(242 days)
The Hudson RCI® TurboMist™ Nebulizer is intended to be used to aerosolize liquid medication into gases that are delivered directly to the patient for breathing.Its use is indicated when a licensed healthcare professional prescribes or administers medical aerosol to a patient using a small volume nebulizer.
The patient population includes adult and pediative (greater than 22 lbs or 10 kg) patients that are spontaneously breathing.
The product is a single patient, multi-use, non-sterile, disposable, prescriptive device intended to be used in a hospital or homecare environment.
The Hudson RCI® TurboMist™ Nebulizer System (herein referred to as "TurboMist system" or "subject device") consists of the TurboMist small volume nebulizer and a patient interface, which may include a swivel mouthpiece ors an aerosol mask and elbow adaptor. The aerosol mask is available in adult and pediatric versions. The TurboMist small volume nebulizer is a hand-held, breath-enhanced jet nebulizer designed to aerosolize liquid medications as prescribed by a physician. The nebulizer is powered by an external compressed air or oxygen source, and the aerosol is created by an internal jet located inside the nebulizer jar. The nebulizer is designed to entrain additional room air upon patient inhalation, enhancing aerosol generation and resulting in a faster nebulization rate than traditional jet nebulizers.
The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the Hudson RCI® TurboMist™ Nebulizer System. It details the device's indications for use, technological characteristics, comparison to predicate devices, and a summary of non-clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Study/Characteristic | Acceptance Criteria (Implied/Stated) | Reported Device Performance/Conclusion |
|---|---|---|
| Particle Size Characterization | All pre-determined acceptance criteria for particle size and overall performance (not explicitly detailed, but implied to be within clinically acceptable range and comparable to predicate devices). Cascade Impactor vacuum flow rate of 15 LPM was utilized, per FDA's "Reviewer Guidance for Nebulizer, Metered Dose Inhalers, Spacers and Actuators" (FDA/CDRH - 1993). | Particle size characterization results for the TurboMist nebulizers with both mouthpiece and mask, using 15 LPM impactor vacuum flow rate, met all pre-determined acceptance criteria and demonstrated that the device meets its product specifications. Results for the subject device, primary predicate (AirLife Misty Fast Small Volume Nebulizer), and secondary predicate (MC 300*) were considered comparable and within the clinically acceptable range. |
| Shelf Life | Demonstrated ability to maintain performance after the equivalent of five years aging. | Shelf life testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) after the equivalent of five years aging. (Implies it met criteria, though not explicitly stated as "met"). Real-time aging studies have been initiated. |
| Useful Life | Determined to be 7 days or 50 cleaning cycles. | Useful life testing was performed on the subject device with both proposed patient interfaces (mouthpiece and aerosol mask) and determined to be 7 days or 50 cleaning cycles. (This is the determined value, implying it’s a qualified useful life). |
| Cleaning & Disinfection | Compliance with guidelines in FDA Guidance: "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling", AAMI TIR12:2010, and AAMI TIR30:2011. The nebulizer should be cleanable and disinfectable effectively. | All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU. |
| Biocompatibility | Evaluation and/or testing for specific biological endpoints based on nature and duration of contact (External communicating, Tissue/bone/dentin communicating, Surface Contact, Mucosal Membrane; Permanent duration of use > 30 days). Common aerosolized medications contacts were considered. Endpoints included: Carcinogenicity, Genotoxicity, Cytotoxicity, Sensitization, Irritation or Intracutaneous Reactivity, Material Mediated Pyrogenicity, Acute Systemic Toxicity, Subacute Toxicity, Subchronic Toxicity, Chronic Toxicity, Implantation, Extractables/Leachables, Chemical characterization of materials (per ISO 10993 standards). | Biocompatibility evaluation and testing was performed on the subject device and associated patient interfaces. The materials were characterized as permanent contact. (Implies satisfactory results as no issues were reported and it supports substantial equivalence). |
| Gas Pathway | Evaluation and/or testing for emissions of particulate matter (including PM2.5), volatile organic compounds (VOCs), and leachables in condensate (per ISO 18562 standards). | Gas pathway evaluation and testing was performed on the subject device and associated patient interfaces per ISO 18562-1. Endpoints assessed included: Emissions of Particulate Matter (including PM2.5) (ISO 18562-2:2017), Emissions of Volatile Organic Compounds (VOCs) (ISO 18562-3:2017), Evaluated Leachables In Condensate (ISO 18562-4:2017). (Implies satisfactory results as no issues were reported and it supports substantial equivalence). |
| Overall Substantial Equivalence | The device must meet the requirements of its pre-defined acceptance criteria and intended use, demonstrating equivalence to predicate devices without raising new questions of safety and effectiveness. | Based on testing data, including biocompatibility tests and aerosol particle performance tests, the TurboMist™ Nebulizer System meets the requirements of its pre-defined acceptance criteria and intended use. Therefore, the subject device is substantially equivalent to the primary predicate device for hospital setting and secondary predicate device for homecare setting. |
2. Sample Sizes Used for the Test Set and Data Provenance:
- Particle Size Characterization: Not explicitly stated, but testing was performed on "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)" and "the primary predicate with a mouthpiece and aerosol mask." This implies at least one sample of each configuration for each device. The data for the secondary predicate was a "review of published test data in the 510(k) summary table."
- Shelf Life: Not explicitly stated how many samples were aged, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
- Useful Life: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
- Cleaning & Disinfection: Not explicitly stated how many samples were tested, but it was "the subject device with both proposed patient interfaces (mouthpiece and aerosol mask)."
- Biocompatibility: Not explicitly stated, but testing was performed on "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."
- Gas Pathway: Not explicitly stated how many samples were tested, but it was "the subject device as well as both proposed patient interfaces (mouthpiece and aerosol mask)."
Data Provenance: The studies appear to be prospective testing conducted specifically for this 510(k) submission, with the exception of the secondary predicate's particle size data which was a retrospective review of published data. The document does not specify the country of origin for the data generation, but it is for a US FDA submission by Medline Industries LP (headquartered in Northfield, Illinois, USA), suggesting the testing was performed, overseen, or compiled for a US regulatory context.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document describes non-clinical performance and safety testing of a medical device (nebulizer). It does not involve human subject data or diagnostic performance where "ground truth" would be established by experts or adjudicated. The "ground truth" for these tests is defined by established engineering and scientific standards (e.g., ISO, AAMI, FDA guidance) for physical and chemical properties, functionality, and biological safety. Therefore, this section is not applicable in the context of this 510(k) summary.
4. Adjudication Method for the Test Set:
Not applicable, as this is a non-clinical device performance and safety study, not a diagnostic study requiring expert adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
No, an MRMC comparative effectiveness study was not done. This document describes the substantial equivalence of a physical medical device (nebulizer) through non-clinical performance and safety testing, not the comparative diagnostic effectiveness of a reader-dependent system or AI.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
Not applicable. This is not an AI/algorithm-based device.
7. The Type of Ground Truth Used:
As noted in section 3, the "ground truth" for the non-clinical tests is represented by the established scientific and engineering standards, guidance documents (e.g., FDA guidance, ISO standards, AAMI standards), and the pre-defined product specifications/acceptance criteria that the device must meet to demonstrate safe and effective performance and substantial equivalence to predicate devices. These are objective measures rather than expert consensus on a diagnostic outcome or pathology.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable. This is not an AI/machine learning 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).