(30 days)
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and is to be discarded after each removal.
The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear is available as a spherical lens, spherical multifocal lens and an astigmatic (toric) lens. The lens material (etafilcon A) is a copolymer of 2- hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1- trimethylol propane trimethacrylate and ethylene glycol trimethacrylate. The VISTAKON® Contact Lens with visibility tint is tinted blue using Reactive Blue Dye #4 to make the lens more visible for handling. A benzotriazole UV absorbing monomer is used to block UV radiation. The average transmittance characteristics are less than 5 % in the UVB range of 280 to 315 nm and less than 30 % in the UVA range of 316 to 380 nm. The lens is a hemispherical shell.
Here's the breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Predicate Label Claim) | Reported Device Performance (Subject Device Label Claim) |
|---|---|---|
| Water Content, % | 58 | 58 |
| Refractive Index @ 20° C | 1.40 | 1.40 |
| Dk-Fatt method, non-edge corrected (cm²/sec)(ml O₂/mlmmHg) | 28.0 x 10⁻¹¹ | 28.0 x 10⁻¹¹ |
| Specific Gravity, (calc.) | 0.98 - 1.12 | 0.98 - 1.12 |
| Light Transmission | Minimum 85% | Minimum 85% |
| Base Curve Radius, mm | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm |
| Diameter, mm | 12.0 mm to 15.0 mm | 12.0 mm to 15.0 mm |
| Power, Diopters | Varies with power: 0.06 mm to 1.00 mm | Varies with power: -20.0 D to + 20.0 D |
| Center Thickness, mm | -20.0 D to + 20.0 D | 0.06 mm to 1.00 mm |
Note on Power and Center Thickness: The table in the document has the Power and Center Thickness rows swapped in the "Subject Device Label Claim" column compared to the "Predicate Device Label Claim" column. I have listed them as they appear in the document for the subject device.
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "The technological characteristics, formulation, manufacturing, and sterilization processes are the same as the predicate device, therefore no clinical data is required." This implies that there was no separate "test set" in the context of a clinical study for the subject device. The equivalence was established based on non-clinical testing and comparison to the predicate device's established performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical test set requiring expert ground truth was performed for the subject device.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a contact lens, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a contact lens, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for the subject device's performance was established through:
- Non-clinical testing: This includes Toxicology Testing (Cytotoxicity, Ocular Irritation, Systemic Toxicity), Leachables, Physical/Chemical Testing, and Stability Testing.
- Comparison to a legally marketed predicate device: The predicate device, 1-DAY ACUVUE® Brand (etafilcon A) Contact Lens cleared via K013973, served as the established "ground truth" for acceptable performance and safety. The subject device demonstrated substantial equivalence based on identical technological characteristics and non-clinical test results.
8. The Sample Size for the Training Set
Not applicable. The document describes a medical device (contact lens), not a machine learning or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
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Special 510 (k) Summary of Safety and Effectiveness
| Name andAddress ofSubmitter | VISTAKON, Division of Johnson & Johnson Vision Care, Inc.7500 Centurion Parkway, Suite 100Jacksonville, Florida 32256Contact: Susan MorrisPhone: (904) 443-1428Date Prepared: July 12, 2005 | ||
|---|---|---|---|
| DeviceIdentificationand Class | Common Name: | Soft (hydrophilic) contact lenses for dailywear | |
| Trade/Proprietary Name: | VISTAKON® (etafilcon A) Soft(hydrophilic) Contact Lens, Clear andVisibility Tinted with UV Blocker forDaily Disposable Wear | ||
| Classification: | Class II, under 21 CFR 886.5925 | ||
| PredicateDeviceInformation | The predicate device is the 1-DAY ACUVUE® Brand (etafilcon A)Contact Lens, Clear and Visibility Tinted, with UV Blocker fordisposable daily wear most recently cleared via K013973. | ||
| DeviceDescription | The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clearand Visibility Tinted with UV Blocker for Daily Disposable Wear isavailable as a spherical lens, spherical multifocal lens and an astigmatic(toric) lens. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate and ethylene glycol trimethacrylate.The VISTAKON® Contact Lens with visibility tint is tinted blue usingReactive Blue Dye #4 to make the lens more visible for handling. Abenzotriazole UV absorbing monomer is used to block UV radiation.The average transmittance characteristics are less than 5 % in the UVBrange of 280 to 315 nm and less than 30 % in the UVA range of 316 to380 nm. The lens is a hemispherical shell. |
Continued on next page
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Special 510 (k) Summary of Safety and Effectiveness, Continued
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens Indications (spherical), Clear and Visibility Tinted with UV Blocker, for Daily for Use Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens. Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eves who may have 0.75 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less.
VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye.
The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and is to be discarded after each removal.
Continued on next page
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Special 510 (k) Summary of Safety and Effectiveness, Continued
Technological Characteristics
Comparison to Predicate Device
The table below shows a side-by-side comparison of the label claim characteristics of the modified device to the predicate device.
| Property | Subject DeviceLabel Claim | Predicate DeviceLabel Claim |
|---|---|---|
| Water Content, % | 58 | 58 |
| Refractive Index@ 20° C | 1.40 | 1.40 |
| Dk-Fatt method, non-edge corrected(cm²/sec)(ml O₂/mlmmHg) | $28.0 x 10^{-11}$ | $28.0 x 10^{-11}$ |
| Specific Gravity,(calc.) | 0.98 - 1.12 | 0.98 - 1.12 |
| Light Transmission | Minimum 85% | Minimum 85% |
| Base Curve Radius,mm | 7.85 mm to 10.0 mm | 7.85 mm to 10.0 mm |
| Diameter, mm | 12.0 mm to 15.0 mm | 12.0 mm to 15.0 mm |
| Power, Diopters | Varies with power: 0.06 mm to 1.00 mm | Varies with power:0.06 mm to 1.00 mm |
| Center Thickness,mm | -20.0 D to + 20.0 D | -20.0 D to + 20.0 D |
Summary of Non-clinical Testing
The following tests were conducted as recommended by the FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact lenses, May 12, 1984:
- Toxicology Testing .
- o Cytotoxicity using the ISO Agarose Overlay
- 0 ISO Ocular Irritation Study
- o USP & ISO Systemic Toxicity in Mice
- · Leachables
- Physical/Chemical Testing .
- Stability Testing .
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Special 510 (k) Summary of Safety and Effectiveness,
Continued
.
:
.
:
| Clinical Testing | The technological characteristics, formulation, manufacturing, and sterilization processes are the same as the predicate device, therefore no clinical data is required. |
|---|---|
| Substantial Equivalence | The VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear that are the subject of this 510(k) submission are equivalent to the predicate device. Successful results from chemical/physical, stability and toxicology tests confirm the lenses are within established finished product specifications, remain stable, and are non-toxic and biocompatible with the ocular environment. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem of an eagle with three lines representing its wings and two curved lines representing its body.
Public Health Service
AUG 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vistakon® Division of Johnson & Johnson Vision Care, Inc. c/o Susan Morris Project Manager, Regulatory Submissions 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K051900
Trade/Device Name: Vistakon (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear (packaged in buffered saline with Povidone) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: MVN; LPL Dated: July 12, 2005 Received: July 13, 2005
Dear Ms. Morris:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 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); 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.
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Page 2 - Susan Morris
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (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 Manufacturers, International and Consumer 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
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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Indications for Use Statement
..............................................................................................................................................................................
| 510(k) Number | Unknown |
|---|---|
| Device Name | VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear |
| Indications for Use | The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with not diseased eyes who may have 1.00D or less of astigmatism. |
| The VISTAKON (etafilcon A) Soft (hydrophilic) Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic, aphakic or not-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less. | |
| The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes who are hyperopic or myopic and may have 10.00 D of astigmatism or less. | |
| The VISTAKON (etafilcon A) Soft (hydrophilic) Toric Bifocal Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or not aphakic persons with non-diseased who may have 10.00 D of astigmatism or less. | |
| VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear help protect against transmission of harmful UV radiation to the cornea and into the eye. | |
| The VISTAKON (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tinted with UV Blocker, for Daily Disposable Wear is to be prescribed for Daily Disposable Wear and 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)
ming cham
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
| Prescription Use(Per 21 CFR 801.109) | 510(k) Number K051900 OR Over-the-Counter Use |
|---|---|
| ------------------------------------------ | ----------------------------------------------- |
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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.