(33 days)
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or notaphakic 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.
Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eye care professional. The lens may be disinfected using a chemical disinfection system.
The PureVision Multi-Focal Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The lens material is the same silicone-hydrogel material as the visibility tinted balafilcon A contact lens described in K972454 and P980006. The color additive conforms with 21 CFR Part 73.3106.
I am sorry, but the provided text is a 510(k) Premarket Notification for a contact lens, not a description of a study with acceptance criteria for a device's performance that would typically involve AI/ML.
Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
The document focuses on demonstrating substantial equivalence to predicate devices based on material, design, and indications for use, rather than presenting a performance study with specific acceptance criteria that your questions imply for AI/driven devices.
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Ka50948
510(k) PREMARKET NOTIFICATION BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens April 2005
MAY 1 8 2005
510(k) SUMMARY SUMMARY OF SAFETY AND EFFECTIVENESS
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens
1. Submitter Information:
Bausch & Lomb Incorporated 1400 North Goodman Street Rochester, NY 14609
| Contact Person: | Anne Zavertnik | |
|---|---|---|
| Manager, Regulatory Affairs | ||
| Telephone No.: | (585) 338-5816 |
2. Device Identification:
| Common Name: | Soft (hydrophilic) contact lens |
|---|---|
| Proprietary Name: | BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A)Visibility Tinted Contact Lens |
| Classification Name: | Daily Wear, Soft (hydrophilic) Contact Lens |
| Device Classification: | Class II, 21 CFR 886.5925 |
3. Description of Device:
The PureVision Multi-Focal Contact Lens is a hemispherical flexible shell which covers the cornea and may cover a portion of the adjacent sclera. The lens material is the same silicone-hydrogel material as the visibility tinted balafilcon A contact lens described in K972454 and P980006. The color additive conforms with 21 CFR Part 73.3106.
| Parameter Ranges | Specification |
|---|---|
| Diameter: | 13.5 to 15.5 mm |
| Base Curve Range: | 7.5 to 9.5 mm |
| Center Thickness: | varies with power, 0.05 to 0.50mm |
| Powers: | +20.00D to -20.00D |
| Add Powers: | +0.75 to +5.00D |
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4. Indications for Use:
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or notaphakic 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.
Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The lens is to be cleaned, rinsed and disinfected each time it is removed from the patient's eve and discarded after the recommended wearing period prescribed by the eye care professional. The lens may be disinfected using a chemical disinfection system.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the PureVision™ Multi-Focal 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 professional. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the PureVision™ Multi-Focal Contact Lens is to be discarded after each removal.
5. Predicate Devices:
The predicate devices were selected to address material type, lens design and indications for use.
Lens material:
Bausch & Lomb® PureVision™ (balafilcon A) Visibility Tinted Contact Lens, FDA Group III, low water, ionic contact lens, is marketed under K972454 and P980006.
Lens Design and Indications for use:
Bausch & Lomb® SofLens® Multi-Focal (polymacon) Visibility Tinted Contact Lens is an aspheric lens design and is marketed for daily wear of correction of presbyopia under K020927.
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6. Substantial Equivalence:
| Material Similarities | ||
|---|---|---|
| PureVisionTMMulti-Focal Contact Lens(subject device) | PureVisionTMContact Lens | |
| Material | Balafilcon A | Balafilcon A |
| Water Content | 36% | 36% |
| FDA Group | Group III(low water/ionic) | Group III(low water/ionic) |
| Oxygen Permeability(Dk)† | 91*101** | 91*101** |
| Color Additive | Reactive Blue Dye 246 | Reactive Blue Dye 246 |
| Manufacturing Method | Cast Mold | Cast Mold |
| Lens Design and Indications Similarities | ||
| PureVisionTMMulti-Focal Contact Lens(subject device) | SofLens® Multi-FocalContact Lens | |
| Lens Design | Aspheric MultifocalConcentric - Center Near | Aspheric MultifocalConcentric - Center Near |
| Intended Use | Multifocal - daily wear forthe correction ofrefractive ametropia(myopia, hyperopia, andastigmatism) andpresbyopia | Multifocal - daily wear forthe correction ofrefractive ametropia(myopia, hyperopia, andastigmatism) andpresbyopia |
1 Dk Units = x10 1 1 cm 0 (STP)xcm]/(secxcm2xmm Hg)@35°C (Polarographic Method) *Boundary and Edge Corrected ** Boundary and Non-Edge Corrected
By reference, data from the series of non-clinical laboratory tests and clinical studies previously performed to assess the safety and effectiveness of the balafilcon A contact lens can be found in K944895, cleared December 19, 1994 and K972454, cleared August 8, 1997.
Conclusion
The PureVision Multi-Focal Contact Lens is substantially equivalent to predicate devices currently legally marketed for the lens material, design and intended uses. The risks and benefits of the PureVision Multi-Focal Contact Lens are the same as those normally attributed to the wearing of soft (hydrophilic) contact lenses on a daily wear basis.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like symbol with three curved lines representing its body and wings. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 8 2005
Bausch & Lomb, Inc. c/o Ms. Ann Zavertnik 1400 North Goodman St. Rochester, NY 14609
Re: K050948
KUJU946
Trade/Device Name: Baush & Lomb® PureVision™ Multi-Focal (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: April 13, 2005 Received: April 18, 2005
Dear Ms. Ann Zavertnik:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becaon 910(x) premained is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosure) to regally manative personal provice Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, devices that have occh reculised in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that Go not requence subject to the general controls provisions of the Act. The You may, mercrore, market the act include requirements for annual registration, listing of general controls provisions of the 120 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is olassinod (600 wor of ols. Existing major regulations affecting your device can Inay be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Obacements 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 that I DA has made a and regulations administered by other Federal agencies. You must of any I coural statutes und regulatents including, but not limited to: registration and listing Comply with an the rece requirements, monthly good manufacturing practice requirements as set (21 CFR Part 607), laborang (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I his iciter will anow you to ought finding of substantial equivalence of your device to a legally prematicated predicated." 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), please If you desire spocific advisor Jan (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mionnation on Joan Copsumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
David M. Whipple
David M. Whipple Acting Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) PREMARKET NOTIFICATION ว ใน(K) PREMARKET NOTH 1071-10711-11-11
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens April 2005
Bausch & Lomb 1400 North Goodman Street Rochester, NY 14609
Indications for Use Statement
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Device Name: Visibility Tinted Contact Lens
Indications for Use:
BAUSCH & LOMB® PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in aphakic and/or not-(11) play 11) 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.
Replacement schedules may vary from patient to patient, and should be decided by eye care practitioners in consultation with their patients. The 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 professional. The lens may be disinfected using a chemical disinfection system.
FREQUENT/PLANNED REPLACEMENT WEAR
When prescribed for Frequent/Planned Replacement Wear, the PureVision™ Multi-Focal 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 professional. The lens may be disinfected using a chemical disinfection system.
DISPOSABLE WEAR
When prescribed for Disposable Wear, the PureVision™ Multi-Focal Contact Lens is to be discarded after each removal.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF
NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V
Over-The-Counter-Use _ OR
| ::vision Sign-Off) |
|---|
| Division of Ophthalmic Ear |
| Nose and Throat Devises |
510(k) Number K050948
Page 3
§ 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.