(98 days)
The VISTAKON® (narafilcon B) 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 B) 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 4.00D of ADD power or less and 0.75D of astigmatism or less.
The VISTAKON® (narafilcon B) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon B) 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 eves who may have 4.00D of ADD power or less and 10.00D of astigmatism or less.
VISTAKON® (narafilcon B) 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 disinfection is required.
The VISTAKON® (narafilcon B) Contact Lens 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 B) Contact Lens 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 280-315nm and less than 10% in the UVA range of 316-380nm. The VISTAKON® (narafilcon B) 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 52% narafilcon B and 48% water by weight when hydrated and stored in the buffered saline solution.
Here's a summary of the acceptance criteria and study details for the VISTAKON® (narafilcon B) Contact Lens, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly list distinct "acceptance criteria" with specific thresholds for the clinical study. Instead, it describes "primary endpoints" and indicates that the device demonstrated "similar overall performance" to the control lens. The comparison focuses on non-inferiority to a predicate device, rather than meeting predefined numerical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and Efficacy comparable to predicate device | Non-clinical testing (in-vitro and in-vivo toxicology, biocompatibility) demonstrated: - Lens material and/or extracts are non-toxic, non-irritating, and non-sensitizing. - Lens physical and material properties are consistent with currently marketed lenses. |
| Clinical evaluation demonstrated similar overall performance in clinically relevant areas of vision and health compared to concurrent controls (1∙DAY ACUVUE® Brand Contact Lenses) under daily wear single-use conditions. | |
| Primary Endpoints for Clinical Study: | |
| Slit lamp findings | Demonstrated similar performance to control lens. |
| Symptoms Problems and complaints | Demonstrated similar performance to control lens. |
| Visual acuity | Demonstrated similar performance to control lens. |
| Average wear time | Demonstrated similar performance to control lens. |
| Additional Parameters Measured: | |
| Adverse reactions | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Keratometry changes | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Reasons for discontinuation | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Number and reasons for unscheduled lens replacements | Not explicitly detailed, but implied to be acceptable based on overall safety and effectiveness conclusion. |
| Biocompatibility/Toxicology | The lens material and/or extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions. |
| Physical and Material Properties | The lens physical and material properties are consistent with currently marketed lenses. (Specifically compared to VISTAKON® (narafilcon A) Contact Lens for water content, refractive index, Dk, base curve, diameter, and power – see Technological Characteristics table for values, though no acceptance criteria are given for these, only comparative values). |
Study Details
-
Sample size used for the test set and the data provenance:
- Clinical Study (Test Set): 48 subjects, with a 1:1 ratio between the test lens (VISTAKON® (narafilcon B) Contact Lens) and the control lens (1∙DAY ACUVUE® Brand Contact Lenses).
- Data Provenance: The document does not specify the country of origin. The study was a "one-month clinical study" performed to evaluate safety and efficacy, implying it was prospective. Non-clinical studies were "in-vitro and in-vivo preclinical toxicology and biocompatibility tests."
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not specify the number or qualifications of experts involved in establishing ground truth for the clinical study's endpoints (e.g., slit lamp findings, visual acuity). These are typically assessed by trained clinical investigators (e.g., optometrists, ophthalmologists) following standard clinical protocols.
-
Adjudication method for the test set:
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical study. Clinical studies typically rely on predefined assessments by trained personnel.
-
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, an MRMC comparative effectiveness study involving human readers and AI assistance was not done. This device is a contact lens, not an AI-based diagnostic tool. The clinical study directly compared the performance of the new contact lens to an existing control lens in human subjects.
-
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a contact lens, not an algorithm. The non-clinical testing included standalone in-vitro tests of the lens material and in-vivo preclinical toxicology/biocompatibility, but not algorithm-only performance.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Clinical Study: The "ground truth" for the clinical study outcomes was based on direct clinical observation and measurement of various physiological parameters and patient-reported outcomes (e.g., slit lamp findings, visual acuity, symptoms, wear time). This falls under a combination of "expert assessment" and "outcomes data" as measured in a controlled clinical environment.
- Non-clinical Testing: Ground truth for these tests would be established by standard analytical and experimental methodologies for toxicology, biocompatibility, and material properties, against predefined benchmarks or comparisons (e.g., ISO standards, predicate device characteristics).
-
The sample size for the training set:
- Not applicable as this is a physical medical device (contact lens), not a machine learning algorithm that requires a training set.
-
How the ground truth for the training set was established:
- Not applicable for the same reason as above.
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MAY 2 ] 2010
510(k) Summary
.
| SubmitterInformation | Company: | Johnson & Johnson Vision Care, Inc.7500 Centurion ParkwaySuite 100Jacksonville, FL 32256 | |
|---|---|---|---|
| Contact Person: | Catherine Dillon | ||
| Email: | cdillon9@its.jnj.com | ||
| Telephone: | 904-443-3180 | ||
| FAX: | 904-443-1424 | ||
| Date Prepared: | February 8, 2010 | ||
| Identification ofthe Device | Common Name: | Soft Contact Lens | |
| Device Name: | VISTAKON® (narafilcon B) Contact Lens | ||
| Classification Name: | Soft Hydrophilic Contact Lens, Daily Wear | ||
| Device Classification: | Class II, 21 CFR 886.5925 (b) (1). | ||
| PredicateDevice(s) | MaterialVISTAKON® (narafilcon A) Contact Lens – K073485(FDA Group I; low water, nonionic polymer) | ||
| Indication, Wear ScheduleVISTAKON® (etafilcon A) Contact Lenses – K962804(Daily wear, single use) |
.
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| Description of Device | The VISTAKON® (narafilcon B) Contact Lens 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 B) Contact Lens 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 280-315nm and less than 10% in the UVA range of 316-380nm. The VISTAKON® (narafilcon B) 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 52% narafilcon B and 48% water by weight when hydrated and stored in the buffered saline solution. |
|---|---|
| ----------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Continued on next page
.
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・ Ind
| Indications forUse | Lens Design | Indication |
|---|---|---|
| Spherical | The VISTAKON® (narafilcon B) Contact Lens isindicated for daily wear single use only for the opticalcorrection of refractive ametropia (myopia andhyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less ofastigmatism. | |
| Multifocal | The VISTAKON® (narafilcon B) Contact Lens isindicated for daily wear single use only for the opticalcorrection of distance and near vision in presbyopic,phakic or aphakic persons with non-diseased eyes whomay have 4.00D of ADD power or less and 0.75D ofastigmatism or less. | |
| Toric | The VISTAKON® (narafilcon B) Contact Lens isindicated for daily wear single use only for the opticalcorrection of visual acuity in phakic or aphakic personswith non-diseased eyes that are hyperopic or myopicand may have 4.00D of ADD power or less and 10.00Dor less of astigmatism. | |
| MultifocalToric | The VISTAKON® (narafilcon B) Contact Lens isindicated for daily wear single use only for the opticalcorrection of distance and near vision in presbyopicphakic or aphakic persons with non-diseased eyes whomay have 4.00D of ADD power or less and 10.00D ofastigmatism or less. |
- VISTAKON® (narafilcon B) 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 disinfection is required.
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Technological Characteristics
The technological characteristics of the VISTAKON® (narafilcon B) Contact Lenses are compared to the characteristics of the predicate device, VISTAKON® (narafilcon A) Contact Lens, in the following tables.
| Predicate Device | Subject Device | |
|---|---|---|
| Product Name | VISTAKON®(narafilcon A)Contact Lens | VISTAKON®(narafilcon B)Contact Lens |
| Material USAN Name | narafilcon A | narafilcon B |
| 510(k) Number | K073485 | TBD - This submission |
| FDA Category (Group) | Group I | Group I |
| Manufacturing Method | Molded | Molded |
| Sterilization | Moist Heat | Moist Heat |
| Packaging | Blister | Blister |
| Visibility Tint | Blue | Blue |
| Parameter Comparison | ||||
|---|---|---|---|---|
| Predicate DeviceVISTAKON®(narafilcon A) ContactLens-K073485 | Subject DeviceVISTAKON®(narafilcon B)Contact Lens | |||
| Measured | Labeled | Measured | Labeled | |
| Water Content, % | 47 | 46 | 48 | 48 |
| Refractive Index @ 20°C | 1.40 | 1.41 | 1.41 | 1.41 |
| Dk, edge corrected | 96 | 100 | 52 | 55 |
| Base Curve, mm | 8.53 | 8.5 | 8.49 | 8.5 |
| Diameter, mm | 14.26 | 14.2 | 14.19 | 14.2 |
| Power, D | -0.92 | -1.00 | -0.98 | -1.00 |
Polarographic Method, Dk units: 10 -11(cm+/sec)(ml O2/ml x mmHg)
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| Non-clinicalTesting | A series of in-vitro and in-vivo preclinical toxicology andbiocompatibility tests were performed to assess the safety andeffectiveness of the contact lens. All tests were conducted inaccordance with the GLP regulation (21 CFR Part 56) or according tovalid scientific protocols. |
|---|---|
| The results of the non-clinical testing/evaluation demonstrate that: | |
| the lens material and/or extracts are non-toxic, non-irritating andnon-sensitizing under the experimental conditions; and the lens physical and material properties are consistent withcurrently marketed lenses. | |
| Clinical Testing | A one-month clinical study was completed to evaluate the safety andefficacy of the VISTAKON® (narafilcon B) Contact Lens for single.use daily wear only. |
| The study evaluated 48 subjects with a 1:1 ratio between the test lensand the control lens (1·DAY ACUVUE® Brand Contact Lenses). Theprimary endpoints were slit lamp findings, symptoms, problems andcomplaints, visual acuity and average wear time. Additional |
parameters measured included adverse reactions, keratometry changes, reasons for discontinuation, and the number and reasons for unscheduled lens replacements.
The clinical evaluation demonstrated similar overall performance in the clinically relevant areas of vision and health as compared to concurrent controls when used under daily wear single use conditions.
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Conclusions Drawn from Studies
| Validity ofScientific Data | A contract laboratory under Good LaboratoryPractice Regulations conducted toxicology studies.Microbiology, chemistry, shelf-life stability, andleachability studies were conducted by VISTAKON®laboratories and followed scientific protocols. Thedata were determined to be scientifically valid under21 CFR 860.7. |
|---|---|
| SubstantialEquivalence | Information presented in this Premarket Notificationestablishes that the VISTAKON® (narafilcon B)Contact Lens is as safe and effective as the predicatedevice when used in accordance with the labeleddirections for use and for the requested indication. |
| Risk andBenefits | The risks of the subject device are the same as thosenormally attributed to the wearing of soft(hydrophilic) contact lenses on a daily wear singleuse basis. The benefits to the patient are the same asthose for other soft (hydrophilic) contact lenses. |
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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with its wings spread, positioned above a wavy line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Johnson & Johnson Vision Care, Inc. C/O Catherine C. Dillon Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K100349
Trade/Device Name: VISTAKON® (narafilcon B) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 4, 2010 Received: May 5, 2010
Dear Ms. Dillon:
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.
MAY 2 1 2010
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.
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
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Page 2 – Ms. Catherine C. Dillon
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 11 70 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/7/Picture/8 description: The image shows a handwritten word that appears to be "for". The script is cursive and the letters are connected. The "f" has a prominent loop extending below the baseline, and the "o" and "r" are joined together at the top.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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 (if known):
Device Name:
VISTAKON® (narafilcon B) Contact Lens Visibility Tinted, with UV Blocker
Indications for Use:
The VISTAKON® (narafilcon B) 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.
100349
The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 0.75D of astigmatism or less.
The VISTAKON® (narafilcon B) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon B) 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 eves who may have 4.00D of ADD power or less and 10.00D of astigmatism or less.
VISTAKON® (narafilcon B) 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 disinfection is required.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Kaur Warburton
vision Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100349
§ 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.