The Vibrant Vue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

Device Description

The VibrantVue Scleral Saline is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial. The VibrantVue Scleral Saline is a 0.9 % saline solution that conforms to the requirements of USP saline. The rinsing solution removes loose debris and lens cleaners off rigid gas permeable (RGP) contact lenses following proper disinfection as recommended by the eye care practitioner. The sterile solution can be used to rinse contact lens cases and contact lenses as needed throughout the day.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the VibrantVue Scleral Saline:

This document describes a medical device, VibrantVue Scleral Saline, and its clearance through the FDA's 510(k) pathway. The 510(k) process is for devices found to be "substantially equivalent" to a legally marketed predicate device, rather than requiring extensive clinical trials to prove efficacy from scratch. As such, the "acceptance criteria" discussed below relate to demonstrating substantial equivalence and meeting established standards for saline solutions and contact lens care products.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't present a formal table of "acceptance criteria" with numerical performance metrics in the way one might expect for a diagnostic or AI device. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to the predicate device and meeting recognized standards for saline solutions and contact lens care products.

Acceptance Criterion (Implicit)	Reported Device Performance
Intended Use Equivalence: The new device's intended use should be substantially equivalent to the predicate device.	The VibrantVue Scleral Saline has an identical intended use to the predicate, Menicon Saline Rinse Solution, for rinsing and insertion of large diameter RGP contact lenses, rinsing cases, and rinsing lenses throughout the day. The only difference noted is the predicate's additional indication for soft and hard contact lenses, which the new device does not claim.
Indications for Use Equivalence: The new device's indications for use should be substantially equivalent to the predicate device.	The indications for use are described as being substantially equivalent.
Actions Equivalence: The mechanism/function of the new device should be substantially equivalent to the predicate device.	The "actions" are deemed substantially equivalent. The device removes loose debris and lens cleaners.
Classification Equivalence: The new device should fall under the same regulatory classification as the predicate.	Both devices are classified under 21 CFR 886.5918 (Rigid Gas Permeable Contact Lens Care Products) and are Class II devices. (Predicate also had 21 CFR 886.5928; new device did not claim it). Both have product code MRC. (Predicate also had LPN; new device did not claim it).
Formulation Equivalence: The new device should have a substantially equivalent formulation to the predicate, particularly for key characteristics.	Both are described as sterile, preservative-free, unbuffered, single-dose, 0.9% saline solutions conforming to USP monograph. Both are supplied in 5 mL single-dose vials and plastic resin containers with twist-off caps.
Physical Compatibility: The device should be physically compatible with currently marketed rigid gas permeable (RGP) contact lenses.	Demonstrated through non-clinical studies.
Packaging Safety: The packaging should be non-toxic and non-irritating.	Demonstrated through non-clinical studies.
Stability and Sterility: The product inside its packaging should remain stable and sterile throughout its proposed expiration date.	Demonstrated through non-clinical studies.
Safety and Effectiveness: The device must be as safe and effective as the legally marketed predicate device. This is the overarching goal of the substantial equivalence determination.	Concluded based on composition and non-clinical testing results, supporting labeling directions and proposed indication.

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

The document states that only non-clinical studies were conducted. There was no "test set" in the context of human patient data for the VibrantVue Scleral Saline device.

The non-clinical studies would have involved laboratory testing of the saline solution itself, its packaging, and its interaction with contact lens materials. The data provenance for these non-clinical studies is not specified (e.g., in-house lab, third-party lab), nor are specific sample sizes for these tests detailed in this summary.

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

Not applicable. No clinical test set involving human data was used, therefore no experts were required to establish ground truth for such a set. The "ground truth" for the non-clinical tests would be defined by established scientific methods, standards (e.g., USP monograph for 0.9% saline), and regulatory requirements for sterility, compatibility, and toxicity.

4. Adjudication Method for the Test Set

Not applicable. As there was no clinical test set requiring human interpretation, no adjudication method was used. Non-clinical studies rely on standardized test protocols and objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used to assess human reader performance, often with and without AI assistance, for diagnostic or interpretive tasks. The VibrantVue Scleral Saline is a contact lens care solution, not a diagnostic or AI-powered device, so such a study is not relevant or required for its clearance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. The VibrantVue Scleral Saline is a physical medical device (a saline solution), not an algorithm or AI system. Therefore, "standalone (algorithm only)" performance is not relevant.

7. The Type of Ground Truth Used

For the non-clinical studies, the "ground truth" was established based on:

USP Monograph for 0.9% Saline: This defines the chemical composition and purity standards for saline.
Industry Standards and Regulatory Requirements: For sterility, packaging safety (non-toxicity, non-irritating), and physical compatibility with RGP contact lenses. These are typically objective, measurable criteria.

8. The Sample Size for the Training Set

Not applicable. As VibrantVue Scleral Saline is a physical medical device and not an AI/ML algorithm, there was no "training set."

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

Not applicable. There was no training set.

Summary

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July 31, 2020

Dry Eye Innovations, LLC % Bret Andre Principal Consultant EyeReg Consulting, Inc. 6119 Canter Ln West Linn, OR 97068

Re: K201069

Trade/Device Name: VibrantVue Scleral Saline Regulation Number: 21 CFR 886.5918 Regulation Name: Rigid Gas Permeable Contact Lens Care Products Regulatory Class: Class II Product Code: MRC Dated: June 29, 2020 Received: July 2, 2020

Dear Bret 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. 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K201069

Device Name VibrantVue Scleral Saline

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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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: K201069

I. SUBMITTER

Date Prepared:	June 29th, 2020
Name:	Dry Eye Innovations LLC
Address:	1200 Harger RdSuite 211Oak Brook, IL 60523
Contact Person:	Donald R. SandersManager and CEO
Phone number:	(630) 530-9700
Consultant:	Bret AndreEyeReg Consulting, Inc.6119 Canter Ln.West Linn, OR 97068
Phone number:	(503) 372-5226

II. DEVICE

Trade Name:	VibrantVue Scleral Saline
CommonName:	Contact Lens Insertion Solution
ClassificationName:	Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918)
RegulatoryClass:	Class II
Product Code:	MRC

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PREDICATE DEVICE III.

The VibrantVue Scleral Saline is substantially equivalent in terms of actions and indications to the following predicate device:

o "Menicon Saline Rinse Solution" By Menicon Co., Ltd. 510(k) number: K151768 Device Classification: II

IV. DEVICE DESCRIPTION

V. INDICATIONS FOR USE

The VibrantVue Scleral Saline is indicated for use following proper lens disinfection as recommended by the eye care practitioner. The VibrantVue Scleral Saline is for rinsing large diameter (scleral) rigid gas permeable (RGP) contact lenses prior to lens insertion. This solution may also be used as an insertion solution for large diameter (scleral) contact lenses, as a rinse for contact lens cases, and may be used as needed throughout the day to rinse contact lenses.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH PREDICATE DEVICE

The VibrantVue Scleral Saline solution is substantially equivalent to the predicate device in terms of the following:

Intended use
Indications for use
트 Actions
Classification - Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918)
트 How supplied (sterile, single dose)
Unbuffered, preservative free formulation ■
Formulation conforms to USP monograph for 0.9% saline

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The following matrix illustrates the intended use and other characteristics of the VibrantVue Scleral Saline solution, as well as the predicate device.

	Visionary Optics LLC	Menicon Co., Ltd.
	VibrantVue Scleral Saline	Menicon Saline Rinse Solution
	New Device	Predicate Device (K151768)
Intended Use	The VibrantVue Scleral Saline solution isindicated for use following proper lensdisinfection as recommended by the eye carepractitioner. The VibrantVue Scleral Salinesolution is for rinsing large diameter (scleral)rigid gas permeable (RGP) contact lensesprior to lens insertion. This solution may alsobe used as an insertion solution for largediameter (scleral) contact lenses, as a rinsefor contact lens cases, and may be used asneeded throughout the day to rinse contactlenses.	The Menicon Saline Rinse Solution isindicated for use following proper lensdisinfection as recommended by the eyecare practitioner. The Menicon SalineRinse Solution is for rinsing soft(hydrophilic), rigid gas permeable andhard contact lenses prior to lensinsertion. This solution may also be usedas an insertion solution for largediameter (scleral) contact lenses, as arinse for contact lens cases, and may beused as needed throughout the day torinse contact lenses.
Classification	21 CFR 886.5918	21 CFR 886.5918 ; 21 CFR 886.5928
Product Code	MRC	MRC; LPN
Class	Class II	Class II
Volume	5 mL per dose	5 mL per dose
Preservative Free	Yes	Yes
Single or Multi Dose	Single Dose	Single Dose
Sterility	Sterile	Sterile
Container	Plastic resin container with twist off cap	Plastic resin container with twist off cap
Unbuffered	Yes	Yes
Formulation Conforms to USPMonograph for 0.9% Saline	Yes	Yes

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VII. PERFORMANCE DATA

~ Non-Clinical Studies ~

A series of studies were completed to demonstrate the substantial equivalence of the VibrantVue Scleral Saline solution to the predicate device. Results of non-clinical testing demonstrate:

The VibrantVue Scleral Saline solution is physically compatible with currently marketed rigid gas permeable contact lenses
The packaging is non-toxic and non-irritating ●
The VibrantVue Scleral Saline solution is stable and sterile throughout the proposed ● expiration date

~ Clinical Studies ~

Clinical studies involving the saline solution were unnecessary for this application. The VibrantVue Scleral Saline is a 0.9 % saline solution that meets the requirements of USP saline. Lens care solutions used with this saline solution are already cleared for use as cleaning, rinsing, disinfection and storage solutions for contact lenses.

CONCLUSIONS VIII.

Substantial Equivalence

Based on the composition of the solution and results of non-clinical testing presented in this Premarket Notification, the VibrantVue Scleral Saline solution is as safe and effective as the predicate device when used in accordance with the labeled directions for use and for the proposed indication.

Regulation Number and Section

§ 886.5918 Rigid gas permeable contact lens care products.

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