(439 days)
No
The document describes a microprocessor-controlled ventilator with standard ventilation modes and a comprehensive alarm system. There is no mention of AI, ML, or any features that would suggest the use of such technologies for decision-making, control, or analysis.
Yes
The device is a ventilator, which provides mechanical ventilation support to patients who require it, directly intervening to support a physiological function.
No.
The device is a ventilator used to provide mechanical ventilation, which is a treatment, not a diagnostic procedure.
No
The device description explicitly details hardware components such as a compressor, exhalation valve, electrical boards (Main, Power, Communication), and internal batteries, indicating it is a physical medical device with integrated software, not a software-only device.
Based on the provided information, the FLIGHT 60 Ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous or intermittent mechanical ventilation support for the care of individuals who require mechanical ventilation." This is a life support function performed directly on a patient, not a test performed on a sample taken from the body.
- Device Description: The description details a mechanical ventilator with components like a compressor, exhalation valve, and alarm system. These are all related to delivering air and controlling breathing, not analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening based on sample analysis
The FLIGHT 60 Ventilator is a medical device used for life support and treatment, not for in vitro diagnostic testing.
N/A
Intended Use / 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.
Product codes
CBK, NOU
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 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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult and pediatric (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 lbs).
Intended User / Care Setting
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.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation activities were conducted to establish the performance characteristics of the FLIGHT 60 Ventilator. All testing demonstrated that the FLIGHT 60 Ventilator met required design verification criteria and has acceptable performance when used in accordance with its labeling. The device's intended use, operating principles, ventilation modes and performance parameters are comparable to the referenced predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 ●
1
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
2
| | Equivalence Table:
Trilogy100 Ventilator | Vela Ventilator | FLIGHT 60 Ventilator | FLIGHT 60-O₂ (100)
Ventilator |
|----------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | | |
| | Respironics Inc.
K083526
CBK | Bird Products Corp
K032451
CBK | Flight Medical Innovations Ltd
K120726
CBK, NOU | Flight Medical Innovations Ltd
K130171
CBK, NOU |
| | The Respironics Trilogy 100
system provides continuous
or intermittent ventilatory
support for the care of
individuals who require
mechanical ventilation.
Trilogy 100 is intended for
pediatric through adult
patients weighing at least 5
kg (11 lbs.).
The device is intended to be
used in home,
institution/hospital, and
portable applications such as
wheelchairs and gurneys,
and may be used for both
invasive and non-invasive
ventilation. It is not intended
to be used as a transport
ventilator. | The TBird VELA Ventilator is intended
to provide continuous or intermittent
mechanical ventilatory support for the
care of individuals who require
mechanical ventilation. The ventilator
is a restricted medical device intended
for use by qualified, trained personnel
under the direction of a physician.
Specifically, the ventilator is applicable
for adult and pediatric patients
weighing at least 10 kg (22 lbs.), who
require the following general types of
ventilatory support, as prescribed by
an attending physician:
• Positive pressure ventilation
• Assist/Control, SIMV, CPAP modes of
ventilation
The ventilator is suitable for use in
institutional and transport settings. It
is not intended for use as an emergency
medical transport ventilator. | 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. | 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. |
| Features | | | | |
| | | Yes | | Yes |
| | | Yes | | Yes |
| | | Yes | | Yes |
| | Yes | | | Yes |
| | Yes | | | Yes |
| | | | | |
·
:
Equivalence Table:
.
3
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 for
safety and essential performance |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| IEC 60601-1-2:2007 | Medical electrical equipment General requirements for basic safety
essential performance. Collateral standard. Electromagnetic
compatibility. Requirements and tests |
| IEC 60601-1-8:2006 | Medical electrical equipment -- Part 1-8: General requirements
safety and essential performance -- Collateral standard: General
requirements, tests and guidance for alarm systems in medical
equipment and medical electrical systems |
| IEC 60601-2-12:2001 | Medical electrical equipment -- Part 2-12: Particular requirement
the safety of lung ventilators -- Critical care ventilators |
| ASTM F 1246-91 | Standard Specification for Electrically Powered Home Care Ventilators
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.
4
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.
5
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
6
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