The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 5.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Device Description

The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is a soft hydrophilic contact lens which is available in a toric lens design for the correction of astigmatism. The lens is made from the hilafilcon B material, a hydrophilic copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone, and is 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246.

AI/ML Overview

The provided document describes the SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens, and its substantial equivalence to previously cleared predicate devices. The document explicitly states that preclinical and clinical studies were completed and previously submitted for the predicate devices. It does not provide new acceptance criteria or specific study results for the SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens itself, but rather leverages the data from its predicates.

Therefore, for aspects like acceptance criteria, device performance, sample sizes, expert qualifications, and ground truth establishment, the information presented below reflects what would have been applicable to the predicate devices, or what can be inferred from the nature of the device and regulatory process.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission relies on substantial equivalence and refers to previous studies, specific acceptance criteria and reported performance for the new device are not explicitly detailed. However, for contact lenses, acceptance criteria typically revolve around visual acuity, fitting characteristics, oxygen permeability, comfort, and safety endpoints (e.g., adverse events). The "reported device performance" for the new lens is broadly understood to be equivalent to its predicates.

Acceptance Criteria Category	Typical Acceptance Criteria (Inferred for Contact Lenses)	Reported Device Performance (Inferred as equivalent to predicates)
Visual Acuity	Maintenance or improvement of corrected visual acuity; no significant loss of best-corrected visual acuity.	Expected to provide sharp and stable vision, equivalent to or better than spectacles for the indicated correction of refractive ametropia (myopia, hyperopia, and astigmatism).
Fit & Stability	Proper centering, movement, and coverage; stable axis orientation for toric lenses; minimal discomfort from fit.	Stable and comfortable fit with adequate movement and oxygen transmission, consistent with the hilafilcon B material and toric design.
Safety	Absence of significant adverse events (e.g., corneal ulcer, infiltrates, severe conjunctivitis); biocompatibility of material.	Biologically safe and well-tolerated, as established for the hilafilcon B material and daily disposable modality in predicate devices.
Material Properties	Oxygen transmissibility, water content, modulus, tensile strength meeting established standards for extended wear.	Meets established standards for hilafilcon B (59% water content) to ensure corneal health.
Sterility	Maintenance of sterility throughout shelf life.	Demonstrates continued sterility for its stated shelf-life (5 years).
Discomfort/Wear Time	Acceptable comfort during daily wear.	Comfortable for daily wear, consistent with the "daily disposable" modality.

2. Sample Size Used for the Test Set and Data Provenance

The document states: "A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370."

Test Set Sample Size: Not specified for the current device's assessment, as it leverages prior studies. For the predicate devices, sample sizes would have been determined based on statistical requirements for non-inferiority or equivalence trials for contact lenses.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for the predicate studies. However, clinical trials for medical devices like contact lenses are typically prospective multicenter studies conducted in various countries, with the US often being a primary location.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the supplied text for the current device, as it relies on substantial equivalence to predicate devices. For the predicate clinical studies, the ground truth (e.g., visual acuity measurements, slit lamp examinations for ocular health, subjective comfort ratings) would have been established by:

Optometrists and Ophthalmologists: Qualified eyecare professionals (often with several years of experience) who conducted clinical examinations, performed refractions, assessed lens fit, and evaluated adverse events. The specific number is not disclosed in this summary.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method for the test set, as no new primary clinical study data is presented for this specific 510(k) submission. In multi-center clinical trials for the predicate devices, adjudication of adverse events or ambiguous findings would typically involve:

Independent Clinical Monitors: To ensure protocol adherence and data accuracy.
Clinical Endpoints Committee (CEC): A small group of clinicians who independently review and adjudicate key clinical endpoints, especially adverse events, often blinded to treatment assignment.
Data Safety Monitoring Board (DSMB): For ongoing monitoring of patient safety in larger trials.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance

N/A. This device is a contact lens and does not involve AI assistance or "human readers" in the context of diagnostic interpretation. Therefore, an MRMC comparative effectiveness study regarding improvement with AI assistance is not applicable.

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

N/A. This device is a contact lens and does not involve any algorithm that operates in a standalone manner without human intervention.

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

For the predicate clinical studies, the ground truth would have been established through a combination of:

Clinical Examination Findings: Objective measurements by eye care professionals (e.g., visual acuity charts, slit lamp biomicroscopy for corneal health, keratometry for corneal shape, lens fit assessment).
Patient Reported Outcomes (PROs): Subjective data regarding comfort, vision quality, and overall satisfaction.
Refractive Measurements: Objective and subjective refraction to determine the lens's corrective power.
Adverse Event Reporting: Detailed documentation and classification of any ocular or systemic adverse events.

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of the 510(k) submission, as it leverages previous clinical data on predicate devices rather than developing a new algorithm with a training/test split. For contact lenses, "training set" is not a standard term unless referring to material development or specific design optimization, which wouldn't typically be a detailed part of a 510(k) summary. The "training" for such devices is based on extensive research and development in materials science and optical design.

9. How the Ground Truth for the Training Set was Established

As explained in point 8, the concept of a "training set" with established ground truth is not directly applicable in the context of this 510(k) summary for a physical medical device like a contact lens. The "ground truth" for the development of contact lens materials (hilafilcon B) and designs (toric, daily disposable) would have been built upon decades of ophthalmological and optometric understanding, extensive material testing, and prior clinical trials for predecessors. This continuous feedback loop from clinical performance and patient outcomes informs the iterative design process in contact lens development.

Summary

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080755

JUN 1 0 2008

510(K) SUMMARY Bausch & Lomb, Inc. 510(k) Premarket Notification Bausch & Lomb® SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens

Applicant's Name and Address 1.

Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609

Susan Pate 2. Contact Person Associate Manager Global Regulatory Affairs Bausch & Lomb, Inc. 1400 North Goodman Street Rochester, NY 14609 (585) 338-6362 susan.m.pate@bausch.com

3. Identification of Device

Common Name:	soft contact lens (hydrophilic)
Trade Name:	SofLens® daily disposable toric (hilafilcon B)Visibility Tinted
Classification:	Daily Wear Contact Lens
Device classification:	Class II (21 CFR 886.5925)
Product Code:	MVN

Predicate Devices:

The predicate devices, SofLens daily disposable (hilafilcon B) and SofLens59 (hilafilcon B) Contact Lenses, were selected to demonstrate substantial equivalence of the lens material, hilafilcon B, and replacement modality, singleuse disposable lens. The predicate device SofLens toric (alphafilcon A) Contact Lenses was selected to demonstrate substantial equivalence to the Bausch & Lomb toric lens design.

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The SofLens daily disposable toric (hilafilcon B) Visibility Contact Lens is substantially equivalent to the currently marketed SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared in 510(k) Premarket Notification No. K061158 on June 22, 2006, SofLens59 (hilafilcon B) Visibility tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000 and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification No. K941370 cleared on April 2,1994.

The differences between the devices follow.

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Feature	SofLens daily disposable toric	SofLens daily disposable	SofLens59	SofLens Toric
FDA Group	Group II(high water/non-ionic)	Group II(high water/non-ionic)Castmolded	Group II(high water/non-ionic)Castmolded	Group II(high water/non ionic)Castmolded
ManufacturingProcess	Castmolded	Castmolded	Castmolded	Castmolded
USAN Name	hilafilcon B	hilafilcon B	hilafilcon B	alphafilcon A
Indications	ToricDaily Wear	SphericalDaily Wear	SphericalDaily Wear	ToricDaily Wear
Modality	Single-use disposable	Single-use disposable	Frequent replacement	Single-use disposable orFrequent replacement
Design Properties
Diameter	14.2mm	14.2mm	14.2mm	14.5mm
Center Thickness(-3.00D)	0.125mm	0.090mm	0.140mm	0.190mm
Base Curve	8.6mm	8.6mm	8.6mm	8.5mm
Sphere powers	Plano to -6.00D in 0.25Dsteps-6.50D to -9.00D in 0.50Dsteps	+6.50D to -6.50D in 0.25Dsteps-7.00D to -9.00D in 0.50Dsteps	+6.50D to -6.50D in 0.25Dsteps-7.00D to -9.00D in 0.50Dsteps	+6.00D to -6.00D in 0.25Dsteps-6.50D to -9.00D in 0.50Dsteps
Cylinder Powers	-0.75D, -1.25D, -1.75D	n/a	n/a	-0.75D, -1.25D, -1.75D,-2.25D and -2.75D
Axis	0° to 180° in 10°Increments	n/a	n/a	0° to 180° in 10°Increments
Aspheric Optics	Yes	Yes	No	No

SIMILARITIES and DIFFERENCES

Section 5, Page 4

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4. Description of device

5. Intended use

The SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia, and astigmatism) in not-aphakic persons with non-diseased eves, exhibiting astigmatism of 5.00 diopters or less, that does not interfere with visual acuity. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

ે. Description of Safety and Substantial Equivalence

A series of preclinical and clinical studies were completed and previously submitted in Premarket Notifications K061157, K994125 and K941370.

Non-Clinical Laboratory Testing:

A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens material, hilafilcon B. Testing was performed in accordance with FDA quideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. The non-clinical testing can be found in the currently marketed SofLens®59 (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000.

Stability testing has demonstrated a five vear expiration date for the sterile lenses.

Clinical Testing:

The clinical performance to confirm safety and effectiveness of the lens material, hilafilcon B, was conducted on the SofLens59 (hilafilcon B) Visibility Tinted Contact Lens and cleared in the Premarket Notification K994125 on March 3. 2000. The clinical performance to confirm the safety and effectiveness of the lens modality, daily disposable, was conducted on the SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens cleared under Premarket

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Notification K061157 on June 22, 2006. The Bausch & Lomb toric contact lens design was cleared in the SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens Premarket Notification K941370 on April 2, 1994.

7. Substantial Equivalence

The SofLens daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens is substantially equivalent to the currently marketed SofLens daily disposable (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K061157 cleared on June 22, 2006; SofLens59 (hilafilcon B) Visibility Tinted Contact Lens 510(k) Premarket Notification K994125 cleared on March 3, 2000; and SofLens Toric (alphafilcon A) Visibility Tinted Contact Lens 510(k) Premarket Notification K941370 cleared on April 2, 1994. The lenses are similar in that all lenses fall into FDA Group II for soft (hydrophilic) contact lenses because the ionic content is less than 1% (nonionic polymer material), the water content is greater than 50% (hilafilcon B - 59% and alphafilcon A - 66%) and are manufactured with the same manufacturing process (cast molding).

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Image /page/5/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 0 2008

Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Global Regulatory Affairs 1400 North Goodman St. Rochester, NY 14609

Re: K080755

Trade/Device Name: Bausch & Lomb® SofLens® Daily Disposable Toric (hilafilcon B) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: MVN Dated: March 14, 2008 Received: March 18, 2008

Dear Ms. Ketchum:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Ilsting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 – Ms. Debra Ketchum

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M. B. Egerlton, mD

Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):
K080755

Device Name:

SofLens® daily disposable toric (hilafilcon B) Visibility Tinted Contact Lens

Indication for Use

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Prescription Use X

Over-the -counter-use_ ાર

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Njudiet

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number K080755

Section 4, Page 2

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.