(144 days)
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 Pegaso Cough Assist is a negative pressure, non-invasive ventilation system useful in clearing retained bronchopulmonary secretions. It produces a patient "cough" simulation, applying a positive pressure to the airway, then rapidly going to a negative pressure. At the end of this pressure shifting, the Pegaso Cough leaves the airway free, at zero pressure, for a pause time determined by the operator. The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low.
This "forced insufflation-exsufflation" is designated for patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis, and respiratory muscle paralysis such as spinal cord injury. Even patients with other diseases, such as emphysema and cystic fibrosis, can be treated with the Pegaso Cough. It may be used with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. The Pegaso Cough is indicated for use in a hospital, institutional setting, or home use given adequate training.
The Cough Assist device applies a positive pressure in the airway initially. The device shifts to a negative pressure through a facemask, mouthpiece, or an adapter to the patient's endotracheal tube or tracheostomy tube. The rapid shift produces a high expiratory flow from the lungs simulating a cough and clearing secretions. At the end of this pressure shifting, the Pegaso Cough leaves the airway free at zero or ambient pressure. A pause time between cycles is operator selected.
FDA classifies this device as a noncontinuous ventilator under 868.5905. Product Code NHJ under the Anesthesiology Review Panel. The device meets the requirements for medical equipment general requirements for basic and essential safety performance and electromagnetic compatibility.
The Pegaso Cough is comparable to the Emerson Cough Assist cleared under K002598 and have the similar indications for use.
The device is software controlled and has safety alarms for no pressure, high pressure, valve fault, low pressure, and power failure. Performance is controlled from a touch screen keyboard in manual or automatic modes.
This 510(k) summary describes the Pegaso Cough device and its substantial equivalence to the Emerson Cough Assist. It primarily focuses on comparing specifications and features rather than reporting on a specific study designed to meet acceptance criteria through device performance metrics.
Therefore, many of the requested sections (e.g., sample size, data provenance, ground truth establishment, MRMC study, standalone performance) cannot be fully populated as the document provided does not contain a detailed performance study with quantitative results against acceptance criteria.
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for device performance in the form of a study. Instead, substantial equivalence is claimed based on comparable features and meeting general safety and ventilator standards. The performance metrics are presented as device specifications.
| Feature | Acceptance Criteria (Implied by Predicate) | Reported Pegaso Cough Performance |
|---|---|---|
| Use settings | Home, hospital/institution (Emerson) | Home, hospital/institution |
| Patient Use | Adult and pediatric (Emerson) | Adult and pediatric |
| Maximum Positive Pressure | +60 cm H2O (Emerson) | +70 cm H2O |
| Maximum Negative Pressure | -60 cm H2O (Emerson) | -70 cm H2O |
| Maximum Inhalation Flow | 3.3 liters/second (Emerson) | 2.9 liters/second |
| Positive Pressure Range | 0 to +70 cm H2O (Emerson) | +5 to +70 cm H2O, 1 cm H2O steps |
| Negative Pressure Range | 0 to -70 cm H2O (Emerson) | -5 to -70 cm H2O, 1 cm H2O steps |
| Mode of Operation | Automatic and manual timing (Emerson) | Automatic and manual modes |
| Cycle Timings (Inhalation, Exhalation, Pause) | 0 to 5 seconds (Emerson) | 0.1 to 9.9 seconds |
| Blower Type | Two speed, AC/DC brush motor (Emerson) | Brushless blower, High, Medium, and Low speeds |
| Safety Standards | EN60601-1, others (Emerson) | IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, EMC IEC 6060101-2, FCC Part 15, Class B |
| Safety Alarms | Power Failure, Others Unknown (Emerson) | Power Failure, No pressure, High pressure, Valve fault, Low pressure, Fuse Failure |
| Contraindications | Bullous emphysema, Pneumothorax, Pneumo-mediastinum, Barotrauma (Emerson) | Bullous lung disease, Pneumothorax, Extremely low blood pressure, Pneumocephalus or pre-existing CSF leaks or head trauma, Severe cardiac rhythm disturbances, Acute facial trauma |
2. Sample sized used for the test set and the data provenance
The document does not describe a clinical performance study with a test set. This 510(k) relies on comparing device specifications and meeting recognized standards, rather than clinical data from a human test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring ground truth establishment by experts is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication is described.
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 device is not an AI-assisted diagnostic device, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for physical therapy, not an algorithm. Its performance is inherent to its mechanical and electrical specifications and functionality. The document implies that the device performs its intended function based on its design and compliance with safety standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for device performance comparison. The "ground truth" for demonstrating substantial equivalence is the predicate device's established performance and the general safety and ventilator standards (IEC 60601 series, EN 794-1 and -2).
8. The sample size for the training set
Not applicable, as no machine learning algorithm development (which would require a training set) is described.
9. How the ground truth for the training set was established
Not applicable, as no machine learning algorithm development is described.
Study Proving Device Meets Acceptance Criteria:
The provided document does not describe a specific clinical study with defined acceptance criteria and corresponding performance metrics demonstrating safety and effectiveness. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Emerson Cough Assist, Model CA-3000, K002598) and compliance with recognized safety and performance standards.
The "study" for this 510(k) is essentially a comparison of technical specifications, intended use, and adherence to regulatory standards.
Key aspects of this demonstration include:
- Comparison Table: A detailed comparison table ([{3}]) outlines the similarities and differences between the Pegaso Cough and the predicate device across various features, including pressure ranges, modes of operation, timing control, power supply, and safety features.
- Statements of Similarities and Differences: The document explicitly lists 11 similarities and 4 differences to highlight the comparable nature of the devices ([{5}]). The differences (e.g., higher max pressure, wider timing range, lighter weight, software control) are presented as not raising new questions of safety or effectiveness.
- Standards Met: The Pegaso Cough is stated to meet a range of international and European standards, including IEC 60601-1 (Medical Equipment), IEC 60601-1-4 (Programmable Electrical Medical Systems), EN ISO 9703-3 (Alarm Signals), EN 60601-1-2 (Electromagnetic Compatibility), and EN 794-1 and -2 (Lung Ventilator) ([{2}]). These standards serve as proxies for demonstrating basic safety and performance "acceptance criteria."
The FDA's letter of clearance ([{6}]-[{7}]) confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. This determination itself serves as the "proof" that the device meets the implied regulatory acceptance criteria for market authorization via the 510(k) pathway, specifically by demonstrating equivalence to a predicate.
§ 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).