(105 days)
To be used in conjunction with a nebulizer, the contents of these vials are for the induction of sputum production where sputum production is indicated.
The subject devices are 4mL Sodium Chloride Inhalation Solution USP, 3%, 7% or 10%. The single-use devices are a clear blow-fill-sealed, low density polyethylene (LDPE) vials containing sterile, preservative-free, clear, colorless, aqueous solution as labeled for induction of sputum production where specimen collection is indicated. Sodium Chloride Inhalation Solution USP, 3%, 7% or 10% are used in conjunction with a nebulizer. The product contains 3%, 7% or 10% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
The provided text is a 510(k) summary for Sodium Chloride Inhalation Solution USP, 3%, 7%, and 10%. This document is for a medical device (a saline solution for nebulizers) and primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study of the device's diagnostic or predictive capabilities.
Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets the acceptance criteria are not applicable in this context. The information provided heavily emphasizes that clinical testing was not necessary because the device's equivalence could be shown through in vitro analytical methods and physico-chemical characteristics.
Here’s a breakdown based on the provided text, indicating where information is not applicable:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Meet USP monograph requirements for solution composition | Formulation components meet their respective USP monograph criteria. |
| Meet container criteria (e.g., direct food and drug contact) | Component materials meet criteria for direct food and drug contact/additive. Formed units meet criteria for direct food and drug contact as prefilled unit containers. |
| Sterility | Subjected to testing to meet stated USP monograph and container criteria, including sterility. |
| Fill uniformity | Subjected to testing to meet stated USP monograph and container criteria, including fill uniformity. |
| Container integrity | Subjected to testing to meet stated USP monograph and container criteria, including container integrity. |
| Physico-chemical characteristics (solution properties, unit configuration) | Properties are similar to predicate devices; no technological differences raise new questions of safety and effectiveness; performance characteristics are equal to or greater than predicate devices. |
| Labeling requirements | Device containers have embossed unit identification and shelf carton labeling to meet label requirements. |
| Manufacturing under cGMP | Manufactured under conditions of current Good Manufacturing Practices (cGMP) using Blow/Fill/Seal system. |
| Equivalent safety and efficacy for intended use | Analytical testing demonstrates comparable safety and efficacy in use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. The submission 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." Therefore, there was no "test set" in the context of clinical or diagnostic performance evaluation with human data. The "testing" referred to in the document is for product specifications and quality control.
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. No clinical or diagnostic test set was used requiring experts to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No clinical or diagnostic test set was used.
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 a diagnostic device involving human readers or AI.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not Applicable. This is not a device with an algorithm for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth," in the context of this device, refers to established USP monograph requirements and container criteria. The device is evaluated against these pre-defined specifications rather than a ground truth derived from clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
- Not Applicable. There was no training set in the context of machine learning or diagnostic algorithm development. The "training" for this device would refer to the processes and controls for manufacturing and testing to meet specifications.
9. How the ground truth for the training set was established
- Not Applicable. No training set was used. The "ground truth" (USP specifications, etc.) is established by recognized pharmacopeia and regulatory standards.
§ 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).