The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

Device Description

The Ventoux Ventilator is an electrically powered, microprocessor-controlled multi-parameter ventilator, which can be: Time, Pressure, Flow or Volume triggered; Volume or Pressure controlled; Time or Flow cycled.

Manual inflation is allowed, and the Ventoux supports the emergency intake of ambient air which permits the patient to pull ambient air into the breathing circuit in the event of a complete loss of air/gas supply.

Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level.

Ventilation is possible in both Invasive and Noninvasive settings.

The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control.

The Ventoux can be powered by external power (100 – 240 VAC, 50-60 HZ or 10 – 30 VDC) and/or by its two swappable internal Li Ion rechargeable batteries, which provide full operating power the to the ventilator for a minimal operating time of 6 hours when operating on standard ventilation parameters.

A comprehensive alarm system is built-in to alert the user to violations of set safety limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.

The electrical system is comprised of three primary boards: The main board (motherboard) which holds the majority of the electronics including the main CPU and the display CPU. the power board, which holds the power subsystems, and internal communication functions, and the Communication board, which holds internal communication and external communication connectors. The main component of the pneumatic system is an electrically controlled compressor (pump). This compressor provides a compressed gas source so no external air compressor is needed. Additionally, the exhalation valve is activated by an electrically controlled proportional solenoid that provides a built in PEEP.

AI/ML Overview

The provided FDA 510(k) summary (K223120 for the Ventoux Ventilator) does not contain information about an AI/ML powered device. The document describes a traditional medical device (a continuous ventilator) and its comparison to predicate devices based on established engineering and performance standards.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, human reader improvement with AI assistance, or ground truth establishment for an AI/ML model. The 510(k) summary specifically states:

"No clinical testing was conducted or required in support of this premarket notification." and "The software design and validation process, together with the bench testing of the device, demonstrated Ventoux Ventilator performs as intended."

This indicates that the device's performance was validated through bench testing and compliance with recognized standards, not through studies involving AI/ML performance metrics, expert consensus, or multi-reader studies as would be typical for AI-powered diagnostic aids.

The document focuses on:

Technological Characteristics Comparison: Showing the Ventoux has similar features and functionalities to predicate devices.
Performance Data: Demonstrating compliance with various IEC and ISO standards related to electrical safety, EMC, basic safety and essential performance of ventilators, alarm systems, gas monitors, pulse oximeters, environmental testing (shock, rough handling, vibration), altitude, internal temperature, and battery validation.
Software Design and Validation: Stating that this was performed and contributed to demonstration of intended performance.
Bench Testing: Stating that bench testing was conducted to verify compliance with predefined specifications and internal procedures.
Biocompatibility: Assessment of gas pathways.

To answer your request, an AI/ML-specific device submission would be needed, which would detail metrics like sensitivity, specificity, AUC, and studies with expert readers. This document does not provide such information.

Summary

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December 2, 2024

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

Flight Medical Innovations Ltd. Ken Raichman Director of QA & Regulatory Affairs 7 Hatnufa St. Petach Tikva, 4951025 Israel

Re: K223120

Trade/Device Name: Ventoux Ventilator; Models VC2 VC3 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK, BTT, DOA Dated: October 31, 2024 Received: November 4, 2024

Dear Ken Raichman:

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/cdrb/cfdocs/cfpm/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.

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).

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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 OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.70) 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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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).

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Sincerely,

Ethan L. Nyberg -S

Ethan Nyberg, Ph.D. Assistant Director DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices 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) K223120

Device Name Ventoux Ventilator; Models VC2 VC3

Indications for Use (Describe)

The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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510(K) Summary [as required by section 807.92(c)] Ventoux Ventilator

510(k) Number K__ 223120_

Applicant's Name:

Flight Medical Innovations Ltd. 7 Hatnufa St. Kiryat Arie Petach-Tikva 4951025 Israel

Contact Person:

Eval Ozeri, QA & Regulatory Telephone: +972 (3) 9385845 Mobile: 972-545834611 E-mail: eyalo@flight-medical.com

Trade Name:

Ventoux Ventilator

Classification Name:

Continuous Ventilator

Classification:

FDA has classified continuous ventilators as class II devices (product code 73 CBK and DOA) and they are reviewed by the Anesthesiology panel

Predicate Device:

Flight 60 Ventilator cleared under K143035

Reference Device: HAMILTON C6 Ventilator cleared under K201658

Device Description:

Volume triggered is based on Inspiratory trig response time ≤100 ms from pressure drop/flow rise to PEEP level.

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Ventilation is possible in both Invasive and Noninvasive settings.

The system can be expanded to include additional parameter monitoring to allow for Sp02, etC02 and Cuff Pressure Control.

Technological characteristics

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Table 1: A comparative summary of the technological characteristics of the Ventoux with the predicate and reference devices.

Parameters	Proposeddevice:VENTOUX	Predicate device:Flight 60 turbineK143035	Comparison toFlight 60 turbine	Referencedevice:HAMILTON C6K201658
Intended use	The VENTOUX isintended to providecontinuous orintermittentmechanicalventilation supportfor the care ofindividuals whorequire mechanicalventilation.Specifically,theVENTOUX isapplicable foradult and pediatric(i.e., infant, childand adolescent)patients whoweigh at least 5 kg(11 lbs).	The VENTOUX isintended to providecontinuous orintermittentmechanicalventilation supportfor the care ofindividuals whorequire mechanicalventilation.Specifically, theVENTOUX isapplicable for adultand pediatric (i.e.,infant, child andadolescent) patientswho weigh at least 5kg (11 lbs).	SubstantiallyEquivalent	TheHAMILTON-C6ventilator isintended toprovide positivepressureventilatorysupport to adultsand pediatrics andoptionally infantsand neonates.TheHAMILTON-C6Ventilator is amedical deviceintended for useby qualified,trainedpersonnel underthedirection of aphysician andwithin the limitsofits statedtechnicalspecifications
	The VENTOUX is arestrictedmedical deviceintended for useby qualified,trained personnelunder thedirection of aphysician; it issuitable for use inhospitalenvironments.	The VENTOUX is arestricted medicaldevice intended foruse by qualified,trained personnelunder the directionof a physician; it issuitable for use inhospital, sub-acute,emergency room,and home careenvironments, aswell as for transportand emergencyresponseapplications.	SubstantiallyEquivalentbut withreducedenvironmentto hospitaluse.	Intended areas ofuse:In the intensivecare ward,intermediatecare ward,emergencyward, long-termacute carehospital or in therecovery room.During transfer ofventilatedpatients withinthe hospital
Productclassificationcode and CFRcitation	CBK(subsequent:DQA)21 CFR 868.5895	CBK, NOU21 CFR 868.5895	DQAreferenced aspart ofOximetry,NOU notreferenced due tono Home Care	CBK (subsequent:DQA)21 CFR 868.5895
Principaloperator	Qualified, trainedpersonnel underthe direction of aphysician	Qualified, trainedpersonnel under thedirection of aphysician	Substantiallyequivalent	same
Environmentof use	Intended areasof use:hospitals.	Intended areas ofuse:hospitals, sub-acuteemergencyrooms Transportandemergencyresponseapplications. Home care use	The Ventoux isequivalent tothe F60 turbineexcept that theVentoux isapproved onlyfor Hospital useThe Ventoux isprovided in twoversions,whereas theFlight 60turbine is asingle unitcovering allenvironmentalapplications:	Intended areas ofuse:Healthcarefacilities DuringtransferofVentilatedpatientswithin healthcare facilities
Intendedpatientpopulation	Adult andpediatric (i.e.,infant, child andadolescent)patients whoweigh at least 5 kg(11 lbs).	Adult and pediatric(i.e., infant, childand adolescent)patients who weighat least 5 kg (11 lbs).	SubstantiallyEquivalent	Adults, pediatrics,infants andneonates
Patientinterface	Deliveredinvasively (via ETtube) ornoninvasively(via a mask)	Delivered invasively(via ET tube) ornoninvasively (via amask)	SubstantiallyEquivalent	The same
Power source	AC, DC, Battery	AC, DC, Battery	SubstantiallyEquivalent	The same
Operationalmodes	AC-VC	ACMV-VCV	EquivalentName changemorecommonlyused terminology	(S)CMV (only foradult/pediatricpatients)
	AC-PC	ACMV-PCV	EquivalentEquivalentName changemorecommonlyused terminology	PCV+
	AC-PRVC	ACMV-PRVC	EquivalentName changemorecommonlyused terminology	-
	SIMV-VC	SIMV-VC	Equivalent	SIMV (only foradult/pediatricpatients)
	SIMV-PCAC-PRVC	SIMV-PCACMV-PRVC	Equivalent	PSIMV+APVcmv/(S)CMV+
	SIMV-PRVCAPRV	SIMV-PRVCB-LEV	EquivalentName changemorecommonlyused terminology	APVsimv/SIMV+APRV
	CPAP/PSV	SPONT	EquivalentName changemorecommonlyused terminology	SPONT
	VG	VtG	EquivalentName changemorecommonlyused terminology	-
	HFOT	---	Not available inF60T	HiFlowO2
	Not available	ASV / INTELLİVENT-ASV	Not Relevant	Not available
	NIV (non- invasiveventilation) isavailable in allmodes for thedevice (exceptfor HFOT)	NIV (non- invasiveventilation) isavailable in all modesfor the device	Equivalent	NIV
Therapy Types	Invasive,Noninvasive,02 %DeliveryHiFlowO2	Does not contain HiFlow 02 Mode	The High FlowO2 mode is onlya SW change thatuses the samecomponents thatare used for 02% Delivery	Invasive,Noninvasive,02 % DeliveryHiFlowO2
Emergency airintake	In case of a powersupply, technical,orpneumaticsfailure theventilatorvalves allowspontaneousambientbreathing.	In case of a powersupply, technical, orpneumaticsfailure theventilator valvesallowspontaneousambient breathing.	Equivalent	Yes
Exhalationvalve	Yes, pneumatic	Yes, pneumatic	Equivalent	Yes
Alarms andmonitoring	Yes	Yes	Equivalent	Yes
Supply gas	Oxygen, ambientair	Oxygen, ambient air	Substantiallyequivalent	Yes
Method ofsupply gaspressurization	Internal turbinefor air,compressedsource for02	Internal turbine forair, compressedsource for02	Substantiallyequivalent	Yes
Capnographymonitoringoption	Yes	No	Equivalent toreferencedevice	Yes
Oximetry(Sp02)monitoringoption	Yes	No	Equivalent toreferencedevice	Yes
Cuff pressurecontrol	Yes	No	Equivalent toreferencedevice	Yes
Transportation	Transportable	Yes	Equivalent	Mobile
Data Storage	NVRAM + eMMC	NVRAM	Equivalent	Compact flash
Ingress of Dustand Water	IP 34	IP 34	Equivalent	IP21

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Table 1 above demonstrate that the proposed device Ventoux has the same technological characteristics as the predicate device. Altogether, the technological characteristics of the proposed device Ventoux are substantially equivalent to the predicate device. Thus, the comparison of the Ventoux to its predicate device does not raise new safety and effectiveness concerns.

Intended Use:

The Ventoux is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the Ventoux is applicable for adult and pediatric (i.e., infant, child and adolescent) patients who weigh at least 5 kg (11 lbs). The Ventoux is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is suitable for use in hospital environments.

Performance Data:

The Ventoux Ventilator meets all applicable device specification requirements for performance testing as identified in the FDA reviewer guidance for ventilators. Verification of compliance with recognized standards has been made to support safe use of the device for its intended use and in its intended environment.

A series of tests and analyses were performed to evaluate the safety and effective performance of the Ventoux Ventilator. Presented below is a list of standards the Ventoux Ventilator complies with and tests that have been successfully performed.

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· IEC 60601-1: (ed. 3.1, 2012) Medical Electrical Equipment -Part 1: General Requirements for Basic Safety and Essential Performance
· IEC 60601-1-2: (ed. 4, 2015) Medical Electrical Equipment -Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-2: (4.1 ed. 2020) EMC Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
ISO 80601-2-12 :(ed. 1, 2011) Medical Electrical Equipment -- Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators
· IEC 60601-1-8: (ed. 2.1, 2012) Medical Electrical Equipment -Part 1-8: General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical System
· ISO 80601-2-55: 2018 Medical electrical equipment -- Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors -anesthetic gas monitoring, carbon dioxide monitoring, and oxygen monitoring.
· ISO 80601-2-61: 2018 Medical electrical equipment -- Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment
· ISO 80601-2-84:2018 Medical electrical equipment Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
IEC 60601-1-6 : 2020 General requirements for basic ● safety and essential performance - Collateral standard : Usability
IEC 62304 : 2015 Edition 1.1 SW Life Cycle .
CISPR 11: 2016 (- Limits and Methods of Measurement of ● Radio Disturbance Characteristics of Industrial, Scientific, and Medical (I.S.M) Radio Frequency Equipment – covered under IEC 60601-1-2 (4.1 ed. 2020) above.
Environmental: . IEC 60529 Degrees of Protection Provided by Enclosures (IP 34 Code) – covered under IEC 60601-1: (ed. 3.1, 2012) above.
- o IEC 60068-2-27 (ed. 4, 2008) Environmental Testing Part 2-27: Tests -

Test Ea and Guidance: Shock

IEC 60068-2-31 (ed. 2, 2008) Environmental Testing o

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Part 2-31: Tests - Test Ec: Rough Handling Shocks, Primarily for Equipment-Type Specimens

IEC 60068-2-64 (ed. 2, 2008) Environmental Testing o Part 2-64: Tests - Test Fh: Vibration, Broadband Random and Guidance – Covered under ISO 80601-2-84:2018
Altitude Validation ●
Internal Temperature Validation ●
Verification and Validation of Li-Ion Battery .
Measurement of Expiratory Volume ●

The software design and validation process, together with the bench testing of the device, demonstrated Ventoux Ventilator performs as intended. Additional testing were conducted to assure that the Ventoux ventilator meets its predefined specifications in accordance with internal procedures as mandated by the quality Management system.

The ventilation modes were subjected to waveform performance testing. The data provided from these tests was shown to support substantial equivalency to the legally marketed devices

Biocompatibility:

The gas pathways of the Ventoux were assessed and tested in accordance with ISO 18562:2024, parts 1,2&3.

Summary of clinical testing:

No clinical testing was conducted or required in support of this premarket notification.

Conclusion:

Substantial equivalence has shown similar technological characteristics, intended use, principles of operation and verification and validation. The proposed device has software and hardware to maintain the intended performance. No new questions of safety and effectiveness have been raised. The Ventoux ventilator is as substantially equivalent as the legally marketed devices identified in this submission. Flight Medical Innovations Ltd. believes that, based on the information provided in this submission, the Ventoux Ventilator is substantially equivalent to its predicate devices.

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).