(119 days)
Not Found
No
The summary describes a contact lens made of a specific material for vision correction and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No
The device is indicated for the correction of refractive ametropia (myopia, hyperopia, and astigmatism), which are refractive errors, not diseases. It primarily aims to improve visual acuity rather than treating a disease or condition.
No
Explanation: The document describes a contact lens used for vision correction (refractive ametropia), not for diagnosing medical conditions. Its purpose is to correct existing vision impairments, not to identify or measure them.
No
The device description clearly states it is a soft hydrophilic contact lens made from a specific material, indicating it is a physical 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 device is a contact lens, which is a physical device placed on the eye for vision correction. IVDs are typically reagents, instruments, or systems used to examine specimens from the human body to provide information for diagnosis, monitoring, or treatment.
- Anatomical Site: The device is used on the eyes, which is an external anatomical site. While some IVDs might involve samples from the eye (like tears), the device itself is not analyzing a biological specimen.
- Lack of Diagnostic Function: There is no mention of the device being used to detect, measure, or analyze any biological markers or substances to diagnose a condition.
The device is clearly intended for vision correction, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) 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 lenses may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in powers ranging from +20.00D to -20.00D for daily wear.
The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated 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 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens are soft hydrophilic contact lens. The lenses are made from the balafilcon A material, a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wetting monomer, tinted blue with Reactive Blue Dye 246.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioners
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)
There has been no change made to this device and therefore no non-clinical testing was required to demonstrate substantial equivalence to the predicate device.
There has been no change made to this device and therefore no clinical studies were required to demonstrate the safety or effectiveness of the subject device.
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
K122575
Page 1 of 4
510(k) SUMMARY
DEC 2 0 2012
Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens
1.0 Submitter Information:
| Bausch & Lomb |
|---|
| 1400 North Goodman Street |
| Rochester, NY 14609 |
| Contact: Nancy Fehrman |
| Senior Specialist, Global Regulatory Affairs |
| 1400 North Goodman Street |
| Rochester, NY 14609 |
| (585) 338-5735 (office) |
| (585) 338-0702 (fax) |
| Nancy.a.fehrman@bausch.com |
| Preparation Date: August 22, 2012 |
2.0 Device Name:
| Trade Name: | Bausch & Lomb PureVision (balafilcon A) Visibility
Tinted Contact Lens and Bausch & Lomb PureVision
Toric (balafilcon A) Visibility Tinted Contact Lens |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name: | soft (hydrophilic) contact lens |
| Device Classification: | Class II (21 CFR 886.5925 (b) (1)) |
3.0 Predicate Device
The predicate device; OxyCor (balafilcon A) Visibility Tinted Contact Lens was selected to demonstrate substantial equivalence of the lens material, replacement schedules, and indications for use. OxyCor was cleared in 510(k) Premarket Notification K972454 on August 8, 1997.
4.0 Device Description
The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens are soft hydrophilic contact lens. The lenses are made from the balafilcon A material, a copolymer of a silicone vinyl carbamate, N-vinyl-pyrrolidone, a siloxane crosslinker and a vinyl alanine wetting monomer, tinted blue with Reactive Blue Dye 246.
1
5.0 Intended Use
The Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) 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 lenses may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in powers ranging from +20.00D to -20.00D for daily wear.
The Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is indicated 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 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.
2
K122575
Page 3 of 4
6.0 Technological Characteristics (comparison to Predicate Device)
The subject devices are identical to the predicate device cleared under K972454. The table below shows a side-by-side comparison of the predicate device to the subject devices:
| Property | OxyCor (balafilcon A) Visibility Tinted
Contact Lens | PureVision and PureVision Toric
(balafilcon A) Visibility Tinted
Contact Lens |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K972454 | |
| Material | Balafilcon A | |
| Water Content | 36% | |
| Physical/optical
properties | Specific Gravity: 1.064 | |
| | Refractive Index: 1.426 | |
| | Surface Character: Hydrophilic | |
| Oxygen
Permeability* | 91 (Boundary and Edge Corrected) | |
| | 101 (Boundary and Non-Edge Corrected)
*Dk Units = x10-11
[cm3O2(STP)xcm]/(secxcm2xmm Hg)@35°C
(Polarographic Method) | |
| Color Additive | Reactive Blue Dye 246 | Same |
| Manufacturing
Method | Cast Mold | |
| Lens Design | Spherical and Toric | |
| Replacement | Frequent/Planned Replacement or
Disposable Wear | |
| Base Curve | 7.8 to 9.5 mm | |
| Diameter | 13.5 to 15.0 mm | |
| Sphere Powers | +20.00D to -20.00D | |
| Cylinder Powers | 0.00D to 10.00D | |
| Axis | 0° to 180° | |
| Center Thickness | 0.05 mm to 0.50 mm (varies with power) | |
| Difference | | |
| Indications For
Use | Exhibiting Astigmatism up to 10.00
diopters | Exhibiting Astigmatism up to
2.00 diopters (spherical design)
or up to 5.00 diopters
(toric design)
(within currently cleared
indications) |
7.0 Summary of Non-Clinical Testing
There has been no change made to this device and therefore no non-clinical testing was required to demonstrate substantial equivalence to the predicate device.
3
8.0 Clinical Testing
There has been no change made to this device and therefore no clinical studies were required to demonstrate the safety or effectiveness of the subject device.
9.0 Substantial Equivalence
There has been no change made to the predicate device. The Indications for Use are within the range previously cleared under K972454. This submission only provides specificity to the Indications for Use for the eye care practitioners regarding prescribing these lenses for frequent/planned replacement wear or disposable wear and to limit the use within the currently cleared indications. Therefore, the Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and the Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens are substantially equivalent to the OxyCor (balafilcon A) Visibility Tinted Contact Lens cleared in 510(k) Premarket Notification K972454 on August 8, 1997.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 stylized eagle with three curved lines representing its wings and body. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle's perimeter.
December 20, 2012
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Bausch & Lomb, Incorporated % Ms. Nancy A. Fehrman Senior Specialist, Global Regulatory Affairs 1400 North Goodman Street Rochester, New York 14609
Re: K122575
Trade/Device Name: Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens, Bausch & Lomb Pure Vision Toric (balafilcon A) Visibility Tinted Contact Lens
Regulation Number: 21 CFR 886.5925
Regulation Name: Soft (hydrophilic) contact lens
Regulatory Class: Class II
Product Code: LPL
Dated: December 7, 2012
Received: December 10, 2012
Dear Ms. Fehrman:
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.
5
Page 2 - Ms. Nancy A. Fehrman
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eric A. Mann 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
6
Indications for Use
510(k) Number (if known):
Device Name:
Bausch & Lomb PureVision (balafilcon A) Visibility Tinted Contact Lens and Bausch & Lomb PureVision Toric (balafilcon A) Visibility Tinted Contact Lens
Indications for Use:
The BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) 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 may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.
The BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted 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 non-diseased eyes, exhibiting astigmatism of up to 5.00 diopters, that does not interfere with visual acuity. The lens may be prescribed for Frequent/Planned Replacement Wear or Disposable Wear in spherical powers ranging from +20.00D to -20.00D for daily wear.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the BAUSCH & LOMB PureVision (balafilcon A) Visibility Tinted Contact Lens and BAUSCH & LOMB PureVision Toric (balafilcon A) Visibility Tinted Contact Lens is to be discarded after each removal.
Over-The-Counter Use AND/OR Prescription Use V (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
A
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K122575