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.

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.

AI/ML Overview

The provided document is a 510(k) Premarket Notification for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A). It focuses on demonstrating substantial equivalence to predicate and reference devices, primarily through technological characteristics and non-clinical performance data, rather than new clinical performance data for the subject device.

Therefore, the document does not contain the following information typically associated with a study proving a device meets acceptance criteria:

A table of acceptance criteria and reported device performance based on a new clinical study.
Sample sizes used for a new clinical test set.
Number of experts used to establish ground truth or qualifications of those experts.
Adjudication methods for a new clinical test set.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone (algorithm only) performance data.
Type of ground truth used (as no new clinical ground truth development is described).
Sample size for a training set (as this is not an AI/ML device with a training phase).
How ground truth for a training set was established.

Instead, the document states:

"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."

This indicates that the acceptance criteria for this device's approval were primarily based on its technological similarity and non-clinical performance data being equivalent to already approved devices, rather than a new clinical trial proving performance against defined clinical acceptance criteria.

However, the document does list non-clinical performance data (in-vitro and in-vivo tests) that were performed to assess properties, safety, and effectiveness. While not a "clinical study" in the sense of patient outcomes for acceptance criteria, these tests serve a similar purpose for demonstrating safety and performance.

Here's an attempt to extract relevant information based on the provided text, interpreting "acceptance criteria" as meeting the standards set by the predicate/reference devices and safety tests, since a traditional clinical study with defined performance metrics isn't presented:

Acceptance Criteria and Device Performance (Based on Non-Clinical Data and Substantial Equivalence)

The approval of the ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) was primarily based on demonstrating substantial equivalence to predicate and reference devices through:

Comparison of technological characteristics.
Non-clinical performance data (in-vitro and in-vivo tests) to assess properties and safety.

The acceptance criteria are implicitly met by demonstrating that the subject device's properties and safety profile are comparable to or within acceptable ranges of previously cleared devices and established safety standards.

1. Table of Acceptance Criteria (Implied by Predicate/Reference Equivalence and Non-Clinical Tests)

Characteristic/Property	Acceptance Criteria (Implied by Predicate/Reference & Standards)	Reported Device Performance (Subject Device)
Material	senofilcon A	senofilcon A
ISO Classification Group	Group 5C (Silicone hydrogel: low water subgroup)	Group 5C (Silicone hydrogel: low water subgroup)
UV Blocker	Yes	Yes
Water Content	38%	38%
Refractive Index	1.42	1.42
Oxygen Permeability (Dk)	103 x 10⁻¹¹ (cm²/sec)(mL O₂/mL * mm Hg)	103 x 10⁻¹¹ (cm²/sec)(mL O₂/mL * mm Hg)
Specific Gravity	0.98-1.12	0.98-1.12
Light Transmittance: Visible (380-780 nm)	≥ 78%	≥ 78% (varies with power)
Light Transmittance: (451-780 nm)	≥ 90%	≥ 90%
Light Transmittance: (380-450 nm)	< 45%	< 45%
Light Transmittance: UVA (315-380 nm)	< 10.0%	< 10.0%
Light Transmittance: UVB (280-315 nm)	< 1.0%	< 1.0%
Biocompatibility	Non-toxic, non-irritating (per ISO 10993 standards)	Non-toxic, non-irritating
Indicated Use & Wear Schedule	Equivalent to predicate/reference for daily disposable wear	Equivalent to predicate/reference for daily disposable wear

2. Sample Sizes and Data Provenance (for Non-Clinical Tests)

Sample Sizes: Not explicitly stated for each specific non-clinical test (e.g., number of lenses tested for oxygen permeability, number of animals in biocompatibility studies). The document mentions "a series of in-vitro and in-vivo tests."
Data Provenance: The tests were conducted following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. Biocompatibility tests were conducted in accordance with GLP regulation (21 CFR Part 58). Other testing was conducted according to valid scientific protocols. The location of these tests (e.g., country of origin) is not specified. The data is retrospective in the sense that it was collected prior to this submission but not from a new clinical patient study.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable as the submission relies on non-clinical tests and substantial equivalence to previously approved devices, not a new clinical study requiring human expert consensus for ground truth on patient data.

4. Adjudication Method for the Test Set

Not applicable, as there was no clinical test set requiring human adjudication for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI/ML device that assists human readers, nor is it a device that measures improved diagnostic accuracy over human readers. Its approval is based on safety, physical properties, and equivalence to existing contact lenses.

6. Standalone Performance

Not applicable in the context of AI/ML or diagnostic devices. The "standalone performance" of the device refers to its inherent physical, chemical, and optical characteristics and biocompatibility, as detailed in the non-clinical performance data.

7. Type of Ground Truth Used

For the purpose of substantial equivalence and safety, the "ground truth" is derived from:
- Established industry standards and material properties: Such as ISO standards (e.g., ISO 18369-1:2017) for material classification and physicochemical test methods (e.g., Fatt method for Dk).
- Regulatory safety guidelines: FDA Guidance Document for Daily Wear Contact Lenses (1994) and GLP regulations (21 CFR Part 58).
- Prior approval for predicate/reference devices: The performance and safety profiles of the VISTAKON (senofilcon A) Soft Contact Lens (K042275) and ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia (K141670) serve as the "ground truth" for equivalence.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no AI/ML training set.

Summary

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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.

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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

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Indications for Use

510(k) Number (if known) K210930

Device Name ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)

Indications for Use (Describe)

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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510(K) SUMMARY

Submitter Information

Company:	Johnson & Johnson Vision Care, Inc.7500 Centurion Parkway, Suite 100Jacksonville, 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

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Description of Device

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)	< 45%
Light Transmittance: UVA (315 nm to 380 nm)	< 10.0%
Light Transmittance: 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: 0.085 mm+3.00D: 0.173 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

Physicochemical Properties and Parameters Table 1:

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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 (myopic) or farsighted (hyperopic) and may have 1.00D or less of astigmatism that does not interfere with visual acuity.

The lenses are to be prescribed for daily disposable wear. Therefore, no cleaning or disinfection is required. Lenses should be discarded upon removal.

Technological Characteristics

The technological characteristics of the subject device are compared to the characteristics of the predicate and reference devices in Table 2 and Table 3.

The single vision and toric optical designs for the subject device are the same as the predicate optical lens designs. The multifocal and multifocal toric optical designs for the subject device are the same as the reference device optical lens designs.

Property	Predicate Device	Subject Device
Material	senofilcon A	senofilcon A
ISO Classification Groupª	Group 5C(Silicone hydrogel: low watersubgroup)	Group 5C(Silicone hydrogel: low watersubgroup)
UV Blocker	Yes	Yes
Water Content, %	38	38
Refractive Index	1.42	1.42
Oxygen Permeability (Dk)b	103	103
Specific Gravity (calculated)	0.98-1.12	0.98-1.12

Table 2: Material & Physicochemical Comparison

4 As referenced in ISO 18369-1:2017

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510(k) Premarket Notification ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) Johnson & Johnson Vision Care, Inc. (JJVCI)

b Dk units = x 10-11 (cm²/sec)(mL O₂/mL * mm Hg), 35°C Fatt method, edge corrected

	Table 3:	Indication Comparison
--	----------	-----------------------	--

Indication	Predicate Device	Subject Device
Spherical	For daily wear for the correction ofrefractive ametropia (myopia andhyperopia) in phakic or aphakicpersons with non-diseased eyes whohave 1.00D or less of astigmatism.	For daily disposable wear for thecorrection of vision in people withnon-diseased eyes who arenearsighted (myopic) or farsighted(hyperopic) and may have 1.00D orless of astigmatism that does notinterfere with visual acuity.
Toric	For daily wear for the correction ofrefractive ametropia (myopia andhyperopia) in phakic or aphakicpersons with non-diseased eyes whomay have 10.00D or less ofastigmatism.	For daily disposable wear for thecorrection of vision in people withnon-diseased eyes who may benearsighted (myopic) or farsighted(hyperopic) and have 10.00D or lessof astigmatism.
Multifocal	For daily wear for the correction ofdistance and near vision inpresbyopic, phakic or aphakic personswith non-diseased eyes who may have0.75D or less of astigmatism.	For daily disposable wear for thecorrection of vision in people withnon-diseased eyes who are presbyopicand may be nearsighted (myopic) orfarsighted (hyperopic) and may have0.75D or less of astigmatism that doesnot interfere with visual acuity.
Multifocal Toric	For daily wear for the correction ofdistance and near vision in presbyopicphakic or aphakic persons withnon-diseased eyes who may have10.00D of astigmatism or less.	For daily disposable wear for thecorrection of vision in people withnon-diseased eyes who are presbyopicand may be nearsighted (myopic) orfarsighted (hyperopic) and have10.00D or less of astigmatism.

Wear/ Replacement Schedule Comparison Table 4:

Wear/ReplacementSchedule	Predicate Device	Subject Device
	Eye Care Professionals mayprescribe the lenses either forsingle--use disposable wear orfrequent/planned replacement wearwith cleaning, disinfection andscheduled replacement. Whenprescribed for frequent/plannedreplacement wear, the lenses may becleaned and disinfected using achemical disinfection system only.	The lenses are to be prescribed fordaily disposable wear. Therefore, nocleaning or disinfection is required.Lenses should be discarded uponremoval.

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Non-clinical Performance Data

A series of in-vitro and in-vivo tests were performed to assess the properties and safety and effectiveness of the contact lens following the 1994 FDA Guidance Document for Daily Wear Contact Lenses. 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 l
- 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)

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.

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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.

Conclusions Drawn from the Non-clinical Tests

Substantial Equivalence: Information presented in this Premarket Notification establishes that the subject device is as safe and effective as the predicate device when used in accordance with the labeled directions for use. All potential risks associated with the proposed modification, have been thoroughly addressed. No new questions of safety and efficacy compared to the predicate device have been identified.

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.

Regulation Number and Section

§ 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.