The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:

Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP and NPPV modes of ventilation.
The ventilator is suitable for use in institutional or transport settings.

Device Description

The VM-2000 allows for rapid initiation of emergency ventilation based on default parameters. An operator can quickly begin ventilation by connecting the patient to the breathing circuit, and if necessary, adjusting ventilatory settings using the touch screen input before selecting start.
Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.
The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.

AI/ML Overview

This document does not contain the specific information required to complete the requested table and study description regarding acceptance criteria and performance data for a device, particularly an AI-powered one.

The provided text is an FDA 510(k) clearance letter and a summary for the Ventis Medical VM-2000 ventilator. This device is a continuous ventilator, not an AI-powered diagnostic or therapeutic device that would typically have acceptance criteria presented as sensitivity, specificity, or other performance metrics against a "ground truth" established by experts.

Instead, the document details a comparison of the VM-2000 to predicate ventilator devices (Cardinal Health LTV 1200 and Respironics Trilogy EVO) to establish substantial equivalence. The "performance testing" mentioned refers to compliance with various safety and performance standards for medical devices (e.g., IEC 60601 series, ISO 80601 series, MIL-STD-810G), not a study demonstrating AI performance on a test set.

Therefore, I cannot extract the requested information such as:

A table of acceptance criteria and reported device performance related to AI.
Sample size used for an AI test set or data provenance.
Number of experts for ground truth establishment or their qualifications.
Adjudication method for an AI test set.
MRMC comparative effectiveness study results.
Standalone AI performance.
Type of ground truth (expert consensus, pathology, outcomes data).
Sample size for an AI training set.
How ground truth for a training set was established.

The "Performance Testing" section (page 13) simply lists the standards the device was tested against and states that the "non-clinical performance testing included testing of a set of ventilation modes... The data demonstrates that the technological characteristics of the VM-2000 ventilator are substantially equivalent with the predicate device." This refers to engineering and safety performance, not AI-driven diagnostic accuracy.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 13, 2024

Ventis Medical, Inc. % Paul Dryden Consultant ProMedic Consulting LLC 131 Bay Point Drive NE Saint Petersburg, Florida 33704

Re: K240807

Trade/Device Name: VM-2000 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK Dated: July 15, 2024 Received: July 15, 2024

Dear Paul Dryden:

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 (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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices

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OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240807

Device Name VM-2000

Indications for Use (Describe)

The VM-2000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation in emergency and transport situations. The ventilator is a medical for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult patients, who require the following types of ventilatory support:

Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask). - Assist/Control, SIMV, CPAP and NPPV modes of ventilation.

The ventilator is suitable for use in institutional or transport settings.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Date Prepared:	09-Aug-2024
Sponsor:	Ventis Medical, Inc.515 Executive DrivePrinceton, NJ 08540(609) 373-6229
Sponsor Contact:	Glenn W. Laub, M.D. - CEO
Submission Contact:	Paul DrydenProMedic Consulting, LLC
Proprietary or Trade Name:	VM-2000
Common/Usual Name:	Emergency and Transport Ventilator
Classification Name:	Continuous ventilator
CFR:	868.5895
Product Classification:	CBK
Primary Predicate Device:	Cardinal Health LTV 1200 - K083688
Classification Name:	Continuous ventilator
CFR:	868.5895
Product Classification:	CBK
Secondary Predicate Device:	Respironics Trilogy EVO – K181166
Classification Name:	Continuous ventilator
CFR:	868.5895
Product Classification:	CBK and NOU
Reference Device:	Inovytec - Ventway Sparrow – K202970
Classification Name:	Continuous ventilator
CFR:	868.5895
Product Classification:	CBK

Device Description:

Once the therapy is initiated, breaths are delivered to the patient based on the configured settings. If the situation allows, qualified operators can adjust desired Mode, Tidal Vol, Respiratory Rate, PEEP, PIP, T Insp, P Insp and Sensitivity. Operators can monitor patients closely through a graphical breath-by-breath display to deliver highquality care. Audio and visual alarm indicators help troubleshoot issues.

The VM-2000 uses a single-patient-use breathing circuit with a Pressure Monitoring Line, and Flow Sensor to deliver air to patients using a motor-blower system. The unit has a Type BF Applied Part, which is the breathing circuit. The device can run on AC wall power and / or batteries. To support use in environments where compressed Oxygen is unavailable or ill-advised, the device does not require compressed Oxygen. The VM-2000 is compatible with low pressure oxygen sources and blenders but will function without supplemental FiO2.

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Principle of Operation:

The VM-2000 Ventilator is a portable ventilator designed to provide continuous or intermittent ventilatory support for individuals who require mechanical ventilation. The VM 2000 is a blower based positive pressure ventilator. It includes pressure and flow sensors as well as alarms.

Indications for Use:

Positive Pressure Ventilation, delivered invasively (via endotracheal tube or trach tube) or non-invasively (via mask).
Assist/Control, SIMV, CPAP and NPPV modes of ventilation. -

The ventilator is suitable for use in institutional or transport settings.

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510(k) Summary Page 3 of 10

K240807

Comparison
Features	Subject DeviceVentis - VM-2000	Primary Predicate – K083688LTV 1200	Secondary Predicate – K181166Respironics Trilogy Evo	Remarks, Substantial equivalence
Picture	Image: Ventis - VM-2000	Image: LTV 1200	Image: Respironics Trilogy Evo
Indications forUse	The VM-2000 ventilator is intendedto provide continuous or intermittentventilatory support for the care ofindividuals who require mechanicalventilation in emergency andtransport situations. The ventilator isa medical device intended for use byqualified, trained personnel under thedirection of a physician. Specifically,the ventilator is applicable for adultpatients, who require the followingtypes of ventilatory support:- Positive PressureVentilation, delivered invasively (viaendotracheal tube or trach tube) ornon-invasively (via mask).- Assist/Control, SIMV,CPAP and NPPV modes ofventilation.The ventilator is suitable for use ininstitutional or transport settings.	The LTV® 1200 ventilator isintended to provide continuous orintermittent ventilatory support forthe care of the individuals whorequire mechanical ventilation. Theventilator is a medical deviceintended for use by qualified, trainedpersonnel under the direction of aphysician. Specifically, the ventilatoris applicable for adult and pediatricpatients weighing at least 5kg (11lbs.), who require the following typesof ventilatory support:• Positive Pressure Ventilation,delivered invasively (viaendotracheal tube or trach tube) ornon-invasively (via mask).• Assist/Control, SIMV, CPAP, andNPPV modes of ventilation. The	The Trilogy Evo ventilator providescontinuous or intermittent positivepressure ventilation for the care ofindividuals who require mechanicalventilation. Trilogy Evo is intendedfor pediatric through adult patientsweighing at least 2.5 kg. Theventilator can measure, display,record, and alarm SpO2, FiO2, CO2,Respiratory Rate, and Pulse Ratedata when integrated with theappropriate accessories. Theventilator is suitable for use ininstitutional, home, and non-emergency transport settings forexample wheelchair or personalvehicle. It may be used for bothinvasive and noninvasive ventilation.	All devices provide ventilatorysupport and can be consideredsubstantially equivalent.The Indications for Use for theapplication device is a subset of theIndications for Use of the predicates.In particular, the application devicetreats only adult patients, whereas thepredicate have a broader range ofpatients.The ventilation modes are identicalbetween the subject and the primarypredicate device, and are a subset ofthe secondary predicate.VM-2000 environment of use is asubset of the primary predicate.
Features	Subject DeviceVentis - VM-2000	Primary Predicate – K083688LTV 1200	Secondary Predicate – K181166Respironics Trilogy Evo	Remarks, Substantial equivalence
		ventilator is suitable for use ininstitutional, home, or transportsettings.		The VM-2000 is not intended forhome use.
Environment ofUse	Institutional and transport settings.	Institutional, home, and transportsettings.	Institutional, home, and non-emergency transport settings forexample wheelchair or personalvehicle.	VM-2000 is intended to be used in asubset of environments (institutionaland transport) of use of the primarypredicate.The lack of home use does not raisedifferent safety concerns for the
				intended Environments of Use.
Qualified users	Intended for use by qualified, trainedpersonnel under the direction of aphysician.	Intended for use by qualified, trainedpersonnel under the direction of aphysician.	Intended for use by qualified, trainedpersonnel under the direction of aphysician.	Identical
Patientpopulation	Adult patients	Pediatric through adult patientsweighing at least 5 kg.	Pediatric through adult patientsweighing at least 2.5 kg.	The subject device is intended foradult patients. This is a subset of theintended cohorts of the predicatedevices.
MRI suite	No	No	No	Identical
VentilationModes	• Assist/Control (AC)• SIMV• CPAP• NPPV	• Assist/Control (AC)• SIMV• CPAP• NPPV	• Assist/Control (AC)• SIMV• CPAP• NPPV• Other Modes	The subject device offers an identicalset of modes as the Primary Predicate(LTV) and a subset of the SecondaryPredicate (Trilogy EVO).
Features	Subject DeviceVentis - VM-2000	Primary Predicate - K083688LTV 1200	Secondary Predicate - K181166Respironics Trilogy Evo	Remarks, Substantialequivalence
Use Interface	Graphical User Interface using atouch screen display, status LEDsand dedicated keys for user input.	Graphical User Interface using a 7-segment display, status LEDs anddedicated keys / knob for user input.	Graphical User Interface using atouch screen display, status LEDsand dedicated keys for user input.	Subject device useinterface is similar to thatof the Secondary Predicate(Trilogy EVO). Anydifference in user interfacewould not be consideredsignificant based uponHuman Factors testing.
Waveformcomparison	We have performed waveform comparison to the predicates, K181166 Respironics Trilogy Evo and K083688 LTV 1200
Flowmeasurement	Proximal flow sensor	Proximal flow sensor	Proximal flow sensor	Identical
EtCO2	In-line EtCO2 sensor (conforms withISO 80601-2-55)	External EtCO2 sensor available	In-line EtCO2 sensor (conforms withISO 80601-2-55)	All devices can measureEtCO2. The subject deviceand the secondarypredicate (Trilogy EVO)both support the use of anEtCO2 sensor
AccessoriesUser supplied	Standard single limb ventilatorcircuit with Exhalation ValveIn-line EtCO2 adapter	Standard single limb ventilatorcircuit with Exhalation Valveand Proximal flow sensor	Standard single limb ventilatorcircuit with Exhalation ValveIn-line EtCO2 adapter	All devices utilize a singlelimb circuit.The subject device andsecondary predicate arevery similar to each otherregarding the externalpatient circuit.
Features	Subject DeviceVentis - VM-2000	Primary Predicate - K083688LTV 1200	Secondary Predicate - K181166Respironics Trilogy Evo	Remarks, Substantialequivalence
Sponsor supplied	Proximal flow sensor	Proximal flow sensor	Proximal flow sensor	Identical
Transport Caseand MountingSystem	Ambulance and Helicopter TransportCase and Mounting System	Transport mountings not specified	Not specified	There are similar thirdparty supplied mountingsystems for these transportmodes. Shock andAcceleration testing wasperformed and whencompared to the predicatemount does not raise newor different questions ofsafety or effectiveness.
Power supply	100 - 240VAC, 24VDC	110V or 220V AC power source, or11V to 15V DC power source.	100 - 240VAC, 24VDC	Similar for all devices.
Battery	Rechargeable Li-Ion and disposablebatteries	Rechargeable lead acid batteries	Rechargeable Li-Ion batteries	All devices contain backupbatteries.
Systemarchitecture	Microprocessor controlled.VM-2000's pneumatics deliver gas,and its electrical systems controlpneumatics, monitor alarms, anddistribute power.	Microprocessor controlled.LTV 's pneumatics deliver gas, andits electrical systems controlpneumatics, monitor alarms, anddistribute power.	Microprocessor controlled.Trilogy EVO 's pneumatics delivergas, and its electrical systems controlpneumatics, monitor alarms, anddistribute power.	All devices utilize similartechnology.
Controlarchitecture	User inputs become instructions forthe VM-2000 pneumatics to deliverprecisely controlled ventilation to thepatient.	User inputs become instructions forthe LTV pneumatics to deliverprecisely controlled ventilation to thepatient.	User inputs become instructions forthe Trilogy EVO pneumatics todeliver precisely controlledventilation to the patient.	All devices utilize similartechnology and aresubstantially equivalent.
Features	Subject DeviceVentis - VM-2000	Primary Predicate - K083688LTV 1200	Secondary Predicate - K181166Respironics Trilogy Evo	Remarks, Substantialequivalence
Exhalation ValveControl	During exhalation, a solenoid valve ismodulated to allow airway pressure toreturn to PEEP via a pilot line to asingle limb circuit.The blower is used as a pressuresource for this control.	During exhalation, an accumulator iscontrolled via solenoids to allowairway pressure to return to PEEPvia a pilot line to a single limbcircuit.The blower is used as a pressuresource for this control.	During exhalation, a valve moduleconsisting of a solenoid andproportional valve are modulated toallow airway pressure to return toPEEP via a pilot line to a single limbcircuit.The blower is used as a pressuresource for this control.	All devices utilize similartechnology and havesubstantially equivalentperformance.
Gas source	Blower + low flow 02	Blower + low flow 02High pressure 02 source	Blower + low flow 02	Similar and use ofReference K202970 forsimilarity of oxygenreservoir tubeconfiguration.
Gas source anddelivery	Electronically controlled pneumaticventilation system with an integratedair compressing system.VM-2000 uses room air and low flowoxygen. Air enters through a freshgas intake port and is compressedtogether with the oxygen by theblower. Low flow oxygen entersthrough a reservoir coupled to theintake port.	Electronically controlled pneumaticventilation system with an integratedair compressing system.LTV uses room air and low flowoxygen. Air enters through a freshgas intake port and is compressedtogether with the oxygen by theblower. Low flow oxygen entersthrough a reservoir coupled to theintake port.	Electronically controlled pneumaticventilation system with an integratedair compressing system.Trilogy EVO uses air and low flowoxygen. Air enters through a freshgas intake port and is compressedtogether with the oxygen by theblower. Low flow oxygen entersthrough a reservoir coupled to theintake port.	Similar
Features	Subject DeviceVentis - VM-2000	Primary Predicate - K083688LTV 1200	Secondary Predicate - K181166Respironics Trilogy Evo	Remarks, Substantialequivalence
Exhalation	Gas exhaled by the patient passesthrough the flow sensor and exitsthrough the expiratory exhalationvalve with a membrane.The exhalation valve is part of thecircuit thus ensuring that no exhaledgas comes into contact with anyinternal part of the VM-2000.	Gas exhaled by the patient passesthrough the flow sensor and exitsthrough the expiratory exhalationvalve with a membrane.The exhalation valve is part of thecircuit thus ensuring that no exhaledgas comes into contact with anyinternal part of the LTV.	Gas exhaled by the patient passesthrough the flow sensor and exitsthrough the expiratory exhalationvalve with a membrane.The exhalation valve is part of thecircuit thus ensuring that no exhaledgas comes into contact with anyinternal part of Trilogy EVO.	Similar
Sensors andMonitoring	VM-2000 receives inputs from theproximal Flow Sensor and othersensors within the ventilator.Monitored data is also displayed bythe graphic user interface.A galvanic oxygen sensor (oxygencell) monitors the concentration ofthe gas to be delivered	LTV receives inputs from theproximal Flow Sensor and othersensors within the ventilator.Monitored data is also displayed bythe graphic user interface.An external galvanic oxygen sensoris available.	Trilogy EVO receives inputs from theproximal Flow Sensor and othersensors within the ventilator.Monitored data is also displayed bythe graphic user interface.A galvanic oxygen sensor (oxygencell) monitors the concentration ofthe gas to be delivered	All devices have similarsensors and technology.
Alarming	A comprehensive system of visualand audible alarms helps ensure thepatient is monitored. Clinical alarmscan indicate an abnormalphysiological condition. Technicalalarms, triggered by the ventilator'sself-tests, including ongoingbackground checks, can indicate ahardware or software failure.	A comprehensive system of visualand audible alarms helps ensure thepatient is monitored. Clinical alarmscan indicate an abnormalphysiological condition. Technicalalarms, triggered by the ventilator'sself-tests, including ongoingbackground checks, can indicate ahardware or software failure.	A comprehensive system of visualand audible alarms helps ensure thepatient is monitored. Clinical alarmscan indicate an abnormalphysiological condition. Technicalalarms, triggered by the ventilator'sself-tests, including ongoingbackground checks, can indicate ahardware or software failure.	All devices have similarand applicable alarms.Use of reference K202970for lack of overhead alarmnurse call capabilities.
Features	Subject DeviceVentis - VM-2000	Primary Predicate – K083688LTV 1200	Secondary Predicate – K181166Respironics Trilogy Evo	Remarks, Substantialequivalence
Safety Features	Conforms to ventilator consensusstandard safety requirements for ISO80601-2-12, ISO 80601-2-84 such as:- Maximum limited pressureprotection device- High airway pressure alarmcondition and protection device- Obstruction alarm condition- Disconnection alarm conditionThese safety requirements includeensuring minimal breathingresistance to prevent asphyxiation incase of power supply loss.	Conforms to ventilator consensusstandard safety requirements for ISO80601-2-12 such as:- Maximum limited pressureprotection device- High airway pressure alarmcondition and protection device- Obstruction alarm condition- Disconnection alarm conditionThese safety requirements includeensuring minimal breathingresistance to prevent asphyxiation incase of power supply loss.	Conforms to ventilator consensusstandard safety requirements for ISO80601-2-12 such as:- Maximum limited pressureprotection device- High airway pressure alarmcondition and protection device- Obstruction alarm condition- Disconnection alarm conditionThese safety requirements includeensuring minimal breathingresistance to prevent asphyxiation incase of power supply loss.	All devices meet relevantconsensus standards forcritical care ventilators.
PerformanceTesting	IEC 60601-1IEC 60601-1-2IEC 60601-1-8IEC 60601-1-12AIM 7351731 RFIDISO 80601-2-12ISO 80601-2-55ISO 80601-2-84MIL-STD-810GAltitude TestingHuman Factors	IEC 60601-1IEC 60601-1-2IEC 60601-1-1IEC 60601-1-2ISO 3864IEC 417IEC 60417IEC 68-2-27IEC 68-2-6IEC 68-2-34MIL-STD-810E	IEC 60601-1IEC 60601-1-2IEC 60601-1-8IEC 60601-1-12AIM 7351731 RFIDISO 80601-2-12ISO 80601-2-55ISO 80601-2-84Human FactorsISO 80601-2-72	All devices comply withthe applicable standards atthe time of clearance.Similar standards wereapplied, tested, and passed.

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K240807 510(k) Summary Page 4 of 10

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510(k) Summary

Page 5 of 10

Comparison of Technological Characteristics

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510(k) Summary Page 6 of 10

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510(k) Summary Page 7 of 10

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510(k) Summary Page 8 of 10

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510(k) Summary Page 9 of 10

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Discussion of the Comparison and Differences

We present the comparison to the predicate in the above tables. The main differences of the subject device and predicate are:

. Patient population is limited to adult patients.
- This is a subset of the predicates but addresses the intended population O
- Environment of use is a subset of the Primary Predicate
  - Subject device is not intended for home setting use o
. Use of reference - K202970 for similarity of oxygen reservoir design, lack of overhead alarm / nurse call capabilities.

These differences do not raise different concerns of safety or effectiveness compared to the predicates.

Performance Testing

●

The VM-2000 was subjected to performance tests including: reliability testing, alarm tests, design control verification, software verification, and electromagnetic compliance, electrical safety, packaging verification, environmental testing, waveform testing and biocompatibility testing:

Tested according to .
- ES 60601-1 ●
- . IEC 60601-1-2
- IEC 60601-1-8 ●
- IEC 60601-1-12
- . AIM Standard 7351731
- . ISO 80601-2-12
- ISO 80601-2-55
- ISO 80601-2-84 ●
- Altitude Testing ●
Reliability testing has been performed for subject device. ●

The non-clinical performance testing included testing of a set of ventilation modes as described above. The data demonstrates that the technological characteristics of the VM-2000 ventilator are substantially equivalent with the predicate device.

Biocompatibility of Materials

The patient contact is Externally Communicating, Tissue, Prolonged. As for ventilators the testing included VOC (gas emission test method), CO, CO2, Ozone and PM2,5 and PM10 testing. We performed a risk based assessment for the results and the materials in patient contact meet the biological endpoints. Use of Reference device - K202970 for a prolonged duration of use.

Usabilitv

Summative usability tests was performed with a user group of respiratory therapists.

Substantial Equivalence Conclusion

Ventis Medical concludes that the VM-2000 ventilator is substantially equivalent in Indications for Use, technology, design, performance, user interface, and use context to the primary predicate LTV 1200 (K083688) and the secondary predicate, the Respironics Trilogy EVO (K181166). The sponsor has demonstrated via comparative bench testing and through non-clinical testing that the subject device does not raise different concerns of safety when compared to the predicates.

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).