(112 days)
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) 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 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.
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens is made from nesofilcon A material, a hydrophilic copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone. The lens is 78% water by weight when immersed in a sterile borate buffered saline with 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. The lenses are tinted blue for visibility with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106.
The lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
Refractive index: 1.374
Light transmission: 99%
Water Content: 78%
Specific Gravity: 1.039
Oxygen Permeability: 42 x 10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (polarographic method)
The lens will be manufactured in 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
Add Power: +0.75D to +5.00D
The lens is packaged in disposable blister packages containing borate buffered saline solution with poloxamine and provided sterile. Blister packages are labeled with the lot number, expiration date and applicable lens parameters.
The provided text describes a 510(k) premarket notification for a contact lens, not an AI device. As such, most of the requested information regarding AI device acceptance criteria and study particulars (like sample size for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable.
However, I can extract information related to the device's characteristics, performance, and the basis for its approval, which is substantial equivalence to predicate devices, rather than meeting specific performance criteria demonstrated by an independent clinical study for the new device itself.
Here's the relevant information based on the provided document:
1. A table of acceptance criteria and the reported device performance
For a medical device like a contact lens, "acceptance criteria" and "reported device performance" are often tied to demonstrating safety and effectiveness based on established standards, comparison to predicate devices, and specific physical/functional properties. The document explicitly states that the safety and effectiveness were demonstrated through preclinical testing and the applicability of a clinical study performed on a predicate device due to substantial equivalence.
| Acceptance Criteria (Demonstrated via Preclinical & Predicate Device Clinical Data) | Reported Device Performance (as per specifications and comparison) |
|---|---|
| Material Safety & Biocompatibility: Performed according to FDA guidance "Premarket Notification (510(k)) Guidance document for Daily Wear Contact Lenses, May 1994" and GLP regulation 21 CFR part 58. Includes: - Leachables - Ocular Irritation (Lens device, Packaging, Lens Mold) - Sensitization - Systemic Toxicity (Lens device, Packaging, Lens Mold) | Demonstrated to be safe and effective through a series of in vitro and in vivo preclinical toxicology and biocompatibility testing for nesofilcon A material. The subject device uses the identical lens material, manufacturing process, sterilization process, and packaging as the predicate device (Bausch + Lomb nesofilcon A contact lens, K113703), and its finished lens parameters fall within previously cleared ranges. |
| Functional Performance: Conformance to predetermined specifications and verification that the device performs as expected without creating additional risk to the user. | The device functions as a refractive medium to focus light. Physical properties: Refractive index: 1.374, Light transmission: 99%, Water Content: 78%, Specific Gravity: 1.039, Oxygen Permeability: 42 x 10-11. Parameter ranges: Diameter: 13.5mm-15.0mm, Center Thickness: 0.05mm-0.75mm, Base Curve: 7.8mm-9.5mm, Power Range: +20.00D to -20.00D, Add Power: +0.75D to +5.00D. These are stated as conforming to specifications. |
| Stability: Demonstrated product stability over its intended shelf-life. | Stability testing (real-time and accelerated aging) demonstrated the product is stable for four years. |
| Clinical Safety & Effectiveness: Confirmation of safety and effectiveness of the nesofilcon A lens material in the daily disposable modality. | Clinical performance data was obtained via a clinical study of the predicate device (Bausch + Lomb nesofilcon A contact lens). Due to the similarities between the subject device and the predicate device, this clinical study was deemed applicable, and no additional clinical study was performed for the subject device. The predicate device's study demonstrated safe and effective functioning. |
| Indications for Use: Ensure the new device aligns with the predicate device's indications or is otherwise justified. | Indications for Use for the new device are "Same as predicate" (BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact Lens, K050948). The new device is indicated for daily wear for correction of refractive ametropia 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. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for the clinical study that was referenced. The document only states that "clinical performance data... was obtained via a clinical study of the Bausch + Lomb nesofilcon A contact lens" (which is the predicate device for material, not the multifocal predicate). It does not specify the sample size, country of origin, or if it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/not provided. The device is a contact lens, and its clinical performance was established by reference to a prior study on a similar device. There's no mention of "ground truth" adjudicated by experts in the context of an AI system.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided. This refers to methods for establishing ground truth in AI studies, which is not relevant here.
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 information is not applicable/not provided. This relates to AI system evaluation, which is not the subject of this 510(k). The device is a contact lens.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/not provided. This relates to AI system evaluation, which is not the subject of this 510(k).
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As it is a contact lens, the "ground truth" (or evidence of safety and effectiveness) for the clinical performance was based on the outcomes data from a clinical study on a predicate device (Bausch + Lomb nesofilcon A contact lens). This study demonstrated that the predicate device functions in a safe and effective manner.
8. The sample size for the training set
This information is not applicable/not provided. This is an AI-specific term and not relevant to a contact lens approval via substantial equivalence.
9. How the ground truth for the training set was established
This information is not applicable/not provided. This is an AI-specific term and not relevant to a contact lens approval via substantial equivalence.
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DEC 2 0 2013
510(k) Summary
Submitter Information:
| Date Prepared: | December 20, 2013 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman StreetRochester, NY 14609 |
| Contact Person: | Jennifer KnicleySr. Manager, Regulatory Affairs |
| Phone Number: | (585) 338-6307(585) 338-0702 (fax) |
| Email: | Jennifer.knicley@bausch.com |
Device Information:
| Trade Names: | Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A)Soft (Hydrophilic) Contact Lens |
|---|---|
| Common Name: | Soft daily disposable contact lens |
| Classification Name: | Soft (hydrophilic) contact lens (21 CFR 886.5925) |
| Device Classification: | Class II |
| Product Code: | MVN, LPL |
Predicate Devices:
- Bausch + Lomb nesofilcon A contact lens (K113703) .
- BAUSCH & LOMB PureVision® Multi-Focal (balafilcon A) Visibility Tinted Contact . Lens (K050948)
Device Description:
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens is made from nesofilcon A material, a hydrophilic copolymer of 2hydroxyethyl methacrylate and N-vinyl pyrrolidone. The lens is 78% water by weight when immersed in a sterile borate buffered saline with poloxamine solution. A UVabsorbing monomer is used to block UV radiation. The transmittance characteristics are
ﻟﻠﻘﺎﻧﻮﻥ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤ
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less than 5% in the UVB range of 280nm to 315nm and less than 50% in the UVA range of 316nm to 380nm. The lenses are tinted blue for visibility with Reactive Blue Dye 246. The color additive conforms to 21 CFR Part 73.3106.
The lens is to be prescribed for single-use disposable wear.
The physical properties of the lens are:
| Refractive index | 1.374 |
|---|---|
| Light transmission | 99% |
| Water Content | 78% |
| Specific Gravity | 1.039 |
| Oxygen Permeability | 42 x 10-11[cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(polarographic method) |
The lens will be manufactured in 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 |
| Add Power | +0.75D to +5.00D |
The lens is packaged in disposable blister packages containing borate buffered saline solution with poloxamine and provided sterile. Blister packages are labeled with the lot number, expiration date and applicable lens parameters.
Indications for Use:
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) 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 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.
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K132715
Page 3 of 5
Technological Characteristics (comparison to Predicate Device)
·
| Property | Predicate Device | New Device |
|---|---|---|
| Bausch + Lomb nesofilcon Acontact lens | Bausch + Lomb Biotrue®ONEday for Presbyopia(nesofilcon A) Contact Lens | |
| Functionality | The contact lens acts as arefractive medium that focus lightrays from near and distant objectson the retina. | Same as predicate |
| Modality | Daily wear contact lens | Same as predicate |
| ManufacturingMethod | Cast Molded | Same as predicate |
| Material Group | Group II(high water, no ionic polymers) | Same as predicate |
| USAN Name | nesofilcon A | Same as predicate |
| Water Content | 78% | Same as predicate |
| UV Blocker | Yes | Same as predicate |
| Sterilization | Air over steam | Same as predicate |
| Packaging | Polypropylene blister with plasticcoated aluminium foil blister | Same as predicate |
| Packaging solution | Borate buffered saline withpoloxamine | Same as predicate |
{3}------------------------------------------------
The lens design and indications for use of the proposed device are identical to the · selected predicate device as identified in the table below.
| Property | Predicate DeviceBAUSCH & LOMB PureVision®Multi-Focal (balafilcon A) VisibilityTinted Contact Lens | New DeviceBausch + Lomb Biotrue®ONEday for Presbyopia(nesofilcon A) Contact Lens |
|---|---|---|
| Lens Design | Multifocal | Same as predicate |
| Indication for Use | Indicated for daily wear for thecorrection of refractive ametropia(myopia, hyperopia, andastigmatism) and presbyopia inaphakic and/or not-aphakicpersons with non-diseased eyes,exhibiting astigmatism of 2.00diopters or less, that does notinterfere with visual acuity. Thelens provides a power range of+20.00 to -20.00 diopters with addpower ranging from +0.75D to+5.00D | Same as predicate |
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, nesofilcon 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:
- · Leachables
- · Ocular Irritation Lens device, Packaging, Lens Mold
- · Sensitization
- · Systemic Toxicity Lens device, Packaging, Lens Mold
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, both real-time and accelerated aging, was performed on the nesofilcon A contact lens and demonstrates that the product is stable for four years.
The testing performed on the predicate device, Bausch + Lomb nesofilcon 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, and the finished lens parameters fall within the ranges previously cleared for the predicate device and therefore the previous testing is fully applicable.
{4}------------------------------------------------
K132715
Page 5 of 5
Summary of Clinical Performance Data
Clinical performance data to confirm safety and effectiveness of the nesofilcon A lens material in the daily disposable modality was obtained via a clinical study of the Bausch + Lomb nesofilcon A contact lens. Due to the similarities between the Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Contact Lens (subject device) and the Bausch + Lomb nesofilcon A contact lens (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 Biotrue® ONEday for Presbyopia (nesofilcon A) Contact Lens is substantially equivalent in principles of operation, technology, materials and indications for use to the predicate devices listed above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic element to the right, which is three curved shapes stacked on top of each other. To the left of the graphic is text arranged in a circular pattern, reading "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 20, 2013
Bausch + Lomb, Incorporated % Ms. Jennifer S. Knicley Senior Manager, Regulatory Affairs 1400 North Goodman Street Rochester, NY 14609
Re: K132715
Trade/Device Name: Bausch + Lomb Biotrue ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) Contact Lens
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL, MVN Dated: November 22, 2013 Received: November 25, 2013
Dear Ms. Knicley:
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. 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 complics with other requirements of the Ador any Federal statutes and regulations administered by other Federal agencies.
{6}------------------------------------------------
Page 2 - Ms. Jennifer S. Knicley
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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincercly yours,
Kesia Y. Alexander -S
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
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Bausch + Lomb Traditional 510(k) Premarket Notification Bausch + Lomb Biotrue ONEday for Presbyopia (nesofilcon A) Contact Lens
INDICATIONS FOR USE
Indications for Use Statement
510{k} Number (if known):
Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft Device Name: (Hydrophilic) Contact Lens
Indications for Use:
The Bausch + Lomb Biotrue® ONEday for Presbyopia (nesofilcon A) Soft (Hydrophilic) 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 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.
Over-The-Counter Use Prescription Use V AND/OR . (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of Center for Devices and Radiological Health (CDRH)
J Angelo Green/A
2013.12.12.16:44:08 -05'00'
(Division Sign-Off) Division of Ophthalmic and Ear, Nose and Throat Devices
510(k) Number: K132715
§ 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.