Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eves in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and presbyopia in aphakic and/ or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

Device Description

The Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) are clear, visibility-tinted and include UV blocker-containing. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

AI/ML Overview

The provided document (K222885) is a 510(k) Premarket Notification for contact lenses, specifically Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).

It is crucial to understand that this document describes a submission for a medical device (contact lenses), NOT an AI/ML-powered diagnostic device. Therefore, the standard acceptance criteria and study designs typically associated with AI/ML systems (such as those involving test sets, ground truth establishment by experts, MRMC studies, etc.) do not apply to this submission.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance tests conducted to demonstrate the safety and effectiveness of the contact lenses. The acceptance criteria are based on established standards for contact lens properties and safety.

Here's an interpretation based on the provided document, framed within the context of a traditional medical device submission, rather than an AI/ML algorithm:

Acceptance Criteria and Study for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

The device, Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), is a Class II medical device. Its acceptance criteria and proof of meeting them are primarily based on demonstrating substantial equivalence to legally marketed predicate devices through a combination of non-clinical (laboratory) testing and established material safety.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this contact lens device are derived from the performance characteristics of predicate devices and general industry standards for soft contact lenses. The reported device performance is compared against these benchmarks to demonstrate substantial equivalence.

Characteristic / Acceptance Criteria	Predicate Device K201268 (Ethos Aquell)	Predicate Device K213119 (Innova Vision Hydrogel)	Proposed Device (Pegavision)
Production Method	Cast-Molded	Cast-Molded	Cast-Molded
USAN Name	Hioxifilcon A	Hioxifilcon A	Hioxifilcon A
Material Classification	Group II (high water non-ionic)	Group II (high water non-ionic)	Group II (high water non-ionic)
Water Content (%)	59%	59%	59%
Refractive Index	1.400	1.400	1.400
Oxygen Permeability (edge corrected) @ 35°C ($\text{cm}^2/\text{sec} \cdot \text{mlO}_2/\text{ml} \cdot \text{mmHg}$)	$20.6 \times 10^{-11}$	$25 \times 10^{-11}$	$23.2 \times 10^{-11}$
Transmittance Visible light @ 380-780nm	> 95%	> 95%	> 95%
Transmittance UVA @ 380-315nm	< 50%	< 50%	< 50%
Transmittance UVB @ 315-280nm	< 5%	< 5%	< 5%
Lens Design	Sphere, Asphere, Toric	Sphere, Asphere, Toric, Multifocal, Multifocal Toric	Sphere, Asphere, Toric, Multifocal
Indications for Use	Daily wear for correction of ametropia (myopia/hyperopia) and/or astigmatism.	Daily wear for correction of refractive ametropia and emmetropia (myopia/hyperopia) and/or presbyopia and/or astigmatism.	Daily wear for correction of refractive ametropia (myopia/hyperopia) and/or presbyopia and/or astigmatism.

Key Findings:

The proposed device matches the material, water content, refractive index, visible light transmittance, and UV blocking properties of the predicate devices.
The oxygen permeability of the proposed device ($23.2 \times 10^{-11}$) falls within the range and is comparable to the predicate devices ($20.6 \times 10^{-11}$ and $25 \times 10^{-11}$).
The lens designs (Sphere, Asphere, Toric, Multifocal) are covered by the combined designs of the two predicate devices, demonstrating equivalence in functionality.
The indications for use are also substantially equivalent to or within the scope of the predicate devices.

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

For this type of device (contact lenses), there isn't a "test set" in the common AI/ML sense (i.e., a dataset of images or patient records for algorithmic evaluation). Instead, the "testing" involves laboratory characterization of the physical and chemical properties of manufactured lenses.

Sample Size: The document does not specify the exact sample sizes for each non-clinical test (e.g., how many lenses were tested for oxygen permeability). This information would typically be detailed in the full test reports referenced in the submission, conforming to relevant ISO standards or FDA guidance.
Data Provenance: The tests are performed on samples of the manufactured Pegavision contact lenses themselves. The document states, "All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses." This implies the testing was likely conducted in a controlled laboratory environment, presumably by the manufacturer or a contracted lab, with methodologies defined by regulatory guidance. The country of origin of the data is Taiwan, where Pegavision Corporation is located. The studies are prospective in the sense that they are specifically conducted to characterize the new device.

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

This concept is not applicable to this type of medical device submission. Ground truth for contact lenses is established through objective physical and chemical measurements (e.g., refractometers for refractive index, oxygen permeameters for oxygen permeability, spectrophotometers for light transmittance). There is no "expert consensus" on the "truth" of a lens's physical property; it's a direct measurement.

4. Adjudication Method for the Test Set

This concept is not applicable. Since the "ground truth" for the non-clinical tests is directly measured physical properties, there is no need for adjudication of human interpretations.

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

This concept is not applicable. An MRMC study is a clinical study design used primarily for diagnostic devices, especially those involving human interpretation of medical images (e.g., radiologists reading X-rays). This submission is for a physical medical device (contact lenses), not an AI algorithm assisting human readers.

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

This concept is not applicable. This is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to objectively measured physical and chemical properties of the contact lenses. This includes:

Physicochemical Properties: Refractive Index, Oxygen Permeability, Water Content, Extractables, Mechanical Properties, Light Transmittance.
Biocompatibility: Cytotoxicity, Ocular Irritation, Acute Systemic Toxicity (these tests assess the biological response to the material).
Shelf Life and Sterility: Confirming the product's integrity and safety over time.

These are established through laboratory testing using validated methods and scientific instrumentation, not expert consensus or outcomes data in the typical sense of a diagnostic trial.

8. The Sample Size for the Training Set

This concept is not applicable. "Training set" is a term used in machine learning for data used to develop and optimize an algorithm. This submission is for a manufactured physical product, not an AI algorithm.

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

This concept is not applicable for the reasons stated above.

Summary regarding this specific submission (K222885):

The FDA's decision of substantial equivalence for these contact lenses is based on the following:

Comparison to Predicate Devices: The proposed device uses the same USAN material (Hioxifilcon A) and has highly similar technological characteristics (water content, refractive index, UV blocking, oxygen permeability) to already cleared predicate devices.
Non-Clinical Testing: The manufacturer performed standard non-clinical tests (physicochemical properties, biocompatibility, shelf life, sterility) in accordance with FDA guidance for Class II contact lenses. These tests demonstrated that the specific manufactured lenses meet safety and performance standards comparable to the predicates.
No Clinical Study Required: Given the well-documented safety and effectiveness of the Hioxifilcon A material and the substantial equivalence to existing devices, the FDA deemed that clinical studies were "not required for the premarket notification." This is common for 510(k) submissions of well-understood device types with established predicates.

Summary

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May 31, 2023

Pegavision Corporation Estela Lin Regulatory Affair Senior Engineer 2F-1, No. 5, Shing Yeh St. Taoyuan City, Guishan Dist. 33341 Taiwan

Re: K222885

Trade/Device Name: Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) Regulation Number: 21 CFR 886.5925 Regulation Name: Soft (Hydrophilic) Contact Lens Regulatory Class: Class II Product Code: LPL, MVN Dated: April 27, 2023 Received: April 27, 2023

Dear Estela Lin:

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.

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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 devicerelated 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-regulatoryinformation/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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 titled, "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-devicereporting-mdr-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 -S

Image /page/1/Picture/6 description: The image shows the letters 'FDA' in a light blue color. The letters are large and take up most of the frame. The background is white.

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 Quality Center for Devices and Radiological Health

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K22885

Device Name

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

Indications for Use (Describe)

Sphere and Asphere

Toric

Multifocal

The lenses are intended for single-use 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

The following 510(K) Summary is being submitted as required by 21CFR 807.92(a).

510(k) Number: K222885

Submitter Information
Company:	PEGAVISION CORPORATION
	2F-1 No.5, Shing Yeh St., Guishan Dist., Taoyuan City 333, Taiwan
Contact Person:	Estela Lin, Regulatory Affair Senior Engineer
Phone:	886-3-329-8808
Fax:	886-3-329-8897
E-Mail:	EstelaLin@pegavision.com
Date Prepared:	April 27, 2023

Identification of Device

Trade Name:	Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Common Name:	Soft (hydrophilic) Contact Lenses (daily wear)
Classification Name:	Lenses, Soft Contact, Daily Wear 21CFR. 886.5925, Product Code LPLLens. Soft Contact (Disposable). 21CFR. 886.5925, Product Code MVN
FDA Classification:	Class II
Predicate Device Name:	K201268, Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)K213119, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

Description of Device

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solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tined with "Reactive Blue19" color additive, 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

Indications for use

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

Sphere and Asphere -

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Sphere and Asphere designs are indicated for daily wear for the correction of ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

Toric -

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Toric designs are indicated for daily wear for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +10.00 to -20.00 diopters and astigmatic corrections from -0.50 to -6.00 diopters.

Multifocal -

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.25 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

The lenses are intended for single-use disposable wear.

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Technological characteristics studies

The technological characteristics of Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) and Predicate Devices are illustrated in the following Table.

	Proposed Device	K201268 Predicate	K213119 Predicate
Production Method	Cast-Molded	Cast-Molded	Cast-Molded
USAN Name	Hioxifilcon A	Hioxifilcon A	Hioxifilcon A
MaterialClassification	Group IIhigh water non-ionic	Group IIhigh water non-ionic	Group IIhigh water non-ionic
Water Content (%)	59%	59%	59%
Refractive Index	1.400	1.400	1.400
OxygenPermeability (edgecorrected) @ 35°C	$23.2 x 10^{-11}$(cm²/sec)(mlO2/ml-mmHg)	$20.6 x 10^{-11}$(cm²/sec)(mlO2/ml-mmHg)	$25 x 10^{-11}$(cm²/sec)(mlO2/ml-mmHg)
TransmittanceVisible light @380~780nm	> 95%	> 95%	> 95%
TransmittanceUVA @ 380-315nmUVB @ 315-280nm	< 50%< 5%	< 50%< 5%	< 50%< 5%
Lens design	Sphere and AsphereToricMultifocal	Sphere and AsphereToric	Sphere and AsphereToricMultifocalMultifocal Toric
Indications for Use	Indicated for daily wear forthe correction of refractiveametropia in aphakic and/ornon-aphakic persons withnon-diseased eyes that aremyopia or hyperopia and/orpresbyopia and/orastigmatism.	Indicated for daily wear forthe correction of refractiveametropia in aphakic and/ornon-aphakic persons withnon-diseased eyes that aremyopia or hyperopia and/orastigmatism.	Indicated for daily wear forthe correction of refractiveametropia and emmetropiain aphakic and/ornon-aphakic persons withnon-diseased eyes that aremyopia or hyperopia and/orpresbyopia and/orastigmatism.

Summary of Clinical Study

Hioxifilcon A lenses have been used widely. Their safety and effectiveness have been well documented. Their safety and effectiveness can be further exemplified by three lenses cleared by FDA. The predicate devices are K201268 and K213119.

K201268_Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact ● Lenses (59% Water)
K213119, Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

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Clinical studies for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) of the present device are not required for the premarket notification, as the USAN name and process are the same as the above-mentioned predicate devices.

Non-clinical Study

All tests were conducted in accordance with the May 1994 FDA guidance title Premarket Notification 510(K) Guidance Document for Class II Contact Lenses. The non-clinical performance tests had been performed to demonstrate the safety and effectiveness of Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water).

Non-Clinical testing performed includes:

Physicochemical Properties
- Refractive Index -
- Oxygen Permeability –
- Water content -
- Extractables -
- Mechanical Property -
- Light Transmittance -
Biocompatibility Test
- Cytotoxicity Test -
- Ocular Irritation Test ।
- Acute Systemic Toxicity Test ।
Shelf Life Test and Sterility Test

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Substantial Equivalence Statement

The physical and chemical properties of Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (Proposed Device) are similar with the commercial soft lens (K201268). It's consistent with Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268). Besides, Multifocal Deisgn is similar with Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119). The proposed device lenses are the same ingredient materials (monomer, UV absorber, dye) as predicated devices K201268 and K213119.

We've conducted manufacturing verification studies for the three alternate lens designs (Sphere/Asphere, Toric and Multifocal) to ensure that lenses meet prescribed specification with established tolerances according to the 1994 FDA Contract Lens Guidance for diameter, power, and base curve.

In conclusion, the information submitted in this premarket notification supports the substantial equivalency, the Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water), with the same established safety profile and effectiveness as the predicate devices - Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) (K201268) and Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens (K213119).

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.