The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 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 BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).

The physical / optical properties of the lens are:

Specific Gravity: 1.068
Refractive Index: 1.38
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 70%
Oxygen Permeability (Dk): 33 x10-11[cm3O₂(STP) x cm]/(sec x cm2 x mmHg)@35°C(Polarographic Method)

The BAUSCH & LOMB SofLens™one day disposable (hilafilcon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:

• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D

Each BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a contact lens, focusing on demonstrating substantial equivalence to a predicate device rather than a study with acceptance criteria and device performance in the typical sense of a diagnostic or treatment effectiveness study.

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" for clinical performance in the way a diagnostic device might (e.g., sensitivity, specificity thresholds). Instead, it aims to show substantial equivalence to an existing predicate device based on physicochemical properties and toxicology. Therefore, the "acceptance criteria" are implicitly that the new device's properties are "equivalent" to the predicate, and toxicity is "none."

Characteristic	Acceptance Criterion (Implicit)	Reported Device Performance
Physicochemical Properties	Equivalent to currently marketed predicate device	"The physicochemical properties... are equivalent to the currently marketed predicate device."
Toxicity / Irritation	No significant quantities of monomer components; no toxicity or irritation	"The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens material demonstrated no toxicity or irritation."
Material Classification	Same FDA material classification grouping (Group II) as predicate	"Both fall into the same FDA material classification grouping (Group II)."
Manufacturing Process	Same manufacturing process (cast molding) as predicate	"Both are manufactured by the same manufacturing process (cast molding)."

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

The study described is preclinical testing (in vitro and in vivo toxicology) and comparison to a predicate device. It is not a clinical study involving human subjects or a "test set" of patient data in the typical sense for evaluating device performance metrics like sensitivity/specificity.

Sample Size: Not specified for the preclinical testing. The focus is on material properties and toxicology rather than a patient-based test set.
Data Provenance: The preclinical tests were conducted in accordance with FDA guidelines and involved in vitro and in vivo studies. Specific country of origin or whether it was retrospective/prospective is not mentioned, but "preclinical" generally implies laboratory-based, controlled studies.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This is not a study that establishes "ground truth" through expert consensus for a diagnostic outcome. The "truth" in this context is the safety and functional properties of the material, assessed through laboratory tests.

4. Adjudication Method:

Not applicable. As this is not a study requiring human interpretation or consensus for a "ground truth," there is no adjudication method described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, typically in diagnostic imaging. This submission concerns a contact lens, not a diagnostic AI tool.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study:

Not applicable. The device is a physical medical device (contact lens), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" in this context is based on preclinical testing results (physicochemical properties, toxicology) and comparison to the known characteristics of a legally marketed predicate device. It's about demonstrating safety and equivalence in material properties and manufacturing.

8. Sample Size for the Training Set:

Not applicable. The device is a physical contact lens, not an AI model that requires a "training set."

9. How the Ground Truth for the Training Set Was Established:

Not applicable, for the same reason as point 8.

Summary

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K011718

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens

SUBMITTER INFORMATION 1.

Bausch & Lomb Incorporated 1400 North Goodman Street P.O. Box 0450 Rochester, NY 14692-0450

Contact Person: Debra Ketchum Manager, Regulatory Affairs (716) 338-8638 Telephone No .:

DEVICE NAME 2.

Classification Name: Soft (hydrophilic) contact lens

Proprietary Name: BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens

PREDICATE DEVICE 3.

The BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens has been selected as the predicate devices for the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent.

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DESCRIPTION OF DEVICE 4.

The physical / optical properties of the lens are:

Specific Gravity:	1.068
Refractive Index:	1.38
Light Transmittance:	C.I.E. Y value - at least 97%
Water Content:	70%
Oxygen Permeability (Dk):	33 x10-11[cm3O₂(STP) x cm]/(sec x cm2 x mmHg)@35°C(Polarographic Method)

The BAUSCH & LOMB SofLens™one day disposable (hilafilcon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:

• Diameter:	13.5mm to 15.0mm
• Center Thickness:	0.05mm to 0.75mm
• Base Curve:	7.8mm to 9.5mm
• Powers (Spherical):	+20.00D to -20.00D

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INDICATIONS FOR USE ধন

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

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALIENCE 6.

A series of preclinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Contact Lens. A summary of results from the preclinical tests is provided below.

Preclinical Testing:

A series of in vitro and in vivo preclinical toxicology testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP regulation.

The results of the preclinical testing on the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent demonstrate that:

The physicochemical properties of the BAUSCH & LOMB® SofLens™ one day (hilafilcon A) disposable Visibility Tinted Contact Lens are equivalent to the currently marketed predicate device, BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens.

The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens material demonstrated no toxicity or irritation.

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Substantial Equivalence

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The DITO bess produced with the monomer diluent is similar to the currently marketed BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens, in that both fall into the same FDA material classification grouping (Group II) and both are manufactured by the same manufacturing process (cast molding). (Group II) CH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The Driver Lens is different from the BAUSCH & LOMB® SofLens™ one day Disposable (hilafileon A) Visibility Tinted Contact Lens in that it is manufactured using a monomer (imamoon is) visioningerol is not included in the weight or mole percentages of the monomer mix, as it does not become part of the lens material. The difference between these two lenses will not have any negative effect on the safety and effectiveness of the device.

All product will be sold as sterile medical devices.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 5 2001

Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Regulatory Affairs 1400 N. Goodman Street P.O. Box 30450 Rochester, NY 14603-0450

Re: K011718

Trade Name: Bausch & Lomb® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulatory Class: Class II Product Code: 86 MVN Dated: June 1, 2001 Received: June 4, 2001

Dear Ms. Ketchum:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, listing 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Debra Ketchum

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,
A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450

Indications for Use Statement

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Device Name: Visibility Tinted Contact Lens

Indications for Use:

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The DAOSCAT & LOND - Bollers
Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and Comact Lelis is indroased for t-sphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may astEmatists of inspherical 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.

Claims:

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility l. Tinted Contact Lens provides vision correction in powers ranging from +20.00D to -20.00D.
The BAUSCH & LOMB® Sofilens™ one day disposable (hilafilcon A) Visibility 2. Tinted Contact Lens is for single-use disposable wear.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X	OR	Over-The-Counter-Use
------------------	---	----	----------------------

Daniel W.C. Brown, Ph.D.

(Division Sign-Off)

(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K011718

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.