(185 days)
The Vital Cough is intended for use on patients unable to cough or clear secretions effectively due to reduced peak cough expiratory flow resulting from high spinal cord injuries, neuromuscular deficits or severe fatigue associated with intrinsic lung disease. It may be used either with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. For use in a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.
The device is an electromechanical software controlled device housed in a metal and polymer case. A touch screen displays outputs and receives commands from the user. The device develops positive and negative pressure through an adjustable blower. In inhale mode the lungs are inflated. The device rapidly shifts to providing negative pressure with the intended goal of rapidly deflating the lungs to stimulate an effective patient cough. A flutter feature developed by an oscillator butterfly valve may be activated during exhalation to assist in loosening and removing secretions.
Here's a breakdown of the acceptance criteria and the study information for the Vital Cough device, based on the provided 510(k) summary:
Acceptance Criteria and Device Performance
The acceptance criteria for the Vital Cough with flutter feature are implicitly established through substantial equivalence claims to two predicate devices: the Vital Cough without a flutter feature (K120277) and the Acapella flutter device (K002768). The study aims to demonstrate that the new device's performance, particularly with the added flutter feature, is comparable and safe for its intended use.
Explicit Performance Characteristics and Comparison:
| Feature | Acceptance Criteria (Predicate - Vital Cough K120277) | Acceptance Criteria (Predicate - Acapella K002768) | Reported Device Performance (Vital Cough with Flutter) |
|---|---|---|---|
| Maximum Pressures | +/- 50 cm H2O | Human effort (19 cm H2O) | +/- 50 cm H2O |
| Maximum Exhalation Peak Flow | 420 LPM | 71 LPM | 269 LPM |
| Flutter Frequency | No flutter | 0-19 Hz | 0-20 Hz |
| Flutter Waveform Technology | No flutter | Square waveform | Square waveform |
| Mode of Operation | Automatic & manual modes, Microprocessor controlled, Limited to 6 cycles | Manual mode, Recommends several cycles | Automatic & manual modes, Microprocessor controlled, Limited to 6 cycles |
| Inhalation, Exhalation, and Pause Times | 0 to 5 seconds, 0.2 second increments | Human effort | 0 to 5 seconds, 0.2 second increments |
| Line Voltage Frequency | 120-240V universal 50/60 Hz | Non-powered | 120-240V universal 50/60 Hz |
| Benefits | Creates negative expiratory and positive inspiratory pressure, improves secretion clearance, adjustable pressure, accommodates low flow rates. | Creates positive expiratory pressure (PEP) and vibration, improves secretion clearance, allows patient to adjust frequency/pressure, accommodates low flow rates. | Creates negative expiratory and positive inspiratory pressure, and vibrations, improves secretion clearance, adjustable frequency and pressure, accommodates low flow rates. |
| Indications for Use | For use on patients unable to cough or clear secretions effectively due to specific conditions (spinal cord injuries, neuromuscular deficits, severe fatigue from intrinsic lung disease), for use with facemask/mouthpiece/adapter to endotracheal/tracheostomy tube, in hospital/institutional/home settings, for adult/pediatric patients. | For use as a PEP device for secretion clearance and lung expansion, creating vibratory positive expiratory pressure. | For use on patients unable to cough or clear secretions effectively due to specific conditions (spinal cord injuries, neuromuscular deficits, severe fatigue from intrinsic lung disease), for use with facemask/mouthpiece/adapter to endotracheal/tracheostomy tube, in hospital/institutional/home settings, for adult/pediatric patients. |
Summary of Device Meeting Acceptance Criteria:
The Vital Cough with flutter demonstrates substantial equivalence primarily by matching or exceeding the performance characteristics of its predicate devices where applicable.
- Pressure and Flutter Characteristics: It achieves the same maximum positive/negative pressures as the original Vital Cough (K120277) and offers a comparable flutter frequency range and waveform technology to the Acapella (K002768).
- Fundamental Functionality: The core MI/E (Mechanical Insufflation-Exsufflation) design is present in both the new device and the predicate Vital Cough. The added flutter feature is directly compared to the Acapella.
- Indications for Use: The new device maintains the same broad indications for use as the original Vital Cough, which covers a wider patient population and method of use than the Acapella.
- Operating Modes and Settings: It shares the same microprocessor-controlled automatic and manual modes, and adjustable time intervals as the original Vital Cough.
The submission specifically highlights that "The Vital Cough with flutter is substantially equivalent to the Vital Cough cleared device cleared under K120277 based on intended use, comparative testing, frequency and waveform. The MIE design is in both devices. The added flutter feature has the same indication for use to clear secretions as the original Vital Cough and the Acapella. The pressure and flow differences are due to the Vital Cough MI/E activity. The flutter activity is substantially equivalent. The Vital Cough with flutter is a mechanical device driven by a fan. The Acapella is driven by himan effort. The Vital Cough device does the work for the patient."
Study Information
The 510(k) summary provided does not describe a clinical study involving human subjects or a large-scale data analysis (like an AI study). Instead, it relies on non-clinical testing to demonstrate substantial equivalence.
- Sample size used for the test set and the data provenance: Not applicable. The documentation refers to "comparative testing" and "waveform characterization and analysis" between the new device and the predicate devices, implying bench testing and engineering comparisons rather than a human-subject test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic AI or clinical studies, is not established here. The comparison is against established technical specifications and performance characteristics of predicate devices.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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 not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is an electromechanical device, not a standalone algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for comparison is the published technical specifications, performance data, and established intended uses of the predicate devices (Vital Cough K120277 and Acapella K002768). For non-clinical testing, this would involve laboratory measurements against those specifications.
- The sample size for the training set: Not applicable. This device does not use machine learning or AI algorithms requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Non-Clinical Testing Details Provided:
The summary states the following non-clinical testing was conducted:
- Compliance with IEC 60601-1 (general requirements for electrical safety).
- Compliance with IEC 60601-1-2 (electromagnetic compatibility standards).
- Verification that no toxic substances were found in the output air.
- Conformity to ISO 9703 (anesthesia and respiratory care alarm signals, auditory and visual).
- Characterization by pressure and flow of the Acapella predicate and the Vital Cough with flutter feature. This is the core of the performance comparison for substantial equivalence.
In essence, the study focuses on engineering and safety testing to demonstrate that the new device, with its added flutter feature, is functionally equivalent and safe compared to already legally marketed devices, primarily the original Vital Cough and the Acapella.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).