(59 days)
No
The summary describes a physical contact lens and its material properties, intended use, and clinical study results. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The device is indicated for the optical correction of refractive ametropia (myopia, hyperopia, and astigmatism) and/or presbyopia, which means it corrects vision rather than treating or preventing a disease or condition. While it contains a UV Blocker, this is described as an ancillary feature to "help protect" rather than a primary therapeutic indication.
No.
This device is a therapeutic device (contact lens) intended for optical correction, not for diagnosing medical conditions.
No
The device description clearly states it is a physical contact lens made of specific materials (senofilcon C and water) and supplied as a sterile, physical product. It is 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 ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia. This is a physical correction of vision, not a diagnostic test performed on samples from the human body.
- Device Description: The device is a contact lens made of specific materials designed to alter the way light enters the eye. It does not contain reagents or components typically associated with in vitro diagnostic tests.
- Lack of Diagnostic Activity: The description focuses on correcting vision and protecting against UV radiation. There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information about a disease or condition.
- Anatomical Site: The device interacts with the cornea and the eye, which is a physical interaction for vision correction, not an in vitro analysis.
In vitro diagnostics are devices intended for use in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, disease or congenital abnormality. This contact lens does not fit this definition.
N/A
Intended Use / Indications for Use
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL is indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in phakic or aphakic persons with nondiseased eyes who may need up to 4.00D of ADD power and may have 0.75D of astigmatism or less.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens 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 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 (see REPLACEMENT SCHEDULE). When prescribed for daily disposable wear, lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional.
Product codes
LPL, MVN
Device Description
The ACUVUE® (senofilcon C) Soft Contact Lens is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 59% senofilcon C and 41% water by weight when hydrated and stored in 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 4-year shelf-life has been established.
The ACUVUE® (senofilcon C) Soft Contact Lens is made of a silicone hydrogel material containing an internal wetting agent. The 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 nm to 315 nm and less than 10% in the UVA range of 316 nm to 380 nm for the entire power range.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes (Cornea)
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 three-month clinical study was conducted in the U.S. to demonstrate the safety and efficacy of the ACUVUE® (senofilcon C) Soft Contact Lens (test lens) by comparison with CooperVision (comfilcon A) contact lenses (control lens) when worn on a daily wear basis. The clinical study provided data to establish substantial equivalence with the predicate, control lens.
The study evaluated 221 subjects, 109 for the test lens and 112 for the control lens in a prospective, randomized, parallel group design. The primary safety and efficacy endpoints were slit lamp findings and visual acuity respectively. Additional variables were evaluated including keratometry changes, problems, symptoms and complaints, daily average wear time, adverse reactions, 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 between the test ACUVUE® (senofilcon C) and control CooperVision (comfilcon A) lenses when worn under daily wear conditions.
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
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, abstract design. The profiles are surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in black, uppercase letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 28, 2016
Johnson & Johnson Vision Care, Inc. Ramona Haile, Pharm.D. Senior Manager, Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K160212
Trade/Device Name: ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens for ASTIGMATISM ACUVUE® VITA™ (senofilcon C) Brand (Soft) MULTIFOCAL Contact Lens ACUVUE® VITA™ (senofilcon C) Brand (Soft) MULTIFOCAL Contact Lens for ASTIGMATISM Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: January 27, 2016 Received: January 29, 2016
Dear Dr. Haile:
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.
1
Page 2 - Ramona Haile, Pharm.D.
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 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education 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.
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
2
Indications for Use
510(k) Number (if known) K160212
Device Name
ACUVUE® (senofilcon C) Soft Contact Lens
Indications for Use (Describe)
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens MULTIFOCAL is indicated for the optical correction of refractive ametropia (myperopia) and/or presbyopia in phakic or aphakic persons with nondiseased eyes who may need up to 4.00D of ADD power and may have 0.75D of astigmatism or less.
The ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens 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 of astigmatism or less.
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 (see REPLACEMENT SCHEDULE). When prescribed for daily disposable wear, lenses should be discarded upon removal. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional.
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)
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5. 510(K) SUMMARY
Submitter Information
| Company: | Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, FL 32256 |
|-----------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Ramona Haile |
| Email: | rhaile@its.jnj.com |
| Telephone: | 904-443-1191 |
| FAX: | 904-443-1424 |
| Date: | March 18, 2016 |
Identification of the Device
| Common Name: | Soft Contact Lens |
|---|---|
| Device/Trade Name: | ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens |
| ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lens | |
| for ASTIGMATISM | |
| ACUVUE® VITA™ (senofilcon C) Brand (Soft) | |
| MULTIFOCAL Contact Lens | |
| ACUVUE® VITA™ (senofilcon C) Brand (Soft) | |
| MULTIFOCAL Contact Lens for ASTIGMATISM | |
| Classification Name: | Soft (Hydrophilic) Contact Lens, Daily Wear |
| Device Classification: | Class II, 21 CFR 886.5925 (b) (1) |
Product Code: LPL, MVN
Predicate Device
- CooperVision Biofinity®1 (comfilcon A) Soft Contact Lens cleared via K052560, ● hereafter also referred to as CooperVision (comfilcon A) or Biofinity®
1 Biofinity® is a registered trademark of CooperVision, Inc.
4
Description of Device
The ACUVUE® (senofilcon C) Soft Contact Lens is a soft (hydrophilic) contact lens available in a spherical, toric, multifocal and/or multifocal-toric design. The composition of the lens is 59% senofilcon C and 41% water by weight when hydrated and stored in 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 4-year shelf-life has been established.
The ACUVUE® (senofilcon C) Soft Contact Lens is made of a silicone hydrogel material containing an internal wetting agent. The 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 nm to 315 nm and less than 10% in the UVA range of 316 nm to 380 nm for the entire power range.
Table 1 contains property and parameter ranges for the subject device.
| Property / Parameter | Subject Device |
|---|---|
| Water Content | 41% |
| 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 Transmission - Visible | 89 to 99% |
| Light Transmission - UVA (316 nm to 380 nm) |