(102 days)
Not Found
No
The summary describes a contact lens and its material properties, intended use, and performance testing. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device corrects refractive errors (myopia, astigmatism, presbyopia) but does not treat a disease or restore a damaged function.
No
Explanation: The device is a contact lens designed for correcting refractive errors (myopia, astigmatism, and presbyopia), not for diagnosing medical conditions. Its function is to alter light entering the eye to improve vision, which is a therapeutic rather than a diagnostic purpose.
No
The device description clearly states it is a physical contact lens made of specific materials (water and samfilcon A) and includes details about its packaging and sterilization, indicating it is a hardware device.
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 Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is a medical device worn on the eye to correct vision. It does not analyze any biological samples from the body.
- Intended Use: The intended use clearly states it's for the "correction of refractive ametropia... and presbyopia." This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description focuses on the material composition and physical characteristics of the lens itself, not on any components designed for analyzing biological samples.
Therefore, based on the provided information, this contact lens is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is 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 up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.
The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters.
Product codes (comma separated list FDA assigned to the subject device)
MVN, LPL
Device Description
The Bausch + Lomb (samfilcon A) Multifocal for Astigmatism Contact Lens is 46% water and 54% samfilcon A material (a siloxane copolymer with N-vinyl pyrrolidone). This lens is tinted blue with Reactive Blue Dye 246 to make them easier to see when handling.
The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine 1107 and a plastic coated aluminium lid stock. The disposable blister container and the lidstock are used in the predicate device. The packaged lenses are steam sterilized in a validated autoclave. Each lens is labelled with the lens parameters, lot number and expiration date.
Lenses have the following physical properties:
Refractive Index: 1.411
Light Transmittance: 97.3%
Water Content: 46%
Specific Gravity: 1.048
Oxygen Permeability: 114 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method)
The lens design includes the following parameter ranges:
Diameter: 13.5mm to 15.0mm
Center Thickness: 0.05mm to 0.75mm (varies with power)
Base Curve: 7.8mm to 9.5mm
Power Range: +20.00D to -20.00D
Cylinder Power (Toric): -0.75D to -5.00D
Cylinder Axis (Toric): 0° to 180°
Add Power (Multi-Focal): +0.75D to +5.00D
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens material, samfilcon A. Testing was performed in accordance with the FDA guidance titled Premarket Notification (510(k)) Guidance document for Daily Wear Contact Lenses, May 1994 and GLP regulation 21 CFR part 58 and included the following:
- Leachable
- Ocular Irritation Lens device, Packaging
- Sensitization
- Systemic Toxicity Lens device, Packaging
Performance testing included conformance to predetermined specifications and functional testing to verify that the device performs as expected without creating additional risk to the user.
Stability testing, real-time, was performed on the samfilcon A contact lens and demonstrates that the product is stable for five years.
The testing performed on the predicate device, Bausch + Lomb Ultra (samfilcon A) Contact Lens, 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 Bausch + Lomb Ultra (samfilcon A) Contact Lens. Therefore the previous testing is fully applicable.
Clinical performance data to confirm safety and effectiveness of the samfilcon A lens material in the daily disposable modality was obtained via a clinical study of the Bausch + Lomb Ultra (samfilcon A) Contact Lens. Due to the similarities between the subject device and the predicate device, the clinical study performed on the predicate device is applicable to the subject device and no additional clinical study was performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 two logos. On the left is the logo for the Department of Health & Human Services - USA. On the right is the logo for the FDA U.S. Food & Drug Administration. The FDA logo is in blue.
November 30, 2018
Bausch & Lomb Incorporated Barbara Klube-Falso Associate Director Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K182249
Trade/Device Name: Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 1, 2018 Received: November 2, 2018
Dear Ms. 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely yours,
J. Angelo Green
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182249
Device Name
Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
Indications for Use (Describe)
The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is indicated for daily wear for the correction of refractive ametropia (myeropia, and astigmatism) and presbyopia in aphakic and/or not-aphakic persons with non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.
The lens may be prescribed for Frequent/Planned Replacement Wear in a power range of +20.00 to -20.00 diopters.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens, is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens, 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: | August 16, 2018 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street |
| Rochester, NY 14609 | |
| Contact Person: | Barbara Klube-Falso |
| Associate Director, Regulatory Affairs | |
| Phone Number: | (585) 338-8503 |
| (585) 338-0702 (fax) | |
| Email: | Barbara.Klube-Falso@bausch.com |
Device Information:
| Trade Name: | Bausch + Lomb Ultra (samfilcon A) Multifocal for
Astigmatism Contact Lens |
|------------------------|------------------------------------------------------------------------------|
| Common Name: | Soft contact lens, daily wear |
| Device Classification: | Class II (21 CFR 886.5925) |
| Classification Name: | Daily Wear Soft (Hydrophilic) Contact Lens |
| Product Code: | MVN, LPL |
Predicate Device:
The predicate devices are
- Bausch + Lomb Ultra (samfilcon A) Visibility Tinted Soft (hydrophilic) Contact ● Lenses cleared under K131208, and
- . Coopervision, Inc., Avaira Vitality (fanfilcon A) Multifocal Toric Soft (hydrophilic) Contact Lens cleared under K160803.
Device Description:
The Bausch + Lomb (samfilcon A) Multifocal for Astigmatism Contact Lens is 46% water and 54% samfilcon A material (a siloxane copolymer with N-vinyl pyrrolidone). This lens is tinted blue with Reactive Blue Dye 246 to make them easier to see when handling.
4
The packaging material consists of a polypropylene blister, borate buffered saline with poloxamine 1107 and a plastic coated aluminium lid stock. The disposable blister container and the lidstock are used in the predicate device. The packaged lenses are steam sterilized in a validated autoclave. Each lens is labelled with the lens parameters, lot number and expiration date.
Lenses have the following physical properties:
| Refractive Index: | 1.411 |
|---|---|
| Light Transmittance: | 97.3% |
| Water Content: | 46% |
| Specific Gravity: | 1.048 |
| Oxygen Permeability: | 114 x 10-11[cm3O2(STP) x cm]/(sec x cm2 x mmHg)@35°C (polarographic method) |
The lens design includes the following parameter ranges:
| Diameter | 13.5mm to 15.0mm |
|---|---|
| Center Thickness | 0.05mm to 0.75mm (varies with power) |
| Base Curve | 7.8mm to 9.5mm |
| Power Range | +20.00D to -20.00D |
| Cylinder Power (Toric) | -0.75D to -5.00D |
| Cylinder Axis (Toric) | 0° to 180° |
| Add Power (Multi-Focal) | +0.75D to +5.00D |
Indications for Use:
The Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is 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 up to 5.00 diopters and require an add power ranging from +0.75D to +5.00D.
The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in a power range of +20.00 to -20.00 diopters.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens, is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
5
DISPOSABLE WEAR
When prescribed for Disposable Wear, the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens, is to be discarded after each removal.
Technological Characteristics:
The table below shows a side-by-side comparison of technological characteristics evaluated to determine substantial equivalence of the new device to the predicate Differences were evaluated during the design and development of the new device. device. Performance testing was completed and demonstrated the proposed device and predicate device are substantially equivalent, and the differences do not negatively impact the safety and efficacy of the device.
| Property | Predicate Device
Bausch + Lomb
(samfilcon A)
K131208 | Predicate Device
Coopervision
Multifocal Toric
(fanfilcon A)
K160803 | New Device
Bausch + Lomb
(samfilcon A) Multifocal
for Astigmatism Lens |
|-------------------------|---------------------------------------------------------------|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| Intended Use | Daily Wear, Daily
Disposable | Daily Wear, Daily
Disposable | Same |
| Lens Material
Group | Silicone Hydrogel | Silicone Hydrogel | Same |
| Visibility Tint | Reactive Blue 246 | Reactive Blue 246 | Same |
| Manufacturing
Method | Cast Molded | Cast molded | Same |
| Lens Designs | Spherical, Toric, Multifocal | Multifocal Toric | Multifocal Toric |
| Sterilization
Method | Moist Heat | Moist Heat | Same |
| Packaging | Polypropylene Blister | blister | Polypropylene Blister |
| Packaging
Solution | Borate Buffered Saline
with Poloxamine | Buffered saline
solution | Borate buffered saline
with Poloxamine |
| USAN Name | samfilcon A | fanfilcon A | samfilcon A |
| Water
Content | 46% | 55% | 46% |
6
Summary of Non-Clinical Performance Data:
A series of in vitro and in vivo preclinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens material, samfilcon Testing was performed in accordance with the FDA quidance titled Premarket A. Notification (510(k)) Guidance document for Daily Wear Contact Lenses, May 1994 and GLP regulation 21 CFR part 58 and included the following:
- Leachable
- · Ocular Irritation Lens device, Packaging
- · Sensitization
- · Systemic Toxicity Lens device, Packaging
Performance testing included conformance to predetermined specifications and functional testing to verify that the device performs as expected without creating additional risk to the user.
Stability testing, real-time, was performed on the samfilcon A contact lens and demonstrates that the product is stable for five years.
The testing performed on the predicate device, Bausch + Lomb Ultra (samfilcon A) Contact Lens, 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 Bausch + Lomb Ultra (samfilcon A) Contact Lens. Therefore the previous testing is fully applicable.
Summary of Clinical Performance Data
Clinical performance data to confirm safety and effectiveness of the samfilcon A lens material in the daily disposable modality was obtained via a clinical study of the Bausch + Lomb Ultra (samfilcon A) Contact Lens. Due to the similarities between the subject device and the predicate device, the clinical study performed on the predicate device is applicable to the subject device and no additional clinical study was performed.
Substantial Equivalence Conclusion:
The information submitted in this premarket notification supports the determination that the Bausch + Lomb Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens is substantially equivalent in principles of operation, technology, materials and indications for use to the predicate devices listed above.