(34 days)
MyNeb is an AC or battery-pack powered nebulizer designed to convert liquid medication into aerosol for inhalation by the patient.
This AC (adaptor with DC converter) or battery-pack powered nebulizer is housed in a plastic case. Dimensions are 4.96"(II) x 2.80° (V) x 1.46"(I) x 1.46"(I) and weighs 4 ounces. It consists of a piezoelectric element driven by a microprocessor with dedicated software. The batteries are rechargeable via an AC power supply (100-240 VAC, 50-60 Hz). The external battery pack is made up of 2 lithium polymer cells.
The following is the method of acrosol generation:
Step 1: Ultrasonic energy is created and focused by a concave piezoelectric element, located within the generator, to a point at the base of the medication chamber that is located at the top of the generator.
Step 2: The focused ultrasonic energy forms a liquid fountain that is driven up through the guide tube inside the nebulizer head. Upon exiting the tube, the energized liquid fountain generates cavitation of acrosol particles and the liquid medication is converted into an aerosol.
Step 3: The forces associated with the fountain generate an air draft whereby air is drawn into the nebulizer head via the air vents. The aerosolized medicine is carried by this air draft, through the nebulizer's chimney and out through the nebulizer's mouthpiece opening.
Step 4: Non aerosolized liquid medication returns back into the medication chamber for re-generation through the guide tube.
Here's the analysis of the provided text regarding the MyNeb Nebulizer, Model RDD100:
Acceptance Criteria and Device Performance Study
Based on the provided 510(k) summary, the MyNeb Nebulizer's acceptance criteria and performance are established through demonstrating substantial equivalence to predicate devices, primarily through non-clinical testing. No clinical studies are mentioned.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Convert liquid medication into aerosol for inhalation by the patient. | The MyNeb nebulizer is designed and functions to convert liquid medication into aerosol for inhalation. It achieves this through a piezoelectric element creating ultrasonic energy, forming a liquid fountain, generating aerosol particles via cavitation, and an air draft for delivery. This functionality is considered "basically the same" as predicate devices. |
| Electrical Safety | Compliance with relevant electrical safety standards for medical devices. | The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." Specific test results are not detailed but compliance is asserted. |
| Mechanical/Environmental | Durability, stability, and operational integrity under specified environmental conditions (e.g., temperature, humidity, shock, vibration). | The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." Specific test results are not detailed. |
| Electromagnetic Compatibility (EMC) | No undue electromagnetic interference with other devices, and proper functioning in the presence of expected EMI. | The device "conforms or will conform to the electromagnetic compatibility, mechanical/environmental, and electrical testing recommendations, described in the Reviewer Guidance for Premarket Notification Submissions (November 1993)." It "meet[s] Environmental Safety and EMC requirements." Specific test results are not detailed. |
| Performance Characteristics | Similar compressor operating pressure and flow ranges to predicate devices; efficient aerosol generation. | The MyNeb's aerosol generation method (piezoelectric element) is explicitly compared to the MABISMist II, noting its use of a piezoelectric element for energy generation. The document states, "Performance characteristics are basically the same" as the predicate devices, implying comparable aerosol output and delivery efficiency. It's noted that all three units (MyNeb and predicates) are lightweight. Although specific pressure and flow ranges are mentioned for predicates, direct values for MyNeb are not provided, only a general "similar" comparison. |
| Design | Portability (lightweight), power options (AC/battery). | Dimensions: 4.96"(II) x 2.80"(V) x 1.46"(I); weighs 4 ounces. Powered by AC (adaptor with DC converter) or battery-pack (2 lithium polymer cells, rechargeable). Unit is described as "lightweight" and comparable to predicates. The housing is plastic. |
| Material Safety | Biocompatibility of materials in contact with medication/patient (not explicitly stated, but implied for medical devices). | Not explicitly discussed in the provided text. Usually addressed under general manufacturing practices and material specifications, which are not detailed in this summary. However, the mention of adhering to "FDA's DCRND 'Reviewer Guidance for Home Use Respiratory Devices'" would imply compliance with material safety for home use devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable (N/A) for human subjects. The testing was non-clinical, focusing on the device itself.
- Data Provenance: N/A. The data originates from internal device testing (electrical, mechanical, environmental, EMC) performed by the manufacturer or a contracted lab to conform to FDA guidance. No patient-derived data is involved.
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, in the context of clinical outcomes or diagnostic accuracy, is not relevant here as no clinical studies were performed.
- Qualifications of Experts: Not applicable. The "ground truth" for the non-clinical tests was established by adhering to recognized testing standards and FDA guidance documents, which are assessed by engineers and regulatory specialists.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There was no human interpretation or decision-making on test "cases" that would require adjudication. Device performance against technical specifications and regulatory guidance was assessed directly.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size of Human Reader Improvement
- MRMC Study: No, an MRMC comparative effectiveness study was explicitly stated as "Not Applicable" for this 510(k) submission.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done
- Standalone Performance: While the device operates automatically (non-human-in-the-loop) once initiated, the term "standalone" usually refers to AI/algorithm performance. This device is a nebulizer, a mechanical medical device with embedded software for control, not an AI diagnostic algorithm. Its "standalone performance" refers to its efficacy in aerosol generation as described, which was assessed through non-clinical testing.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device's safety and effectiveness relies on compliance with established engineering and safety standards, as well as FDA guidance documents. Specifically, "Reviewer Guidance for Premarket Notification Submissions (November 1993)" and "Reviewer Guidance for Home Use Respiratory Devices" served as the benchmarks for determining acceptable performance in electrical, mechanical, environmental, and EMC testing. The "truth" is whether the device meets these pre-defined, objective engineering metrics.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI/machine learning model that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of medical 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).