(67 days)
Not Found
No
The summary describes a contact lens with photochromic and UV-blocking properties. There is no mention of AI or ML technology in the device description, intended use, or performance studies. The clinical study focuses on the lens's effect on vision and driving performance, not on any AI/ML-driven analysis or functionality.
No.
The device is indicated for the optical correction of refractive ametropia and presbyopia, and for the attenuation of bright light and UV blocking. While these functions relate to eye health and comfort, they primarily serve as corrective and protective measures rather than treating a disease or medical condition.
No
Explanation: The device is a soft contact lens intended for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism) and/or presbyopia, as well as for attenuation of bright light and UV blocking. Its purpose is to correct vision and provide protection, not to diagnose medical conditions or diseases.
No
The device is a physical contact lens made of specific materials with a photochromic additive and UV blocker. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens is a medical device intended for the optical correction of refractive errors (myopia, hyperopia, astigmatism, presbyopia) and for the attenuation of bright light and UV radiation. It is worn directly on the eye.
- Intended Use: The intended use clearly states its purpose is for optical correction and light attenuation, not for analyzing biological specimens.
- Device Description: The description focuses on the physical properties and composition of the contact lens itself, not on any components designed for analyzing biological samples.
- Performance Studies: The performance studies described evaluate the impact of the contact lens on vision and driving performance, which are clinical outcomes related to the device's function on the eye, not diagnostic measurements from biological samples.
Therefore, the ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes who may have 10.00D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic persons with non-diseased eyes who may have 0.75D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.
These lenses are also indicated for the attenuation of bright light as they contain a photochromic additive which dynamically absorbs visible light.
These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2-weeks (14 days).
Product codes (comma separated list FDA assigned to the subject device)
LPL, MVN
Device Description
The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.
The subject device is made of a silicone hydrogel material containing an internal wetting agent and UV absorbing monomers. A combination of a benzotriazole UV absorbing monomer and a naphthopyran monomer (photochromic additive) is used to block UV radiation and dynamically absorbs visible light. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 316 nm to 380 nm for the entire power range.
Additionally, the photochromic additive absorbs visible light in the range from 380 nm to 780 nm to a minimum 84% transmittance in the inactivated (closed) state. The activated (open) state dynamically absorbs visible light dependent on the lens thickness and the level of UV and high energy visible (HEV) radiation to a minimum of 23% transmittance.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cornea, eye
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Eye Care Professionals
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)
A clinical study was conducted in Australia to evaluate the effect of the subject device on vision and driving performance in both daytime and nighttime lighting under real world driving conditions. This was achieved through field-based driving studies on a closed-road driving circuit at night and during the day. Quantitative methods were used to assess vision and driving performance under a range of challenging conditions. Appropriate masking, order of testing, randomization and control conditions were used.
The study evaluated 24 subjects in a bilateral, non-dispensing, randomized, partially masked (subject), crossover study. Primary endpoint was overall driving performance score. Secondary endpoint(s) included low luminance high contrast distance visual acuity; distance visual acuity (~1 lux); low luminance (~1 lux) contrast threshold; road sign recognition (percentage); percentage of hazards avoidance and pedestrian recognition distance.
The results of the clinical testing demonstrate there was no evidence of driving performance or visual acuity concerns while wearing the subject device during daytime and nighttime driving.
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
April 10, 2018
Johnson & Johnson Vision Care, Inc. Victoria Brennand Manager, Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K180299
Trade/Device Name: ACUVUE OASYS (senofilcon A) with Photochromic Additive Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 31, 2018 Received: February 2, 2018
Dear Victoria Brennand:
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.
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.
1
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 devicerelated adverse events) (21 CFR 803); 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Denise L. Hampton -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
K180299
Device Name
ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive
Indications for Use (Describe)
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with nondiseased eyes who may have 10.00D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may have 0.75D or less of astigmatism.
The ACUVUE (senofilcon A) Soft (hydrophilic) Contact Lens with photochromic additive MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia, and/or astigmatism) and presbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD power and may have 10.00D or less of astigmatism.
These lenses are also indicated for the attenuation of bright light as they contain a photochromic additive which dynamically absorbs visible light.
These lenses contain a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.
Eye Care Professionals may prescribe the lenses either for daily disposable wear or frequent/planned replacement wear with cleaning, disinfection and scheduled replacement. When prescribed for daily disposable wear, no cleaning or disinfection is required. Lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only and should be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When the lenses are worn in a frequent/planned replacement modality, they are intended to be worn for up to 2-weeks (14 days).
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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510(K) SUMMARY
Submitter Information
| Company: | Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, FL 32256 |
|-----------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Victoria Brennand |
| Email: | vbrenna2@its.jnj.com |
| Telephone: | (904) 443-3160 |
| FAX: | (904) 443-1424 |
| Date: | January 31, 2018 |
Identification of the Device
| Common Name: | Soft Contact Lens |
|---|---|
| Device/Trade Name: | ACUVUE® (senofilcon A) Soft Contact Lens with |
| Photochromic Additive | |
| Classification Name: | Soft (Hydrophilic) Contact Lens, Daily Wear |
| Device Classification: | Class II, 21 CFR 886.5925 (b) (1) |
| Product Code: | LPL, MVN |
Predicate Device
- . ACUVUE OASYS® (senofilcon A) Brand Contact Lens cleared via K042275
5
Description of Device
The subject device is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 62% senofilcon A and 38% water by weight when hydrated and stored in the buffered saline solution with methyl ether cellulose. The lens is supplied sterile (steam) in a foil sealed plastic package. The lenses are hemispherical or hemitoric shells. To date a 2-year shelf-life has been established.
The subject device is made of a silicone hydrogel material containing an internal wetting agent and UV absorbing monomers. A combination of a benzotriazole UV absorbing monomer and a naphthopyran monomer (photochromic additive) is used to block UV radiation and dynamically absorbs visible light. The transmittance characteristics for these lenses are less than 1.0% in the UVB range of 280 nm to 315 nm and less than 10.0% in the UVA range of 316 nm to 380 nm for the entire power range.
Additionally, the photochromic additive absorbs visible light in the range from 380 nm to 780 nm to a minimum 84% transmittance in the inactivated (closed) state. The activated (open) state dynamically absorbs visible light dependent on the lens thickness and the level of UV and high energy visible (HEV) radiation to a minimum of 23% transmittance.
| Property / Parameter | Subject Device | |
|---|---|---|
| Water Content | 38% | |
| Refractive Index | 1.42 | |
| Oxygen Permeability (Fatt method, edge corrected) | 103 x 10-11 (cm2/sec)(mL O2/mL * mm Hg) | |
| Oxygen Permeability | ||
| (Fatt method, non-edge corrected) | 122 x 10-11 (cm2/sec)(mL O2/mL * mm Hg) | |
| Light Transmittance: Visible - closed form | 84% to 94% | |
| Light Transmittance: Visible - open form | ||
| calculated from Delta Optical Density | Minimum 23% ª | |
| Light Transmittance: UVA (316 nm to 380 nm) |