The iLens® (ocufileon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be wom by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. Eye care prescribe the lens for either single-use disposable wear or for frequent replacement wear. When prescribed for frequent replacement wear, the lens may be disinfected using a chemical or hydrogen peroxide disinfecting system. As prescribed for single use daily dispossble wear, patients are instructed to dispose of the lens at each removal. The iLens® Daily Wear Soft (Hydrophilic) Contact Lenses help protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is a . spherical lens with UV blocker. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is . available in hemispherical shell. The lenses are made of HEMA hydrogel. The composition is 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose. A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm. The lens is supplied in a sterile state, packaged in a buffered saline solution.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided 510(k) summary for K141280:

Acceptance Criteria and Device Performance

The provided document does not explicitly present a "table of acceptance criteria" with corresponding "reported device performance" in a typical format of a clinical trial. Instead, it relies on demonstrating substantial equivalence to a predicate device (Biomedics® 55, K091339) through a comparison of technological characteristics, physicochemical properties, and safety/toxicology assessments.

The "acceptance criteria" can be inferred from the characteristics of the predicate device and the general requirements for soft contact lenses. The device performance is then shown by demonstrating that the iLens® either matches or is within acceptable limits compared to the predicate and established standards (like ISO 18369).

Inferred Acceptance Criteria and Reported Device Performance:

Characteristic	Acceptance Criteria (Inferred from Predicate/Standards)	Reported Device Performance (iLens®)
Material	Ocufilcon D (Hydrogel, Group IV Ionic High Water)	Ocufilcon D (Hydrogel, Group IV Ionic High Water)
Water Content	55%	55%
Oxygen Permeability (Dk)	~19.6 (Fatt method)	20 (Fatt method)
Refractive Index	~1.41 (hydrated)	1.405 (hydrated)
Light Transmittance	>95%	>95%
UV Blocking	Less than 5% in UVB (280-315nm) and less than 50% in UVA (316-380nm)	Less than 5% in UVB (280-315nm) and less than 50% in UVA (316-380nm) (as per device description, implies meeting the standard for UV-absorbing lenses)
Manufacturing Method	Cast-Molded	Cast-Molded
Sterilization	Steam	Steam
Packaging	Blister pack	Blister pack
Physicochemical Properties	Within established specifications for soft contact lenses (according to ISO 18369)	"The physical, optical and chemical properties of the lens are within established specifications for the lenses." (11.1)
Toxicology/Biocompatibility	Non-toxic, acceptable in ocular environment	"Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment." (11.2)
Mechanical Strength	Acceptable range, comparable to other predicate devices (specific values not defined as pass/fail in the table below, but comparative data is provided)	Tensile strength: 0.43 Mpa; Modulus: 0.57 Mpa; Elongation at break: 55.8%; Toughness: 0.21 J/m³. (These are compared to two other predicate devices, Sauflon 55 UV and Frequency 55, which have different specific values, but are used to demonstrate the device's mechanical integrity is within an acceptable range for comparison, not necessarily superior or identical to the primary predicate.)
Indications for Use	Daily wear for correction of refractive ametropia (myopia/hyperopia), certain astigmatism, either single-use disposable or scheduled replacement. UV protection.	Matches the predicate device's indications for use.

Note: The provided text primarily establishes substantial equivalence, meaning the device is "as safe, as effective and perform as well as the predicate device" (Conclusion, Section 13). It doesn't set specific quantitative acceptance thresholds for all characteristics in a pass/fail manner but rather shows comparability.

Study Details:

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

Test Set Sample Size: The document explicitly states that no clinical data was required for this 510(k) submission because "The technical characteristics, formulation, manufacturing, and sterilization processes of the subject device are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision" (Section 12, Clinical Studies). Therefore, there is no test set of human subjects in the traditional sense of a clinical study.
Data Provenance: The nonclinical data (physicochemical, toxicology, mechanical strength) would have been generated from laboratory testing of the iLens® product itself. The country of origin for this testing is not specified, but the manufacturer is Taiwanese. This data is prospective with respect to the device's own testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Since no clinical studies were performed on human subjects for this submission, there was no "ground truth" derived from expert assessment of patient outcomes or imaging data in a clinical setting. The "ground truth" here is the established safety and performance profile of the predicate device and the accepted standards for contact lens characteristics (e.g., ISO 18369).

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

Not applicable, as no human test set or clinical study requiring adjudication was conducted.

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 device, not an AI-based diagnostic tool. 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 physical medical device (contact lens), not an algorithm.

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

The "ground truth" in this context is the established performance and safety profile of the legally marketed predicate device (Biomedics® 55) and international standards for contact lenses (ISO 18369). The manufacturer demonstrated that the iLens® shares fundamental technological characteristics with the predicate and meets relevant standards for physicochemical, mechanical, and safety properties, thereby inferring equivalent safety and effectiveness without needing new clinical outcomes data.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI algorithm requiring a training set.

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

Not applicable. No training set was used.

Summary

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K141280 510(K) SUMMARY

Date of the summary prepared: June 10, 2014

1 Establishment Information:

Name	Seinoh Optical Co. Ltd.
Address	3F, No. 14, Wucyuan 3rd Rd., Sinjhuang Dist., NewTaipei City 242, Taiwan, R.O.C.
Phone No	886-2-2298-8255
Fax No.	886-2-2298-8335

2 Owner:

Company	Seinoh Optical Co. Ltd
Name	Vicent Hu
Address	3F, No. 14, Wucyuan 3rd Rd., Sinjhuang Dist.,
	New Taipei City 242, Taiwan, R.O.C.
Phone No	886-2- 2298-8255 ext: 8858
Fax No. .	886-2 —2298-8335

3 US Agent:

Company	ABAND INC.
Address	5581 Daniels Street, Unit A, Chino, CA 91710, USA
Phone No	(866)-886-8888 (Toll free)
Fax No	(909)-627-6207

4 Contact Person:

Name	Jennifer TING
Phone No	886-2-82823192
Fax No	886-2-82867686
e-mail:	jen.medical@msa.hinet.net

5 Device Identification:

Proprietary Name	iLens ® (ocufilcon D) Daily Wear Soft (Hydrophilic)Contact Lens
Common Name	Soft (hydrophilic) Contact Lenses
Classification Name	Lenses, Soft Contact, Daily Wear (21 CFR 886.5925,Product Code LPL)Lenses, Soft Contact, Daily Wear (Disposable),(21 CFR 886.5925, Product Code MVN)
Classification	II

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6 Legally Marketed Equivalent Device:

Predicate Device Name	Biomedics® 55 (ocufilcon D)
Manufacturer	CooperVision, Inc.
510(k) Number	K091339
Product Code	LPL, MVN

7 Device Description

The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is a . spherical lens with UV blocker.
The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is . available in hemispherical shell.
The lenses are made of HEMA hydrogel. The composition is 45% ocufilcon D and 55% water by weight when immersed in normal buffered saline solution.
The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is light blue tinted with "reactive Blue19" for handling visibility purpose.
A benzotriazole UV absorbing monomer is used to block UV radiation. The transmittance characteristics are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
The lens is supplied in a sterile state, packaged in a buffered saline solution. -

8 Indication for Use:

The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or not-aphakic persons with non-disease eyes in power from -20.00D to +20.00D. The lens may be worn by persons who exhibit refractive astigmatism of 2.0 diopters or less where the astigmatism does not interfere with visual acuity. The eye care practitioner may prescribe the lens for either single-use disposable wear or for scheduled replacement wear. When prescribed for scheduled replacement, the lens may be disinfected using a chemical (no heat) or hydrogen peroxide disinfecting system. As prescribed for single use daily disposable wear, patients are instructed to dispose of the lens at each removal. The iLens® (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens help protect against transmission of harmful UV radiation to the cornea and into the eye.

9 Technological characteristics

The spherical lens design specification:

· Diameter 13 mm to 15 mm

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Center Thickness 0.08mm @ -3.00D ●
(Varies with Power) Base Curve 8.2 mm to 9.2 mm ● . Power -20.00D to +20.00D -6.00D to +6.00D (0.25D increments) +20.00D to +6.50D, -6.50D to -20.00D (0.50D increments)

The physical properties of the lenses are:

. Refractive index: 1.405 (hydrated)
Light transmittance: > 95%
Water content: 55% by weight in normal saline .
20 x 10-11 (Fatt method) Oxygen permeability ●

10 Comparison table:

The characteristic comparison to predicate device is summarized in the following table.

Similarities
Item	Device	Predicate (K091339)
Product Name	iLens ® (ocufilcon D) DailyWear Soft (Hydrophilic)Contact Lens	BIOMEDICS UV SPHERESoft Contact Lenses
Manufacturer	Seinoh Optical Co. Ltd	CooperVision, Inc
Intended Use	Daily Wear forFrequent/Planned ReplacementWear or for Daily disposableWear	Daily Wear forFrequent/PlannedReplacement Wear or forDaily disposable Wear
USAN Name	Ocufilcon D	Ocufilcon D
Material	Hydrogel	The same
Lens Design	Spherical	Spheric, aspheric, toric ormultifocal
Classification	Class II,	The same
Type	Group IV Ionic High Water	The same
Water Content	55%	55 %
Oxygen Permeability(DK, 35 °C)	20(Fatt method)	19.6(Fatt method)

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Base Curve Range	8.2 mm to 9.2 mm	6.50 mm to 10.8 mm
Diameter (mm)	13 to 15	12.5 ~ 18.0
Center Thickness	0.08mm @ -3.00D(Varies with power)	Varies with power (0.025 mm to 0.40 mm)
Powers	-20.00D to +20.00D-6.00D to +6.00D(0.25D increments)+20.00D to +6.50D, -6.50D to -20.00D(0.50D increments)	-20.00 D to +20.00 DAdd powers: +0.25 D to +3.00 D
Replacement Schedule	Disposable or Daily wear	Disposable or Daily wear
Refractive Index	1.405	1.41
Light Transmittance	>95%	>95%
Method ofManufacture	Cast-Molded	The same
Surfactant in the finalProduct Saline	None	Yes
Sterilization	steam	The same
Packaging	Blister pack	The same
Blue handling tint	Yes, reactive Blue19	Yes, Entrapment Dye

Mechanical Strength	Device	Predicate(K013649)	Predicate(K000384)
Product Name	iLens	Sauflon 55 UV(methafilcon A)	Frequency 55
Tensile strength (Mpa)	0.43	1.47	0.66
Modulus (Mpa)	0.57	0.52	0.48
Elongation at break (%)	55.8	280	179
toughness (J/m³)	0.21	1.39	0.38
Manufacturing method	Cast Mold	Cast Mold	Cast Mold

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11 Nonclinical Tests Performed

11.1 Physiochemical studies were conducted according to ISO 18369 First edition 2006-08-15, Ophthalmic optics - Contact lenses (Ophthalmic). The physical, optical and chemical properties of the lens are within established specifications for the lenses.
11.2 Toxicology studies report shows that the lenses are non-toxic and biocompatibility result is acceptable in ocular environment.

12 Clinical Studies

The technical characteristics, formulation, manufacturing, and sterilization processes of the subject device are equivalent to ocufilcon D soft contact lenses currently marketed by CooperVision, therefore no clinical data is required.

13 Conclusion

Comparison to the predicate device for chemical composition, physical and optical properties, it shows that "iLens" (ocufilcon D) Daily Wear Soft (Hydrophilic) Contact Lens" is as safe, as effective and perform as well as the predicate device.

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Public Health Service

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

July 18, 2014

Seinoh Optical Co. Ltd. c/o Jennifer Ting Jens Medical Consulting 6F No. 39 Ln. 224. Jixian Road Luzhou Distr. 247. New Taipei City Taiwan ROC

Re: K141280

Trade/Device Name: iLens (ocufileon D) Daily Wear Soft (hydrophilic) Contact Lens Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hydrophilic) contact lens Regulatory Class: II Product Code: LPL, MVN Dated: May 20, 2014 Received: May 22, 2014

Dear Ms. Ting:

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 cither 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.

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Page 2 - Ms. Jennifer Ting

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 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/ucm 115809.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/ReportalProblem/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/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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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510{k) Number (if known) K141280

Device Name

iLens (neufilean D) Daily Wear Soft (Hydrophilic) Contact Lens

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Joseph C. Hutter -S 2014.07.15 16:00:24 -04'00'

This section applies only to requirements of the Paperwork Reduction Act of 1995.

"DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, Including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number.

FORM FDA 3881 (1/14)

PRC Intelleire Seconds (101) 441-67-67-8

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.