ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated 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 4.00D of ADD power and have 0.75D of astigmatism or less.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker is indicated for daily wear for the optical correction of refractive ametropia (myopia, hyperopia, and/or astigmatism) and presbyopia in phakic persons with non-diseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Timed, is also indicated for daily wear to enhance or alter the appearance of the eye.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear contains a UV Blocker to help protect against transmission of harmful UV radiation to the cornea and into the eye.

Eye Care Practitioners may prescribe the ACUVUE® (etafficon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.

When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.

When prescribed for frequent/planned replacement wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be cleaned, rinsed, and disinfected each time the lens is removed. The contact lens is to be discarded after the recommended wearing period as prescribed by the Eye Care Professional. When prescribed for frequent/planned replacement wear, the lenses may be disinfected using a chemical disinfection system only.

Device Description

The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is a soft (hydrophilic) contact lens available in a multifocal and/or multifocal-toric design. The lens material (etafilcon A) is a copolymer of 2-hydroxyethyl methacrylate and methacrylic acid cross-linked with 1,1,1-trimethylol propane trimethacrylate and ethylene glycol dimethacrylate. The composition of the lens is 42% etafilcon A and 58% water by weight when hydrated and stored in buffered saline solution with or without povidone. The lens is supplied in a sterile state.

The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Visibility Tinted with UV Blocker for Daily Wear, 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 UV Blocking for ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lenses for Presbyopia, Visibility Tinted with UV Blocker averages 97% in the UVB range of 280 nm to 315 nm and 82% in the UVA range of 316 nm to 380 nm.

The ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Cosmetically Tinted with UV Blocker for Daily Wear, contains a pigmented area that will enhance or alter the appearance of the eye. The lens is colored with one or more of the following color additives: iron oxides, titanium dioxide, phthalocyaninato (2-) copper, phthalocyanine green, vat orange 1, and Reactive Blue Dye #4.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia:

Based on the provided FDA 510(k) summary, the device being described is a soft contact lens, and the submission is for a new multifocal design (ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear).

Crucially, the document states that clinical performance data was NOT required because the device is substantially equivalent to predicate devices. This means that there wasn't a new clinical study specifically designed to establish the performance of this particular new multifocal design against specific acceptance criteria. Instead, the substantial equivalence relies on the material, manufacturing process, and indications being similar to previously cleared devices, and on non-clinical testing to ensure the modified design meets specifications.

Therefore, many of the questions regarding a study proving acceptance criteria cannot be directly answered from this document because such a study was not conducted for this 510(k) submission.

Here's a breakdown of what information can be extracted:

1. A table of acceptance criteria and the reported device performance

Since a dedicated clinical study for this specific multifocal design was not performed to establish new acceptance criteria or performance metrics, the acceptance criteria are implicitly met by demonstrating substantial equivalence to the predicate devices and through non-clinical verification of specifications.

The document provides the following technical specifications for the device, which serve as performance characteristics that were verified non-clinically:

Characteristic	Acceptance Criteria (Specification)	Reported Device Performance (Verification)
Water Content	58%	58% (Same as predicate)
Refractive Index (@ 20°C)	1.40	1.40 (Same as predicate)
Oxygen Permeability (Dk, Fatt method, edge corrected)	$21.4 \times 10^{-11}$ (cm²/sec)(mL O₂/mL * mm Hg)	$21.4 \times 10^{-11}$ (Same as predicate)
Light Transmission - Visible	Minimum 85%	Achieved (Implied by "Same as predicate")
Light Transmission - UVA (316 nm to 380 nm)	<30.0%	<30.0% (Average 82% blocked)
Light Transmission - UVB (280 nm to 315 nm)	<5.0%	<5.0% (Average 97% blocked)
Diameter	12.0 mm to 15.0 mm	Within range
Center Thickness	0.060 mm to 1.000 mm	Within range
Base curve	7.85 mm to 10.00 mm	Within range
Powers	-20.00D to +20.00D	Within range
Multifocal ADD powers	up to +4.00D	up to +4.00D
Axis (Multifocal-Toric)	2.5° to 180°	Within range
Cylinder (Multifocal-Toric)	Up to -10.00D	Within range

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided as a specific clinical study for this device's performance against clinical acceptance criteria was deemed unnecessary due to substantial equivalence. Non-clinical testing was conducted to verify that the finished products meet specification tolerances, but sample sizes for this internal verification are not detailed.

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)

This information is not provided as a clinical study with expert-established ground truth was not conducted for this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided for the same reason as point 3.

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

This is not applicable. The device is a contact lens, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a contact lens, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided as a clinical study was not required. The "ground truth" for the non-clinical verification would be the established engineering and material specifications.

8. The sample size for the training set

This information is not provided as a clinical study with training and test sets in the typical sense (for algorithm development or performance evaluation) was not performed.

9. How the ground truth for the training set was established

This information is not provided for the same reason as point 8.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The pivotal information regarding the device meeting acceptance criteria is found under the sections "Nonclinical Performance Data" and "Clinical Performance Data."

Nonclinical Performance Data: The submission states that the device is made from the same material and uses the same manufacturing process as a predicate device (VISTAKON® (etafilcon A) cleared under K062614). Therefore, all nonclinical testing supporting that predicate device is considered representative. Additionally, "finished product testing for verification of the modified design was conducted to demonstrate that lenses meet specification tolerances." This refers to internal quality control and verification that the physical dimensions and material properties (as listed in the table above) are within the acceptable ranges.
Clinical Performance Data: The document explicitly states: "clinical performance data to demonstrate substantial equivalence are not required." This is because the new ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia has the same indications, uses the same etafilcon A material, and shares the same manufacturing and sterilization processes as predicate devices (K062614 for material and manufacturing, and K073459 for the multifocal design type). The "demonstration of the physical and chemical equivalency of the subject device to the predicate devices support the safety and effectiveness of the subject device for an alternate multifocal lens design configuration."

Conclusion:

The device did not undergo an independent clinical study to establish new acceptance criteria or prove its performance against such criteria. Instead, its acceptance is based on demonstrating substantial equivalence to already legally marketed predicate devices through:

Sharing the same core material (etafilcon A).
Utilizing the same manufacturing and sterilization processes.
Having comparable technological characteristics (e.g., water content, Dk, UV blocking, physical parameters).
Having similar indications for use.
Performing non-clinical finished product testing to verify the modified design meets established specifications.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus with three intertwined snakes forming a triple helix. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 18, 2014

Johnson & Johnson Vision Care, Inc. Mr. Scott Durland Senior Manager, Regulatory Affairs 7500 Centurion Parkway, Suite 100 Jacksonville, Florida 32256

Re: K141670

Trade/Device Name: ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear Regulation Number: 21 CFR 886.5925 (b) (1) Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: June 20, 2014 Received: June 23, 2014

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. 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. You must comply with all the Act's requirements, including, but not limited to: registration and listing

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related 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,

Kesia Y. Alexander -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) K141670

Device Name

ACUVUE® (etaffilcon A) Soft (hydrophilic) Contact Lear & Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear

Indications for Use (Describe)

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Timed, is also indicated for daily wear to enhance or alter the appearance of the eye.

When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(K) SUMMARY

Submitter Information

Company:	Johnson & Johnson Vision Care, Inc.7500 Centurion Parkway, Suite 100Jacksonville, FL 32256
Contact Person:	Scott Durland
Email:	sdurland@its.jnj.com
Telephone:	904-443-3548
FAX:	904-443-1424
Date:	June 20, 2014

Identification of the Device

Common Name:	Soft Contact Lens
Device Name:	ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens forPresbyopia, Clear and Tinted (Visibility and/or Cosmetically)with UV (ultraviolet) Blocker for Daily Wear
Classification Name:	Soft (Hydrophilic) Contact Lens, Daily Wear
Device Classification:	Class II, 21 CFR 886.5925 (b) (1)
Product Code:	LPL, MVN

Predicate Device(s)

Material: VISTAKON® (etafilcon A) Soft (hydrophilic) Contact Lens, Clear and ● Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear most recently cleared via K062614, hereafter also referred to VISTAKON® (etafilcon A);
Optical Design: CIBA VISION+ (lotrafilcon B) soft contact lenses cleared via ● K073459, hereafter also referred to CIBA VISION (lotrafilcon B)

1 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation.

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Description of Device

S5 Table 1, S5 Table 2, and S5 Table 3 contain property and parameter ranges for the subject device.

Water Content	58%
Refractive Index (@ 20°C)	1.40
Oxygen Permeability (Fatt method, edge corrected)	$21.4 x 10^{-11}$ (cm²/sec)(mL O₂/mL * mm Hg)
Light Transmission - Visible	Minimum 85%
Light Transmission - UVA (316 nm to 380 nm)	<30.0%
Light Transmission - UVB (280 nm to 315 nm)	<5.0%

Note: UVA = ultraviolet A, UVB = ultraviolet B

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Diameter	12.0 mm to 15.0 mm
Center Thickness	0.060 mm to 1.000 mm
Base curve	7.85 mm to 10.00 mm
Powers	-20.00D to +20.00D
Multifocal ADD powers	up to +4.00D

S5 Table 2: Parameter ranges

S5 Table 3: Additional parameter ranges for the multifocal-toric design

Axis	2.5° to 180°
Cylinder	Up to -10.00D

Intended Use

The intended use of ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is the same as the device previously cleared under K062614. The specific indications are listed below.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker 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 have 0.75D of astigmatism or less.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia (Multifocal-Toric), Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker 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 nondiseased eyes who may need up to 4.00D of ADD power and have 10.00D of astigmatism or less.

ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, with UV Blocker, when Cosmetically Tinted, is also indicated for daily wear to enhance or alter the appearance of the eye.

Eye Care Practitioners may prescribe the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia either for single-use disposable wear or frequent/planned replacement wear with cleaning, disinfection, and scheduled replacement.

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When prescribed for single-use disposable wear, the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia is to be discarded after each removal.

Technological Characteristics

The technological characteristics of the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia are compared to the characteristics of the predicate devices, VISTAKON® (etafilcon A) and CIBA VISION (lotrafilcon B) in S5 Table 4, S5 Table 5, and S5 Table 6.

Property	Predicate Device(K062614)	Subject Device
Material	etafilcon A	Same as predicate
FDA Category (Group)	Group IV(high water, ionic polymer)	Same as predicate
UV Blocker	Yes	Same as predicate
Water Content, %	58	Same as predicate
Refractive Index @ 20°C	1.40	Same as predicate
Dk a, edge corrected	21.4	Same as predicate
Specific Gravity (calculated)	0.98 - 1.13	Same as predicate

S5 Table 4: Material and Physicochemical Comparison to VISTAKON® (etafilcon A)

a Dk units = x 10-11 (cm2/sec)(mL O2/mL * mm Hg)

Note: UV = ultraviolet

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Property	Predicate Device(K073459)	Subject Device
Optical Design	Progressive Aspherea	Same as predicate

Multifocal Design Comparison to CIBA VISION* (lotrafilcon B) S5 Table 5: (Air Optix™ Aqua Multifocal)

4 based on available public information and JJVCI measurements

" 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation.

™ 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation.

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	Predicate Device	Predicate Device	Subject Device
	CIBA VISION® (lotrafilcon B)(K073459)	VISTAKON® (etafilcon A)(K062614)	ACUVUE® (etafilcon A) Soft(hydrophilic) Contact Lenses forPresbvopia
Multifocal	for the optical correction of refractiveametropia (myopia & hyperopia) and/orpresbyopia in phakic or aphakic personswith non-diseased eyes who mayrequire reading addition of +3.00D orless and who may have up toapproximately 1.50D of astigmatism	for the optical correction of distanceand near vision in presbyopic phakicor aphakic persons with non-diseasedeyes who may have 0.75D ofastigmatism or less	for the optical correction of refractiveametropia (myopia and hyperopia)and/or presbyopia in phakic or aphakicpersons with non-diseased eyes whomay need up to 4.00D of ADD powerand have 0.75D of astigmatism or less
Multifocal-Toric	for the optical correction of refractiveametropia (myopia, hyperopia,astigmatism and presbyopia) in phakicor aphakic persons with non-diseasedeyes. The lenses may be worn bypersons who have +6.00D or less ofrefractive and/or corneal astigmatism	for the optical correction of distanceand near vision in presbyopic phakicor aphakic persons with non-diseasedeyes who may have 10.00D ofastigmatism or less	for the optical correction of refractiveametropia (myopia, hyperopia, and/orastigmatism) and presbyopia in phakicor aphakic persons with non-diseasedeyes who may need up to 4.00D ofADD power and have 10.00D ofastigmatism or less
Cosmeticallytinted	N/A	to enhance or alter the apparent colorof the eye	to enhance or alter the appearance ofthe eye
UV statement	N/A	helps protect against transmission ofharmful UV radiation to the corneaand into the eye	contains a UV Blocker to help protectagainst transmission of harmful UVradiation to the cornea and into the eye
	Predicate Device	Predicate Device	Subject Device
	CIBA VISION® (lotrafilcon B)(K073459)	VISTAKON® (etafilcon A)(K062614)	ACUVUE® (etafilcon A) Soft(hydrophilic) Contact Lenses forPresbyopia
Wear Schedule	The lenses may be prescribed for dailywear with removal for cleaning anddisinfection (chemical, not heat) prior toreinsertion, as recommended by the eyecare professional.	May be prescribed for daily wear. EyeCare Practitioners my prescribe thelenses either for single-use disposablewear or frequent/planned replacementwear with cleaning, disinfection, andscheduled replacement (see "WearingSchedule").When prescribed for frequent/plannedreplacement wear, the VISTAKON®(etafilcon A) contact lens is to becleaned, rinsed, and disinfected eachtime the lens is removed.The etafilcon A contact lens is to bediscarded after the recommendedwearing period as prescribed by theEye Care Professional. Whenprescribed for frequent/plannedreplacement wear, the lenses may bedisinfected using a chemicaldisinfection system only.When prescribed for single-usedisposable wear, (See "WearingSchedule") the VISTAKON®(etafilcon A) contact lens is to bediscarded after each removal.	Eye Care Practitioners may prescribethe lenses either for single-usedisposable wear or frequent/plannedreplacement wear with cleaning,disinfection, and scheduledreplacement.When prescribed for single-usedisposable wear, the ACUVUE®(etafilcon A) Soft Contact Lens forPresbyopia is to be discarded aftereach removal.When prescribed for frequent/plannedreplacement wear, the ACUVUE®(etafilcon A) Soft Contact Lens forPresbyopia is to be cleaned, rinsed,and disinfected each time the lens isremoved. The contact lens is to bediscarded after the recommendedwearing period as prescribed by theEye Care Professional. Whenprescribed for frequent/plannedreplacement wear, the lenses may bedisinfected using a chemicaldisinfection system only.

Indication Comparison S5 Table 6:

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Indication Comparison (Continued) S5 Table 6:

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510(k) Premarket Notification ACUVUE® (etafilcon A) Soft Contact Lens for Presbyopia, Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear Johnson & Johnson Vision Care, Inc. (JJVCI)

4 3rd party trademarks mentioned herein are trademarks of Novartis AG Corporation. Note: UV = ultraviolet

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Nonclinical Performance Data

The device is made from the same material, and uses the same manufacturing process as the predicate device, VISTAKON® (etafilcon A). Therefore, all nonclinical testing supporting the predicate device in K062614 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.

Clinical Performance Data

The proposed alternative multifocal design has the same indications, is the same etafilcon A material, and uses the same manufacturing and sterilization processes as the predicate device in K062614. Additionally, the multifocal design type is the same as the predicate device cleared under K073459. Demonstration of the physical and chemical equivalency of the subject device to the predicate devices support the safety and effectiveness of the subject device for an alternate multifocal 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 Nonclinical and Clinical Tests

Information presented in this Premarket Notification establishes that the ACUVUE® (etafilcon A) Soft (hydrophilic) Contact Lens for Presbyopia, Clear and Tinted (Visibility and/or Cosmetically) with UV Blocker for Daily Wear is as safe and effective as the predicate devices when used in accordance with the labeled directions for use.

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.