(59 days)
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.
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.
This document is a 510(k) premarket notification for ACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lenses. It details the safety and efficacy of the device by comparing it to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the demonstration of "substantial equivalence" to the predicate device in various safety and performance aspects. The reported device performance is outlined against these implicit criteria through direct comparison with the predicate device.
| Acceptance Criteria (Implicit from Predicate Equivalence) | Reported Device Performance (ACUVUE® (senofilcon C)) |
|---|---|
| Material Properties: | Material Properties: |
| Water Content (Predicate: 48%) | 41% |
| Refractive Index (Predicate: 1.40) | 1.42 |
| Oxygen Permeability (Dk) (Predicate: 128e) | 103d (edge corrected), 122e (non-edge corrected) |
| Specific Gravity (Predicate: 1.04) | 0.98-1.12 |
| UV Blocker presence | Yes (Predicate: No) |
| Indications for Use: | Indications for Use: |
| Spherical Lens: Optical correction of ametropia | Same, with potentially different astigmatism limits (1.00D or less vs. 2.00D or less for predicate) |
| Toric Lens: Optical correction of ametropia (astigmatism) | Same, with different astigmatism limits (10.00D or less vs. 0.25 to -5.00D for predicate) |
| Multifocal Lens: Optical correction of ametropia/presbyopia | Same, with different ADD power and astigmatism limits (up to 4.00D ADD and 0.75D astigmatism or less vs. +0.50 to +3.00D ADD and 2.00D astigmatism or less for predicate) |
| Multifocal-Toric Lens: Optical correction of ametropia/presbyopia/astigmatism | Indicated (Predicate: Not applicable) |
| Daily/Frequent replacement wear | Daily disposable wear or frequent/planned replacement wear |
| Clinical Performance: | Clinical Performance: |
| Overall performance in vision and health comparable to predicate | Demonstrated similar overall performance in clinically relevant areas of vision and health. |
| Safety Profile (e.g., adverse events, slit lamp findings) | Similar to predicate, non-toxic, non-irritating lens material. |
Note: Differences in specific values (e.g., water content, Dk, specific astigmatism limits) are presented and argued not to adversely affect safety and efficacy.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Study):
- Sample Size: 221 subjects total (109 for the test lens, 112 for the control lens).
- Data Provenance: Conducted in the U.S. (United States), described as a prospective, randomized, parallel group design.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for the clinical test set beyond implying the involvement of "Eye Care Professionals" who would make clinical determinations (e.g., for visual acuity, slit lamp findings, etc.). It mentions "clinical evaluation" and "clinically relevant areas of vision and health," which implies expert assessment, but no explicit details on the number or their specific qualifications (e.g., years of experience, subspecialty) are provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It describes a "prospective, randomized, parallel group design" clinical study, where data points like slit lamp findings and visual acuity were collected. This suggests standard clinical assessment by the study's optometrists/ophthalmologists, but no specific multi-reader adjudication process is detailed for reaching a "ground truth."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This study's design was a direct clinical comparison of the new contact lens to a predicate contact lens, focusing on physiological and performance equivalence, not on the improvement of human readers with AI assistance. The device is a contact lens, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. The device is a contact lens, not an algorithm or AI system. Therefore, standalone performance (without human-in-the-loop) is not a relevant concept for this product.
7. The Type of Ground Truth Used
For the clinical study, the "ground truth" was established through standard clinical assessments and measurements performed by Eye Care Professionals during the study. This includes:
- Slit lamp findings
- Visual acuity measurements
- Keratometry changes
- Evaluations of problems, symptoms, and complaints
- Adverse reactions
- Reasons for discontinuation
This can be broadly categorized as expert clinical assessment and outcomes data as observed and recorded during the prospective clinical trial.
8. The Sample Size for the Training Set
This question is not applicable. The device is a contact lens and does not involve AI or machine learning that would require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this device.
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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.
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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
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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 100Jacksonville, 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 LensACUVUE® VITA™ (senofilcon C) Brand (Soft) Contact Lensfor ASTIGMATISMACUVUE® VITA™ (senofilcon C) Brand (Soft)MULTIFOCAL Contact LensACUVUE® 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.
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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-edgecorrected) | 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) | < 10.0% |
| Light Transmission - UVB (280 nm to 315 nm) | < 1.0% |
| Diameter | 12.0 mm to 15.0 mm |
| Center Thickness, varies with power | 0.060 - 1.000 mm-3.00D: 0.070 mm+3.00D: 0.168 mm |
| Base curve | 7.85 mm to 10.00 mm |
| Sphere Powers | -20.00D to +20.00D |
| ADD powers | +0.25D to +4.00D |
| Axis | 2.5° to 180° |
| Cylinder | -0.25D to -10.00D |
| Table 1: | Physicochemical Properties and Parameters |
|---|---|
| ---------- | ------------------------------------------- |
Note: UVA = ultraviolet A, UVB = ultraviolet B
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Indications for Use
ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens (spherical) is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eves who may have 1.00D or less of astigmatism.
ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens – TORIC is indicated for daily wear for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 10.00D or less of astigmatism.
ACUVUE® (senofilcon C) Soft (hydrophilic) Contact Lens – 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 need up to 4.00D of ADD power and may have 0.75D or less of astigmatism.
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. Jenses 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.
Technological Characteristics
The technological characteristics of the ACUVUE® (senofilcon C) Soft Contact Lens are compared to the characteristics of the predicate device, CooperVision (comfilcon A) in Table 2 and Table 3.
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| Property | Predicate Devicea(K052560) | Subject Device |
|---|---|---|
| Material | comfilcon A | senofilcon C |
| Lens Material Group | Group V(Silicone Hydrogel) | Group V(Silicone Hydrogel) |
| UV Blocker | No | Yes |
| Water Content, % | 48 | 41 |
| Refractive Index | 1.40 | 1.42 |
| Oxygen Permeability (Dk)b | 128c | 103d122e |
| Specific Gravity (calculated) | 1.04 | 0.98-1.12 |
| Predicate Device | Subject Device | |
| Indication | CooperVision (comfilcon A) | ACUVUE® (senofilcon C) Soft Contact Lens |
| Spherical | For the correction of ametropia (myopia and hyperopia) inaphakic and non-aphakic persons with non-diseased eyes inpowers from -20.00 to +20.00 diopters. The lenses may beworn by persons who exhibit astigmatism of 2.00 diopters orless that does not interfere with visual acuity. | For daily wear for the optical correction of refractiveametropia (myopia and hyperopia) in phakic or aphakicpersons with non-diseased eyes who may have 1.00D orless of astigmatism. |
| Toric | For the correction of ametropia (myopia and hyperopia) inaphakic and non-aphakic persons with non-diseased eyes inpowers from -20.00 to +20.00 diopters and astigmaticcorrections from -0.25 to -5.00 diopters. | For daily wear for the optical correction of refractiveametropia (myopia and hyperopia) in phakic or aphakicpersons with non-diseased eyes who may have 10.00D orless of astigmatism. |
| Multifocal | For the correction of refractive ametropia (myopia &hyperopia) and emmetropia with presbyopia in aphakic andnon-aphakic persons with non-diseased eyes in powersof -20.00 to +20.00 diopters and with add powers from +0.50to +3.00 diopters. The lenses may be worn by persons whoexhibit astigmatism of 2.00 diopters or less that does notinterfere with visual acuity. | For daily wear for the optical correction of refractiveametropia (myopia and hyperopia) and/or presbyopia inphakic or aphakic persons with non-diseased eyes whomay need up to 4.00D of ADD power and may have0.75D or less of astigmatism. |
| Multifocal-Toric | N/A | For daily wear for the optical correction of refractiveametropia (myopia, hyperopia, and/or astigmatism) andpresbyopia in phakic or aphakic persons with non-diseased eyes who may need up to 4.00D of ADD powerand may have 10.00D or less of astigmatism. |
| UV Statement | N/A | Contain a UV Blocker to help protect against transmissionof harmful UV radiation to the cornea and into the eye. |
| Wear/ReplacementSchedule | Predicate Device | Subject Device |
| CooperVision (comfilcon A) | ACUVUE® (senofilcon C) Soft Contact Lens | |
| The wearing and replacement schedules should bedetermined by the Eye Care Practitioner. Patients tend toover-wear the lenses initially. The Eye Care Practitionershould emphasize the importance of adhering to the initialmaximum wearing schedule. Regular checkups, asdetermined by the eye care practitioner are also extremelyimportant.CooperVision recommends that all Biofinity® lenses bediscarded and replaced with a new lens on a frequentreplacement basis. The eye care practitioner is encouraged todetermine an appropriate lens replacement schedule basedupon the response of the patient.The Eye Care Practitioner should determine the wearing andreplacement schedule, based upon the patient's history andtheir ocular examination, as well as the practitioner'sexperience and clinical judgment. | The wearing schedule should be determined by the EyeCare Professional. Regular checkups, as determined bythe Eye Care Professional, are also extremely important.Patients tend to over wear the lenses initially. The EyeCare Professional should emphasize the importance ofadhering to the initial maximum wearing schedule.Maximum wearing time should be determined by theEye Care Professional based upon the patient'sphysiological eye condition, because individual responseto contact lenses varies.Studies have not been completed to show that the lens issafe to wear during sleeping.When prescribed for daily wear (frequent replacement),it is recommended that the lenses be discarded andreplaced with a new lens each month. However, the EyeCare Professional is encouraged to determine anappropriate lens replacement schedule based upon theresponse of the patient. When prescribed for dailydisposable wear, the lenses should be discarded uponremoval. |
Table 2: Material & Physicochemical Comparison to CooperVision (comfilcon A)
4 Based on available public information
b Dk units = x 10-11 (cm2/sec)(mL O2/mL * mm Hg)
゜34°C Coulometric method
d 35°C Fatt method, edge corrected
゜35°C Fatt method, non-edge corrected
Note: UV = ultraviolet
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Table 3a: Indication Comparison
Note: UV = ultraviolet
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Nonclinical Performance Data
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 following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. All nonclinical toxicology tests were conducted in accordance with the GLP regulation (21 CFR Part 58). All other testing was conducted according to valid scientific protocols.
Non-Clinical testing performed includes:
- . Physicochemical
- Refractive Index o
- Water Content O
- Oxygen Permeability O
- Specific Gravity O
- Modulus O
- Tensile Strength O
- Elongation O
- Dynamic Contact Angle O
- o Leachables
- Biocompatibility
- Ocular Irritation (according to ISO 10993-10:2010) O
- Cytotoxicity (according to ISO 10993-5:2009) O
- Solution Compatibility (according to ISO 11981:2009) and Preservative Uptake/Release . (according to ISO 11986:2010)
- Alexidine Dihydrochloride (Alexidine) O
- Polyhexymethylene Biguanide (PHMB) O
- Polyquaternium-1 (PQ-1) O
- Myristamidopropyl Dimethylamine (Aldox) о
The results of the nonclinical testing on the ACUVUE® (senofilcon C) Contact Lens demonstrate that:
- the lens material and extracts are non-toxic and non-irritating, and ●
- lens physical and material properties are consistent with currently marketed lenses.
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Clinical Performance Data
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.
Conclusions Drawn from the Nonclinical and Clinical Tests
Substantial Equivalence: Information presented in this Premarket Notification establishes that the ACUVUE® (senofilcon C) Soft 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. Any differences that may exist between the senofilcon C Soft Contact Lens and the control lens do not adversely affect the safety and efficacy of the test lens worn according to instructions.
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 basis. The benefits to the patient are the same as those for other soft (hydrophilic) contact lenses.
Other Information
Not applicable.
§ 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.