The BAUSCH & LOMB Phoenix (hilafilcon A) 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 eves, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.

The BAUSCH & LOMB Phoenix (hilaffilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve 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 Phoenix (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)phenylaminolanthraquinone). 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: 1.075
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 Phoenix (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
• Toric (Cylinder): 0 to 10 diopters
• Toric Axis: 0° to 180°

Each BAUSCH & LOMB Phoenix (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

This 510(k) premarket notification for the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens does not contain information commonly found in studies used to establish acceptance criteria and prove device performance in the manner requested. This document is a summary of the device's characteristics and its substantial equivalence to a predicate device, rather than a detailed report of clinical trials or performance testing against specific acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text. However, I can infer some aspects based on the nature of a 510(k) submission for a contact lens.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document speaks about "physicochemical properties" and "established safety profile" being equivalent to the predicate device, but does not explicitly list acceptance criteria in a quantitative sense for the new device, nor does it present detailed performance results from a study conducted on this specific device against those criteria. The physicochemical properties are described as part of the device's specifications, but not as performance measured against a specific acceptance criterion in the context of a clinical study.

Acceptance Criterion	Reported Device Performance
Safety and Effectiveness	The established safety profile (toxicology, physicochemical properties, manufacturing/chemistry) is equivalent to the predicate device.
Compatibility with Care Systems	Not explicitly stated as a separate acceptance criterion for the Phoenix lens, but the predicate device was subjected to care system testing (compatibility testing of recommended lens care regimens and clinical performance testing). The Phoenix lens is deemed substantially equivalent based on this.
Vision Correction (Spherical Power)	Provides vision correction in powers ranging from +20.00D to -20.00D. (This is a claim and expected performance, not an acceptance criterion from a study).
Vision Correction (Astigmatism)	Provides vision correction of refractive astigmatism up to 10.00 diopters. (This is a claim and expected performance, not an acceptance criterion from a study).
Disinfection Compatibility	May be disinfected using a chemical disinfection system. (This is a claim, not an acceptance criterion from a study).
Physical/Optical Properties (Device Specifications)	Specific Gravity: 1.075Refractive Index: 1.38Light 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)
Dimensions (Device Specifications)	Diameter: 13.5mm to 15.0mmCenter Thickness: 0.05mm to 0.75mmBase Curve: 7.8mm to 9.5mmPowers (Spherical): +20.00D to -20.00DToric (Cylinder): 0 to 10 dioptersToric Axis: 0° to 180°

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

This information is not provided for the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens. The document states that the predicate device (SofLens™ one day disposable) "included test data from studies in which hilafilcon A visibility tinted contact lenses were subjected to care system testing, specifically 1) Compatibility testing of the lens care regimens recommended for use in the proposed labeling, and 2) Clinical performance testing." However, the details of these predicate device studies (sample size, provenance, retrospective/prospective nature) are not given here. For the Phoenix lens, the primary "proof" is substantial equivalence, not a new clinical study.

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)

This information is not provided. This type of detail is typical for diagnostic AI devices, not contact lenses proving substantial equivalence.

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

This information is not provided.

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

This type of study is not applicable to a contact lens. MRMC studies are used for diagnostic imaging AI, where human readers (e.g., radiologists) interpret images with and without AI assistance. This device is a contact lens for vision correction, not an AI diagnostic tool.

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

This is not applicable as the device is a physical medical device (contact lens), not an algorithm.

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

For a contact lens seeking substantial equivalence, the "ground truth" for its safety and effectiveness is largely established through physicochemical property testing, toxicology, manufacturing/chemistry data, and clinical performance data from the predicate device. The new device is then shown to have identical technological characteristics and an equivalent safety profile. Outcomes data from clinical performance testing of the predicate device would have been part of its original clearance.

8. The sample size for the training set

This is not applicable. Contact lenses do not involve AI algorithms that require training sets in the computational sense.

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

This is not applicable.

Summary

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K 983 894

510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS

FOR

BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens

Submitter Information: 1.

Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14692-0450

Contact Person: Dennis Hahn Manager, Regulatory Affairs Telephone No .: (716) 338-6813

2. Device Name:

Classification Name: Soft (hydrophilic) contact lens

Proprietary Name: BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens

3. Predicate Device:

The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens has been selected as the predicate device.

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Description of Device 4.

The physical / optical properties of the lens are:

Specific Gravity:	1.075
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 Phoenix (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
• Toric (Cylinder):	0 to 10 diopters
• Toric Axis:	0° to 180°

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INDICATIONS FOR USE ળં

6. Description of Safety and Substantial Equivalence

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens has the same technological characteristics as the predicate device, the BAUSCH & LOMB® Soft ens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens. The established safety profile (toxicology, physicochemical properties, manufacturing / chemistry) of the BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is equivalent to the predicate device.

The SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens was cleared on March 11, 1998, File Number K974780. File K974780 included test data from studies in which hilafilcon A visibility tinted contact lenses were subjected to care system testing, specifically 1) Compatibility testing of the lens care regimens recommended for use in the proposed labeling, and 2) Clinical performance testing.

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens is therefore substantially equivalent to the predicate device, the BAUSCH & LOMB® Soft ens TM one day disposable (hilafilcon A) Visibility Tinted Contact Lens, and does not raise new questions of safety or effectiveness.

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Image /page/3/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. Inside the circle is a stylized symbol that resembles an abstract bird or a series of flowing lines. The symbol is composed of three curved lines that converge at the bottom, creating a sense of movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 1998

BAUSCH & LOMB Dennis Hahn Manager, Regulatory Affairs 1400 North Goodman St. Rochester, NY 14692

Re: K983894 Trade Name: Bausch & Lomb Phoenix (hilafilcon A ) Visibility Tinted Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: October 30, 1998 Received: November 3, 1998

Dear Mr. Hahn:

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 - Mr. Dennis Hahn, Manager, Regulatory Atlairs

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. Roerl. Rosenthal

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

Enclosure

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

Indications for Use Statement

510(k) Number (if known): K983894

BAUSCH & LOMB Phoenix (hilafilcon A)Visibility Tinted Contact Lens Device Name:

Indications for Use:

The BAUSCH & LOMB Phoenix (hilafilcon A) 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.

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact Lens may be prescribed for Frequent/Planned Replacement Wear. 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.

Claims:

The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact provides vision 1. correction in powers ranging from +20.00D to -20.00D.
1. The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact provides vision correction of refractive astigmatism of up to 10.00 diopters.
1. The BAUSCH & LOMB Phoenix (hilafilcon A) Visibility Tinted Contact may be disinfected using a chemical disinfection system.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	✓
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	(Division Sign-Off)
	Division of Ophthalmic Devices

510(k) Number	K983894
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Over-The-Counter-Use	_________________
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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.