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 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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Pegaso V ventilator, asserting its substantial equivalence to a predicate device, the Lifecare NEV-100. The document primarily focuses on demonstrating this equivalence through a comparison of features, technical specifications, and safety standards, rather than detailing a specific study designed to meet quantitative acceptance criteria for device performance.

Therefore, many of the requested details about acceptance criteria, study sample sizes, ground truth establishment, and expert involvement are not explicitly stated in this document. The "acceptance criteria" appear to be satisfied by demonstrating substantial equivalence to the predicate device and meeting relevant electrical and safety standards.

Here's an attempt to extract and infer the information based on the provided text:

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" are implied to be meeting various safety standards and demonstrating comparable performance parameters to the predicate device. The device performance is reported through a comparison table.

Feature	Acceptance Criteria (Implied from Predicate/Standards)	Reported Device Performance (Pegaso V)
Indications for Use	Equivalent to Lifecare NEV-100: Support patient's ventilation by alternately applying and releasing external negative pressure over the diaphragm and upper trunk; works with cuirass, poncho, or ventilating chamber.	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; works with a cuirass, poncho, or ventilating chamber (Porta-Lung). (Stated as equivalent)
Voltage	Comparable to Lifecare NEV-100 (120-240Vac)	110-230Vac
Frequency	Comparable to Lifecare NEV-100 (50/60 Hz)	50/60 Hz
Power	Comparable to Lifecare NEV-100 (500W/600W)	400W
Use settings	Comparable to Lifecare NEV-100 (Home, hospital, institution)	Home, hospital, institution
Patient Use	Comparable to Lifecare NEV-100 (Adult)	Adult
Negative Pressure I	Comparable to Lifecare NEV-100 (Adjustable -5 to -100 cm H2O)	Variable from 0 to -99 cm H2O
Positive/Negative Pressure E	Not specified for predicate	Variable from +99 to -25 cm H2O
Frequency (bpm)	Comparable to Lifecare NEV-100 (4 to 60 bpm)	Variable from 5 to 50 bpm
I/E Ratio	Comparable to Lifecare NEV-100 (Adjustable 1:0.5 to 1:29.1)	Variable from 1/0.5 to 1/99 (based on present frequency and adjustable to clinician's selected setting)
Controls	Comparable to Lifecare NEV-100 (Menu driven, software controlled)	Menu driven, software controlled
Inspiratory Time (Ti)	Comparable to Lifecare NEV-100 (0.5 to 5.0 seconds)	0.1 to 5.0 seconds
Modes	Comparable to Lifecare NEV-100 (Controlled ventilation, Assisted controlled ventilation)	Controlled ventilation, Assisted controlled ventilation, Continuous negative, Assisted with Plateau
Alarms	Comparable to Lifecare NEV-100 (High and Low respiratory pressure, Power Failure, Constant Pressure, Internal failure)	High and Low respiratory pressure, Power Failure
Weight	Comparable to Lifecare NEV-100 (31 pounds)	14.3 pounds
Electrical Safety	Meet IEC 60601 standards (e.g., UL, TUV, CSA for predicate)	EN 60601
Standards	Meet UL 747Y (for predicate cough assist)	EN 60601-1, EN 60601-1-2, EN 60601-1-4
EMC	Meet UL, TUV, FCC Part 15, CSA, Class B (for predicate)	EN 60601-1-2, FCC Part 15, Class B
Environmental Temperature	Comparable to Lifecare NEV-100 (41° F to 104° F)	50° F to 122° F
Safety	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. (This is stated directly as how device safety is demonstrated). Compliance with these specific standards constitutes the acceptance criteria for safety.	"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." The document states this directly, indicating compliance with these standards as the performance.

Study Details

The provided document is a 510(k) summary, which is a premarket notification for a medical device. It aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than providing detailed results of a clinical study or a standalone performance study as might be expected for an AI/CADe device.

As such, for many of the requested points, the answer is "Not applicable" or "Not provided in this document" within the context of a typical AI/CADe diagnostic device performance study.

Sample size used for the test set and the data provenance: Not applicable. This document does not describe a performance study with a test set of patient data. The "test" here refers to demonstrating compliance with engineering and safety standards, and comparing technical specifications to a predicate device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" establishment in the context of diagnostic interpretation is described. The "truth" is established by engineering specifications and compliance with standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a ventilator, not a diagnostic imaging aid.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Its performance is evaluated against engineering specifications and predicate device characteristics, not clinical algorithm performance.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" or basis for evaluation is the engineering specifications of the device, its function, and compliance with recognized safety and performance standards (IEC, EN standards). For substantial equivalence, the "ground truth" is the established characteristics and safety profile of the predicate device.
The sample size for the training set: Not applicable. The device is a hardware ventilator, not an AI model requiring a training set of data.
How the ground truth for the training set was established: Not applicable.

Summary

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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 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-3Plus Pegaso V
Indications for Use	An external negative pressureventilator that is intended tosupport a patient's ventilationby alternately applying andreleasing external pressure overthe diaphragm and upper trunkof the patient. The ventilatorworks with a cuirass, poncho(body suit), or ventilatingchamber (Porta-Lung).	A timed-cycled pressureventilator that is intended tosupport a patient's ventilation byalternately applying andreleasing external negativepressure over the diaphragm andupper trunk of the patient. Theventilator works with a cuirass,poncho (body suit), or ventilatingchamber (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 cmH2O
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(based on present frequency andadjustable to clinician's selectedsetting)
Controls	Menu driven, softwarecontrolled	Menu driven, software controlled
Inspiratory Time (Ti)	0.5 to 5.0 seconds	0.1 to 5.0 seconds
Modes	- Controlled ventilation- Assisted controlledventilation	- Controlled ventilation- Assisted controlled ventilation- Continuous negative- Assisted with Plateau
Alarms	- High and Low respiratorypressure- Power Failure- Constant Pressure- Internal failure	- High and Low respiratorypressure- Power Failure
Weight	31 pounds	14.3 pounds
Accessories	Patient HoseOptional proximal pressure lineNasal CannulaOperator's Manual	Power cord (230V,110V)Vacuum Airflow TubeOperator's Manual
Electrical Safety	UL, TUV, CSA	EN 60601
Feature	Emerson Cough Assist	Dima Italia Negavent DA-3Plus Pegaso Cough
Standards	UL 747Y	EN 60601-1, EN 60601-1-2,EN 60601-1-4
EMC	UL, TUV, FCC Part 15, CSA,Class B	EN 60601-1-2, FCC Part 15,Class B
CE Conformity	Not listed	Risk Class IIb93/42 EEC DirectiveCE 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:

The products have equivalent Indications for Use.
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.
Both devices meet safety evaluations under IEC 60601 standards.
Pressures developed are comparable.

1. Both units are available in 110V and 220/230V versions.
1. Both units are intended for adult patients.
1. Use settings for home, hospital, and institution are the same.
1. Frequencies of breaths are comparable.
1. 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 (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,

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:

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

Regulation Number and Section

§ 868.5935 External negative pressure ventilator.

(a)
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.(b)
Classification. Class II (performance standards).