(220 days)
No
The document describes a mechanical device that simulates a cough using controlled pressure and flow. It mentions electronic sensors and a step-motor for control, and optional features like an oximeter and flow sensor for synchronization. There is no mention of AI, ML, or any learning or adaptive algorithms. The control appears to be based on pre-set parameters and sensor feedback, not on learned patterns or data analysis.
Yes
The device is designed to treat patients unable to cough or clear secretions effectively, and its mechanism of action simulates a cough to clear bronchopulmonary secretions, which is a therapeutic function.
No
Explanation: The device is designed to assist patients in clearing secretions by simulating a cough, which is a therapeutic function, not a diagnostic one. It helps patients manage a condition rather than identify or diagnose it.
No
The device description explicitly states it is an "electric device" and details hardware components like a blower, mechanical valve, step-motor, optical sensor, electronic sensors, and a color TFT display. It also mentions optional hardware like an oximeter and flow sensor. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The PEGASO A-COUGH PERC, PEGASO A-COUGH, and PEGASO COUGH are described as devices that assist patients in clearing secretions by applying and rapidly shifting air pressure to the airway. They simulate a cough.
- Intended Use: The intended use is to help patients who are unable to cough effectively due to various medical conditions. This is a therapeutic intervention, not a diagnostic test performed on a specimen.
- Device Description: The description details the mechanical and electrical components that generate and control air pressure. There is no mention of analyzing biological samples.
- Performance Studies: The performance studies described are bench testing and software testing, not studies involving the analysis of patient specimens.
The device is a therapeutic medical device used to assist with respiratory function, not a diagnostic device that analyzes samples from the body.
N/A
Intended Use / Indications for Use
The 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 endotrached 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 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 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 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.
Product codes
NHJ
Device Description
The Dima Italia Srl 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 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 Pegaso Cough.
It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube.
The 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, Pegaso Cough (without options), Pegaso A-Cough (with the trigger option), Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used.
Pegaso Cough, Pegaso A-Cough, 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.
The settable parameters are:
- Cough assistant modes or Percussion mode (if present)
- Cough Times
- Trigger value (if present)
- Positive Pressure value
- Negative Pressure value
- Percussion Pressure amplitude (if present)
- Percussion Frequency
- Percussion I/E Ratio
- Oximeter configuration and alarms
If the device is in automatic mode, the device will continuously cycle, generating an Inspiration phase, followed by an expiration phase, followed by a pause phase.
If the device is in manual mode, the device will produce an inspiration phase if the operator moves to the right side the lever of a mechanical switch, will produce an expiration phase if the operator moves the lever to the left, generates a pause phase if the lever is in stand-by position.
When the trigger is present, AutoSync and EasyStart modes are enabled. Autosync starts VE/Pause cycles synchronized with the inspiratory effort of the patient. Easystart synchronizes only the first VE/Pause cycle with the inspiratory effort of the patient. All other cycles will follow the set times as for automatic mode.
When the Percussion option is present, the device enable the Percussion mode.
This is a feature that delivers a pressure oscillation based on frequency and amplitude set points.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, lungs, bronchopulmonary
Indicated Patient Age Range
adult patients and pediatric patients 3 years old and up.
Intended User / Care Setting
hospital, institutional setting, or home use given adequate training.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing.
In order to demonstrate that the Pegaso Cough device performs to design input specifications and it is substantially equivalent to predicate devices, black-box performance testing was conducted, using bench testing methodologies.
Worst case scenario inputs that would be experienced use environment has been simulated (null and maximum pressures, minimum and maximum flows, all SpO2 values and all Pulse rate values, all exceptions that external Masimo SpO2 module can activate).
Additional white-box testing verified proper operation under conditions of sensors malfunctions, inaccurate or complete sensor dropout.
For oximeter verification, a Clinical Dynamic Simulator Validation Report has been run by Masimo on Pegaso Cough.
Device Modification Testing Summary
Verification activities have been performed to verify that the device modifications stated above did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing, and code reviews.
Device Characteristics: User Interface, including displayed therapy parameters and oximetry parameters.
Testing Summary: Has been verified to meet product requirements defined for the Pegaso Cough. Bench testing, black-box and white-box testings, code reviews and software unit testing were performed to verify that all display functions, user controls and informational messages performed as intended, including oximeter values. The user interface was verified to ensure that it displayed the proper data and expected therapy information.
Device Characteristics: AutoSync/EasyStart
Testing Summary: The AutoSync and EasyStart features of the Pegaso A-Cough and Pegaso A-Cough Perc device has been verified to meet product specifications with each defined patient case simulation. The operation and triggering performance has been verified to operate across tha range of patient cases.
Device Characteristics: Oscillations (percussion)
Testing Summary: The Percussion feature of the Pegaso A-Cough Perc has been verified to meet product specifications. Bench testing at extreme therapy settings has been executed and waveforms on lung simulator are as attended.
Device Characteristics: Data Management
Testing Summary: Data Management of the Pegaso Cough device has been verified to meet product specifications for internal EEprom and for its downloading from a PC. Bench testing, black-box and white-box testings, code reviews and software unit testing were performed to verify that all memory functions performed as intended.
Device Characteristics: Oximetry Connection
Testing Summary: The oximeter has been tested to verify that the pulse oximetry data perform as intended. Proper values visualization and proper alarms activation has been tested, too. All exception messages have been verified with bench testing and with a clinical dynamic simulator.
Device Characteristics: Case
Testing Summary: The Pegaso Cough structure and materials have been tested to verify the complying to product requirements defined for the device. IEC 60601-1, ISO 10993-1, ISO 9919 tests passed. Third part Test reports.
Device Characteristics: Electrical Safety Class
Testing Summary: The Pegaso Cough has been tested to verify the complying to product requirements defined for the device. IEC 60601-1, IEC 60601-1-2 passed. Third parts Test reports.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K002598, K072292, K121955, K122111
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized image of a human face in profile, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 16, 2014
Dima Italia Srl Mr. Dario Basciu Ouality Assurance Responsible Via Coriolano Vighi, 29 Bologna, ITALY 40133
Re: K140598
Trade/Device Name: Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc Regulation Number: 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: Class II Product Code: NHJ Dated: July 4, 2014 Received: September 4, 2014
Dear Mr. Basciu,
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Basciu
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Teiashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140598
Device Name PEGASO A-COUGH PERC
Indications for Use (Describe)
The 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 endotrached 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
3
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140598
Device Name PEGASO A-COUGH
Indications for Use (Describe)
The 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 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
5
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K140598
Device Name PEGASO COUGH
Indications for Use (Describe)
The 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
7
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
8
510(k) Summary
Administrative Information and Device Identification
| Name and address of the manufacturer
and sponsor of the 510(k) submission | Manufacturer:
Dima Italia Srl
Via Coriolano Vighi, 29
40133, Bologna - Italy
Office: (+39) 051568857
Fax: (+39) 051563994
Sponsor:
Dima Italia Srl
Via Coriolano Vighi, 29
40133, Bologna - Italy
Office: (+39) 051568857
Fax: (+39) 051563994 |
|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA registration number of the
manufacturer of the device: | 3007123976 (Facility Registration number) |
| Official contact person for all
correspondence: | Dario Basciu,
Senior Regulatory Affairs Engineer
Dima Italia Srl
Via Coriolano Vighi, 29
40133, Bologna - Italy
Office: (+39) 051568857
Fax: (+39) 051563994
Email: tech.support@dimaitalia.com |
| United States Agent Information | --- |
| Date Prepared: | October 03, 2014 |
| Proprietary Name of new device: | Pegaso Cough
Pegaso A-Cough
Pegaso A-Cough Perc |
| Common or usual name of the device: | Secretion Clearance Device |
| Dima Italia Srl model number: | Pegaso Cough |
| Classification of new device | Class II |
| Classification of the predicate
device: | Class II |
| Classification Panel: | Anesthesiology |
| Panel Code: | NHJ - noncontinuous ventilator (IPPB) |
9
| CFR Regulation Number: | 21 CFR 868.5905
a) Identification. A noncontinuous ventilator
(intermittent positive pressure breathing – IPPB) is a
device intended to deliver intermittently an aerosol to
a patient's lung ot to assist a patient's breathing.
b) Classification. Class II (performance standards) |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate device Name(s) and
510(k) numbers: | Emerson Cough Assist, Model CA-3000 K002598
Dima Italia Negavent DA-3 Plus Pegaso K072292
Philips Respironics CoughAssist T70 K121955
Respironics SimplyClear Percussor K122111 |
| Reason for submission | Device modification. |
Description of device.
The Dima Italia Srl 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 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 Pegaso Cough.
It can be used with a facemask or, with an adapter, to an endotracheal or tracheostomy tube.
The 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, Pegaso Cough (without options), Pegaso A-Cough (with the trigger option), Pegaso A-Cough Perc (with trigger and percussion options) identification names will be used.
Pegaso Cough, Pegaso A-Cough, 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.
10
The settable parameters are:
- Cough assistant modes or Percussion mode (if present) ●
- Cough Times ●
- Trigger value (if present)
- Positive Pressure value
- Negative Pressure value
- Percussion Pressure amplitude (if present)
- Percussion Frequency
- Percussion I/E Ratio ●
- Oximeter configuration and alarms
If the device is in automatic mode, the device will continuously cycle, generating an Inspiration phase, followed by an expiration phase, followed by a pause phase.
If the device is in manual mode, the device will produce an inspiration phase if the operator moves to the right side the lever of a mechanical switch, will produce an expiration phase if the operator moves the lever to the left, generates a pause phase if the lever is in stand-by position.
When the trigger is present, AutoSync and EasyStart modes are enabled. Autosync starts VE/Pause cycles synchronized with the inspiratory effort of the patient. Easystart synchronizes only the first VE/Pause cycle with the inspiratory effort of the patient. All other cycles will follow the set times as for automatic mode.
When the Percussion option is present, the device enable the Percussion mode.
This is a feature that delivers a pressure oscillation based on frequency and amplitude set points.
Statement of Intended Use.
The Dima Italia Srl Pegaso Cough assists patients in clearing retained bronchopulmonary secretions by gradually applying a positive pressure to the airway, then rapidly shifting to a negative pressure. This rapid shift in pressure, via a facemask, mouthpiece or an endotracheal or tracheostomy tube, produces a high expiratory flow rate from the lungs, simulating a cough.
Indication for use.
The 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 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.
11
Comparison of Device technological Characteristics to predicate device
Substantial Equivalence.
The Dima Italia Srl Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc devices have the following similarities to the previously cleared predicate devices:
- Same intended use ●
- Same operating principle
- . Same technology
- . Same manufacturing process
The Pegaso Cough, Pegaso A-Cough Perc devices have the secretion clearance functionality substantially equivalent to CoughAssist device (K002598), Dima Italia Negavent DA-3 Plus Pegaso (K072292) and the CoughAssist T70 device (K121955).
The Pegaso A-Cough Perc device is useful for the mucus loosening and mobilization. It occurs by applying air pulse generated high frequency oscillatory vibrations on the chest wall via the airways. The high frequency oscillatory vibrations release mucus from the bronchial walls, increasing mobilization.
The Pegaso A-Cough Perc device combines the loosening and mobilization functionality of the Philips Respironics SimplyClear (K12211) with the secretion clearance functionality of the CoughAssist device (K002598), Dima Italia Pegaso (K072292) and the CoughAssist T70 device (K121955).
The table below summarizes the key technical characteristics between the gegaso Cough to those of the predicate devices listed in the submission:
| Technological
Characteristics | Pegaso Cough
Description | Pegaso Cough
Description | Respironics
SimplyClear | Emerson
CoughAssist | Philips
Respironics
CoughAssist
T70 |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | K140598 | K072292 | K122111 | K002598 | K121955 |
| Patient Population | Adult or pediatric
patient unable to cough
or clear secretions
effectively | Adult or pediatric patient
unable to cough or clear
secretions effectively | Adult or pediatric
patients having
difficulty with secretion
clearance and/or
inability to cough | Adult or pediatric
patient with an
ineffective cough due
to muscular
dystrophy,
myasthenia gravis,
poliomyelitis, or other
neurologic disorder
with some paralysis
of the respiratory
muscles, such as
spinal cord injury. | Adult or pediatric
patient unable to cough
or clear secretions
effectively |
| Delivery type | Non Invasive or
Invasive | Non Invasive or Invasive | Non Invasive or
Invasive | Non Invasive or
Invasive | Non Invasive or
Invasive |
| Modes of operation | Manual and Auto | Manual and Auto | Manual and Auto | Manual and Auto | Manual and Auto |
| Inhalation Pressure | 0 to 70 cmH2O | 0 to 70 cmH2O | 0 to 70 cmH2O | 0 to 60 cmH2O | 0 to 70 cmH2O |
| Exhalation Pressure | 0 to -70 cmH2O | 0 to -70 cmH2O | 0 to -70 cmH2O | 0 to -60 cmH2O | 0 to -70 cmH2O |
| Inhale Flow | Low, medium, High,
Peak | Low, medium, High | Low, medium, High | Low, medium, High | Low, medium, High |
| Pause Time | 0 to 9.9 seconds | 0 to 9.9 seconds | 0 to 5 seconds | 0 to 5 seconds | 0 to 5 seconds |
| Phases of Therapy
Cycle | Insufflation,
Exsufflation, Pause | Insufflation, Exsufflation,
Pause | Insufflation,
Exsufflation, Pause | Insufflation,
Exsufflation, Pause | Insufflation,
Exsufflation, Pause |
| Pegaso Cough
Safety Protocols | Dynamic Flow and
Pressure control.
Manufacturer Software
Calibration eliminates
all undesired
oscillations.
Sensor malfunction
detection | Dynamic Flow and
Pressure control.
Manufacturer Software
Calibration eliminates all
undesired oscillations. | Dynamic Stability
Analysis. Flow and
Pressure based
Oscillation Detection
Extreme Flow Rate
Control and Response
Sensor Malfunction
Stability | N/A | Dynamic Stability
Analysis. Flow and
Pressure based
Oscillation Detection
Extreme Flow Rate
Control and Response
Sensor Malfunction
Stability |
| Percussion
Frequency | 50 to 600 bpm | NA | 60 to 1200 bpm | NA | NA |
| Remote Data
Access | An internal memory
stores therapies data.
RS232/USB adapter
transmits to a PC
therapies and technical
data. | NA | | N/A | A secure digital (SD)
card provides means for
data access. |
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The table below provides a description of the modifications to the Dima Italia Srl &gaso Cough device that are subject of this 510(k) submission:
| Device Features | Similarities |
|---|---|
| User Interface | A new graphic display and a new graphical user interface with hierarchical menu system. |
| SIMILARITIES | |
| Philips Respironics CoughAssist T70 K121955 has similar parameters displayed in the main working page. | |
| Philips Respironics CoughAssist T70 K121955 doesn't visualize oximetry parameters on the main page, but the operator has to call a specific function in order to visualize these monitored values. Pegaso (all models) visualizes on the main page the monitored values and the alarms and exceptions that are related to the oximetry. | |
| EasyStart/AutoSync | A feature for patients who can provide a spontaneous breathing effort to trigger the Cough sequence, instead of using manual or auto modes therapy. This software feature monitors the device outlet flow and initiates the insufflation phase of therapy delivery when the flow increases over a set threshold indicative of patient effort. |
| SIMILARITIES | |
| The AutoSync and Easy Start are based on the detection of the patient's inspiratory efforts (triggers). For this detection a digital flow sensor is used. The principle is similar to the Philips Respironics CoughAssist T70 K121955 Cough-Trak feature. | |
| Oscillations (Percussion) | A feature that delivers a pressure oscillation based on frequency and amplitude set points. |
| SIMILARITIES | |
| The feature is similar to the oscillatory vibrations of the Philips Respironics SimplyClear (K122111). In the literature technicians prefer to use the Frequency and I/E Ratio instead of the definition of Inspiratory Time and Expiratory Time. The Pause Time is never used. So, Pegaso A-Cough Perc in the Percussion modality, shows Frequency and I/E Ratio. | |
| Data Management | Therapy data will be stored in an internal memory. On request data are sent to a PC |
| Oximetry Connection | The devices has full compatibility with Masimo Set Technology Oximeters. The device displays current SpO2, Pulse rate, and Perfusion Index received from the oximeter. Minimum and maximum alarms values are present. The device complies with all clauses of ISO 9919:2009 |
| SIMILARITIES | |
| The Pegaso devices (all models) work with a Masimo oximeter. The oximeter is similar to the one used on the Philips Respironics CoughAssist T70 K121955 device. | |
| Case | The case has been modified for higher ergonomics using same materials |
| Electrical Safety Class | The Electrical class is now Class II BF. |
| Labels | The NEW NEGAVENT DA-3 PLUS PEGASO name is substituted. The rear panel label reports now the commercial names Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc identifying the active options. A Barcode has been added, |
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Performance Data
Non-Clinical Testing.
In order to demonstrate that the Pegaso Cough device performs to design input specifications and it is substantially equivalent to predicate devices, black-box performance testing was conducted, using bench testing methodologies.
Worst case scenario inputs that would be experienced use environment has been simulated (null and maximum pressures, minimum and maximum flows, all SpO2 values and all Pulse rate values, all exceptions that external Masimo SpO2 module can activate).
Additional white-box testing verified proper operation under conditions of sensors malfunctions, inaccurate or complete sensor dropout.
For oximeter verification, a Clinical Dynamic Simulator Validation Report has been run by Masimo on Pegaso Cough.
Device Modification Testing Summary
Verification activities have been performed to verify that the device modifications stated above did not affect the safety and effectiveness of the subject device. This included bench testing, software unit testing, and code reviews.
| Device Characteristics | Testing Summary |
|---|---|
| User Interface, including displayed therapy parameters and oximetry parameters. | Has been verified to meet product requirements defined for the Pegaso Cough. Bench testing, black-box and white-box testings, code reviews and software unit testing were performed to verify that all display functions, user controls and informational messages performed as intended, including oximeter values. The user interface was verified to ensure that it displayed the proper data and expected therapy information. |
| AutoSync/EasyStart | The AutoSync and EasyStart features of the Pegaso A-Cough and Pegaso A-Cough Perc device has been verified to meet product specifications with each defined patient case simulation. The operation and triggering performance has been verified to operate across tha range of patient cases. |
| Oscillations (percussion) | The Percussion feature of the Pegaso A-Cough Perc has been verified to meet product specifications. Bench testing at extreme therapy settings has been executed and waveforms on lung simulator are as attended. |
| Data Management | Data Management of the Pegaso Cough device has been verified to meet product specifications for internal EEprom and for its downloading from a PC. Bench testing, black-box and white-box testings, code reviews and software unit testing were performed to verify that all memory functions performed as intended. |
| Oximetry Connection | The oximeter has been tested to verify that the pulse oximetry data perform as intended. Proper values visualization and proper alarms activation has been tested, too. All exception messages have been verified with bench testing and with a clinical dynamic simulator. |
| Case | The Pegaso Cough structure and materials have been tested to verify the complying to product requirements defined for the device. IEC 60601-1, ISO 10993-1, ISO 9919 tests passed. Third part Test reports. |
| Electrical Safety Class | The Pegaso Cough has been tested to verify the complying to product requirements defined for the device. IEC 60601-1, IEC 60601-1-2 passed. Third parts Test reports. |
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Standards Evaluation
The Dima Italia Srl Pegaso Cough device has been designed and tested according to:
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- ISO 14971 Medical devices Application of Risk management to medical devices
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- ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
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- IEC 60601-1 Medical Electric Equipment-Part 1: General Requirements of Safety
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- IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: Electromagnetic Compatibility
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- IEC 60601-1-6 Medical Electrical Equipment-Part 1-6:Usability
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- ISO 9919 Medical Electrical Equipment-Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
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- IEC 62304 Medical Device Software Software life cycle precesses.
The Dima Italia Srl Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc were tested in accordance with applicable voluntary standards. The Dima Italia Srl Pegaso Cough, Pegaso A-Cough, Cegaso A-Cough Perc met the required performance criteria and functioned as intended.
Conclusion
Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc are equivalent devices.
The legaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc modifications that are the subject of this 510(k) submission have been validated using non-clinical tests. A clinical dynamic simulator was used for the pulse oximetry validation.
The Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc devices have been determined to be substantially equivalent to the predicate devices. Bench testing (black-box and white-box) and software code reviews have confirmed that the Pegaso A-Cough, Pegaso A-Cough, Pegaso A-Cough Perc devices performs substantially equivalent to the cited predicated devices.
Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc devices are different from predicate devices on maximum percussion frequency (that is limited to 600cpm).
The indication for use, technological characteristics, and principles of operation are similar to the predicate devices. The Dima Italia Srl Pegaso Cough, Pegaso A-Cough, Pegaso A-Cough Perc devices are as safe and as effective to the predicate devices and the devices do not raise questions of safety and effectiveness