Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for the correction of refractive ametropia) and hyperopia) and presbyopia in aphakic and/or non-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 in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

Device Description

The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline solution with poloxamine, poloxamer 181, glycerin, and erythritol. A UV-absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246. The multifocal lenses will be manufactured with the following parameters: Diameter 13.5mm to 15.0mm, Center Thickness 0.05mm to 0.75mm, Base Curve 7.8mm to 9.5mm, Power Range +20.00D to -20.00D, Add Power (Multifocal) +0.75D to +5.00D. The lenses are packaged in disposable blister packages containing phosphate buffered saline solution.

AI/ML Overview

I'm sorry, but this document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving a device meets them. The document is an FDA 510(k) clearance letter and synopsis for a contact lens, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed report of a specific study's methodology and results against defined acceptance criteria.

Here's what I can extract and what's missing based on your request:

What is available:

Device Performance (from "Physical, Chemical and Spectral Properties"):
- Refractive index: 1.4011
- Light transmission: 97%
- Water Content: 55%
- Specific Gravity: 1.029
- Oxygen Permeability: 107 x 10-11 [cm³O2(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
Non-Clinical Performance Data Overview: The document states that "Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user." It also lists the types of non-clinical tests conducted on the predicate device (K200528), which are deemed applicable to the subject device because it uses the identical lens material, manufacturing process, sterilization process, and packaging. These tests include:
- Toxicology / Biocompatibility (In-Vitro Cytotoxicity, Ocular Irritation Study, Systemic Toxicity)
- Chemistry / Leachables (Leachable Monomer and Additives)
- Physical, Chemical and Spectral Properties (as listed above)
Clinical Performance Data Overview: The document states, "Clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528. Because the subject device is of the identical lens material, kalifilcon A, the clinical study performed on the predicate device is applicable and no additional clinical study was performed."

What is missing from the provided text:

Detailed Acceptance Criteria Table: While mechanical and physical properties for the lens are listed, specific acceptance criteria (e.g., "oxygen permeability must be greater than X") and a direct side-by-side comparison to explicitly stated acceptance criteria are not provided. The document implies "conformance to predetermined specifications" but doesn't list them.
Sample Size for the Test Set: This information is not provided for either non-clinical or clinical studies.
Data Provenance (country of origin, retrospective/prospective): Not specified.
Number of Experts and Qualifications: This would typically be relevant for clinical studies involving expert assessment, which isn't detailed here.
Adjudication Method: Not applicable or provided in this context.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is not applicable to a contact lens approval and is not mentioned.
Standalone Performance (algorithm only): Not applicable as this is a physical medical device, not an AI/algorithm.
Type of Ground Truth Used: Not explicitly stated beyond "clinical performance data to confirm safety and effectiveness" for the predicate device.
Sample Size for the Training Set: Not applicable as this is not an AI/machine learning device.
How Ground Truth for Training Set was Established: Not applicable.

To get the specific acceptance criteria and detailed study methodologies, one would typically need to refer to the full 510(k) submission (K210975) and its referenced predicate (K200528), which are usually much more extensive documents than the clearance letter and summary provided.

Summary

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May 24, 2021

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

Re: K210975

Trade/Device Name: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: March 30, 2021 Received: April 1, 2021

Dear 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/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K210975

Device Name

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

Indications for Use (Describe)

The lens is to be prescribed for single-use disposable wear, and 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:	May 14, 2021
Name:	Bausch & Lomb Incorporated
Address:	1400 North Goodman StreetRochester, NY 14609
Contact Person:	Barbara Klube-FalsoDirector, Regulatory Affairs
Phone Number:	(585) 338-8503(585) 338-0702 (fax)
Email:	barbara.klube-falso@bausch.com

Device Information:

Trade Names:	Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens forPresbyopia
Common Name:	Soft daily disposable contact lens
Classification Name:	Soft (hydrophilic) contact lens (21 CFR 886.5925)
Device Classification:	Class II
Product Code:	LPL, MVN

Predicate Devices:

. Bausch + Lomb kalifilcon A Contact Lens (K200528) cleared on June 2, 2020.
Bausch + Lomb Biotrue ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens . (K132715) cleared on December 20, 2013.

Device Description:

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characteristics are less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. This lens is tinted blue with Reactive Blue Dye 246.

The physical properties of the lens are:

Refractive index	1.4011
Light transmission	97%
Water Content	55%
Specific Gravity	1.029
Oxygen Permeability	107 x 10-11[cm³O2(STP) x cm]/(sec x cm² x mmHg)@35°C(polarographic method)

The multifocal lenses will be manufactured with the following parameters:

Diameter	13.5mm to 15.0mm
Center Thickness	0.05mm to 0.75mm
Base Curve	7.8mm to 9.5mm
Power Range	+20.00D to -20.00D
Add Power (Multifocal)	+0.75D to +5.00D

The lenses are packaged in disposable blister packages containing phosphate buffered saline solution. Blister packages are labeled with lot number, expiration date and applicable lens parameters. Expiration dating is supported by product stability, package integrity, and validation of the sterilization process.

Intended Use:

Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-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 in spherical powers ranging from +20.00D to -20.00D with add powers ranging from +0.75D to +5.00D.

The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.

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Table 1: Technological Characteristics (comparison to predicate device)

Property	Predicate DeviceBausch + Lombkalifilcon A Contact LensK200528	Predicate DeviceBausch + Lomb Biotrue®ONEday for Presbyopia(nesofilcon A) ContactLensK132715	Subject DeviceBausch + Lomb(kalifilcon A) Soft(hydrophilic) ContactLens for PresbyopiaK210975	Material Group	Group 5-BSilicone Hydrogel(high water, non-ionic)	Group II(high water, no ionicpolymers)	SameGroup 5-B (K200528)
Functionality	The contact lens acts as arefractive medium thatfocus light rays from nearand distant objects on theretina.	Same	Same	USAN Name	Kalifilcon A	Nesofilcon A	SameKalifilcon A (K200528)
Lens Design	Spherical and Toric	Multifocal	SameMultifocal (K132715)	Water Content	55%	78%	Same55% (K200528)
Indications for Use	Kalifilcon A Contact Lens:Indicated for daily wear forthe correction of refractiveametropia (myopia andhyperopia) in aphakicand/or non-aphakicpersons with non-diseasedeyes that exhibit refractiveastigmatism of 2.00diopters or less, that doesnot interfere with visualacuity. The lens may beprescribed in sphericalpowers ranging from+20.00D to -20.00D.Kalifilcon A Contact Lensfor Astigmatism:Indicated for daily wear forthe correction of refractiveametropia (myopia,hyperopia, andastigmatism) in aphakicand/or non-aphakicpersons with non-diseasedeyes, exhibitingastigmatism of up to 5.00diopters.The lens is to be prescribedfor single-use disposablewear, and is to bediscarded after eachremoval.Not Indicated for Multifocal	Indicated for daily wear forthe correction of refractiveametropia (myopia,hyperopia, and astigmatism)and presbyopia in aphakicand/or not-aphakic personswith non-diseased eyes,exhibiting astigmatism of2.00 diopters or less, thatdoes not interfere with visualacuity. The lens provides apower range of +20.00 to -20.00 diopters with addpower ranging from +0.75Dto +5.00D.The lens is to be prescribedfor single-use disposablewear, and is to be discardedafter each removal.	Indicated for daily wear forthe correction of refractiveametropia (myopia andhyperopia) and presbyopiain aphakic and/or non-aphakic persons with non-diseased eyes, exhibitingastigmatism of 2.00diopters or less, that doesnot interfere with visualacuity. The lens may beprescribed in sphericalpowers ranging from+20.00D to -20.00D withadd powers ranging from+0.75D to +5.00D.The lens is to be prescribedfor single-use disposablewear, and is to bediscarded after eachremoval.	UV Blocker	Yes	Same	Same
Modality	Daily Disposable	Same	Same	Sterilization	Air Over Steam	Same	Same
ManufacturingMethod	Cast Molded	Same	Same	Packaging	Polypropylene blister withplastic coated aluminiumfoil blister	Same	Same
Packaging Solution	Phosphate Buffered Saline	Borate Buffered Saline	SamePhosphate Buffered Saline(K200528)

A side-by-side comparison of the predicate devices to the new device:

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K210975

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K210975

Summary of Non-Clinical Performance Data:

The testing performed on the Bausch + Lomb kalifilcon A Contact Lens demonstrated that the device functions in a safe and effective manner. Performance testing included conformance to predetermined specifications, functional test results verify that the device performs as expected and is equivalent to the predicate without creating additional risk to the user.

In addition, Bausch + Lomb followed the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994, the following tests were conducted:

Toxicology / Biocompatibility

In-Vitro Cytotoxicity

Ocular Irritation Study

Systemic Toxicity

Chemistry / Leachables

Physical, Chemical and Spectral Properties

Leachable Monomer and Additives

The testing performed on the predicate device, Bausch + Lomb kalifilcon A contact lens, K200528, 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, and the finished lens parameters fall within the ranges previously cleared for the predicate device and therefore the previous testing is fully applicable.

Summary of Clinical Performance Data

Clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528. Because the subject device is of the identical lens material, kalifilcon A, the clinical study performed on the predicate device is applicable and no additional clinical study was performed.

Substantial Equivalence Conclusion:

The information submitted in this premarket notification supports the determination that the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia 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.