The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is sutable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

Device Description

The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: A/CMV Volume or Pressure Control, SIMV Volume or Pressure Control, Pressure Support & SPONT mode with Pressure Support. It can be pressure or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows the patient to pull ambient air into the breathing circuit in the event of a complete loss of supply gas pressure. The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 15 VDC) or by its two internal Li Ion rechargeable batteries. 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 text is a 510(k) summary for the FLIGHT 60 Ventilator, focusing on a modification to its compressor. Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the performance data in narrative form rather than a direct table of acceptance criteria vs. performance. However, it indicates that the device "met the predetermined acceptance criteria" for all tests.

Acceptance Criteria Category	Reported Device Performance and Methodologies
General Safety and Performance	The device was designed and tested in accordance with applicable requirements in relevant FDA guidance documents and international standards, including: - IEC 60601-1: General Requirements for Basic Safety and Essential Performance (2005), including US national deviations. - ISO 80601-2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators (2011). - IEC 60601-1-2: Electromagnetic Compatibility - Requirements and Tests (2007). - EMC Specifics: ESD contact discharge (8 kV), air discharge (15 kV), radiated immunity (30 V/m), magnetic field immunity (30 A/m).
Environmental Performance	Flight 60 was subjected to environmental tests.
Volatile Organic Compounds (VOC)	Tested by EPA test TO-15.
Particulate Matter (PM 2.5)	Tested by EPA's PM 2.5.
Waveform Performance (Non-Clinical)	Side-by-side waveform performance test comparing Flight 60 (revised) to Trilogy 100 (K083526) and Flight 60 (K130171). Characteristics tested included flow, pressure, and volume waveforms, ventilation control parameter accuracy, and patient trigger reliability and synchrony.
Overall Compliance	"All tests confirmed the product met the predetermined acceptance criteria." "The comparison of the recorded waveforms supports the claim that FLIGHT 60 is substantially equivalent to the predicate devices."

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

The document does not specify a "sample size" in terms of number of patients or clinical cases for a test set. The testing described is primarily non-clinical performance testing of a medical device (ventilator). The "test set" consists of the physical device undergoing various engineering and performance evaluations.

Sample Size: Not applicable in the context of clinical patient data. The "sample" is presumably one or more units of the revised FLIGHT 60 Ventilator.
Data Provenance: The data provenance is from laboratory and engineering testing conducted by the manufacturer, Flight Medical Innovations Ltd., as part of the design and verification activities. The country origin is not explicitly stated for the testing itself, but the manufacturer is based in Israel (Petach Tikva). The submission is to the US FDA. This is retrospective in the sense that the testing has already been completed for the submission.

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

This section is not applicable as the described testing is non-clinical performance and engineering validation. "Ground truth" in this context refers to established engineering specifications, performance standards (e.g., IEC, ISO), and comparisons to predicate device measurements, not expert clinical diagnoses. Therefore, there were no clinical experts establishing "ground truth" for the test set.

4. Adjudication Method for the Test Set

The concept of an "adjudication method" (like 2+1 or 3+1) is typically relevant for clinical studies where expert consensus is needed to establish ground truth from ambiguous cases (e.g., in medical imaging interpretation). Since the described testing is non-clinical performance validation, an adjudication method was not used. The performance was directly measured against predetermined engineering specifications and international standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes non-clinical performance testing for a ventilator, not a study involving human readers interpreting cases.

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

This concept is typically applied to AI/ML devices. The FLIGHT 60 Ventilator is a hardware-based medical device with microprocessor control, not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The performance described is the standalone performance of the mechanical ventilator itself, which inherently involves its internal software/firmware control without a "human-in-the-loop" in the sense of an assist/no-assist comparison.

7. The Type of Ground Truth Used

The "ground truth" used for this device validation is based on:

Established engineering specifications: Predefined performance parameters for the ventilator.
International standards: Compliance with standards like IEC 60601-1, ISO 80601-2-12, and IEC 60601-1-2.
Predicate device performance: Comparative measurements against the predicate FLIGHT 60 (K130171) and Trilogy 100 (K083526) to demonstrate substantial equivalence, particularly for waveform characteristics.

8. The Sample Size for the Training Set

Not applicable. The FLIGHT 60 Ventilator is a hardware medical device with embedded software, not a machine learning model that requires a "training set."

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

Not applicable. As a hardware medical device, there is no "training set" or corresponding ground truth establishment process in the context of machine learning.

Summary

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

March 30, 2016

Flight Medical Innovations Ltd. % Bosmat Friedman Regulatory Affairs Consultant MJ RAC 1208-12 Rockford Rd, Toronto. ON M2R 3A2 Canada

Re: K143035 Trade/Device Name: Flight 60® Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK. NOU Dated: March 1, 2016 Received: March 2, 2016

Dear Ms. Friedman,

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.

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportaProblem/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Tejashri Purohit-Sheth, M.D.

Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR

Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K143035

Device Name FLIGHT60® Ventilator

Indications for Use (Describe)

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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510(K) SUMMARY [as required by section 807.92(c)] FLIGHT 60 Ventilator

510(k) Number K143035

1. SUBMITTER

Applicant's Name:

Flight Medical Innovations Ltd. 7 Hatnufa Street Petach Tikva 4951025 Tel: (972) 3-6731660 Fax: (972) 3-6731690

Company Contact:

Yael Spielmann, RA & QA Manager yaels@flight-medical.com

Contact Person:

Bosmat Friedman Regulatory Affairs Consultant, MJ RAC 1208-12 Rockford Rd. Toronto, ON, M2R 3A2, Canada Phone: 647-975-3974; Fax: 647-427-1946; bosmat@pushmed.com

Date Prepared:

March 23, 2016

2. DEVICE

Trade Name: FLIGHT 60 Ventilator

Classification Name: Continuous Ventilator

Classification:

Name: Continuous ventilator Product Code: CBK Regulation No: 868.5895 Class: 2

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Classification Panel: Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID) Respiratory Devices Branch (RPDB)

and

Name: Continuous, Ventilator, Home Use Product Code: NOU Regulation No: 868.5895 Class: 2 Classification Panel: Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID) Respiratory Devices Branch (RPDB)

3. PREDICATE DEVICES

Main Predicate:

Flight 60 Ventilator K130171 ●

Secondary Predicates:

Trilogy 100 K083526 ●

4. DEVICE DESCRIPTION

Flight 60 Ventilator Traditional 510(k)

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

The purpose of this 510(k) is to allow for the addition of a blower type compressor instead of the piston type compressor.

INDICATIONS FOR USE ನ.

The FLIGHT 60 Ventilator is intended to provide continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs). The FLIGHT 60 Ventilator 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, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The suggested modification to the Flight 60 has been tested and validated. No new issues of safety or effectiveness have been identified as a result of this change. A comparison of FLIGHT 60's technological characteristics with the predicate devices is presented in the table below:

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DEVICENAMESUBJECT	FLIGHT 60 (REVISED)	FLIGHT 60	TRILOGY 100
MANUFACTURER	Flight Medical Innovations Ltd.	Flight Medical Innovations Ltd.	Respironics Inc.
510(K) NUMBER		K130171	K083526
PRODUCT CODE	CBK, NOU	CBK, NOU	CBK
INTENDED USE	The FLIGHT 60 Ventilator isintended to provide continuous orintermittent mechanical ventilationsupport for the care of individualswho require mechanical ventilation.Specifically, the FLIGHT 60 isapplicable for adult and pediatric(i.e., infant, child and adolescent)patients, greater than or equal to5kg (11 lbs).	The FLIGHT 60 Ventilator isintended to provide continuous orintermittent mechanicalventilation support for the care ofindividuals who requiremechanical ventilation. Specifically,the FLIGHT 60 is applicable foradult and pediatric (i.e., infant,child and adolescent) patients,greater than or equal to 5kg (11lbs).	The Philips Respironics Trilogy100 system provides continuousor intermittent ventilatorysupport for the care of individualswho require mechanicalventilation. Trilogy 100 isintended for pediatric throughadult patients weighing at least 5kg (11 lbs).
PHYSICALDIMENSIONS	11.641 x 11.457 x 9.803(295mm x 291 mm x 249 mm)	11.641 x 11.457 x 9.803(295mm x 291 mm x 249 mm)	16.68cm x 28.45cm x 23.52cm
USER INTERFACE	Touch screen with alpha numericdata	Touch screen with alpha numericdata	Control buttons, display screen
CONTROL BUTTONS	Touch screen function & buttons	Touch screen function & buttons	Buttons control panel
MECHANICALSYSTEM	Blower type compressor	Piston type compressor	Blower type compressor
POWER SUPPLY AC	100-240V50-60Hz	100-240V50-60Hz	100-240V50-60Hz
EXTERNAL DC	12-30 V	12-30 V	12/14.4 V
INTERNAL BATTERY	Li- ion battery, 12V 5.2Ah	Li- ion battery, 12V 5.2Ah	Li- ion battery, 14.4V 4176mAh
BACK-UP BATTERY	Li-ion, 14.8V 2.6Ah	Li-ion, 14.8V 2.6Ah	Li- ion battery, 14.4V 4176mAh

AVAILABLE MODES	Volume/pressure/PRVC controlACMVVolume/pressure/PRVC controlSIMV + pressure supportSPONT + pressure supportBilevel, MVG, VtG	Volume/pressure/PRVC controlACMVVolume/pressure/PRVC controlSIMV + pressure supportSPONT + pressure supportBilevel, MVG, VtG	Volume/pressure control ACMV,Volume/pressure control SIMV +pressure supportCPAP (bilevel)Bilevel, ST AVAPS, AVAPS
MANDATORYBREATH CONTROLS	Volume/pressure controlFlow/Pressure/time trigger	Volume/pressure controlFlow/Pressure/time trigger	Volume/pressure controlFlow trigger
SPONTANEOUSBREATH SUPPORT	Pressure supportCycle variables: flow or time	Pressure supportCycle variables: flow or time	Pressure supportCycle variables: flow
BASIC PRESSURECONTROL	Pressure targeted waveform	Pressure targeted waveform	Pressure targeted waveform
BASIC FLOWCONTROL	Descending/Square flow waveform	Descending/Square flow waveform	Ramp (=Descending )/SquareFlow Pattern
ALARMS	AC Disconnection, Low Battery,Empty Battery, PatientDisconnection	AC Disconnection, Low Battery,Empty Battery, PatientDisconnection	AC Power Disconnect, LowBattery, Battery Depleted, CircuitDisconnect
Non-invasivepositivepressureventilation(NPPV)	Yes	Yes	Yes
Reusableexhalation valve	Yes	Yes	Yes

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As can be seen in the table above, the Revised Flight 60 has the same technological characteristics as the predicate Flight 60, with the exception of its compressor The same as Trilogy 100's compressor. Altogether, the technological characteristics of the Revised Flight 60 are substantially equivalent to the predicate Flight 60 or the Trilogy 100 (compressor type only). Thus, the comparison of the Revised Flight 60 to its predicate devices do not raise new safety and effectiveness concerns.

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7. PERFORMANCE DATA

Design and verification activities were performed on the FLIGHT 60 as a result of the risk analysis and product requirements. 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. Specifically, FLIGHT 60 was designed and tested in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:

FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
. IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (2005), including US national deviations
. ISO 80601-2-12: Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators (2011); and
. IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: Electromagnetic Compatibility - Requirements and Tests (2007):
- o ESD contact discharge and air discharge test levels were replaced by 8 kV and 15 kV, respectively.
- Radiated immunity test level was 30 V/m. o
- Magnetic field immunity test level was 30 A/m o

Flight 60 was subjected to environmental tests and was tested for Volatile Organic Compounds (VOC) by EPA test TO-15 and for particles by EPA's PM 2.5. All tests confirmed the product met the predetermined acceptance criteria. Testing also included non-clinical side-by-side waveform performance test, in which the waveform characteristics of Flight 60 were compared to those of Trilogy 100 (K083526) and to Flight 60 (K130171). Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy and patient trigger reliability and synchrony. The comparison of the recorded waveforms supports the claim that FLIGHT 60 is substantially equivalent to the predicate devices.

8. CONCLUSION

Flight Medical Innovations Ltd. believes that, based on the information provided in this submission, the FLIGHT 60 Ventilator is substantially equivalent to its predicate device without raising any new safety and effectiveness concerns.

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).