(92 days)
No
The summary describes a standard contact lens made of a specific material and its intended use for vision correction. There is no mention of any computational or analytical functions that would suggest the use of AI or ML.
Yes
The device is a contact lens used for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which falls under the definition of a therapeutic device as it addresses a medical condition (refractive error) to improve vision.
No
Explanation: The device is a contact lens intended for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), not for diagnosing medical conditions.
No
The device description clearly states the device is a contact lens made from a physical material (hydrophilic siloxane copolymer) and is a physical object intended for placement on the eye. It is not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body.
- Contact Lens Function: The Bausch + Lomb kalifilcon A Contact Lens is a device that is placed on the eye to correct vision. It does not perform any diagnostic tests on bodily samples.
- Intended Use: The intended use clearly states it is for the "daily wear correction of refractive ametropia (myopia and hyperopia)" and "correction of refractive ametropia (myopia, hyperopia and astigmatism)". This is a therapeutic/corrective function, not a diagnostic one.
The information provided describes a medical device used for vision correction, which falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Kalifilcon A Contact Lens
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.
Kalifilcon A Contact Lens for Astigmatism
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.
The kalifilcon A contact 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 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with 0.5% poloxamine solution. 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 Lens is to be prescribed for single-use disposable wear.
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 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
Cylinder Power (Toric) -0.75D to -5.00D
Cylinder Axis 0° to 180º
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)
Bausch + Lomb conducted a 3 month, controlled clinical study with approximately 247 patients, comparing the safety and efficacy of the Bausch + Lomb kalifilcon A Contact Lens to the Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens.
The primary safety endpoint was any slit lamp finding greater than Grade 2 over the course of the study. the primary efficacy endpoint was contact lens corrected distance high-contrast visual acuity averaged over all scheduled visits. All primary endpoints were achieved, and the results of the study indicate the test lens is safe and effective.
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 contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is 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 text.
June 02, 2020
Bausch + Lomb, Incorporated Barbara Klube-Falso Director, Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K200528
Trade/Device Name: Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: Mav 4, 2020 Received: May 6, 2020
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.
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
1
(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-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-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, 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) K200528
Device Name
Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens Bausch + Lomb (kalifilcon A) Soft (hydrophilic) Contact Lens for Astigmatism
Indications for Use (Describe)
Kalifilcon A Contact Lens
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.
Kalifilcon A Contact Lens for Astigmatism
Bausch + Lomb kalifilcon A Contact Lens for Astigmatism is indicated for the daily wear correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic persons with non-diseased eves, 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.
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 K200528
Submitter Information:
| Date Prepared: | May 4, 2020 |
|---|---|
| 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 |
Regulation Name: Soft (hydrophilic) Contact Lens
Device Classification: Class II (21 CFR 886.5925)
Predicate Device:
Bausch + Lomb kalifilcon A Contact Lens is substantially equivalent to the following predicate device:
Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens cleared under K113703.
Device Description :
The Bausch + Lomb kalifilcon A material is made from a hydrophilic siloxane copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidone and is 55% water by weight when immersed in a sterile phosphate buffered saline with 0.5% poloxamine solution. A UVabsorbing 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 Lens is to be prescribed for single-use disposable wear.
4
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 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 |
| Cylinder Power (Toric) | -0.75D to -5.00D |
| Cylinder Axis | 0° to 180º |
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:
Kalifilcon A Contact Lens
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.
Kalifilcon A Contact Lens for Astigmatism
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.
The kalifilcon A contact lens is to be prescribed for single-use disposable wear and is to be discarded after each removal.
5
Technological Characteristics (comparison to predicate devices)
A side-by-side comparison of the predicate devices to the new device:
| Property | Predicate Device
Bausch + Lomb
Biotrue ONEday (nesofilcon A)
Contact Lens | Subject Device
Bausch + Lomb
kalifilcon A Contact Lens |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|
| Intended Use | Indicated for the daily wear
correction of refractive
ametropia (myopia, hyperopia
and astigmatism) in aphakic
and/or non-aphakic persons
with non-diseased eyes that
exhibit refractive astigmatism up
to 2.00 diopters or less, 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. | Same as predicate |
| Functionality | 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 wear contact lens | Same as predicate |
| Manufacturing
Method | Cast Molded | Same as predicate |
| Material Group | Group II
Hydrogel
(high water, non-ionic) | Group 5-B
Silicone Hydrogel
(high water, non-ionic) |
| USAN Name | nesofilcon A | kalifilcon A |
| Water Content | 78% | 55% |
| Oxygen
Permeability1
(edge corrected) | 42 | 107 |
| Specific Gravity | 1.039 | 1.029 |
| UV Blocker | Yes | Yes |
1- Oxygen Permeability shown was determined by the polarographic method: x 10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C
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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
Summary of Clinical Performance Data
Bausch + Lomb conducted a 3 month, controlled clinical study with approximately 247 patients, comparing the safety and efficacy of the Bausch + Lomb kalifilcon A Contact Lens to the Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens.
The primary safety endpoint was any slit lamp finding greater than Grade 2 over the course of the study. the primary efficacy endpoint was contact lens corrected distance high-contrast visual acuity averaged over all scheduled visits. All primary endpoints were achieved, and the results of the study indicate the test lens is safe and effective,
Substantial Equivalence Conclusion:
The cumulative results of laboratory, in vitro, in vivo testing as well as the clinical study sponsored by Bausch + Lomb demonstrate that the safety. effectiveness and performance of the Bausch + Lomb kalifilcon A Contact Lens are substantially equivalent to the Bausch + Lomb Biotrue ONEday (nesofilcon A) Contact Lens.