FLIGHT 60 VENTILATOR, MODEL F-60

K100753 · Flight Medical , Ltd. · CBK · Aug 20, 2010 · Anesthesiology

Device Facts

• Record ID: K100753
• Device Name: FLIGHT 60 VENTILATOR, MODEL F-60
• Applicant: Flight Medical , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Aug 20, 2010
• 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 10kg (22 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

Electrically powered, microprocessor-controlled ventilator; provides A/CMV, SIMV, Pressure Support, and SPONT ventilation modes. Inputs: pressure/time triggers; volume/pressure/flow cycling. Internal compressor provides gas source; proportional solenoid controls exhalation valve for PEEP. Powered by AC/DC or internal Li-Ion batteries (up to 12 hours). Emergency intake valve allows ambient air if gas pressure fails. Used in hospital, sub-acute, ER, home, and transport settings by trained clinicians. Features comprehensive alarm system (audible, visual, LED) for safety limit violations. Output: mechanical ventilation support; alarm notifications. Benefits: provides life-sustaining respiratory support in diverse clinical and transport environments.

Clinical Evidence

Bench testing only. The device met all applicable performance specifications identified in FDA reviewer guidance for ventilators. Compliance with recognized standards was verified to support safe use in intended environments.

Technological Characteristics

Electrically powered, microprocessor-controlled. Internal compressor (pump) for gas source. Proportional solenoid for PEEP control. Power: 100-240 VAC, 12-15 VDC, or internal Li-Ion batteries. Three-board architecture: Main (CPU/display), Power, and Communication. Alarm system: audible, screen display, LED. Dimensions/form factor: portable ventilator.

Indications for Use

Indicated for adult and pediatric patients (infant, child, adolescent) weighing ≥10kg (22 lbs) requiring continuous or intermittent mechanical ventilation support. Restricted to 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

• Newport HT50 Ventilator (K992133)
• Newport HT50 Ventilator (K082724)

Submission Summary (Full Text)

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# K100753

AUG 2 0 2010

# 510(K) SUMMARY {as required by section 807.92(c}] FLIGHT 60 Ventilator

#### 510(k) Number K_

#### Applicant's Name:

Flight Medical Innovations Ltd. 13 Hamelacha Street North Industrial Park Lod 71520, Israel Tel: [phone] Fax:[phone] Company Contact:

Aline Peled, RAQA Manager [e-mail]

#### Contact Person: .

Shoshana (Shosh) Friedman, RAC Address: Telephone: [phone] or 704-899-0092 704-899-0098 Fax: [e-mail] E-mail:

#### Trade Name:

FLIGHT 60 Ventilator

#### Classification Name:

Continuous Ventilator

#### Classification:

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

#### Predicate Devices:

Newport HT50 Ventilator cleared under K992133 and K082724

#### 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

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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 10kg (22 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.

#### 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 devices without raising any new safety and/or effectiveness concerns.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, with the top profile being the largest and the bottom profile being the smallest.

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

Flight Medical Limited C/O Ms. Shoshana Friedman Push-Med LLC 1914 JN Pease Place Charlotte, North Carolina 28262

Re: K100753

Trade/Device Name: FLIGHT 60 VENTILATOR, MODEL F-60 Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK,NOU Dated: August 9, 2010 Received: August 11, 2010

AUG 2 0 2010

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 go to

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

Sincerely vours.

hn 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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# K100753

#### 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 10kg (22 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.

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510(k) Number K 100 753

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over the Counter Use_

F. Schult

(Division Sign=Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

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