(79 days)
The VISTAKON® (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (galyfilcon A) Multifocal Contact Lens 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® (galyfilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON® (galyfilcon A) Toric-Multifocal Contact Lens 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® (galyfilcon 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 (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.
• The VISTAKON® (galyfilcon A) Contact Lens Clear and Visibility Tint with UV blocker is available as a spherical lens, a multifocal lens, a toric lens and a toric-multifocal lens.
- The lens material, galyfilcon A, is a copolymer of 2-hydroxyethyl . methacrylate and (3-methacryloxy-2-hydroxypropyloxy) propylbis(trimethylsiloxy)methylsilane and N.Ndimethylacrylamide, and polyvinylpyrrolidone and mPDMSmonomethacrylate (n=11), and 2-propenoic acid, 2-methyl-, 1,2ethandiyl ester.
- The VISTAKON® (galyfilcon 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® (galyfilcon A) Contact Lens is a hemispherical or hemitoric shell.
- . The lens is supplied in a sterile state, packaged in a buffered saline solution with up to 0.01% methyl ether cellulose.
- . The composition of the lens is 53% galyfilcon A and 47% water by weight when hydrated and stored in the buffered saline solution.
The provided document is a 510(k) Premarket Notification for a contact lens, specifically the VISTAKON® (galyfilcon A) Contact Lens. It details the device's characteristics, indications for use, comparison to a predicate device, and the non-clinical and clinical studies conducted. The purpose of a 510(k) is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to prove safety and effectiveness from scratch through detailed performance criteria against absolute benchmarks. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of this document relate to its comparison to the predicate device and adherence to established clinical guidelines for contact lens studies.
Here's an analysis of the provided information:
1. Table of acceptance criteria and the reported device performance
For a 510(k) application for a contact lens, the "acceptance criteria" are implicitly defined by demonstrating substantial equivalence to a predicate device. This is achieved by showing comparable safety and effectiveness, which includes similar material properties, chemical and physical characteristics, and clinical performance (e.g., adverse reaction rates, visual acuity, comfort, fit).
| Acceptance Criteria Category (Implied for 510(k)) | Reported Device Performance (VISTAKON® (galyfilcon A) Contact Lens) |
|---|---|
| Material Composition | Galyfilcon A copolymer (similar to predicate's lotrafilcon A, both FDA Group I) |
| Physical/Chemical Properties | Water Content: 48% (Labeled 47%) - Predicate: 23% (Labeled 24%)Refractive Index @ 20°C: 1.4055 (Labeled 1.41) - Predicate: 1.4263 (Labeled 1.43)Dk (edge corrected): 55.4 (Labeled 60) - Predicate: 141.3 (Labeled 140)Dk (non-edge corrected): 68.3 (Labeled 70) - Predicate: 167.6 (NA)Base Curve, mm: 8.35 (Labeled 8.3) - Predicate: 8.47 (Labeled 8.4)Diameter, mm: 14.11 (Labeled 14.0) - Predicate: 13.8 (Labeled 13.8)Power, D: -1.03 (Labeled -1.00) - Predicate: -1.11 (Labeled -1.00)Note: While some values differ, the intent is to show the device functions as expected within its classification and intended use. |
| Biocompatibility/Toxicity | Not toxic and not irritating (based on in vitro and in vivo preclinical toxicology and biocompatibility tests). |
| Clinical Safety & Efficacy | "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." (Implies comparable adverse event rates and acceptable clinical outcomes to the predicate). |
| Indications for Use | Spherical, Multifocal, Toric, Toric-Multifocal for daily wear, correction of refractive ametropia, presbyopia, astigmatism, with UV blocking. (Comparable to predicate and within general soft contact lens indications). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size (Clinical Study): At least 50 patients (with a 2:1 ratio of subject device to predicate device).
- Data Provenance: The document does not explicitly state the country of origin.
- Study Design: Prospective ("A three-month clinical study was completed to evaluate the safety and efficacy...").
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. For contact lens studies, "ground truth" typically refers to objective clinical measurements and expert clinical evaluations by ophthalmologists or optometrists, but the number and qualifications of such experts are not specified in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not explicitly provided in the document. Clinical studies typically involve expert evaluations, but the specific adjudication method for discrepancies (if any) is not detailed.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is not applicable here as this is a contact lens, not an AI-powered diagnostic device that would involve human "readers" interpreting cases with or without AI assistance. The study compares two contact lenses.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical contact lens, not an algorithm. Its performance is evaluated through clinical use by human wearers. Non-clinical (in vitro) tests were performed on the material itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the clinical study, the "ground truth" and evaluation metrics included:
- Clinical Outcomes Data: Adverse reactions, keratometry changes, reasons for discontinuations, number of reasons for unscheduled lens replacements, and overall clinical performance in terms of vision, health, comfort, and fit.
- Expert Clinical Evaluation: Implicitly, the "clinically relevant areas of vision, health, comfort and fit" would have been assessed by eye care professionals.
For non-clinical testing:
- Laboratory-measured properties: Material composition, water content, refractive index, Dk values, base curve, diameter, power.
- Toxicology and Biocompatibility Tests: These would involve standardized assays and observations to determine toxicity and irritation, which serve as "ground truth" for these specific aspects.
8. The sample size for the training set
This contact lens is not an AI algorithm, so there is no "training set" in the machine learning sense. The manufacturing process and formulation were developed through traditional R&D, not algorithmic training.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" for an AI algorithm. The performance of the contact lens product is evaluated against its intended use and comparison to a predicate device.
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510(k) PREMARKET NOTIFICATION
VISTAKON®® (galyfilcon A) Contact Lens
K 032340
Summary of Safety and Effectiveness
| SubmitterInformation | Company: | VISTAKON®Division of Johnson & Johnson Vision Care,Inc.7500 Centurion ParkwaySuite 100Jacksonville, FL 32256 |
|---|---|---|
| Contact Person: | Jacqueline ZimovanProject LeaderRegulatory & Clinical Affairs | |
| Telephone:FAX: | 904-443-1402904-443-1424 | |
| Date Prepared: | July 28, 2003 | |
| Identification ofthe Device | Common Name:Device Name:Classification Name:Device Classification: | Soft Contact LensVISTAKON® (galyfilcon A) Contact LensSoft Hydrophilic Contact Lens, Daily WearClass II, 21 CFR 886.5925 (b) (1). |
| 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 |
Page 11
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| Description ofDevice | • The VISTAKON® (galyfilcon A) Contact Lens Clear andVisibility Tint with UV blocker is available as a spherical lens, amultifocal lens, a toric lens and a toric-multifocal lens. |
|---|---|
| -------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
- The lens material, galyfilcon A, is a copolymer of 2-hydroxyethyl . methacrylate and (3-methacryloxy-2-hydroxypropyloxy) propylbis(trimethylsiloxy)methylsilane and N.Ndimethylacrylamide, and polyvinylpyrrolidone and mPDMSmonomethacrylate (n=11), and 2-propenoic acid, 2-methyl-, 1,2ethandiyl ester.
- The VISTAKON® (galyfilcon 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® (galyfilcon A) Contact Lens is a hemispherical or hemitoric shell.
- . The lens is supplied in a sterile state, packaged in a buffered saline solution with up to 0.01% methyl ether cellulose.
- . The composition of the lens is 53% galyfilcon A and 47% water by weight when hydrated and stored in the buffered saline solution.
{2}------------------------------------------------
Indications for Use
| Lens Design | Indication |
|---|---|
| Spherical | The VISTAKON® (galyfilcon A) Contact Lens is indicatedfor daily wear for the correction of refractive ametropia(myopia and hyperopia) in aphakic or not-aphakic personswith non-diseased eyes who may have 1.00D ofastigmatism or less. |
| Multifocal | The VISTAKON® (galyfilcon A) Multifocal Contact Lensis indicated for daily wear for the correction of distance andnear vision in presbyopic, aphakic or not-aphakic personswith non-diseased eyes who may have 0.75D ofastigmatism or less. |
| Toric | The VISTAKON® (galyfilcon A) Toric Contact Lens isindicated for daily wear for the correction of visual acuity inaphakic or not-aphakic persons with non-diseased eyes thatare hyperopic or myopic and may have 10.00D ofastigmatism or less. |
| ToricMultifocal | The VISTAKON® (galyfilcon A) Toric-Multifocal ContactLens is indicated for daily wear for the correction ofdistance and near vision in presbyopic aphakic or not-aphakic persons with non-diseased who may have 10.00Dof astigmatism or less. |
- · VISTAKON® (galyfilcon 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® (galyfilcon 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 ANDDAY™ (lotrafilcon A)Contact Lens | VISTAKON®(galyfilcon A)Contact Lens | |
| Material | lotrafilcon A | galyfilcon A |
| Type | Group I | Group I |
| Parameter Comparison | ||
|---|---|---|
| Focus® NIGHT ANDDAYTM (lotrafilcon A)Contact Lens | VISTAKON®(galyfilcon A)Contact Lens | |
| CharacteristicsComparison | Measured Labeled | Measured Labeled |
| Water Content, % | 23 24 | 48 47 |
| Refractive Index @ 20°C | 1.4263 1.43 | 1.4055 1.41 |
| Dk*, edge corrected | 141.3 140 | 55.4 60 |
| Dk*, non-edgecorrected | 167.6 NA | 68.3 70 |
| Base Curve, mm | 8.47 8.4 | 8.35 8.3 |
| Diameter, mm | 13.8 13.8 | 14.11 14.0 |
| Power, D | -1.11 -1.00 | -1.03 -1.00 |
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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 non-clinical toxicology testswere conducted in accordance with the GLP regulation (21 CFR Part56). All other testing was conducted according to valid scientificprotocols.The results of the non-clinical testing on the VISTAKON® (galyfilconA) Contact Lens demonstrate that:The lens material and extracts are not toxic and not irritating Lens physical and material properties are consistent with currentlymarketed lenses. |
|---|---|
| Clinical Testing | A three-month clinical study was completed to evaluate the safety andefficacy of the VISTAKON® (galyfilcon A) Contact Lens when wornby myopic patients on a daily wear basis. The clinical study wasconducted in accordance with FDA's 1994 Guidance Document forDaily Wear Contact Lenses.The study evaluated at least 50 patients with a 2:1 ratio of subjectdevice to predicate device for three (3) months. Parameters measuredincluded adverse reactions, keratometry changes, reasons fordiscontinuations, and the number of reasons for unscheduled lensreplacements.Clinical evaluation demonstrated similar overall performance in theclinically relevant areas of vision, health, comfort and fit as comparedto concurrent controls when used under daily wear conditions. |
{5}------------------------------------------------
Conclusions Drawn from Studies
| Validity ofScientific Data | Toxicology studies were conducted by a contractlaboratory under Good Laboratory Practice Regulations.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® (galyfilcon 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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DEPARTMENT OF HEALTH & HUMAN SERVICES
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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
OCT 1 6 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vistakon c/o Ms. Jacqueline Zimovan Project Leader Regulatory and Clinical Affairs P.O. Box 17700 Jacksonville, FL 32245-7700
Re: K032340.
Trade/Device Name: VISTAKON® (galyfilcon A) Contact Lens (Spherical, Toric, Multifocal and Toric-Multifocal) (Clear and tinted with UV Blocker) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 28, 2003 Received: July 29, 2003
Dear Ms. Zimovan:
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 - Ms. Jacqueline Zimovan
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. Reizi 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
{8}------------------------------------------------
Statement of Indications for Use
510(k) Number:
Device Name:
VISTAKON® (galyfilcon A) Contact Lens Clear and Visibility Tint, with UV blocker
Indications for Use:
The VISTAKON® (galyfilcon A) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The VISTAKON® (galyfilcon A) Multifocal Contact Lens 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® (galyfilcon A) Toric Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or not-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON® (galyfilcon A) Toric-Multifocal Contact Lens 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® (galyfilcon 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 (see "Wearing Schedule"). When prescribed for frequent/planned replacement wear, the lenses 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)
| Prescription Use | OR | Over the Counter | |
|---|---|---|---|
| (Division Sign-Off) Division of Ophthalmic Ear,Nose and Throat Devises | |||
| 510(k) Number . |
§ 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.