(66 days)
Focus® NIGHT AND DAY™ (lotrafilcon A)
Not Found
No
The summary describes a contact lens and its material properties, intended use, and clinical study results. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is indicated for the correction of refractive ametropia (myopia and hyperopia) and presbyopia, which are optical corrections, not treatments for a disease or condition. While they correct vision, they do not provide therapy in the medical sense.
No
The device is a contact lens indicated for the correction of refractive errors and presbyopia, not for diagnosing medical conditions.
No
The device description clearly states the device is a physical contact lens made of silicone hydrogel material.
Based on the provided information, 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 ametropia (myopia, hyperopia, astigmatism, and presbyopia) in phakic or aphakic persons with non-diseased eyes. This is a therapeutic and corrective function, not a diagnostic one.
- Device Description: The description details the physical properties, material composition, and manufacturing of the contact lenses. There is no mention of the device being used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or compatibility testing.
- Performance Studies: The clinical study described evaluates the safety and efficacy of the contact lens in correcting vision and its impact on eye health and comfort. This aligns with the evaluation of a therapeutic or corrective device, not a diagnostic one.
IVD devices are used to perform tests on samples (like blood, urine, tissue) taken from the human body to provide information about a person's health. Contact lenses, as described here, are placed on the surface of the eye to correct vision.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LPL; MVN
Device Description
• 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea and into the eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Practitioners may prescribe the lenses
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)
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.
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)
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
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
042275
i
510(k) PREMARKET NOTIFICATION VISTAKON®® (senofilcon A) Contact Lens
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: | Annette M. Hillring
President
Hillring & Associates, Inc. |
| | Telephone: | 813-269-8246 |
| | FAX: | 813-908-8706 |
| | Date Prepared: | August 20, 2004 |
| Identification of
the Device | Common Name: | Soft Contact Lens |
| | | Device Name: |
| | | Classification Name: |
| | | Device Classification: |
| 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
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
1
| Description of
Device | • 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. |
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 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 of astigmatism or | |
| less. | |
| Multifocal | The VISTAKON® (senofilcon A) Multifocal Contact Lens |
| is indicated for daily wear for the correction of distance and | |
| near vision in presbyopic, phakic or aphakic persons with | |
| non-diseased eyes who may have 0.75D of astigmatism or | |
| less | |
| Toric | 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 10.00D of astigmatism | |
| or less. | |
| Multifocal Toric | The VISTAKON® (senofilcon A) Multifocal-Toric Contact |
| Lens is indicated for daily wear for the correction of | |
| distance and near vision in presbyopic phakic or aphakic | |
| persons with non-diseased eyes who may have 10.00D 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 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® (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-edge | ||||
| corrected | 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)
4
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.
5
Conclusions Drawn from Studies
| Validity of
Scientific Data | Toxicology studies were conducted under the Good
Laboratory Practices Regulations by a contract laboratory.
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® (senofilcon 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
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.
7
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
8
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 |
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