(98 days)
Not Found
No
The summary describes a contact lens made of a specific material with different designs (spherical, multifocal, toric, multifocal-toric). There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The clinical study described is a standard performance evaluation for contact lenses.
Yes
The device is indicated for the "optical correction of refractive ametropia (myopia and hyperopia)" and "optical correction of distance and near vision in presbyopic," which constitutes treating or alleviating a condition.
No
The device is indicated for optical correction of refractive errors, not for diagnosing conditions.
No
The device description clearly describes a physical contact lens made of silicone hydrogel material, 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, or tissue) to detect diseases, conditions, or infections.
- Device Function: The VISTAKON® (narafilcon B) Soft Contact Lens is a device placed on the eye for the optical correction of vision problems (refractive ametropia, presbyopia, astigmatism). It does not perform any tests on bodily samples.
- Intended Use: The intended use clearly states its purpose is for "optical correction of refractive ametropia" and "optical correction of distance and near vision." This is a therapeutic/corrective function, not a diagnostic one.
- Device Description: The description focuses on the physical properties of the lens, its material, tint, UV blocker, and packaging. There is no mention of any components or processes related to analyzing biological samples.
Therefore, the VISTAKON® (narafilcon B) Soft 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® (narafilcon B) 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.
The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 0.75D of astigmatism or less.
The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 10.00D or less of astigmatism.
The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 10.00D of astigmatism or less.
VISTAKON® (narafilcon B) 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 disinfection is required.
Product codes
LPL
Device Description
The VISTAKON® (narafilcon B) Contact Lens 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 B) Contact Lens 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 280-315nm and less than 10% in the UVA range of 316-380nm. The VISTAKON® (narafilcon B) 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 52% narafilcon B and 48% 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 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
Non-clinical Testing: A series of in-vitro and in-vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lens. All tests were conducted in accordance with the GLP regulation (21 CFR Part 56) or according to valid scientific protocols. The results demonstrated that the lens material and/or extracts are non-toxic, non-irritating and non-sensitizing under the experimental conditions; and the lens physical and material properties are consistent with currently marketed lenses.
Clinical Testing: A one-month clinical study was completed to evaluate the safety and efficacy of the VISTAKON® (narafilcon B) Contact Lens for single use daily wear only. The study evaluated 48 subjects with a 1:1 ratio between the test lens and the control lens (1·DAY ACUVUE® Brand Contact Lenses). The primary endpoints were slit lamp findings, symptoms, problems and complaints, visual acuity and average wear time. Additional parameters measured included adverse reactions, keratometry changes, reasons for discontinuation, and the number and reasons for unscheduled lens replacements. The clinical evaluation demonstrated similar overall performance in the clinically relevant areas of vision and health as compared to concurrent controls when used under daily wear single use conditions.
Key Metrics
Not Found
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
MAY 2 ] 2010
510(k) Summary
.
| Submitter
Information | Company: | Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway
Suite 100
Jacksonville, FL 32256 | |
|---------------------------------|-----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------|--|
| | Contact Person: | Catherine Dillon | |
| | Email: | cdillon9@its.jnj.com | |
| | Telephone: | 904-443-3180 | |
| | FAX: | 904-443-1424 | |
| | Date Prepared: | February 8, 2010 | |
| Identification of
the Device | Common Name: | Soft Contact Lens | |
| | Device Name: | VISTAKON® (narafilcon B) Contact Lens | |
| | Classification Name: | Soft Hydrophilic Contact Lens, Daily Wear | |
| | Device Classification: | Class II, 21 CFR 886.5925 (b) (1). | |
| Predicate
Device(s) | Material
VISTAKON® (narafilcon A) Contact Lens – K073485
(FDA Group I; low water, nonionic polymer) | | |
| | Indication, Wear Schedule
VISTAKON® (etafilcon A) Contact Lenses – K962804
(Daily wear, single use) | | |
.
1
| Description of Device | The VISTAKON® (narafilcon B) Contact Lens 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 B) Contact Lens 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 280-315nm and less than 10% in the UVA range of 316-380nm. The VISTAKON® (narafilcon B) 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 52% narafilcon B and 48% water by weight when hydrated and stored in the buffered saline solution. |
|---|---|
| ----------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Continued on next page
.
2
・ Ind
| Indications for
| Use | Lens Design | Indication |
|---|---|---|
| Spherical | The VISTAKON® (narafilcon B) 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 B) 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 4.00D of ADD power or less and 0.75D of | ||
| astigmatism or less. | ||
| Toric | The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 10.00D | ||
| or less of astigmatism. | ||
| Multifocal | ||
| Toric | The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 10.00D of | ||
| astigmatism or less. |
- VISTAKON® (narafilcon B) 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 disinfection is required.
3
Technological Characteristics
The technological characteristics of the VISTAKON® (narafilcon B) Contact Lenses are compared to the characteristics of the predicate device, VISTAKON® (narafilcon A) Contact Lens, in the following tables.
| Predicate Device | Subject Device | |
|---|---|---|
| Product Name | VISTAKON® | |
| (narafilcon A) | ||
| Contact Lens | VISTAKON® | |
| (narafilcon B) | ||
| Contact Lens | ||
| Material USAN Name | narafilcon A | narafilcon B |
| 510(k) Number | K073485 | TBD - This submission |
| FDA Category (Group) | Group I | Group I |
| Manufacturing Method | Molded | Molded |
| Sterilization | Moist Heat | Moist Heat |
| Packaging | Blister | Blister |
| Visibility Tint | Blue | Blue |
| Parameter Comparison | ||||
|---|---|---|---|---|
| Predicate Device | ||||
| VISTAKON® | ||||
| (narafilcon A) Contact | ||||
| Lens-K073485 | Subject Device | |||
| VISTAKON® | ||||
| (narafilcon B) | ||||
| Contact Lens | ||||
| Measured | Labeled | Measured | Labeled | |
| Water Content, % | 47 | 46 | 48 | 48 |
| Refractive Index @ 20°C | 1.40 | 1.41 | 1.41 | 1.41 |
| Dk, edge corrected | 96 | 100 | 52 | 55 |
| Base Curve, mm | 8.53 | 8.5 | 8.49 | 8.5 |
| Diameter, mm | 14.26 | 14.2 | 14.19 | 14.2 |
| Power, D | -0.92 | -1.00 | -0.98 | -1.00 |
Polarographic Method, Dk units: 10 -11(cm+/sec)(ml O2/ml x mmHg)
4
| Non-clinical
Testing | A series of in-vitro and in-vivo preclinical toxicology and
biocompatibility tests were performed to assess the safety and
effectiveness of the contact lens. All tests were conducted in
accordance with the GLP regulation (21 CFR Part 56) or according to
valid scientific protocols. |
|-------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The results of the non-clinical testing/evaluation demonstrate that: |
| | the lens material and/or extracts are non-toxic, non-irritating and
non-sensitizing under the experimental conditions; and the lens physical and material properties are consistent with
currently marketed lenses. |
| Clinical Testing | A one-month clinical study was completed to evaluate the safety and
efficacy of the VISTAKON® (narafilcon B) Contact Lens for single.
use daily wear only. |
| | The study evaluated 48 subjects with a 1:1 ratio between the test lens
and the control lens (1·DAY ACUVUE® Brand Contact Lenses). The
primary endpoints were slit lamp findings, symptoms, problems and
complaints, visual acuity and average wear time. Additional |
parameters measured included adverse reactions, keratometry changes, reasons for discontinuation, and the number and reasons for unscheduled lens replacements.
The clinical evaluation demonstrated similar overall performance in the clinically relevant areas of vision and health as compared to concurrent controls when used under daily wear single use conditions.
5
Conclusions Drawn from Studies
| Validity of
Scientific Data | A contract laboratory under Good Laboratory
Practice Regulations conducted toxicology studies.
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® (narafilcon B)
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 are the same as those
normally attributed to the wearing of soft
(hydrophilic) contact lenses on a daily wear single
use 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 Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle or bird-like figure with its wings spread, positioned above a wavy line.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002
Johnson & Johnson Vision Care, Inc. C/O Catherine C. Dillon Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K100349
Trade/Device Name: VISTAKON® (narafilcon B) Contact Lenses Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: LPL Dated: May 4, 2010 Received: May 5, 2010
Dear Ms. Dillon:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
MAY 2 1 2010
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
7
Page 2 – Ms. Catherine C. Dillon
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 70 http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm11.5809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kesia Alexander
Image /page/7/Picture/8 description: The image shows a handwritten word that appears to be "for". The script is cursive and the letters are connected. The "f" has a prominent loop extending below the baseline, and the "o" and "r" are joined together at the top.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
Indications for Use Statement
510(k) Number (if known):
Device Name:
VISTAKON® (narafilcon B) Contact Lens Visibility Tinted, with UV Blocker
Indications for Use:
The VISTAKON® (narafilcon B) 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.
100349
The VISTAKON® (narafilcon B) 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 4.00D of ADD power or less and 0.75D of astigmatism or less.
The VISTAKON® (narafilcon B) Toric Soft Contact Lens is indicated for daily wear single use only for the optical correction of visual acuity in phakic persons with non-diseased eyes that are hyperopic or myopic and may have 10.00D or less of astigmatism.
The VISTAKON® (narafilcon B) 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 eves who may have 4.00D of ADD power or less and 10.00D of astigmatism or less.
VISTAKON® (narafilcon B) 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 disinfection is required.
Prescription Use X (21 CFR Part 801 Subpart D) And/Or
Over the Counter Use
(21 CFR Part 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE; CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH. Office of Device Evaluation (ODE)
Kaur Warburton
vision Sign-Off Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K100349