(65 days)
Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated.
The proposed inhaled saline solutions are in 3.5%, 6% and 7% concentrations. They are packaged sterile in 4 ml vials for use as indicated.
Here's a breakdown of the acceptance criteria and study information based on the provided text, but it's important to note that this document does not contain the level of detail typically found in a clinical study report regarding device performance beyond a basic declaration of substantial equivalence.
The provided text is a 510(k) Premarket Notification for a saline solution, not a complex AI/ML-driven medical device. Therefore, many of the requested categories (like sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, etc.) are not applicable or not present in this type of submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance and Remarks |
|---|---|
| Intended Use | Used in conjunction with a nebulizer for induction of sputum production where specimen collection is indicated. Performance is deemed substantially equivalent to the predicate device for this intended use. |
| Environments of Use | Hospital, sub-acute care or home. Performance is deemed substantially equivalent to the predicate device in these environments. |
| Patient Population | Any patient population. Performance is deemed substantially equivalent to the predicate device for this patient population. |
| Contraindications | None. No contraindications were identified, consistent with the predicate device. |
| Prescription Status | Prescription Use. This matches the requirement and is considered acceptable. |
| Design (Composition) | USP sodium chloride solutions of 3.5%, 6% and 7% concentrations, packaged sterile in 4 ml vials. The design is described and considered substantially equivalent to the predicate. |
| Performance (General) | "None applicable" beyond adherence to USP monograph. The core acceptance criterion is "substantial equivalence" to the predicate device (DEY Laboratories – K972778) with "no significant differences that affect the safety or effectiveness." The performance is implicitly accepted as equivalent to a legally marketed device for the stated indications. |
Study Information (Based on Available Text)
-
Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/Not provided. This is a 510(k) submission for a saline solution, which typically relies on chemical and manufacturing standards, and substantial equivalence to a predicate, rather than large-scale clinical trials with test sets in the context of an AI/ML device.
- Data Provenance: Not applicable in the context of clinical trial data. The data provenance primarily relates to the formulation and manufacturing process ensuring compliance with USP standards, and the comparison to an existing legally marketed device.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of clinical outcomes or expert consensus for interpretation tasks is not relevant for this type of device. The "ground truth" here is adherence to chemical specifications and the established safety and effectiveness of the predicate device.
-
Adjudication method for the test set:
- Not applicable. No clinical test set requiring adjudication in the context of diagnostic or interpretive accuracy is mentioned.
-
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 device is not an AI/ML-driven diagnostic or assistive tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a saline solution, not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established chemical standards (USP monograph) for sodium chloride solutions and the demonstrated safety and effectiveness of a legally marketed predicate device (DEY K972778) as determined by the FDA's substantial equivalence review process. Real-world clinical outcomes or pathology data were not used to establish a performance "ground truth" in the way they would be for a diagnostic tool.
-
The sample size for the training set:
- Not applicable. There is no concept of a "training set" for a saline solution in the context of AI/ML.
-
How the ground truth for the training set was established:
- Not applicable.
§ 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).