The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport.

This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The intended patient population includes infant through adult patients who require pressurebased or volume-based continuous respiratory support with tidal volumes as low as 5 ml and inspiratory pressures as low as 1 cm H2O.

The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support.

The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

Device Description

The Inspiration™ 71 / 51 Ventilator System provides continuous ventilation to patients requiring respiratory support by means of pressure-based and volume-based mandatory and spontaneous breaths. The device is identical to the cleared device, the Inspiration™ Ventilator System (K072950), with the following additions:

. a GUI change to deliver a GUI similar to that of the eVolution ventilator.
Additional monitored and trended parameters. .
. Additional waveforms and loops.
Additional medium and high priority alarms. .
. Additional patient setup and default setting criteria.
. : Integration of SNMP fields for settings, monitored and trended data.
. Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature.
Integration of various maneuvers

AI/ML Overview

The eVent Medical Ltd. Inspiration 5i/7i Ventilator System is a continuous ventilator. The provided text outlines the device's characteristics and its substantial equivalence to previously cleared predicate devices, but it does not contain typical acceptance criteria and study data as one might expect for an AI/ML powered medical device. Instead, the document focuses on demonstrating substantial equivalence through a comparison of technical characteristics and compliance with established performance standards for ventilators.

Here's a breakdown based on the provided text, aligning with the requested information to the best extent possible given the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a ventilator), "acceptance criteria" are generally tied to meeting established performance standards for medical electrical equipment and critical care ventilators, rather than statistical performance metrics like sensitivity/specificity for an AI model.
The device demonstrates performance by adhering to the following standards:

Acceptance Criteria (Standards Compliance)	Reported Device Performance
IEC 60601-1: 1995 (Medical Electrical Equipment, Safety)	The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with this standard.
IEC 60601-1-2:2004 (Medical Electrical Equipment, EMC)	The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with this standard.
IEC 60601-2-12:2001 (Medical Electrical Equipment, Lung Ventilators Safety)	The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with this standard.
ASTM F1100-90 (Standard Specification for Ventilators in Critical Care)	Performance was conducted using this standard to demonstrate the durability that the predicate ventilator met and to which compliance has been routinely accepted as requisite to any substantial equivalence claim.

The document also provides a detailed comparison to predicate devices, showing that the Inspiration 5i/7i shares similar specifications for:

Description: Functionally identical, with added features (GUI, monitored parameters, waveforms, alarms, setup criteria, SNMP, Capnography, maneuvers).
Indications for Use: Expanded patient weight and tidal volume ranges (0.3kg-200kg, 5ml-2000ml) compared to the predicate's general "infant through adult" but remains within the same scope.
Patient Types: Adult, Pediatric, Infant.
Ventilation Modes (Volume, Pressure, VTV, Apnea backup): All listed modes are identical to the predicate.
Settings/Controls: Similar primary and advanced settings.
Monitoring: Includes expanded monitoring parameters compared to the predicate. Integration of Volumetric and Sidestream Capnography capability (7i model only) is a new feature, for which the predicate Hamilton G-5 Ventilator also monitors Capnography parameters.
Electrical, Battery, Physical, and Environmental Specifications: All are identical or substantially similar to the predicate.

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

This document does not describe a test set in the context of validating an AI/ML model with a specific sample size. The "performance" assessment is based on compliance with established engineering and medical device standards for ventilators, which typically involve testing the physical device against specified operational parameters, safety limits, and durability. Such testing would involve:

Test Setup: Specialized test lungs, flow meters, pressure sensors, gas analyzers, and other equipment designed to simulate various patient conditions and measure ventilator performance.
Data Provenance: The testing would be conducted in a controlled laboratory environment by the manufacturer (eVent Medical, Ltd.). The data generated would be from these laboratory tests rather than patient-derived data from specific countries or being retrospective/prospective in nature.

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

This information is not applicable to this submission. Ground truth, in the context of AI/ML, refers to expert-labeled data used to train or evaluate models. For a ventilator, the "ground truth" for performance is defined by the technical specifications outlined in the referenced standards (e.g., how accurately a set tidal volume is delivered, or how precisely a pressure control algorithm maintains a target pressure). Performance is measured by calibrated instruments, not by expert human assessment of outputs that require subjective interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Since there is no expert labeling or subjective interpretation of results, no adjudication among experts is required. The device's performance is objectively measured against quantitative 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

An MRMC comparative effectiveness study is not applicable here. This type of study is relevant for diagnostic or interpretive AI systems where human readers (e.g., radiologists) rely on the AI's output. The Inspiration 5i/7i Ventilator System is a life-support device that directly delivers therapy, not an AI-powered diagnostic or interpretive tool that assists human decision-making in the same way.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This concept is not applicable in the AI/ML sense. The ventilator itself operates as a "standalone" system in delivering ventilation based on its internal algorithms and controls, but this is not analogous to the standalone performance of a diagnostic AI algorithm. The device's performance stands alone in its ability to ventilate according to user settings and clinical needs, guided by its software and hardware. The evaluation of its "standalone" performance is covered by the compliance testing to the referenced standards.

7. The Type of Ground Truth Used

The "ground truth" for this device is the technical specifications and performance requirements defined by recognized medical device standards (e.g., IEC 60601-1, IEC 60601-2-12, ASTM F1100-90). The device is tested to ensure it operates within the defined tolerances and safety limits specified by these standards. This is a form of engineering or objective performance ground truth, derived from established industry requirements, rather than expert consensus, pathology, or outcomes data.

8. The Sample Size for the Training Set

This information is not applicable. The Inspiration 5i/7i Ventilator System, as described in the submission, is a traditional medical device with software control, not an AI/ML device that undergoes a "training" phase with a large dataset. Its development involves traditional software engineering, control system design, and rigorous testing against specifications.

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

This information is not applicable. As it is not an AI/ML device, there is no "training set" in the context of machine learning, and therefore no ground truth established for such a set. The design and validation relied on established engineering principles, safety standards, and performance test protocols for ventilators.

Summary

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Inspiration 5i/7i 510(k) Premarket Submission

eVent Medical Ltd.

Section E: 510(k) Summary

[As required by 21 CFR 807.92]

Inspiration 5i/7i Ventilator System

This summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92.

Submitter:	eVent Medical, Ltd.60 Empire DriveLake Forest, CA 92630
Registration Number:	3003638180
Contact Person:	Rick WatersVice President, Regulatory Affairs and Quality Assurance
Phone:	949-900-1917 x232
Fax:	949-900-1905
Date Prepared:	January 18, 2013
Device Trade Name:	Inspiration 5i/7i Ventilator System
Common Name:	Continuous Ventilator
Device Class:	Class IIper 21 CFR 868.5895
Product Code:	73 CBK
Predicate Device:	The predicate devices are:

Table 1 - Predicate Devices

OCT 2 9 2013

Manufacturer/Product	510(k)	Classification
eVent MedicalInspiration™ Ventilator System	- K072590	Class IIContinuous Ventilatorper 21 CFR 868.5895
Hamilton G-5 Ventilator	K103803	Class IIContinuous Ventilatorper 21 CFR 868.5895

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Device Description:

. a GUI change to deliver a GUI similar to that of the eVolution ventilator.
Additional monitored and trended parameters. .
. Additional waveforms and loops.
Additional medium and high priority alarms. .
. Additional patient setup and default setting criteria.
. : Integration of SNMP fields for settings, monitored and trended data.
. Integration of Volumetric and Sidestream Capnography capability (7i model only) The capnography addition will require specific adaptors and sensors to allow use of this feature.
Integration of various maneuvers

Intended Use:

The Inspiration® 7i / 5i Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcarc professionals in hospitals or healthcare facilities.

This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support.

The device is not to be used in the presence of flammable anesthetics.

The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

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Summary of Performance Data and Substantial Equivalence:

The Inspiration 5i/7i ventilator has the same intended use as that for the eVent Inspiration Series Ventilators identified as cleared predicate device. The technical characteristics of the Inspiration 5i/7i ventilator do not introduce new questions regarding safety or effectiveness associated with critical care ventilators.

The following table provides a comparison to the predicate device:

Comparison Parameter	Predicate: InspirationVentilator System K072590	Inspiration 5i/7i VentilatorSystem
Description	The Inspiration® LS ventilator is anelectrically powered,microprocessor and servocontrolled, software-drivenventilator. It has a dynamic range ofbreathing gas delivery that providesfor infant through adult patients. Itutilizes a flat panel colour LCD withreal time graphic displays and digitalmonitoring capabilities, a touchscreen for easy interaction,membrane keys and a dial forchanging settings and operatingparameters, a gas delivery enginewith servo-controlled activeinhalation and exhalation valves.The Inspiration® Ventilator System isintended to provide continuousventilation for patients requiringrespiratory support.	The Inspiration® 7i / 5i ventilator is afifth generation, electricallypowered, microprocessor and servocontrolled, software-drivenventilator. It has a dynamic range ofbreathing gas delivery that providesfor neonatal through adult patients.It utilizes a flat panel colour LCDwith real time graphic displays anddigital monitoring capabilities, atouch screen for easy interaction,membrane keys and a dial forchanging settings and operatingparameters, a gas delivery enginewith servo-controlled activeinhalation and exhalation valves.The Inspiration® Ventilator System isintended to provide continuousventilation for patients requiringrespiratory support.
Indications for Use	The Inspiration® Ventilator isindicated for use with a wide rangeof patients from infant throughadult, requiring respiratory supportfor a wide range of clinicalconditions in hospital, hospital-typefacilities and intra-hospitaltransport.	The Inspiration® 7i / 5i VentilatorSystem is intended for use withpatients having body weights in therange of 0.3kg to 200kg and TidalVolumes of 5ml to 2000ml. TheInspiration® Ventilator System is tobe used by healthcare professionalsin hospitals or healthcare facilities.This product is intended for a widerange of patients from infant toadult and for a wide variety ofclinical conditions.The intended patient populationincludes infant through adultpatients who require pressure-based or volume-based continuousrespiratory support with tidalvolumes as low as 5 ml andinspiratory pressures as low as 1 cmH2O.The device is intended for use in
Comparison Parameter	Predicate: InspirationVentilator System K072590	Inspiration 5i/7i VentilatorSystem
		hospitals and hospital-type facilities,which provide respiratory care forpatients requiring respiratorysupport.The device is not to be used in thepresence of flammable anesthetics.The device is intended for sale by oron the order of a physician only. Thedevice is intended for operation bytrained and qualified personnel.
Patient Types	Adult, Pediatric, Infant	Adult, Pediatric, Infant
Ventilation Modes
Volume Modes	V-CMV, V-SIMV	V-CMV, V-SIMV
Pressure Modes	P-CMV, P-SIMV, SPAP, SPONT( CPAP+ PS), NCPAP, NCPAP+, NIV	P-CMV, P-SIMV, SPAP, SPONT( CPAP+ PS), NCPAP, NCPAP+, NIV
VTV Modes	PRVC-CMV, PRVC-SIMV, VS	PRVC-CMV, PRVC-SIMV, VS
Apnea backup	Volume, Pressure	Volume, Pressure
Settings/Controls
	Patient Type, Rate, Tidal Volume,	Patient Type, Rate, Tidal Volume,
	Inspiratory Pressure, Peak Flow,	Inspiratory Pressure, Peak Flow,
	Primary Settings	Inspiratory Pause, InspiratoryTime, PSV, PEEP, Flow Trigger,Pressure Trigger, Pressure High,Pressure Low, Time High, TimeLow
	Advanced Settings	Bias Flow, PS Tmax, Exp Sens%,Rise Time, Advance Flow Control
	Monitoring	Inspiratory Tidal Volume,Expiratory Tidal Volume,Spontaneous Tidal Volume,Mandatory Tidal Volume, Vti/Kg,Vte/Kg, Rate, Rate Spont, MinuteVentilation (Ve), SpontaneousMinute Volume (Ve Spont),Ve/Kg, I:E, H:L, Ppeak, Ptrach,Pmean, Pplateau, PEEP, AutoPEEP, Pmin, Inspiratory PeakFlow (PF), Expiratory Peak Flow(PFe), Ti/Ttotal, Inspiratory Time,Expiratory Time, StaticCompliance (Cstat), Cstat/kg,Dynamic Compliance (Cdyn),Cdyn/kg, Inspiratory Resistance


	(Rinsp), Expiratory Resistance
	(Rexp), Leak, RSBI, O2, HeO2,
	Event History, PO.1, PiMax,
	PO.1/PiMax, C20/C, WOBimp,
Monitoring: Capnography	PetCO2, PeCO2, VCO2/min,	Predicate: Hamilton G-5
	VtiCO2, VteCO2, FetCO2, FeCO2,	Ventilator (K103803):
	Vd ana, Vd alv, Vd/Vt/phy, Valy,	PetCO2, PeCO2, VCO2/min,
	Valv/min	VtiCO2, VteCO2, FetCO2, FeCO2,
		Vd ana, Vd alv, Valy, Valv/min

Type	Alternating Current (AC)	Alternating Current (AC)
Voltage Range	100 to 240 V	100 to 240 V
Frequency	50 - 60 Hz	50 - 60 Hz
Battery Type	Lead Acid (Optional battery pack =Lithium Ion)	Lead Acid (Optional battery pack =Lithium lon)
Battery Time	1 Hour (1 hour per optional hotswappable battery) Hold 4-8batteries	1 Hour (1 hour per optional hotswappable battery) Hold 4-8batteries
Battery Capacity	Amp/hours	Amp/hours
Weight	53 lbs (24kg) without Cart	53 lbs (24kg) without Cart
	98 lbs (44.5kg) with Transport Cart	98 lbs (44.5kg) with Transport Cart
Operating Temperature	10 to 40 º C	10 to 40 ª C
Operating Humidity	10 to 80%	10 to 80%
Storage Temperature	-10 to 60 a C	-10 to 60 º C
Storage Humidity	5 to 95%	5 to 95%

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The design and development process at eVent Medical, Ltd. requires adherence to internal procedures written to comply with the Design Control requirements of the Quality System Regulations defined in 21 CFR 820.30.

FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices, dated May 29, 1998, was used to define, the software design and development activities required for the software developed for the Inspiration 5i/7i based on the determined Level of

Concern.
The Inspiration 5i/7i Ventilator System has been tested and shown to be compliant with the following standards documents:

1. IEC 60601-1: 1995, Medical Electrical Equipment, Part 1: General Requirements for Safety
1. IEC 60601-1-2:2004, Medical Electrical Equipment Part 1-2: General requirements for safety-Collateral standard: Electromagnetic compatibility-Requirements and tests

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1. IEC 60601-2-12:2001, Medical Electrical Equipment. Particular requirements for the safety of lung ventilators. Critical care ventilators.
1. ASTM F1100-90 Standard Specification for Ventilators Intended for Use in Critical Care.

Performance was conducted using ASTM F1100-90 Standard Specification for Ventilators Intended for Use in Critical Care to demonstrate the durability that the predicate ventilator met and to which compliance has been routinely accepted as requisite to any substantial equivalence claim.

Conclusion:

eVent Medical Ltd. hereby presents data as part of the 510(k) process to support the Inspiration 51/7i ventilator substantial equivalence to the identified predicates currently marketed and previously cleared by the FDA.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three wavy lines representing the branches of government. The logo is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The text is in all capital letters and is written in a sans-serif font.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2013

eVent Medical, Limited Mr. Rick Waters Vice President, Regulatory Affairs and Quality Assurance 971 Calle Amanecer SAN CLEMENTE CA 92673

Re: K130178

Trade/Device Name: Inspiration 5i/7i Ventilator System Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: September 25, 2013 Received: September 27, 2013

Dear Mr. Waters:

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. Waters

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Image /page/7/Picture/7 description: The image shows a signature above the text "Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID FOR". The text is likely part of a formal letter or document. The signature is illegible but appears to be handwritten.

Kwame Ulmer M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Inspiration 5i7i 510(k) Premarket Submission

eVent Medical Ltd.

SECTION D: Indications for Use Statement INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K130178

Device Name: {device name(s)}

Indications for Use:

The Inspiration® 7 / 51 Ventilator System is intended for use with patients having body weights in the range of 0.3kg to 200kg and Tidal Volumes of 5ml to 2000ml. The Inspiration® Ventilator System is to be used by healthcare professionals in hospitals or healthcare facilities and intrahospital transport.

This product is intended for a wide range of patients from infant to adult and for a wide variety of clinical conditions.

The device is intended for use in hospital-type facilities, which provide respiratory care for patients requiring respiratory support.

The device is intended for sale by or on the order of a physician only. The device is intended for operation by trained and qualified personnel.

Over-The-Counter Use _ Prescription Use X ___________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) AND/OR

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

lly signed by Anya C. Harry -S o=U.S. Government, ou=HHS, Anva C. Harin People, ChaAnya C. Harry -S, 9200300.100.11.1=00111.1=00111.315590.
9200300.100.11.1=00111.1=00111.315590.100.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.300.3

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of _1

(Posted November 13, 2003)

Regulation Number and Section

§ 868.5895 Continuous ventilator.

(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).