For 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 a hospital, institutional setting, or home use given adequate training. For use on adult or pediatric patients.

Device Description

The Pegaso Cough Assist is a negative pressure, non-invasive ventilation system useful in clearing retained bronchopulmonary secretions. It produces a patient "cough" simulation, applying a positive pressure to the airway, then rapidly going to a negative pressure. At the end of this pressure shifting, the Pegaso Cough leaves the airway free, at zero pressure, for a pause time determined by the operator. The Peak Inspiratory Flow can be selected on three different levels: High, Medium, Low.

This "forced insufflation-exsufflation" is designated for patients with reduced coughing possibilities due to muscular dystrophy, myasthenia gravis, poliomyelitis, and respiratory muscle paralysis such as spinal cord injury. Even patients with other diseases, such as emphysema and cystic fibrosis, can be treated with the Pegaso Cough. It may be used with a facemask, mouthpiece, or an adapter to a patient's endotracheal tube or tracheostomy tube. The Pegaso Cough is indicated for use in a hospital, institutional setting, or home use given adequate training.

The Cough Assist device applies a positive pressure in the airway initially. The device shifts to a negative pressure through a facemask, mouthpiece, or an adapter to the patient's endotracheal tube or tracheostomy tube. The rapid shift produces a high expiratory flow from the lungs simulating a cough and clearing secretions. At the end of this pressure shifting, the Pegaso Cough leaves the airway free at zero or ambient pressure. A pause time between cycles is operator selected.

FDA classifies this device as a noncontinuous ventilator under 868.5905. Product Code NHJ under the Anesthesiology Review Panel. The device meets the requirements for medical equipment general requirements for basic and essential safety performance and electromagnetic compatibility.

The Pegaso Cough is comparable to the Emerson Cough Assist cleared under K002598 and have the similar indications for use.

The device is software controlled and has safety alarms for no pressure, high pressure, valve fault, low pressure, and power failure. Performance is controlled from a touch screen keyboard in manual or automatic modes.

AI/ML Overview

This 510(k) summary describes the Pegaso Cough device and its substantial equivalence to the Emerson Cough Assist. It primarily focuses on comparing specifications and features rather than reporting on a specific study designed to meet acceptance criteria through device performance metrics.

Therefore, many of the requested sections (e.g., sample size, data provenance, ground truth establishment, MRMC study, standalone performance) cannot be fully populated as the document provided does not contain a detailed performance study with quantitative results against acceptance criteria.

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical targets for device performance in the form of a study. Instead, substantial equivalence is claimed based on comparable features and meeting general safety and ventilator standards. The performance metrics are presented as device specifications.

Feature	Acceptance Criteria (Implied by Predicate)	Reported Pegaso Cough Performance
Use settings	Home, hospital/institution (Emerson)	Home, hospital/institution
Patient Use	Adult and pediatric (Emerson)	Adult and pediatric
Maximum Positive Pressure	+60 cm H2O (Emerson)	+70 cm H2O
Maximum Negative Pressure	-60 cm H2O (Emerson)	-70 cm H2O
Maximum Inhalation Flow	3.3 liters/second (Emerson)	2.9 liters/second
Positive Pressure Range	0 to +70 cm H2O (Emerson)	+5 to +70 cm H2O, 1 cm H2O steps
Negative Pressure Range	0 to -70 cm H2O (Emerson)	-5 to -70 cm H2O, 1 cm H2O steps
Mode of Operation	Automatic and manual timing (Emerson)	Automatic and manual modes
Cycle Timings (Inhalation, Exhalation, Pause)	0 to 5 seconds (Emerson)	0.1 to 9.9 seconds
Blower Type	Two speed, AC/DC brush motor (Emerson)	Brushless blower, High, Medium, and Low speeds
Safety Standards	EN60601-1, others (Emerson)	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, EMC IEC 6060101-2, FCC Part 15, Class B
Safety Alarms	Power Failure, Others Unknown (Emerson)	Power Failure, No pressure, High pressure, Valve fault, Low pressure, Fuse Failure
Contraindications	Bullous emphysema, Pneumothorax, Pneumo-mediastinum, Barotrauma (Emerson)	Bullous lung disease, Pneumothorax, Extremely low blood pressure, Pneumocephalus or pre-existing CSF leaks or head trauma, Severe cardiac rhythm disturbances, Acute facial trauma

2. Sample sized used for the test set and the data provenance
The document does not describe a clinical performance study with a test set. This 510(k) relies on comparing device specifications and meeting recognized standards, rather than clinical data from a human test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set requiring ground truth establishment by experts is described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring adjudication is described.

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
Not applicable. This device is not an AI-assisted diagnostic device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device for physical therapy, not an algorithm. Its performance is inherent to its mechanical and electrical specifications and functionality. The document implies that the device performs its intended function based on its design and compliance with safety standards.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for device performance comparison. The "ground truth" for demonstrating substantial equivalence is the predicate device's established performance and the general safety and ventilator standards (IEC 60601 series, EN 794-1 and -2).

8. The sample size for the training set
Not applicable, as no machine learning algorithm development (which would require a training set) is described.

9. How the ground truth for the training set was established
Not applicable, as no machine learning algorithm development is described.

Study Proving Device Meets Acceptance Criteria:

The provided document does not describe a specific clinical study with defined acceptance criteria and corresponding performance metrics demonstrating safety and effectiveness. Instead, the submission relies on demonstrating substantial equivalence to a legally marketed predicate device (Emerson Cough Assist, Model CA-3000, K002598) and compliance with recognized safety and performance standards.

The "study" for this 510(k) is essentially a comparison of technical specifications, intended use, and adherence to regulatory standards.

Key aspects of this demonstration include:

Comparison Table: A detailed comparison table ([{3}]) outlines the similarities and differences between the Pegaso Cough and the predicate device across various features, including pressure ranges, modes of operation, timing control, power supply, and safety features.
Statements of Similarities and Differences: The document explicitly lists 11 similarities and 4 differences to highlight the comparable nature of the devices ([{5}]). The differences (e.g., higher max pressure, wider timing range, lighter weight, software control) are presented as not raising new questions of safety or effectiveness.
Standards Met: The Pegaso Cough is stated to meet a range of international and European standards, including IEC 60601-1 (Medical Equipment), IEC 60601-1-4 (Programmable Electrical Medical Systems), EN ISO 9703-3 (Alarm Signals), EN 60601-1-2 (Electromagnetic Compatibility), and EN 794-1 and -2 (Lung Ventilator) ([{2}]). These standards serve as proxies for demonstrating basic safety and performance "acceptance criteria."

The FDA's letter of clearance ([{6}]-[{7}]) confirms that based on the provided information, the device is deemed "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market under general controls. This determination itself serves as the "proof" that the device meets the implied regulatory acceptance criteria for market authorization via the 510(k) pathway, specifically by demonstrating equivalence to a predicate.

Summary

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510(k) Summary

Dima Italia Srl Via C. Vighi 29 Bologna, Italy 40133

Lewis Ward Consultant

Prepared 7-13-07

L.W. Ward and Associates, Inc. 4655 Kirkwood Court Boulder, CO 80301 303-530-3279 303-530-4774 Fax

Device Name: Pegaso Cough

Indications for Use:

K072292

JAN - 7 2008

{1}------------------------------------------------

Device: Positive Pressure Intermittent Breathing Device

Common Name: Cough Assist Device

SE Predicate: Emerson Cough Assist, Model CA-3000 J.H. Emerson Company K002598 868.5902

Device Description:

The Pegaso Cough is comparable to the Emerson Cough Assist cleared under K002598 and have the similar indications for use.

{2}------------------------------------------------

Standards Met:

IEC 60601-1 Medical Equipment
Programmable Electrical Medical Systems IEC 60601-1-4
EN ISO 9703-3 Anesthesia and Respiratory Care Alarm Signals
EN 60601-1-2 Electromagnetic Compatibility
EN 794-1 and -2 Lung Ventilator

{3}------------------------------------------------

Comparison Table

Feature	Emerson Cough Assist	Dima Italia Negavent DA-3Plus Pegaso Cough
Use settings	Home, hospital/institution	Home, hospital/institution
Patient Use	Adult and pediatric	Adult and pediatric
Maximum Positive Pressure	+60 cm H2O (44 mm Hg)	+70 cm H2O
Maximum Negative Pressure	-60 cm H2O (44 mm Hg)	-70 cm H2O
Maximum Inhalation Flow	3.3 liters/second	2.9 liters/second
Positive Pressure	0 to +70 cm H2O	+5 to +70 cm H2O,1 cm H2O steps
Negative Pressure	0 to -70 cm H2O	-5 to -70 cm H2O,1 cm H2O steps
Mode of Operation	- Automatic and manual timing- Mechanical switch controlled	- Automatic and manual modes- Microprocessor controlled
Inhalation, Exhalation, andPause Times	0 to 5 seconds	0.1 to 9.9 seconds
Blower	Two speed, High & Low,centrifugal with AC/DC brushmotor	Brushless blower, High,Medium, and Low speeds
Input voltage	60 Hz	50/60 Hz
Power Supply	110/220V	110/230V
Weight	24 pounds	9.9 pounds
Humidity
Operating humidity range	30-75%	10-90%
Storage humidity range	10-90%	10-90%
Safety
Class	BF type equipment	BF
Standards	EN60601-1EN60601-1-2EN60601-1-4	IEC 60601-1IEC 60601-1-2IEC 60601-1-4EMC IEC 6060101-2, FCCPart 15, Class B
CE Conformity	Risk Class IIbCE 0413	Risk Class IIb93/42 EEC DirectiveCE 0476
Line
Voltage	110-230Vac	110-230Vac
Frequency	50/60 Hz	50/60 Hz
Power		250W through removable cables
Fuses	T 3.0 AL 250VUnknown 110V	2x3.15 A-T for 110V2x2A-T for 230V
Feature	Emerson Cough Assist	Dima Italia Negavent DA-3Plus Pegaso Cough
Signaling of Alarm	- Power Failure- Others Unknown	- Power Failure- No pressure- High pressure- Valve fault- Low pressure- Fuse Failure
Contraindications	- Bullous emphysema- Pneumothorax- Pneumo-mediastinum- Barotrauma	- Bullous lung disease- Pneumothorax- Extremely low blood pressure- Pneumocephalus or pre-existing CSF leaks or head trauma- Severe cardiac rhythm disturbances- Acute facial trauma

{4}------------------------------------------------

{5}------------------------------------------------

Pegaso Cough Assist Similarities and Differences

The Dima Italia Pegaso Cough ventilator is substantially equivalent to the Emerson Cough Assist device.

Similarities:

Both devices have similar Indications for Use.
The fundamental technology is similar. Both produce positive and negative pressures to simulate a patient's cough reflex. Both are controlled to sense pressures and develop negative and positive pressures in a controlled manner.
Both devices meet safety evaluations under ISO 60601 standards and ventilator standards.
Pressures developed for positive and negative values are comparable.
Pressures are developed by electronically powered blowers for both products.
Both units are available in 110V and 220V/230V versions.
Both units are intended for adult and pediatric patients in home, hospital, and institutional settings.
Both have comparable adjustments to produce positive and negative pressures, and rapid shifting resulting in a simulated patient cough reflex.
Both products simulate a cough using "mechanical insufflation". This is achieved in both devices by applying a positive pressure to the airway initially and rapidly shifting to a negative pressure. The change in pressure effect produces a high expiratory flow from the lungs. 10. Both devices may be used with a facemask, mouthpiece, and patient's endotracheal or tracheostomy tube.
Both devices operate in a manual mode or in an automatic mode.

Differences:

Maximum positive and negative pressures are comparable, but the Pegaso Cough has a maximum capability 16% higher than the Emerson.
Inhalation, exhalation, and pause times differ. Emerson controls these events to 0 to 5 seconds. The Pegaso Cough allows operator control from 0.1 to 9.9 seconds allowing a wider range as needed by patients.
Unit weight of the Pegaso is less than half that of the Emerson unit through use of lightweight materials.
The Pegaso Cough is software controlled whereas the Emerson device is controlled by electrical switches.

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Image /page/6/Picture/1 description: The image shows the logo for the Department of Health and Human Services. The logo features a stylized eagle with three stripes above its head, all enclosed within a circle. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.

JAN - 7 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Dima Italia SRL C/O Mr. Lewis Ward Consultant L.W. Ward and Associates, Incorporated 4655 Kirkwood Court Boulder, Colorado 80301

Re: K072292

Trade/Device Name: Pegaso Cough Regulation Number: 21 CFR 868.5905 Regulation Name: Noncontinuous Ventilator (IPPB) Regulatory Class: II Product Code: NHJ Dated: November 30, 2007 Received: December 7, 2007

Dear Mr. Ward:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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,

{7}------------------------------------------------

Page 2 - Mr. Ward

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Sygitte Y. Michael Dis

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{8}------------------------------------------------

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Pegaso Cough

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

acting B.C.

K072292

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).