(84 days)
Not Found
Not Found
No
The summary describes a standard contact lens with different designs (spherical, multifocal, toric, toric multifocal) and material properties. There is no mention of any computational or analytical functions that would suggest the use of AI or ML. The performance studies focus on material safety and clinical equivalence to a predicate device, not on algorithmic performance.
No.
The device is used for the correction of refractive ametropia and presbyopia, which are vision impairments, not diseases that are being treated. While it improves vision, it does not treat or cure an underlying medical condition.
No
The VISTAKON Contact Lens is indicated for the correction of refractive errors and vision, not for the diagnosis of eye conditions. Its purpose is to correct vision, not to identify or characterize a disease or condition.
No
The device description clearly states that the device is a physical contact lens made of a specific material (lenefilcon A) and is available in different physical forms (spherical, multifocal, toric, toric multifocal). This indicates it is a hardware device, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The VISTAKON Contact Lens is a device that is placed directly on the eye to correct vision. It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states the correction of refractive errors and presbyopia. This is a therapeutic/corrective function, not a diagnostic one.
- Device Description: The description focuses on the material composition and physical form of the lens, not on any components or processes related to analyzing biological samples.
Therefore, the VISTAKON Contact Lens falls under the category of a medical device for vision correction, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less.
The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less.
The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less.
The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons who may have 10.00 D of astigmatism or less.
Eye care practitioners may prescribe the lens 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 lens may be disinfected using a chemical disinfection system only.
Product codes (comma separated list FDA assigned to the subject device)
86 LPL
Device Description
The VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a multifocal lens, a toric lens and a toric multifocal lens.
The lens material (lenefilcon A) is a copolymer of 2-hydroxyethyl 2-methyl-2 propenoate and 2-propenic acid, 2-methyl-2,3-dihydroxypropyl ester cross-linked with poly (oxy-1,2-ethanediyl) (4) bis (2-methyl-2-propenoate). The VISTAKON Contact Lens Visibility Tint with UV Blocker 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 280nm to 315nm and less than 10% in the UVA range of 316nm to 380nm. The VISTAKON Contact Lens is a hemispherical or hemitoric shell.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye care practitioners
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)
Clinical studies: The safety of the lens material in the spherical design has been confirmed through a clinical trial for daily wear contact lens materials with a new USAN name according to the Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses (May 1994). 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, symptoms, problems and complaints, slit lamp evaluations, visual acuity, lens wear time, fit assessment and discontinuations. The VISTAKON (lenefilcon A) trial contact lens was found to be at least substantially clinically equivalent to the predicate device.
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.
NewVues® (vifilcon A) Soft Contact Lens
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
K9839/2
Summary of 510(k) Submission
| Summary | The 510(k) submission summary consists of these sections Name and address of submitterIdentification of devicePredicate deviceDescription of deviceIntended use CharacteristicsNon clinical studiesClinical studiesConclusions drawn from studiesFlow Chart for 510(k) Daily Wear Contact Lens Materials |
|---|---|
| Name and address of submitter | Vistakon, Johnson & Johnson Vision Products, Inc. |
| 4500 Salisbury Road, Suite 300 | |
| Jacksonville, Florida 32216 | |
| Contact: Sharon A. Briggs | |
| Phone: 904/443-1471 | |
| Date Prepared: November 2, 1998 | |
| Identification of Device | Trade name: VISTAKON (lenefilcon A) Contact Lens Clear and Visibility tint with UV blocker.Common or usual name: Soft (hydrophilic) Contact Lens (daily wear)FDA Classification: Class II |
| Predicate Device | NewVues® (vifilcon A) Soft Contact Lens |
Continued on next page
1
| Description of Device | The VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens is available as a spherical lens, a multifocal lens, a toric lens and a toric multifocal lens.
The lens material (lenefilcon A) is a copolymer of 2-hydroxyethyl 2-methyl-2 propenoate and 2-propenic acid, 2-methyl-2,3-dihydroxypropyl ester cross-linked with poly (oxy-1,2-ethanediyl) (4) bis (2-methyl-2-propenoate). The VISTAKON Contact Lens Visibility Tint with UV Blocker 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 280nm to 315nm and less than 10% in the UVA range of 316nm to 380nm. The VISTAKON Contact Lens is a hemispherical or hemitoric shell. | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Spherical lens | The VISTAKON Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00 D of astigmatism or less. |
| | Multifocal lens | The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 0.75 D of astigmatism or less. |
| | Toric lens | The VISTAKON TORIC Contact Lens is indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00 D of astigmatism or less. |
| | Toric Multifocal lens | The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-aphakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. |
| | Eye care practitioners may prescribe the lens for single-use disposable wear or for frequent/planned replacement wear, with cleaning, disinfection and scheduled replacement (see "WEARING SCHEDULE"). When prescribed for frequent/planned replacement, the lens may be disinfected using a chemical disinfection system only. | |
Continued on next page
2
The VISTAKON (lenefilcon A) Contact Lens is classified into FDA Group II Characteristics for contact lens materials. The predicate device is classified into FDA Group IV. The predicate device was chosen because the water content and Dk value are the same as the subject device, the predicate device is available in similar base curve and diameter configurations and both subject and predicate devices are visibility tinted. The characteristics of the VISTAKON (lenefilcon A) Contact Lens are compared to the characteristics of the predicate device in the following table.
| | VISTAKON (lenefilcon A)
Contact Lens Visibility Tint
with UV Blocker | | NewVues® (vifilcon A) Soft
Contact Lens | |
|-------------------------|----------------------------------------------------------------------------|-------|--------------------------------------------|-------|
| | Measured | Label | Measured | Label |
| Water Content, % | 55 | 55 | 56 | 55 |
| Refractive Index @ 20°C | 1.41 | 1.41 | #1.41 | 1.415 |
| Dk, edge corrected | 17 | 16 | 18 | 16 |
| Dk, non-edge corrected | 22 | 21 | 22 | 16 |
| Color (if tinted) | Blue | Blue | Blue | Blue |
| Base Curve, mm | 8.86 | 8.84 | 8.5 | 8.5 |
| Diameter, mm | 14.10 | 14.05 | 14.3 | 14.0 |
| Power, D | -0.79 | -0.74 | -1.02 | -1.00 |
Dk units = x 10-11 (cm²/sec) (ml O2/ml x mm Hg) * edge correction method not identified in CIBA Vision® labeling # calculated from water content
| Non clinical
Studies | Included as non clinical studies are
• chemistry,
• toxicology, lenses and package,
• microbiology | |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Chemistry | Material property data were generated on the subject device and the predicate
device. The data for both devices reflect properties of Group II and Group IV
lenses, respectively. The lens care product manufacturers have previously
shown compatibility of Group II and Group IV lenses with their products.
The shelf-life stability for VISTAKON (lenefilcon A) Contact Lenses is
based upon stability protocols included with this notification or referenced.
Studies were conducted to determine the leachable monomers from the
subject device. | |
| Toxicology,
lenefilcon A
lens material | In accordance with the May 1994 Guidance Document for Daily Wear contact
lenses, toxicology studies have been conducted on the VISTAKON
(lenefilcon A) soft (hydrophilic) Contact Lenses Clear and Visibility Tint
with UV blocker. The results are summarized below: | |
| | Cytotoxicity
Test | The negative controls and the positive controls performed as
anticipated. Under the conditions of this study, the test article
showed no evidence of causing cell lysis or toxicity. The test
article was not cytotoxic and passed this ISO study. |
| | Ocular
Irritation
Study in the
Rabbit | Under the conditions of this study, there was no evidence of
significant irritation in the test eye or control eye of any
rabbit. The SC and CSO test article extracts would not be
considered irritants to the ocular tissue of the rabbit. |
| | Acute
Systemic
Toxicity in
the Mouse | Under the conditions of this study, there was no mortality or
evidence of significant systemic toxicity from the extracts.
Each test article extract met the ISO requirements. |
| Toxicology,
package
materials | No additional toxicology studies have been conducted on the plastic primary
packaging materials, as the materials are the same as those previously tested
and reported under N18-033. | |
| Microbiology | The lens sterilization process, moist heat sterilization, has been validated to
deliver a minimum SAL of 10-6. The lens care product manufacturers have
established a reasonable assurance of disinfection efficacy of their care
products with the lens groups for which they are approved. There are shelf-
life stability data that support lens sterility throughout the shelf-life claimed
for the product. | |
| Clinical studies | The safety of the lens material in the spherical design has been confirmed
through a clinical trial for daily wear contact lens materials with a new USAN
name according to the Premarket Notification (510(k)) Guidance Document
for Daily Wear Contact Lenses (May 1994). 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, symptoms, | |
| Clinical studies | problems and complaints, slit lamp evaluations, visual acuity, lens wear time,
fit assessment and discontinuations. The VISTAKON (lenefilcon A) trial
contact lens was found to be at least substantially clinically equivalent to the
predicate device. | |
| 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
leachables studies were conducted by in-house laboratories
and followed scientific protocols. The data were
determined to be scientifically valid under 21 CFR 860.7. |
| | Substantial
Equivalence | The data presented in this Premarket Notification support
the subject device is as safe, as effective and performs as
well as or better than 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 are 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. |
Continued on next page
3
Continued on next page
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4
5
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 26 1999
Ms. Sharon A. Briggs Group Leader, Regulatory Submissions Vistakon Johnson and Johnson Vision Prouducts, Inc. P.O. Box 10157 Jacksonville, FL 32247
Re: K983912
Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lenses Clear and Visibiltiy Tint with UV Blocker (Cast molded, Spherical, Toric, Multifocal Designs for daily wear)
Regulatory Class: II Product Code: 86 LPL Dated: November 2, 1998 Received: November 3, 1998
Dear Ms. Briggs:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations .
6
Page 2 - Mr. Sharon A. Briggs
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
A. Roerl forenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Page 1 of 1
510 (k) Number (if known) : K9 8 3 9 / 乙
Device Name: VISTAKON (lenefilcon A) Contact Lens, clear and visibility tint with UV Blocker
Indications for Use:
| Spherical
lens | The VISTAKON Contact Lens is indicated for daily wear for the correction
of refractive ametropia (myopia and hyperopia) in aphakic or non-aphakic
persons with non-diseased eyes who may have 1.00 D of astigmatism or less. |
|-----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Multifocal
lens | The VISTAKON MULTIFOCAL Contact Lens is indicated for daily wear
for the correction of distance and near vision in presbyopic aphakic or non-
aphakic persons with non-diseased eyes who may have 0.75 D of
astigmatism or less. |
| Toric lens | The VISTAKON TORIC Contact Lens is indicated for daily wear for the
correction of visual acuity in aphakic or non-aphakic persons with non-
diseased eyes that are hyperopic or myopic and may have 10.00 D of
astigmatism or less. |
| Toric
Multifocal
lens | The VISTAKON TORIC MULTIFOCAL Contact Lens is indicated for daily
wear for the correction of distance and near vision in presbyopic aphakic or
non-aphakic persons with non-diseased eyes who may have 10.00 D of
astigmatism or less. |
Eye care practitioners may prescribe the lens 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 lens 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)
(Optional Format 3 - 10 - 09)
(Posted July 1, 1998)
Miz-Chuen Shui
(Division Sign Off) Division of Ophthalmic Devi ಸ 510(k) Number _
Prescription Use
(Per 21 CFR 801.109)