(51 days)
BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens
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No
The document describes a standard contact lens and its physical properties. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
Yes
The device is indicated for the "correction of refractive ametropia (myopia and hyperopia)," which means it is used to treat or manage an abnormal refractive condition of the eye, thus fitting the definition of a therapeutic device.
No
Explanation: The device is indicated for the "correction of refractive ametropia" and its description focuses on its physical properties as a contact lens, not on detecting, monitoring, or analyzing health conditions.
No
The device description clearly describes a physical contact lens made of specific materials with defined physical and optical properties and dimensions. 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 is for the correction of refractive ametropia (myopia and hyperopia) in the eye. This is a therapeutic and vision correction purpose, not a diagnostic one.
- Device Description: The description details the physical properties and composition of a contact lens, which is a medical device used for vision correction.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze a sample from the body, or provide information about a patient's health status.
- Preclinical Testing: The preclinical testing focuses on the safety and effectiveness of the contact lens for its intended use (vision correction), not on its diagnostic capabilities.
IVD devices are used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. This contact lens does not perform any such function.
N/A
Intended Use / Indications for Use
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting 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.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Product codes
86 MVN
Device Description
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
Specific Gravity: 1.068
Refractive Index: 1.38
Light Transmittance: C.I.E. Y value - at least 97%
Water Content: 70%
Oxygen Permeability (Dk): 33 x10-11[cm3O₂ (STP) x cm]/(sec x cm2 x mmHg)@35°C (Polarographic Method)
The BAUSCH & LOMB SofLens™one day disposable (hilafilcon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
• Diameter: 13.5mm to 15.0mm
• Center Thickness: 0.05mm to 0.75mm
• Base Curve: 7.8mm to 9.5mm
• Powers (Spherical): +20.00D to -20.00D
Each BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Contact Lens. A series of in vitro and in vivo preclinical toxicology testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP regulation.
The results of the preclinical testing on the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent demonstrate that:
The physicochemical properties of the BAUSCH & LOMB® SofLens™ one day (hilafilcon A) disposable Visibility Tinted Contact Lens are equivalent to the currently marketed predicate device, BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens.
The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens material demonstrated no toxicity or irritation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens
SUBMITTER INFORMATION 1.
Bausch & Lomb Incorporated 1400 North Goodman Street P.O. Box 0450 Rochester, NY 14692-0450
Contact Person: Debra Ketchum Manager, Regulatory Affairs (716) 338-8638 Telephone No .:
DEVICE NAME 2.
Classification Name: Soft (hydrophilic) contact lens
Proprietary Name: BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens
PREDICATE DEVICE 3.
The BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens has been selected as the predicate devices for the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent.
1
DESCRIPTION OF DEVICE 4.
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. It consists of a copolymer of 2-hydroxyethyl methacrylate and N-vinyl pyrrolidinone, and is 70% water by weight when immersed in a sterile saline solution. This lens is tinted blue with either D&C Green #6 or Reactive Blue Dye 246 ((1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone). The color additives conform with 21 CFR Part 74.3206 and 21 CFR Part 73.3106, respectively. The lens may also be supplied clear (no tint).
The physical / optical properties of the lens are:
| Specific Gravity: | 1.068 |
|---|---|
| Refractive Index: | 1.38 |
| Light Transmittance: | C.I.E. Y value - at least 97% |
| Water Content: | 70% |
| Oxygen Permeability (Dk): | 33 x10-11[cm3O₂(STP) x cm]/(sec x cm2 x mmHg)@35°C |
| (Polarographic Method) |
The BAUSCH & LOMB SofLens™one day disposable (hilafilcon) Visibility Tinted Contact Lens is a hemispherical shell of the following dimensions:
| • Diameter: | 13.5mm to 15.0mm |
|---|---|
| • Center Thickness: | 0.05mm to 0.75mm |
| • Base Curve: | 7.8mm to 9.5mm |
| • Powers (Spherical): | +20.00D to -20.00D |
Each BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is supplied in a plastic blister container with a saline solution. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date.
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INDICATIONS FOR USE ধন
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and hyperopia) in aphakic and not-aphakic persons with non-diseased eyes, exhibiting 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.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALIENCE 6.
A series of preclinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB SofLens™ one day disposable (hilafilcon A) Contact Lens. A summary of results from the preclinical tests is provided below.
Preclinical Testing:
A series of in vitro and in vivo preclinical toxicology testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guideline titled Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 1994. All non-clinical laboratory studies were conducted in compliance with the GLP regulation.
The results of the preclinical testing on the BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens produced with the monomer diluent demonstrate that:
The physicochemical properties of the BAUSCH & LOMB® SofLens™ one day (hilafilcon A) disposable Visibility Tinted Contact Lens are equivalent to the currently marketed predicate device, BAUSCH & LOMB® SofLens™ One Day (hilafilcon A) Visibility Tinted Contact Lens.
The extracts of the lens material do not show any significant quantities of monomer components and toxicity testing results of lens material demonstrated no toxicity or irritation.
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Substantial Equivalence
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The DITO bess produced with the monomer diluent is similar to the currently marketed BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens, in that both fall into the same FDA material classification grouping (Group II) and both are manufactured by the same manufacturing process (cast molding). (Group II) CH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The Driver Lens is different from the BAUSCH & LOMB® SofLens™ one day Disposable (hilafileon A) Visibility Tinted Contact Lens in that it is manufactured using a monomer (imamoon is) visioningerol is not included in the weight or mole percentages of the monomer mix, as it does not become part of the lens material. The difference between these two lenses will not have any negative effect on the safety and effectiveness of the device.
All product will be sold as sterile medical devices.
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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 5 2001
Bausch & Lomb, Inc. c/o Ms. Debra Ketchum Manager, Regulatory Affairs 1400 N. Goodman Street P.O. Box 30450 Rochester, NY 14603-0450
Re: K011718
Trade Name: Bausch & Lomb® SofLens™ one day disposable (hilafilcon A) Visibility Tinted Contact Lens Regulation Number: 21 CFR 886.5925 Regulatory Class: Class II Product Code: 86 MVN Dated: June 1, 2001 Received: June 4, 2001
Dear Ms. Ketchum:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Debra Ketchum
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-6413. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".
Sincerely yours,
A. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450
Indications for Use Statement
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Device Name: Visibility Tinted Contact Lens
Indications for Use:
The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility Tinted The DAOSCAT & LOND - Bollers
Contact Lens is indicated for the daily wear correction of refractive ametropia (myopia and Comact Lelis is indroased for t-sphakic persons with non-diseased eyes, exhibiting astigmatism of 2.00 diopters or less, that does not interfere with visual acuity. The lens may astEmatists of inspherical powers ranging from +20.00D to -20.00D.
The lens is to be prescribed for single-use disposable wear, and is to be discarded after each removal.
Claims:
- The BAUSCH & LOMB® SofLens™ one day disposable (hilafilcon A) Visibility l. Tinted Contact Lens provides vision correction in powers ranging from +20.00D to -20.00D.
- The BAUSCH & LOMB® Sofilens™ one day disposable (hilafilcon A) Visibility 2. Tinted Contact Lens is for single-use disposable wear.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X | OR | Over-The-Counter-Use |
|---|---|---|---|
| ------------------ | --- | ---- | ---------------------- |
Daniel W.C. Brown, Ph.D.
(Division Sign-Off)
(Division Sign-Off) Division of Ophthalmic Devices 510(k) Number_K011718