(370 days)
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens maybe prescribed in spherical powers ranging from +20.00D to -20.00D.
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.
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 acuty. 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.
The Bausch + Lomb kalifilcon A material is made from a hvdrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with poloxamine, poloxamer 181, qlycerin, erythritol, and polyguaternium. 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 Bausch + Lomb kalifilcon A Contact Lenses are to be prescribed for single-use disposable wear.
The physical properties of the lenses 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 lenses will be manufactured in spherical, toric and multifocal designs 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
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis: 0° to 180°
Add Power (Multi-Focal): +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.
The provided text describes the acceptance criteria and a study for the Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens. It is important to note that this is a 510(k) submission, meaning the device is being cleared as "substantially equivalent" to predicate devices, rather than requiring a full demonstration of novel safety and effectiveness through extensive new clinical trials. Therefore, the "study" demonstrating it meets acceptance criteria largely relies on equivalence to previously cleared devices and specific non-clinical and limited clinical testing.
Here's the breakdown of the information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" in a quantitative table for "performance" as one might expect for a diagnostic or AI-driven device. Instead, the "acceptance criteria" for this contact lens are implicitly met through demonstrating:
- Conformance to predetermined specifications: Physical properties, dimensional parameters, materials, and manufacturing processes.
- Functional performance: The device performs as expected.
- Safety and effectiveness equivalence: To predicate devices by showing identical lens material, manufacturing process, sterilization process, packaging, and that finished lens parameters fall within previously cleared ranges.
- Biocompatibility and toxicology: Showing the device is non-cytotoxic, not an ocular irritant, and not a sensitizing agent.
Here's a table summarizing the physical properties that are part of the device's specifications and performance:
| Property | Acceptance Criteria (Predicate/Subject Device Performance) |
|---|---|
| Material Group | Group 5-B Silicone Hydrogel (high water, non-ionic) |
| USAN Name | kalifilcon A |
| 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) |
| UV Blocker | Yes (transmittance < 5% in UVB, < 50% in UVA) |
| Sterilization | Air Over Steam |
| Packaging | Polypropylene blister with plastic coated aluminum foil blister |
| Packaging Solution | Phosphate Buffered Saline with polyquaternium (for subject device) |
| Daily Wear Indication | Correction of refractive ametropia (myopia/hyperopia/astigmatism/presbyopia) in non-diseased eyes |
| 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 |
| Cylinder Power (Toric) | -0.75D to -5.00D |
| Cylinder Axis | 0° to 180° |
| Add Power (Multi-Focal) | +0.75D to +5.00D |
| Cytotoxicity | Non-cytotoxic |
| Ocular Irritation | Not an ocular irritant |
| Systemic Toxicity | Not a sensitizing agent |
The device performance aligns with these specifications, as the submission states that "The testing performed on the Bausch + Lomb kalifilcon A Contact Lens demonstrated that the device functions in a safe and effective manner" and its "finished lens parameters fall within the ranges previously cleared for the predicate device."
2. Sample size used for the test set and the data provenance
For this 510(k) submission, the "test set" to demonstrate safety and effectiveness for the subject device heavily relies on the clinical data from its predicate devices due to the identical lens material, manufacturing process, and sterilization. Therefore:
- Sample size used for the test set: Not directly provided for new clinical data specific to this submission. The clinical performance data to confirm safety and effectiveness of the kalifilcon A lens material was obtained and provided in K200528 (one of the predicate devices).
- Data provenance: The original clinical data for the kalifilcon A material comes from the predicate device K200528. This document does not specify the country of origin or whether it was retrospective or prospective, but clinical trials for medical devices are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. Given that the clinical data is leveraged from a predicate device (K200528), the details about how clinicians or experts were involved in establishing "ground truth" (e.g., patient outcomes, visual acuity measurements) would be in the original K200528 submission. For a contact lens, "ground truth" often relates to objective measures of visual acuity, comfort, lens fit, and ocular health assessments by ophthalmologists or optometrists.
4. Adjudication method for the test set
This information is not provided in the document. As with the expert details, any adjudication methods for clinical outcomes would be found in the documentation for the predicate studies (K200528 and K210975).
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 is not applicable to this device. A contact lens is a medical device for vision correction, not an AI-assisted diagnostic or imaging device that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable to this device. It is a physical contact lens, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the referenced clinical data from K200528 (predicate device), the "ground truth" would primarily be outcomes data related to contact lens wear, including:
- Visual acuity measurements
- Lens fit assessments
- Measures of ocular health (e.g., absence of adverse events like infection, corneal staining, neovascularization)
- Patient comfort and satisfaction.
These outcomes would typically be assessed by eye care professionals.
8. The sample size for the training set
This is not applicable as this is a physical medical device, not an AI/machine learning model that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable for the reason stated in point 8.
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March 8, 2023
Bausch & Lomb Incorporated Barbara Klube-Falso Director, Regulatory Affairs 1400 North Goodman street Rochester, NY 14609
Re: K220613
Trade/Device Name: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism, 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: January 31, 2023 Received: February 3, 2023
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 mediation-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 -S
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) K220613
Device Name
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia
Indications for Use (Describe)
Kalifilcon A Contact Lens
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens maybe prescribed in spherical powers ranging from +20.00D to -20.00D.
Kalifilcon A Contact Lens for Astigmatism
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (ന്യാഗ്രം, hyperopia and astigmatism) in aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.
Kalifilcon A Contact Lens for Presbyopia
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 acuty. 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.
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 K220613
Submitter Information:
| Date Prepared: | January 31, 2023 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman StreetRochester, NY 14609 |
| Contact Person: | Barbara Klube-FalsoDirector, Regulatory Affairs |
| Phone Number: | (585) 338-8503 |
| Email: | Barbara.Klube-Falso@bausch.com |
Device Information:
| Trade Name: | Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens, |
|---|---|
| Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens forAstigmatism, and | |
| 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) Soft (hydrophilic) Contact Lens and Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism cleared under K200528
and
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens cleared under K210975.
Device Description:
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The Bausch + Lomb kalifilcon A material is made from a hvdrophilic siloxane copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with poloxamine, poloxamer 181, qlycerin, erythritol, and polyguaternium. 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 Bausch + Lomb kalifilcon A Contact Lenses are to be prescribed for single-use disposable wear.
The physical properties of the lenses 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 lenses will be manufactured in spherical, toric and multifocal designs 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 |
| Cylinder Power (Toric) | -0.75D to -5.00D |
| Cylinder Axis | 0° to 180° |
| Add Power (Multi-Focal) | +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.
Indications for Use:
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes that exhibit refractive 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.
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters.
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
{5}------------------------------------------------
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.
| Property | Predicate DeviceBausch + Lombkalifilcon A Contact LensesK200528 | Predicate DeviceBausch + Lombkalifilcon A Contact Lens forPresbyopiaK210975 | Subject DeviceBausch + Lombkalifilcon A ContactLenses |
|---|---|---|---|
| Intended Use | Bausch + Lomb kalifilcon AContact Lens is indicated for thedaily wear correction of refractiveametropia (myopia and hyperopia)in aphakic and/or non-aphakicpersons with non-diseased eyesthat exhibit refractive astigmatismof 2.00 diopters or less, that doesnot interfere with visual acuity. Thelens may be prescribed inspherical powers ranging from+20.00D to -20.00D.Bausch + Lomb kalifilcon AContact Lens for Astigmatism isindicated for the daily wearcorrection of refractive ametropia(myopia, hyperopia andastigmatism) in aphakic and/ornon-aphakic persons with non-diseased eyes, exhibitingastigmatism of up to 5.00 diopters,that does not interfere with visualacuity.The lens is to be prescribed forsingle-use disposable wear and isto be discarded after eachremoval. | Bausch + Lomb (kalifilcon A)Soft (hydrophilic) ContactLens for Presbyopia isindicated for daily wear for thecorrection of refractiveametropia (myopia andhyperopia) and presbyopia inaphakic and/or non-aphakicpersons with non-diseasedeyes, exhibiting astigmatismof 2.00 diopters or less, thatdoes not interfere with visualacuity. The lens may beprescribed in sphericalpowers ranging from +20.00Dto -20.00D with add powersranging from +0.75D to+5.00D.The lens is to be prescribedfor single-use disposablewear and is to be discardedafter each removal. | Same as predicate |
| Functionality | The contact lenses act as arefractive medium that focus lightrays from near and distant objectson the retina. | The contact lenses act as arefractive medium that focuslight rays from near anddistant objects on the retina. | Same as predicate |
| Modality | Daily Disposable | Daily Disposable | Same as predicate |
| ManufacturingMethod | Cast Molded | Cast Molded | Same as predicate |
| MaterialGroup | Group 5-B Silicone Hydrogel(high water, non-ionic) | Group 5-B Silicone Hydrogel(high water, non-ionic) | Same as predicate |
| USAN Name | kalifilcon A | kalifilcon A | Same as predicate |
| WaterContent | 55% | 55% | Same as predicate |
| UV Blocker | Yes | Yes | Same as predicate |
| Sterilization | Air Over Steam | Air Over Steam | Same as predicate |
| Packaging | Polypropylene blister with plasticcoated aluminium foil blister | Polypropylene blister withplastic coated aluminium foilblister | Same as predicate |
| PackagingSolution | Phosphate Buffered Saline | Phosphate Buffered Saline | PhosphateBuffered Salinewithpolyquaternium |
Technological Characteristics (comparison to predicate devices):
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Summary of Non-Clinical Testing:
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 Chemistry / Leachables testing performed on the predicate device, Bausch + Lomb (kalifilcon A) Soft (hydrophilic) 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.
Due to the additional inqredient in the packaging solution, toxicology and biocompatibility testing was repeated on the subject devices. The results were consistent with the predicate devices, the kalifilcon A contact lenses are non-cytotoxic, not an ocular irritant or a sensitizing agent.
Summary of Clinical Performance Data
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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 Contact Lenses are substantially equivalent in principles of operation, technology, materials and indications for use to the predicate devices listed above.
§ 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.