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.

AI/ML Overview

This document describes a 510(k) premarket notification for the IntelliWave3 Silicone Hydrogel Daily Wear Soft Contact Lens. It does not present acceptance criteria or a study proving that the device meets them in the traditional sense of a performance study with defined metrics and a test set.

Instead, the submission aims to demonstrate substantial equivalence to a previously cleared predicate device (also named IntelliWave3, K100221) by showing that it has:

Similar technological characteristics.
Similar indications for use.
No new questions of safety or effectiveness.

Therefore, many of the requested items in your prompt are not applicable to this type of submission. Below is a breakdown based on the provided text, indicating where information is present or absent:

Acceptance Criteria and Device Performance

The concept of "acceptance criteria" in this document is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance metrics against a predefined threshold. The "reported device performance" refers to its measured physical properties and the results of non-clinical bench testing and biocompatibility studies, which are compared against those of the predicate device.

Table of Acceptance Criteria and Reported Device Performance

Parameter	Acceptance Criteria (Implied: Substantial Equivalence to Predicate)	Reported Subject Device Performance (IntelliWave3, K230824)	Reported Predicate Device Performance (IntelliWave3, K100221)
Physical/Material Properties
Refractive Index (wet)	Similar to Predicate	1.3770	1.3762
Visible light transmission (%) @ 380-780nm	Similar to Predicate	94.4%	97.4%
Specific Gravity (wet)	Similar to Predicate	1.049	1.048
Water Content	74 ± 2%	74 ± 2%	74 ± 2%
Oxygen Permeability (Dk) ISO/FATT Method	Similar to Predicate	$56.0 \times 10^{-11} (\text{cm}^2/\text{sec}) (\text{ml O}_2/\text{ml} \times \text{mm Hg @ 35°C)}$	$59.8 \times 10^{-11} (\text{cm}^2/\text{sec}) (\text{ml O}_2/\text{ml} \times \text{mm Hg @ 35°C)}$
Manufacturing Tolerances (Subject Device)
Base Curve	N/A (Internal spec)	Range: 7.4mm to 9.5mm, Tolerance: ± 0.20mm	N/A (Internal spec)
Center Thickness	N/A (Internal spec)	Range: 0.01mm to 0.60mm, Tolerance: ≤ 0.10 mm → ±0.010 mm + 10%; > 0.10 mm → ±0.015 mm + 5%	N/A (Internal spec)
Diameter	N/A (Internal spec)	Range: 12.00mm to 16.00mm, Tolerance: ± 0.20mm	N/A (Internal spec)
Spherical Power	N/A (Internal spec)	Range: -23.50 D to +23.50 D, Tolerance: 0.00 < F'v ≤ 10.00 D → ±0.25 D; 10.00 < F'v ≤ 20.00 D → ±0.50 D	N/A (Internal spec)
Cylindrical Power (Toric)	N/A (Internal spec)	Range: -0.25 D to -12.00 D, Tolerance: 0.00 < F'v ≤ 2.00 D → ±0.25 D; 2.00 < F'v ≤ 4.00 D → ±0.37 D; F'v > 4.00 D → ±1.00 D	N/A (Internal spec)
Cylindrical Power (Multifocal Toric)	N/A (Internal spec)	Range: -0.25 D to -4.00 D, Tolerance: 0.00 < F'v ≤ 2.00 D → ±0.25 D; 2.00 < F'v ≤ 4.00 D → ±0.37 D; F'v > 4.00 D → ±1.00 D	N/A (Internal spec)
Cylindrical Axis	N/A (Internal spec)	Range: 1° to 180° (in 1° steps), Tolerance: ± 5°	N/A (Internal spec)
Add Power (Multifocal)	N/A (Internal spec)	Range: +0.50 D to +4.00 D, Tolerance: ± 0.25D	N/A (Internal spec)
Biocompatibility	Non-cytotoxic, Not acutely systemically toxic, No ocular irritation, No skin sensitization	Passed (In-Vitro Cytotoxicity, Systemic Toxicity, Acute Ocular Irritation, Skin Sensitization, 22-Day Ocular Irritation)	(Previously addressed under predicate K100221)
Preservative Uptake and Release	Sub-detection limit amounts of release	Demonstrated sub-detection limit amounts of release at each time point evaluated.	Not explicitly detailed for predicate, but assumed to be similar due to material equivalence.
Solution Compatibility	Physically compatible with commonly available cleaning and disinfection solutions	Confirmed physical compatibility with peroxide and MPDS systems.	Not explicitly detailed for predicate, but assumed to be similar due to material equivalence.
Bench Testing - Manufacturing Verification	(Implied: Lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance)	All lenses manufactured to established finished product specifications within the ANSI Z80.20 tolerance.	Not explicitly detailed for predicate, but assumed to be similar.

Detailed breakdown of your requested information:

A table of acceptance criteria and the reported device performance:
- See table above. The "acceptance criteria" are implied by demonstrating substantial equivalence, meaning the new device performs similarly to or better than the predicate, and meets relevant safety standards. For internal manufacturing parameters, specific tolerances are listed.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This submission does not involve a clinical test set or patient data in the way a diagnostic AI device might. The "testing" refers primarily to non-clinical bench testing of the physical contact lenses and material properties. The sample sizes for these tests (e.g., number of lenses tested for Dk, water content, tensile strength, or in toxicology studies) are not specified in this summary.
- The provenance (country of origin, retrospective/prospective) is not applicable as there are no clinical studies on human subjects described in this 510(k) summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This submission is for a medical device (contact lens), not an AI/ML diagnostic or image analysis device that would require expert-established ground truth on a test set. The ground truth for performance is established through standardized physical, chemical, and biological testing methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no clinical test set requiring adjudication in this submission.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a contact lens and does not involve AI assistance or human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical contact lens; there is no algorithm involved.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For the physical and chemical properties, the "ground truth" is based on measurements obtained using standardized laboratory methods (e.g., ISO standards for Dk, preservative uptake/release).
- For biocompatibility, the "ground truth" is established by results from validated biological tests (e.g., ISO 10993 series for cytotoxicity, systemic toxicity, irritation, sensitization).
- There is no "expert consensus" or "pathology" in the context of clinical disease for this submission, as clinical studies were deemed unnecessary.
The sample size for the training set:
- Not applicable. This submission does not involve machine learning or a "training set."
How the ground truth for the training set was established:
- Not applicable. There is no "training set" in this submission.

Summary

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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

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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

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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)

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.

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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.
Address	3175 3 Mile Rd NWGrand Rapids, MI 49534
Contact Person:	Jill AnastorPresident
Phone number:	(630) 530-9700
Consultant/Correspondent:	EyeReg Consulting, Inc.Bret Andre6119 Canter LaneWest Linn, OR 97068
Phone number	(503) 372-5226
II. DEVICE

Trade Name:	IntelliWave³, Silicone Hydrogel Daily Wear Soft ContactLens (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

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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

	IntelliWave³, Silicone Hydrogel Daily Wear SoftContact 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 .:

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Parameter	Range	Tolerance
Base Curve	7.4mm to 9.5mm	± 0.20mm
Center Thickness	0.01mm to 0.60mm	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Diameter	12.00mm to 16.00mm	± 0.20mm
Spherical Power	-23.50 D to +23.50 D(in .25D steps)	When 0.00 $< F'v $ ≤ 10.00 D → ±0.25 DWhen 10.00 $< F'v $ ≤ 20.00 D → ±0.50 D
Cylindrical Power (Toric)	-0.25 D to -12.00 D	When 0.00 $< < F'v $ ≤ 2.00 D → ±0.25 DWhen 2.00 $< < F'v $ ≤ 4.00 D → ±0.37 DWhen $< F'v $ > 4.00 D → ±1.00 D
Cylindrical Power (Multifocal Toric)	-0.25 D to -4.00 D	When 0.00 $< < F'v $ ≤ 2.00 D → ±0.25 DWhen 2.00 $< < F'v $ ≤ 4.00 D → ±0.37 DWhen $< F'v $ > 4.00 D → ±1.00 D
Cylindrical Axis	1° 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 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.

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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 WearSoft Contact Lenses	IntelliWave3 Silicone Hydrogel Daily Wear SoftContact Lenses
	Subject Device	Predicate Device
510(k) Number		K100221
Intended Use	Daily Wear	Daily Wear
Device andClassification	Class IISoft (hydrophilic) contact lens. (21 CFR886.5925)	Class IISoft (hydrophilic) contact lens. (21 CFR886.5925)
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

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	Indications for Use
IntelliWave3, SiliconeHydrogel Daily WearSoft Contact Lenses(Subject Device)	The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for thecorrection of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lensmay be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does notinterfere with visual acuity.
	The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for thecorrection of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/orpossesses refractive astigmatism not exceeding 12 diopters.
	The IntelliWave3 multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated forthe correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyesand/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 indicatedfor the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyesand/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 areindicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may beprescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular cornealconditions such as keratoconus and post graft fitting.
	Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection andscheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned anddisinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
IntelliWave3 SiliconeHydrogel Daily WearSoft Contact Lenses(Predicate Device:K100221)	The IntelliWave3 sphere (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for thecorrection of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes. The lensmay be worn by persons who exhibit refractive astigmatism of .75 diopters or less where the astigmatism does notinterfere with visual acuity.
	The IntelliWave3 toric (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated for thecorrection of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/orpossesses refractive astigmatism not exceeding 12 diopters.
	The IntelliWave3 multifocal (efrofilcon A) Silicone Hydrogel Soft Contact Lenses for daily wear are indicated forthe correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyesand/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 indicatedfor the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyesand/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 areindicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons and may beprescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular cornealconditions such as keratoconus and post graft fitting.
	Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection andscheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleaned anddisinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

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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

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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.

Regulation Number and Section

§ 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.