(63 days)
Not Found
No
The document describes contact lenses and a labeling modification, with no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
The device's intended use is to correct refractive errors (myopia, hyperopia, astigmatism, presbyopia), which falls under vision correction rather than therapy for a disease or condition.
No
The device is a contact lens intended for vision correction, not for identifying or diagnosing a medical condition.
No
The device is a contact lens, which is a physical medical 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this device is a contact lens used for the correction of refractive errors (myopia, hyperopia, astigmatism) and presbyopia. It is worn on the eye itself, not used to test samples from the body.
- Anatomical Site: The anatomical site is the "eyes," which is where the device is applied, not where samples are taken for testing.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
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 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 10.00 D of astigmatism or less.
VISTAKON 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
LPL
Device Description
The device description does not change from that cleared under K991163.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
This 510(k) describes a labeling modification which is supported by clinical studies published in the July 1999 CLAO Journal (see Attachment A). There is no change in lens material, the manufacturing process, nor the parameters and properties, therefore, the clinical data previously submitted in K991163 supports the clinical safety of the subject device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
FEB 2 3 2000
K 9943/8
Summary of 510(k) Submission
| Name and
address of
submitter | Vistakon, Johnson & Johnson Vision Products, Inc.
7500 Centurion Parkway
Jacksonville, Florida 32256
Contact: Sharon Briggs
Phone: (904) 443-1471
Date Prepared: December 21, 1999 | | | | | |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|
| Identification of
device | • The trade name is VISTAKON (lenefilcon A) soft (hydrophilic) contact
lenses, clear and visibility Tinteded, 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 Tinteded, with UV blocker, for daily wear covered
under K991163. | | | | | |
| Description of
device | The device description does not change from that cleared under K991163. | | | | | |
| Continued on next page | | | | | | |
1
Summary of 510(k) Submission, Continued
| 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 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
10.00 D of astigmatism or less.
VISTAKON 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
:
| Reason for
510(k) | The reason for the 510(k) is to revise the “Wear Schedule” in the Draft
Package Insert, and the “Introduction” statements in the Draft Patient
Instruction Guides (Disposable and Frequent Replacement) for VISTAKON
(lenefilcon A) soft (hydrophilic) contact lenses, clear and visibility tinted,
with UV blocker, for daily wear to include the following statement:
When VISTAKON UV Blocking Contact Lenses are replaced at
intervals ranging from 1 day to 2 weeks, the risk of developing giant
papillary conjunctivitis may be reduced . |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Characteristics | The characteristics do not change. They are the same as previously submitted
in K991163. |
| Non-clinical
studies | Non-clinical studies (chemistry, toxicology, microbiology, shelf-life, and
leachability) on the lens material were not conducted because the lens
material, lenefilcon A, does not change. |
| Clinical studies | This 510(k) describes a labeling modification which is supported by clinical
studies published in the July 1999 CLAO Journal (see Attachment A). There
is no change in lens material, the manufacturing process, nor the parameters
and properties, therefore, the clinical data previously submitted in K991163
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 K991163 support the non-clinical and clinical
safety of the subject device. The clinical studies published in the July 1999
CLAO Journal support the labeling modification that is the subject of this
510(k). |
・・・・・・・
·
For the disposable patient guide, the statement is revised to: "When VISTAKON UV Blocking Contact Leases are replaced daily, the risk of developing giant papillary conjunctivitis may be reduced."
3
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 3 2000
Ms. Sharon A. Briggs Manager, Regulatory Submissions VISTAKONTM 7500 Centurion Parkway Jacksonville, FL 32256
Re: K994318
Trade Name: VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens Clear and Visibility Tinted with UV blocker
Regulatory Class: II Product Code: 86 LPL Dated: December 21, 1999 Received: December 22, 1999
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 .
4
Page 2 - Ms. 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. Ralph Rosenthal, M.D. Director Division of Ophthalmic Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications Statement
510(k) Number (if known):
VISTAKON (lenefilcon A) Soft (hydrophilic) Contact Lens Clear and Device Name: Visibility Tinted with UV blocker
Indication for Use:
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 eves 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 nondiseased 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 10.00 D of astigmatism or less.
VISTAKON 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)
| Prescription Use | X |
|---|---|
| OR | Over the Counter |
(Division Sign-Off)
Division of Ophthalmic Devices
510(k) Number_K 99 43 | 4