(82 days)
Not Found
No
The summary describes a contact lens made of a specific material with UV blocking properties and different designs (spherical, multifocal, toric). There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The device is a physical product for vision correction.
No
The device is indicated for the optical correction of refractive ametropia, not for treating a disease or condition.
No
The device is a contact lens used for optical correction of vision, not for diagnosing conditions. Its intended use is to correct refractive errors (myopia, hyperopia, astigmatism, presbyopia), not to identify or detect medical conditions.
No
The device description clearly indicates that the device is a physical contact lens made of silicone hydrogel material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the optical 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 characteristics and composition of a contact lens, which is a medical device used for vision correction.
- No mention of in vitro testing: There is no indication that this device is used to examine specimens derived from the human body outside of the body to provide information for diagnosis, monitoring, or compatibility.
IVD devices are used to perform tests on samples like blood, urine, or tissue to detect diseases, conditions, or infections. This device is a contact lens, which is placed directly on the eye for vision correction.
N/A
Intended Use / Indications for Use
The VISTAKON® (narafilcon A) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical 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® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical 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.
The VISTAKON® (narafilcon A) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical 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® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Product codes (comma separated list FDA assigned to the subject device)
LPL
Device Description
• The VISTAKON® (narafilcon A) Contact Lens Clear and Visibility Tinted with UV blocker is available as a spherical lens, multifocal lens; toric lens, and toric-multifocal lens.
• The lenses are made of a silicone hydrogel material containing an internal wetting agent.
• The VISTAKON® (narafilcon 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® (narafilcon A) Contact Lens is a hemispherical or hemitoric shell.
• The lens is supplied in a sterile state, packaged in a buffered saline solution with methyl ether cellulose.
• The composition of the lens is 54% narafilcon A and 46% 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
Eye Care Professional
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)
Not Found
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.
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) Summary
| Submitter
Information | Company:
Contact Person:
Email:
Telephone:
FAX:
Date Prepared: | VISTAKON®
Division of Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Suite 100
Jacksonville, FL 32256
Rosalind Baker Williams
rbaker@visus.jnj.com
904-403-1504
904-403-1424
December 11, 2007 |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Identification of
the Device | Common Name:
Device Name:
Classification Name:
Device Classification: | Soft Contact Lens
VISTAKON® (narafilcon A) Contact Lens
Soft Hydrophilic Contact Lens, Daily Wear
Class II, 21 CFR 886.5925 (b) (1). |
| Predicate
Device(s) | Material
VISTAKON® (galyfilcon A) Contact Lens ">– K032340
(FDA Group I; low water, nonionic polymer)
Indication, Wear Schedule
VISTAKON® (etafilcon) Contact Lenses – K962804
(Daily wear, single use) | |
:
Continued on next page
1
Executive Summary, Continued
| Description of
Device | • The VISTAKON® (narafilcon A) Contact Lens Clear and
Visibility Tinted with UV blocker is available as a spherical lens,
multifocal lens; toric lens, and toric-multifocal lens. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | • The lenses are made of a silicone hydrogel material containing an
internal wetting agent. |
| | • The VISTAKON® (narafilcon 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® (narafilcon A) Contact Lens is a hemispherical
or hemitoric shell. |
| | • The lens is supplied in a sterile state, packaged in a buffered saline
solution with methyl ether cellulose. |
| | • The composition of the lens is 54% narafilcon A and 46% 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
Continued on next page
2
510(k) Summary, Continued
Indications for Use
| Lens Design | Indication |
|---|---|
| Spherical | The VISTAKON® (narafilcon A) Contact Lens is indicated |
| for daily wear single use only for the optical 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. | |
| Multifocal | The VISTAKON® (narafilcon A) Contact Lens is indicated |
| for daily wear single use only for the optical 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® (narafilcon A) Contact Lens is indicated |
| for daily wear single use only for the optical correction of | |
| visual acuity in phakic or aphakic persons with non- | |
| diseased eyes that are hyperopic or myopic and may have | |
| 10.00D or less of astigmatism. | |
| Multifocal | |
| Toric | The VISTAKON® (narafilcon A) Contact Lens is indicated |
| for daily wear single use only for the optical 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® (narafilcon A) Contact Lenses contain a UV Blocker to . help protect against transmission of harmful UV radiation to the cornea and into the eye.
- The Eye Care Professional should prescribe the lenses for daily wear . single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
Continued on next page
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 eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Vistakon c/o Rosalind Baker Williams 7500 Centurion Parkway, Ste. 100 Jacksonville FL 32256
MAR - 3 2008
Re: K073485
Trade/Device Name: VISTAKON® (narafilcon A) Contact Lens for Daily Wear Single Use Only
Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: December 11, 2007 Received: December 12, 2007
Dear Ms. Williams:
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,
4
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Malina Bepelaia, und
Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number:
Device Name:
VISTAKON® (narafilcon A) Contact Lens Clear and Visibility Tinted, with UV blocker
Indications for Use:
The VISTAKON® (narafilcon A) Soft Contact Lens (spherical) is indicated for daily wear single use only for the optical 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® (narafilcon A) Multifocal Soft Contact Lens is indicated for daily wear single use only for the optical 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.
The VISTAKON® (narafilcon A) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic or aphakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon A) Multifocal-Toric Soft Contact Lens is indicated for daily wear single use only for the optical 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® (narafilcon A) Contact Lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
The Eye Care Professional should prescribe the lenses for daily wear single use only. The lenses are to be discarded upon removal; therefore, no cleaning or disinfecting is required.
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 Ear,
Nose and Throat Devises
| 510(k) Number | K073485 |
|---|---|
| --------------- | --------- |
CONFIDENTIAL