(38 days)
The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens is indicated for vision correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens may be disinfected using either a heat or chemical disinfection system. Eye Care Practitioners may prescribe the lens for traditional or frequent/planned replacement wearing schedule, with cleaning, disinfection and scheduled replacement of the lens.
The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Timed 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 a silicone vinylcarbamate, N-vinyl pyrrolidinone, a siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by weight when immersed in a sterile borate buffered saline solution. The lens is tinted blue with up to 300ppm of the color additive Reactive Blue Dye 246 [(1, 4-Bis[4-(2-methacry) oxyethyl) phenylamino] anthraquinone]. The color additive conforms with 21 CFR Part 73.3106.
The physical / optical properties of the lens are:
Specific Gravity: 1.064
Refractive Index: 1.426
Light Transmittance: C.I.E. Y value - at least 95%
Water Content: 36%
Oxygen Permeability (Dk): 99 x 10-11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C (Polarographic Method)
The BAUSCH & LOMB OxyCor (balafilcon A) 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
Toric (Cylinder): 0 to 10 Diopters
Toric Axis: 0° to 180°
Each BAUSCH & LOMB OxyCor (balafilcon A) Visibility Tinted Contact Lens is supplied in a glass vial container with a solution of borate buffered saline. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date. In addition to the above, toric lenses are marked with cylinder power and axis information.
This 510(k) submission (K972454) for the BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens does not contain the information requested in your prompt.
The document describes the device, its intended use, and states that preclinical and clinical testing were performed to demonstrate safety and effectiveness. However, it only provides a summary of preclinical testing results and does not detail the acceptance criteria or results of the clinical study in the way you've outlined.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance for clinical endpoints.
- Sample size used for a test set or data provenance for a clinical study.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for a test set.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or effect sizes of AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (beyond general "safety and effectiveness").
- Sample size for a training set.
- How ground truth for a training set was established.
The document mainly focuses on demonstrating substantial equivalence to predicate devices (BAUSCH & LOMB® Premier 90 and BAUSCH & LOMB Optima™ 38) based on physicochemical properties and a statement that preclinical testing showed the material is not toxic and extracts are not irritating.
To answer your request, clinical study data with specific acceptance criteria and detailed performance metrics would be required, which is absent from the provided 510(k) summary.
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AUG - 8 1997
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
FOR
BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens
Submitter Information: 1.
Bausch & Lomb Incorporated Global Vision Care Division 1400 North Goodman Street Rochester, NY 14692-0450
Contact Person: Dennis Hahn Manager, Regulatory Affairs Telephone No .: (716) 338-6813
2. Device Name:
Classification Name: Soft (hydrophilic) contact lens
Proprietary Name: BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens
3. Predicate Device:
The BAUSCH & LOMB® Premier 90 (balafilcon A) Contact Lens (clear lens) and the BAUSCH & LOMB Optima™ 38 (polymacon) Visibility Tinted Contact Lens have been selected as the predicate devices for the BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens.
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DESCRIPTION OF DEVICE . ব,
The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Timed 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 a silicone vinylcarbamate, N-vinyl pyrrolidinone, a siloxane crosslinker and a vinyl alanine wetting monomer, and is 36% water by weight when immersed in a sterile borate buffered saline solution. The lens is tinted blue with up to 300ppm of the color additive Reactive Blue Dye 246 [(1, 4-Bis[4-(2-methacry) oxyethyl) phenylamino] anthraquinone]. The color additive conforms with 21 CFR Part 73.3106.
The physical / optical properties of the lens are:
| Specific Gravity: | 1.064 |
|---|---|
| Refractive Index: | 1.426 |
| Light Transmittance: | C.I.E. Y value - at least 95% |
| Water Content: | 36% |
| Oxygen Permeability (Dk): | 99 x 10 -11 [cm³O₂(STP) x cm]/(sec x cm² x mmHg)@35°C(Polarographic Method) |
The BAUSCH & LOMB OxyCor (balafilcon A) 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 |
| Toric (Cylinder): | 0 to 10 Diopters |
| Toric Axis: | 0° to 180° |
Each BAUSCH & LOMB OxyCor (balafilcon A) Visibility Tinted Contact Lens is supplied in a glass vial container with a solution of borate buffered saline. The container is marked with the manufacturing lot number of the lens, the base curve, sphere power, diameter and expiration date. In addition to the above, toric lenses are marked with cylinder power and axis information.
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INDICATIONS FOR USE ળે
The BAUSCH & LOMB OxyCor (balafilcon A) Visibility Tinted Contact Lens is indicated for vision correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens may be disinfected using either a heat or chemical disinfection system. Eye Care Practitioners may prescribe the lens for traditional or frequent/planned replacement wearing schedule, with cleaning, disinfection and scheduled replacement of the lens.
ર્ભ. DESCRIPTION OF SAFETY AND SUBSTANTIAL EQUIVALENCE
A series of preclinical and clinical testing was performed to demonstrate the safety and effectiveness of the BAUSCH & LOMB OxyCor (balafilcon A) Contact Lens. A summary of results from the preclinical and clinical tests is provided below.
Preclinical Testing:
A series of in vitro and in vivo preciinical toxicology and biocompatibility testing was performed to assess the safety and effectiveness of the contact lens device. Testing was performed in accordance with FDA guidelines titled, Guidance document for Class III Contact Lenses, April 1989 and 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 OxyCor (balafilcon A) Visibility Tinted Contact Lens demonstrate that:
The physicochemical properties of the BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens are equivalent to the predicate device, BAUSCH & LOMB® Premier 90 (balafilcon A) Contact Lens (clear lens). Differences in spectral properties of the two devices are due to the addition of the tint. Differences in oxygen permeability are due to process improvements.
The lens material is not toxic and the extracts are not irritating.
The extracts of the lens material do not show any detectable quantities of monomer components.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG - 8 1997
Mr. Dennis Hahn Manager, Regulatory Affairs BAUSCH & LOMB, Inc. 1400 N. Goodman Street P.O. Box 450 Rochester, NY 14692-0450
Re: K972454 Trade Name: BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens for Daily Wear Regulatory Class: II Product Code: 86 LPL Dated: June 27, 1997 Received: July 1, 1997
Dear Mr. Hahn:
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 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 mayor 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.
Image /page/3/Picture/9 description: The image shows the seal of the Department of Health & Human Services USA. The seal features the department's name in a circular arrangement around a central emblem. The emblem consists of a stylized representation of three human profiles facing right, with overlapping lines suggesting unity and connection.
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Page 2 - Mr. Dennis Hahn
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) 594-4613. 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" (21 CFR 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/dsmamain.html".
Sincerely yours,
A Roerl Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14692-0450
Indications for-Use Statement
510(k) Number (if known): K972454
Device Name: BAUSCH & LQMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens
Indications for Use:
The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens is indicated for vision correction of refractive ametropia (myopia, hyperopia and astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes, that exhibit refractive astigmatism up to 10.00 diopters. The lens may be prescribed in spherical powers ranging from +20.00D to -20.00D.
The lens may be disinfected using either a heat or chemical disinfection system. Eye Care Practitioners may prescribe the lens for traditional or frequent/planned replacement wearing schedule, with cleaning, disinfection and scheduled replacement of the lens.
Claims:
- The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens 1. provides vision correction in powers ranging from +20.00D to -20.00D.
- The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Leus 2. provides vision correction of refractive astigmatism in powers up to 10.00 diopters.
- The BAUSCH & LOMB® OxyCor (balafilcon A) Visibility Tinted Contact Lens may be 3. disinfected using either a heat or chemical disinfection system.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED! Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
OR
Over-The-Counter-Use __
Daniel W. C. Brown, Ph.D.
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number K972454
§ 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.