(58 days)
The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.
The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.
The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.
This 510(k) premarket notification is for Sterile Water for Inhalation, USP. This product is a Class II medical device, specifically an accessory to medicinal non-ventilatory nebulizers and a nebulizer accessory.
Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (What they aimed to demonstrate) | Reported Device Performance (How the device performs) |
|---|---|
| Safety and Efficacy: Substantial equivalence to predicate devices for intended use. | * "Analytical testing to the stated specifications demonstrates that these devices will have comparable safety and efficacy in use." (Section 8. Summary Conclusions) |
| USP Monograph Criteria for Sterile Water for Inhalation, USP: | * "The formulation components of the filled device solution have been substantiated to each meet their respective USP monograph criteria." (Section 7. Non-Clinical and Clinical Testing) |
- "Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7. Non-Clinical and Clinical Testing) |
| Container Integrity: Meet container criteria and direct food and drug contact standards. | * "The component materials of the accessory device container have been substantiated to each meet criteria for direct food and drug contact or additive respectively." (Section 7. Non-Clinical and Clinical Testing) - "Each of the finished devices undergoes testing to meet the stated USP monograph and container criteria." (Section 7. Non-Clinical and Clinical Testing) |
| Sterility: Device is sterile. | * "The single-use devices... are sterile and pyrogen-free." (Section 4. Description of the Devices) - One of the in vitro analytical methods used to demonstrate equivalence is "sterility." (Section 7. Non-Clinical and Clinical Testing) |
| Pyrogen-free: Device is pyrogen-free. | * "The single-use devices... are sterile and pyrogen-free." (Section 4. Description of the Devices) |
| Fill Uniformity: Consistent fill volume. | * One of the in vitro analytical methods used to demonstrate equivalence is "fill uniformity." (Section 7. Non-Clinical and Clinical Testing) |
| Water Purity: Meet purity standards. | * "The water raw material source is Water for Injection, USP produced at Holopack." (Section 6. Technological Characteristics) - One of the in vitro analytical methods used to demonstrate equivalence is "water purity." (Section 7. Non-Clinical and Clinical Testing) |
| Physical-Chemical Characteristics: (e.g., water properties, unit configuration) | * These characteristics were used in "various in vitro analytical methods" to demonstrate equivalence. (Section 7. Non-Clinical and Clinical Testing) |
2. Sample Size Used for the Test Set and Data Provenance:
The document explicitly 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 (water purity, fill uniformity; sterility; container integrity) and physical-chemical characteristics (water properties; unit configuration) available which demonstrate this equivalence." (Section 7. Non-Clinical and Clinical Testing)
Therefore, there appears to be no "test set" in the traditional sense of a clinical study involving human subjects or a defined dataset for AI model evaluation. The assessment was based on analytical and physical-chemical testing of the manufactured product. The data provenance is internal to the manufacturer's quality control and testing processes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
Given that no clinical "test set" was used, the concept of experts establishing ground truth for such a set is not applicable here. The ground truth for the product specifications (e.g., USP monograph criteria) would have been established by the United States Pharmacopeia (USP) and other relevant regulatory bodies.
4. Adjudication Method for the Test Set:
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This device is a sterile solution (Sterile Water for Inhalation, USP). It is not an imaging or diagnostic device that would typically involve human readers or an AI algorithm requiring an MRMC study.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance:
Not applicable. This device is a physical product (sterile water), not an algorithm or AI system.
7. Type of Ground Truth Used:
The "ground truth" used for this device's acceptance was:
- USP Monograph Criteria: The legally defined specifications for Sterile Water for Inhalation, USP.
- Manufacturer's Internal Quality Control Specifications: Based on the USP and good manufacturing practices.
- Predicate Device Characteristics: The known and established characteristics of legally marketed predicate devices.
8. Sample Size for the Training Set:
Not applicable. This is not an AI/ML device that requires a training set. The manufacturing processes and quality checks are based on established scientific principles and regulatory standards, not on data-driven learning models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as 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).