MINIPEGASO COUGH, MINIPEGASO A-COUGH, MINIPEGASO A-COUG PERC

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 3, 2014 Dima Italia Srl Dario Basciu Senior Regulatory Affairs Engineer Via Coriolano Vighi, 29 40133. Bologna - Italy Re: K140605 Trade/Device Name: Mini Pegaso Cough, Mini Pegaso A-Cough, Mini 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 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. of Surveillance and Biometrics/Division of Postmarket Surveillance. 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) K140605 Device Name MINI PEGASO A-COUGH PERC #### Indications for Use (Describe) 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. 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) {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) K140605 Device Name MINI PEGASO A-COUGH #### Indications for Use (Describe) 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. 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. {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) K140605 Device Name MINI PEGASO COUGH #### Indications for Use (Describe) 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. 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<br>and sponsor of the 510(k) submission | Manufacturer:<br>Dima Italia Srl<br>Via Coriolano Vighi, 29<br>40133, Bologna - Italy<br>Office: (+39) 051568857<br>Fax: (+39) 051563994<br>Sponsor:<br>Dima Italia Srl<br>Via Coriolano Vighi, 29<br>40133, Bologna - Italy<br>Office: (+39) 051568857<br>Fax: (+39) 051563994 | |------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA<br>registration<br>number<br>of<br>the<br>manufacturer of the device: | 3007123976 (Facility Registration number) | | Official contact person<br>for all<br>correspondence: | Dario Basciu,<br>Senior Regulatory Affairs Engineer<br>Dima Italia Srl<br>Via Coriolano Vighi, 29<br>40133, Bologna - Italy<br>Office: (+39) 051568857<br>Fax: (+39) 051563994<br>Email: tech.support@dimaitalia.com | | Date Prepared: | October 03, 2014 | | Proprietary Name of new device: | Mini Pegaso Cough<br>Mini Pegaso A-Cough<br>Mini Pegaso A-Cough Perc | | Common or usual name of the device: | Secretion Clearance Device | | Dima Italia Srl model number: | Mini Pegaso Cough | | Classification of new device | Class II | | Classification of the predicate<br>device: | Class II | | Classification Panel: | Anesthesiology | | Panel Code: | NHJ - noncontinuous ventilator (IPPB) | | CFR Regulation Number: | 21 CFR 868.5905<br>a) Identification. A noncontinuous ventilator<br>(intermittent positive pressure breathing – IPPB) is a<br>device intended to deliver intermittently an aerosol to<br>a patient's lung ot to assist a patient's breathing.<br>b) Classification. Class II (performance standards) | | Predicate device Name(s) and<br>510(k) numbers: | Emerson Cough Assist, Model CA-3000 K002598<br>Dima Italia Nagavent DA-3 Plus Pegaso K072292 | {9}------------------------------------------------ | | Philips Respironics CoughAssist T70<br>Respironics SimplyClear Percussor | K121955<br>K122111 | |-----------------------|--------------------------------------------------------------------------|--------------------| | Reason for submission | New Device. | | ## Description of device. 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. The settable parameters are: - Cough assistant modes or Percussion mode (if present) - Cough Times - Trigger value (if present) - Positive Pressure value {10}------------------------------------------------ - 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 I/E/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 Mini 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 (for all Models) 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 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 Mini Pegaso Cough device has the following similarities to the previously cleared predicate devices: - Same intended use ● - Same operating principle - . Same technology - . Same manufacturing process The MiniPegaso Cough, MiniPegaso A-Cough, MiniPegaso 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 MiniPegaso 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 MiniPegaso 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). New software features between the MiniPeaaso Cough. MiniPeaso A-Cough. MiniPeaso A-Cough Perc and the Mini Pegaso Cough K140605 include new software features which do not raise concerns of safety or effectiveness. The table below summarizes the key technical characteristics between the Mini Pegaso Cough to those of the predicate devices listed in the submission: | Technological<br>Characteristics | Mini Pegaso Cough<br>Description<br>K140605 | Pegaso Cough<br>Description<br>K072292 | Respironics<br>SimplyClear<br>K122111 | Emerson<br>CoughAssist<br>K002598 | Philips Respironics<br>CoughAssist K121955 | |--------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Patient Population | Adult or pediatric<br>patient unable to cough<br>or clear secretions<br>effectively | Adult or pediatric patient<br>unable to cough or clear<br>secretions effectively | Adult or pediatric<br>patients having<br>difficulty with secretion<br>clearance and/or<br>inability to cough | Adult or pediatric<br>patient with an<br>ineffective cough due<br>to muscular<br>dystrophy,<br>myasthenia gravis,<br>poliomyelitis, or other<br>neurologic disorder<br>with some paralysis<br>of the respiratory<br>muscles, such as<br>spinal cord injury. | Adult or pediatric<br>patient unable to cough<br>or clear secretions<br>effectively | | Delivery type | Non Invasive or<br>Invasive | Non Invasive or Invasive | Non Invasive or<br>Invasive | Non Invasive or<br>Invasive | Non Invasive or<br>Invasive | | Modes of operation | Manual and Auto | Manual and Auto | Manual and Auto | Manual and Auto | Manual and Auto | | Inhalation Pressure | 0 to 50 cmH2O | 0 to 70 cmH2O | 0 to 70 cmH2O | 0 to 60 cmH2O | 0 to 70 cmH2O | | Exhalation Pressure | 0 to -50 cmH2O | 0 to -70 cmH2O | 0 to -70 cmH2O | 0 to -60 cmH2O | 0 to -70 cmH2O | | Inhale Flow | Low, medium, High,<br>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<br>Cycle | Insufflation,<br>Exsufflation, Pause | Insufflation, Exsufflation,<br>Pause | Insufflation,<br>Exsufflation, Pause | Insufflation,<br>Exsufflation, Pause | Insufflation,<br>Exsufflation, Pause | | MiniPegaso Cough<br>Safety Protocols | Dynamic Flow and<br>Pressure control.<br>Manufacturer Software<br>Calibration eliminates<br>all undesired<br>oscillations.<br>Sensor malfunction<br>detection | Dynamic Flow and<br>Pressure control.<br>Manufacturer Software<br>Calibration eliminates all<br>undesired oscillations. | Dynamic Stability<br>Analysis. Flow and<br>Pressure based<br>Oscillation Detection<br>Extreme Flow Rate<br>Control and Response<br>Sensor Malfunction<br>Stability | N/A | Dynamic Stability<br>Analysis. Flow and<br>Pressure based<br>Oscillation Detection<br>Extreme Flow Rate<br>Control and Response<br>Sensor Malfunction<br>Stability | | Percussion<br>Frequency | 50 to 600 bpm | NA | 60 to 1200 bpm | NA | NA | {12}------------------------------------------------ | Remote Data<br>Access | An internal memory<br>stores therapies data.<br>RS232/USB adapter<br>transmits to a PC<br>therapies and technical<br>data | NA | N/A | A secure digital (SD)<br>card provides means for<br>data access. | |-----------------------|---------------------------------------------------------------------------------------------------------------------------|----|-----|------------------------------------------------------------------| |-----------------------|---------------------------------------------------------------------------------------------------------------------------|----|-----|------------------------------------------------------------------| | Device Features | Similarities | |---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User Interface,<br>including displayed<br>therapy parameters<br>and oximetry<br>parameters. | Philips Respironics CoughAssist T70 K121955 has similar parameters displayed in<br>the main working page.<br>Philips Respironics CoughAssist T70 K121955 doesn't visualize oximetry<br>parameters on the main page, but the operator has to call a specific function in order to<br>visualize these monitored values. MiniPegaso (all models) visualizes on the main page<br>the monitored values and the alarms and exceptions that are related to the oximetry. | | AutoSync/EasyStart | The AutoSync and Easy Start are based on the detection of the patient's inspiratory efforts<br>(triggers). For this detection a digital flow sensor is used. The principle is similar to the<br>Philips Respironics CoughAssist T70 K121955 Cough-Trak feature. | | Automatic and<br>Manual Modes | These modalities are the same of the Dima Italia Srl Pegaso Cough K072292 with no<br>change. | | Oscillations<br>(percussion) | The feature is similar to the oscillatory vibrations of the Philips Respironics<br>SimplyClear (K122111). In the literature technicians prefer to use the Frequency and<br>I/E Ratio instead of the definition of Inspiratory Time and Expiratory Time. The Pause<br>Time is never used. So, MiniPegaso A-Cough Perc in the Percussion modality, shows<br>Frequency and I/E Ratio. | | Oximetry<br>Connection | The MiniPegaso devices (all models) work with a Masimo oximeter. The oximeter is<br>similar to the one used on the Philips Respironics CoughAssist T70 K121955 device. | # Performance Data Non-Clinical Testing. In order to demonstrate that the Mini 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 in the intended 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 Mini Pegaso Cough. {13}------------------------------------------------ # Device Testing Summary Verification activities have been performed to verify that the device meets the specification requirements. This included bench testing, software unit testing, hardware unit testing for SpO2 introduction, and code reviews. | Device<br>Characteristics | Testing Summary | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | User Interface,<br>including displayed<br>therapy parameters<br>and oximetry<br>parameters. | Has been verified to meet product requirements defined for the Mini Pegaso Cough.<br>Bench testing, black-box and white-box testings, code reviews and software unit<br>testing were performed to verify that all display functions, user controls and<br>informational messages performed as intended, including oximeter values. The user<br>interface was verified to ensure that it displayed the proper data and expected therapy<br>information. | | AutoSync/EasyStart | The AutoSync and EasyStart features of the Mini Pegaso A-Cough and Mini Pegaso<br>A-Cough Perc device has been verified to meet product specifications with each<br>defined patient case simulation. The operation and triggering performance has been<br>verified to operate across tha range of patient cases. | | Oscillations<br>(percussion) | The Percussion feature of the Mini Pegaso A-Cough Perc has been verified to meet<br>product specifications. Bench testing at extreme therapy settings has been executed and<br>waveforms on lung simulator are as attended. | | Data Management | Data Management of the Mini Pegaso Cough device has been verified to meet product<br>specifications for internal EEprom and for its downloading from a PC.<br>Bench testing, black-box and white-box testings, code reviews and software unit<br>testing were performed to verify that all memory functions performed as intended. | | Oximetry<br>Connection | The oximeter has been tested to verify that the pulse oximetry data perform as<br>intended. Proper values visualization and proper alarms activation has been tested, too.<br>All exception messages have been verified with bench testing and with a clinical<br>dynamic simulator. | | Case | The Mini Pegaso Cough structure and materials have been tested to verify the<br>complying to product requirements defined for the device. IEC 60601-1, ISO 10993-1,<br>ISO 9919 tests passed. Third part Test reports. | | Electrical Safety<br>Class | The Mini Pegaso Cough has been tested to verify the complying to product<br>requirements defined for the device. IEC 60601-1, IEC 60601-1-2 passed. Third parts<br>Test reports. | {14}------------------------------------------------ # Standards Evaluation The Dima Italia Srl Mini Pegaso Cough device has been designed and tested according to: - 1. ISO 14971 Medical devices Application of Risk management to medical devices - 2. ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process - 3. IEC 60601-1 Medical Electric Equipment-Part 1: General Requirements of Safety - 4. IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: Electromagnetic Compatibility - 5. IEC 60601-1-6 Medical Electrical Equipment-Part 1-6:Usability - 6. ISO 9919 Medical Electrical Equipment-Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use - 7. IEC 62304 Medical Device Software Software life cycle processes. The Dima Italia Srl Mini Pegaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc were tested in accordance with applicable voluntary standards. The Dima Italia Srl Mini Pegaso Cough, Mimi Pegaso A-Cough, Mini Pegaso A-Cough Perc met the required performance criteria and functioned as intended. # Conclusion Mini Peaaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc are equivalent devices. The Mini Pegaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc specifications 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. Mini Pegaso Cough, Mini Pegaso A-Cough, Mini 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 Mini Pegaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc device performs substantially equivalent to the cited predicated devices. Mini Pegaso Cough, Mini Legaso A-Cough, Mini Pegaso A-Cough Perc devices are different from predicate devices on maximum pressure (that is limited to 50cmH2O), and 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 Mini Pegaso Cough, Mini Pegaso A-Cough, Mini Pegaso A-Cough Perc devices are substantially equivalent to the predicate devices and the devices do not raise questions of safety and effectiveness.