The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is indicated for daily wear for the correction of refractive ametropia (myeropia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.

The lens may be prescribed for Frequent/Planned Replacement Wear in a power range of +20.00 to -20.00 diopters.

Device Description

The Bausch + Lomb (samfilcon A) Multifocal for Astigmatism Contact Lens 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 1107 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.

AI/ML Overview

This document is a 510(k) premarket notification for the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens. It asserts substantial equivalence to previously cleared predicate devices, using existing data for safety and effectiveness. Therefore, the information provided does not describe a new study conducted to establish acceptance criteria or device performance for this specific multifocal astigmatism lens. Instead, it leverages data from the predicate devices.

Based on the provided text, a new study for this specific device to establish acceptance criteria and device performance was not conducted. The provided text relies on the established safety and effectiveness of predicate devices and the material used. As such, direct answers to many of your questions regarding a new study's acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone performance are not present.

However, I can extract the information related to the performance data and the basis for the declaration of substantial equivalence.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the context of a new study for the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens. Instead, it references conformance to "predetermined specifications and functional testing to verify that the device performs as expected without creating additional risk to the user" for the predicate device's material.

The physical properties of the new device are reported, which can be considered performance characteristics that would need to meet certain specifications.

Physical Property	Reported Device Performance
Refractive Index	1.411
Light Transmittance	97.3%
Water Content	46%
Specific Gravity	1.048
Oxygen Permeability	114 x 10^-11 [cm^3 O^2 (STP) x cm] / (sec x cm^2 x mmHg) @35°C

2. Sample size used for the test set and the data provenance

The document explicitly states: "Due to the similarities between the subject device and the predicate device, the clinical study performed on the predicate device is applicable to the subject device and no additional clinical study was performed."

Therefore, there is no new test set sample size reported for the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens. The provenance of the data is based on the clinical study of the predicate device, Bausch + Lomb Ultra (samfilcon A) Contact Lens. The document does not specify the country of origin or whether the predicate study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

As no new clinical study was performed for this specific device, this information is not provided in the document.

4. Adjudication method for the test set

As no new clinical study was performed for this specific device, this information is not provided in the document.

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 device is a contact lens and not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and not mentioned.

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

This device is a contact lens and not an algorithm. Therefore, a standalone performance study for an algorithm is not applicable and not mentioned.

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

For the predicate device's clinical study, the "ground truth" would implicitly be related to patient outcomes, visual acuity, comfort, and physiological responses associated with contact lens wear, which are typically assessed by eye care professionals. However, the exact type of ground truth and how it was established for the predicate study is not detailed in this 510(k) summary. The summary mentions "clinical performance data to confirm safety and effectiveness" of the samfilcon A lens material.

8. The sample size for the training set

This contact lens is not an AI algorithm, so there is no training set in the context of machine learning. The data used for establishing the safety and effectiveness of the material comes from a clinical study of the predicate device, but the sample size of that study is not detailed here.

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

As there is no training set for an AI algorithm, this question is not applicable. For the predicate clinical study, the safety and effectiveness data would have been collected and evaluated by relevant healthcare professionals. The specific methodology for establishing "ground truth" in that clinical study is not detailed in this document.

Summary

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November 30, 2018

Bausch & Lomb Incorporated Barbara Klube-Falso Associate Director Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609

Re: K182249

Trade/Device Name: Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 1, 2018 Received: November 2, 2018

Dear Ms. Barbara 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely yours,

J. Angelo Green

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) K182249

Device Name

Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens

Indications for Use (Describe)

The lens may be prescribed for Frequent/Planned Replacement Wear in a power range of +20.00 to -20.00 diopters.

FREQUENT/PLANNED REPLACEMENT WEAR

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

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

Submitter Information:

Date Prepared:	August 16, 2018
Name:	Bausch & Lomb Incorporated
Address:	1400 North Goodman StreetRochester, NY 14609
Contact Person:	Barbara Klube-FalsoAssociate Director, Regulatory Affairs
Phone Number:	(585) 338-8503(585) 338-0702 (fax)
Email:	Barbara.Klube-Falso@bausch.com

Device Information:

Trade Name:	Bausch + Lomb Ultra (samfilcon A) Multifocal forAstigmatism Contact Lens
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:	MVN, LPL

Predicate Device:

The predicate devices are

Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact ● Lenses cleared under K131208, and
. Coopervision, Inc., Avaira Vitality (fanfilcon A) Multifocal Toric Soft (hydrophilic) Contact Lens cleared under K160803.

Device Description:

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The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine 1107 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 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method)

The lens design includes 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

Indications for Use:

The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens 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 non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.

The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters.

FREQUENT/PLANNED REPLACEMENT WEAR

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DISPOSABLE WEAR

When prescribed for Disposable Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens, is to be discarded after each removal.

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 DeviceBausch + Lomb(samfilcon A)K131208	Predicate DeviceCoopervisionMultifocal Toric(fanfilcon A)K160803	New DeviceBausch + Lomb(samfilcon A) Multifocalfor Astigmatism Lens
Intended Use	Daily Wear, DailyDisposable	Daily Wear, DailyDisposable	Same
Lens MaterialGroup	Silicone Hydrogel	Silicone Hydrogel	Same
Visibility Tint	Reactive Blue 246	Reactive Blue 246	Same
ManufacturingMethod	Cast Molded	Cast molded	Same
Lens Designs	Spherical, Toric, Multifocal	Multifocal Toric	Multifocal Toric
SterilizationMethod	Moist Heat	Moist Heat	Same
Packaging	Polypropylene Blister	blister	Polypropylene Blister
PackagingSolution	Borate Buffered Salinewith Poloxamine	Buffered salinesolution	Borate buffered salinewith Poloxamine
USAN Name	samfilcon A	fanfilcon A	samfilcon A
WaterContent	46%	55%	46%

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Summary of Non-Clinical Performance Data:

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 material, samfilcon Testing was performed in accordance with the FDA quidance titled Premarket A. Notification (510(k)) Guidance document for Daily Wear Contact Lenses, May 1994 and GLP regulation 21 CFR part 58 and included the following:

Leachable
· Ocular Irritation Lens device, Packaging
· Sensitization
· Systemic Toxicity Lens device, Packaging

Performance testing included conformance to predetermined specifications and functional testing to verify that the device performs as expected without creating additional risk to the user.

Stability testing, real-time, was performed on the samfilcon A contact lens and demonstrates that the product is stable for five years.

The testing performed on the predicate device, Bausch + Lomb Ultra (samfilcon A) Contact Lens, demonstrated that the device functions in a safe and effective manner. The subject device is of the identical lens material, manufacturing process, sterilization process, and packaging, as the predicate device Bausch + Lomb Ultra (samfilcon A) Contact Lens. Therefore the previous testing is fully applicable.

Summary of Clinical Performance Data

Clinical performance data to confirm safety and effectiveness of the samfilcon A lens material in the daily disposable modality was obtained via a clinical study of the Bausch + Lomb Ultra (samfilcon A) Contact Lens. Due to the similarities between the subject device and the predicate device, the clinical study performed on the predicate device is applicable to the subject device and no additional clinical study was performed.

Substantial Equivalence Conclusion:

The information submitted in this premarket notification supports the determination that the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is substantially equivalent in principles of operation, technology, materials and indications for use to the predicate devices listed above.

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.