FLIGHT 60 VENTILATOR

K120726 · Flight Medical Innovations , Ltd. · CBK · Jul 6, 2012 · Anesthesiology

Device Facts

• Record ID: K120726
• Device Name: FLIGHT 60 VENTILATOR
• Applicant: Flight Medical Innovations , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Jul 6, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

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 Story

FLIGHT 60 is an electrically powered, microprocessor-controlled ventilator providing A/CMV, SIMV, Pressure Support, and SPONT ventilation modes. Device uses internal electrically controlled compressor for gas delivery; eliminates need for external air source. Features include pressure/time triggering; volume/pressure limiting; time/pressure/flow cycling; and emergency intake valve for ambient air during gas pressure loss. Powered by AC/DC or internal Li-Ion batteries (up to 12 hours). System architecture includes main, power, and communication boards. Exhalation valve uses proportional solenoid for PEEP. Integrated alarm system provides audible, visual, and LED alerts for safety limit violations. Used in hospital, sub-acute, ER, home, and transport settings by trained clinicians. Output allows monitoring of ventilation parameters; assists in managing respiratory support for patients ≥5kg.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with FDA reviewer guidance for ventilators. Verification of compliance with recognized standards performed to support safety and effectiveness.

Technological Characteristics

Electrically powered, microprocessor-controlled. Internal compressor (pump) for gas source. Proportional solenoid-controlled exhalation valve for PEEP. Li-Ion battery power. Three-board architecture: Main (CPU/Display), Power, and Communication. Connectivity includes external power and communication connectors. Software-controlled ventilation modes (A/CMV, SIMV, Pressure Support, SPONT).

Indications for Use

Indicated for adult and pediatric patients (infant, child, adolescent) weighing ≥5kg (11 lbs) requiring continuous or intermittent mechanical ventilation support. Restricted to prescription use by qualified, trained personnel under physician direction.

Regulatory Classification

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.

Predicate Devices

• Flight 60 Ventilator (K111683)
• Vela Ventilator (K032451)
• Trilogy 100 Ventilator (K083526)

Submission Summary (Full Text)

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# 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: [phone] Fax:[phone] Company Contact:

Yanir Shaked, RAQA Manager [e-mail]

#### Contact Person:

Shoshana (Shosh) Friedman, RAC Address: 1914 J N Pease Pl., Charlotte, NC 28262 Telephone: [phone] or 704-899-0092 704-899-0098 Fax: E-mail: [e-mail]

## 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.

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### 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.

### Intended Use:

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..

### 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.

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## 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

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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 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 [phone] or [phone] 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

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# INDICATIONS FOR USE STATEMENT

### 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

#### Device Name:

FLIGHT60® Ventilator

# Indications for Use:

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.

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