(62 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies focus on material, manufacturing, and labeling changes, not algorithmic capabilities.
No
This device is for vision correction (myopia, hyperopia, astigmatism, presbyopia) and UV protection, which falls under corrective or protective functions rather than active treatment or therapy for a disease.
No.
The device is a contact lens intended for the correction of refractive errors, not for diagnosing medical conditions.
No
The 510(k) summary describes contact lenses, which are physical medical devices, not software.
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. This is a therapeutic or corrective function, not a diagnostic one.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The VISTAKON Contact Lens does not perform this function.
- Device Description: The description refers to a previous clearance for contact lenses, which are generally considered medical devices for vision correction, not IVDs.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a patient's health status.
The device is a medical device intended for vision correction.
N/A
Intended Use / Indications for Use
The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The VISTAKON BIFOCAL 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 or less of astigmatism.
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 or less of astigmatism.
The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
VISTAKON 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 either single-use disposable wear or for 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
86 LPL
Device Description
The device description does not change from that cleared under K983912.
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
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
This 510(k) describes a labeling modification: an additional Indications Statement. There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K983912 supports the clinical safety of the subject device.
Key Metrics
The average UV blocking for VISTAKON (lenefilcon A) Contact Lenses with UV Blocker for UVA is 95% and for UVB is 99.9%.
Predicate Device(s)
Reference Device(s)
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
K991163
Summary of 510(k) Submission
| Name and
address of
submitter | Vistakon, Johnson & Johnson Vision Products, Inc.
4500 Salisbury Road, Suite 300
Jacksonville, Florida 32216
Contact: Martine D. Martino
Phone: (904) 443-1808
Date of Original: April 22, 1999
Date Modified: May 26, 1999 |
|-------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of
device | The trade name is VISTAKON (lenefilcon A) soft (hydrophilic) contact
lenses, clear and visibility tint, with UV blocker, for daily wear The common or usual name is Soft (hydrophilic) Contact Lens (daily
wear). The FDA Classification is Class II. |
| Predicate
devices | The predicate device is VISTAKON (lenefilcon A) soft (hydrophilic) contact
lenses, clear and visibility tint, with UV blocker, for daily wear covered under
K983912. |
| Description of
device | The device description does not change from that cleared under K983912. |
1
Summary of 510(k) Submission, Continued
The reason for the 510(k) is to add the following Indications Statement (see Intended use bold text) for VISTAKON (lenefilcon A) soft (hydrophilic) contact lenses, clear and visibility tint, with UV blocker, for daily wear. The revised Indications Statement is included with this 510(k): The VISTAKON Contact Lens (spherical) 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 or less of astigmatism. The VISTAKON BIFOCAL 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 or less of astigmatism. 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 or less of astigmatism. The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less. VISTAKON 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 either single-use disposable wear or for 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.
Continued on next page
2
Summary of 510(k) Submission, Continued
| Characteristics | The characteristics do not change. They are the same as previously submitted
in K983912. |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Non-clinical
studies | Non-clinical studies (microbiology, toxicology, chemistry, shelf-life, and
leachability) on the lens material were not conducted because the lens
material, lenefilcon A, does not change. Non-clinical studies were conducted to support the following modified
Actions in the labeling. The average UV blocking for VISTAKON (lenefilcon A) Contact
Lenses with UV Blocker for UVA is 95% and for UVB is 99.9%. |
| Clinical studies | This 510(k) describes a labeling modification: an additional Indications
Statement. There is no change in lens material, the manufacturing process,
nor the parameters and properties, therefore, the clinical data previously
submitted in K983912 supports the clinical safety of the subject device. |
| Conclusions
drawn from
studies | Additional studies were not conducted, therefore, the conclusions drawn from
studies previously submitted in K983912 support the non-clinical and clinical
safety of the subject device. |
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized depiction of an eagle with three stripes forming its wing, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the eagle. The text is in all caps and is in a sans-serif font.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 1699
Ms. Martin D. Martino Regulatory Affairs Specialist Vistakon Johnson & Johnson Vision Products, Inc. 4500 Salisbury Road Suite 300 Jacksonville, FL 32216
Re: K991163
Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens, Clear and Visibility Tint, with UV Blocker, for daily Wear
Regulatory Class: II Product Code: 86 LPL Dated: April 6, 1999 Received: April 7, 1999
Dear Ms. Martino:
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
4
Page 2 - Ms. Martin D. Martino
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. Ralph Rosenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications Statement
K991163 510(k) Number:
VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Device Name: Tint with UV Blocker
The VISTAKON Contact Lens (spherical) is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic or nonaphakic persons with non-diseased eyes who may have 1.00 D or less of astigmatism.
The VISTAKON BIFOCAL 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 or less of astigmatism.
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 or less of astigmatism.
The VISTAKON TORIC BIFOCAL Contact Lens is indicated for daily wear for the correction of distance and near vision in presbyopic aphakic or non-phakic persons with non-diseased eyes who may have 10.00D of astigmatism or less.
VISTAKON 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 either single-use disposable wear or for 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)
(Division Sign-Off)
Division of Ophthalmic Devices
| 510(k) Number | K991163 |
|---|---|
| Prescription Use | |
| OR Over the Counter |