(53 days)
Not Found
No
The summary describes a contact lens and its material properties, manufacturing process, and performance testing. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is indicated for the correction of refractive ametropia and hyperopia and presbyopia, which are vision corrections, not therapeutic treatments for a disease or condition.
No
Explanation: The device is a soft hydrophilic contact lens indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia. It is a corrective device, not a diagnostic one.
No
The device description clearly indicates it is a physical contact lens made of a specific material, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is a medical device designed to be worn directly on the eye to correct vision. It does not analyze any biological samples.
- Intended Use: The intended use clearly states it's for the "correction of refractive ametropia) and hyperopia) and presbyopia". This is a therapeutic and corrective function, not a diagnostic one based on in vitro analysis.
The information provided describes a contact lens, which is a Class II medical device regulated by the FDA, but it falls under the category of ophthalmic devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is indicated 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.
Product codes
LPL, MVN
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. Underneath the square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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)
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.
| 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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3
510(k) Summary
Submitter Information:
| Date Prepared: | May 14, 2021 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street |
| Rochester, NY 14609 | |
| Contact Person: | Barbara Klube-Falso |
| Director, 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 for
Presbyopia |
|------------------------|--------------------------------------------------------------------------------|
| 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:
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
4
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 Device
Bausch + Lomb
kalifilcon A Contact Lens
K200528 | Predicate Device
Bausch + Lomb Biotrue®
ONEday for Presbyopia
(nesofilcon A) Contact
Lens
K132715 | Subject Device
Bausch + Lomb
(kalifilcon A) Soft
(hydrophilic) Contact
Lens for Presbyopia
K210975 | Material Group | Group 5-B
Silicone Hydrogel
(high water, non-ionic) | Group II
(high water, no ionic
polymers) | Same
Group 5-B (K200528) |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|------------------------------------------------------------------------|------------------------------------------------|--------------------------------|
| Functionality | The contact lens acts as a
refractive medium that
focus light rays from near
and distant objects on the
retina. | Same | Same | USAN Name | Kalifilcon A | Nesofilcon A | Same
Kalifilcon A (K200528) |
| Lens Design | Spherical and Toric | Multifocal | Same
Multifocal (K132715) | Water Content | 55% | 78% | Same
55% (K200528) |
| Indications for Use | Kalifilcon A Contact Lens:
Indicated for daily wear for
the 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.
Kalifilcon A Contact Lens
for Astigmatism:
Indicated for daily wear for
the 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.
The lens is to be prescribed
for single-use disposable
wear, and is to be
discarded after each
removal.
Not Indicated for Multifocal | 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
2.00 diopters or less, that
does not interfere with visual
acuity. The lens provides a
power range of +20.00 to -
20.00 diopters with add
power 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. | 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. | UV Blocker | Yes | Same | Same |
| Modality | Daily Disposable | Same | Same | Sterilization | Air Over Steam | Same | Same |
| Manufacturing
Method | Cast Molded | Same | Same | Packaging | Polypropylene blister with
plastic coated aluminium
foil blister | Same | Same |
| Packaging Solution | Phosphate Buffered Saline | Borate Buffered Saline | Same
Phosphate Buffered Saline
(K200528) | | | | |
A side-by-side comparison of the predicate devices to the new device:
6
K210975
7
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.