(253 days)
The Electro Flo® 6 Airway Clearance System is intended to provide Airway Clearance Therapy and promote bronchial drainage where external manipulation of the physician's choice of treatment. It is indicated for patients having difficulty with secretion clearance, or the presence of atelectasis caused by mucus plugging.
The device is intended for home or institutional use by patients weighing at least 23 Kg.
The Electro Flo® 6 Airway Clearance System is a High Frequency Chest Wall Oscillation System (HFCWO), including all accessories and supplies.
Electro Flo® 6 Airway Clearance System comprises:
- An electrically powered Control Box with a power switch on the back and two knobs on the front: one knob provides five intensity settings, and the other provides six frequency settings,
- The Power Head, connected by a cable to the Control Box, ●
- The Carrying Case,
- The Information Manual, ●
- The Optional Self-Administrator® Strap that can hold the Electro Flo® 6 system Power Head and enable a patient to apply therapy to the back, unassisted.
The Electro Flo® 6 Airway Clearance System's operating mechanism is an electromechanical "hammer and anvil"; the hammer is the handheld body of the Power Head, and the anvil is the surface of the Power Head that is held in contact with the chest. Repeated electrical pulses from the Control Box separate the hammer and anvil. The Frequency knob of the Control Box controls the repetition rate, and the Power knob controls the pulse duration; there are 30 combinations.
When each electrical pulse ends, the force applied by the therapist's hand forces the hammer through the gap until it strikes the anvil and delivers a mechanical impulse to the chest. The resulting pressure wave radiates into the chest cavity to shake mucus loose. Because the energy transmitted to the chest vibrations is a multiple of the force applied by hand, the Electro Flo® 6 system acts as a "force multiplier" that provides the therapist with additional control.
The provided text is a 510(k) premarket notification for the Electro Flo® 6 Airway Clearance System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies or extensive standalone testing.
Therefore, many of the requested details, such as a table of acceptance criteria with reported performance, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, and detailed standalone algorithm performance, are not applicable or not present in this type of FDA submission document.
Here's a breakdown based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not contain a table of specific performance acceptance criteria for clinical outcomes or diagnostic accuracy per se. Instead, it focuses on demonstrating that the device is substantially equivalent to legally marketed predicate devices in terms of indications for use, intended use, and technological characteristics.
The "performance data" section (Section XI) refers to bench testing to characterize mechanical performance and verify its nature as a high-frequency chest wall oscillator.
| Performance Metric (Bench Data) | Reported Performance (Qualitative) |
|---|---|
| Mechanism Category | At all settings, most of the power generated was in the acoustic frequency range of 16 - 127 Hz, consistent with High Frequency Chest Wall Oscillation (HFCWO). |
| Control of Power Output | Varying the static load could control the power output, as predicted by the force multiplier design principle. |
2. Sample Size for the Test Set and Data Provenance:
- Test Set Sample Size: Not applicable. The "test set" here refers to bench testing of the device itself, not a clinical patient cohort. The testing involved various settings (frequency, power, static loads) on a single physical device within a controlled laboratory setup.
- Data Provenance: The bench testing was conducted by Aeromethod Precision Engineering and Manufacturing, San Diego, CA, and analysis was performed by BioMedical Strategies, White River Junction, VT. This is laboratory-generated data, not from patient populations. It is inherently "prospective" in the sense of being planned testing, but not clinical.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. For this type of mechanical device and 510(k) submission, "ground truth" is established through engineering and physics principles, and measured physical parameters, not expert human interpretation of complex data (like radiology images). The objective measurements from the bench test served as the data.
4. Adjudication Method for the Test Set:
Not applicable. There was no "adjudication" necessary as the test involved objective mechanical measurements.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:
Not applicable. This device is a therapeutic/clearance system, not a diagnostic AI tool, so a MRMC study is not relevant to its performance demonstration. The submission focuses on comparison to predicate mechanical devices.
6. Standalone (i.e., algorithm only without human-in-the-loop performance):
- Yes, in the context of mechanical performance. The "bench data" section describes the standalone mechanical characterization of the device itself.
- The study demonstrated that the device, on its own when operated, functions as a high-frequency chest wall oscillator and its power output can be controlled.
7. Type of Ground Truth Used:
- Engineering/Physics Measurements: The ground truth for the bench testing was objective, quantitative measurements of mechanical output (vibration data, power spectra) collected from the device under controlled laboratory conditions, analyzed based on established engineering and physics principles.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a "training set" of data in the computational sense. Its design and development would have involved engineering principles and iterative testing, but not "training data" in the AI context.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no "training set" in the AI/ML sense for this 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).