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: 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, 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 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.

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 provided text regarding the FLIGHT 60 Ventilator, focusing on acceptance criteria and supporting studies.

Important Note: The provided document is a 510(k) summary for a medical device (a ventilator). Unlike AI/ML-driven devices, traditional medical devices like ventilators do not typically have "acceptance criteria" in the same way an AI algorithm has performance metrics (e.g., sensitivity, specificity, AUC). Instead, they meet performance specifications and recognized standards to ensure safety and effectiveness. The "study" here refers to the verification and validation (V&V) testing.

Therefore, many of the requested categories (sample size for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable in the context of a ventilator's regulatory submission. This information is primarily relevant for AI/ML devices that make diagnostic or prognostic predictions.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Performance Specifications/Standards)	Reported Device Performance
Applicable Device Specification Requirements for Performance Testing (as identified in FDA reviewer guidance for ventilators)	Met all applicable device specification requirements.
Compliance with Recognized Standards for safe use of the device in its intended environment.	Verification of compliance with recognized standards has been made.
Substantial Equivalence to Predicate Devices (Flight 60, K111683; Vela, K032451; Trilogy 100, K083526) without raising new safety or effectiveness concerns.	Demonstrated substantial equivalence without raising any new safety and/or effectiveness concerns.

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

This information is not applicable as this is a physical medical device (ventilator), not a diagnostic algorithm. The "test set" for a ventilator would involve rigorous engineering and safety testing under various simulated and real-world conditions, rather than a dataset of patient information. The document refers to "performance testing" and "verification of compliance," which implies testing of the physical device's functionality and adherence to safety standards.

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

This information is not applicable. The "ground truth" for a ventilator's performance is objective physical measurements and safety standards (e.g., gas flow rates, pressure delivery, alarm functionality, battery life, power consumption). This does not involve expert consensus on medical images or diagnoses. Experts (e.g., engineers, clinicians) would be involved in designing the specifications and evaluating test results, but not in establishing a "ground truth" that is then compared against an algorithm's output.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations, typically for establishing ground truth in diagnostic studies. For a ventilator, performance is objectively measured against specifications and standards, not subject to subjective adjudication in this way.

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

This information is not applicable. MRMC studies are designed to assess the impact of an AI system on human reader performance, usually in image interpretation. This ventilator is a life-support device, not a diagnostic imaging aid. The "comparison" mentioned in the document is between the new FLIGHT 60 and its predicate devices to demonstrate substantial equivalence, not an assessment of human reader performance with or without AI assistance.

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

This information is not applicable. The FLIGHT 60 is a ventilator, a standalone medical device that performs a mechanical function. It's not an algorithm that makes diagnostic predictions. Its performance is its own operation, and it's designed to be used with human oversight, but not as an "AI-only" component.

7. The Type of Ground Truth Used

The "ground truth" for a ventilator's performance is typically defined by:

Engineering specifications: Precise measurements of gas delivery, pressure, oxygen concentration, flow rates, alarm thresholds, battery duration, power consumption, etc.
Recognized national and international standards: Adherence to standards like ISO 80601-2-12 for critical care ventilators, or specific electrical safety standards.
Biocompatibility testing: Ensuring materials are safe for patient contact.
Electromagnetic compatibility (EMC) testing: Ensuring it doesn't interfere with or get interfered by other devices.
Environmental testing: Performance under varying temperatures, humidity, and vibration.

It is not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The Sample Size for the Training Set

This information is not applicable. Ventilators do not have "training sets" in the context of machine learning. Their functionality is programmed and engineered, not "learned" from data.

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

This information is not applicable. As there is no "training set" for a ventilator in the AI/ML sense, there's no ground truth to establish for it. The ventilator's operational parameters are based on scientific and medical principles, engineering design, and regulatory standards.

Summary

{0}------------------------------------------------

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

510(k) Number K_120726

6 2012 JUL

Date Prepared:

March 7, 2012

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 Person:

Shoshana (Shosh) Friedman, RAC Address: 1914 J N Pease Pl., Charlotte, NC 28262 Telephone: 704-430-8695 or 704-899-0092 704-899-0098 Fax: E-mail: shosh@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 K111683, manufactured by Flight Medical Innovations Ltd
Vela Ventilator, cleared under K032451, manufactured by Bird Products . Corp .
Trilogy 100 Ventilator, cleared under K083526, manufactured . by Respironics Inc.

{1}------------------------------------------------

Device Description:

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.

Intended Use:

Performance Data

The FLIGHT 60 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. Additionally, comparison between the performance of the revised Flight 60 Ventilator (subject of this submission) with its predicate devices demonstrated that the FLIGHT 60 Ventilator is substantially equivalent to it predicate devices without raising any new safety and/or effectiveness concerns.

{2}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Flight Medical Innovations, Limited C/O Ms. Shoshana Friedman President & CEO Push-Med LLC 1914 J.N. Pease Place Charlotte, North Carolina 28262

Re: K120726

Trade/Device Name: FLIGHT60® Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK, NOU Dated: June 11, 2012 Received: June 12, 2012

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 Eederal Register.

6 2012 JUL

{3}------------------------------------------------

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 go to

http://www.fda.goy/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours.

For

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

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)

L. Shulthe

(Division Sign-Uff) Division of Anesthesiology, General Hospital nfection Control, Dental Devices

*10(k) Number: k/20726

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).