(53 days)
Not Found
No
The summary describes a physical contact lens and its material properties, manufacturing parameters, and performance testing. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for the correction of refractive ametropia (myopia, hyperopia and astigmatism), which are medical conditions affecting vision, thus serving a therapeutic purpose.
No
This device is a contact lens designed for correction of refractive ametropia (myopia, hyperopia, and astigmatism), not for diagnosing medical conditions.
No
The device description clearly details a physical contact lens made of specific materials with defined physical properties and dimensions. It is a tangible medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) 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 designed to be worn on the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is applied to the eye, which is an external anatomical site for this purpose, not an internal sample source for diagnostic testing.
IVD devices are specifically designed to perform tests in vitro (outside the body) on samples taken from the body. This contact lens is a medical device used in vivo (on the body) for vision correction.
N/A
Intended Use / Indications for Use
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.
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 Biotrue ONEday for Astigmatism (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
Cylinder Powers: -0.75D to -5.00D
Cylinder Axis: 0° to 180°
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 quidance 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 Astigmatism (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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, with flowing lines connecting them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 13, 2015
Bausch & Lomb Incorporated Ms. Jessica M. Burger Specialist, Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609
Re: K143632
Trade/Device Name: Bausch + Lomb Biotrue Oneday For Astigmatism (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: December 18, 2014 Received: December 22, 2014
Dear Ms. Burger:
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 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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
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 Industry and Consumer Education at its toll-free 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" (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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Y. Alexander -S
for Malvina B. Eydelman, MD 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) K143632
Device Name
Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens
Indications for Use (Describe)
The Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.
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
Submitter Information:
| Date Prepared: | December 18, 2014 |
|---|---|
| Name: | Bausch & Lomb Incorporated |
| Address: | 1400 North Goodman Street |
| Rochester, NY 14609 | |
| Contact Person: | Jessica M. Burger |
| Specialist, Regulatory Affairs | |
| Phone Number: | (585) 338-5665 |
| (585) 338-0702 (fax) | |
| Email: | Jessica.Burger@bausch.com |
Device Information:
| Trade Names: | Bausch + Lomb Biotrue ONEday for Astigmatism (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: | LPL, MVN |
Predicate Devices:
- Bausch + Lomb nesofilcon A Contact Lens (K113703) ●
- . Bausch + Lomb (samfilcon A) Contact Lens for Astigmatism (K131208)
Device Description:
The Bausch + Lomb Biotrue ONEday for Astigmatism (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
4
Bausch + Lomb Traditional 510(k) Premarket Notification Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Contact Lens
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 |
| Cylinder Powers | -0.75D to -5.00D |
| Cylinder Axis | 0° to 180° |
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 Astigmatism (nesofilcon A) Soft (hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or not-aphakic persons with nondiseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens provides a power range of +20.00 to -20.00 diopters for daily wear.
The lens is to be prescribed for single-use disposable wear, and is to be discarded affer each removal.
5
Bausch + Lomb Traditional 510(k) Premarket Notification Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Contact Lens
Technological Characteristics (comparison to Predicate Device)
| Property | Predicate Device | New Device |
|---|---|---|
| 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 aluminum foil blister | Same as predicate | |
| Packaging solution | Borate buffered saline with | |
| poloxamine | Same as predicate | |
| Bausch + Lomb nesofilcon A | ||
| Contact Lens | Bausch + Lomb Biotrue | |
| ONEday for Astigmatism | ||
| (nesofilcon A) Contact Lens |
6
Bausch + Lomb Traditional 510(k) Premarket Notification Bausch + Lomb Biotrue ONEday for Astigmatism (nesofilcon A) Contact Lens
510(K) SUMMARY
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 (samfilcon A)
Contact Lens for Astigmatism | New Device
Bausch + Lomb Biotrue
ONEday for Astigmatism
(nesofilcon A) Contact Lens |
|--------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| Lens Design | Toric | Same as predicate |
| Indication for Use | Indicated for daily wear for the
correction of refractive ametropia
(myopia, hyperopia and
astigmatism) in aphakic and/or not
aphakic persons with non-
diseased eyes, exhibiting
astigmatism of up to 5.0 diopters,
that does not interfere with visual
acuity. | 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 quidance 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.
7
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 Astigmatism (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 Astigmatism (nesofilcon A) Contact Lens is substantially equivalent in principles of operation, technology, materials and indications for use to the predicate devices listed above.