating that the finished lenses are not cytotoxic.
  • Systemic Toxicity: The finished lenses meet the requirements of the systemic . injection test in accordance with ISO 10993-11 and are considered not acutely systemically toxic.
  • Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance ● with ISO 10993-10, and the extracts from finished lenses produced no ocular irritation.
  • Skin Sensitization Study (Maximization Test): The skin sensitization study was . conducted on the finished lenses in accordance with ISO 10993-10, and the contact lens extracts did not produce skin sensitization.
  • 22-Day Ocular Irritation: The 22-day ocular irritation test was conducted in . accordance with ISO 9394 on the finished lenses, and the finished contact lenses produced no ocular irritation.

Biocompatibility of the primary packaging and packaging solution has been previously addressed under the predicate K100221 and there are no changes to these components as compared to the predicate.

Preservative Uptake and Release—efrofilcon A. Silicone Hydrogel Daily Wear Soft Contact Lenses were analyzed for uptake and release of preservatives found in lens care

10

products. Testing was conducted according to ISO 11986:2017, Ophthalmic optics -Contact lenses and contact lens care products - Determination of preservative uptake and release. Uptake and release profiles of efrofilcon A contact lenses for the preservatives tested demonstrate sub-detection limit amounts of release at each time point evaluated.

Solution Compatibility-The physical compatibility of efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses with commonly available cleaning and disinfection solutions (peroxide and MPDS) was confirmed following the methodology described in ISO 11981:2017, Ophthalmic optics - Contact lenses and contact lens care products -Determination of physical compatibility of contact lens care products with contact lenses.

~ Clinical Studies ~

Clinical testing was not necessary for this application.

~ Conclusions Drawn from Testing ~

Results from testing presented in this premarket notification for the IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses demonstrate no relevant differences from the predicate devices and supports the substantial equivalence claim.

VIII. CONCLUSIONS

Substantial Equivalence

Information presented in this premarket notification establishes that IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lenses for daily wear are as safe and effective as the predicate device 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 soft (hydrophilic) daily wear contact lenses. The benefits to the patient are the same as those for other soft contact lenses.