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Contents of these products may be sterile water or a 0.45% sodium chloride solution (half-normal saline). Vials are factory-sealed, made of translucent, color-coded polyethylene, and are available in two sizes (3mL and 5mL). These products are single-use, and intended for inhalation only. Color-coded vials identify contents as sterile water (blue) and half-normal 0.45% saline (green).

The pre-filled vials have a perforated, break-away twist cap for dispensing solution. When twisted by the user, cap breaks away and open a small hole for solution to pass through. Vials are designed with inverted graduations to allow the clinician to read volume while dispensing solution. Addipak unit dose vials conforms to the specifications of United States Pharmacopeia – National Formulary, Sterile Water for Inhalation and Sterile Sodium Chloride for Inhalation monograph.

AI/ML Overview

This document pertains to the clearance of a medical device (Hudson RCI® AddiPak® Unit Dose Vial) and does not describe artificial intelligence (AI) or machine learning (ML) device performance. Therefore, many of the requested categories related to AI/ML device studies are not applicable.

Acceptance Criteria and Device Performance

The acceptance criteria for the Hudson RCI® AddiPak® Unit Dose Vial are based on demonstrating substantial equivalence to a predicate device (Hudson RCI® AddiPak® Unit Dose Vials K142153) and satisfying various non-clinical testing requirements. The reported device performance is presented through a comparison of the proposed device's characteristics against the predicate and reference devices, along with summaries of non-clinical testing.

Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Tests	Reported Device Performance	Comments
Intended Use	The device should be used in conjunction with a non-ventilator nebulizer for lavage therapy or tracheal irrigation. Single-use, disposable, and intended for inhalation only.	Same as predicate and reference devices.	The proposed device (Sterile Water and 0.45% Half Normal Saline) covers the same intended uses as the predicate (0.9% Full Normal Saline) and reference devices (Sterile Water and 0.45% Half Normal Saline).
Technological Characteristics	Matching or being substantially equivalent in key characteristics to the predicate and reference devices.	See "Summary of Technological Characteristics" table on pages 5-7. All characteristics (Product Code, Regulation Number, Materials in fluid contact, Prescription vs. OTC, Contraindications, Sterile vs. Non-Sterile, Vial Design, Single Use vs. Reusable, Patient Population, Used with Nebulizers, Inhalation Only, Manufacturing Process) were found to be the "Same" as the predicate or reference devices. Differences in solution type, packaging size, and the inclusion of a nebulizer were addressed by reference devices.	Demonstrates equivalence in fundamental design and operational principles.
Biocompatibility	Meeting specified biocompatibility standards.	Passed all listed tests: Cytotoxicity, Sensitization, Intracutaneous Reactivity, Material Mediated Pyrogenicity, Chemical Characterization with Toxicological Risk Assessment, USP 661, USP 788.	No adverse findings reported, indicating the materials are safe for intended use.
Performance Testing (Bench)	Meeting specified stability and sterility standards.	Passed Stability and Sterility tests.	Confirms the product maintains its integrity and purity over its shelf life.
Shelf Life	A specified duration from the date of manufacture.	2 years from date of manufacture.	Matches the predicate device's shelf life.
Packaging Size	Available in specified volumes.	3mL, 5mL.	Matches sizes available in reference devices. Predicate included a 15mL option, which is not part of the proposed device.
Solution Type	Sterile water and 0.45% Half Normal Saline.	Matches the solutions available in reference devices. Predicate specifically contained 0.9% Full Normal Saline.	The range of solutions is effectively covered by combining the predicate and reference devices.

Study Details (Not Applicable for this Device Type)

The provided document describes the FDA clearance for a physical medical device (unit dose vials containing saline or sterile water) and its equivalence to a predicate device. It does not involve any artificial intelligence (AI) or machine learning (ML) components. Therefore, the following information fields, which are specific to AI/ML device studies, are not applicable to this submission:

Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable, no ML test set.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable, no ground truth for ML.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no ML test set.
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, no AI component.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no ground truth for ML.
The sample size for the training set: Not applicable, no ML training set.
How the ground truth for the training set was established: Not applicable, no ML training set.

In summary, the FDA clearance for the Hudson RCI® AddiPak® Unit Dose Vial was based on demonstrating substantial equivalence through non-clinical testing of material properties, performance, and comparison to existing predicate and reference devices, not on AI/ML performance studies.

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