(370 days)
Not Found
No
The document describes a contact lens and its physical properties, materials, and intended use. 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 (myopia, hyperopia, and astigmatism) and presbyopia, which are optical corrections, not therapeutic treatments for a disease.
No
Explanation: The device is a contact lens indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia. Its purpose is to correct vision, not to diagnose a medical condition.
No
The device description clearly details a physical contact lens made from a specific material with defined physical properties and manufacturing parameters. It is a tangible hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "daily wear correction of refractive ametropia (myopia and hyperopia)" and "correction of refractive ametropia (myopia, hyperopia and astigmatism)" and "correction of refractive ametropia) and hyperopia) and presbyopia". These are all related to correcting vision problems, not diagnosing a disease or condition through in vitro examination of specimens.
- Device Description: The description focuses on the physical properties and materials of a contact lens designed to be worn on the eye.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.
The device is a medical device, specifically a contact lens, intended for vision correction.
N/A
Intended Use / 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 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 (myopia, 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.
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 with poloxamine, poloxamer 181, glycerin, 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.
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)
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 ingredient 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:
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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 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
Image /page/1/Picture/9 description: The image shows the logo for the Food and Drug Administration (FDA). The logo consists of the letters "FDA" in a sans-serif font. The letters are a light blue color. The logo is simple and recognizable, and it is often used on products that have been approved by the FDA.
2
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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3
510(k) SUMMARY K220613
Submitter Information:
| Date Prepared: | January 31, 2023 |
|---|---|
| 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 |
| 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 for | |
| Astigmatism, and | |
| 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) 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:
4
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 Device
Bausch + Lomb
kalifilcon A Contact Lenses
K200528 | Predicate Device
Bausch + Lomb
kalifilcon A Contact Lens for
Presbyopia
K210975 | Subject Device
Bausch + Lomb
kalifilcon A Contact
Lenses |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|
| Intended Use | Bausch + Lomb kalifilcon A
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
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,
that does not interfere with visual
acuity.
The lens is to be prescribed for
single-use disposable wear and is
to be discarded after each
removal. | 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. | Same as predicate |
| Functionality | The contact lenses act as a
refractive medium that focus light
rays from near and distant objects
on the retina. | The contact lenses act as a
refractive medium that focus
light rays from near and
distant objects on the retina. | Same as predicate |
| Modality | Daily Disposable | Daily Disposable | Same as predicate |
| Manufacturing
Method | Cast Molded | Cast Molded | Same as predicate |
| Material
Group | 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 |
| Water
Content | 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 plastic
coated aluminium foil blister | Polypropylene blister with
plastic coated aluminium foil
blister | Same as predicate |
| Packaging
Solution | Phosphate Buffered Saline | Phosphate Buffered Saline | Phosphate
Buffered Saline
with
polyquaternium |
Technological Characteristics (comparison to predicate devices):
6
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
7
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.