(90 days)
For respiratory therapy and tracheal lavage
The subject device is 3 mL Steri-Neb Saline, 0.9% "/v Sodium Chioride Inhalation Solution USP. Steri-Neb Saline is used for respiratory therapy and tracheal lavage. For respiratory therapy, Steri-Neb Saline is used for dilution of solutions used in nebulizers. Steri-Neb Saline is a unit dose low density polyethylene vial containing sterile, preservative-free, clear, colourless, aqueous solution. The Steri-Neb Saline product contains 0.9% w/v Sodium Chloride USP in Water for Injection USP. The formulation contains no additives.
The provided document is a 510(k) summary for a medical device called "3mL Steri-Neb Saline, 0.9% w/v Sodium Chloride Inhalation Solution USP." It focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study with acceptance criteria for device performance as would be expected for a novel device or software.
Therefore, many of the requested elements regarding acceptance criteria and study design (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, training set details) are not typically included in a 510(k) summary for a product of this nature. This document primarily emphasizes the technological characteristics and intended use comparison to an already cleared predicate device.
However, I can extract information related to the comparison to the predicate, which serves as the "study" for establishing substantial equivalence.
Here's the information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For this type of 510(k), acceptance criteria are not in the form of performance metrics (like sensitivity/specificity for an AI model) but rather revolve around demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness.
| Acceptance Criteria (Implied for 510(k) Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence: The subject device must have the same intended use as the predicate device. | The subject device, 3 mL Steri-Neb Saline, 0.9% w/v Sodium Chloride Inhalation Solution USP, is used for respiratory therapy and tracheal lavage, including dilution of solutions in nebulizers. |
| The predicate device, Dey's 3 mL 0.9% w/v Sodium Chloride Inhalation Solution USP, is also used for respiratory therapy and tracheal lavage. Both have the same intended use. | |
| Technological Characteristics Equivalence: The subject device must have the same technological characteristics, or any differences must not raise new questions of safety or effectiveness. | Both devices are plastic unit-dose vials containing 0.9% Sodium Chloride Inhalation Solution USP. |
| Both are sterile, preservative-free, clear, colorless, aqueous solutions. | |
| The subject device contains 0.9% w/v Sodium Chloride USP in Water for Injection USP, with no additives. | |
| No technological differences identified that raise new questions of safety and effectiveness. (Details stated to be in Attachments 3-8, which are not provided here). | |
| Formulation Equivalence: The active ingredients and key properties should be the same. | Both contain 0.9% w/v Sodium Chloride Inhalation Solution USP. Both are single-use products. |
| Sterility/Preservation Equivalence: Both devices should be sterile and preservative-free. | Both the predicate and subject device are sterile and preservative-free. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the context of this 510(k). This is a comparison of product specifications and intended use, not a clinical trial or performance evaluation with a "test set" of patients or data.
- Data Provenance: The data is based on the description and specifications of the subject device and the predicate device. No specific "country of origin" for data or "retrospective/prospective" study design is mentioned, as it's not a data-driven performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. Ground truth for device performance in a clinical or AI context is not established for this type of submission. The judgment of substantial equivalence is made by the FDA based on the provided technical documentation and comparison to the predicate.
- Qualifications of Experts: The submission was prepared by Steripak Limited, with John William Holloway B.Sc. CChem MRSC MBIRA, Head of Product Development and Regulatory Affairs, signing the document. The FDA, specifically the Division of Cardiovascular, Respiratory, and Neurological Devices, evaluates the submission.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no "test set" requiring adjudication. The process is a regulatory review by the FDA.
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
- MRMC Study: No. This is a saline solution, not an AI device or diagnostic imaging tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is not an algorithm.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" in this context is the established safety and effectiveness of the predicate device, as accepted by the FDA. The subject device is deemed "substantially equivalent" to this established predicate. The parameters for comparison are the device's intended use, technological characteristics (physical form, chemical composition), and labeling.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. There is no algorithm or AI model involved that would require a training set.
9. How the Ground Truth for the Training Set was Established
- How Ground Truth for Training Set was Established: Not applicable, as there is no training set.
§ 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).