The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

Device Description

The BAUSCH & LOMB® 2-Week (hilafilcon B) 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 59% water by weight when immersed in a sterile saline solution. This lens is tinted blue with Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl) phenylamino] anthraquinone). The color additive conforms with 21 CFR Part 73.3106. The lens may also be supplied clear (no tint).

The physical / optical properties of the lens are:
Specific Gravity: 1.119
Refractive Index: 1.4036
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 59%
Oxygen Permeability (Dk): 22 x 10-11 [cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (Polarographic Method)

The BAUSCH & LOMB 2-Week (hilafilcon B) 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
• Toric (Cylinder): 0 to 10 diopters
• Toric Axis: 0° to 180°

Each BAUSCH & LOMB 2-Week (hilafilcon B) 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 BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens was evaluated through a one-month, randomized clinical study to demonstrate its safety and efficacy compared to a predicate device, the Bausch & Lomb SofLens one day™ Contact Lens. The study aimed to establish statistical equivalence between the two lenses for both safety and efficacy endpoints.

1. Table of Acceptance Criteria and Reported Device Performance

Endpoint/Category	Acceptance Criteria	Reported Device Performance
Safety: Proportion of total grade 2 or greater positive slit lamp findings (Any Finding)	Statistical equivalence between Test and Control lenses. (Comparison of proportion of findings.)	"There were no significant differences in the proportion of total grade 2 or greater slit lamp findings, for the category of Any Finding, between the Test and Control lenses (all p-values > 0.05). Therefore, the safety end-point defined in the protocol was achieved."
Efficacy: Proportion of lens visual acuities at the level of 20/40 or better	Statistical equivalence between Test and Control lenses. (Comparison of proportion of visual acuities.)	"There were no significant differences in the proportion of lens visual acuities at the level of 20/40 or better between the Test and Control lenses (all p-values > 0.05). Therefore, the efficacy end-point defined in the protocol was achieved."

2. Sample Size and Data Provenance

Test Set Sample Size: The document does not explicitly state the exact number of participants in the clinical study. It refers to a "one month, randomized clinical study" comparing the Test and Control lenses.
Data Provenance: The document does not explicitly state the country of origin. It is a submission to the FDA, suggesting the study was conducted to meet US regulatory requirements, which often involve data from within the US or studies designed to be acceptable for US submissions. The study was prospective in nature, as it was a "one month, randomized clinical study" designed to evaluate the safety and efficacy of the device.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide details on the number or qualifications of experts used to establish ground truth for the clinical study. Slit lamp findings and visual acuity measurements are typically obtained by trained ophthalmic professionals (e.g., optometrists, ophthalmologists, or certified technicians).

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1). The "safety end-point" was based on "the proportion of total grade 2 or greater positive slit lamp findings," and the "efficacy end-point" was based on "the proportion of lens visual acuities at the level of 20/40 or better." This suggests direct measurement and analysis, rather than a consensus-based adjudication process for individual cases.

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

No MRMC comparative effectiveness study was done. This study compares the new device to a predicate device in a single-reader (patient wear) context, not the performance of human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

No standalone (algorithm only) performance study was done. This device is a contact lens, meaning its performance is directly related to wear by human subjects. There is no "algorithm only" component to evaluate.

7. Type of Ground Truth Used

The ground truth for the clinical study was based on:

Clinical Observations/Measurements: Slit lamp findings for safety (clinical signs of ocular irritation or adverse events).
Objective Clinical Measurements: Visual acuity measurements for efficacy.

8. Sample Size for the Training Set

This product is a physical medical device (contact lens), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning. The clinical study served as the primary evaluation of the device's performance.

9. How Ground Truth for the Training Set Was Established

As this is not an AI/algorithm-based device, the concept of a "training set" and establishing ground truth for it does not apply. The safety and efficacy of the contact lens were established through the clinical study described, where outcomes were measured directly from patient wear.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the text "MAR - 3 2000" on the left and "K994125" on the right. The date indicates March 3, 2000. The alphanumeric string "K994125" appears to be a code or identifier.

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens

Submitter Information: 1.

Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14603-0450

Contact Person: Glenn A. Davies, O.D. Director, Regulatory Affairs Telephone No.: (716) 338-8215

Device Name: 2.

Classification Name: Soft (hydrophilic) contact lens

Proprietary Name: BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens

3. Predicate Devices:

Soft ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens (K974780)

Phoenix (hilafilcon A) Visibility Tinted Contact Lens (K983894)

{1}------------------------------------------------

DESCRIPTION OF DEVICE 4.

The physical / optical properties of the lens are:

Specific Gravity:	1.119
Refractive Index:	1.4036
Light Transmittance:	C.I.E. Y value - at least 97%
Water Content:	59%
Oxygen Permeability (Dk):	22 x 10-11 [cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C(Polarographic Method)

The BAUSCH & LOMB 2-Week (hilafilcon B) 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
• Toric (Cylinder):	0 to 10 diopters
• Toric Axis:	0° to 180°

{2}------------------------------------------------

5. INDICATIONS FOR USE

DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE ર-

A series of non-clinical laboratory testing and clinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB 2-Week (hilafficon B) Contact Lens. A summary of results from the preclinical and clinical tests is provided below.

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 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-chinical laboratory studies were conducted in compliance with the GLP regulation.

The results of the preclinical testing on the BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens demonstrate that:

The hilafilcon B contact lens material is similar to the hilafilcon A contact lens material. The differences between the two lens materials are primarily due to the difference in water content. The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens extracts and lens material demonstrated no toxicity or irritation. The lenses are compatible with chemical disinfection systems (including hydrogen peroxide.

Stability testing has demonstrated a three year expiration date for the sterile lenses.

{3}------------------------------------------------

Clinical Testing:

A one month, randomized clinical study was completed to evaluate the safety and efficacy of the Bausch & Lomb 2-Week Contact Lens (Test) compared to the Bausch & Lomb SofLens one day™ Contact Lens (Control) when worn by myopic, phakic patients on a daily wear basis with no scheduled replacements.

The primary endpoints were:

Statistical equivalence in the proportion of total grade 2 or greater positive slit . Safety: lamp findings, between the Test and Control lenses, was considered clinically acceptable.
Statistical equivalence in the proportion of lens visual acuities at the level of Efficacy: . 20/40 or better, between Test and Control lenses, was considered clinically acceptable.

There were no significant differences in the proportion of total grade 2 or greater slit lamp findings, for the category of Any Finding, between the Test and Control lenses (all p-values > 0.05). Therefore, the safety end-point defined in the protocol was achieved.

There were no significant differences in the proportion of lens visual acuities at the level of 20/40 or better between the Test and Control lenses (all p-values > 0.05). Therefore, the efficacy end-point defined in the protocol was achieved.

The Sponsor concludes, based on the data presented, that the protocol-specified endpoints were achieved, and that the Bausch & Lomb 2-Week Contact Lens is equivalent in safety and efficacy to the SoftLens one day™ Contact Lens, when worn on a daily wear basis. The Bausch & Lomb 2-Week Contact Lens is a safe and effective means of daily wear vision correction.

Substantial Equivalence

The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens is similar to the 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). The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens is different from the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens in that it has a different USAN name suffix (hilafilcon B vs. hilafilcon A). The differences between these two lenses will not have any negative effect on the safety and effectiveness of the device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around the perimeter. In the center of the circle is a stylized image of an eagle with three wavy lines extending from its head, representing the department's mission to protect and promote the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 3 2000

Bausch & Lomb Incorporated Glenn A. Davies, O.D. Director, Regulatory Affairs 1400 N. Goodman Street Rochester, NY 14603-0450

Re: K994125 Trade Name: Bausch & Lomb 2-Week (hilafilcon B) Visibility Tinted Contact Lens Regulatory Class: II Product Code: 86 LPL Dated: December 6, 1999 Received: December 7, 1999

Dear Dr. Davies:

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 .

{5}------------------------------------------------

Page 2 - Glenn A. Davies, O.D.

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) 594-4613. 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" (21 CFR 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/dsmamain.html".

Sincerely yours,

A. Roer L. Rosenthal

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

Enclosure

{6}------------------------------------------------

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

Indications for Use Statement

510(k) Number (if known): K994125

BAUSCH & LOMB® 2-Week (hilafilcon B)Visibility Tinted Contact Lens Device Name:

Indications for Use:

The BAUSCH & LOMB® 2-Week (hilafilcon B) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10:00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

CRLEASE 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
------------------	---	----	----------------------	--

(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number	K994125
---------------	---------

PH.D.

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.