The One Day Flat Pack (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 One Day Flat Pack (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 One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper eye insertion. The approximately 1mm flat packaging system is easily opened and reinforces the single-use factor. The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycero) Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifileon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive 'Reactive Blue # 19', 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 eve covering the corner and extending slightly beyond the limbus forming a colorless, 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

AI/ML Overview

Here's an analysis of the provided information, focusing on the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in a quantitative or pass/fail format beyond demonstrating substantial equivalence to the predicate device. Instead, it focuses on showing that the new packaging system does not negatively impact the established properties and safety of the contact lens. The "reported device performance" is essentially a comparison of the key physical and material properties of the lens in the new Flat Pack packaging versus the predicate device (Clear 1-Day - blister pkg.).

Property/Characteristic	Acceptance Criteria (Implied: Substantial Equivalence to Predicate)	Reported Device Performance (One Day Flat Pack)	Predicate Device Performance (Clear 1-Day - Blister Pkg.)
Lens diameter	Equivalent to predicate	14.2	14.2
Lens base curve	Equivalent to predicate	8.6	8.6
Lens power	Equivalent to or within established ranges of predicate	+5D ~ -10D	+10D ~ -20D
Refractive index	Equivalent to predicate	1.4011	1.4011
Light transmittance	Equivalent to or exceeding predicate	>95%	>95%
Surface character	Equivalent to predicate	Hydrophilic	Hydrophilic
Specific gravity	Equivalent to predicate	1.086	1.086
Oxygen permeability	Equivalent to predicate	25.38	25.38
Sterility	Sterile	Sterile	(Implied Sterile for Predicate)
Packaging material toxicity	Not toxic	Not toxic	(Implied Non-toxic for Predicate)
Packaging material irritation	Not irritating	Not irritating	(Implied Non-irritating for Predicate)
Lens orientation upon opening	Anterior side up	Anterior side up	Unknown (Predicate)

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the "acceptance criteria" (i.e., substantial equivalence) involved a series of non-clinical studies.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify a numerical sample size for the "test set" (which in this context refers to the samples used in the non-clinical studies). It refers to "a series of in vivo preclinical toxicology and biocompatibility tests," "packaging integrity tests, stress tests, and simulations tests."
Data Provenance: The document does not explicitly state the country of origin for the non-clinical study data. It can be assumed it was conducted as part of the manufacturer's (Menicon Co., Ltd., Japan) R&D processes. The studies are described as retrospective in the sense that they are presented as completed tests rather than ongoing trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document. Given that the studies are non-clinical (toxicology, biocompatibility, packaging integrity, physical/material properties), the "ground truth" would be established by the results of validated laboratory tests and analyses, not by expert consensus on observational data.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods (like 2+1 or 3+1) are typically used in clinical studies where human interpretation of medical images or patient outcomes requires a standardized method to resolve discrepancies between readers. This submission relies on objective laboratory measurements and tests for its non-clinical studies.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers (e.g., radiologists) might use AI assistance. The device in question is a contact lens and its packaging, which does not involve AI or human readers in a diagnostic context.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This is also not applicable to a contact lens and its packaging.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical studies is based on:

Objective laboratory measurements: for physical and material properties (e.g., refractive index, light transmission, water content, oxygen permeability, lens diameter, base curve, power, specific gravity).
Validated toxicology and biocompatibility test results: to ensure the materials and extracts are not toxic or irritating.
Packaging integrity, stress, and simulation test results: to confirm the robustness and integrity of the packaging system.
Sterility testing: to confirm the lenses are sterile.

8. The Sample Size for the Training Set

Not Applicable. This submission details the substantial equivalence of a medical device (contact lens packaging) and does not involve AI/machine learning, therefore there is no "training set."

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

Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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Summary of Safety and Effectiveness

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

K102895 The assigned 510 (k) number is:

Applicant information:

Date Prepared:

March 1, 2011

Menicon Co., Ltd.

Company Name: Address:

Contact Person/ Official Correspondent: Phone number: Fax number:

Nagoya, Japan 460-0006 Mr. Takahiro Ochi

21-19 Aoi, 3-Chome, Naka-Ku

(81)-52-937-5021 (81)-52-935-1121

Medvice Consulting, Inc. U.S. Consultant Martin Dalsing Contact Person: (970) 243-5490 Phone number: (970) 243-5501 Fax number:

Device Information:

Device Classification:	Class II
Classification number:	LPL
Classification name:	Lenses, Soft Contact, Daily Disposable
Trade name:	One Day Flat Pack (hioxifilcon A) Daily Disposable SoftContact Lens

Menicon Co., Ltd.

Page SSE 1

APR 2 8 2011

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Purpose of 510(k) notification:

1. Change in lens packaging system to new and innovative, 'Flat Pack Technology'.
  Was: Traditional, 'Blister' packaging Now: Innovative, 'Flat Pack' packaging

Equivalent Predicate Devices:

The One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses are substantially equivalent to the following predicate device:

Clear 1-Day (hioxifilcon A), K080632, Manufactured by Clearlab SG Pte Ltd.

Device Description:

The One Day Flat Pack Daily Disposable Contact Lens packaging system is designed to reduce lens handling by always presenting the lens anterior side up upon opening, which ensures correct lens orientation for proper eye insertion. The approximately 1mm flat packaging system is easily opened and reinforces the single-use factor.

The non-ionic lens material, (hioxifilcon A) is a random copolymer of 2- hydroxyethyl methacylate (2-HEMA) and 2,3-Dihydroxypropyl Methacrylate (Glycero) Methacrylate, GMA) cross-linked with ethylene glycol dimethacrylate. It consists of 42% hioxifileon A and 58% water by weight when immersed in a buffered saline solution. The lens is available with a blue visibility-handling tint, color additive 'Reactive Blue # 19', 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 eve covering the corner and extending slightly beyond the limbus forming a colorless, 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 appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.

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510(k) PREMARKET NOTIFICATION One Day Flat Pack (hioxifilcon A) Single Use Contact Lens

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 21°C:	1.4011(wet)
Light Transmission:	> 95%
Surface Character:	Hydrophilic
Water Content at 21°C:	58.0 %
Specific Gravity at 21°C:	1.086(wet)
Oxygen Permeability at 34-36°C:	25.38 x 10 -11 (cm 2 /sec) (ml O 2 /ml x mm Hg), (revised Fatt method).

Substantial Equivalence:

Lenses supplied in the Flat Packaging are within established specifications for the lens design and are equivalent to the predicate device lenses supplied in the blister pack packaging. The lens design maintains established physical characteristics, and are stable and biocompatible with the ocular environment.

. Both the blister and flat package have components made from polypropylene and laminated foil.
. Traditional blister pack has its base made from polypropylene with a laminated foil sealed on top. Flat package uses the same material with 2 laminated foils and an additional polypropylene disc to ensure correct lens orientation when opened.

The following non-clinical studies demonstrate that lenses supplied in the Flat Pack packaging are substantially equivalent to lenses supplied in the blister pack.

Non-clinical Studies A series of in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the contact lenses packaged in the Flat Packaging system. All non-clinical testing was conducted according to valid scientific protocols.

Furthermore, a series of packaging integrity tests, stress tests, and simulations tests were performed on the Flat Packaging system to assess overall robustness and demonstrate the integrity of the packaging system.

Test results of the non-clinical testing on the One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens demonstrate that:

Lenses supplied in the Flat Pack packaging system are sterile, .
The packaging material and extracts are not toxic and not irritating, and .

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510(k) PREMARKET NOTIFICATION One Day Flat Pack (hioxifilcon A) Single Use Contact Lens

The lens physical and material properties are consistent with lenses packaged in . a blister package. See chart below.

Lens phys/mtl property	One Day Flat Pack	Clear 1-Day -blister pkg.
Lens diameter	14.2	14.2
Lens base curve	8.6	8.6
Lens power	+5D ~ -10D	+10D ~ -20D
Refractive index	1.4011	1.4011
Light transmittance	>95%	>95%
Surface character	Hydrophilic	Hydrophilic
Specific gravity	1.086'	1.086
Oxygen permeability	25.38	25.38

No clinical data is required for this submission, as the safety and efficacy of the contact lens itself has been previously established in 510(k) K080632.

HOW SUPPLIED/OPENED

Each lens is supplied sterile, in a non-traditional packaging system, the Flat Pack, containing buffered saline solution. Each container of 90 Flat Packs, as well as each Flat Pack is marked with dioptric power, Single Patient Use, Rx Symbol, Sterile Symbol, composition of the lens, manufacturing lot number and expiration date of the lens.

The pack is opened by grasping both top and bottom foil tabs and peeling them apart to fully expose the lens.

Image /page/3/Picture/8 description: The image shows two hands opening a package of disposable contact lenses. The text in the image says "Peel/Pull apart here" and "ONE Day disposable lens". The hands are pulling apart the package to reveal the contact lens inside.

Peel/Pull apart here

Clinical Testing

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Technological Characteristics:

The technological characteristics of the One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens, as compared to the predicate device is illustrated in the following table.

Pre-Clinicalequivalency /Device	One Day Flat Pack(hioxifilcon A)New Device	Clearl-Day®(hioxifilcon A)Predicate Device
Intended Use	Indicated for dailywear for the opticalcorrection ofrefractive ametropia(myopia andhyperopia) in phakicor aphakic personswith non-diseasedeyes.	Indicated for dailywear for the opticalcorrection ofrefractive ametropia(myopia andhyperopia) in phakicor aphakic personswith non-diseasedeyes.
Functionality	The contact lenses actas a refractivemedium that focuslight rays from nearand distant objects onthe retina.	The contact lenses actas a refractivemedium that focuslight rays from nearand distant objects onthe retina.
Indications	Daily Disposable,Soft (hydrophilic)contact lens for singleuse only.	Daily Disposable,Soft (hydrophilic)contact lens for singleuse only.
Production Method	Spun-Cast	Spun-Cast
Packaging Method	Flat Pack Technology(FPT)	Blister Pack
Lens Orientationupon opening	Anterior side up	Unknown
FDA Group #	Group #2 >50%Water, non-ionicPolymer	Group #2 >50%Water, non-ionicPolymer
USAN name	Hioxifilcon A	Hioxifilcon A
Water Uptake (%)	58.0%	59.8%

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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

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

Menicon Company, Ltd. C/O Mr. Martin Dalsing Official Correspondent 806 Kimball Avenue Grand Junction, CO 81501

APR 2 8 2011

Re: K102895

Trade/Device Name: One Day Flat Pack Regulation Number: 21 CFR 886.5925 Regulation Name: Lenses, Soft Contact, Daily Wear Regulatory Class: Class II Product Code: LPL Dated: April 12, 2011 Received: April 15, 2011

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. 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 (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

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Page 2 - Mr. Martin Dalsing

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Kesia Alexander

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

$\fr$

Enclosure

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K102895 INDICATIONS FOR USE STATEMENT

One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lenses. DEVICE NAME:

INDICATIONS FOR 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.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use X

Over-The-Counter Use

(Per 21 CFR 801.109) (Optional Format 1-2-96)

Denise Hampton

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

K102895 510(k) Number

Qne Day Flat Pack (hioxifilcon A) Daily Disposable, Soft Contact Lens

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.