(245 days)
No
The document describes a contact lens and its physical properties and intended use. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML.
No
The device is indicated for "correction of vision" in people with "non-diseased eyes," not for treating or curing a disease.
No
Explanation: This device is a contact lens intended to correct vision, not diagnose a condition. The "Intended Use / Indications for Use" section clearly states its purpose is for "correction of vision" in people with "non-diseased eyes."
No
The device description clearly states it is a soft (hydrophilic) contact lens, which is a physical medical device, 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 correction of vision in people with non-diseased eyes. This is a therapeutic or corrective function, not a diagnostic one.
- Device Description: The device is a contact lens, which is a medical device used to correct vision by being placed on the surface of the eye.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It does not analyze samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Testing Performed: The testing described focuses on the physical properties, biocompatibility, safety, and effectiveness of the lens for vision correction. There are no tests related to diagnostic accuracy or performance.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This contact lens does not fit that description.
N/A
Intended Use / Indications for Use
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity.
ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.
ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity.
ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.
The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.
Product codes
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. The lens is tinted using Reactive Blue 247. A benzotriazole UV absorbing monomer is used to block UV radiation in combination with a novel fused tricyclic chromophore that also blocks UV radiation and reduces transmittance in the range from 380 nm to 450 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eyes
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-clinical performance data (in-vitro and in-vivo tests) were performed to assess the properties and safety and effectiveness of the contact lens. All biocompatibility 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 Properties: Refractive Index, Oxygen Permeability, Specific Gravity, Modulus, Tensile Strength, Elongation, Dynamic Contact Angle, Leachables, Light Transmittance.
- Biocompatibility: Bacterial Reverse Mutation Study (according to ISO 10993-3:2014), Cytotoxicity Study Using the ISO Direct Contact Method (according to ISO 10993-5:2009), 22-Day Rabbit Contact Lens Study (according to ISO 9394:2012), ISO Ocular Irritation Study in Rabbits (according to ISO 10993-10:2010), ISO Acute Systemic Toxicity Study in Mice (according to ISO 10993-11:2017), Guinea Pig Maximization Sensitization Study (according to ISO 10993-10:2010).
Key results:
- The results of the non-clinical testing on the subject device 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.
- Note: The packing solution and packaging system are the same as referenced in K042275.
Clinical Performance Data:
- The subject device uses the same lens material, senofilcon A, has the same indications, has the same sphere and toric lens designs and utilizes the same manufacturing and sterilization processes as the predicate device in K042275. Additionally, the multifocal and multifocal toric optical design types are the same as the reference device in K141670.
- Demonstration of the physical, chemical and sphere/toric optical design equivalency of the subject device to the predicate device and multifocal design equivalency to the reference device supports the safety and effectiveness of the subject device. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" above the word "ADMINISTRATION". The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
November 29, 2021
Johnson & Johnson Vision Care, Inc. Jamie Frenz-Ross Manager, Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, Florida 32256
Re: K210930
Trade/Device Name: ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: October 28, 2021 Received: October 29, 2021
Dear Jamie Frenz-Ross:
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.
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatoryinformation/postmarketing-safety-reporting-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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210930
Device Name ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)
Indications for Use (Describe)
ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are nearsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity.
ACUVUE® OASYS MAX 1-DAY Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.
ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and may have 0.75D or less of astigmatism that does not interfere with visual acuity.
ACUVUE® OASYS MAX 1-DAY MULTIFOCAL Contact Lenses for ASTIGMATISM (senofilcon A) are indicated for daily disposable wear for the correction of vision in people with non-diseased eyes who are presbyopic and may be nearsighted (myopic) or farsighted (hyperopic) and have 10.00D or less of astigmatism.
The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.
| 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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3
510(K) SUMMARY
Submitter Information
| Company: | Johnson & Johnson Vision Care, Inc.
7500 Centurion Parkway, Suite 100
Jacksonville, FL 32256 |
|-----------------|----------------------------------------------------------------------------------------------------|
| Contact Person: | Jamie Frenz-Ross |
| Email: | jfrenzro@its.jnj.com |
| Telephone: | 561-373-7697 |
| Date: | November 19, 2021 |
Identification of the Device
| Common Name: | Soft Contact Lens |
|---|---|
| Device/Trade Name: | ACUVUE ® OASYS MAX 1-DAY Contact Lenses |
| (senofilcon A) | |
| 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) Soft Contact Lens, cleared via K042275 .
Reference Device: Multifocal and Multifocal Toric Optical Designs
- ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted . (Visibility and/or Cosmetically) with UV Blocker for Daily Wear, cleared via K141670
4
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. The lens is tinted using Reactive Blue 247. A benzotriazole UV absorbing monomer is used to block UV radiation in combination with a novel fused tricyclic chromophore that also blocks UV radiation and reduces transmittance in the range from 380 nm to 450 mm.
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) | |
| Light Transmittance: Visible (380 nm to 780 nm), | ||
| varies with power | ≥ 78% | |
| Light Transmittance: (451 nm to 780 nm) | ≥ 90% | |
| Light Transmittance: (380 nm to 450 nm) |