The Metro Soft, 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

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

The Metro Soft, 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 Metro Soft, irregular cornea (efrofileon 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 wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.

Device Description

The Metro Soft, 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 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-Methacryloxyethyl) 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 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, multifocal toric and irregular cornea configurations.

The lens is supplied sterile in vials containing a buffered saline solution.

AI/ML Overview

Here's an analysis of the acceptance criteria and supporting studies for the Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A), based on the provided text:

Important Note: The provided document is a 510(k) summary for a contact lens. For medical devices like this, the "acceptance criteria" generally refer to established standards and benchmarks for safety and performance (e.g., ISO standards, physical property ranges), and the "study that proves the device meets the acceptance criteria" refers to the non-clinical and, if applicable, clinical testing performed to demonstrate compliance and substantial equivalence to a predicate device. This is different from the type of "acceptance criteria" and "study" typically associated with AI/ML-based diagnostic devices, which would involve metrics like sensitivity, specificity, AUC, and performance against a ground truth dataset.

Since this is a contact lens and not an AI/ML device, many of the requested fields regarding AI/ML-specific study design (test set sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set) are not applicable to this submission.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Metro Soft contact lens are primarily defined by:

Compliance with established ISO standards for biocompatibility and material properties.
Meeting specified physical and optical parameter ranges with defined tolerances.
Demonstrating similar performance characteristics (material properties, shelf life, solution compatibility) to the predicate devices.
Having an equivalent Indications for Use statement to the predicate devices.

Acceptance Criteria (General Category/Standard)	Specific Acceptance Criteria (Example)	Reported Device Performance (Metro Soft)
Material Properties:
Refractive Index (wet)	Not explicitly stated as an "acceptance criterion" value, but compared to predicate.	1.3770
Visible Light Transmission (%).	Not explicitly stated as an "acceptance criterion" value, but compared to predicate.	94.4%
Specific Gravity (wet)	Not explicitly stated as an "acceptance criterion" value, but compared to predicate.	1.049
Water Content	74 ± 2%	74 ± 2% (Meets criterion)
Oxygen Permeability (Dk)	Not explicitly stated as an "acceptance criterion" value, but compared to predicate.	56 x 10-11 (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)
Device Parameters (with Tolerances):
Base Curve	Range: 8.0mm to 9.5mm; Tolerance: ± 0.20mm	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance. (Implies all these parameters meet their respective tolerances.)
Center Thickness	Range: 0.01mm to 0.50mm; Tolerance: ≤ 0.10 mm → ±0.010 mm + 10%; > 0.10 mm → ±0.015 mm + 5%	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Diameter	Range: 12.00mm to 16.00mm; Tolerance: ± 0.20mm	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Spherical Power	Range: -20.00 D to +20.00 D; Tolerance: 0.00 < F'v ≤ 10.00 D → ±0.25 D; 10.00 < F'v ≤ 20.00 D → ±0.50 D	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Cylindrical Power (Toric)	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	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Cylindrical Power (Multifocal Toric)	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	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Cylindrical Axis	Range: 1º to 180º; Tolerance: ± 5º	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Add Power (Multifocal)	Range: +0.50 D to +4.00 D; Tolerance: ± 0.25D	All lenses manufactured to established finished product specifications within ANSI Z80.20 tolerance.
Biocompatibility:
In-Vitro Cytotoxicity	Not cytotoxic (ISO 10993-5)	Results indicate finished lenses are not cytotoxic. (Meets criterion).
Systemic Toxicity	Not acutely systemically toxic (ISO 10993-11)	Finished lenses meet requirements of systemic injection test and are considered not acutely systemically toxic. (Meets criterion).
Acute Ocular Irritation	No ocular irritation (ISO 10993-10)	Extracts from finished lenses produced no ocular irritation. (Meets criterion).
Skin Sensitization	No skin sensitization (ISO 10993-10)	Contact lens extracts did not produce skin sensitization. (Meets criterion).
22-Day Ocular Irritation	No ocular irritation (ISO 9394)	Finished contact lenses produced no ocular irritation. (Meets criterion).
Shelf Life & Stability:	Demonstrate stability, sterility, and package integrity over labeled expiration date.	Data presented supports establishment of the proposed shelf life. (Meets criterion).
Preservative Uptake & Release:	Demonstrate sub-detection limit amounts of release at each time point evaluated (ISO 11986:2017).	Preservative 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. (Meets criterion).
Solution Compatibility:	Demonstrate physical compatibility with commonly available cleaning and disinfection solutions (ISO 11981:2017).	Physical compatibility with peroxide and MPDS solutions was confirmed. (Meets criterion).
Manufacturing Verification:	Ability to manufacture finished lenses to a variety of prescribed parameters, repeatably, and within ANSI Z80.20 tolerance.	Bench testing demonstrated the firm's ability to manufacture finished lenses on a repeatable basis to established finished product specifications within the ANSI Z80.20 tolerance. (Meets criterion).
Indications for Use (Equivalence):	Indications for Use for subject device should be substantially equivalent to predicate device(s).	The Indications for Use for the Metro Soft (Subject Device) are identical to the Metro Soft (Predicate Device: K100244) across all lens types (sphere, toric, multifocal, multifocal toric, irregular cornea). They are also almost identical to the IntelliWave³ (Predicate Device: K230824), with only minor wording variations (e.g., "IntelliWave3 sphere" vs. "Metro Soft, sphere"). This demonstrates substantial equivalence in intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of an AI/ML algorithm. For physical testing (e.g., tensile strength, Dk, water content, biocompatibility), samples are drawn from production batches according to statistical sampling plans relevant to the specific test method and ISO standards. For manufacturing verification, typically multiple lenses are measured.
Data Provenance: Not specified, but the context implies laboratory testing and manufacturing data. It is not patient data from a specific country.
Retrospective or Prospective: The testing described (bench testing, shelf life, toxicology, performance testing) is prospective testing conducted specifically for this submission.

3. 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 is not an AI/ML diagnostic device requiring expert interpretation for ground truth. Biocompatibility results are interpreted by toxicologists/biologists according to standard protocols. Physical property measurements are based on objective metrics.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No human adjudication method, as would be used for clinical interpretations, is described or required for this type of device submission. Results from bench tests and biocompatibility are objective measurements or interpretations of standard biological responses.

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

Not Applicable. This is a physical contact lens, not an AI-assisted diagnostic device. No human reader studies (MRMC or otherwise) are referenced in the provided text.

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

Not Applicable. This is not an algorithm or software. It is a physical medical device (contact lens).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Ground Truth for Physical Properties: Established by validated laboratory measurement techniques and instrumentation (e.g., refractometers for refractive index, Dk sensors for oxygen permeability, calipers for dimensions, tensile testers for mechanical properties) against recognized scientific principles and standards (e.g., ISO, ANSI Z80.20).
Ground Truth for Biocompatibility: Established by adherence to international standards (ISO 10993 series) and observation of biological responses in in vitro (cell culture) and in vivo (animal) models, interpreted by qualified personnel (e.g., toxicologists).
Ground Truth for Clinical Performance: Clinical studies were explicitly stated as "not necessary for this application," implying that equivalence to the predicate (which has a known safety and effectiveness profile) based on material and physical characteristics was deemed sufficient.

8. The sample size for the training set

Not Applicable. No "training set" in the context of AI/ML is relevant for this device. The phrase "training set" usually refers to data used to train an AI model.

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

Not Applicable. No "training set" or corresponding ground truth establishment method for AI/ML is relevant for this device.

Summary

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February 6, 2024

Metro Optics of Austin, Inc. % Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K233221

Trade/Device Name: Metro Soft, 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: January 10, 2024 Received: January 11, 2024

Dear Bret Andre:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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.

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).

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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 (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/postmarketingsafety-reporting-combination-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-devicereporting-mdr-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,

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

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Indications for Use

510(k) Number (if known) K233221

Device Name

Metro Soft, 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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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:		K233221
I.	SUBMITTER
	Date Prepared:	January 5th, 2024
	Name:Address	Metro Optics of Austin, Inc.15802 Vision DrivePflugerville, TX 78660
	Contact Person:	Steve WebbPresident
	Phone number:	(512) 251-2382
	Consultant/Correspondent:	Andre Vision and Device ResearchBret Andre6119 Canter LaneWest Linn, OR 97068
	Phone number	(503) 372-5226
II.	DEVICE
	Trade Name:	Metro Soft, Silicone Hydrogel Daily Wear SoftContact 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:	LPI

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III. PREDICATE DEVICE

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

. "Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" Manufactured by Metro Optics of Austin, Inc. 510(k) Number: K100244
"IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)" Manufactured by Art Optical Contact Lens, Inc. 510(k) number: K230824

DEVICE DESCRIPTION IV.

The physical properties of the Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) are as follows:

	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)	56 x 10-11 (cm2/sec) (ml O2/ml x mm Hg @ 35°C)
ISO/FATT Method

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Parameter	Range	Tolerance
Base Curve	8.0mm to 9.5mm	± 0.20mm
Center Thickness	0.01mm to 0.50mm	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	-20.00 D to +20.00 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 D
Cylindrical Axis	1º to 180º (in 1º steps)	± 5º
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 Metro Soft, 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 0.75 diopters or less where the astigmatism does not interfere with visual acuity.

The Metro Soft, 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 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters.

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The Metro Soft, 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 Metro Soft, 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.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. PREDICATE DEVICE

The Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is substantially equivalent to the Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) (predicate device - K100244) 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 Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) in comparison with the predicate devices.

	Metro Soft, SiliconeHydrogel Daily Wear SoftContact Lens	Metro Soft, SiliconeHydrogel Daily WearSoft Contact Lens	IntelliWave³ SiliconeHydrogel Daily Wear SoftContact Lenses
	Subject Device	Predicate Device	Predicate Device
510(k) Number		K100244	K230824
Intended Use	Daily Wear	Daily Wear	Daily Wear
Device andClassification	Class IISoft (hydrophilic) contactlens. (21 CFR 886.5925)	Class IISoft (hydrophilic)contact lens. (21 CFR886.5925)	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 SiliconeHydrogel	Group # V SiliconeHydrogel	Group # V Silicone Hydrogel
Refractive Index (wet)	1.3770	1.3762	1.3770
Visible lighttransmission (%) @ 380-780nm	94.4%	97.4%	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/mlx mm Hg @ 35°C)	$59.8 x 10^{-11}$ (cm²/sec) (ml O₂/ml x mm Hg @ 35°C)	$56.0 x 10^{-11}$ (cm²/sec) (ml O₂/ml xmm Hg @ 35°C)
Refractive Index (wet)	1.3770	1.3762	1.3770

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	Indications for Use
Metro Soft, SiliconeHydrogel Daily WearSoft Contact Lens(efrofilcon A) (SubjectDevice)	The Metro Soft, 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-diseasedeyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where theastigmatism does not interfere with visual acuity.
	The Metro Soft, 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 Metro Soft, 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 0.75 diopters and are presbyopic requiring addpower of up to +4.00 diopters.
	The Metro Soft, 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 withnon-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopicrequiring add power of up to +4.00 diopters.
	The Metro Soft, 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,disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfectionsystems.
Metro Soft, SiliconeHydrogel Daily WearSoft Contact Lens(efrofilcon A) (PredicateDevice: K100244)	The Metro Soft, 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-diseasedeyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where theastigmatism does not interfere with visual acuity.
	The Metro Soft, 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 Metro Soft, 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 0.75 diopters and are presbyopic requiring addpower of up to +4.00 diopters.
	The Metro Soft, 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 withnon-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopicrequiring add power of up to +4.00 diopters.
	The Metro Soft, 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,disinfection, and scheduled replacement. When prescribed for frequent/planned replacement wear, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfectionsystems.
IntelliWave³ SiliconeHydrogel Daily WearSoft Contact Lenses(Predicate Device:K230824)	The IntelliWave3 sphere (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. 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 forthe correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseasedeyes and/or possesses refractive astigmatism not exceeding 12 diopters.The IntelliWave3 multifocal (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 withnon-diseased eyes and/or possesses refractive astigmatism not exceeding .75 diopters and are presbyopicrequiring add power of 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 withnon-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopicrequiring 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 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,disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lensmay be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfectionsystems.

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VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

The following non-clinical testing was performed on Metro Soft, Silicone Hydrogel Daily Wear Soft 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.

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.

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.

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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.
The following non-clinical testing was performed previously or by the lens material manufacturer for finished contact lenses manufactured from efroficon 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 under the predicate K100244 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 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.

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~ Clinical Studies ~

Clinical testing was not necessary for this application.

~ Conclusions Drawn from Testing ~

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

VIII. CONCLUSIONS

Substantial Equivalence

Information presented in this premarket notification establishes that Metro Soft, 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.