The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the spherical design is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the toric design is indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal design is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and with add powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the multifocal-toric design is indicated for daily wear for the optic correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes in powers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters and astigmatism corrections from -0.25 to -2.25 diopters.

Eye Care Practitioners may prescribe the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement, or for single-use disposable wear.

When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

Device Description

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is for daily wear and is fully molded in the sphere, toric, multifocal-toric design configurations. The hydrophilic characteristics allow aqueous solutions to enter the lenses are fabricated from senofilcon C, which contains silicone hydrogel material and other hydrophilic monomers. The lens consists of 59.0% senofilcon C and 41.0% water by weight when immersed in saline solution. The senofilcon C name has been adopted by the United States Adopted Names Council (USAN).

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens contains Reactive Blue 246 (21 CFR Part 73.3106) for visibility and handling. The Lucens 41 (senofileon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens incorporates a benzotriazole UV blocking monomer to help protect against transmission of harmful UV radiation. The lens blocks >95% in the UVB range (280nm - 315nm), and >50% in the UVA range (315nm - 380mm).

AI/ML Overview

This looks like a 510(k) summary for a contact lens, not a software device that would typically have the kind of acceptance criteria and study details you're asking about (e.g., AI performance metrics, expert consensus, MRMC studies, ground truth establishment methods for training sets).

The document details the Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens and its substantial equivalence to a predicate device (ACUVUE (senofilcon C) Soft Contact Lens).

Therefore, answering your request using this document for the specified criteria (e.g., "effect size of how much human readers improve with AI vs without AI assistance") is not possible because this is not an AI/software device.

However, I can extract the closest analogous information from this document regarding its "acceptance criteria" through performance testing and the "study" (non-clinical performance testing and substantial equivalence argument) used to prove it meets them.

Here's a breakdown of the available information, addressing what can be, and explaining why other points cannot be, derived from this specific document:

Acceptance Criteria and Device Performance (Analogous for a Contact Lens)

For a contact lens, "acceptance criteria" are typically related to its physical, chemical, and biological properties, and meeting the performance characteristics of a legally marketed predicate device. "Device performance" would be the results from their testing.

Acceptance Criteria (Analogous)	Reported Device Performance (Lucens 41)
Biocompatibility/Toxicology:	In-Vitro Cytotoxicity: Packaging solution, and extracts from finished lenses and packaging materials are not cytotoxic. Systemic Toxicity: Finished lenses and packaging materials meet the requirements of the systemic injection test and do not produce acute systemic toxicity. Acute Ocular Irritation: Packaging solution and extracts from finished lenses and packaging materials produced no ocular irritation.
Shelf Life: Stability, sterility, and package integrity over duration of labeled expiration.	Data presented supports establishment of the proposed shelf life. This implies the device met the criteria for stability, sterility, and integrity over time.
Physicochemical and Mechanical Properties: Refractive index, water content, Dk, % transmission (visible & UV), tensile strength, modulus, % elongation to break, specific gravity, quantification of polymerization residuals.	Results of physicochemical and mechanical property testing demonstrate consistent material properties between the Lucens 41 and the predicate device. Specific values are listed in Section IV (e.g., Water Content: 41% ±2%, Oxygen Permeability: 103, UV Blocker: >95% UVB, >50% UVA, Visible Light Transmittance: >89%, Refractive Index: 1.420). These also act as implicit acceptance criteria, with the reported values falling within the listed tolerances.
Substantial Equivalence to Predicate Device:	Claimed to be substantially equivalent in: FDA category (Group V), FDA classification, Product codes, USAN Material (senofilcon C), Intended use (daily wear), Actions, Indications for use, Lens design configurations, Benzotriazole UV absorbing monomer, Cast molded production method, Injection molded polypropylene blister packaging. The comparative matrix in Section VI explicitly shows that the Lucens 41 matches the predicate device (ACUVUE Soft Contact Lens, K160212) across these critical parameters.

Study Details (Analogous for a Contact Lens)

Sample size used for the test set and the data provenance:
- The document primarily relies on non-clinical performance testing (toxicology, shelf life, bench tests). It does not specify "sample sizes" in the context of patient data or test sets like AI studies would.
- Data Provenance: The studies were conducted in accordance with GLP (Good Laboratory Practice) regulations, implying a controlled laboratory environment, rather than clinical patient data from a specific country. This is retrospective/bench data for device characterization, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This concept is not applicable here. Ground truth, in the context of a medical device like a contact lens, relates to established scientific methods and standards for material properties, biocompatibility, and physical dimensions. There are no "experts" establishing ground truth in the way a radiologist might for an image-based diagnosis. The "ground truth" is determined by validated laboratory test methods and established international standards (e.g., ISO, FDA guidance).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This is not applicable for non-clinical performance testing of a contact lens. Adjudication methods are used in clinical studies, particularly in AI or diagnostic settings where human interpretation differences need to be resolved.
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:
- No. This is a contact lens. There are no human "readers" or AI assistance involved in evaluating its performance in this context.
- The study focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For this device, the "ground truth" is based on:
  - Standardized physicochemical measurements: (e.g., refractive index, water content, oxygen permeability) conducted in a laboratory setting using validated equipment and methods.
  - Biological safety standards: (e.g., ISO 10993 for biocompatibility/toxicology) which define acceptable limits for cytotoxicity, systemic toxicity, and ocular irritation.
  - Product specifications and tolerances: (e.g., sphere power, diameter, base curve) that must be met during manufacturing.
The sample size for the training set:
- Not applicable. This is not a machine learning/AI device, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set, there is no ground truth established for it in this context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 8, 2024

Lucens Technology Co., Ltd C/o Bret Andre Principal Consultant Andre Vision and Device Research 6119 Canter Lane West Linn, OR 97068

Re: K242391

Trade/Device Name: Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 8, 2024 Received: August 12, 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 (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/cdrb/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 titled "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 (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-devices/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.

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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) K242391

Device Name

Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens

Indications for Use (Describe)

Sphere:

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the spherical design is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes in powers from -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopter or less that does not interfere with visual acuity.

Toric:

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens in the toric design is indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and nonaphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.

Multifocal:

Multifocal-Toric:

When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

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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510 (k) SUMMARY

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

The assigned 510(k) number is: K242391

I. SUBMITTER

September 9, 2024 Date Prepared:

Name:	LUCENS TECHNOLOGY Co., Ltd
Address:	8F.-1, No. 31, Xintai Rd.,Zhubei City, Hsinchu County,Taiwan (R.O.C.).

Contact Person:	Kari Huang
Section Manager
Phone number:	+886-3-450-1986
Consultant:	Bret Andre
	EyeReg Consulting, Inc.
	6119 Canter Ln.
	West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
CommonName:	Contact Lens, Daily Wear
ClassificationName:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
RegulatoryClass:	Class II
Product Codes:	LPL; MVN

Purpose of 510(k) Submission: ~ New Device ~

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III. PREDICATE DEVICE

The Lucens 41 (senofilcon C) Silicone Hydrogel Soft (Hydrophilic) Contact Lens is substantially equivalent to the following predicate device:

I "ACUVUE (senofilcon C) Soft Contact Lens" By Johnson & Johnson Vision Care, Inc. 510(k) number; K160212 Primary Predicate

IV. DEVICE DESCRIPTION

Parameter	Range	Tolerance
Chord Diameter	13.00 mm to 15.00 mm	±0.20 mm
Center Thickness	0.050 mm to 0.580 mm	When ≤ 0.10 mm → ±0.010 mm + 10%When > 0.10 mm → ±0.015 mm + 5%
Base Curve	8.0 mm to 9.8 mm	±0.20 mm
Back Vertex Power (F'v)	-20.00 D to +20.00 D(in 0.25 D steps)	When 0.00 < F'v ≤ 10.00 D → ±0.25 DWhen 10.00 < F'v ≤ 20.00 D→±0.50 D
Cylinder Power (F'c)	-0.25 D to -2.25 D(in 0.25 D steps)	When 0.00 < F'c ≤ 2.00 D → ±0.25 DWhen 2.00 < F'c ≤4.00 D→±0.37 D
Cylinder Axis	10° to 180°(in 10° steps)	When 0.00 < F'c ≤ 1.50 D → ± 8°When F'c > 1.50 D→± 5°
Multifocal Power	+0.25 D to +4.00 D(in 0.25 D steps)	±0.25D
Oxygen Permeability( x 10-11 (cm2•mlO2)/(sec•ml•mmHg))	103	±20%
Visible Light Transmittance	>89%	±5%
Ultraviolet radiation Transmittance	< 5% TUVB<50% TUVA	TUVB (280 to 315nm) < 0.05 TVTUVA (315 to 380nm) < 0.05 TV
Water Content	41%	±2%
Refractive Index	1.420	±0.005

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V. INDICATIONS FOR USE

Sphere:

Toric:

Multifocal:

Multifocal-Toric:

When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eve Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection only.

When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after each removal.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is substantially equivalent to the primary predicate device (K160212) in the following areas:

I FDA category - Group V
FDA classification - Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Product codes: LPL; MVN 트
USAN Material (senofilcon C)
Intended use - daily wear contact lenses
트 Actions
트 Indications for use
" Lens design configurations
I Benzotriazole UV absorbing monomer
Cast molded production method
I Injection molded polypropylene blister packaging

The following matrix illustrates the production method, lens function and material characteristics of the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens, as well as the predicate device.

	Lucens 41By LUCENS TECHNOLOGY Co., Ltd.(Subject Device)	ACUVUE Soft Contact LensBy Johnson & Johnson Vision Care, Inc.(K160212)
Intended Use	Daily wear,Soft (hydrophilic) contact lens	Daily wear,Soft (hydrophilic) contact lens
Actions	In its hydrated state, the contact lens, when placed on thecornea, acts as a refracting medium to focus light rays onthe retina	In its hydrated state, the contact lens, when placed onthe cornea, acts as a refracting medium to focus lightrays on the retina
FDA Classification	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)	Soft (hydrophilic) Contact Lens (21 CFR886.5925)
FDA ClassificationProduct Code(s)	LPL; MVN	LPL; MVN
FDA Group	FDA Group V	FDA Group V
USAN name	senofilcon C	senofilcon C
Water Content (%)	41±2%	41±2%
Oxygen Permeabilityx 10-11 (cm2/sec)(mlO2)/(ml x mmHg @35°C)) (revised Fatt method)	103	103
Refractive Index(hydrated)	1.420	1.420
UV Blocker	Yes - benzotriazole	Yes - benzotriazole
Manufacturing	Cast-Molded	Cast-Molded
Color	Blue Handling TintReactive Blue 246	Blue Handling TintReactive Blue Dye #4
Packaging	PP Blister Pack	PP Blister Pack

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The following matrix compares the indications for use of the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens with the predicate device.

	Indications for Use
Lucens 41By LUCENSTECHNOLOGYCo., Ltd.(Subject Device)	Sphere:The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) ContactLens in the spherical design is indicated for daily wear for the correction of ametropia(myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes inpowers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibitastigmatism of 1.00 diopter or less that does not interfere with visual acuity.Toric:The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) ContactLens in the toric design is indicated for daily wear for the correction of ametropia (myopiaor hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseasedeyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -2.25 diopters.Multifocal:The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) ContactLens in the multifocal design is indicated for daily wear for the correction of refractiveametropia (myopia and hyperopia) and emmetropia with presbyopia in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and withadd powers from +0.25 to +4.00 diopters. The lenses may be worn by persons who exhibitastigmatism of 1.00 diopter or less that does not interfere with visual acuity.Multifocal-Toric:The Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) ContactLens in the multifocal-toric design is indicated for daily wear for the optic correction ofdistance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes inpowers of -20.00 to +20.00 diopters with add powers from +0.25 to +4.00 diopters andastigmatism corrections from -0.25 to -2.25 diopters.Eye Care Practitioners may prescribe the Lucens 41 (senofilcon C) Silicone HydrogelDaily Wear Soft (Hydrophilic) Contact Lens for frequent/planned replacement wear, withcleaning, disinfection and scheduled replacement, or for single-use disposable wear.When prescribed for frequent/planned replacement, the Lucens 41 (senofilcon C) SiliconeHydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be cleaned, rinsed anddisinfected each time the lens is removed. The contact lens is to be discarded after therecommended wearing period as prescribed by the Eye Care Professional. Whenprescribed for frequent/planned replacement wear, the lenses may be disinfected using achemical disinfection only.When prescribed for single-use disposable wear, Lucens 41 (senofilcon C) SiliconeHydrogel Daily Wear Soft (Hydrophilic) Contact Lens is to be discarded after eachremoval.
ACUVUE SoftContact LensJohnson &Johnson VisionCare, Inc.(K160212)	ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated fordaily wear for the optical correction of refractive ametropia (myopia and hyperopia) inphakic or aphakic persons with non-diseased eyes who may have 1.00D or less ofastigmatism.ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens – TORIC is indicated for dailywear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic oraphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.

ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens - MULTIFOCAL is indicatedfor daily wear for the optical correction of refractive ametropia (myopia and hyperopia)and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may need upto 4.00D of ADD power and may have 0.75D or less of astigmatism.
ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens - MULTIFOCAL-TORIC isindicated for daily wear for the optical correction of refractive ametropia (myopia,hyperopia and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less ofastigmatism.
These lenses contain a UV Blocker to help protect against transmission of harmful UVradiation to the cornea and into the eye. Eye Care Professionals may prescribe the lenseseither for daily disposable wear or frequent/planned replacement wear with cleaning,disinfection and scheduled replacement (see REPLACEMENT SCHEDULE).
When prescribed for daily disposable wear, lenses should be discarded upon removal.When prescribed for frequent/planned replacement wear, the lenses may be disinfectedusing a chemical disinfection system only. The contact lens is to be discarded after therecommended wearing period as prescribed by the Eye Care Professional.

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PERFORMANCE DATA VII.

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Performance Testing

A series of non-clinical performance tests were performed to demonstrate the safety and effectiveness of the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens. The results support the claim that the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is substantially equivalent to the currently marketed predicate devices. Refer below to a summary of the results from the non-clinical studies.

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 packaging solution, and extracts from the finished lenses and packaging materials are not cytotoxic.
· Systemic Toxicity: The finished lenses and packaging materials meet the requirements of the systemic injection test in accordance with ISO 10993-11 and do not produce acute systemic toxicity.
· Acute Ocular Irritation: Acute ocular irritation testing was performed in accordance with ISO 10993-23. The packaging solution and extracts from finished lenses and packaging materials produced no ocular irritation.

Shelf Life:

Testing was performed to evaluate the stability, sterility, and package integrity of the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens over the duration of the labeled expiration date. The data presented supports establishment of the proposed shelf life.

Performance Testing - Bench:

The following bench tests were completed: refractive index, water content. Dk. % transmission (visible & UV), 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 Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens and the predicate device.

Clinical Testing

Contact lenses manufactured from senofilcon C (USAN) material are currently marketed in the United States. Clinical performance testing for the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is not required for this application.

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VIII. CONCLUSIONS

Validity of Scientific Data

Laboratories under Good Laboratory Practice regulations conducted toxicology and microbiology studies following scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7.

Substantial Equivalence

Information presented in this Premarket Notification establishes that the Lucens 41 (senofilcon C) Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens is as safe and effective as the predicate device when used in accordance with the labeled directions for the proposed indication.

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 (hydrophilic) daily wear 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.