(79 days)
Focus® NIGHT AND DAY™ (lotrafilcon A)
To answer your question, information about "Reference Device(s)" must be in the "Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text." section.
In this case, the text explicitly states: Not Found for the "Reference Device(s)".
No
The document describes a contact lens made of a specific material and design for vision correction. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies are clinical trials evaluating the physical properties and clinical outcomes of the lens itself.
No
The device is indicated for the correction of ametropia (myopia and hyperopia) and presbyopia, which are refractive errors, not diseases. While it helps protect against UV transmission, its primary function is visual correction, not the treatment or prevention of a disease or medical condition.
No
The VISTAKON® (galyfilcon A) Contact Lens is indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia, meaning it is a corrective device, not one used for diagnosis.
No
The device description clearly describes a physical contact lens made of specific materials and supplied in a sterile solution. This is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the VISTAKON® contact lenses are for the correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) in the eye. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties and composition of the contact lens itself, which is a medical device designed to be placed on the eye. It does not describe any components or processes used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Anatomical Site: The device is applied to the eye and cornea, which is consistent with a corrective medical device, not an IVD that analyzes biological samples.
- Performance Studies: The performance studies focus on the safety and efficacy of the lens in terms of vision, health, comfort, and fit when worn on the eye. This is typical for a medical device, not an IVD which would evaluate diagnostic performance metrics like sensitivity and specificity.
In vitro diagnostics are devices used to perform tests on samples such as blood, urine, or tissue, outside of the body, to detect diseases, conditions, or infections. The VISTAKON® contact lens does not perform any such tests.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
• 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing: A series of in vitro and in vivo preclinical toxicology and 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® (galyfilcon A) Contact Lens demonstrate that:
The lens material and extracts are not toxic and not irritating 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® (galyfilcon 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Focus® NIGHT AND DAY™ (lotrafilcon A), FDA Group I.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
510(k) PREMARKET NOTIFICATION
VISTAKON®® (galyfilcon A) Contact Lens
K 032340
Summary of Safety and Effectiveness
| Submitter
Information | Company: | VISTAKON®
Division of Johnson & Johnson Vision Care,
Inc.
7500 Centurion Parkway
Suite 100
Jacksonville, FL 32256 |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | Jacqueline Zimovan
Project Leader
Regulatory & Clinical Affairs |
| | Telephone:
FAX: | 904-443-1402
904-443-1424 |
| | Date Prepared: | July 28, 2003 |
| Identification of
the Device | Common Name:
Device Name:
Classification Name:
Device Classification: | Soft Contact Lens
VISTAKON® (galyfilcon A) Contact Lens
Soft Hydrophilic Contact Lens, Daily Wear
Class II, 21 CFR 886.5925 (b) (1). |
| Predicate
Device | The predicate device was selected to address both intended use (daily
wear) 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
1
| Description of
Device | • 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.
2
Indications for Use
| Lens Design | Indication |
|---|---|
| Spherical | 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 of | |
| astigmatism or less. | |
| Multifocal | 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 0.75D of | |
| astigmatism or less. | |
| Toric | 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 10.00D of | |
| astigmatism or less. | |
| Toric | |
| Multifocal | 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 10.00D | |
| 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 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.
3
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 AND | ||
| DAY™ (lotrafilcon A) | ||
| Contact Lens | VISTAKON® | |
| (galyfilcon A) | ||
| Contact Lens | ||
| Material | lotrafilcon A | galyfilcon A |
| Type | Group I | Group I |
| Parameter Comparison | ||
|---|---|---|
| Focus® NIGHT AND | ||
| DAYTM (lotrafilcon A) | ||
| Contact Lens | VISTAKON® | |
| (galyfilcon A) | ||
| Contact Lens | ||
| Characteristics | ||
| Comparison | 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-edge | ||
| corrected | 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 |
4
| Non-clinical
Testing | A series of in vitro and in vivo preclinical toxicology and
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® (galyfilcon
A) Contact Lens demonstrate that:
The lens material and extracts are not toxic and not irritating 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® (galyfilcon 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. |
5
Conclusions Drawn from Studies
| Validity of
Scientific Data | Toxicology studies were conducted by a contract
laboratory under Good Laboratory Practice Regulations.
Microbiology, chemistry, shelf-life stability, and
leachability studies were conducted by VISTAKON®
laboratories and followed scientific protocols. The data
were determined to be scientifically valid under 21 CFR
860.7 |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial
Equivalence | Information presented in this Premarket Notification
establishes that the VISTAKON® (galyfilcon A) Contact
Lens is as safe and effective as the predicate device when
used in accordance with the labeled directions for use and
for the requested indication. |
| Risk and
Benefits | The risks of the subject device as the same as those
normally attributed to the wearing of soft (hydrophilic)
contact lenses on a daily wear basis. The benefits to the
patient are the same as those for other soft (hydrophilic)
contact lenses. |
6
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.
7
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 . |