FLIGHT 60 VENTILATOR

K130171 · Flight Medical Innovations , Ltd. · CBK · Apr 8, 2014 · Anesthesiology

Device Facts

• Record ID: K130171
• Device Name: FLIGHT 60 VENTILATOR
• Applicant: Flight Medical Innovations , Ltd.
• Product Code: CBK · Anesthesiology
• Decision Date: Apr 8, 2014
• 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

Electrically powered, microprocessor-controlled ventilator providing continuous/intermittent mechanical ventilation. Supports ACMV (Volume, Pressure, PRVC), SIMV (Volume, Pressure, PRVC), PSV/SPONT (with Volume Guarantee), and Bi-Level (APRV) modes. Inputs include patient respiratory effort (pressure, flow, or time-triggered). Internal compressor provides gas source; exhalation valve with proportional solenoid provides PEEP. Powered by AC/DC or internal Li-Ion batteries (up to 12 hours). Features comprehensive alarm system (audible, visual, LED) for safety limit violations. Operated by qualified personnel in clinical, home, and transport environments. Output data informs clinicians of ventilation status and safety limit adherence, facilitating respiratory support and patient stabilization.

Clinical Evidence

Bench testing only. Verification and validation activities confirmed the device meets design specifications and performance requirements per FDA guidance for ventilators. Compliance with recognized standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 60601-2-12, and ASTM F 1246-91) was demonstrated.

Technological Characteristics

Electrically powered, microprocessor-controlled ventilator. Features internal compressor, proportional solenoid exhalation valve, and Li-Ion battery power. Connectivity includes internal/external communication boards. Standards: IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-8 (alarms), IEC 60601-2-12 (ventilators), ASTM F 1246-91 (home care ventilators).

Indications for Use

Indicated for adult and pediatric (infant, child, adolescent) patients ≥ 5kg (11 lbs) requiring continuous or intermittent mechanical ventilation. Restricted to use by qualified, trained personnel under physician direction in hospital, sub-acute, emergency room, home care, transport, and emergency response settings.

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 (K120726)
• Vela Ventilator (K032451)

Reference Devices

• 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 K130171

### Date Prepared (revised):

April 7, 2014

## 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 Persons:

Shoshana (Shosh) Friedman, RAC; and Bosmat Friedman 1914 J N Pease Pl., Charlotte, NC 28262 Address: Telephone: [phone] or 704-899-0092 704-899-0098 Fax: [e-mail] 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 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:<br>Trilogy100 Ventilator | Vela Ventilator | FLIGHT 60 Ventilator | FLIGHT 60-O₂ (100)<br>Ventilator |
|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| | Respironics Inc.<br>K083526<br>CBK | Bird Products Corp<br>K032451<br>CBK | Flight Medical Innovations Ltd<br>K120726<br>CBK, NOU | Flight Medical Innovations Ltd<br>K130171<br>CBK, NOU |
| | The Respironics Trilogy 100<br>system provides continuous<br>or intermittent ventilatory<br>support for the care of<br>individuals who require<br>mechanical ventilation.<br>Trilogy 100 is intended for<br>pediatric through adult<br>patients weighing at least 5<br>kg (11 lbs.).<br>The device is intended to be<br>used in home,<br>institution/hospital, and<br>portable applications such as<br>wheelchairs and gurneys,<br>and may be used for both<br>invasive and non-invasive<br>ventilation. It is not intended<br>to be used as a transport<br>ventilator. | The TBird VELA Ventilator is intended<br>to provide continuous or intermittent<br>mechanical ventilatory support for the<br>care of individuals who require<br>mechanical ventilation. The ventilator<br>is a restricted medical device intended<br>for use by qualified, trained personnel<br>under the direction of a physician.<br>Specifically, the ventilator is applicable<br>for adult and pediatric patients<br>weighing at least 10 kg (22 lbs.), who<br>require the following general types of<br>ventilatory support, as prescribed by<br>an attending physician:<br>• Positive pressure ventilation<br>• Assist/Control, SIMV, CPAP modes of<br>ventilation<br>The ventilator is suitable for use in<br>institutional and transport settings. It<br>is not intended for use as an emergency<br>medical transport ventilator. | The FLIGHT 60 Ventilator is<br>intended to provide continuous<br>or intermittent mechanical<br>ventilation support for the care<br>of individuals who require<br>mechanical ventilation.<br>Specifically, the FLIGHT 60 is<br>applicable for adult and pediatric<br>(i.e., infant, child and adolescent)<br>patients, greater than or equal to<br>5kg (11 lbs).<br>The FLIGHT 60 Ventilator is a<br>restricted medical device<br>intended for use by qualified,<br>trained personnel under the<br>direction of a physician; it is<br>suitable for use in hospital, sub-<br>acute, emergency room, and<br>home care environments, as well<br>as for transport and emergency<br>response applications. | The FLIGHT 60 Ventilator is<br>intended to provide<br>continuous or intermittent<br>mechanical ventilation<br>support for the care of<br>individuals who require<br>mechanical ventilation.<br>Specifically, the FLIGHT 60 is<br>applicable for adult and<br>pediatric (i.e., infant, child and<br>adolescent) patients, greater<br>than or equal to 5kg (11 lbs).<br>The FLIGHT 60 Ventilator is a<br>restricted medical device<br>intended for use by qualified,<br>trained personnel under the<br>direction of a physician; it is<br>suitable for use in hospital,<br>sub-acute, emergency room,<br>and home care environments,<br>as well as for transport and<br>emergency response<br>applications. |
| 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<br>+A1:1991+A2:1995 | Medical electrical equipment - Part 1: General requirements for<br>safety and essential performance |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2007 | Medical electrical equipment General requirements for basic safety<br>essential performance. Collateral standard. Electromagnetic<br>compatibility. Requirements and tests |
| IEC 60601-1-8:2006 | Medical electrical equipment -- Part 1-8: General requirements<br>safety and essential performance -- Collateral standard: General<br>requirements, tests and guidance for alarm systems in medical<br>equipment and medical electrical systems |
| IEC 60601-2-12:2001 | Medical electrical equipment -- Part 2-12: Particular requirement<br>the safety of lung ventilators -- Critical care ventilators |
| ASTM F 1246-91 | Standard Specification for Electrically Powered Home Care Ventilators<br>Part 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 [phone] or [phone] 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 [phone] or [phone] 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:

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)

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

FLIGHT 60 Ventilator - Page 4-2