The BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or 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 for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.

The BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.

Device Description

The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens are soft hydrophilic contact lens. The lenses are made from the balafilcon A material, a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wetting monomer, tinted blue with Reactive Blue Dye 246.

AI/ML Overview

The provided 510(k) summary for the Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens does not describe any new studies or acceptance criteria.

Instead, the submission hinges on demonstrating substantial equivalence to a previously cleared predicate device (OxyCor (balafilcon A) Visibility Tinted Contact Lens, K972454). The core argument is that there has been no change made to the device itself. The submission clarifies the indications for use within the already cleared range, providing more specific guidance for eye care practitioners regarding prescribing for frequent/planned replacement wear or disposable wear, and limiting astigmatism indications to within previously cleared levels.

Therefore, the requested information elements related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance are not applicable to this 510(k) submission.

Here's a breakdown based on the provided document:

Table of acceptance criteria and the reported device performance:
- Not Applicable. No new acceptance criteria were established, and no new performance data was generated or reported for this submission. The device is considered to meet the performance of the predicate device due to being identical.
Sample sized used for the test set and the data provenance:
- Not Applicable. No new test set or associated data was used. The submission relies on the data that supported the clearance of the predicate device (K972454).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. No new ground truth establishment was conducted for this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No new test set required adjudication.
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:
- Not Applicable. This device is a contact lens, not an AI diagnostic tool. No MRMC study was conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This device is a contact lens, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No new ground truth was established for this submission. The safety and effectiveness of the device were established by demonstrating its identical nature to a previously cleared device.
The sample size for the training set:
- Not Applicable. This is a medical device, not a machine learning algorithm requiring a training set.
How the ground truth for the training set was established:
- Not Applicable. No training set ground truth was established.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or rather, the basis for clearance, is a comparative analysis demonstrating substantial equivalence to a predicate device (OxyCor (balafilcon A) Visibility Tinted Contact Lens, K972454).

Rationale: The submission explicitly states: "There has been no change made to this device" (Section 7.0 Non-Clinical Testing and Section 8.0 Clinical Testing) and "The subject devices are identical to the predicate device cleared under K972454" (Section 6.0 Technological Characteristics).
Methodology: The sponsor provided a side-by-side comparison of the technological characteristics (material, water content, physical/optical properties, oxygen permeability, color additive, manufacturing method, lens design, replacement, base curve, diameter, sphere powers, cylinder powers, axis, center thickness) of the subject device to the predicate device. This comparison confirmed their identical nature, with a minor difference noted in the "Indications for Use" which was explained as being "within currently cleared indications" for the predicate.
Conclusion: Because the device is identical to the legally marketed predicate device, and the stated indications for use are within the scope of the predicate, the device is considered substantially equivalent, thus meeting the relevant regulatory acceptance criteria for market clearance without requiring new performance data or clinical trials.

Summary

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K122575
Page 1 of 4

510(k) SUMMARY

DEC 2 0 2012

Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens

1.0 Submitter Information:

Bausch & Lomb
1400 North Goodman Street
Rochester, NY 14609
Contact: Nancy Fehrman
Senior Specialist, Global Regulatory Affairs
1400 North Goodman Street
Rochester, NY 14609
(585) 338-5735 (office)
(585) 338-0702 (fax)
Nancy.a.fehrman@bausch.com
Preparation Date: August 22, 2012

2.0 Device Name:

Trade Name:	Bausch & Lomb PureVision (balafilcon A) VisibilityTinted Contact Lens and Bausch & Lomb PureVisionToric (balafilcon A) Visibility Tinted Contact Lens
Common Name:	soft (hydrophilic) contact lens
Device Classification:	Class II (21 CFR 886.5925 (b) (1))

3.0 Predicate Device

The predicate device; OxyCor (balafilcon A) Visibility Tinted Contact Lens was selected to demonstrate substantial equivalence of the lens material, replacement schedules, and indications for use. OxyCor was cleared in 510(k) Premarket Notification K972454 on August 8, 1997.

4.0 Device Description

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5.0 Intended Use

The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lenses may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in powers ranging from +20.00D to -20.00D for daily wear.

The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.

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K122575
Page 3 of 4

6.0 Technological Characteristics (comparison to Predicate Device)

The subject devices are identical to the predicate device cleared under K972454. The table below shows a side-by-side comparison of the predicate device to the subject devices:

Property	OxyCor (balafilcon A) Visibility TintedContact Lens	PureVision and PureVision Toric(balafilcon A) Visibility TintedContact Lens
	K972454
Material	Balafilcon A
Water Content	36%
Physical/opticalproperties	Specific Gravity: 1.064
	Refractive Index: 1.426
	Surface Character: Hydrophilic
OxygenPermeability*	91 (Boundary and Edge Corrected)
	101 (Boundary and Non-Edge Corrected)*Dk Units = x10-11[cm3O2(STP)xcm]/(secxcm2xmm Hg)@35°C(Polarographic Method)
Color Additive	Reactive Blue Dye 246	Same
ManufacturingMethod	Cast Mold
Lens Design	Spherical and Toric
Replacement	Frequent/Planned Replacement orDisposable Wear
Base Curve	7.8 to 9.5 mm
Diameter	13.5 to 15.0 mm
Sphere Powers	+20.00D to -20.00D
Cylinder Powers	0.00D to 10.00D
Axis	0° to 180°
Center Thickness	0.05 mm to 0.50 mm (varies with power)
Difference
Indications ForUse	Exhibiting Astigmatism up to 10.00diopters	Exhibiting Astigmatism up to2.00 diopters (spherical design)or up to 5.00 diopters(toric design)(within currently clearedindications)

7.0 Summary of Non-Clinical Testing

There has been no change made to this device and therefore no non-clinical testing was required to demonstrate substantial equivalence to the predicate device.

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8.0 Clinical Testing

There has been no change made to this device and therefore no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

9.0 Substantial Equivalence

There has been no change made to the predicate device. The Indications for Use are within the range previously cleared under K972454. This submission only provides specificity to the Indications for Use for the eye care practitioners regarding prescribing these lenses for frequent/planned replacement wear or disposable wear and to limit the use within the currently cleared indications. Therefore, the Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens are substantially equivalent to the OxyCor (balafilcon A) Visibility Tinted Contact Lens cleared in 510(k) Premarket Notification K972454 on August 8, 1997.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 stylized eagle with three curved lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.

December 20, 2012

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Bausch & Lomb, Incorporated % Ms. Nancy A. Fehrman Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609

Re: K122575

Trade/Device Name: Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens, Bausch & Lomb Pure Vision Toric (balafilcon A) Visibility Tinted Contact Lens

Regulation Number: 21 CFR 886.5925

Regulation Name: Soft (hydrophilic) contact lens

Regulatory Class: Class II

Product Code: LPL

Dated: December 7, 2012

Received: December 10, 2012

Dear Ms. Fehrman:

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, 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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Page 2 - Ms. Nancy A. Fehrman

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 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Eric A. Mann for

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

510(k) Number (if known):

K122575

Device Name:

Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens

Indications for Use:

FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned Replacement Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact 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.

DISPOSABLE WEAR

When prescribed for Disposable Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.

Over-The-Counter Use AND/OR Prescription Use V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

A
(Division Sign-Off)

Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K122575

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.