(379 days)
The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.
The AeroSol™ Radioaerosol System generates and administers a fine droplet aerosol to the breathing areas of the lungs for diagnostic imaging. It has an injection site, a nebulizer, aerosol conduit, aerosol trapping and is manufactured of materials and components used in previously cleared 510(k) devices.
The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. The device is intended for patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed.
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Specification) | Reported Device Performance (Proposed AeroSol™ System (K063716)) |
|---|---|
| Indications for Use | The AeroSol™ Radioaerosol System is intended to deliver an aerosol of diagnostic nuclear medicine to the lung for imaging. |
| Patient Populations | For patients undergoing diagnostic nuclear lung ventilation imaging in a hospital or settings where nuclear medicine clinical testing is performed. |
| Environment of Use | Hospitals or settings where nuclear medicine clinical testing is performed. |
| Performance | Nebulize radioaerosols |
| Nebulizer Performance tested via Malvern Laser Diffraction | Yes (Stated as "Yes" under the Proposed AeroSol™ System column, indicating the performance was tested and met the criteria based on predicate device similarity) |
| Circuit with conduits, valves, nebulizer, mouthpieces, and various adapters and connectors and aerosol trapping filter | Yes (Stated as "Yes" under the Proposed AeroSol™ System column, indicating the system features these components, mirroring the predicate device) |
| Materials - PVC, LDPE, K-Resin, Bromobutyl etc. | Yes (Stated as "Yes" under the Proposed AeroSol™ System column, indicating the materials used are similar to the predicate device) |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for a clinical study comparing the AeroSol™ Radioaerosol System against a gold standard or human readers. The submission relies on substantial equivalence to predicate devices, rather than a de novo clinical performance study with a test set of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical test set is described, there's no information regarding experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable. Since no clinical test set is described, no adjudication method is mentioned.
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. The device is a radioaerosol system for delivering diagnostic medicine, not an AI-powered diagnostic imaging interpretation device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This device is not an algorithm, but a medical delivery system. Its performance evaluation focuses on its ability to nebulize radioaerosols and its structural and material equivalence to predicate devices.
7. The Type of Ground Truth Used
The "ground truth" for this device's acceptance is based on demonstrating substantial equivalence to existing legally marketed predicate devices, specifically the CIS-US Aerotech Aerosol Delivery System (K873930) and the AMICI Xenon System (K865084).
The "truth" for this 510(k) submission is that the proposed device shares the same indications for use, patient populations, environment of use, performance characteristics (e.g., ability to nebulize radioaerosols, nebulizer performance tested by Malvern Laser Diffraction), circuit components, and materials as the predicate devices. The document explicitly states: "There are no significant differences that affect the safety, use or effectiveness of the intended device as compared to the predicate devices."
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, no ground truth was established for it.
§ 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).