The Chic View (polymacon) Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

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

Frequent/Planned Replacement Wear:

Eyecare practitioners may prescribe any of the above lenses for frequent/planned replacement wear, with cleaning disinfection and scheduled replacement. When prescribed for frequent/planned replacement wear, the lens may be disinfected using a chemical disinfecting system.

Disposable Wear:

Eyecare practitioners may prescribe any of the above lenses for Daily Disposable Wear. When Prescribed for Daily Disposable Wear the lenses are not to be used with disinfecting systems as they are to be discarded after a single use.

Device Description

The ChicView soft contact lenses are hemispherical shells with molded spherical base curves and molded front surfaces. The ChicView soft contact lenses are fabricated from polymacon, which has been adopted by the United States Adopted Names Council (USAN). The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution.

The nonionic lens material. (polymacon) is a hydrophilic polymer of 2-Hydroxyethyl methacrylate (2-HEMA) and cross-linked with ethylene glycol dimethacrylate (EGDMA), plus an initiator. The co-polymer consists of 62% polymacon and 38% water by weight when immersed in saline solution.

ChicView lenses are available clear, tinted for visibility/handling, and tinted to enhance or alter the apparent color of the eye. Tinted or color lens designs may be distributed under unique or "private label" trade names. ChicView lenses are available in gray, green, violet, brown, blue or blackwhich are tinted with one or a combination of one or more of the following "listed" color additives:

Name of Colorant	Listing
D&C Yellow 10	21 CFR § 74.3710
Titanium Dioxide	21 CFR § 73.3126
Iron Oxide (Red)	21 CFR § 73.3125
D&C Green No. 6	21 CFR § 74.3206
Reactive Blue 19	21 CFR § 73.3127
C.I. Reactive black 5	21 CFR § 73.3127

Lenses that contain a unique tinting pattern are subsequently processed to incorporate the 'listed' color additives, and contain only the amount of color additive needed to accomplish the intended coloring effect. When producing the tinted or color lenses, the manufacturing process alters and/or changes the specifications to the clear version of a contact lens by entrapment of the listed color additives in the center of the contact lens (surrounded by layers of contact lens material) in a location that corresponds to the iris. The color additives used are not removed by lens handling and cleaning/disinfecting procedures. Except for affecting the amount of light transmittance through the lens, the coloring process does not alter the original characteristics of the pre-tinted lens. The color lens tinting pattern has a minimum Clear Pupil diameter of 6.0 mm.

In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a transparent or colored optical surface. The (polymacon) soft hydrophilic contact lens has a spherical back 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; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

Refractive Index	1.435
Light Transmission (clear)	greater than 98%
Light Transmission (tinted/color)	greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter);Opaque or 0-10% (at tinted region corresponding to iris)
Surface Character	hydrophilic
Water Content	38±2%
Specific Gravity	1.17 (hydrated)
Oxygen Permeability	11.15 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)

The hydrophilic characteristics allow aqueous solution to enter the lens, and in its fully hydrated state the lens is approximately 38% water by weight. The lenses will be manufactured in the spherical configuration with the following features and properties:

Chord Diameter:	12.00 mm to 15.50 mm
Center Thickness:	0.07 mm to 0.13 mm
Base Curve:	7.0 mm to 9.0 mm
Power Range	-20.00D to +20.00D in 0.25D steps

ChicView lenses are supplied sterile in saline solution containing blister packages with a base made from polypropylene and a laminated foil seal on top. Blister package labeling is printed with the appropriate lot numbering, expiration dating, and lens parameter identification. Expiration dating has been established based on studies of product stability, package integrity, and validation of the sterilization process.

AI/ML Overview

The provided document describes the submission for a 510(k) premarket notification for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical superiority or a specific performance metric like an AI/ML algorithm might. Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are framed in terms of comparing the device to predicates based on established physical properties and non-clinical as well as previously established clinical performance, rather than the kind of AI/ML or diagnostic study that would typically involve acceptance criteria for metrics like sensitivity, specificity, or AUC.

However, I can extract the relevant information from the document to address the spirit of your request with respect to the contact lenses' properties and testing.

Here's an interpretation based on the provided text:

Acceptance Criteria and Device Performance (in the context of Substantial Equivalence)

The "acceptance criteria" for a 510(k) submission are not expressed as specific performance thresholds for "metrics" like accuracy, sensitivity, or specificity, but rather as demonstrating that the new device is as safe and effective as a predicate device and shares similar technological characteristics. The performance is assessed against the established properties of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Property	Acceptance Criteria (Predicate "Comfort 38" / "Neo Cosmo")	Reported Device Performance ("ChicView")
Indications for Use	Correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia; astigmatism up to 0.75D-4.00D. Available clear or colored.	Correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia; astigmatism up to 0.75D. Available clear or colored. (Slightly narrower astigmatism range than one predicate, but still considered substantially equivalent)
Functionality	Acts as a refractive medium to focus light on the retina.	Same as predicate device.
Classification	Daily Wear, Soft (hydrophilic) Contact Lens (Class II).	Daily Wear, Soft (hydrophilic) Contact Lens (Class II).
Production Method	Fully-molded.	Fully-molded.
USAN Name	polymacon.	polymacon.
Water Content (%)	38±2%.	38±2%.
Oxygen Permeability	9.89 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C) (Comfort 38); 9.77 x 10⁻¹¹ (Neo Cosmo).	11.15 x 10⁻¹¹ (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C). (Higher than predicates, implying better oxygen flow)
Specific Gravity	1.18 (hydrated) for Comfort 38.	1.17 (hydrated). (Similar to Comfort 38)
Refractive Index	Not explicitly stated for predicates, but implied similar.	1.435.
Light Transmission (clear)	Not explicitly stated for predicates, but implied similar.	greater than 98%.
Light Transmission (tinted/color)	Not explicitly stated for predicates, but implied similar.	greater than 98% (clear region); Opaque or 0-10% (tinted region).
Surface Character	Not explicitly stated for predicates, but implied similar.	hydrophilic.
Minimum Clear Pupil Diameter	Not explicitly stated for predicates, but implied similar.	6.0 mm.
Sterility	Implicitly sterile for predicate devices.	Sterile for the indicated shelflife.
Packaging Material & Extracts Toxicity/Irritation	Implicitly non-toxic/non-irritating for predicate devices.	Not toxic and not irritating.
Lens Physical & Material Properties	Consistent with currently marketed lenses (predicates).	Consistent with currently marketed lenses.

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

Sample Size for Test Set: The document does not specify a "test set" in the context of an algorithm's performance. Instead, it refers to non-clinical testing (in vitro and in vivo toxicology and biocompatibility) and notes that clinical performance of the polymacon lens material has been previously established, therefore, was not required for this 510(k). This implies that the "data" for establishing substantial equivalence primarily relies on previously conducted studies on polymacon lenses and specific tests on the ChicView product for its physical/material properties and sterility. No specific patient sample size for a "test set" is provided for this type of medical device submission.
Data Provenance: The new device manufacturer is Joowon Innovation Co., Ltd. from South Korea. The non-clinical toxicology tests were conducted in accordance with GLP (Good Laboratory Practice) regulations, and other testing according to valid scientific protocols. The document does not specify if these were retrospective or prospective studies, but implies data collected specifically for the submission. The "previously established" clinical performance likely refers to prior clinical trials or post-market data on polymacon lenses in general, not specific to this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This is not applicable to a 510(k) submission for contact lenses, which relies on objective physical measurements, chemical analysis, sterility testing, and comparison to existing, widely accepted predicate devices. There is no "ground truth" to be established by multiple human experts in the way there would be for an AI diagnostic algorithm interpreting images.

4. Adjudication Method for the Test Set

Not applicable for this type of device submission. Ground truth for properties like water content, oxygen permeability, sterility, and material composition are determined by laboratory testing and validated methods, not by human adjudication of ambiguous cases.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for diagnostic devices, particularly those involving human interpretation of data (e.g., radiologists reading images with or without AI assistance). This submission concerns contact lenses, which are therapeutic/corrective devices, not diagnostic ones that involve human interpretation of complex data with varying expert opinions. The "clinical performance" here refers to the physiological compatibility and visual correction properties of the lens material and design, not an improvement in human reading accuracy with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. There is no algorithm for diagnostic or interpretative purposes in this contact lens submission. The performance assessment is focused on the physical, chemical, and biological properties of the lens itself.

7. Type of Ground Truth Used

The "ground truth" for this device's performance is based on:
- Laboratory Measurements: Quantifiable physical properties (e.g., water content, oxygen permeability, refractive index, dimensions), and chemical composition analysis.
- Standardized Biological/Toxicological Tests: In vitro and in vivo biocompatibility and toxicology tests.
- Sterility Testing: Validation of the sterilization process and maintenance of sterility over shelflife.
- Established Clinical Performance of the Material: Relying on the known safety and effectiveness profile of polymacon, which has been widely used in contact lenses.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

Summary

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

August 22, 2016

Joowon Innovation Co., Ltd. % Mr. Bret Andre Consultant/ Official Correspondent EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K161098

Trade/Device Name: ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (hvdrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: July 7, 2016 Received: July 11, 2016

Dear Mr. Andre:

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

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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 (OS) 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,

Kesia Alexander

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) K161098

Device Name

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

Indications for Use (Describe)

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:

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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510 (k) 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.

The assigned 510(k) number is:	K161098
Applicant information:
Date Prepared:	April 6th, 2016
Name:	Joowon Innovation Co., Ltd.44, Sureteo 1-gil, Cheonan-si, Seobuk-guChung Cheong Nam-doSouth Korea
Contact Person:	Lee Hae-HangPresident
Phone number:	+82-41-5826117
Consultant:	Bret J AndreEyeReg Consulting, Inc.6119 Canter LnWest Linn, OR 97068United States
Phone number:	(503) 372-5226
Device Information:
Device Classification:	Class II
Product Code:	LPL; MVN
Classification Name:	Soft (hydrophilic) Contact Lens (21 CFR 886.5925)
Trade Name:	ChicView (polymacon) Daily Wear Soft (hydrophilic)Contact Lenses (Tinted/Color)

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Predicate Devices:

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) are substantially equivalent to the following predicate devices:

"Comfort 38" . By Migwang Contact Lens Co., Ltd. 510(k) number; K051477
. "Neo Cosmo" By Neo Vision Co., Ltd. 510(k) number: K142275

Device Description:

Name of Colorant	Listing
D&C Yellow 10	21 CFR § 74.3710
Titanium Dioxide	21 CFR § 73.3126
Iron Oxide (Red)	21 CFR § 73.3125
D&C Green No. 6	21 CFR § 74.3206
Reactive Blue 19	21 CFR § 73.3127
C.I. Reactive black 5	21 CFR § 73.3127

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hydrophilic contact lens has a spherical back 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; it will return to its proper configuration when completely rehydrated in the proper storage solution.

The physical properties of the lens are:

Refractive Index	1.435
Light Transmission (clear)	greater than 98%
Light Transmission (tinted/color)	greater than 98% (at clear region corresponding to pupil, minimum 6.0 mm diameter);Opaque or 0-10% (at tinted region corresponding to iris)
Surface Character	hydrophilic
Water Content	38±2%
Specific Gravity	1.17 (hydrated)
Oxygen Permeability	11.15 x 10-11 (cm²/sec)(mlO₂)/(ml x mmHg @ 35°C)) (revised Fatt method)

Chord Diameter:	12.00 mm to 15.50 mm
Center Thickness:	0.07 mm to 0.13 mm
Base Curve:	7.0 mm to 9.0 mm
Power Range	-20.00D to +20.00D in 0.25D steps

Intended Use:

The ChicView (polymacon) Spherical Soft Contact Lenses for daily wear are indicated for the correction of visual acuity in aphakic and not aphakic persons with non-diseased eyes with myopia or hyperopia. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The lens is available clear or tinted and may be used to enhance or alter the apparent color of the eye.

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

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Frequent/Planned Replacement Wear:

Disposable Wear:

Testing:

Non-clinical Testing A series of in vitro and in vivo preclinical toxicology and biocompatibility tests were performed to assess the safety and effectiveness of the ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses. All non-clinical toxicology tests were conducted in accordance with the GLP regulation. All other testing was conducted according to valid scientific protocols. Test results of the non-clinical testing on the ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses demonstrate that: ● Lenses supplied in blister packages are sterile for the indicated shelflife, The packaging material and extracts are not toxic and not irritating, ● and

Lens physical and material properties are consistent with currently marketed lenses.
Clinical Data The clinical performance of the (polymacon) lens material has been previously established, and therefore was not required for this 510(k).

Conclusions Drawn from Studies

Validity of Scientific Data

Several laboratories under Good Laboratory Practice regulations conducted toxicology studies, microbiology, chemistry, shelf-life stability studies and followed scientific protocols. The data were determined to be scientifically valid under 21 CFR 860.7

Substantial Equivalence

Information presented in this Premarket Notification establishes that the ChicView. (polymacon) Soft Contact Lenses for Daily Wear is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the requested indication.

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Risks and Benefits

The risks of the subject device are the same as those normally attributed to the wearing of daily wear soft contact lenses. The benefits to the patient are the same as those for other daily wear soft contact lenses.

Substantial Equivalence:

The ChicView Soft Contact Lens will be manufactured according to specified process controls and a cGMP quality assurance program currently in place. The established safety profile (pre-clinical toxicology and manufacturing/chemistry data) of the ChicView contact lens material is equivalent to the predicate devices identified previously. Being similar with respect to indications for use, materials, physical construction and safety & effectiveness to the predicate devices, this meets the requirements per section 510(k) of the act regarding substantial equivalence and does not raise different questions of safety and effectiveness than the predicate device identified above.

The following matrix illustrates the equivalencies of the ChicView Soft (hydrophilic) Contact Lens, as well as the substantial equivalent predicate devices.

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Substantial Equivalence Matrix

	Joowon Innovation Co., Ltd.“ChicView”(polymacon)New Device	Migwang Co., Ltd.“Comfort 38”(polymacon)Predicate Device	Neo Vision Co., Ltd.“Neo Cosmo”(polymacon)Predicate Device
Indications	Indicated for daily wear for thecorrection of visual acuity in aphakicand not aphakic persons with non-diseased eyes with myopia orhyperopia and/or possesses refractiveastigmatism not exceeding 0.75diopters. The lens is available clear orcolored and may be used toenhance or alter the apparentcolor of the eye.	Indicated for daily wear for thecorrection of visual acuity in aphakic andnot aphakic persons with non-diseasedeyes with myopia or hyperopia and/orpossesses refractive astigmatism notexceeding 4.00 diopters. NOTE:refractive astigmatism N/A for sphericallenses. The lens is available clear orcolored and may be used toenhance or alter the apparentcolor of the eye.	Indicated fordaily wear for the correction ofvisual acuity in aphakic andnon-aphakic persons withnon-diseased eyes withmyopia or hyperopia. Thelens may be worn by personswho exhibit refractiveastigmatism of 0.50 dioptersor less where the astigmatismdoes not interfere with visual acuity.The lens is available clear orcolored and may be used toenhance or alter the apparentcolor of the eye.
Functionality	Same as predicate device	The contact lenses act as a refractivemedium that focus light rays from nearand distant objects on the retina	The contact lenses act as a refractivemedium that focus light rays from near anddistant objects on the retina
Classification	Daily Wear, Soft (hydrophilic)Contact Lens (Class II)	Daily Wear, Soft (hydrophilic)Contact Lens (Class II)	Daily Wear, Soft (hydrophilic)Contact Lens (Class II)
ProductionMethod	Fully-molded	Fully-molded	Fully-molded
USAN name	polymacon	polymacon	polymacon
Water Content(%)	38±2%	38±2%	38±2%
OxygenPermeability	11.15 x $10^{-11}$ (cm²/sec)(mlO₂)/(mlx mmHg @ 35°C)) (revised Fattmethod)	9.89 x $10^{-11}$ (cm²/sec)(mlO₂)/(ml xmmHg @ 35°C)) (revised Fatt method)	9.77 x $10^{-11}$ (cm²/sec)(mlO₂)/(ml xmmHg @ 35°C)) (revised Fatt method)
Specific Gravity	1.17 (hydrated)	1.18 (hydrated)	-

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.