(100 days)
No
The device is a saline solution for rinsing contact lenses and does not involve any computational or analytical functions that would utilize AI/ML. The description focuses on the chemical composition and intended use as a rinsing agent.
No.
The device is a saline solution for rinsing contact lenses and cases, which is for maintenance of a medical device (contact lenses) and not directly for treating a medical condition or ailment in a patient.
No.
The device is a saline solution for rinsing and inserting contact lenses, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, preservative-free, unbuffered saline solution in a single dose 5 ml vial, which is a physical product, not software.
Based on the provided information, the VibrantVue Scleral Saline is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for rinsing and inserting contact lenses, rinsing contact lens cases, and rinsing contact lenses throughout the day. This is a direct interaction with a medical device (contact lens) and the user, not for examining specimens from the human body to provide diagnostic information.
- Device Description: The description details a sterile saline solution for rinsing and insertion, not for analyzing biological samples.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or aid in the treatment of any disease or condition by examining in vitro specimens.
- Performance Studies: The performance studies focus on physical compatibility, packaging toxicity, stability, and sterility, which are relevant for a contact lens solution, not for evaluating diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. The VibrantVue Scleral Saline does not fit this description.
N/A
Intended Use / 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 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.
Product codes
MRC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
eye care practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
1
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)
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.
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 Rd |
| Suite 211 | |
| Oak Brook, IL 60523 | |
| Contact Person: | Donald R. Sanders |
| Manager and CEO | |
| Phone number: | (630) 530-9700 |
| Consultant: | Bret Andre |
| EyeReg Consulting, Inc. | |
| 6119 Canter Ln. | |
| West Linn, OR 97068 | |
| Phone number: | (503) 372-5226 |
II. DEVICE
| Trade Name: | VibrantVue Scleral Saline |
|---|---|
| Common | |
| Name: | Contact Lens Insertion Solution |
| Classification | |
| Name: | Rigid Gas Permeable Contact Lens Care Products (21 CFR 886.5918) |
| Regulatory | |
| Class: | Class II |
| Product Code: | MRC |
4
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
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.
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 is | |
| indicated for use following proper lens | ||
| disinfection as recommended by the eye care | ||
| practitioner. The VibrantVue Scleral Saline | ||
| solution 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. | The Menicon Saline Rinse Solution is | |
| indicated for use following proper lens | ||
| disinfection as recommended by the eye | ||
| care practitioner. The Menicon Saline | ||
| Rinse Solution is for rinsing soft | ||
| (hydrophilic), rigid gas permeable and | ||
| hard 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. | ||
| 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 USP | ||
| Monograph 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.