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510(k) Data Aggregation
(141 days)
FLENTS PLASTIC EYE WASH CUP
The Apothecary Products, Inc. Plastic Eye Wash Cup is intended to hold liquids such as eye wash solutions, used to flush out the eye.
The Flents Plastic Eye Wash Cup is a 0.65 fl. oz. (19 mL) plastic cup manufactured with Chi- Mei ABS PA-757 White plastic that is 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 Flents Plastic Eye Wash Cup is non-sterile and is reusable.
This document describes a 510(k) premarket notification for the Flents Plastic Eye Wash Cup, focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the way one might for a novel diagnostic or therapeutic device. Therefore, many of the requested elements for describing a study proving performance against acceptance criteria are not directly applicable or present in this submission.
However, I will extract the relevant information where available and explain why other sections are not filled based on the provided text.
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
This 510(k) submission for the Flents Plastic Eye Wash Cup does not present a study with specific performance acceptance criteria in the format typically seen for novel medical devices (e.g., diagnostic accuracy, efficacy endpoints). Instead, it demonstrates substantial equivalence to a previously cleared predicate device, K051414 (Tollot Pty. Ltd. (Aaxis Pacific) Eye Cup), primarily through biocompatibility testing and comparison of fundamental attributes.
The "acceptance criteria" are effectively the demonstration that the new device is as safe and effective as the predicate device such that no new questions of safety or effectiveness are raised. The "study" performed is biocompatibility testing of the materials and a comparison of design and intended use to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a relatively low-risk device, the "acceptance criteria" are implicitly met by demonstrating that the materials are biocompatible and the design and intended use are comparable to a legally marketed predicate.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (Summary of Findings) |
|---|---|
| Biocompatibility: No evidence of cellular or systemic toxicity, ocular irritation, or sensitization response for materials in contact with eyewash solutions and the eye. | Biocompatibility testing (Acute Systemic Toxicity, In-vitro Cytotoxicity, Ocular Irritation, Maximization Sensitization) showed no evidence of cellular or systemic toxicity, ocular irritation, or a sensitization response. All materials demonstrated safety for intended use. |
| Intended Use: Device holds liquids such as eye wash solutions to flush out the eye, similar to the predicate. | The Flents Plastic Eye Wash Cup's intended use is identical to the predicate device: "intended to hold liquids such as eye wash solutions, used to flush out the eye." |
| Design: Similar design to predicate, an ABS plastic receptacle for eyewash solutions. | Design is "similar" to the predicate, being an ABS Plastic receptacle for eyewash solutions. Dimensions and volume are specified. |
| Safety and Effectiveness: No new questions of safety or effectiveness raised compared to the predicate device. | Based on biocompatibility testing and comparison of attributes, the device is considered substantially equivalent in safety and effectiveness. Instructions for reusable, non-sterile use (washing before use) address a key difference. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: For the biocompatibility testing, the sample size is not explicitly stated in the provided text (e.g., number of animals for in-vivo tests, number of cell cultures for in-vitro tests). It generally refers to the samples of the "Chi Mei ABS PA-757 White plastic" material itself, and possibly its colorant.
- Data Provenance: The biocompatibility testing was "performed by third-party laboratories." The country of origin for the data is not specified. The studies are assumed to be prospective in nature, meaning they were conducted specifically for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: This information is not explicitly provided. Biocompatibility studies are typically conducted by qualified laboratory personnel following established standards (e.g., ISO 10993). The interpretation of results and overall conclusion of safety would be overseen by toxicologists or similar experts.
- Qualifications of Experts: Not specified in detail, but implied to be qualified personnel within the third-party laboratories performing the tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable in the context of biocompatibility testing. The "ground truth" for biocompatibility is determined by the results of the standardized biological tests themselves against accepted cytotoxicity, irritation, and sensitization criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for imaging devices or diagnostic aids where human readers interpret output, and the goal is to quantify the improvement in human performance with AI assistance. The Flents Plastic Eye Wash Cup is a simple mechanical device; such a study is not applicable.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance Study: No, a standalone performance study (in the context of an algorithm's performance without human intervention) was not done. This is not an AI/algorithm-driven device. The "standalone performance" of the device itself relates to its physical properties and material safety, which was assessed through biocompatibility testing.
7. The Type of Ground Truth Used
- Ground Truth: For the "study" (biocompatibility testing), the ground truth is based on standardized biological test results and accepted criteria for biocompatibility (e.g., ISO 10993 standards). For the comparison to the predicate, the "ground truth" is the established safety and effectiveness of the legally marketed predicate device.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This device does not involve machine learning or an "algorithm" in the sense that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device submission.
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