(46 days)
The ACUVUE® (senofilcon A) Soft Contact Lens 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 need up to 4.00 of ADD power and have 0.75D or less of astigmatism.
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, 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.
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).
The subject device is a soft (hydrophilic) contact lens available in a 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.
The subject device 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 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 315 nm to 380 nm for the entire power range.
This document is a 510(k) summary for the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL and ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC. It discusses the substantial equivalence of the new device to previously cleared predicate and reference devices.
Here's an analysis of the provided text in the context of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a study endpoint. Instead, it presents physicochemical properties and parameters of the subject device, which are implicitly the performance characteristics that need to be within an acceptable range to demonstrate equivalence to the predicate and reference devices.
In this case, the "device performance" is the reported property/parameter values.
| Property / Parameter | Reported Device Performance (ACUVUE® (senofilcon A) Soft Contact Lens Multifocal) |
|---|---|
| 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 | 89% to 99% |
| Light Transmittance: UVA (315 nm to 380 nm) | < 10.0% |
| Light Transmittance: UVB (280 nm to 315 nm) | < 1.0% |
| DCA Advancing Contact Angle (degree) | 38 – 74 |
| 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: 0.147 mm) |
| Base Curve | 7.85 mm to 10.00 mm |
| Sphere Powers | -20.00D to +20.00D |
| ADD Powers | Up to +4.00D |
| Axis | 2.5° to 180° |
| Cylinder | -0.25D to -10.00D |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "clinical performance data to demonstrate substantial equivalence are not required."
Therefore, there is no "test set" in the context of clinical performance data described in this document. The non-clinical performance data involved "finished product testing for verification of the modified design," but no specific sample sizes or data provenance are provided for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable, as no clinical performance data requiring expert ground truth for a test set was conducted or reported in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical performance data requiring adjudication was conducted or reported in this document.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a contact lens, not an AI-powered diagnostic device. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a contact lens, not an AI-powered algorithm. No standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable, as no clinical performance data requiring ground truth was conducted or reported in this document. The "ground truth" for the non-clinical tests would be the established specifications and measurement standards for the material and design properties.
8. The sample size for the training set
Not applicable, as no AI/machine learning model was developed for this device. Therefore, there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for an AI/ML model for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 17, 2020
Johnson & Johnson Vision Care, Inc. Mr. Scott Durland Associate Director, Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, FL 32256
Re: K200243
Trade/Device Name: ACUVUE® (senofilcon A) Soft Contact Lens Multifocal, ACUVUE® (senofilcon A) Soft Contact Lens Multifocal Toric Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL. MVN Dated: January 29, 2020 Received: January 31, 2020
Dear Mr. Durland:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-safety/medical-devicereporting-mdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200243
Device Name
ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL, ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC
Indications for Use (Describe)
The ACUVUE® (senofilcon A) Soft Contact Lens 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 need up to 4.00 of ADD power and have 0.75D or less of astigmatism.
The ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL TORIC is indicated for daily wear for the optical correction of refractive ametropia (myperopia, 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.
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)
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| -------------------------------------------------------------------------- | ----------------------------------------------------------- |
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510(K) SUMMARY
Submitter Information
| Company: | Johnson & Johnson Vision Care, Inc7500 Centurion Parkway, Suite 100Jacksonville, FL 32256 |
|---|---|
| Contact Person: | Scott Durland |
| Email: | sdurland@its.jnj.com |
| Telephone: | 904-443-3458 |
| FAX: | 904-443-1424 |
| Date: | January 31, 2020 |
Identification of the Device
| Common Name: | Soft Contact Lens |
|---|---|
| Device/Trade Name: | ACUVUE® (senofilcon A) Soft Contact Lens MultifocalACUVUE® (senofilcon A) Soft Contact Lens Multifocal Toric |
| Classification Name: | Soft (Hydrophilic) Contact Lens, Daily Wear |
| Device Classification: | Class II, 21 CFR 886.5925 (b) (1) |
| Product Code: | LPL, MVN |
Predicate Device:
- VISTAKON® (senofilcon A) Contact Lens, cleared via K042275 ●
Reference Device: Optical Design
- ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted ● (Visibility and/or Cosmetically) with UV Blocker for Daily Wear, cleared via K141670
Description of Device
The subject device is a soft (hydrophilic) contact lens available in a 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.
The subject device 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 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 315 nm to 380 nm for the entire power range.
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Premarket Notification K200243 ACUVUE® (senofilcon A) Soft Contact Lens Multifocal Johnson & Johnson Vision Care, Inc. (JJVCI)
Table 1 details properties and parameters of the subject device.
| 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 | 89% to 99% |
| Light Transmittance: UVA (315 nm to 380 nm) | < 10.0% |
| Light Transmittance: UVB (280 nm to 315 nm) | < 1.0% |
| DCA Advancing Contact Angle (degree) | 38 – 74 |
| 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: 0.147 mm |
| Base Curve | 7.85 mm to 10.00 mm |
| Sphere Powers | -20.00D to +20.00D |
| ADD Powers | Up to +4.00D |
| Axis | 2.5° to 180° |
| Cylinder | -0.25D to -10.00D |
Table 1: Physicochemical Properties and Parameters
Indications for Use
The intended use of ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is for vision correction in a presbyopic population. The specific indications for use are provided below followed by a comparison to the predicate device in Table 2.
The ACUVUE® OASYS (senofilcon A) Soft 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 4.00 of ADD power and have 0.75D or less of astigmatism.
The ACUVUE® OASYS (senofilcon A) Soft 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.
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
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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).
| Indication | Predicate Device(K042275) | Subject Device |
|---|---|---|
| Multifocal | For daily wear for the correction ofdistance and near vision in presbyopic,phakic or aphakic persons withnon-diseased eyes who may have0.75D of astigmatism or less. | For daily wear for the optical correctionof refractive ametropia (myopia andhyperopia) and/or presbyopia in phakic oraphakic persons with non-diseased eyeswho may need up to 4.00D of ADDpower and have 0.75D of astigmatism orless. |
| MultifocalToric | For daily wear for the correction ofdistance and near vision in presbyopic,phakic or aphakic persons withnon-diseased eyes who may have 10.00D ofastigmatism or less. | For daily wear for the optical correctionof refractive ametropia (myopia,hyperopia, and/or astigmatism) andpresbyopia in phakic or aphakic personswith non-diseased eyes who may need upto 4.00D of ADD power and have 10.00Dof astigmatism or less. |
| Wear/ReplacementSchedule | Eye Care Practitioners may prescribethe lenses either for single-usedisposable wear or frequent/plannedreplacement wear with cleaning,disinfection and scheduled replacement.When prescribed for frequent/plannedreplacement wear, the lenses may bedisinfected using a chemicaldisinfection system only. | Eye Care Professionals may prescribe thelenses either for daily disposable wear orfrequent/planned replacement wear withcleaning, disinfection and scheduledreplacement.When prescribed for daily disposablewear, no cleaning or disinfection isrequired. Lenses should be discardedupon removal. When prescribed forfrequent/planned replacement wear, thelenses may be disinfected using achemical disinfection system only andshould be discarded after therecommended wearing period asprescribed by the Eye Care Professional.When the lenses are worn in afrequent/planned replacement modality,they are intended to be worn for up to2 weeks (14 days). |
Indication Comparison Table 2:
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Technological Characteristics
The technological characteristics of the subject device are compared to the characteristics of the predicate and reference devices in Table 3.
| Property | Predicate Device(K042275) | Reference Device(K141670) | Subject Device |
|---|---|---|---|
| Optical Design Type | Alternating zone | Progressive asphere | Progressive asphere |
| Material | senofilcon A | etafilcon A | senofilcon A |
| Material ClassificationGroupa | Group VC(Enhanced OxygenPermeable: low watersub group) | Group IV(High water, ionicpolymer) | Group VC(Enhanced OxygenPermeable: low watersub group) |
| UV Blocker | Yes | Yes | Yes |
| Water Content, % | 38 | 58 | 38 |
| Refractive Index | 1.42 | 1.40 | 1.42 |
| Oxygen Permeability (Dk)b | 103c122d | 21.4c28.0d | 103c122d |
| Specific Gravity (calculated) | 0.98-1.12 | 0.98-1.13 | 0.98-1.12 |
Table 3: Material & Physicochemical Comparison
a As referenced in ANSI Z80.20-2016, section 4.2, Material Classification
b Dk units = x 10-11 (cm2/sec)(mL O2/mL * mm Hg)
C 35°C Fatt method, edge corrected
d 35°C Fatt method, non-edge corrected
Non-clinical Performance Data
The device uses the same manufacturing process and is made from the same material as the predicate device, VISTAKON® (senofilcon A). Therefore, all nonclinical testing supporting the predicate device in K042275 is also representative of the subject device.
Additionally, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, finished product testing for verification of the modified design was conducted to demonstrate that lenses meet specification tolerances.
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Clinical Performance Data
The proposed alternative multifocal and multifocal toric designs have the same indications, use the same material, senofilcon A. and utilize the same manufacturing and sterilization processes as the predicate device in K042275. Additionally, the optical design type is the same as the reference device in K141670. Demonstration of the physical and chemical equivalency of the subject device to the predicate device and design equivalence to the reference device supports the safety and effectiveness of the subject device for an alternate multifocal and multifocal toric lens design configuration. Therefore, in accordance with FDA Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, May 12, 1994, clinical performance data to demonstrate substantial equivalence are not required.
Conclusions Drawn from the Non-clinical and Clinical Tests
Substantial Equivalence: Information presented in this Premarket Notification establishes that the ACUVUE® (senofilcon A) Soft Contact Lens MULTIFOCAL is as safe and effective as the predicate device when used in accordance with the labeled directions for use.
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.