(82 days)
The VISTAKON® (narafilcon A) Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less.
The VISTAKON® (narafilcon A) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
• The VISTAKON® (narafilcon A) Contact Lens Clear and Visibility Tinted with UV blocker is available as a spherical lens, multifocal lens; toric lens, and toric-multifocal lens.
• The lenses are made of a silicone hydrogel material containing an internal wetting agent.
• The VISTAKON® (narafilcon A) Contact Lens may be 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 transmittance characteristics are less than 1% in the UVB range of 280 – 315nm and less than 10% in the UVA range of 316 – 380nm.
• The VISTAKON® (narafilcon A) Contact Lens is a hemispherical or hemitoric shell.
• The lens is supplied in a sterile state, packaged in a buffered saline solution with methyl ether cellulose.
• The composition of the lens is 54% narafilcon A and 46% water by weight when hydrated and stored in the buffered saline solution.
This is a 510(k) summary for a contact lens, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a clinical study with acceptance criteria in the same way an AI/ML diagnostic software might. Therefore, many of the requested categories (like number of experts, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or typically reported in this type of submission for a contact lens.
However, I can extract information related to the device itself and its indicated performance from the provided text.
Here's an analysis based on the available information:
Description of Acceptance Criteria and the Study that Proves the Device Meets the Acceptance Criteria
For a contact lens 510(k) submission, the "acceptance criteria" are generally established by demonstrating that the new device is substantially equivalent to a legally marketed predicate device in terms of safety, effectiveness, and intended use. This typically involves showing comparable material properties, design, indications for use, and performance, often through bench testing and, in some cases, clinical trials to assess comfort, visual acuity, and ocular health. The provided document does not detail specific quantitative acceptance criteria or the study data that proved the device met them directly (e.g., in a performance table as one might find for an AI algorithm). Instead, the submission argues for substantial equivalence.
The "study that proves the device meets the acceptance criteria" in this context refers to the body of evidence provided in the 510(k) submission (bench tests, biocompatibility tests, and potentially clinical trial data for safety and effectiveness) that demonstrates the VISTAKON® (narafilcon A) Contact Lens is as safe and effective as its predicate devices. The summary itself does not contain the detailed study results/data, but rather the conclusions and the FDA's determination of substantial equivalence.
1. Table of Acceptance Criteria and the Reported Device Performance
As mentioned, specific quantitative acceptance criteria and a direct "reported device performance" table like one would see for an AI diagnostic are not present in this 510(k) summary. The "performance" is implicitly deemed acceptable by the FDA's substantial equivalence determination to the predicate devices.
However, based on the description of the device and its indications, we can infer some "performance" aspects:
| Aspect | Implied "Acceptance Criteria" (Substantial Equivalence) | Reported Device Performance (as stated in the 510(k) summary) |
|---|---|---|
| Optical Correction | Comparable to predicate lenses for refractive ametropia (myopia, hyperopia), presbyopia, and astigmatism. | Spherical: Optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism. Multifocal: Optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less. Toric: Optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism. Multifocal Toric: Optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. |
| Wear Schedule | Comparable to predicate for daily wear single use. | Daily wear single use only. Lenses are discarded upon removal; no cleaning/disinfecting required. |
| UV Blocking | Effective UV protection comparable to other UV-blocking lenses. | Contains a UV Blocker. Transmittance characteristics: less than 1% in UVB (280–315nm) and less than 10% in UVA (316–380nm). |
| Material Composition | Safe and effective silicone hydrogel material with similar properties to predicate devices. | Made of a silicone hydrogel material (narafilcon A) containing an internal wetting agent. 54% narafilcon A and 46% water by weight when hydrated. |
| Biocompatibility/Safety | Biocompatible and safe for ocular contact during daily wear. | Based on FDA's substantial equivalence determination, the material and design are considered safe for their intended use. (Specific biocompatibility test results are not in summary but would be part of full 510(k)). |
2. Sample Size Used for the Test Set and the Data Provenance
The 510(k) summary provided does not disclose the sample size for any clinical or non-clinical "test set" used to evaluate the device performance. The data provenance (country of origin, retrospective/prospective) is also not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This is not applicable for a contact lens 510(k) submission. The evaluation focuses on material properties, design, and clinical performance parameters (e.g., visual acuity, comfort, ocular health assessments performed by optometrists/ophthalmologists in clinical trials, not "experts establishing ground truth" in the AI sense).
4. Adjudication Method for the Test Set
This is not applicable for a contact lens 510(k) submission.
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
This is explicitly not applicable, as this is a contact lens, not an AI diagnostic software.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is explicitly not applicable, as this is a contact lens, not an AI algorithm.
7. The Type of Ground Truth Used
For a contact lens, "ground truth" would relate to objective measurements of material properties (e.g., oxygen permeability, water content, UV blocking efficacy) and clinical outcomes (e.g., Snellen visual acuity, slit lamp examination findings, patient reported comfort). These are established through validated testing methods and clinical assessments, rather than an "expert consensus" on imaging interpretation or pathology.
8. The Sample Size for the Training Set
This is explicitly not applicable, as this is a contact lens, and there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
This is explicitly not applicable, as this is a contact lens, and there is no "training set" or "ground truth establishment" in the AI/ML sense.
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510(k) Summary
| SubmitterInformation | Company:Contact Person:Email:Telephone:FAX:Date Prepared: | VISTAKON®Division of Johnson & Johnson Vision Care, Inc.7500 Centurion ParkwaySuite 100Jacksonville, FL 32256Rosalind Baker Williamsrbaker@visus.jnj.com904-403-1504904-403-1424December 11, 2007 |
|---|---|---|
| Identification ofthe Device | Common Name:Device Name:Classification Name:Device Classification: | Soft Contact LensVISTAKON® (narafilcon A) Contact LensSoft Hydrophilic Contact Lens, Daily WearClass II, 21 CFR 886.5925 (b) (1). |
| PredicateDevice(s) | MaterialVISTAKON® (galyfilcon A) Contact Lens ">– K032340(FDA Group I; low water, nonionic polymer)Indication, Wear ScheduleVISTAKON® (etafilcon) Contact Lenses – K962804(Daily wear, single use) |
:
Continued on next page
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Executive Summary, Continued
| Description ofDevice | • The VISTAKON® (narafilcon A) Contact Lens Clear andVisibility Tinted with UV blocker is available as a spherical lens,multifocal lens; toric lens, and toric-multifocal lens. |
|---|---|
| • The lenses are made of a silicone hydrogel material containing aninternal wetting agent. | |
| • The VISTAKON® (narafilcon A) Contact Lens may be tinted blueusing Reactive Blue Dye #4 to make the lens more visible forhandling | |
| • A benzotriazole UV absorbing monomer is used to block UVradiation. The transmittance characteristics are less than 1% in theUVB range of 280 – 315nm and less than 10% in the UVA rangeof 316 – 380nm. | |
| • The VISTAKON® (narafilcon A) Contact Lens is a hemisphericalor hemitoric shell. | |
| • The lens is supplied in a sterile state, packaged in a buffered salinesolution with methyl ether cellulose. | |
| • The composition of the lens is 54% narafilcon A and 46% waterby weight when hydrated and stored in the buffered salinesolution. |
and the comments of the comments of the comments of the comments of the comments of the comments of
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510(k) Summary, Continued
Indications for Use
| Lens Design | Indication |
|---|---|
| Spherical | The VISTAKON® (narafilcon A) Contact Lens is indicatedfor daily wear single use only for the optical correction ofrefractive ametropia (myopia and hyperopia) in phakic oraphakic persons with non-diseased eyes who may have1.00D or less of astigmatism. |
| Multifocal | The VISTAKON® (narafilcon A) Contact Lens is indicatedfor daily wear single use only for the optical correction ofdistance and near vision in presbyopic, phakic or aphakicpersons with non-diseased eyes who may have 0.75D ofastigmatism or less. |
| Toric | The VISTAKON® (narafilcon A) Contact Lens is indicatedfor daily wear single use only for the optical correction ofvisual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have10.00D or less of astigmatism. |
| MultifocalToric | The VISTAKON® (narafilcon A) Contact Lens is indicatedfor daily wear single use only for the optical correction ofdistance and near vision in presbyopic phakic or aphakicpersons with non-diseased eyes who may have 10.00D ofastigmatism or less. |
- VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to . help protect against transmission of harmful UV radiation to the cornea and into the eye.
- The Eye Care Professional should prescribe the lenses for daily wear . single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
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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 with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vistakon c/o Rosalind Baker Williams 7500 Centurion Parkway, Ste. 100 Jacksonville FL 32256
MAR - 3 2008
Re: K073485
Trade/Device Name: VISTAKON® (narafilcon A) Contact Lens for Daily Wear Single Use Only
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: December 11, 2007 Received: December 12, 2007
Dear Ms. Williams:
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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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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Malina Bepelaia, und
Malvina B. Eydelman, M. 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:
Device Name:
VISTAKON® (narafilcon A) Contact Lens Clear and Visibility Tinted, with UV blocker
Indications for Use:
The VISTAKON® (narafilcon A) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic, phakic or aphakic persons with non-diseased eyes who may have 0.75D of astigmatism or less.
The VISTAKON® (narafilcon A) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of distance and near vision in presbyopic phakic or aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
VISTAKON® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
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 |
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
| 510(k) Number | K073485 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL
§ 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.