(66 days)
The VISTAKON® (senofilcon A) Contact Lens is indicated for daily wear for the 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® (senofilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakit persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON® (senofilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON® (senofilcon A) Multifocal-Toric Contact Lens is indicated for daily wear for the correction of distance and near vision in presby opic phakic or apakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lenses 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 lenses may be disinfected using a chemical disinfection system only.
• The VISTAKON® (senofilcon A) Contact Lens Clear and Visibility Tint with UV Blocker is available as a spherical lens, a multifocal lens, a toric lens and a multifocal-toric lens.
• The lenses are made of a silicone hydrogel material containing an internal wetting agent.
• The VISTAKON® (senofilcon 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® (senofilcon A) Contact Lens is a hemispherical or hemitoric shell.
• The lens is supplied in a sterile state, packaged in a buffered saline solution with 0.005% methyl ether cellulose.
• The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution.
Here's a summary of the acceptance criteria and study information for the VISTAKON® (senofilcon A) Contact Lens, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission focuses on establishing substantial equivalence to a predicate device rather than setting specific numeric acceptance criteria for revolutionary performance. The "acceptance criteria" here are implied through comparative performance to the predicate and general safety/effectiveness.
| Characteristic / Study Outcome | Predicate Device (Focus® NIGHT AND DAY™ (lotrafilcon A) Contact Lens) | VISTAKON® (senofilcon A) Contact Lens | Acceptance Criteria (Implied) | Reported Performance (VISTAKON®) |
|---|---|---|---|---|
| Material Type | Group I | Group I | Matching predicate material group | Group I |
| Water Content (%) | Labeled: 24, Measured: 23 | Labeled: 38, Measured: 38 | Safe, effective, and similar in overall performance to predicate | 38% |
| Refractive Index @ 20°C | Labeled: 1.43, Measured: 1.43 | Labeled: 1.42, Measured: 1.42 | Safe, effective, and similar in overall performance to predicate | 1.42 |
| Dk (edge corrected) | Labeled: 140, Measured: 141 | Labeled: 103, Measured: 107 | Safe, effective, and similar in overall performance to predicate | 107 |
| Dk (non-edge corrected) | NA, Measured: 168 | NA, Measured: 126 | Safe, effective, and similar in overall performance to predicate | 126 |
| Base Curve (mm) | Labeled: 8.4, Measured: 8.47 | Labeled: 8.8, Measured: 8.81 | Safe, effective, and similar in overall performance to predicate | 8.81 |
| Diameter (mm) | Labeled: 13.8, Measured: 13.80 | Labeled: 14.6, Measured: 14.62 | Safe, effective, and similar in overall performance to predicate | 14.62 |
| Power (D) | Labeled: -1.00, Measured: -1.11 | Labeled: -0.50, Measured: -0.35 | Safe, effective, and similar in overall performance to predicate | -0.35 |
| Toxicology/Biocompatibility | N/A - Predicate established as safe | Not toxic, not irritating | Not toxic and not irritating | Confirmed non-toxic and non-irritating |
| Lens Physical/Material Properties | Consistent with currently marketed lenses | Consistent with currently marketed lenses | Consistent with currently marketed lenses | Confirmed consistent |
| Clinical Performance (Safety/Efficacy) | N/A - Predicate established as safe/effective | Similar overall performance to concurrent controls | Similar overall performance in vision, health, comfort, and fit compared to controls | Demonstrated similar overall performance |
2. Sample Size for Test Set and Data Provenance
- Sample Size: "at least 50 patients" were evaluated in the clinical study.
- Data Provenance: The document does not explicitly state the country of origin for the clinical study. It was a prospective clinical study conducted over "three (3) months".
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth within the clinical study. The clinical study evaluated parameters like adverse reactions, keratometry changes, reasons for discontinuations, and unscheduled lens replacements, which would typically be assessed by eye care professionals.
4. 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 data or outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (MRMC for AI assistance) is not applicable to this device, which is a contact lens and not an AI-powered diagnostic or assistive tool. The study was a clinical trial comparing the new contact lens to a predicate lens.
6. Standalone (Algorithm Only) Performance
Not applicable. This device is a contact lens and does not involve an algorithm.
7. Type of Ground Truth Used
The ground truth for the clinical study appears to be based on clinical assessments and observations by investigators during the study, evaluating parameters such as visual acuity, ocular health, comfort, and fit, as well as adverse reactions. For toxicology and biocompatibility, the ground truth was established through in vitro and in vivo preclinical toxicology and biocompatibility tests following GLP regulations.
8. Sample Size for the Training Set
Not applicable. This device is a contact lens and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI algorithm, there is no training set or ground truth for a training set.
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042275
i
510(k) PREMARKET NOTIFICATION VISTAKON®® (senofilcon A) Contact Lens
Summary of Safety and Effectiveness
| SubmitterInformation | Company: | VISTAKON®Division of Johnson & Johnson Vision Care, Inc.7500 Centurion ParkwaySuite 100Jacksonville, FL 32256 |
|---|---|---|
| Contact Person: | Annette M. HillringPresidentHillring & Associates, Inc. | |
| Telephone: | 813-269-8246 | |
| FAX: | 813-908-8706 | |
| Date Prepared: | August 20, 2004 | |
| Identification ofthe Device | Common Name: | Soft Contact Lens |
| Device Name: | ||
| Classification Name: | ||
| Device Classification: | ||
| PredicateDevice | The predicate device was selected to address both intended use (dailywear) and material type (FDA Group I; low water, nonionic polymer):• Focus® NIGHT AND DAY™ (lotrafilcon A), FDA Group I. |
Continued on next page
and the same of the same of the same of the same of the same of the same of the same of the seat the seat the seat the seat of the seat of the seat of the seat of the seat of
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| Description ofDevice | • The VISTAKON® (senofilcon A) Contact Lens Clear and VisibilityTint with UV Blocker is available as a spherical lens, a multifocallens, a toric lens and a multifocal-toric lens. |
|---|---|
| • The lenses are made of a silicone hydrogel material containing aninternal wetting agent. | |
| • The VISTAKON® (senofilcon 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 range of316 – 380nm. | |
| • The VISTAKON® (senofilcon A) Contact Lens is a hemispherical orhemitoric shell. | |
| • The lens is supplied in a sterile state, packaged in a buffered salinesolution with 0.005% methyl ether cellulose. | |
| • The composition of the lens is 62% senofilcon A and 38% water byweight when hydrated and stored in the buffered saline solution. |
and the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the comments of the contra
{2}------------------------------------------------
Indications for Use
| Lens Design | Indication |
|---|---|
| Spherical | The VISTAKON® (senofilcon A) Contact Lens is indicatedfor daily wear for the correction of refractive ametropia(myopia and hyperopia) in phakic or aphakic persons withnon-diseased eyes who may have 1.00D of astigmatism orless. |
| Multifocal | The VISTAKON® (senofilcon A) Multifocal Contact Lensis indicated for daily wear for the correction of distance andnear vision in presbyopic, phakic or aphakic persons withnon-diseased eyes who may have 0.75D of astigmatism orless |
| Toric | The VISTAKON® (senofilcon A) Toric Contact Lens isindicated for daily wear for the correction of visual acuity inphakic or aphakic persons with non-diseased eyes that arehyperopic or myopic and may have 10.00D of astigmatismor less. |
| Multifocal Toric | The VISTAKON® (senofilcon A) Multifocal-Toric ContactLens is indicated for daily wear for the correction ofdistance and near vision in presbyopic phakic or aphakicpersons with non-diseased eyes who may have 10.00D ofastigmatism or less. |
- VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
- Eye care practitioners may prescribe the lens for single-use disposable wear, or for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement. When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only.
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Technological Characteristics The characteristics of the VISTAKON® (senofilcon A) Contact Lens are compared to the characteristics of the predicate device, Focus® NIGHT & DAY™ (lotrafilcon A) Contact Lens, in the following tables.
| Material Comparison | ||
|---|---|---|
| Focus® NIGHT AND DAY™ (lotrafilcon A) Contact Lens | VISTAKON® (senofilcon A) Contact Lens | |
| Material | lotrafilcon A | senofilcon A |
| Type | Group I | Group I |
| Parameter Comparison | ||||
|---|---|---|---|---|
| Focus® NIGHT AND DAY™ (lotrafilcon A) Contact Lens | VISTAKON® (senofilcon A) Contact Lens | |||
| Measured | Labeled | Measured | Labeled | |
| Water Content, % | 23 | 24 | 38 | 38 |
| Refractive Index @20°C | 1.43 | 1.43 | 1.42 | 1.42 |
| Dk*, edge corrected | 141 | 140 | 107 | 103 |
| Dk*, non-edgecorrected | 168 | NA | 126 | 122 |
| Base Curve, mm | 8.47 | 8.4 | 8.81 | 8.8 |
| Diameter, mm | 13.80 | 13.8 | 14.62 | 14.6 |
| Power, D | -1.11 | -1.00 | -0.35 | -0.50 |
*Dk units: 10 -11(cm2/sec)(ml O2/ml x mmHg)
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A series of in vitro and in vivo preclinical toxicology and Non-clinical Testing biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All non-clinical toxicology tests were conducted in accordance with the GLP regulation (21 CFR Part 56). All other testing was conducted according to valid scientific protocols.
The results of the non-clinical testing on the VISTAKON® (senofilcon A) Contact Lens demonstrate that:
- · the lens material and extracts are not toxic and not irritating, and
- · lens physical and material properties are consistent with currently marketed lenses.
- Clinical Testing A three-month clinical study was completed to evaluate the safety and efficacy of the VISTAKON® (senofilcon A) Contact Lens when worn by myopic patients on a daily wear basis. The clinical study was conducted in accordance with FDA's 1994 Guidance Document for Daily Wear Contact Lenses.
The study evaluated at least 50 patients with a 2:1 ratio of subject device to predicate device for three (3) months. Parameters measured included adverse reactions, keratometry changes, reasons for discontinuations, and the number of reasons for unscheduled lens replacements.
Clinical evaluation demonstrated similar overall performance in the clinically relevant areas of vision, health, comfort and fit as compared to concurrent controls when used under daily wear conditions.
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Conclusions Drawn from Studies
| Validity ofScientific Data | Toxicology studies were conducted under the GoodLaboratory Practices Regulations by a contract laboratory.Microbiology, chemistry, shelf-life stability, andleachability studies were conducted by VISTAKON®laboratories and followed scientific protocols. The datawere determined to be scientifically valid under 21 CFR860.7 |
|---|---|
| SubstantialEquivalence | Information presented in this Premarket Notificationestablishes that the VISTAKON® (senofilcon A) ContactLens is as safe and effective as the predicate device whenused in accordance with the labeled directions for use andfor the requested indication. |
| Risk andBenefits | The risks of the subject device as 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/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 8 2004
Vistakon c/o Ms. Annette M. Hillring President, Hillring & Associates, Inc. 3012 St. Charles Drive Tampa, FL 33618
Re: K042275
Ro-ZZ75
Trade/Device Name: Vistakon8 (senofilcon A) Contact Lens for Daily Wear (Clear and Visibility Tint with UV Blocker) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL; MVN Dated: August 20, 2004 Received: August 23, 2004
Dear Ms. Hillring:
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 Office of Compliance at (301) 594-4613. 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/dsma/dsmamain.html
Sincerely yours,
A. kelpi Rosenthal
A. Ralph Rosenthal, M.D. 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
510(k) Number:
Device Name:
VISTAKON® (senofilcon A) Contact Lens Clear and Visibility Tint, with UV blocker
Indications for Use:
The VISTAKON® (senofilcon A) Contact Lens is indicated for daily wear for the 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® (senofilcon A) Multifocal Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic, phakic or aphakit persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON® (senofilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON® (senofilcon A) Multifocal-Toric Contact Lens is indicated for daily wear for the correction of distance and near vision in presby opic phakic or apakic persons with non-diseased eyes who may have 10.00 D of astigmatism or less.
VISTAKON® (senofilcon A) UV Blocking Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Practitioners may prescribe the lenses 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 lenses may be disinfected using a chemical disinfection system only.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Ophthalmic Ear, Nose and Throat Devises | |
| 510(k) Number | K042275 |
Page 1 of
§ 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.