(84 days)
The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-aphakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
The VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a multifocal lens, a toric lens and a toric multifocal lens.
The lens material (lenefilcon A) is a copolymer of 2-hydroxyethyl 2-methyl-2 propenoate and 2-propenic acid, 2-methyl-2,3-dihydroxypropyl ester cross-linked with poly (oxy-1,2-ethanediyl) (4) bis (2-methyl-2-propenoate). The VISTAKON Contact Lens Visibility Tint with UV Blocker 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 transmittance characteristics are less than 1% in the UVB range of 280nm to 315nm and less than 10% in the UVA range of 316nm to 380nm. The VISTAKON Contact Lens is a hemispherical or hemitoric shell.
The VISTAKON (lenefilcon A) Soft Contact Lens is a contact lens with various designs (spherical, multifocal, toric, and toric multifocal) intended for daily wear to correct refractive ametropia. The study for this device did not involve an AI component, nor did it involve the evaluation of expert performance with or without AI assistance. Instead, it was a clinical and non-clinical study to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria / Predicate Device Performance (NewVues® (vifilcon A)) | Reported Device Performance (VISTAKON (lenefilcon A)) |
|---|---|---|
| Material Properties: | ||
| Water Content, % | 55 (labeled) / 56 (measured) | 55 (labeled) / 55 (measured) |
| Refractive Index @ 20°C | 1.415 (labeled) / #1.41 (calculated) | 1.41 (labeled) / 1.41 (measured) |
| Dk, edge corrected | 16 (labeled) / 18 (measured) | 16 (labeled) / 17 (measured) |
| Dk, non-edge corrected | 16 (labeled) / 22 (measured) | 21 (labeled) / 22 (measured) |
| Color (if tinted) | Blue | Blue |
| Physical Dimensions: | ||
| Base Curve, mm | 8.5 (labeled) / 8.5 (measured) | 8.84 (labeled) / 8.86 (measured) |
| Diameter, mm | 14.0 (labeled) / 14.3 (measured) | 14.05 (labeled) / 14.10 (measured) |
| Power, D | -1.00 (labeled) / -1.02 (measured) | -0.74 (labeled) / -0.79 (measured) |
| Toxicology: | No evidence of toxicity/irritation and meeting ISO requirements | Passed Cytotoxicity, Ocular Irritation (Rabbit), Acute Systemic Toxicity (Mouse) |
| Microbiology: | Minimum SAL of 10-6 for sterilization; demonstrated disinfection efficacy with care products | Sterilization process validated to minimum SAL of 10-6; shelf-life stability data support sterility |
| Clinical Equivalence: | Substantial clinical equivalence to predicate device | Found to be at least substantially clinically equivalent to the predicate device |
| UV Blocker Transmittance: | N/A (implicit that it blocks UV) | Less than 1% in UVB (280-315nm), less than 10% in UVA (316-380nm) |
Notes on Acceptance Criteria:
- The acceptance criteria for the material properties and physical dimensions are implied by demonstrating substantial equivalence to the predicate device. The performance data for the VISTAKON lens is compared directly to the predicate device's data.
- For non-clinical studies (toxicology, chemistry, microbiology), the acceptance criteria are based on established standards and previous demonstrations of compatibility (e.g., ISO studies, validated sterilization processes).
2. Sample Size for Test Set and Data Provenance
- Sample Size for Test Set: At least 50 patients participated in the clinical trial. The ratio of subject device to predicate device was 2:1.
- Data Provenance: Not explicitly stated, but clinical trials for US FDA submissions are typically conducted in the US. The study evaluated "Daily Wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994)," which implies US-centric regulatory guidelines. The study was prospective as it involved a clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The submission does not specify the number or qualifications of experts (e.g., ophthalmologists, optometrists) involved in establishing the ground truth or evaluating patient outcomes in the clinical trial. However, clinical trials for contact lenses typically involve qualified eye care professionals for examinations and assessments.
4. Adjudication Method for the Test Set
The submission does not explicitly describe an adjudication method for the clinical study's evaluations (e.g., 2+1, 3+1). Clinical trials generally involve standardized protocols for examinations and reporting adverse events, which implicitly serve as a form of "ground truth" establishment by the clinical investigators.
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
No such study was performed or is applicable to this device. This submission is for a medical device (contact lens), not an AI-powered diagnostic or assistive 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 and does not involve an algorithm or AI.
7. The Type of Ground Truth Used
For the clinical study:
- The "ground truth" was established through direct clinical observation and measurement of various parameters in patients wearing the contact lenses. These parameters included:
- Adverse reactions
- Symptoms
- Problems and complaints reported by patients
- Slit lamp evaluations (objective assessment of ocular health)
- Visual acuity (objective measurement of vision correction)
- Lens wear time
- Fit assessment
- Discontinuations from the study
- For non-clinical studies (chemistry, toxicology, microbiology), the ground truth was based on established scientific protocols, validated methods, and regulatory standards (e.g., ISO studies, validated sterilization processes).
8. The Sample Size for the Training Set
Not applicable. This device is a contact lens, not an AI model requiring a training set. The "training" for the device would be its manufacturing process and design, refined through R&D.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for an AI model. The development of the VISTAKON contact lens material and design would have involved extensive R&D, material characterization, and design optimization based on scientific principles and previous knowledge of contact lens technology.
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K9839/2
Summary of 510(k) Submission
| Summary | The 510(k) submission summary consists of these sections Name and address of submitterIdentification of devicePredicate deviceDescription of deviceIntended use CharacteristicsNon clinical studiesClinical studiesConclusions drawn from studiesFlow Chart for 510(k) Daily Wear Contact Lens Materials |
|---|---|
| Name and address of submitter | Vistakon, Johnson & Johnson Vision Products, Inc.4500 Salisbury Road, Suite 300Jacksonville, Florida 32216Contact: Sharon A. BriggsPhone: 904/443-1471Date Prepared: November 2, 1998 |
| Identification of Device | Trade name: VISTAKON (lenefilcon A) Contact Lens Clear and Visibility tint with UV blocker.Common or usual name: Soft (hydrophilic) Contact Lens (daily wear)FDA Classification: Class II |
| Predicate Device | NewVues® (vifilcon A) Soft Contact Lens |
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| Description of Device | The VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a multifocal lens, a toric lens and a toric multifocal lens.The lens material (lenefilcon A) is a copolymer of 2-hydroxyethyl 2-methyl-2 propenoate and 2-propenic acid, 2-methyl-2,3-dihydroxypropyl ester cross-linked with poly (oxy-1,2-ethanediyl) (4) bis (2-methyl-2-propenoate). The VISTAKON Contact Lens Visibility Tint with UV Blocker 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 transmittance characteristics are less than 1% in the UVB range of 280nm to 315nm and less than 10% in the UVA range of 316nm to 380nm. The VISTAKON Contact Lens is a hemispherical or hemitoric shell. | |
|---|---|---|
| Intended Use | Spherical lens | The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less. |
| Multifocal lens | The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less. | |
| Toric lens | The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less. | |
| Toric Multifocal lens | The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. | |
| Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement (see "WEARING SCHEDULE"). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only. |
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The VISTAKON (lenefilcon A) Contact Lens is classified into FDA Group II Characteristics for contact lens materials. The predicate device is classified into FDA Group IV. The predicate device was chosen because the water content and Dk value are the same as the subject device, the predicate device is available in similar base curve and diameter configurations and both subject and predicate devices are visibility tinted. The characteristics of the VISTAKON (lenefilcon A) Contact Lens are compared to the characteristics of the predicate device in the following table.
| VISTAKON (lenefilcon A)Contact Lens Visibility Tintwith UV Blocker | NewVues® (vifilcon A) SoftContact Lens | |||
|---|---|---|---|---|
| Measured | Label | Measured | Label | |
| Water Content, % | 55 | 55 | 56 | 55 |
| Refractive Index @ 20°C | 1.41 | 1.41 | #1.41 | 1.415 |
| Dk, edge corrected | 17 | 16 | 18 | 16 |
| Dk, non-edge corrected | 22 | 21 | 22 | 16 |
| Color (if tinted) | Blue | Blue | Blue | Blue |
| Base Curve, mm | 8.86 | 8.84 | 8.5 | 8.5 |
| Diameter, mm | 14.10 | 14.05 | 14.3 | 14.0 |
| Power, D | -0.79 | -0.74 | -1.02 | -1.00 |
Dk units = x 10-11 (cm²/sec) (ml O2/ml x mm Hg) * edge correction method not identified in CIBA Vision® labeling # calculated from water content
| Non clinicalStudies | Included as non clinical studies are• chemistry,• toxicology, lenses and package,• microbiology | |
|---|---|---|
| Chemistry | Material property data were generated on the subject device and the predicatedevice. The data for both devices reflect properties of Group II and Group IVlenses, respectively. The lens care product manufacturers have previouslyshown compatibility of Group II and Group IV lenses with their products.The shelf-life stability for VISTAKON (lenefilcon A) Contact Lenses isbased upon stability protocols included with this notification or referenced.Studies were conducted to determine the leachable monomers from thesubject device. | |
| Toxicology,lenefilcon Alens material | In accordance with the May 1994 Guidance Document for Daily Wear contactlenses, toxicology studies have been conducted on the VISTAKON(lenefilcon A) soft (hydrophilic) Contact Lenses Clear and Visibility Tintwith UV blocker. The results are summarized below: | |
| CytotoxicityTest | The negative controls and the positive controls performed asanticipated. Under the conditions of this study, the test articleshowed no evidence of causing cell lysis or toxicity. The testarticle was not cytotoxic and passed this ISO study. | |
| OcularIrritationStudy in theRabbit | Under the conditions of this study, there was no evidence ofsignificant irritation in the test eye or control eye of anyrabbit. The SC and CSO test article extracts would not beconsidered irritants to the ocular tissue of the rabbit. | |
| AcuteSystemicToxicity inthe Mouse | Under the conditions of this study, there was no mortality orevidence of significant systemic toxicity from the extracts.Each test article extract met the ISO requirements. | |
| Toxicology,packagematerials | No additional toxicology studies have been conducted on the plastic primarypackaging materials, as the materials are the same as those previously testedand reported under N18-033. | |
| Microbiology | The lens sterilization process, moist heat sterilization, has been validated todeliver a minimum SAL of 10-6. The lens care product manufacturers haveestablished a reasonable assurance of disinfection efficacy of their careproducts with the lens groups for which they are approved. There are shelf-life stability data that support lens sterility throughout the shelf-life claimedfor the product. | |
| Clinical studies | The safety of the lens material in the spherical design has been confirmedthrough a clinical trial for daily wear contact lens materials with a new USANname according to the Premarket Notification (510(k)) Guidance Documentfor Daily Wear Contact Lenses (May 1994). The study evaluated at least 50patients with a 2:1 ratio of subject device to predicate device for three (3)months. Parameters measured included adverse reactions, symptoms, | |
| Clinical studies | problems and complaints, slit lamp evaluations, visual acuity, lens wear time,fit assessment and discontinuations. The VISTAKON (lenefilcon A) trialcontact lens was found to be at least substantially clinically equivalent to thepredicate device. | |
| Conclusionsdrawn fromstudies | Validity ofScientific Data | Toxicology studies were conducted by a contractlaboratory under Good Laboratory Practice Regulations.Microbiology, chemistry, shelf-life stability, andleachables studies were conducted by in-house laboratoriesand followed scientific protocols. The data weredetermined to be scientifically valid under 21 CFR 860.7. |
| SubstantialEquivalence | The data presented in this Premarket Notification supportthe subject device is as safe, as effective and performs aswell as or better than the predicate device when used inaccordance with the labeled directions for use and for therequested indication. | |
| Risk and Benefits | The risks of the subject device are the same as thosenormally attributed to the wearing of soft (hydrophilic)contact lenses on a daily wear basis. The benefits to thepatient are the same as those for other soft (hydrophilic)contact lenses. |
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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Ms. Sharon A. Briggs Group Leader, Regulatory Submissions Vistakon Johnson and Johnson Vision Prouducts, Inc. P.O. Box 10157 Jacksonville, FL 32247
Re: K983912
Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lenses Clear and Visibiltiy Tint with UV Blocker (Cast molded, Spherical, Toric, Multifocal Designs for daily wear)
Regulatory Class: II Product Code: 86 LPL Dated: November 2, 1998 Received: November 3, 1998
Dear Ms. Briggs:
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 (for the indications for use stated in the enclosure) 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 major 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 .
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Page 2 - Mr. Sharon A. Briggs
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 forenthal
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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Page 1 of 1
510 (k) Number (if known) : K9 8 3 9 / 乙
Device Name: VISTAKON (lenefilcon A) Contact Lens, clear and visibility tint with UV Blocker
Indications for Use:
| Sphericallens | The VISTAKON Contact Lens is indicated for daily wear for the correctionof refractive ametropia (myopia and hyperopia) in aphakic or non-aphakicpersons with non-diseased eyes who may have 1.00 D of astigmatism or less. |
|---|---|
| Multifocallens | The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wearfor the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D ofastigmatism or less. |
| Toric lens | The VISTAKON TORIC Contact Lens is indicated for daily wear for thecorrection of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D ofastigmatism or less. |
| ToricMultifocallens | The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for dailywear for the correction of distance and near vision in presbyopic aphakic ornon-aphakic persons with non-diseased eyes who may have 10.00 D ofastigmatism or less. |
Eye care practitioners may prescribe the lens either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfection system only.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3 - 10 - 09)
(Posted July 1, 1998)
Miz-Chuen Shui
(Division Sign Off) Division of Ophthalmic Devi ಸ 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)
§ 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.