(251 days)
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.
§ 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).