OPTIXON I- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.

Device Description

OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)

The contact lenses contain 59% water by weight and is sold in the blister package immersed in packaging saline. RB 246 pigment conforms to 21 CFR Part 73.3106 is used to provide the handling blue tint for the lens.

The device is a corneal contact lens having a total diameter more than the visible iris diameter and is designed to be worn in its entirety on the cornea. The device has an aspheric front curve (external curve) which is tri-curve and spherical base curve (internal curve).

The contact lenses are hydrophilic, soft and it is supplied in sterile state.

AI/ML Overview

The provided document is a 510(k) summary for the OPTIXON 1-DAY contact lenses. It states that no clinical studies were required to demonstrate the safety or effectiveness of the device because its technological characteristics, formulation, manufacturing, and sterilization processes are the same as two predicate devices (Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lenses K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302).

Therefore, there is no information in this document regarding:

A test set or data provenance for a clinical study
Experts used to establish ground truth
Adjudication methods
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm only) performance
Training set sample size or ground truth establishment for a training set

However, the document does describe physiochemical and toxicology studies that were conducted to establish substantial equivalence. These studies serve as the "study that proves the device meets the acceptance criteria" in lieu of a clinical trial.

Here's a summary of the acceptance criteria and reported performance from these non-clinical studies:

1. Table of Acceptance Criteria and Reported Device Performance

Study Type	Acceptance Criteria	Reported Device Performance
Physiochemical Studies	Within established specifications for the lenses (per ISO 18369-4:2006 and ISO 18369-3:2006)	Passed
Cytotoxicity test	According to EN ISO 10993-5:2009	Passed
Skin sensitization test	According to EN ISO 10993-10:2010	Passed
Ocular irritation test	According to EN ISO 10993-10:2010	Passed
Acute Systemic Toxicity test	According to ISO 10993-11:2017	Passed

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

The document does not specify the sample sizes for the physiochemical or toxicology tests. The data provenance is not explicitly stated beyond referencing the ISO and EN ISO standards, which implies the tests were conducted in accordance with international standards. There is no indication of retrospective or prospective data as these are laboratory tests, not human trials.

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

Not applicable as these are non-clinical (laboratory) tests, not involving expert interpretation of medical images or data from human subjects.

4. Adjudication method for the test set

Not applicable for non-clinical laboratory tests.

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. No MRMC study was performed as no clinical studies were required.

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

Not applicable. The device is a contact lens, not an AI or algorithmic medical device.

7. The type of ground truth used

For the physiochemical studies, the ground truth is defined by the established specifications for contact lenses as outlined in ISO 18369-4:2006 and ISO 18369-3:2006.

For the toxicology studies, the ground truth is determined by the "Passed" outcome according to the specific biocompatibility standards (EN ISO 10993-5:2009, EN ISO 10993-10:2010, ISO 10993-11:2017). These standards define what constitutes a non-toxic or non-irritating result.

8. The sample size for the training set

Not applicable. The device is a contact lens, not an AI/ML algorithm that requires a training set. The substantial equivalence relies on comparison to predicate devices, not on a machine learning model.

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

Not applicable. There is no training set for this device.

Summary

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September 18, 2020

Optixon Inc. % Eunbae Cho General Manager IGC Co., Ltd. Rm. 501, Daeryung techno town 7th, #638, Seobusaet-gil, Geumcheon-gu Seoul, Republic of Korea 08504

Re: K201013

Trade/Device Name: Optixon 1-Day Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: August 13, 2020 Received: August 17, 2020

Dear Eunbae Cho:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

J. Angelo Green, Ph.D. Assistant Director DHT1A: Division of Ophthalmic Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201013

Device Name OPTIXON 1- DAY

Indications for Use (Describe)

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

Depository Use (Part 21 CFR 601 Subpart D)
Own-Use Sample (21 CFR 601 Subpart D)

Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(K) SUMMARY

Preparation Date: Sep 10, 2020

A.510k Number: K201013

B. Applicant: Company name: OPTIXON Inc

Address: 105/106 ho, 164, Obonq-ro, Buk-Gu, Daequ, Rep. of Korea

C. Proprietary and Established Names: OPTIXON Inc Address: 105/106 ho, 164, Obong-ro, Buk-Gu, Daegu, Rep. of Korea

D. Regulatory Information

Classification Name: lenses, soft contact, daily wear
Common / Usual Name: Soft (hydrophilic) contact lens
Proprietary Name: OPTIXON 1- DAY
Classification / Product Code: Class 2 / LPL (21 CFR 886.5925)

E. Indications for Use

OPT IXON 1- DAY are indicated for single-use, disposable daily wear for the correction of visual acuity in non-aphakic persons with non-diseased eyes that are myopic and exhibit astigmatism of 1.00D or less that does not interfere with visual acuity.

F. Description

OPTIXON 1- DAY (omafilcon A)is daily disposable soft contact lenses(single use) produced from the HEMA-MPC copolymer material. MPC is similar to phospholipids (e.g., phosphatidylcholine)

The contact lenses are hydrophilic, soft and it is supplied in sterile state.

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G. Substantial Equivalence Information

-Predicate Device-1 SE Number: K162223 Product name: Aveo (omafilcon A) 1-Day Aspheric Soft (Hydrophilic) Contact Lenses Company: Supervision Optimax Sdn Bhd

-Predicate Device-2 SE Number: K 112302 Product name: Proclear lens Company: CooperVision, Inc.

Manufacturer	OPTIXON Inc	Supervision OptimaxSdn Bhd	CooperVision, Inc
Device name	OPTIXON 1-DAY	Aveo (omafilcon A)1-DAY Aspheric Soft(Hydrophilic) ContactLens	Proclear (omafilcon A)Soft Contact Lenses
510(k) No.	-	K162223	K 112302
Intended Use	OPTIXON 1- DAY areindicated for single-use,disposable daily wear forthe correction of visualacuity in non-aphakicpersons withnon-diseased eyes thatare myopic and exhibitastigmatism of 1.00D orless that does notinterfere with visualacuity.	Aveo (omafilcon A) 1-DayAspheric Soft(Hydrophilic) ContactLenses are indicated fordaily wear for thecorrection of visual acuityin not aphakic personswith nondiseased eyesthat are myopic orhyperopic and exhibitastigmatism of 1.00D orless that does notinterfere with visualacuity. The contact lensesare intended for dailywear, single use and areto be discarded at the endof the day.	Proclear Asphereomafilcon A) SoftContact lenses areindicated for daily wearfor the correction ofvisual acuity innonaphakic personswith non-diseased eyesthat are myopic orhyperopic and exhibitastigmatism of 2.00D orless that does notinterfere with visualacuity.
Modality	Daily Wear	Daily Wear	Daily Wear
MaterialUSAN Name	omafilcon A	omafilcon A	omafilcon A
FDA Category	Group II	Group II	Group II
(Group)	Non-ionic, High water	Non-ionic, High water	Non-ionic, High water
ManufacturingMethod	Cast Molded	Cast Molded	Finished InsidePolymerization SystemII
Curing	Thermal Cure	Thermal Cure	Thermal Cure

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Sterilization	Moist heat sterilization	Moist heat sterilization	Moist heat sterilization
Visibility Tint	Reactive Blue Dye 246	Reactive Blue Dye 246	VAT Blue 6
WaterContent	59% ± 2%	59% ± 2%	59% ± 2%
PackageSaline	PhosphateSaline	PhosphateSaline	Phosphate BuffersPEG200 and Tween 80
OxygenPermeability(Dk) x10-11	25.68	25.68	21.05
Lighttransmission	98%	98%	>90%
Base Curve	8.4mm to 8.8mm	8.4mm to 8.8mm	8.0mm to 9.3mm
Diameter Øт	14.0 to 14.4mm	14.0mm to 14.4mm	13.6mm to 15.2mm
Power	-0.50D to - 10.0D	-10.00 to +6.00	-20.00 to +20.00

H. Substantial Equivalent Based on Assessment of Non-Clinical Performance Data

Physiochemical Studies

The physiochemical studies were conducted according to ISO 18369-4:2006 Ophthalmic Optics-Contact Lenses-Part 4: Physiochemical properties of contact lens materials and ISO 18369-3:2006 Ophthalmic Optic-Contact Lenses-Part 3: Measurement methods. The physical, optical and chemical properties of the lens are within established specifications for the lenses.

Toxicology Studies

Toxicology (in-vivo and in-vitro) studies reports show that the lenses are non-toxic and biocompatible with the ocular environment.

Cytotoxicity test	According to EN ISO 10993- 5 :2009	Passed
Skin sensitization test	According to EN ISO 10993-10 :2010	Passed
Ocular irritation test	According to EN ISO 10993-10 :2010	Passed
Acute Systemic Toxicity	According to ISO 10993-11 : 2017	Passed

I. Clinical Test

The technological characteristics, formulation, manufacturing and sterilization processes are the same as the predicate device Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lens K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302. Therefore, no clinical studies were required to demonstrate the safety or effectiveness of the subject device.

J. Conclusion

OPTIXON 1-DAY is substantially equivalent to the predicate device. Aveo (omafilcon A) 1-DAY Aspheric Soft (Hydrophilic) Contact Lens K162223 and Proclear (omafilcon A) Soft Contact Lenses K 112302 in term of optical property, Physiochemical and pre-clinical toxicology. They

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are produced from the same material (omafilcon A), have the same functional and scientific technology, lens characteristics and the intended use is identical. It is concluded that the lenses are as safe, as effective and perform as well as the predicate devices.

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.