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The AddiPak® Unit Dose Vial may be used in conjunction with a non-ventilator nebulizer for lavage therapy, or for tracheal irrigation.

These products are single-use, disposable, and intended for inhalation only.

AddiPak® unit dose solutions are pre-filled vials of bland liquids for inhalation therapy.

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.

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

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:

1. 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.
2. 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.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable, no ML test set.
4. 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.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, no algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, no ground truth for ML.
7. The sample size for the training set: Not applicable, no ML training set.
8. 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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This sterile, single-use device is intended to be used as an accessory to medicinal nonventilatory nebulizers for respiratory therapy or for tracheal irrigation or lavage therapy.

This device is not intended for parenteral use or for preparations intended for parenteral use.

The subject device is 3mL or 5 mL Sodium Chloride Inhalation Solution USP, 0.9%. The single-use device is a color-coded (pink) blow-fill-sealed, low density polyethylene (LDPE) vial containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for inhalation therapy (respiratory therapy and tracheal lavage. For respiratory therapy, Sodium Chloride Inhalation Solution USP, 0.9% is used for dilution of solutions used in nebulizers. The product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.

The provided documentation is a 510(k) premarket notification summary for Sodium Chloride Inhalation Solution USP, 0.9% manufactured by Nephron Pharmaceuticals Corporation. This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than providing extensive clinical study results as would be required for a novel device.

Therefore, the study design and acceptance criteria outlined in the original request (which are typically for demonstrating device performance against specific metrics) are not applicable in the context of this 510(k) submission.

Here's an explanation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable.
This 510(k) is based on demonstrating substantial equivalence to predicate devices, not on meeting specific performance acceptance criteria from a clinical study. The document states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (assay; fill uniformity; sterility; container integrity) and physical-chemical characteristics (solution properties; unit configuration) available which demonstrate this equivalence."

The "performance" cited is related to meeting USP monograph requirements and container criteria, not clinical outcomes.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable.
No clinical test set was used for a performance study. Testing involved "various in vitro analytical methods" and analysis of "physical-chemical characteristics" to demonstrate equivalence to USP standards and predicate devices. The document does not specify sample sizes for these in vitro tests, nor is data provenance (country of origin, retrospective/prospective) relevant to these types of tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable.
No clinical test set requiring expert ground truth establishment was conducted. The equivalence is based on meeting established USP monograph criteria and comparison to predicate devices.

4. Adjudication Method for the Test Set

Not Applicable.
No clinical test set requiring adjudication was conducted.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not Applicable.
No MRMC study was performed as this is a pharmaceutical accessory device, not a diagnostic or AI-assisted device. The concept of human readers improving with AI assistance is not relevant here.

6. Standalone (Algorithm Only) Performance Study

Not Applicable.
This device is a saline solution, not an algorithm or AI-based system. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

Not Applicable.
For this 510(k) submission, the "ground truth" equivalent would be the USP monograph criteria for Sodium Chloride Inhalation Solution USP, 0.9% and the established characteristics of the predicate devices. The device's components and solution are substantiated to meet these criteria.

8. Sample Size for the Training Set

Not Applicable.
There is no "training set" in the context of a 510(k) for a medical device accessory like a saline solution. The relevant "training" relates to the manufacturing process adhering to cGMP and meeting USP standards.

9. How the Ground Truth for the Training Set Was Established

Not Applicable.
As explained above, there is no training set in the AI/machine learning sense. The "ground truth" for the device's characteristics is established by existing USP monographs and regulatory standards for pharmaceutical manufacturing and quality control, which the device aims to meet.

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