(54 days)
The Electromed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport.
The proposed MedPulse® Respiratory Vest System Model 2000ez is designed to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport. The primary components of the MedPulse® System include an Air-Pulse Generator, an Inflatable Vest and Vest/Generator Connector Hose. The Air-Pulse Generator produces oscillating pressurized air-pulses that are delivered to the Inflatable Vest by the Vest/Generator Hose. The air-pulses produced by the Generator cause the Vest to rapidly inflate and deflate against the external chest wall of a patient to promote airway clearance by creating high-frequency chest wall oscillation (HFCWO) resulting in mobilization of bronchial secretions.
The Electromed MedPulse® Respiratory Vest System Model 2000ez was deemed substantially equivalent to a predicate device (MedPulse® Respiratory Vest System Model 2000, 510(K) number: K982889). Therefore, the acceptance criteria and study design focused on demonstrating that changes made to the new model did not negatively impact its performance or safety compared to the predicate.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Maintain identical indications and intended use as the predicate device. | The MedPulse® Respiratory Vest System Model 2000ez has identical indications and intended use: "to deliver high-frequency chest wall oscillation to promote airway clearance and improve bronchial drainage. The MedPulse® System is indicated when external chest manipulation is the physician's treatment of choice to enhance mucus transport." |
| Maintain identical technological characteristics and principles of operation. | The Model 2000ez continues to use the same method of generating pressurized air-pulses (dual acting pneumatic diaphragm technology). Users can still adjust air pulse frequency and pressure amplitude. The Inflatable Vest and Vest/Generator Connector Hose remain unchanged. The only changes are to the Air-Pulse Generator's motor (servo brush to brushless) and frequency control (analog to digital), both of which were described as maintaining or improving performance without changing the fundamental operating principle. |
| No change in output performance compared to the predicate device. | Functional performance tests were conducted and explicitly stated to have "demonstrated no change in output performance." While specific quantitative metrics are not provided, the claim is that the output performance remains equivalent. |
| No new safety issues to result from the proposed changes. | Electrical safety tests were performed and explicitly stated to have "demonstrated no ... safety issues to result from the changes proposed." |
| Enhanced reliability and longer lifespan of the motor (brushless motor change). | The change to a brushless motor was intended to make the motor "more reliable and have a longer life span." While this is an stated intent, the performance testing section focuses on demonstrating no change in output performance or safety, rather than providing specific data on enhanced lifespan/reliability. |
| Enhanced robustness and reliability of frequency control (digital control change). | The change to digital frequency control was considered to make the motor "more robust and reliable." Similar to the motor lifespan, the performance testing focused on maintaining output performance and safety, not on quantifying the enhancement in robustness or reliability from this specific change. The digital control also presented the opportunity to "remember" user settings, improving ease and reliability of use, though this is a feature enhancement rather than a core performance metric for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for the Test Set: Not explicitly stated in the provided text. The document mentions "Functional performance and electrical safety tests were performed," but does not specify the number of units tested or the duration of testing.
- Data Provenance: The study was conducted by Electromed, Inc., (New Prague, MN, USA) for submission to the FDA. Given it is a premarket notification for a new version of an existing device, the data is prospective testing of the new device and comparative testing against the predicate.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This type of information is not applicable to this submission. The submission is for a medical device (Respiratory Vest System) that does not involve diagnostic image interpretation or complex clinical judgment that would require expert consensus for a test set ground truth. The "ground truth" here is the established performance and safety characteristics of the predicate device, against which the modified device is being compared.
4. Adjudication Method for the Test Set:
- This information is not applicable as the evaluation involved functional performance and electrical safety testing, not subjective interpretation requiring adjudication among experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human readers interpret results, and the AI's impact on reader performance is being evaluated. This device is a therapeutic physical therapy device.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Yes, in essence, a standalone performance study was done. The "Functional performance and electrical safety tests" conducted on the MedPulse® Respiratory Vest System Model 2000ez represent a standalone evaluation of the device's operational characteristics (e.g., air pulse generation, frequency, pressure stability, electrical integrity) independent of human operation. The intent was to show that the device itself, with its modifications, performs no worse than the predicate.
7. Type of Ground Truth Used:
- The "ground truth" for this substantial equivalence claim is the established performance and safety characteristics of the predicate device (MedPulse® Respiratory Vest System Model 2000, K982889). The study's goal was to demonstrate that the new device's performance and safety metrics were equivalent to or better than this established baseline. This would involve objective measurements against design specifications and relevant safety standards.
8. Sample Size for the Training Set:
- This information is not applicable. This is a hardware medical device, not an AI or algorithm-driven system that requires a "training set" in the machine learning sense. The device's design is based on engineering principles and previous device models, not on learning from a dataset.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable for the reasons stated above (not an AI/ML device).
§ 868.5665 Powered percussor.
(a)
Identification. A powered percussor is a device that is intended to transmit vibration through a patient's chest wall to aid in freeing mucus deposits in the lung in order to improve bronchial drainage and that may be powered by electricity or compressed gas.(b)
Classification. Class II (performance standards).