Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eves that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic. The lens may be worn by persons who have astigmatism of 5.00D or less.

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not aphakic persons with non-diseased eves. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.

Multifocal Toric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.

Proclear XC and Proclear 1 Day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

FREQUENT/PLANNED REPLACEMENT WEAR

When prescribed for Frequent/Planned replacement the lenses are to be cleaned, rinsed and disinfected each time they are removed from the patient's eye and discarded after the recommended wearing period prescribed by the eye care practitioner. The lens may be disinfected using a chemical disinfection system.

DISPOSABLE WEAR

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

Device Description

The Proclear (omafilcon A) are Daily Wear soft contact lenses intended for single use daily disposable wear or Scheduled Replacement wear. The Proclear (omafilcon A) Soft (hydrophilic) contact lenses are a hemispherical shell. The Proclear lens is available in several designs. Spherical or aspherical soft contact lens; Toric is a back surface toric; Multifocal has multiple curves with complementary reverse geometry (N and D) which allows for correction of presbyopia in persons who are myopic or hyperopic; Multifocal Toric has an aspheric front surface with anterior having two multifocal zones with a toric generated surface for the purpose of correcting vision in an eye that is astigmatic. The omafilcon A lens material is equivalent to other omafilcon A daily wear hydrophilic contact lenses cleared under several 510(k) notifications. Omafilcon A is composed of polymer of 2-hydroxy-ethylmethacylate and 2-metacryloloyoxyethyl phosphoryIcholine cross linked with ethylmethacrylate. The lenses are tinted from edge to edge for visibility purposes with the color additive Vat Blue 6.

AI/ML Overview

This document is a 510(k) premarket notification for contact lenses, which primarily focuses on demonstrating substantial equivalence to previously cleared devices rather than extensive new clinical studies with acceptance criteria for device performance. Therefore, many of the requested elements for describing acceptance criteria and a study proving device adherence are either not applicable, not explicitly detailed as a separate "study" in the traditional sense, or are referred to through equivalence to predicate devices.

Here's an attempt to answer the questions based on the provided text, highlighting where information is not present or not directly applicable:

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

The document does not explicitly present a table of "acceptance criteria" against which "reported device performance" is measured in a comparative fashion, as it is a substantial equivalence submission. Instead, the device's physical and material properties are compared to predicate devices for equivalency. The implied acceptance criterion for the subject device is that its characteristics fall within ranges considered equivalent and safe, as demonstrated by the predicate devices.

Characteristic	Acceptance Criteria (Implied: Equivalent to Predicate)	Reported Device Performance (Subject Device)
Material USAN Name	Omafilcon A	Omafilcon A
FDA Category	Group II (Non-Ionic, High Water Content)	Group II (Non-Ionic, High Water Content)
Manufacturing method	Cast Molded	Cast Molded
Sterilization	Steam: validated autoclave	Steam: validated autoclave
Packaging	Blister Pack	Blister Pack
Labeled Water Content	60-62% (referencing predicates)	60%
Visibility Tint	Vat Blue 6 or C.I Reactive Blue 4 or Clear	Vat Blue 6
Color Process	Entrapment or Reactive or No tint	Entrapment
Intended Use (Sphere/Asphere)	Correction of visual acuity in myopic/hyperopic persons, astigmatism ≤ 2.00D. Non-aphakic, non-diseased eyes.	Same
Intended Use (Toric)	Correction of visual acuity in myopic/hyperopic persons, astigmatism ≤ 5.00D. Non-aphakic, non-diseased eyes.	Same
Intended Use (Multifocal)	Correction of refractive ametropia (myopia, hyperopia, astigmatism) and presbyopia. Astigmatism ≤ 2.00D. Non-aphakic, non-diseased eyes.	Same
Intended Use (Multifocal Toric)	Correction of visual acuity in myopic/hyperopic persons, astigmatism ≤ 10.00D, presbyopic. Non-aphakic, non-diseased eyes.	Same
Improved Comfort Claim	Provide improved comfort related to dryness (Evaporative Tear Deficiency or Aqueous Tear Deficiency).	Same
Daily Disposable Indication	Discarded after each removal.	Same
Physiochemical Studies	Substantial equivalency with predicate devices, within established specifications.	"Results... show substantial equivalency with the predicate devices, and are within established specifications."
Toxicology Studies	Non-toxic and biocompatible with the ocular environment.	"Results... verify that lenses remain nontoxic and biocompatible with the ocular environment."

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 states, "The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required." This indicates that a separate, formal "test set" and a clinical study to prove the device meets acceptance criteria in a new cohort were not performed for this submission. The "test set" implicitly refers to the data and studies associated with the predicate devices which established their safety and effectiveness.

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 new clinical study with a "test set" requiring ground truth establishment by experts was conducted for this 510(k) submission.

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

Not applicable, 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

Not applicable. This is a contact lens submission, not an AI or imaging device, and no MRMC study was performed.

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

Not applicable. This is a contact lens submission, not an AI or algorithm-based device.

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

Not applicable, as no new clinical study with a "test set" requiring ground truth establishment was conducted for this 510(k) submission. The "ground truth" for demonstrating safety and effectiveness relies on the previously established regulatory clearances of the predicate devices based on their initial studies (which presumably included clinical trials and robust testing at the time).

8. The sample size for the training set

Not applicable. This is a contact lens submission and does not involve a training set for an algorithm. The "training" in this context refers to the accumulated knowledge and testing performed on the predicate devices over time.

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

Not applicable, for the same reason as point 8. The "ground truth" for the predicate devices' safety and efficacy would have been established through a combination of physical/chemical testing, toxicology studies, and likely clinical trials performed at the time of their original submissions.

Summary

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4. Device Description

NOV 2 2 2006

Chord Diameter	13.0 mm to 15.5 mm
Central Zone Diameter	1.7 mm to 2.6 mm
Center Thickness	0.035 mm to 0.96 mm (varies with power and lens design)
Base Curve	8.00 mm to 9.50 mm
Power Range	-20.00 D to +20.00 D
Add power range	+0.25D to +5.00D as applicable
Cylinder Power	-0.50 D to -10.00D as applicable
Axis	Axis 1° to 180° as applicable
Refractive Index	1.40
Water Content	60% ± 2%
Oxygen Permeability
Polarographic Fatt Method	21 x 1011 (cm²/sec) (ml O2/ml x mm Hg)
Modified Fatt Method Guard Ring	25 x 10-11 (cm²/sec) (ml O2/ml x mm Hg)
Edge corrected	at 35° C. as measured by 201T Permeometer connected to apolarographic cell.
Light Transmittance	>90%

5. Intended Use

Proclear XC and Proclear 1 day

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) and presbyopia in not

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Image /page/1/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the company name in a sans-serif font, with a stylized "C" that resembles two interlocking circles. To the right of the name is a square graphic with a white circle inside, possibly representing a contact lens. The text and graphic are black against a white background.

aphakic persons with non-diseased eves. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.

Daily wear replacement schedules may vary from patient and should be decided by eyecare practitioners in consultation with their patients.

FREQUENT/PLANNED REPLACEMENT WEAR

DISPOSABLE WEAR

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

6. Predicate Device(s)

Predicate Device Materials

omafilcon A:

Proclear Daily Wear (Omafilcon A) Soft Contact Lenses (K952152) Proclear Compatibles Daily Wear Contact Lens (Omafilcon A) Soft Contact Lenses (K970095) Proclear and Proclear Compatibles (Omafilcon A) Soft Contact Lenses (K974408)

VAT Blue 6 (tint):

Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389)

Predicate Device Lens Designs and Indications for Use

Proclear Compatibles Daily Wear (Omafilcon A) Soft Contact Lenses (K970095) Proclear Compatibles Multifocal (Omafilcon A) Soft Contact Lenses (K032873) Proclear Multifocal (Omafilcon A), Proclear Toric (Omafilcon A) and Proclear Multifocal Toric (Omafilcon A) Soft) Soft Contact Lenses (K050717) Biomedics 52 1-Day (ocufilcon B) UV Blocking Daily Wear Soft (hydrophilic) Contact Lens (K020389)

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perVision �

7. Characteristics of Substantial Equivalence

MATERIAL COMPARISON TABLE

Reference	SUBJECTDEVICEProclear Aspheric,Proclear Toric,Proclear Multifocal,Proclear MultifocalToric	PREDICATEDEVICEK970095 K974408	PREDICATEDEVICEK952152 K974408	PREDICATEDEVICEK020389
MaterialUSAN Name	Omafilcon A	Omafilcon A	Omafilcon A	Ocufilcon B
FDA Category(Group)	Group IINon-lonicHigh WaterContent	Group IINon-lonicHigh WaterContent	Group IINon-lonicHigh WaterContent	Group IVIonicHigh WaterContent
Manufacturingmethod	Cast Molded	Cast Molded	Lathe-Cut	Cast Molded
Sterilization	Steam: validatedautoclave	Steam:validatedautoclave	Steam:validatedautoclave	Steam:validatedautoclave
Packaging	Blister Pack	Blister Pack	Vial	Blister Pack
Labeled WaterContent(Thermogravimetricmethod)	60%	62%	59%	52%
Visibility Tint	Vat Blue 6	C.I ReactiveBlue 4	Clear	Vat Blue 6
Color Process	Entrapment	Reactive	No tint	Entrapment

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Image /page/3/Picture/0 description: The image shows the word "CooperVision" in a stylized font. The word is written in black and has a unique design, with the first "C" enclosed in a partial circle that extends under the first two letters. To the right of the word, there is a square containing a white circle, possibly representing an eye or lens, set against a dark background.

LENS DESIGN AND INDICATIONS FOR USE COMPARISON TABLE

No change to established spherical, asphere, toric, multifocal toric lens designs.

	SUBJECT DEVICE	PREDICATE DEVICE K032873
LensDesign	Multifocal	Multifocal
Intendeduse	Correction of Visual acuity in patients withmyopia or hyperopia and are presbyopic	Correction of Visual acuity in patients withmyopia or hyperopia and are presbyopic
	SUBJECT DEVICE	PREDICATE DEVICE K050717
LensDesign	Multifocal Toric	Multifocal Toric
Intendeduse	Correction of Visual acuity in patients withmyopia or hyperopia and are astigmaticand presbyopic	Correction of Visual acuity in patients withmyopia or hyperopia and are astigmaticand presbyopic
	SUBJECT DEVICE	PREDICATE DEVICE K970095
LensDesign	Sphere, Asphere	Sphere
Intendeduse	Correction of Visual acuity in patients withmyopia or hyperopia	Correction of Visual acuity in patients withmyopia or hyperopia
	SUBJECT DEVICE	PREDICATE DEVICE K050717
LensDesign	Toric	Toric
Intendeduse	Correction of Visual acuity in patients withmyopia or hyperopia and are astigmatic.	Correction of Visual acuity in patients withmyopia or hyperopia and are astigmatic.
	SUBJECT DEVICE	PREDICATE DEVICE K020389
Indication	Daily Disposable	Daily Disposable
Intendeduse	When prescribed for Daily DisposableWear the lens is to be discarded after eachremoval.	When prescribed for Daily DisposableWear the lens is to be discarded aftereach removal.

8. Physiochemical Studies

Results from physical, optical and chemical properties show substantial equivalency with the predicate devices, and are within established specifications for the lenses.

9. Toxicology Studies

Results from in-vivo and in-vitro studies were conducted and verify that lenses remain nontoxic and biocompatible with the ocular environment.

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Image /page/4/Picture/0 description: The image shows the logo for CooperVision. The logo consists of the word "CooperVision" in a stylized font. To the right of the word is a square with a white circle inside, resembling an eye.

10. Clinical Studies

The technical characteristics, formulation, manufacturing, and sterilization processes of this lens are equivalent to omafilcon A soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.

11. Conclusions

Based on evaluation of material, manufacturing methods, lens parameters and indicated use, the omafilcon A soft contact lens described in this document is substantially equivalent with the predicate devices. Evaluation of chemical/physical properties, biocompatibility and stability studies, confirm the lenses are within established finished product specifications, remain stable, and are non-toxic and biocompatible with the ocular environment and the lens is shown to be safe for its indicated use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and is in a sans-serif font. The logo is black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

CooperVision, Inc. c/o Lisa Hahn Global Regulatory Affairs Director 1215 Boissevain Ave. Norfolk, VA 23507

NOV 2 2 2006

Re: K061948

Trade/Device Name: Proclear® XC (omafilcon A) and Proclear® 1 day (omafilcon A) Hydrophilic Contact Lenses for Daily Wear Regulation Number: 21 CFR 886.5925

Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: Class II Product Code: MVN, LPL Dated: November 17, 2006 Received: November 20, 2006

Dear Ms. Hahn:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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Page 2 — Lisa Hahn

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to 1egally marketed predicate device results in a classification for your device and thus, permitts your revice to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation only, pro "Misbranding by reference to premarket notification" (21CFR Part 807.97). You mon vitain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M.B. Eychlemin SimD

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): K061948

Device Name: Proclear XC Proclear 1 day

Indications For Use:

Sphere and Aspheric: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic and exhibit astigmatism of 2.00D or less that does not interfere with visual acuity.

Multifocal: (omafilcon A) Soft (hydrophilic) Contact Lenses are indicated for daily wear for the correction of refractive ametropia (myopia, and astigmatism) and presbyopia in not aphakic persons with nondiseased eyes. The lens may be worn by persons who have astigmatism of 2.00D or less that does not interfere with visual acuity.

Multifocal Toric: (omafilcon A) Soft (Hydrophilic) Contact Lenses are indicated for daily wear for the correction of visual acuity in not aphakic persons with non-diseased eyes that are myopic or hyperopic, possess astigmatism of 10.00 diopters or less, and are presbyopic.

Proclear XC and Proclear 1day (omafilcon A) Soft (hydrophilic) Contact lenses may provide improved comfort for contact lens wearers who experience mild discomfort or symptoms related to dryness during lens wear associated with Evaporative Tear Deficiency or from Aqueous Tear Deficiency (non-Sjogren's only).

Daily wear replacement schedules may vary from patient and should be decided by evecare practitioners in consultation with their patients.

FREQUENT/PLANNED REPLACEMENT WEAR

DISPOSABLE WEAR

When prescribed for Daily Disposable Wear the lens is to be discarded after each removal.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Myra Smith

Page 1 of

(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

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.