The Bausch + Lomb (samfilcon A) Soft (hydrophilic) 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.

The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism 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.

The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with nondiseased 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 a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.

Device Description

The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is 46% water and 54% samfilcon A material (a siloxane copolymer with N-vinyl pyrrolidone). This lens is tinted blue with Reactive Blue Dye 246 to make them easier to see when handling.

The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine and a plastic coated aluminium lid stock. The disposable blister container and the lidstock are used in the predicate device. The packaged lenses are steam sterilized in a validated autoclave. Each lens is labelled with the lens parameters, lot number and expiration date.

Lenses have the following physical properties:
Refractive Index: 1.411
Light Transmittance: 97.3%
Water Content: 46%
Specific Gravity: 1.048
Oxygen Permeability: 114 x 10 to the power of -11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)

The lens designs include spherical, toric and multifocal lenses in the following parameter ranges:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis (Toric): 0° to 180°
Add Power (Multi-Focal): +0.75D to +5.00D

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, and its astigmatism and presbyopia variants.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (Pre-established)	Reported Device Performance (Summary)
Non-Clinical Testing	Conformance to predetermined specifications (for physiochemical, biocompatibility, ocular irritation, stability, preservative uptake, extractables, solution compatibility tests).	All test results met the pre-established acceptance criteria. The testing demonstrates the lens is safe and effective and is substantially equivalent to the predicate device without adversely impacting safety and efficacy.
Clinical Testing (Safety)	Primary safety variable: biomicroscopy findings. No adverse events occurred.	Primary safety endpoint was achieved; no adverse events occurred during the study.
Clinical Testing (Efficacy)	Primary efficacy variable: visual acuity. Achieved.	Primary efficacy endpoint was achieved.
Overall Comparison	Substantial equivalence to predicate device (Bausch + Lomb PureVision (balafilcon A) Contact Lens).	Demonstrated substantial equivalence to the predicate device. The results demonstrated the lens is safe and effective and is substantially equivalent.

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

Sample Size (Clinical Study): Not explicitly stated with a specific number of subjects. The text mentions "a prospective, three-month randomized clinical study utilizing adopted soft contact lens wearers."
Data Provenance: The study was a prospective clinical study. The country of origin is not specified but is implied to be within the scope of FDA approval requirements (likely conducted in the US or under protocols acceptable to the FDA).

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

Number of Experts: Not explicitly stated.
Qualifications of Experts: Not explicitly stated. For a contact lens clinical study, the assessment of safety (biomicroscopy findings) and efficacy (visual acuity) would typically be performed by trained ophthalmologists, optometrists, or qualified clinical staff.

4. Adjudication Method for the Test Set

Adjudication Method: Not explicitly mentioned. Clinical studies often involve multiple observers for key endpoints, but no specific adjudication method (e.g., 2+1, 3+1) is detailed in the summary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

MRMC Study: No, an MRMC comparative effectiveness study was not mentioned or conducted. This would typically apply to diagnostic imaging devices where multiple readers interpret cases. For this contact lens, a clinical trial comparing the new lens to a predicate device in human subjects was performed.
Effect Size of Human Readers Improvement with AI vs. without AI Assistance: Not applicable, as this is not an AI-assisted device.

6. If a Standalone (Algorithm only without human-in-the-loop performance) was done

Standalone Performance: Not applicable, as this is a contact lens and not an algorithm or AI device. The tests performed are on the physical device and its clinical performance with human users.

7. The Type of Ground Truth Used

Ground Truth (Clinical Study): The ground truth for the clinical study was established through primary safety variables (biomicroscopy findings) and primary efficacy variables (visual acuity), along with additional variables like refraction, keratometry, and ratings of vision, comfort, and handling. This is essentially clinical observation and measurement by healthcare professionals.

8. The Sample Size for the Training Set

Sample Size (Training Set): Not applicable. This device is a physical contact lens, not a machine learning algorithm that requires a training set. The "testing" refers to non-clinical and clinical evaluation of the device itself.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Summary

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K131208

2013

Bausch + Lomb Traditional 510(k) Premarket Notification Bausch + Lomb samfilcon A Contact Lens

510(k) SUMMARY

Submitter Information:

Date Prepared:	August 14, 2013
Name:	Bausch & Lomb Incorporated
Address:	1400 North Goodman StreetRochester, NY 14609
Contact Person:	Barbara Klube-FalsoSr. Regulatory Specialist, Global Regulatory Affairs
Phone Number:	(585) 338-8503(585) 338-0702 (fax)
Email:	Barbara.Klube-Falso@bausch.com

Device Information:

Trade Name:

Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens

Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism

Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia

Common Name: Soft contact lens, daily wear

Device Classification: Class II (21 CFR 886.5925)

Classification Name: Daily Wear Soft (Hydrophilic) Contact Lens

Product Code: LPL, MVN

Predicate Device:

The predicate device is the

Bausch + Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens cleared . under K122575,
Bausch + Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens . cleared under K122575,
Bausch + Lomb PureVision Multi-Focal (balafilcon A) Visibility Tinted Contact . Lens cleared under K050948.

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Bausch + Lomb	Page 2 of 5
Traditional 510(k) Premarket Notification	SECTION 5
Bausch + Lomb samfilcon A Contact Lens	510(k) SUMMARY

Device Description:

Lenses have the following physical properties:

Refractive Index:	1.411
Light Transmittance:	97.3%
Water Content:	46%
Specific Gravity:	1.048
Oxygen Permeability:	114 x $10^{-11}$ [cm³O₂(STP) x cm]/(sec x cm² xmmHg)@35°C (polarographic method)

The lens designs include spherical, toric and multifocal lenses in the following parameter ranges:

Diameter	13.5mm to 15.0mm
Center Thickness	0.05mm to 0.75mm (varies with power)
Base Curve	7.8mm to 9.5mm
Power Range	+20.00D to -20.00D
Cylinder Power (Toric)	-0.75D to -5.00D
Cylinder Axis (Toric)	0° to 180°
Add Power (Multi-Focal)	+0.75D to +5.00D

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Bausch + Lomb	Page 3 of 5
Traditional 510(k) Premarket Notification	SECTION 5510(k) SUMMARY
Bausch + Lomb samfilcon A Contact Lens

Indications for Use:

to -20.00D.

The Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia 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 a power range of +20.00 to -20.00 diopters with add power ranging from +0.75D to +5.00D.

FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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 (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, and Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.

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Bausch + LombTraditional 510(k) Premarket NotificationBausch + Lomb samfilcon A Contact Lens	Page 4 of 5SECTION 5510(k) SUMMARY
------------------------------------------------------------------------------------------------------	--------------------------------------------

Technological Characteristics:

The table below shows a side-by-side comparison of technological characteristics evaluated to determine substantial equivalence of the new device to the predicate Differences were evaluated during the design and development of the new device. device. Performance testing was completed and demonstrated the proposed device and predicate device are substantially equivalent and the differences do not negatively impact the safety and efficacy of the device.

Property	Predicate Device(s)Bausch +Lomb PureVision(balafilcon A) Product FamilyK050948 and K122575	New DeviceBausch + Lomb (samfilcon A)Product Family
Intended Use	Daily Wear, Daily Disposable	Same
Lens Material Group	Silicone Hydrogel	Same
Visibility Tint	Reactive Blue 246	Same
ManufacturingMethod	Cast Molded	Same
Lens Designs	Spherical, Toric, Multifocal	Same
Sterilization Method	Autoclave	Same
Packaging	Polypropylene Blister	Same
Packaging Solution	Borate Buffered Saline	Borate buffered saline withPoloxamine
USAN Name	balafilcon A	samfilcon A
Water Content	36%	46%

Summary of Non-Clinical Testing:

Non-clinical testing was conducted to verify substantial equivalence of the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens to the predicate, Bausch & Lomb PureVision (balafilcon A) Contact Lens. Non-clinical biocompatibility was conducted in accordance with FDA's Premarket Notification 510(k) Guidance Document for Daily Wear Contact Lenses, May 1994 and GLP regulation (21 CFR part 58).

Non-clinical testing performed includes:

physiochemical per ISO 18369-4, .
biocompatibility per ISO 10993-5, ISO 10993-10 and ISO 10993-11, .
ocular irritation per ISO 9394, .

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Bausch + Lomb Page 5 of 5 SECTION ! Traditional 510(k) Premarket Notification 510(k) SUMMAR Bausch + Lomb samfilcon A Contact Lens

stability per ISO 11987, .
preservative uptake per ISO 11986, .
. extractables per ISO 18369-4 and
. solution compatibility ISO 11981.

All test results met the pre-established acceptance criteria.

The testing performed on the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens demonstrates the lens is safe and effective. Non-clinical testing included conformance to predetermined specifications. All test results verify that the device performs as expected and is substantially equivalent to the predicate device without adversely impacting safety and efficacy.

Summary of Clinical Performance Data:

A prospective, three-month randomized clinical study utilizing adopted soft contact lens wearers was conducted. This study evaluated the safety and effectiveness of the Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens. In addition, the study was performed to establish substantial equivalence to the predicate device, Bausch & Lomb PureVision (balafilcon A) Contact Lens.

The primary safety variable was biomicroscopy findings and the primary efficacy variable was visual acuity. Additional variables were tested, including refraction, keratometry and ratings of vision, comfort, and handling and "other" symptoms.

The primary safety and efficacy endpoints were achieved and no adverse events occurred during the study.

In conclusion, the results of the study demonstrated that the lens is safe and effective and is substantially equivalent to the predicate device.

Risks and Benefits:

The risks of the subject device are the same as those found in the predicate device. The benefits to the patient are the same as those in the predicate device and outweigh the risks when worn according to instructions.

Substantial Equivalence Conclusion:

The cumulative results of the non-clinical testing sponsored by Bausch + Lomb demonstrate that the safety, efficacy and performance of Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens are substantially equivalent to the predicate lenses and similar to other daily wear soft contact lenses on the market.

Any differences that may exist between the samfilcon A contact lens and other silicone hydrogels do not adversely affect the safety and efficacy of the Bausch + Lomb (samfilcon A) Contact Lens when worn according to instructions.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/5/Picture/2 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine.

September 11, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-(1609 Silver Spring, MD 20993-0002

Bausch + Lomb % Ms. Barbara Klube-Falso Sr. Specialist. Global Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K131208

Trade/Device Name: Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (samfileon A) Soft (hydrophilic) Contact Lens for Astigmatism, Bausch + Lomb (samfilcon A) Soft (hydrophilic) Contact Lens for Presbropia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 15. 2013 Received: August 19. 2013

Dear Ms. Klube-Falso:

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.

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.

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Page 2 - Ms. Barbara Klube-Falso

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 (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Kesia Y. Alexander -S

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):

Device Name: Bausch + Lomb samfilcon A Soft (hydrophilic) Contact Lens; Bausch + Lomb samfilcon A Soft (hydrophilic) Contact Lens for Astigmatism; Bausch + Lomb samfilcon A Soft (hydrophilic) Contact Lens for Presbyopia.

Indications For Use:

FREQUENT/PLANNED REPLACEMENT WEAR

Page 1 of 2

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DISPOSABLE WEAR

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Marc W. Robbov -5

-04-00, 17 12:31:15
03:50 PM (Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices 510(k) Number K131208

0392796

Digitally signed by Marc W.

DN c=US, o=U.S. Government, DUMHS. OU=FDA QU=People

cn=Marc W. Robboy -5.
0.9.2342.19200300.100.1.1=130

Page 2 of 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.