(207 days)
The MINI PEGASO A-COUGH PERC is designed for the 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 hospital, institutional setting, or home use given adequate training. For use on adult patients and pediatric patients 3 years old and up.
The MINI PEGASO A-COUGH is designed for the 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. For use in hospital, institutional setting, or home use given adequate training. For use on adult patients and pediatric patients 3 years old and up.
The MINI PEGASO COUGH is designed for the 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. For use in hospital, institutional setting, or home use given adequate training. For use on adult patients and pediatric patients 3 years old and up.
The Dima Italia Srl Mini Pegaso Cough is an electric device useful in clearing retained bronchopulmonary secretions. It acts a "cough" patient simulation, applying a positive air pressure to the airway, then rapidly shifting to a negative air pressure. At the end of this pressure shifting, the Mini Pegaso Cough leaves the airways free, at zero pressure, for a pause time determined by operator. The Inspiratory Flow rising time can be selected on four levels: Peak, High, Medium, Low. This "Forced Insufflation" is destinated to patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis respiratory muscles paralysis, such as spinal cord injury. Even patients with other diseases, such emphysema, cystic fibrosis, can be treated with Mini Pegaso Cough. It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube. The Mini Pegaso Cough is realized with a blower, used as pressure and flow generator, and a mechanical valve, commanding the sign and the air pressure intensity outing to the patient. The blower takes air from atmosphere, and compresses it in order to generate a positive or negative pressure. The pressure value is controlled by an electronic sensors. In order to reduce the risks of adverse reactions, an (optional) Masimo oximeter has been added. An optional flow sensor (trigger) has been added in order to synchronize the inspiration cycles to the first or all the inspiratory efforts of the patient. An optional high frequency oscillatory vibration (percussion mode) has been added in order to help to clear retained bronchopulmonary secretions. So, Mini Pegaso Cough (without options), Mini Pegaso A-Cough (with the trigger option), Mini Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used. Mini Pegaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc are equivalent devices. The Inspiratory/Expiratory cycles are determined by the blower rotation and the mechanical valve positioning. This valve is connected to a step-motor, whose position is detected through an optical sensor. The valve lets the positive flow go toward the patient and the negative flow toward the atmosphere or, instead, the positive flow to the atmosphere and the negative flow toward the patient. The working parameters are visualized on a colour TFT display and modified through a touch keyboard.
This document describes the Dima Italia Srl Mini Pegaso Cough, Mini Pegaso A-Cough, and Mini Pegaso A-Cough Perc devices, which are secretion clearance devices. The information provided is primarily focused on demonstrating substantial equivalence to existing predicate devices for FDA 510(k) clearance.
Here's an analysis of the provided text in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like a typical clinical study would. Instead, it describes "product requirements" and various types of testing to verify that the device meets "specifications." The closest it comes to a direct comparison of performance is in the "Technological Characteristics" table (pages 11-12) which compares the Mini Pegaso Cough's specifications to those of predicate devices.
Interpretation for Acceptance Criteria: The "acceptance criteria" here are implicitly the device's design input specifications and its ability to achieve performance comparable to predicate devices within those defined parameters.
Reported Device Performance (Excerpted from "Technological Characteristics" and "Performance Data" sections):
| Acceptance Criteria (Implied from Device Specifications) | Reported Device Performance (Mini Pegaso Cough K140605) |
|---|---|
| Patient Population | Adult or pediatric patient unable to cough or clear secretions effectively |
| Delivery Type | Non Invasive or Invasive |
| Modes of Operation | Manual and Auto |
| Inhalation Pressure | 0 to 50 cmH2O (differs from some predicates with up to 70 cmH2O) |
| Exhalation Pressure | 0 to -50 cmH2O (differs from some predicates with up to -70 cmH2O) |
| Inhale Flow | Low, medium, High, Peak |
| Pause Time | 0 to 9.9 seconds |
| Phases of Therapy Cycle | Insufflation, Exsufflation, Pause |
| Safety Protocols | Dynamic Flow and Pressure control, Manufacturer Software Calibration, Sensor malfunction detection |
| Percussion Frequency (if Percussion option present) | 50 to 600 bpm (differs from one predicate with up to 1200 bpm) |
| Remote Data Access | Internal memory stores therapies data, RS232/USB adapter transmits to a PC |
| User Interface and Display Parameters | Verified to meet product requirements; displays proper data and therapy information, including oximeter values and alarms. |
| AutoSync/EasyStart Performance | Verified to meet product specifications across defined patient case simulations; operation and triggering performance verified. |
| Oscillations (percussion) Performance | Verified to meet product specifications; bench testing at extreme therapy settings executed, waveforms on lung simulator as attended. |
| Data Management Performance | Verified to meet product specifications for internal EEprom and PC downloading. |
| Oximetry Connection Performance | Tested to verify pulse oximetry data performs as intended; proper values visualization and alarms tested; exception messages verified with bench and clinical dynamic simulator. |
| Device Case Compliance | Tested according to IEC 60601-1, ISO 10993-1, ISO 9919. Passed. |
| Electrical Safety Class Compliance | Tested according to IEC 60601-1, IEC 60601-1-2. Passed. |
| Standards Compliance | Designed and tested according to ISO 14971, ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, ISO 9919, IEC 62304. |
Study Proving Acceptance Criteria:
The document states that the devices were proven to meet these criteria through non-clinical testing, specifically:
- Bench testing: including black-box and white-box testing.
- Software unit testing.
- Hardware unit testing (for SpO2 introduction).
- Code reviews.
- Clinical Dynamic Simulator Validation Report (specifically for oximeter verification, run by Masimo).
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the test set. It refers to "patient case simulations" for AutoSync/EasyStart verification and "extreme therapy settings" for percussion testing, suggesting a range of conditions were tested on a bench/simulator, but no number of individual "cases" or "samples" is given.
- Data Provenance: The data provenance is from non-clinical bench testing and simulations, conducted by the manufacturer, Dima Italia Srl, and Masimo for oximeter verification. It is not patient data; therefore, there is no country of origin or retrospective/prospective designation in the human health context.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: This information is not provided in the document.
- Qualifications of Experts: This information is not provided in the document.
Given that the testing involved non-clinical bench testing and simulations, the "ground truth" would be established by the expected outputs/measurements based on the device's design specifications and engineering principles, rather than expert clinical consensus on actual patient data.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method like 2+1 or 3+1, which are typically used for disagreements among human experts evaluating clinical data. Since the testing was non-clinical and primarily bench-based, such a method would not be applicable. Device performance was assessed against predefined technical specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The document explicitly states that "non-clinical tests" were used for validation, and only mentions a "clinical dynamic simulator" for pulse oximetry. There is no mention of human readers, clinical cases, or AI assistance for human readers.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
This question is not directly applicable in the context of this device. The Mini Pegaso Cough is a medical device, not an AI algorithm. Its "standalone" performance refers to its ability to operate according to its specifications during bench testing, which was done (e.g., "black-box performance testing," "white-box testing"). The device's operation is essentially "algorithm only" in the sense that it functions based on its programmed logic and hardware, without requiring human intervention for its core function during a therapy cycle, though it is human-operated.
7. Type of Ground Truth Used
The ground truth used was primarily engineering specifications and expected physical measurements/outputs based on the device's design. This includes:
- Expected pressure values (e.g., 0 to 50 cmH2O).
- Expected flow characteristics (Low, medium, High, Peak).
- Correct operation of modes (Manual, Auto).
- Accurate display of therapy parameters.
- Correct triggering performance for AutoSync/EasyStart.
- Accurate percussion frequency and waveform on a lung simulator.
- Proper data management functionality.
- Accurate pulse oximetry data visualization and alarm activation as verified by a clinical dynamic simulator.
- Compliance with various electrical safety, biocompatibility, and risk management international standards (e.g., IEC 60601-1, ISO 10993-1, ISO 9919).
8. Sample Size for the Training Set
This information is not applicable and not provided. This device is a hardware-based medical device with integrated software, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. The software development process likely involved various levels of testing and verification, but not "training" using a specific dataset like an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons mentioned in point 8.
§ 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).