The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

Device Description

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is available as a single vision spherical lens. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The non-ionic lens material, (hioxifilcon A) is a ultra high molecular weight random copolymer of 2hydroxyethyl methacrylate (2-HEMA) and 2,3-Dihydroxpropyl Methacrylate (Glycerol Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifilcon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a pale blue visibilityhandling tint, color additive 'Reactive Blue # 4', 21 CFR part 73.3121. The United States Adopted Names Council (USAN) has adopted the (hioxifilcon A) name,

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a coloriess, transparent optical surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard and appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:

Refractive Index at 21ºC: 1.4011(wet)
Light Transmission: > 95%
Surface Character: Hydrophilic
Water Content at 21ºC: 59.77 %
Specific Gravity at 21ºC: 1.086(wet)
Oxygen Permeability at 34-36°C: 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).

AI/ML Overview

The provided text describes a 510(k) summary for a soft contact lens and does not contain information about a study that tests the device against acceptance criteria in the context of AI/medical imaging performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth for a device performance study.

The document is a regulatory submission for a contact lens, which is a physical medical device, not an AI or imaging diagnostic tool. The "acceptance criteria" discussed in such a submission would typically relate to manufacturing specifications, material properties, and clinical safety/performance in human trials (bio-compatibility, visual acuity achieved, adverse event rates), rather than statistical metrics like sensitivity, specificity, or F1-scores derived from an AI model's output compared to ground truth.

Specifically, the document states:

"The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate devices: Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp. and Clear All Day (hioxifilcon A), K052290, Manufactured by Clearlab SG Pte Ltd."
The comparison is made on "Technological Characteristics" such as intended use, functionality, indications, production method, FDA group #, USAN name, water uptake (%), oxygen permeability (Dk), and specific gravity (wet).

These are not acceptance criteria or performance metrics related to an AI device's diagnostic accuracy.

Summary

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OCT 1 5 2008

510(k) SUMMARY

This summary of 510 (k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92

(65)-6282 3953

The assigned 510 (k) number is: K080632

Applicant information:

Fax number:

Initial Date Prepared:	29 February 2008
Name:	Clearlab SG Pte Ltd
Address:	139, Joo Seng RoadSingapore 368362
Contact Person/Official Correspondent:	Tan Hwee Ee
Phone number:	(65)-63801-347

FDA US Agent/	Medvice Consulting, Inc
Contact Person:	Martin Dalsing
Phone number:	(970) 243-5490
Fax number:	(970) 243-5501

Device Information:

Device Classification:	Class II
Classification number:	LPL
Classification name:	Lenses, Soft Contact, Daily Disposable
Trade name:	Clear1-day® (hioxifilcon A) Daily Disposable Soft ContactLens

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Equivalent Predicate Devices:

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate devices:

1. Extreme H2O (hioxifilcon A), K992692, Manufactured by Hydrogel Vision Corp.
1. Clear All Day (hioxifilcon A), K052290, Manufactured by Clearlab SG Pte Ltd.

Device Description:

The hydrophilic characteristics allow aqueous solutions to enter the lens and in its fully hydrated state the lens is approximately 58% water by weight. The physical properties of the lens are:

Refractive Index at 21ºC: Light Transmission: Surface Character: Water Content at 21ºC: Specific Gravity at 21ºC: Oxygen Permeability at 34-36°C: 1.4011(wet) > 95% Hydrophilic 59.77 % 1.086(wet) 25.38 x 10-11(cm2/sec) (ml O2/ml x mm Hg), (revised Fatt method).

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Intended Use:

The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

Technological Characteristics:

The technological characteristics of the Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens as compared to the technological characteristics of the predicate devices are illustrated in the following table.

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Pre-Clinicalequivalency/Device	Clear1-day®(hioxifilcon A)New Device	Clear All Day(hioxifilcon A)Predicate Device	Extreme H2O(hioxifilcon A)Predicate Device
Intended Use	Indicated for dailywear for thecorrection of visualacuity in non-aphakic personswith non-diseasedeyes with myopia orhyperopia.	Indicated for dailywear for thecorrection of visualacuity in aphakicand non-aphakicpersons with non-diseased eyes withmyopia orhyperopia.	Indicated for dailywear for thecorrection of visualacuity in aphakicand non-aphakicpersons with non-diseased eyes withmyopia orhyperopia.
Functionality	The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina.	The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina.	The contact lensesact as a refractivemedium that focuslight rays from nearand distant objectson the retina.
Indications	Daily Disposable,Soft (hydrophilic)contact lens	Daily Wear, Soft(hydrophilic)contact lens	Daily Wear, Soft(hydrophilic)contact lens
Production Method	Spun-Cast	Cast-molded	Cast-molded
FDA Group #	Group #2 >50%Water, non-ionicPolymer	Group #2 >50%Water, non-ionicPolymer	Group #2 >50%Water, non-ionicPolymer
USAN name	Hioxifilcon A	Hioxifilcon A	Hioxifilcon A
Water Uptake (%)	59.77%	56.47%	60.24%
OxygenPermeability (Dk)	25.38 x 10-11(cm2/sec) (mlO2/ml x mm Hg)	25.29 x 10-11(cm2/sec) (mlO2/ml x mm Hg)	28.91 x 10-11(cm2/sec) (mlO2/ml x mm Hg)
Specific Gravity(wet) (g/cm3)	1.086	1.113	1.088

. . . . . . . .

・

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, symbolizing protection and care. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, with the eagle figure in the center.

OCT 1 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Clearlab SG Pte. Ltd. c/o Martin Dalsing, Official Correspondent Medvice Consulting, Inc. 806 Kimball Ave. Grand Junction, CO 81501

Re: K080632

Trade/Device Name: Clear 1-Day Daily Disposable Soft Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lenses Regulatory Class: Class II Product Code: MVN, LPL Dated: September 8, 2008 Received: September 12, 2008

Dear Mr. Dalsing:

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 mav 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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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 a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain 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. Egerkins, mD

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 STATEMENT

Device Name: Clear1-day® (hioxifilcon A) Daily Disposable Soft Contact Lenses

INDICATIONS FOR USE:

The Clearl-day® (hioxifilcon A) Daily Disposable Soft Contact Lens is indicated for daily wear single use only for the optical correction of refractive ametropia (myopia and hyperopia) in phalic anglaalic persons with non-diseased eyes who may have 1.00D or less of astigmatism.

The lens is intended to be worn once and then discarded at the end of each wearing period on a daily basis. The patient should be instructed to start the next wearing period with a new lens.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Myna Smith

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

510(k) Number K080632

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.