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.

Device Description

The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlled ventilator with the following types of ventilatory support: ACMV Volume, Pressure or PRVC, SIMV Volume, Pressure or PRVC, PSV/SPONT mode with Pressure Support and Volume Guarantee, Bi-Level (APRV). It can be pressure, flow 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, which power the ventilator for up to 12 hours when fully charged.

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 subsystem 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 built in PEEP.

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.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information for the FLIGHT 60 Ventilator, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on establishing substantial equivalence to predicate devices and adherence to medical device standards. It does not present specific quantitative acceptance criteria alongside corresponding performance metrics in a direct table format for the FLIGHT 60 Ventilator itself. Instead, it makes a general statement about meeting "applicable device specification" and compliance with recognized standards.

However, we can infer the "acceptance criteria" through the mentioned standards and the general statement about meeting design verification criteria. The "reported device performance" is essentially the statement of compliance.

Acceptance Criteria (Inferred from Standards & General Statements)	Reported Device Performance
Compliance with IEC 60601-1:1998 (+A1:1991+A2:1995) (Medical electrical equipment - Part 1: General requirements for safety and essential performance)	Device is compliant with this standard.
Compliance with IEC 60601-1-2:2007 (Electromagnetic compatibility. Requirements and tests)	Device is compliant with this standard.
Compliance with IEC 60601-1-8:2006 (General requirements, tests and guidance for alarm systems in medical equipment and medical electrical systems)	Device is compliant with this standard.
Compliance with IEC 60601-2-12:2001 (Particular requirement for the safety of lung ventilators -- Critical care ventilators)	Device is compliant with this standard.
Compliance with ASTM F 1246-91 (Standard Specification for Electrically Powered Home Care Ventilators Part 1-Positive-Pressure Ventilators and Ventilator Circuits)	Device is compliant with this standard.
Meeting all applicable device specifications (general statement)	Device met required design verification criteria.
Acceptable performance when used in accordance with its labeling	Device has acceptable performance when used as intended.
Performance parameters comparable to referenced predicate devices	Performance parameters are comparable to predicate devices.

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

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance data. The "Performance Data" section merely states: "FLIGHT 60 Ventilator meets all applicable device specification... Verification of compliance with recognized standard has been made to support use of the device for its intended use and in its intended environment." This suggests testing was conducted, but the specifics of the test set are not detailed.

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

The document does not mention the use of experts to establish ground truth for a test set. This type of evaluation is common for diagnostic/AI devices, but for a ventilator, performance is typically assessed against engineering specifications and international standards, often through bench testing and simulated use, rather than requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Since the document does not describe a study involving a "test set" in the context of expert review or clinical outcomes requiring adjudication, there is no mention of an adjudication method.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, the document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. This type of study is more relevant for diagnostic imaging devices where human readers interpret medical images, and the performance of AI-assisted reading is compared to unassisted reading. The FLIGHT 60 Ventilator is a treatment device, not a diagnostic one in that context.

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

The concept of "standalone performance" typically applies to AI algorithms that provide a diagnostic or predictive output without human intervention. The FLIGHT 60 Ventilator is a physical medical device. Its "performance" is inherently standalone in that it functions independently according to its design and specifications. There's no AI algorithm in the sense of a diagnostic one being evaluated for standalone performance here. The document states it is "microprocessor controlled" but doesn't imply an AI component requiring this type of assessment.

7. The Type of Ground Truth Used

For medical devices like ventilators, the "ground truth" for performance evaluation is typically established through:

Engineering specifications and design requirements: The device's output (e.g., delivered volume, pressure, flow) is measured and compared against its programmed settings and acceptable tolerances.
International standards conformance: Performance is assessed against the requirements of relevant ISO and IEC standards (as listed), which define acceptable ranges and behaviors for medical electrical equipment and specific device types.
Simulated physiological models: Ventilator performance can be tested using lung simulators that mimic various patient conditions.

The document explicitly states that "Verification and validation activities were conducted to establish the performance characteristics of the FLIGHT 60 Ventilator" and that "All testing demonstrated that the FLIGHT 60 Ventilator met required design verification criteria and has acceptable performance when used in accordance with its labeling." This indicates that the ground truth was based on pre-defined engineering standards and specified performance parameters.

8. The Sample Size for the Training Set

The document does not mention a "training set." This term is specific to the development and evaluation of machine learning or artificial intelligence algorithms. The FLIGHT 60 Ventilator is a microprocessor-controlled device, but the context provided does not indicate it uses a machine learning model that would require a distinct training set for its core functionality.

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

As no "training set" for a machine learning algorithm is discussed, there is no information on how its ground truth might have been established.

Summary

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

510(k) Number K130171

Date Prepared (revised):

April 7, 2014

Applicant's Name:

Flight Medical Innovations Ltd. 13 Hamelacha Street North Industrial Park Lod 71520, Israel Tel: (972) 8-9235111 Fax:(972) 8-9236111 Company Contact:

Yanir Shaked, RAQA Manager yanirs@flight-medical.com

Contact Persons:

Shoshana (Shosh) Friedman, RAC; and Bosmat Friedman 1914 J N Pease Pl., Charlotte, NC 28262 Address: Telephone: 704-430-8695 or 704-899-0092 704-899-0098 Fax: shosh@pushmed.com E-mail: bosmat@pushmed.com

Trade Name:

FLIGHT 60 Ventilator

Common & Classification Name:

Continuous Ventilator

Classification:

Class II; product code 73 CBK and NOU; regulation 21 CFR 868.5895

Classification and Review Panel:

Anesthesiology

Predicate Devices:

Flight 60 Ventilator, cleared under K120726, manufactured by Fligh . Medical Innovations Ltd
Vela Ventilator, cleared under K032451, manufactured by Bird Product ●

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Device Description:

The FLIGHT 60 Ventilator is an electrically powered, microprocessor controlle ventilator with the following types of ventilatory support: ACMV Volume Pressure or PRVC, SIMV Volume, Pressure or PRVC, PSV/SPONT mode wit Pressure Support and Volume Guarantee, Bi-Level (APRV). It can be pressur flow or time triggered; volume or pressure limited; time, pressure or flow cycled. Manual inflation is possible, and an emergency intake valve allows th patient to pull ambient air into the breathing circuit in the event of a complet loss of supply gas pressure.

The FLIGHT 60 may be powered by external power (100 - 240 VACS or 12 - 1 VDC) or by its two internal Li Ion rechargeable batteries, which power th ventilator for up to 12 hours when fully charged.

The electrical system is comprised of three primary boards: the Main boar (motherboard) which holds the majority of the electronics including the mai CPU and the display CPU, the Power board, which holds the power subsystem 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 controlle compressor (pump). This compressor provides a compressed gas source so n external air compressor is needed. Additionally, the exhalation valve activated by an electrically controlled proportional solenoid that provides built in PEEP.

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

Intended Use:

The FLIGHT 60 Ventilator is intended to provide continuous or intermitter mechanical ventilation support for the care of individuals who require mechanical ventilation. Specifically, the FLIGHT 60 is applicable for adult an pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5k (11 lbs).

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

Performance Data

FLIGHT 60 Ventilator meets all applicable device specification The requirements for performance testing as identified in the FDA reviews guidance for ventilators. Verification of compliance with recognized standard has been made to support use of the device for its intended use and in i intended environment. Additionally, comparison between the performance the revised Flight 60 Ventilator (subject of this submission) with its predica

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	Equivalence Table:Trilogy100 Ventilator	Vela Ventilator	FLIGHT 60 Ventilator	FLIGHT 60-O₂ (100)Ventilator

	Respironics Inc.K083526CBK	Bird Products CorpK032451CBK	Flight Medical Innovations LtdK120726CBK, NOU	Flight Medical Innovations LtdK130171CBK, NOU
	The Respironics Trilogy 100system provides continuousor intermittent ventilatorysupport for the care ofindividuals who requiremechanical ventilation.Trilogy 100 is intended forpediatric through adultpatients weighing at least 5kg (11 lbs.).The device is intended to beused in home,institution/hospital, andportable applications such aswheelchairs and gurneys,and may be used for bothinvasive and non-invasiveventilation. It is not intendedto be used as a transportventilator.	The TBird VELA Ventilator is intendedto provide continuous or intermittentmechanical ventilatory support for thecare of individuals who requiremechanical ventilation. The ventilatoris a restricted medical device intendedfor use by qualified, trained personnelunder the direction of a physician.Specifically, the ventilator is applicablefor adult and pediatric patientsweighing at least 10 kg (22 lbs.), whorequire the following general types ofventilatory support, as prescribed byan attending physician:• Positive pressure ventilation• Assist/Control, SIMV, CPAP modes ofventilationThe ventilator is suitable for use ininstitutional and transport settings. Itis not intended for use as an emergencymedical transport ventilator.	The FLIGHT 60 Ventilator isintended to provide continuousor intermittent mechanicalventilation support for the careof individuals who requiremechanical 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 is arestricted medical deviceintended for use by qualified,trained personnel under thedirection of a physician; it issuitable for use in hospital, sub-acute, emergency room, andhome care environments, as wellas for transport and emergencyresponse applications.	The FLIGHT 60 Ventilator isintended to providecontinuous or intermittentmechanical ventilationsupport for the care ofindividuals who requiremechanical ventilation.Specifically, the FLIGHT 60 isapplicable for adult andpediatric (i.e., infant, child andadolescent) patients, greaterthan or equal to 5kg (11 lbs).The FLIGHT 60 Ventilator is arestricted medical deviceintended for use by qualified,trained personnel under thedirection of a physician; it issuitable for use in hospital,sub-acute, emergency room,and home care environments,as well as for transport andemergency responseapplications.
Features
		Yes		Yes
		Yes		Yes
		Yes		Yes
	Yes			Yes
	Yes			Yes

Equivalence Table:

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Standards

FLIGHT 60 Ventilator has been tested and shown to be compliant with the fo standards:

IEC 60601-1:1998+A1:1991+A2:1995	Medical electrical equipment - Part 1: General requirements forsafety and essential performance
IEC 60601-1-2:2007	Medical electrical equipment General requirements for basic safetyessential performance. Collateral standard. Electromagneticcompatibility. Requirements and tests
IEC 60601-1-8:2006	Medical electrical equipment -- Part 1-8: General requirementssafety and essential performance -- Collateral standard: Generalrequirements, tests and guidance for alarm systems in medicalequipment and medical electrical systems
IEC 60601-2-12:2001	Medical electrical equipment -- Part 2-12: Particular requirementthe safety of lung ventilators -- Critical care ventilators
ASTM F 1246-91	Standard Specification for Electrically Powered Home Care VentilatorsPart 1-Positive-Pressure Ventilators and Ventilator Circuits

Conclusion

Verification and validation activities were conducted to establish the perfi characteristics of the FLIGHT 60 Ventilator. All testing demonstrated that the 60 Ventilator met required design verification criteria and has acceptable perfec when used in accordance with its labeling. The device's intended use, o principles, ventilation modes and performance parameters are comparable referenced predicate devices. Therefore, the FLIGHT 60 Ventilator is subs equivalent to the predicate devices.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Public Health Service

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

April 8, 2014

Flight Medical Innovations, Ltd C/O Ms. Soshana Friedman, President Push-Med LLC 1914 J.N. Pease Place Charlotte, NC 28262

Re: K130171

Trade/Device Name: FLIGHT 60 Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Class: II Product Code: CBK Dated: March 18, 2014 Received: March 19, 2014

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.

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Page 2 - Ms. Friedman

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/ResourcesforYou/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/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 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.

Sincerely vours.

Image /page/5/Picture/8 description: The image contains a logo or seal on the left side, which is abstract and difficult to decipher. To the right of the logo, there is text that reads "Tejashri Purohit-Sheth, M.D.," followed by "Clinical Deputy Director" and "DAGRID." The word "FOR" is located in the bottom right corner of the image.

Erin I. Keith, M.S. Acting 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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INDICATIONS FOR USE STATEMENT

510(k) Number (if known):__K130171

Device Name:

FLIGHT60® Ventilator

Indications for Use:

Prescription Use X-(Per 21 CFR 801 Subpart D) OR

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anya C. Harry -S 2014.04.08 15:03:12 -04'00'

FLIGHT 60 Ventilator - Page 4-2

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).