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510(k) Data Aggregation
(100 days)
VibrantVue Scleral Saline
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.
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.
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.
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