(173 days)
The ultrasonic mesh nebulizer model NE105 is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize medications for inhalation by the patient. The device may be used by adult and pediatric patients at the discretion of their physician at home, hospital &sub-acute care setting.
The Ultrasonic Mebulizer NE105 is similar to the predicate device, the FDA-cleared Model NE-U22 Micro Air Vibrating Mesh Nebulizer, cleared under 510(k) K062263. Similarities are that both, the NE105 and the predicate NE-U22, are identical in purpose, function, core technology and method of operation. They are single-patient use, reusable electronic nebulizers, using micro-perforated vibrating mesh technology to aerosolize liquid medications. They have the same 'Indication for Use' stating that they are for inhalation therapy by adults and pediatric patients in a home, hospital & sub-acute care setting. Both devices are hand-held and portable. Power input for both devices is provided by either AA batteries or an AC/DC adapter. The model NE105 incorporates several design differences in comparison with the predicate NE-U22, mainly body shape, dimension/weight, a larger capacity reservoir, power source and software controlled electronics.
The provided 510(k) summary for the Ultrasonic Mesh Nebulizer NE105 focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with acceptance criteria and performance data in a typical clinical trial format.
Here's a breakdown of the requested information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission for a nebulizer, the "acceptance criteria" are primarily based on demonstrating performance similar to the predicate device and compliance with relevant safety and performance standards. There isn't a direct table of clinical performance metrics like sensitivity/specificity. Instead, the performance is assessed through non-clinical tests.
| Acceptance Criteria (Demonstrated Equivalence/Compliance) | Reported Device Performance |
|---|---|
| EMC and Electrical Safety (Compliance with IEC 60601-1, IEC 60601-1-2) | Verification by testing laboratories; certified with Declaration of Conformity. Device conforms to all applicable requirements in its intended operational environment. |
| Biocompatibility (Compliance with ISO 10993-1 for body-contacting components) | Testing (Cytotoxicity, Sensitization, Subchronic Toxicity, Genotoxicity, Implantation) confirmed biocompatibility of materials. |
| Software Performance (Performs within specifications, safe for intended use) | Test results concluded software performs within specifications and is safe. Permanent hazard analysis implemented in development process; clear software architecture; test protocol sufficiently verifies main functional operation. |
| Cleaning Effectiveness (Sufficiency of cleaning instructions) | Validation of manual cleaning method confirmed nebulizer can be cleaned as per instructions. |
| Simulated Lifetime Performance (No change in performance, effectiveness, safety after simulated lifetime) | "Simulated Lifetime Study" by renowned laboratory and in-house 1000-cycle life test concluded no change in performance, effectiveness, and safety when cleaned as per instructions. |
| Aerosol Characterization (Particle Size Distribution) (Results in line with predicate device) | Performed by Piper Medical Lab. All tests confirmed results were in line with the predicate device. |
| Aerosol Characterization (Total Medication Dose Delivered) (Results in line with predicate device) | Performed by Piper Medical Lab. All tests confirmed results were in line with the predicate device. |
| Inter-Sample and Intra-Sample Variability (No measurable inter-sample variance) | Tests showed no indication of any measurable inter-sample variance. |
| Overall Performance Equivalence to Predicate | Model NE105 performed equally well compared with the predicate device across all aerosol characterization tests. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document does not specify a "sample size" in the context of human subjects or clinical data, as it explicitly states, "The NE105 did not conduct, nor rely upon, clinical tests to determine substantial equivalence." The testing described is primarily laboratory-based and engineering/design validation. For simulated lifetime testing, "an in-house 1000-cycle life test was performed," which could be considered a sample size for that specific test.
- Data Provenance: Not applicable as clinical data was not used for this submission. The tests were performed by various "testing laboratories" and "Piper Medical Lab," implying engineering/testing facilities. The submitter is from China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on objective engineering and laboratory test results against established standards and comparison to a predicate device, not subjective expert assessment of clinical data to establish a "ground truth."
4. Adjudication Method for the Test Set
Not applicable. There's no clinical test set requiring adjudication in this submission.
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. This is a medical device for drug delivery (nebulizer), not an AI-powered diagnostic or interpretive device. Therefore, no MRMC or AI-assisted studies were performed or are relevant.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device does not involve an algorithm for interpretation or diagnosis; it is a physical device for drug delivery.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is established through:
- Compliance with recognized standards: IEC 60601-1, IEC 60601-1-2, ISO 10993-1.
- Benchmarking against a predicate device: Specifically for aerosol characterization (particle size distribution and total medication dose delivered).
- Design validation tests: Ensuring the device meets its own specified design requirements (e.g., software functionality, cleaning effectiveness, simulated lifetime).
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 no training set was used.
§ 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).