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.

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.

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.

AI/ML Overview

The provided text describes the Pegaso Cough, Pegaso A-Cough, and Pegaso A-Cough Perc devices, which are noncontinuous ventilators. The submission is a 510(k) premarket notification for device modifications.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria with specific thresholds for device performance. Instead, it details that various features and modifications were verified to meet product requirements/specifications or performed as intended. The "performance data" section focuses on testing methodologies and successful verification of features against design inputs and product specifications, rather than numerical performance metrics against pre-defined acceptance criteria.

However, based on the Comparison of Device technological Characteristics to predicate device and Device Modification Testing Summary, we can infer some performance expectations and the results of the testing:

Feature/Characteristic	Acceptance Criteria (Inferred from Predicate Equivalence & Product Requirements)	Reported Device Performance
Cough Assist Functionality	Equivalent to predicate devices (Emerson Cough Assist K002598, Dima Italia Negavent DA-3 Plus Pegaso K072292, Philips Respironics CoughAssist T70 K121955) in clearing bronchopulmonary secretions.	"substantially equivalent" to predicate devices in secretion clearance functionality (Pegaso Cough, Pegaso A-Cough Perc). Performance verified through black-box performance testing and simulations of worst-case scenarios.
Percussion Feature	Similar to oscillatory vibrations of Philips Respironics SimplyClear (K12211) for mucus loosening and mobilization. Met product specifications.	"similar to the oscillatory vibrations of the Philips Respironics SimplyClear (K122111)." Verified to meet product specifications. Bench testing at extreme therapy settings executed, and waveforms on lung simulator were "as attended" (as expected). Note: Maximum percussion frequency is different from predicates (600cpm vs. 60-1200 bpm).
User Interface	Display functions, user controls, and informational messages perform as intended, including oximeter values. Proper data and expected therapy information displayed.	Verified to meet product requirements. All display functions, user controls, and informational messages performed as intended, including oximeter values. Verified to ensure it displayed proper data and expected therapy information.
EasyStart/AutoSync	Operate across the range of patient cases. Triggering performance functions as designed.	Verified to meet product specifications with each defined patient case simulation. Operation and triggering performance verified to operate across the range of patient cases. Principles are similar to Philips Respironics CoughAssist T70 K121955 Cough-Trak feature.
Data Management	Store therapy data in internal memory and allow for data download to PC, meeting product specifications for EEPROM and download.	Verified to meet product specifications for internal EEPROM and for downloading from a PC. All memory functions performed as intended.
Oximetry Connection	Proper visualization of SpO2, Pulse rate, Perfusion Index; proper alarm activation; compliance with ISO 9919:2009.	Tested for proper values visualization and proper alarm activation. All exception messages verified with bench testing and a clinical dynamic simulator. Complies with ISO 9919:2009.
Case (Structure & Materials)	Comply with product requirements (e.g., IEC 60601-1, ISO 10993-1, ISO 9919).	Structure and materials tested to verify compliance to product requirements. Passed IEC 60601-1, ISO 10993-1, ISO 9919 tests. Third-party test reports cited.
Electrical Safety Class	Comply with product requirements (e.g., IEC 60601-1, IEC 60601-1-2).	Tested to verify compliance with product requirements. Passed IEC 60601-1, IEC 60601-1-2. Third-party test reports cited.

2. Sample Size Used for the Test Set and the Data Provenance

The document does not specify a separate "test set" in the context of patient data or clinical trials. The performance data discussed is based on non-clinical bench testing, black-box testing, white-box testing, software unit testing, code reviews, and simulations.

Sample Size: Not applicable in the traditional sense of patient samples. The testing involved various worst-case scenario inputs and simulations. For the oximeter verification, a "Clinical Dynamic Simulator Validation Report" was run.
Data Provenance: The data is generated from bench testing methodologies, simulating use environments and inputs for the device itself. It's retrospective in the sense that it evaluates the device's adherence to pre-defined specifications after manufacturing/design. No country of origin for patient data is mentioned as this was not a clinical study involving patients.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. This was a non-clinical, bench-testing focused evaluation. There were no "experts" establishing clinical ground truth for a patient test set, nor were patient outcomes involved. The ground truth for the engineering tests was the device's design specifications and regulatory standards.

4. Adjudication Method for the Test Set

Not applicable. No "adjudication method" in the context of expert review or consensus for patient data was performed. The verification activities (bench testing, code reviews, etc.) served as the method to determine if the device met its design inputs and relevant standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC study was done. This device is a noncontinuous ventilator used for secretion clearance, not an AI-assisted diagnostic or imaging device that would typically involve human "readers." The submission focuses on the safety and effectiveness of the device itself and its modifications, demonstrating substantial equivalence to predicates through engineering and performance testing.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the testing described is primarily standalone device performance. The "device modification testing summary" and "non-clinical testing" sections detail evaluations of the device's various features (User Interface, AutoSync/EasyStart, Oscillations, Data Management, Oximetry Connection, Case, Electrical Safety) independent of human operators, ensuring the device functions according to specifications. While "AutoSync" and "EasyStart" relate to patient inspiratory effort, the testing of these features focuses on the device's ability to detect and respond to that effort, not on human-in-the-loop performance.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The ground truth used for these non-clinical tests was the product design specifications, engineering requirements, and recognized international standards (e.g., ISO 14971, ISO 10993-1, IEC 60601-1, ISO 9919, IEC 62304). For the oximeter, a "Clinical Dynamic Simulator Validation Report" by Masimo was used, implying that the simulator's output served as the ground truth for oximetry values.

8. The Sample Size for the Training Set

Not applicable. This device does not employ machine learning or AI that would require a "training set" in the computational sense. The device's operation is based on programmed logic and physical mechanisms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI/ML algorithm.

Summary

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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.

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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 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

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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)

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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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)

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.

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) K140598

Device Name 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
FDA registration number of themanufacturer of the device:	3007123976 (Facility Registration number)
Official contact person for allcorrespondence:	Dario Basciu,Senior Regulatory Affairs EngineerDima Italia SrlVia Coriolano Vighi, 2940133, Bologna - ItalyOffice: (+39) 051568857Fax: (+39) 051563994Email: tech.support@dimaitalia.com
United States Agent Information	---
Date Prepared:	October 03, 2014
Proprietary Name of new device:	Pegaso CoughPegaso A-CoughPegaso 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 predicatedevice:	Class II
Classification Panel:	Anesthesiology
Panel Code:	NHJ - noncontinuous ventilator (IPPB)

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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 Negavent DA-3 Plus Pegaso K072292Philips Respironics CoughAssist T70 K121955Respironics SimplyClear Percussor K122111
Reason for submission	Device modification.

Description of device.