The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes and or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) 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 Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Device Description

The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) 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 become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (efrofilcon A) is a 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 and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethy]) phenylamino]-9, 10-Anthraquinone) as an integrated handling tint. The lenses are made by lathe-cut for individual patients. 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

This document is a 510(k) Pre-market Notification for a contact lens, specifically the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A). It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of the device's performance against specific clinical acceptance criteria.

Based on the provided text, a conventional acceptance criteria table and performance study of an AI/algorithm-driven device meeting those criteria cannot be constructed because:

The device is a physical product (contact lens), not an AI/algorithm system.
The document describes a "Special 510(k) Summary," which typically relies on demonstrating equivalence to legally marketed predicate devices rather than proving performance against novel clinical acceptance criteria through new clinical trials.
The document explicitly states "Clinical testing was not necessary for this application."

However, I can extract the bench test performance data and compare it to reported values of the predicate devices, which serves as a form of "acceptance criteria" for demonstrating substantial equivalence for a physical product by showing similar physical and chemical properties.

Here's the information structured to best fit your request, interpreting "acceptance criteria" as the properties of the predicate devices that the new device aims to match or be comparable to:

1. Table of Acceptance Criteria and Reported Device Performance

For a physical device like a contact lens, "acceptance criteria" in this context refer to physicochemical properties that demonstrate the new device is comparable to legally marketed predicate devices. The "reported device performance" refers to the measurements taken on the Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A).

Parameter	Acceptance Criteria (Predicate Device K100443)	Acceptance Criteria (Predicate Device K230824)	Reported Device Performance (Flexlens Silicone Hydrogel)
Refractive Index (wet)	1.38	1.3770	1.3770
Visible light transmission (%) @ 380-780nm	>97%	94.4%	94.4%
Specific Gravity (wet)	1.048	1.049	1.049
Water Content	74±2%	74±2%	74±2%
Oxygen Permeability (Dk) ISO/FATT Method	59.8 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)	56.0 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)	56.0 x 10⁻¹¹ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)

Note: The document states that the Flexlens Silicone Hydrogel device is "substantially equivalent" to both predicate devices. The table above shows that its properties align perfectly with one (K230824) and are very close to the other (K100443). The small differences (e.g., Dk value relative to K100443, Visible light transmission relative to K100443) were deemed non-relevant for substantial equivalence by the manufacturer.

2. Sample size used for the test set and the data provenance

Test Set Description: Non-clinical (bench) testing was conducted.
Sample Size: The document does not specify exact sample sizes for each non-clinical test (e.g., number of lenses tested for Dk, water content, etc.). It refers to "Bench Testing-manufacturing verification testing" to demonstrate ability to manufacture lenses "on a repeatable basis" to established specifications, and "Performance Testing" for various physicochemical properties.
Data Provenance: The data is from non-clinical (bench) tests performed by the manufacturer (X-CEL SPECIALTY CONTACTS) or a lens material manufacturer for testing of efrofilcon A contact lens blanks. The location is implied to be within the United States, given the FDA submission context. The data is retrospective in the sense that it represents lab measurements, not a prospective clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This question is not applicable. The "ground truth" for a physical device's characteristics (like refractive index, water content, Dk) is established through standardized laboratory measurement methods (e.g., ISO standards), not by expert consensus or interpretation of images.

4. Adjudication method for the test set

This question is not applicable. Adjudication methods are typically used in clinical studies or for interpreting subjective data (like image readings), which was not conducted or required for this device's submission. The "adjudication" for bench tests would be the adherence to validated testing methodologies and equipment calibration.

5. 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

This question is not applicable. This is not an AI/algorithm device, and no MRMC study was performed as clinical testing was not necessary.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This question is not applicable. This is not an AI/algorithm device.

7. The type of ground truth used

The "ground truth" for the non-clinical tests (physicochemical properties like Dk, water content, refractive index, etc.) are the measurements obtained using standardized laboratory testing methods (e.g., ISO standards for Dk, preservative uptake/release). For biocompatibility, the ground truth is established by adherence to GLP regulations and ISO 10993 standards, with results like "not cytotoxic," "no evidence of systemic toxicity," "no ocular irritation," and "did not produce skin sensitization."

8. The sample size for the training set

This question is not applicable. This is not an AI/algorithm device that requires a training set. The device manufacturing processes are based on established engineering principles and material science.

9. How the ground truth for the training set was established

This question is not applicable. There is no "training set" for this physical device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.

August 14, 2024

X-Cel Specialty Contacts, A Walman Optical Company Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K242059

Trade/Device Name: Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL Dated: March 28, 2024 Received: July 15, 2024

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 (the 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 available 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

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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,

J Angelo Green -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K242059

Device Name

Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)

Indications for Use (Describe)

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

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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SPECIAL 510 (k) SUMMARY

This special 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:	K242059
I.	SUBMITTER
Date Prepared:	June 20, 2024
Name:	X-CEL SPECIALTY CONTACTS, A WalmanOptical Company
Address:	2775 Premiere Pkwy Ste 600DULUTH, GA 30097United States
Contact Person:	Hue TangDirector of Quality Assurance
Phone number:	(770) 709-3324
Consultant/
Correspondent:	ANDRE VISION AND DEVICE RESEARCHBret Andre6119 Canter LaneWEST LINN, OR 97068United States
Phone number	(503) 372-5226
II.	DEVICE
Trade Name:	Flexlens Silicone Hydrogel Daily Wear Soft(Hydrophilic) 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

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III. PREDICATE DEVICE

The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is substantially equivalent to the following predicate devices:

"Definitive, Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" Manufactured by X-CEL SPECIALTY CONTACTS 510(k) Number: K100443
"IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" ● Manufactured by Art Optical Contact Lens, Inc. 510(k) number: K230824

DEVICE DESCRIPTION IV.

	Flexlens 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	$56 \times 10^{-11} \frac{cm^2}{sec} \frac{ml O_2}{ml \times mm Hg} @ 35°C$

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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, multifocal toric and irregular cornea configurations with the following features and properties.:

Parameter	Range	Tolerance
Base Curve	8.0mm to 9.5mm	$\pm$ 0.20mm
Center Thickness	0.01mm to 0.50mm	When $\leq$ 0.10 mm $\rightarrow$ $\pm$ 0.010 mm + 10%When > 0.10 mm $\rightarrow$ $\pm$ 0.015 mm + 5%
Diameter	12.00mm to 16.00mm	$\pm$ 0.20mm
Spherical Power	-20.00 D to +20.00 D(in .25D steps)	When 0.00 < F'L $\leq$ 10.00 D $\rightarrow$ $\pm$ 0.25 DWhen 10.00 < F'L $\leq$ 20.00 D $\rightarrow$ $\pm$ 0.50 D
Cylindrical Power (Toric)	-0.25 D to -12.00 D	When 0.00 < F'L $\leq$ 2.00 D $\rightarrow$ $\pm$ 0.25 DWhen 2.00 < F'L $\leq$ 4.00 D $\rightarrow$ $\pm$ 0.37 DWhen F'L > 4.00 D $\rightarrow$ $\pm$ 1.00 D
Cylindrical Power (Multifocal Toric)	-0.25 D to -4.00 D	When 0.00 < F'L $\leq$ 2.00 D $\rightarrow$ $\pm$ 0.25 DWhen 2.00 < F'L $\leq$ 4.00 D $\rightarrow$ $\pm$ 0.37 D
Cylindrical Axis	1° to 180° (in 1° steps)	$\pm$ 5°
Add Power (Multifocal)	+0.50 D to +4.00 D	$\pm$ 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 Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 12 diopters.

The Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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 Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) 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.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) is substantially equivalent to the Definitive. Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (predicate device - K100443) 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 ●

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The following table depicts the classification and technical characteristics of the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) in comparison with the predicate devices.

Flexlens Silicone HydrogelDaily Wear Soft ContactLens	Flexlens Silicone HydrogelDaily Wear Soft ContactLens	IntelliWave³ SiliconeHydrogel Daily Wear SoftContact Lenses
	Subject Device	Predicate Device	Predicate Device
510(k) Number		K100443	K230824
Intended Use	Daily Wear	Daily Wear	Daily Wear
Device andClassification	Class IISoft (hydrophilic) contactlens. (21 CFR 886.5925)	Class IISoft (hydrophilic) contactlens. (21 CFR 886.5925)	Class IISoft (hydrophilic) contactlens. (21 CFR 886.5925)
Product Code	LPL	LPL	LPL
Production Method	Lathe-cut	Lathe-cut	Lathe-cut
Material (USAN)	Efrofilcon A	Efrofilcon A	Efrofilcon A
FDA Group #	Group # V Silicone Hydrogel	Group # V Silicone Hydrogel	Group # V Silicone Hydrogel
Refractive Index (wet)	1.3770	1.38	1.3770
Visible light transmission(%) @ 380-780nm	94.4%	>97%	94.4%
Specific Gravity (wet)	1.049	1.048	1.049
Water Content	74±2%	74±2%	74±2%
Oxygen Permeability(Dk) ISO/FATT Method	$56.0 x 10^{-11}$ (cm²/sec) (ml O₂/ml xmm Hg @ 35 °C)	$59.8 x 10^{-11}$ (cm²/sec) (ml O₂/ml xmm Hg @ 35°C)	$56.0 x 10^{-11}$ (cm²/sec) (ml O₂/ml xmm Hg @ 35°C)

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	Indications for Use
Flexlens SiliconeHydrogel Daily WearSoft Contact Lens(Subject Device)	The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear areindicated 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 0.75 diopters or lesswhere the astigmatism does not interfere with visual acuity.The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear areindicated 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 Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear areindicated 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 0.75 diopters and are presbyopic requiringadd power of up to ±4.00 diopters.The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wearare indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons withnon-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiringadd power of up to +4.00 diopters.The Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for dailywear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic personsand may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management ofirregular 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 maybe cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfectionsystems.
Flexlens SiliconeHydrogel Daily WearSoft Contact Lens(Predicate Device:K100443)	Same as the subject device
IntelliWave³ SiliconeHydrogel Daily WearSoft Contact Lenses(Predicate Device:K230824)	The IntelliWave3 sphere (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 eyes.The lens may be worn by persons who exhibit refractive astigmatism of .75 diopters or less where theastigmatism does not interfere 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 eyesand/or possesses refractive astigmatism not exceeding 12 diopters.The IntelliWave3 multifocal (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-diseasedeyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopic requiring add powerof up to +4.00 diopters.The IntelliWave3 multifocal-toric (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 with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring addpower 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 maybe prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregularcorneal conditions such as keratoconus and post graft fitting.Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfectionand scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be cleanedand disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

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VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

The following non-clinical testing was performed on Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A):

Bench Testing-manufacturing verification testing was conducted to demonstrate our firm's ability to manufacture the finished 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.

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. The extracts from finished lenses produced no evidence of systemic toxicity.
. Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23. The extracts from finished lenses produced no evidence of ocular irritation.

The following non-clinical testing was performed previously or by the lens material manufacturer for finished contact lenses manufactured from efrofilcon A contact lens blanks:

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

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.

The biocompatibility of the primary packaging and packaging solution have been previously addressed by reference to 510(k) K100443 and there are no changes to these components as compared to the predicate.

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

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properties between the efrofilcon A, Silicone Hydrogel Daily Wear Soft Contact Lenses and the predicate device.

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.

Shelf Life-Testing was performed to evaluate the stability, sterility, and package integrity of the lenses over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

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

~ Conclusions Drawn from Testing ~

Results from testing presented in this premarket notification for the Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) demonstrate no relevant differences from the predicate devices and support the substantial equivalence claim.

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VIII. CONCLUSIONS

Substantial Equivalence

Information presented in this premarket notification establishes that Flexlens Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) 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.