(82 days)
The Dynarex Eye Cup is a non-sterile device made of opaque Polyethylene designed to be filled with an eyewash solution and placed over the eye to allow the solution to wash out or flush the affected eye.
The Dynarex Eye Cup is a 12ml plastic cup, manufactured with polyethylene plastic that is designed to be filled with an eye wash solution and placed over the eye to allow the solution to wash out or flush the affected eye. The cup is non-sterile and is re-usable.
The provided document describes the Dynarex Eye Cup (K151575) and its equivalence to a predicate device. However, it does not contain information about acceptance criteria, device performance, a specific study proving those criteria, or details regarding sample sizes, expert involvement, ground truth, or comparative effectiveness studies.
The document makes a claim of "substantial equivalence" based on similar intended use, design, and biocompatibility testing. The "biocompatibility testing" is presented as the study proving safety and effectiveness, but no detailed results or comparative data against specific acceptance criteria for performance are provided.
Here's a breakdown of the information that is and is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device's function (washing/flushing the eye). The equivalence is largely based on material safety and basic design.
- Reported Device Performance: No quantitative performance metrics are provided. The "performance" is implicitly tied to its function of holding eyewash solution and being placed over the eye.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
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: Not applicable. This device is an eye cup, not an AI-powered diagnostic tool requiring human reader studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used: Not explicitly stated, as no performance study is detailed. The "ground truth" for the substantial equivalence claim relies on the predicate device's established safety and effectiveness.
8. The sample size for the training set: Not applicable, as this is a physical device and not an AI algorithm.
9. How the ground truth for the training set was established: Not applicable.
Summary of Bio-compatibility Testing (as presented as the "study"):
The document states one "study" was conducted, focusing on biocompatibility.
- Study Name/Type: Biocompatibility testing.
- Tests Performed: Acute Systemic Toxicity, In-Vitro Cytotoxicity, Ocular Irritation, and Maximization (sensitization).
- Results: "Results of the biocompatibility testing showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response."
- Conclusion: "All materials used in the manufacture of the Dynarex Eye Wash Cup have demonstrated to be substantially equivalent in regards to safety and effectiveness to the predicate device and are safe for its intended use."
Comparison Table as provided in the document (illustrates equivalence, not performance against criteria):
| Characteristic | Applicant Device Dynarex Eye Cup | Predicate Device Flents Plastic Eye Wash Cup |
|---|---|---|
| Classification Name | Cup, Eye | Cup, Eye |
| Intended Use | The Dynarex Eye Cup is a non-sterile device is placed over the eye to allow the solution to wash out or flush the affected eye. | The Flents Eye Wash Cup is intended to hold liquids such as eye wash solution, used to flush out the eye. |
| Design | Polyethylene | ABS Plastic |
| Color | Natural molded color - no colorant - whitish/opaque | TZE Kun Plastic Materials. No. 216941 White |
| Volume | 17ml | 0.65 fl. Oz. (19ml) |
| Dimensions | 1.732 in x 1.062 in | 1.903 in x 1.353 in |
| Materials | Sinopec Yangzi Pertrochemical Co. Ltd. LDPE - No. 2426H | Chi Mei ABS No. PA-757 |
| Sterility | Non Sterile | Non Sterile |
| Reuse | Reusable | Reusable |
| Labeling / Cleaning | "Wash cup thoroughly with soap and warm water before use. Rinse well and dry to ensure eye wash cup is not contaminated with any previous liquids or materials prior to each use" | "Wash cup thoroughly with soap and warm water before use. Rinse well and dry to ensure eye wash cup is not contaminated with any previous liquids or materials prior to each use" |
The document focuses on demonstrating that the Dynarex Eye Cup is substantially equivalent to a predicate device, as opposed to providing detailed performance data against specific, quantitatively defined acceptance criteria for its function. The "study" mentioned pertains solely to the biocompatibility of the materials.
N/A