The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

Device Description

The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.

The proposed device consists of two versions:

For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and
For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.

AI/ML Overview

The provided document describes the VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning System. It does not contain a study explicitly proving the device meets acceptance criteria. Instead, it relies on a battery of non-clinical tests and a comparison of technological characteristics with predicate devices to establish substantial equivalence.

Therefore, many of the requested details about a specific study, acceptance criteria for performance, and ground truth establishment cannot be extracted directly from this document.

However, I can provide the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly define "acceptance criteria" for device performance in the form of specific thresholds or metrics for cleaning effectiveness. Instead, it lists the non-clinical tests performed, implying that satisfactory results from these tests constitute meeting the requirements for substantial equivalence. The "reported device performance" in terms of cleaning effectiveness is described through the successful completion of a "Protein and Lipid Removal Test."

Test Category	Specific Test	Relevant Standard/Guidance	Implied Acceptance: Satisfactory Result
Cleaning Performance	Protein and Lipid Removal Test	Citation (specific not provided)	The test results demonstrate adequate protein and lipid removal, supporting the device's cleaning function (implied by "test results show that the devices are substantially equivalent").
Biocompatibility	Ocular Irritation	ISO 10993-10, 12	Device materials are not ocular irritants.
	In Vitro Cytotoxicity Test	ISO 10993-5	Device materials are not cytotoxic.
	Sensitization	ISO 10993-10	Device materials do not cause sensitization.
	Systemic Toxicity	ISO 10993-11, 12	Device materials do not cause systemic toxicity.
Electrical Safety and EMC	General Requirements electromagnetic compatibility	IEC 60601-1-2	The device meets electromagnetic compatibility requirements.
	General Requirements electrical safety	IEC 60601-1	The device meets general electrical safety requirements.
	General Requirements home healthcare environment	IEC 60601-1-11	The device meets safety requirements for home healthcare use.
Usability	Human Factor Engineering and Usability Engineering Evaluation Report	IEC62366-1:2015	The device is user-friendly and safe for its intended use, based on human factors principles.
Material Safety	Total Extractive Residues	FDA 21 CFR 177.2600	The device's materials do not release unacceptable levels of extractive residues.
Software	Software Validation	FDA Guidance	The software components of the device are validated and function as intended.
Lens Compatibility	Lens Compatibility Test	ISO 18369-2:2017	The device is compatible with the specified types of contact lenses (soft, hybrid, rigid) without causing damage.

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

The document does not specify the sample size for the "Protein and Lipid Removal Test" or any other non-clinical test. It also does not explicitly state the country of origin of the data or whether the data was retrospective or prospective.

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

This information is not provided in the document. The document describes non-clinical tests, which typically rely on standardized protocols and laboratory measurements rather than expert consensus for ground truth.

4. Adjudication method for the test set

This information is not provided.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned. The device is a contact lens cleaning system, not an AI-powered diagnostic or interpretive tool that would involve human readers.

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

This concept is not directly applicable to a contact lens cleaning device. The "algorithm" in this context refers to the device's mechanical cleaning mechanism (3D sonic vibration technology), which operates in a "standalone" manner in that it performs its cleaning function without human intervention during the cleaning cycle. However, the overall process requires human interaction for placement of lenses and solution.

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

For the "Protein and Lipid Removal Test," the ground truth would likely be established through quantitative laboratory measurements of protein and lipid levels on the contact lenses before and after cleaning, using standardized analytical methods. For other non-clinical tests (e.g., biocompatibility), the ground truth is based on the adherence to specified ISO standards and the absence of adverse biological reactions or safety failures.

8. The sample size for the training set

This information is not applicable and not provided. The device is a mechanical cleaning system and does not employ a machine learning model that would require a training set in the conventional sense.

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

This information is not applicable and not provided, as there is no mention of a machine learning model or a training set.

Summary

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April 1, 2021

VueSonic, LLC % Marc Sanchez Regulatory Attorney Contract In-House Counsel and Consultants, LLC 1717 Pennsylvania Ave. NW, Suite #1025 Washington, D.C. 20006

Re: K210300

Trade/Device Names: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System Regulation Number: 21 CFR 886.5928 Regulation Name: Soft (Hydrophilic) Contact Lens Care Products Regulatory Class: Class II Product Code: LYL, MRC Dated: February 2, 2021 Received: February 3, 2021

Dear Marc Sanchez:

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.

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ence determination does not mean that FDA

Page 2

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 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 medical devices and radiation-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.

for Angelo Green, PhD 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

Enclosure

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Indications for Use

510(k) Number (if known)

K210300

Device Name

VueSonic One Contact Lens Cleaning System VueSonic Advance 2 Contact Lens Cleaning System

Indications for Use (Describe)

The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

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 information is provided as required by 21 CFR

807.92 for the VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning System 510(k) premarket notification.

Sponsor:	VueSonic LLC1234 Washington Ave, Suite 205Miami Beach, FL 33139Establishment Registration: to be determinedPh: 855-770-0883
Manufacturer:	VueSonic LLC1234 Washington Ave, Suite 205Miami Beach, FL 33139Establishment Registration: to be determinedPh: 855-770-0883
Contact:	Marc C. Sanchez, Esq.Contract In-House Counsel and Consultants, LLC1717 Pennsylvania Ave. NW, Suite #1025Washington, D.C. 20006Ph: 202-765-4491Email: msanchez@fdaatty.com

Date of 510(k) Summary Preparation: March 18, 2021

Proprietary Names: VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System

Common Name: Accessories, Solution, Ultrasonic Cleaners For Lenses

Regulation Number: 21 CFR 886.5928/21 CFR 886.5918

Regulatory Class: Class II

Product Code: LYL/MRC

Predicate Device(s): New Comfort Contact Lens Accessory (K974724) and AUTOLENS® System (K021699)

Device Description: The VueSonic One Contact Lens Cleaning System and VueSonic Advance 2 Contact Lens Cleaning Systems are cleaning systems for contact lenses. Both devices consist of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The systems are designed to mimic human hand rubbing. This is done by the 3D

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multi-frequency.

The proposed device consists of two versions:

. For Rigid Lenses, VueSonic Advance 2 Contact Lens Cleaning System; and
. For Soft and Hybrid Lenses, VueSonic One Contact Lens Cleaning System.

VueSonic One:

The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses. It consists of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens.

The system is de- signed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.

The proposed device is compatible with Soft and Hybrid contact lens from all the brands with a diameter equal or less than 15mm. This limitation is due to the size of the device and in particular the damping head.

The proposed device is compatible with all "multi-purpose" cleaning solution such as Bausch & Lomb Multi-action Solution and Opti-Free. The only incompatible solution is Clear Care and Clear Care Plus because Clear Care requires its own standing case and contains 3% Hydrogen Peroxide, which may cause serious damage to eyes when used improperly.

VueSonic Advance 2

The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses. It consists of a device body, a contact lens holder, which houses the cleaning cushions and the damping heads. The contact lens holder, cleaning cushions and damping heads are made of soft medical silicone, which will not damage the lens. The system is designed to mimic human hand rubbing. This is done by the 3D multi-frequency modulated stereo power source and corresponding intelligent control circuit, which make a uniform three-dimensional relative movement between the damping heads and cleaning cushion.

The proposed device is compatible with Rigid contact lens from all the brands with a diameter equal or less than 15mm. This limitation is due to the size of the device and in particular the damping head.

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Indications for Use:

The VueSonic One Contact Lens Cleaning System is a cleaning system for Soft and Hybrid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

The VueSonic Advance 2 Contact Lens Cleaning System is a cleaning system for Rigid contact lenses by mimicking digital rubbing with 3-D sonic Vibration Technology.

Summary of Non-Clinical Test Reports

The following tests were performed on the subject devices and the test results show that the devices are substantially equivalent to the predicate devices on the market.

Table 1Summary of Non- Clinical Test Reports
Biocompatibility	Ocular Irritation	ISO 10993-10, 12
	In Vitro Cytotoxicity Test	ISO 10993-5
	Sensitization	ISO 10993-10
	Systemic Toxicity	ISO 10993-11, 12
Electrical Safety and ElectromagneticCompatibility	GeneralRequirementselectromagneticcompatibility	IEC 60601-1-2
	General Requirements electricalsafety	IEC 60601-1
	General Requirementshome healthcareenvironment	IEC 60601-1-11
Usability	Human Factor Engineering andUsabilityEngineeringEvaluation Report	IEC62366-1:2015
Protein and Lipid Removal Test	Protein and Lipid Removal Test	Citation
Total Extractive Residues	Total Extractive Residues	FDA 21 CFR 177.2600
Software	Software Validation	FDA Guidance
Lens Compatibility Test	Lens Compatibility Test	ISO 18369-2:2017

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Traditional 510(k) Submission

Summary of Substantial Equivalence

The VueSonic One Contact Lens Cleaning System, VueSonic Advance 2 Contact Lens Cleaning System, and the predicates use a multipurpose contact lens solution and a physical mode of action to clean contact lenses. The proposed device uses a sophisticated multi-frequency modulated stereo power system, while K974724 uses ultrasonic waves and K021699 uses a tumbling motion. The different motions are all aimed at mimicking hand rubbing to physically clean contact lenses. There may be minor differences in labeling but this does not raise any new questions of safety or effectiveness.

DeviceName/Model	Vue Sonic OneContact LensCleaning System,Vue SonicAdvance 2Contact LensCleaning System	New Comfort ContactLens Accessory	AUTOLENS® System
510(k) Number	K210300	K974724	K021699

Table 2 Technological Characteristics

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Indications for Use
	The VueSonicOne Contact LensCleaning System is acleaning system for Softand Hybrid contactlenses by mimickingdigital rubbing with 3-Dsonic VibrationTechnology. TheVueSonicAdvance 2Contact Lens CleaningSystem is a cleaningsystem for Rigid contactlenses by mimickingdigital rubbing with 3-Dsonic VibrationTechnology.	The New Comfort ContactLens Care Accessory isintended for use inconjunction with contact lenssolutions as an accessory inthe cleaning of contact lenses.The New Comfort ContactLens Care Accessory isindicated as aid for cleaningas an accessory for softhydrophilic lenses and gaspermeable lenses when usedwith the appropriateAllergan® Soft Mate®solutions such as the	The AUTOLENS® AutomaticContact Lens CleaningAccessory is indicated for thecleaning of soft (hydrophilic)rigid gas permeable (RGP)and hard(PMMA) contact lenseswhen used withAUTOLENS® MultipurposeSolution. This automaticcontact lens cleaningaccessory cleans contactlenses without digital

	Consept® Cleaning andDisinfection System which iscomprised of theAllergan® Soft Mate®Consept®-1 Cleaning andDisinfecting solution andAllergan® Soft Mate®Consept®-2 Neutralizing andRinsing Solution or Spray.The New Comfort ContactLens Care Accessory isindicated for use for gaspermeable solutions such asAllergan® Gas PermeableDaily Cleaner andAllergan® ComfortCare GPWetting and SoakingSolution. The NewComfort ContactLens Care Accessory may beused for a receptacle forchemical disinfection.	rubbing. The AUTOLENS®Automatic Contact LensCleaning Accessory may beused as a receptacle forchemical disinfection withAUTOLENS® MultipurposeSolution.AUTOLENS®Multipurpose Solution isindicated for use in cleaning,rinsing, chemical (not heat)disinfecting and proteinremoval, storing soft(hydrophilic), rigid gaspermeable fluoro-siliconeacrylate and silicone acrylate)and PMMAcontact lenses asrecommendedby your eye care practitioner.
Mode ofAction	3D multi-frequencymodulated stereopower source andcorrespondingintelligent controlcircuit, which make auniform threedimensional relativemovement betweenthe damping heads and	Bubbles created from piezoelectric crystal (ultrasonic)	Tumble motion

Power Source	1.5~3Vbattery (one or two"AAA"batteries)	110/120v (standard powerusing four- foot UL cord)	1.5v (three"AA"batteries)
Materials	Medical gradesilicone	ABS	Polypropylene resin plastic
Cleaning Time	2 minutes	Unknown	Unknown
Watts ofPower perMilliliter ofFluid	0.37 to 0.72 watt/ ml	Unknown	Unknown

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Conclusion:

Therefore, taking into consideration Table 1 for Substantial Equivalence, an analysis of safety, indications, intended uses, performance, and technological properties, the VueSonic Contact Lens Cleaning System raises no new issues of safety or effectiveness and has been found to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 886.5928 Soft (hydrophilic) contact lens care products.

(a)
Identification. A soft (hydrophilic) contact lens care product is a device intended for use in the cleaning, rinsing, disinfecting, lubricating/rewetting, or storing of a soft (hydrophilic) contact lens. This includes all solutions and tablets used together with soft (hydrophilic) contact lenses and heat disinfecting units intended to disinfect a soft (hydrophilic) contact lens by means of heat.(b)
Classification. Class II (Special Controls) Guidance Document: “Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products.”