(112 days)
Not Found
No
The 510(k) summary describes a physical contact lens and its material properties. There is no mention of software, algorithms, or any computational processing that would involve AI or ML.
No.
The contact lens is indicated for the correction of refractive errors and presbyopia, which are optical corrections rather than therapeutic treatments for a disease.
No
Explanation: The device is a contact lens indicated for the correction of refractive errors and presbyopia, which are therapeutic functions, not diagnostic ones. It helps to correct vision rather than detect or diagnose a medical condition.
No
The device description clearly indicates it is a physical contact lens made of specific materials with defined physical properties and manufacturing parameters. It is a tangible medical device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for the correction of refractive ametropia and presbyopia in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and materials of a contact lens, which is a medical device used for vision correction.
- Performance Studies: The performance studies focus on biocompatibility, toxicology, and functional performance of the contact lens in the eye. There is no mention of analyzing samples from the body to provide diagnostic information.
- Anatomical Site: The anatomical site is the eyes, where the device is placed for vision correction. IVDs typically analyze samples taken from the body (like blood, urine, tissue).
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or condition. This contact lens does not perform such a function.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
MVN, LPL
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 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.
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, 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.
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.
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
DEC 2 0 2013
510(k) Summary
Submitter Information:
| Date Prepared: | December 20, 2013 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street |
| Rochester, NY 14609 | |
| Contact Person: | Jennifer Knicley |
| Sr. 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
1
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.
2
K132715
Page 3 of 5
Technological Characteristics (comparison to Predicate Device)
·
| Property | Predicate Device | New Device |
|---|---|---|
| Bausch + Lomb nesofilcon A | ||
| contact lens | Bausch + Lomb Biotrue® | |
| ONEday for Presbyopia | ||
| (nesofilcon A) Contact Lens | ||
| Functionality | The contact lens acts 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 | |
| (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 plastic | |
| coated aluminium foil blister | Same as predicate | |
| Packaging solution | Borate buffered saline with | |
| poloxamine | 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 Device
BAUSCH & LOMB PureVision®
Multi-Focal (balafilcon A) Visibility
Tinted Contact Lens | New Device
Bausch + Lomb Biotrue®
ONEday for Presbyopia
(nesofilcon A) Contact Lens |
|--------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Lens Design | Multifocal | Same as predicate |
| Indication for Use | 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 | 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.
5
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
7
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