(318 days)
Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 7%, and 10%.
The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 3%, 3.5%, 7%, and 10% with a nominal fill volume of 4 mL and supplied in single-use low density polyethylene (LDPE) vials.
The provided document describes the predicate device and the new device being submitted for 510(k) clearance, which is a Sodium Chloride Inhalation Solution, USP in various concentrations (3%, 3.5%, 7%, and 10%). This is not a device that involves AI/ML, human readers, or image analysis. Therefore, many of the requested fields are not applicable in this context.
Here's an analysis based on the available information:
1. Table of acceptance criteria and the reported device performance
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Design Verification | Device met predetermined acceptance criteria for: |
- Identity
- Assay
- pH
- Endotoxin
- Sterility
- Fill Weight
- Vial Attributes
- Vial Function (e.g., vial separation, cap removal, occluded orifice) | All results met the predetermined acceptance criteria. |
| Biocompatibility | Biocompatibility risk assessment performed in accordance with FDA Guidance ISO 10993-1.
Chemical characterization per ISO 10993-18.
Assessment of extractable constituents based on ISO 10993-17:2002.
Extraction solvent selection aligned with ISO 10993-12:2021.
Toxicological risk assessment on chemicals observed above 1.5 µg/day considered to have low potential for toxicity and an acceptable margin of safety.
Material-mediated pyrogenicity testing in accordance with USP met requirements for absence of material-mediated pyrogens. | The organic chemicals extracted above the threshold of 1.5 µg/day are considered to have a low potential for toxicity (low potency) and the calculated margin of safety is acceptable. Therefore, the chemicals observed do not pose significant systemic, genotoxic, or carcinogenic toxicological safety risks to all patients (adult and child).
Material-mediated pyrogenicity testing met the requirements for the absence of material-mediated pyrogens under the conditions employed. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of a clinical study with patients or data points, as it primarily involves laboratory testing of a pharmaceutical product. The sample sizes for the various material and chemical tests (e.g., identity, assay, pH, endotoxin, sterility, fill weight, vial attributes, chemical characterization, pyrogenicity) are not provided. The data provenance is not stated, but it can be inferred that these are in-house laboratory tests conducted by The Ritedose Corporation or their contracted laboratories to demonstrate compliance with established standards.
3. 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. This device is a pharmaceutical product, not an AI/ML-based diagnostic or imaging device. Ground truth, in this context, refers to established chemical, physical, and biological standards and methodologies (e.g., USP monographs, ISO standards, FDA guidance). Expert consensus in the traditional sense of clinical opinion is not relevant here; rather, it relies on accepted scientific and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, this device does not involve a "test set" that requires adjudication by human readers. The verification relies on physicochemical and biological testing against predefined specifications.
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 is not an AI/ML-based device and does not involve human readers or image analysis.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI system. Its performance is evaluated through laboratory testing of the solution itself and its container.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by:
- United States Pharmacopeia (USP) monographs: These define the identity, strength, quality, and purity of drug substances and drug products, including acceptance limits for assays, pH, and other parameters.
- International Organization for Standardization (ISO) standards: Specifically, ISO 10993 series for biocompatibility (ISO 10993-1, ISO 10993-18, ISO 10993-17, ISO 10993-12), which provide methodologies for biological evaluation of medical devices and chemical characterization.
- FDA Guidance documents: These provide recommendations on how to comply with regulatory requirements, such as the "Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process'."
- Predetermined acceptance criteria: These are specifications set by the manufacturer based on the above standards and internal quality control for specific tests (e.g., endotoxin limits, sterility requirements, fill weight tolerance, vial function).
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 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).