(144 days)
No
The description focuses on the mechanical function of pressure application and shifting, with operator-selected parameters and software control for basic functions and safety alarms. There is no mention of AI or ML in the device description, intended use, or performance studies.
Yes
The device is described as assisting patients with reduced coughing capabilities due to various medical conditions (e.g., muscular dystrophy, spinal cord injury, cystic fibrosis) by simulating a cough to clear bronchopulmonary secretions, which is a therapeutic action.
No
The device description indicates that the Pegaso Cough Assist is a therapeutic device designed to clear bronchopulmonary secretions by simulating a cough, not to diagnose a medical condition.
No
The device description clearly states it is a "negative pressure, non-invasive ventilation system" and describes the physical mechanism of applying positive and negative pressure to the airway. While it is software-controlled, it is fundamentally a hardware device that delivers therapy.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Pegaso Cough Assist is a mechanical device that assists patients with clearing secretions from their airways by applying positive and negative pressure. It directly interacts with the patient's respiratory system.
- Intended Use: The intended use clearly describes a therapeutic intervention to help patients with impaired coughing ability. It does not involve the analysis of biological specimens.
- FDA Classification: The FDA classifies this device as a "noncontinuous ventilator" (868.5905) under the Anesthesiology Review Panel. This classification is for devices that support breathing, not for diagnostic testing of specimens.
Therefore, based on its function, intended use, and FDA classification, the Pegaso Cough Assist is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
NHJ
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
airway, lungs
Indicated Patient Age Range
adult or pediatric patients.
Intended User / Care Setting
hospital, institutional setting, or home use given adequate training.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).
0
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:
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.
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 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.
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-3
Plus 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, and
Pause Times | 0 to 5 seconds | 0.1 to 9.9 seconds |
| Blower | Two speed, High & Low,
centrifugal with AC/DC brush
motor | 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 | EN60601-1
EN60601-1-2
EN60601-1-4 | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-4
EMC IEC 6060101-2, FCC
Part 15, Class B |
| CE Conformity | Risk Class IIb
CE 0413 | Risk Class IIb
93/42 EEC Directive
CE 0476 |
| Line | | |
| Voltage | 110-230Vac | 110-230Vac |
| Frequency | 50/60 Hz | 50/60 Hz |
| Power | | 250W through removable cables |
| Fuses | T 3.0 AL 250V
Unknown 110V | 2x3.15 A-T for 110V
2x2A-T for 230V |
| Feature | Emerson Cough Assist | Dima Italia Negavent DA-3
Plus 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.
6
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:
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.
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.