(266 days)
The Hudson RCI® Addipak® Unit Dose Vial, 0.9% Full Normal Saline Solution may be used in conjunction with a non-ventilatory nebulizer for lavage therapy, or for tracheal irrigation.
Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution is a pre-filled vial of sterile 0.9% saline for inhalation therapy. The content of this product is a 0.90% sodium chloride solution (normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in three sizes (3mL, 5mL, and 15mL). These products are single-use, disposable, and intended for inhalation only.
Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution filled with sterile saline solutions conforms to the specifications of the USP monograph for Sodium Chloride Inhalation Solution.
Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution have a perforated, break-away twist cap for dispensing the solution. When twisted by the user, the cap breaks away and opens a small hole for solution to pass through. The Hudson RCT® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution are designed with inverted graduations to allow the clinician to read volume while dispensing the solution.
This document is a 510(k) Pre-market Notification for a medical device called the "Hudson RCI® AddiPak® Unit Dose Vial, 0.9% Full Normal Saline Solution." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the safety and efficacy of a novel device through extensive clinical trials.
Therefore, the provided document does not contain the kind of information typically associated with AI/ML diagnostic device studies. Specifically, it lacks:
- Acceptance Criteria for AI Performance: There's no AI model, so no performance metrics like sensitivity, specificity, AUC, F1-score, etc., are defined or measured.
- Sample Size for Test/Training Sets, Data Provenance, Ground Truth Experts/Methods, MRMC Studies, Standalone Performance: These are all concepts related to the evaluation of AI algorithms, which are not applicable to this saline solution product.
Instead, this document describes a non-clinical evaluation comparing a new saline solution product to existing, legally marketed predicate devices. The goal is to demonstrate that the new device is "substantially equivalent" and raises no new questions of safety or effectiveness.
Here's a breakdown of the relevant information provided in the document regarding the acceptance criteria and study for the saline solution product:
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't present acceptance criteria and performance in a single table for the saline solution itself. Instead, it outlines bench testing conducted to ensure the proposed device performs as intended and is substantially equivalent to predicate devices. The "performance" is demonstrated by meeting the standards of these non-clinical tests.
| Test Performed | Principle of Test | Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|---|---|
| Leak Test | Leak detection in polyethylene vial by vacuum method | No leaks detected | "performed to verify that the performance...will perform as intended." (No leaks detected) |
| Twist-Off Test | A manual removal of the twist-off cap to ensure proper dispensing of solution when inverted and squeezed | Cap twists off easily, and solution dispenses properly | "performed to verify that the performance...will perform as intended." (Cap functions as designed) |
| Ship Test | Shipping simulation (ISTA 1A) to ensure vials are damage-free and do not leak | Vials are damage-free and do not leak after shipping simulation | "performed to verify that the performance...will perform as intended." (Vials withstand shipping simulation successfully) |
| Biocompatibility | Cytotoxicity, irritation, sensitization, genotoxicity, and implantation testing (ISO 10993-1) | All patient-contacting materials comply with ISO 10993-1 | "All patient contacting materials are in compliance with ISO 10993-1." |
| Material Testing | USP physiochemical test for plastics (nonvolatile residue, heavy metals, buffering capacity) | Meet USP criteria | "found to meet the criteria for nonvolatile residue, heavy metals and buffering capacity." |
| Solution Purity | Conforms to USP monograph for Sodium Chloride Inhalation Solution | Conforms to USP specifications | "conforms to the specifications of the USP monograph for Sodium Chloride Inhalation Solution." |
| Sterilization | Per USP | Meets USP sterility requirements | "Per USP " (implies compliance) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not explicitly stated for each test. The testing is non-clinical bench testing.
- Data Provenance: The tests are conducted in a laboratory setting by the manufacturer (Teleflex Medical, Inc.). This is likely an internal, prospective study as part of the product development and regulatory submission. No country of origin for "data" in the sense of patient data is applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. There is no "ground truth" established by experts in the context of an AI/ML diagnostic device. The evaluation relies on standardized physical, chemical, and biological tests for product performance and safety.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication" in the context of human expert disagreement on interpretations for an AI model. The tests have objective pass/fail criteria.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This is not an AI/ML diagnostic device, and thus no MRMC study, human reader improvement with AI, or effect size is relevant.
6. Standalone Performance Study
Not applicable in the context of AI. The device is the saline solution itself, and its performance is evaluated in a standalone manner via bench testing as detailed in point 1.
7. The Type of Ground Truth Used
Not applicable in the AI sense. The "ground truth" for this product's evaluation is defined by:
- Physical characteristics (e.g., absence of leaks, proper cap function).
- Chemical specifications (e.g., 0.90% sodium chloride solution, meeting USP monograph).
- Biocompatibility standards (e.g., ISO 10993-1).
- Sterility standards (e.g., USP ).
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device, so there is no training set or ground truth establishment for it.
In summary: This document is a regulatory submission for a simple medical device (a saline solution) demonstrating its substantial equivalence to previously approved devices through non-clinical bench testing and adherence to recognized standards. It does not involve any artificial intelligence or machine learning components, and thus the questions pertinent to AI device evaluation are not addressed.
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).