PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS

K072290 · Dima Italia Srl · BYT · May 29, 2008 · Anesthesiology

Device Facts

• Record ID: K072290
• Device Name: PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS
• Applicant: Dima Italia Srl
• Product Code: BYT · Anesthesiology
• Decision Date: May 29, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5935
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or a ventilating chamber (Porta-Lung).

Device Story

Pegaso V is an assisted/controlled non-invasive external negative pressure ventilator. It uses an electric blower as a pressure/flow generator and a mechanical valve controlled by a step-motor to alternate positive and negative pressures over the patient's diaphragm and upper trunk. The device interfaces with a cuirass, poncho, or ventilating chamber. An optional trigger senses spontaneous patient demands, enabling Synchro/Timed, Spontaneous/Timed, and Spontaneous with Plateau modes. The system includes an 'Autoparameters Function' to evaluate respiratory frequency and I/E ratio. Operational parameters (respiratory time, pressure values) are set via a touch keyboard and displayed on an LCD. The device is intended for use in home, hospital, and institutional settings by clinicians or patients. It compensates for leaks cycle-by-cycle. By providing mechanical ventilation similar to spontaneous breathing, it supports patients with respiratory insufficiency.

Clinical Evidence

Bench testing only. Device safety demonstrated through compliance with IEC 60601-1, EN 60601-1-2, EN 60601-1-4, EN ISO 9703-3, EN 794-1, and EN 794-2 standards. No clinical data provided.

Technological Characteristics

External negative pressure ventilator; electric blower-driven; mechanical valve with step-motor and optical sensor; touch keyboard interface with LCD; 110-230Vac power; software-controlled; dimensions/weight: 14.3 lbs; operating temperature 50°F to 122°F; safety standards: EN 60601-1, EN 60601-1-2, EN 60601-1-4.

Indications for Use

Indicated for adult patients requiring ventilatory support via external negative pressure applied to the diaphragm and upper trunk. Compatible with cuirass, poncho, or ventilating chamber (Porta-Lung).

Regulatory Classification

Identification

An external negative pressure ventilator (e.g., iron lung, cuirass) is a device chamber that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient.

Predicate Devices

• Lifecare Services Inc. NEV-100, Non-invasive Extrathoracic Ventilator (K910947)

Reference Devices

• Dima Italia Negavent DA-3 Plus Pegaso Cough

Submission Summary (Full Text)

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

Lewis Ward Consultant

Prepared 2-13-08

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

Device Trade Name: Pegaso V

Indications for Use:

The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patilator works with a cuirass, poncho, or a ventilating chamber (Porta-Lung).

Classification Name: Positive Pressure Intermittent Breathing Device

Classification: 868.5935, Product Code BYT

868.5935

Common Name: External Negative Pressure Ventilator

SE Predicate: Lifecare Services Inc. NEV-100, Non-invasive Extrathoracic Ventilator K910947

#### Device Description:

The Pegaso V is an assisted/controlled non-invasive ventilation system. It can work with a cuirass, poncho, or a ventilating chamber (Porta-Lung). An optional Trigger can be installed, sensing the spontaneous demands of the patient and permitting the use in Synchro/Timed, Spontaneous/Timed and Spontaneous with Plateau modes. If the Triggers are installed, the Autoparameters Function is enabled too, permitting the evaluation of the Respiratory Frequency and I/E Ratio of the patient in automatic mode.

The Pegaso V is substantially equivalent to the Lifecare NEV-100. Equivalent technologies are used.

Page 1 of 5

510(k) Summary

K072290

MAY 2 9 2008

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The negative pressure ventilation is a mechanical kind of ventilation similar to the human spontaneous ventilation. The Pegaso V is designed around 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 the atmosphere, compresses it in order to generate a pressure/depressure controlled by electronic sensors. Leaks are compensated cycle by cycle.

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 compressed flow go toward the patient and the depressed flow toward the atmosphere or, instead, the compressed flow to the atmosphere and the depressed flow toward the patient. The working parameters are displayed on an LCD and controlled through a touch keyboard.

The selectable parameters are:

- . Respiratory Time
- Positive Pressure Value .
- Negative Pressure Value .

Device Safety is demonstrated through meeting device safety standards IEC, EN 60601-1-2, EN ISO 9703-3, EN 794-1, and EN 794-2.

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# Comparison Table

| Feature | Lifecare NEV-100 | Dima Italia Negavent DA-3<br>Plus Pegaso V |
|------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | An external negative pressure<br>ventilator that is intended to<br>support a patient's ventilation<br>by alternately applying and<br>releasing external pressure over<br>the diaphragm and upper trunk<br>of the patient. The ventilator<br>works with a cuirass, poncho<br>(body suit), or ventilating<br>chamber (Porta-Lung). | A timed-cycled pressure<br>ventilator that is intended to<br>support a patient's ventilation by<br>alternately applying and<br>releasing external negative<br>pressure over the diaphragm and<br>upper trunk of the patient. The<br>ventilator works with a cuirass,<br>poncho (body suit), or ventilating<br>chamber (Porta-Lung). |
| Line | | |
| Voltage | 120-240Vac | 110-230Vac |
| Frequency | 50/60 Hz | 50/60 Hz |
| Power | 500W/600W | 400W |
| Use settings | Home, hospital, institution | Home, hospital, institution |
| Patient Use | Adult | Adult |
| Negative Pressure I | Adjustable -5 to -100 cm H2O | Variable from 0 to -99 cm H2O |
| Positive/Negative Pressure E | Unknown | Variable from +99 to -25 cm<br>H2O |
| Frequency | 4 to 60 bpm | Variable from 5 to 50 bpm |
| I/E Ratio | Adjustable 1:0.5 to 1:29.1 | Variable from 1/0.5 to 1/99<br>(based on present frequency and<br>adjustable to clinician's selected<br>setting) |
| Controls | Menu driven, software<br>controlled | Menu driven, software controlled |
| Inspiratory Time (Ti) | 0.5 to 5.0 seconds | 0.1 to 5.0 seconds |
| Modes | - Controlled ventilation<br>- Assisted controlled<br>ventilation | - Controlled ventilation<br>- Assisted controlled ventilation<br>- Continuous negative<br>- Assisted with Plateau |
| Alarms | - High and Low respiratory<br>pressure<br>- Power Failure<br>- Constant Pressure<br>- Internal failure | - High and Low respiratory<br>pressure<br>- Power Failure |
| Weight | 31 pounds | 14.3 pounds |
| Accessories | Patient Hose<br>Optional proximal pressure line<br>Nasal Cannula<br>Operator's Manual | Power cord (230V,110V)<br>Vacuum Airflow Tube<br>Operator's Manual |
| Electrical Safety | UL, TUV, CSA | EN 60601 |
| Feature | Emerson Cough Assist | Dima Italia Negavent DA-3<br>Plus Pegaso Cough |
| Standards | UL 747Y | EN 60601-1, EN 60601-1-2,<br>EN 60601-1-4 |
| EMC | UL, TUV, FCC Part 15, CSA,<br>Class B | EN 60601-1-2, FCC Part 15,<br>Class B |
| CE Conformity | Not listed | Risk Class IIb<br>93/42 EEC Directive<br>CE 0476 |
| Environmental Temperature | 41° F to 104° F | 50° F to 122° F |

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510(k) Summary Page 4 of 5

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## Pegaso V Similarities and Differences

The Dima Italia ventilator is substantially equivalent to the Lifecare NEV-100 Non-invasive Extrathoracic Ventilator.

#### Similarities:

1. The products have equivalent Indications for Use.

2. The fundamental technology is the same. An electric powered blower produces positive and negative pressures. The pressures are alternately applied/released over the diaphragm and upper trunk of the patient.

3. Both devices meet safety evaluations under IEC 60601 standards.

4. Pressures developed are comparable.

- 5. Both units are available in 110V and 220/230V versions.
- 6. Both units are intended for adult patients.
- 7. Use settings for home, hospital, and institution are the same.
- 8. Frequencies of breaths are comparable.
- 9. Both systems are software controlled.

### Differences:

No major differences.

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Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 9 2008

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

Re: K072290

Trade/Device Name: Pegaso V Regulation Number: 21 CFR 868.5935 Regulation Name: External Negative Pressure Ventilator Regulatory Class: II Product Code: BYT Dated: May 20, 2008 Received: May 23, 2008

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.

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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

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#### INDICATIONS FOR USE

510(k) Number (if known):

Device Name: Pegaso V

Indications for Use:

The New Negavent Ventilator DA-3 Plus Pegaso V is a timed-cycled, pressure ventilator that is intended to support a patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk of the patient. The ventilator works with a cuirass, poncho, or ventilating chamber (Porta-Lung).

Prescription Use X (Part 21 CFR 801 Subpart D) Over-the-Counter Use (21 CFR 801 Subpart C)

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

AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kiri Te Kanawa

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K072296