The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eye who may have 1.00 D or less astigmatism. The UNICON (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear are single disposable wear and are to be discarded after each removal. UNICON (etaffilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

Device Description

UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is available as aspherical lenses manufactured by case-molding method. The model illuminated with high water content (58 %). The hydrogel lens' material is a random copolymer composed of 2-hydroxyethyl methacrylate (HEMA) and methacrylic acid (MAA), which was cross-linked with Trimethylolpropane trimethacrylate (TMPTMA) and Ethylene Glycol Dimethacrylate (EGDMA) via UV photo-polymerization. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear with visible tint is light tinted blue using Blue 15:3 to make the lens more visible for handling. The lenses also contain a UV absorber { { 2-[ 3-( 2 -( 2 -( 2 -( ) - 4 - h dr ox y p hen y l which is included during the manufacturing process as a monomer to block UV radiation. The average transmittance characteristics are less than 5% in the UVB range of 280 to 315 nm and less than 30% in the UVA range of 316 to 380nm.

With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.

AI/ML Overview

The document provided is a 510(k) premarket notification for a soft contact lens. It aims to establish substantial equivalence to a predicate device rather than presenting a study proving a device meets specific acceptance criteria in the context of an AI/algorithm-driven medical device.

Therefore, many of the requested elements (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, training set sample size, and ground truth establishment for the training set) are not applicable to this type of submission.

However, I can extract the acceptance criteria as defined by the non-clinical testing performed and compare them to the device's reported performance as presented in the "Substantial Equivalence Determination" section.

Here's an interpretation based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The device (UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear) is asserting substantial equivalence to the VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (K051900). The "acceptance criteria" here are effectively the performance characteristics of the predicate device, which the proposed device aims to match or demonstrate equivalency to.

Metric	Acceptance Criteria (Predicate Device K051900)	Reported Device Performance (UNICON K141917)
General Characteristics
Regulatory Number	886.5925	886.5925
Classification	II	II
Prescription Use	Yes	Yes
Single Use	Yes	Yes
Material	Etafilcon A	Etafilcon A
Manufacturing Method	Cast Molded	Cast Molded
Sterilization Method	Traditional moist heat	Traditional moist heat
Primary Packaging	PP container with aluminum foil sealing	PP container with aluminum foil sealing
Physical/Optical Properties
Base Curve	7.85mm to 10.0mm	7.85mm to 10.0mm
Diameter	12.0mm to 15.0mm	12.0mm to 15.0mm
Water Content	58%	58%
UV Transmittance @280~315 nm	Avg < 5%	Avg < 5%
UV Transmittance @316~380 nm	Avg < 30%	Avg < 30%
UV Absorbing	Benzotriazole	Benzotriazol
Refractive Index	1.40	1.399
Power	+20.00D to -20.00D	+6.00D to -13.00D
Specific Gravity	0.98-1.12	1.14
Tensile Strength	2.00 Mpa	1.66 Mpa
Break Elongation	189%	393%
Secant Modulus	1.06 Mpa	0.43 Mpa
Oxygen Permeability (edged corrected) @ 35°C	28 x 10-11 (cm2/sec) (mlO2/ml-mmHg)	30.8 x 10-11 (cm2/sec) (mlO2/ml-mmHg)
Visible Light Transmittance	Minimum 85%	Minimum 90%
Color & Tint	Reactive Blue Dye #4	Blue 15:3
FDA 21 CFR (Color additive)	73.3121 Poly(hydroxyethyl methacrylate)-dye copolymers	74.3045 [Phthalocyaninato(2-)]copper

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated as a "test set" in the context of an algorithm. For non-clinical tests (sterilization, shelf life, biocompatibility, mechanical properties, etc.), samples of the manufactured contact lenses would have been tested. The exact number of lenses or batches tested for each non-clinical parameter is not provided in this summary.
Data Provenance: The non-clinical tests were performed in "UNICON QC lab and subcontracted test services" (Taiwan, based on submitter address). These are prospective tests on the manufactured device.

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

This is not applicable to this type of device submission. There is no mention of expert-established ground truth as would be relevant for an AI/algorithm.

4. Adjudication method for the test set:

Not applicable.

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, not an AI-assisted diagnostic device.

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

Not applicable.

7. The type of ground truth used:

For the non-clinical tests, the "ground truth" is defined by the established industry standards and recognized consensus standards (e.g., EN/ISO 17665 for sterilization, FDA guidance for daily wear contact lenses) which specify acceptable ranges or thresholds for each parameter. For example, for sterilization, achievement of a Sterility Assurance Level (SAL) of 10^-6 is the "ground truth" or acceptance criterion.

8. The sample size for the training set:

Not applicable. This is a manufactured physical device, not an algorithm that requires a training set.

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

Not applicable.

Summary of Device Performance against Acceptance Criteria

The submission asserts that "All the test results were met the requirements of products specification" (page 6). The comparative table (pages 7-9) shows that the proposed device is largely identical or very similar to the predicate device across most physical, chemical, and performance characteristics.

Key observations:

Intended Use, Material, Manufacturing, Sterilization, Water Content, UV Blocking: The proposed device matches the predicate.
Power Range: The proposed device has a narrower power range (+6.00D to -13.00D) compared to the predicate (+20.00D to -20.00D). This is a difference, but typically a narrower range for a device is not considered a safety or effectiveness concern unless it fails to meet its own stated range.
Specific Gravity: The proposed device (1.14) is slightly outside the predicate's range (0.98-1.12). The significance of this difference is not discussed in detail other than the general statement of substantial equivalence.
Tensile Strength, Break Elongation, Secant Modulus: There are differences in these mechanical properties (Tensile Strength: 1.66 MPa vs 2.00 MPa; Break Elongation: 393% vs 189%; Secant Modulus: 0.43 MPa vs 1.06 MPa). The differences are significant in magnitude. The submission implicitly indicates these are acceptable variations for substantial equivalence.
Oxygen Permeability: The proposed device (30.8 x 10^-11) has slightly higher oxygen permeability than the predicate (28 x 10^-11), which is generally a positive attribute for contact lenses.
Visible Light Transmittance: The proposed device (Minimum 90%) has a slightly higher minimum transmittance than the predicate (Minimum 85%), also generally a positive attribute.
Color & Tint / FDA Color Additive: This is identified as the main difference between the devices. The proposed device uses Blue 15:3 (Phthalocyaninato(2-)]copper) which is approved under 21 CFR 874.3045, while the predicate uses Reactive Blue Dye #4 (Poly(hydroxyethyl methacrylate)-dye copolymers) approved under 21 CFR 73.3121. The submission explicitly states that "the difference of proposed device and predicate device did not raise any problems of safety or effectiveness" and therefore does not impede substantial equivalence.

Conclusion from the document: The manufacturer concludes, and the FDA agrees by issuing the letter, that the UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is substantially equivalent to the predicate device based on the non-clinical tests performed and the comparison of characteristics. The clinical safety and effectiveness were established through the predicate device.

Summary

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

October 17, 2014

Unicon Optical Co., Ltd. % Mr. Michael Lee President No. 45, Mingsheng Rd., Danshui District New Taipei, 251 TW

Re: K141917

Trade/Device Name: Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 8, 2014 Received: July 15, 2014

Dear Mr. Lee.

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.

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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 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.

Eric A. Mann -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) K141917

Device Name

Unicon (etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear

510(k) Summary

5.1	Type of Submission:	Traditional
5.2	Preparation Date:	7th July, 2014
5.3	Submitter:	UNICON Optical Co., LTD.
	Address:	No 16, Gongye E. 9th Rd., Hsinchu Science Park,Baoshan Township, Hsinchu County 30075,Taiwan
	Phone:	+886-3-5775586
	Fax:	+886-3-5777868
	Contact:	Robert

5.4 Identification of the Device:

Proprietary/Trade name:	UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear
Common Name:	Soft (hydrophilic) contact lenses for daily wear
Classification Name:	LENS, CONTACT, (DISPOSABLE)
Device Classification:	II
Regulation Number:	886.5925
Panel:	Ophthalmic
Product Code:	MVN ; LPL

5.5 Identification of the Predicate Device:

Predicate DeviceName:	VISTAKON (Etafilcon A) Soft (hydrophilic)Contact Lens (spherical), Clear and VisibilityTinted with UV Blocker for Daily DisposableWear
Manufacturer:	VISTAKON
Product Code:	MVN ; LPL
510(k) Number:	K051900

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5.6 Intended Use and Indications for Use of the subject device.

The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic or non-aphakic persons with non-diseased eyes who may have 1.00D or less astigmatism. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear are indicated for single-use disposable wear and are to be discarded after each removal. The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear helps protect against transmission of harmful UV radiation to the cornea and into the eye.

5.7 Device Description

With more specific explanation, the "UNICON (Etafilcon A) Soft (Hydrophilic)

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Contact Lens with UV Blocker for Daily Wear' is 58% water and 42% HEMA/MAA cast-molding aspherical soft contact lens. It is blister packaged and produced from +4.00D to -6.00D in 0.25D per step, from +4.50D to +6.00D in 0.50D per step, and from -6.50D to -13.00D in 0.50D per step.

5.8 Non-clinical Testing

A series of non-clinical studies were completed on this product. The tests and studies were performed in UNICON QC lab and subcontracted test services which were according to the FDA guidance (Premarket Notification (510(k)) Guidance Document for Daily Wear Contact Lenses, February 27, 1997) and related recognized consensus standards. All the test results were met the requirements of products specification.

The following tests were conducted on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear'':

. Sterilization Test
o Shelf Life Test
Biocompatibility
- -Cytotoxicity
- Irritation -
- -Acute Systemic toxicity
Water Content
. Mechanical Properties of Materials
. Refractive Index
Oxygen Permeability
Transmittance
Extractables Test

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. Specific Gravity
The Sterilization Method used on "UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear" is moist heat sterilization and the study for sterilization is based on the EN/ISO 17665 : 2006 Sterilization of health care product-Moist heat-Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. The overkill method is used as validation method for sterilization and the results demonstrates achievement of the required sterility assurance limit (SAL) of 10 °.

5.9 Clinical Testing

The safety and effectiveness of etafilcon A lenses have been established through previous clinical performance testing. And the pre-clinical testing results are sufficient in establishing substantial equivalence.

5.10 EMC and Electrical safety

The devices do not require EMC/Electrical Safety evaluation.

5.11 Substantial Equivalence Determination

The UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear submitted in this 510(k) file is substantially equivalent in intended use, main materials, design, safety and performance claims to the cleared VISTAKON (Etafilcon A) Soft (hydrophilic) Contact Lens (spherical), Clear and Visibility Tinted with UV Blocker for Daily Disposable Wear which is the subject of K051900. Differences between the devices cited in this section do not raise any new issues of safety or effectiveness.

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UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear

	Proposed Device	Predicate Device
Device name	UNICON (Etafilcon A) Soft(Hydrophilic) Contact Lenswith UV Blocker for DailyWear	VISTAKON (Etafilcon A) Soft(hydrophilic) Contact Lens(spherical), Clear and VisibilityTinted with UV Blocker forDaily Disposable Wear
RegulatoryNumber	886.5925	886.5925
Classification	II	II
Intended Use	The UNICON (Etafilcon A)Soft (Hydrophilic) Contact Lenswith UV Blocker for DailyWear is indicated for daily wearfor the correction of ametropia(myopia and hyperopia) inaphakic or non-aphakic personswith non-diseased eyes whomay have 1.00D or lessastigmatism. The UNICON(Etafilcon A) Soft (Hydrophilic)Contact Lens with UV Blockerfor Daily Wear are indicated forsingle-use disposable wear andare to be discarded after eachremoval. The UNICON(Etafilcon A) Soft (Hydrophilic)Contact Lens with UV Blockerfor Daily Wear helps protectagainst transmission of harmfulUV radiation to the cornea andinto the eye.	The VISTAKON (Etafilcon A)Soft (hydrophilic) Contact Lens(spherical), Clear and VisibilityTinted with UV Blocker for DailyDisposable Wear for thecorrection of refractive ametropia(myopia and hyperopia) inaphakic or not-aphakic personswith not diseased eyes who mayhave 1.00D or less ofastigmatism.VISTAKON (Etafilcon A) Soft(hydrophilic) Contact Lens, Clearand Visibility Tinted with UVBlocker for Daily DisposableWear help protect againsttransmission of harmful UVradiation to the cornea and intothe eye.The VISTAKON (Etafilcon A)Soft (hydrophilic) Contact Lens,Clear and Visibility Tinted withUV Blocker for Daily DisposableWear is to be prescribed for DailyDisposable Wear and is to bediscarded after each removal.
Prescription Use	Yes	Yes
Single Use	Yes	Yes

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Material	Etafilcon A	Etafilcon A
Base Curve	7.85mm to 10.0mm	7.85mm to 10.0mm
Diameter	12.0mm to 15.0mm	12.0mm to 15.0mm
Water Content	58%	58%
UVtransmittance@280~~315 nm@316~~380 nm	Avg < 5%Avg < 30%	Avg < 5%Avg < 30%
UV absorbing	Benzotriazol	Benzotriazole
Refractive Index	1.399	1.40
ManufacturingMethod	Cast Molded	Cast Molded
Sterilizationmethod	Traditional moist heat	Traditional moist heat
Primarypackaging	PP container with aluminumfoil sealing	PP container with aluminumfoil sealing
Power	+6.00D to -13.00D	+20.00D to -20.00D
Specific Gravity	1.14	0.98-1.12
Tensile Strength	1.66 Mpa	2.00 Mpa
Break Elongation	393%	189%
Secant Modulus	0.43 Mpa	1.06 Mpa
Oxygenpermeability(edged corrected)@ 35°C	30.8 x 10-11 (cm2/sec)(mlO2/ml-mmHg)	28 x 10-11 (cm2/sec)(mlO2/ml-mmHg)
Visible LightTransmittance	Minimum 90%	Minimum 85%
Color & Tint	Blue 15:3	Reactive Blue Dye #4
FDA 21 CFR(Color additive)	74.3045[Phthalocyaninato(2-)]copper	73.3121Poly(hydroxyethylmethacrylate)-dye copolymers

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5.12 Similarity and differences

The difference between the proposed device and predicate device is color additive. The color additive used on proposed device is Blue 15:3 ([Phthalocyaninato (2-)]copper) which has already been approved by US FDA. According to FDA 21 CFR 874.3045, this color additive may be safely used for coloring contact lenses. Therefore, the difference of proposed device and predicate device did not raise any problems of safety or effectiveness. The proposed device is substantially equivalent to the predicate device in intended use, main materials, design, safety and performance claims.

5.13 Conclusion

After analyzing bench tests and clinical test, it can be concluded that UNICON (Etafilcon A) Soft (Hydrophilic) Contact Lens with UV Blocker for Daily Wear is substantially equivalent to the predicate device.

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.