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.

Device Description

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.

AI/ML Overview

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.

Summary

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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.

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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

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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)

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)

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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:

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"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."

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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)

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.

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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.

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."

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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)

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.

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."

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510(k) Summary

Administrative Information and Device Identification

Name and address of the manufacturerand sponsor of the 510(k) submission	Manufacturer:Dima Italia SrlVia Coriolano Vighi, 2940133, Bologna - ItalyOffice: (+39) 051568857Fax: (+39) 051563994Sponsor:Dima Italia SrlVia Coriolano Vighi, 2940133, Bologna - ItalyOffice: (+39) 051568857Fax: (+39) 051563994
FDAregistrationnumberofthemanufacturer of the device:	3007123976 (Facility Registration number)
Official contact personfor allcorrespondence:	Dario Basciu,Senior Regulatory Affairs EngineerDima Italia SrlVia Coriolano Vighi, 2940133, Bologna - ItalyOffice: (+39) 051568857Fax: (+39) 051563994Email: tech.support@dimaitalia.com
Date Prepared:	October 03, 2014
Proprietary Name of new device:	Mini Pegaso CoughMini Pegaso A-CoughMini 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 predicatedevice:	Class II
Classification Panel:	Anesthesiology
Panel Code:	NHJ - noncontinuous ventilator (IPPB)
CFR Regulation Number:	21 CFR 868.5905a) Identification. A noncontinuous ventilator(intermittent positive pressure breathing – IPPB) is adevice intended to deliver intermittently an aerosol toa patient's lung ot to assist a patient's breathing.b) Classification. Class II (performance standards)
Predicate device Name(s) and510(k) numbers:	Emerson Cough Assist, Model CA-3000 K002598Dima Italia Nagavent DA-3 Plus Pegaso K072292

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	Philips Respironics CoughAssist T70Respironics SimplyClear Percussor	K121955 K122111
Reason for submission	New Device.

Description of device.

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

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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.

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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:

TechnologicalCharacteristics	Mini Pegaso CoughDescriptionK140605	Pegaso CoughDescriptionK072292	RespironicsSimplyClearK122111	EmersonCoughAssistK002598	Philips RespironicsCoughAssist K121955
Patient Population	Adult or pediatricpatient unable to coughor clear secretionseffectively	Adult or pediatric patientunable to cough or clearsecretions effectively	Adult or pediatricpatients havingdifficulty with secretionclearance and/orinability to cough	Adult or pediatricpatient with anineffective cough dueto musculardystrophy,myasthenia gravis,poliomyelitis, or otherneurologic disorderwith some paralysisof the respiratorymuscles, such asspinal cord injury.	Adult or pediatricpatient unable to coughor clear secretionseffectively
Delivery type	Non Invasive orInvasive	Non Invasive or Invasive	Non Invasive orInvasive	Non Invasive orInvasive	Non Invasive orInvasive
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,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 TherapyCycle	Insufflation,Exsufflation, Pause	Insufflation, Exsufflation,Pause	Insufflation,Exsufflation, Pause	Insufflation,Exsufflation, Pause	Insufflation,Exsufflation, Pause
MiniPegaso CoughSafety Protocols	Dynamic Flow andPressure control.Manufacturer SoftwareCalibration eliminatesall undesiredoscillations.Sensor malfunctiondetection	Dynamic Flow andPressure control.Manufacturer SoftwareCalibration eliminates allundesired oscillations.	Dynamic StabilityAnalysis. Flow andPressure basedOscillation DetectionExtreme Flow RateControl and ResponseSensor MalfunctionStability	N/A	Dynamic StabilityAnalysis. Flow andPressure basedOscillation DetectionExtreme Flow RateControl and ResponseSensor MalfunctionStability
PercussionFrequency	50 to 600 bpm	NA	60 to 1200 bpm	NA	NA

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Remote DataAccess	An internal memorystores therapies data.RS232/USB adaptertransmits to a PCtherapies and technicaldata	NA	N/A	A secure digital (SD)card provides means fordata access.
-----------------------	---------------------------------------------------------------------------------------------------------------------------	----	-----	------------------------------------------------------------------

Device Features	Similarities
User Interface,including displayedtherapy parametersand oximetryparameters.	Philips Respironics CoughAssist T70 K121955 has similar parameters displayed inthe main working page.Philips Respironics CoughAssist T70 K121955 doesn't visualize oximetryparameters on the main page, but the operator has to call a specific function in order tovisualize these monitored values. MiniPegaso (all models) visualizes on the main pagethe 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(triggers). For this detection a digital flow sensor is used. The principle is similar to thePhilips Respironics CoughAssist T70 K121955 Cough-Trak feature.
Automatic andManual Modes	These modalities are the same of the Dima Italia Srl Pegaso Cough K072292 with nochange.
Oscillations(percussion)	The feature is similar to the oscillatory vibrations of the Philips RespironicsSimplyClear (K122111). In the literature technicians prefer to use the Frequency andI/E Ratio instead of the definition of Inspiratory Time and Expiratory Time. The PauseTime is never used. So, MiniPegaso A-Cough Perc in the Percussion modality, showsFrequency and I/E Ratio.
OximetryConnection	The MiniPegaso devices (all models) work with a Masimo oximeter. The oximeter issimilar 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.

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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.

DeviceCharacteristics	Testing Summary
User Interface,including displayedtherapy parametersand oximetryparameters.	Has been verified to meet product requirements defined for the Mini Pegaso Cough.Bench testing, black-box and white-box testings, code reviews and software unittesting were performed to verify that all display functions, user controls andinformational messages performed as intended, including oximeter values. The userinterface was verified to ensure that it displayed the proper data and expected therapyinformation.
AutoSync/EasyStart	The AutoSync and EasyStart features of the Mini Pegaso A-Cough and Mini PegasoA-Cough Perc device has been verified to meet product specifications with eachdefined patient case simulation. The operation and triggering performance has beenverified to operate across tha range of patient cases.
Oscillations(percussion)	The Percussion feature of the Mini Pegaso A-Cough Perc has been verified to meetproduct specifications. Bench testing at extreme therapy settings has been executed andwaveforms on lung simulator are as attended.
Data Management	Data Management of the Mini Pegaso Cough device has been verified to meet productspecifications for internal EEprom and for its downloading from a PC.Bench testing, black-box and white-box testings, code reviews and software unittesting were performed to verify that all memory functions performed as intended.
OximetryConnection	The oximeter has been tested to verify that the pulse oximetry data perform asintended. Proper values visualization and proper alarms activation has been tested, too.All exception messages have been verified with bench testing and with a clinicaldynamic simulator.
Case	The Mini Pegaso Cough structure and materials have been tested to verify thecomplying to product requirements defined for the device. IEC 60601-1, ISO 10993-1,ISO 9919 tests passed. Third part Test reports.
Electrical SafetyClass	The Mini Pegaso Cough has been tested to verify the complying to productrequirements defined for the device. IEC 60601-1, IEC 60601-1-2 passed. Third partsTest reports.

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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
1. ISO 10993-1 Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process
1. IEC 60601-1 Medical Electric Equipment-Part 1: General Requirements of Safety
1. IEC 60601-1-2 Medical Electrical Equipment-Part 1-2: Electromagnetic Compatibility
1. IEC 60601-1-6 Medical Electrical Equipment-Part 1-6:Usability
1. ISO 9919 Medical Electrical Equipment-Particular requirements for the basic safety and essential performance of pulse oximeter equipment for medical use
1. 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.

Regulation Number and Section

§ 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).