(138 days)
Not Found
No
The description focuses on standard ventilator technology (microprocessor control, pneumatic system, alarms) and does not mention any AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended to provide mechanical ventilation, which is a form of medical therapy for individuals requiring breathing support.
No
The device is a ventilator, which provides mechanical ventilation support. It does not mention any function for diagnosing conditions or diseases.
No
The device description explicitly details hardware components such as a compressor, exhalation valve, power boards, and internal batteries, indicating it is a physical device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 describes a device that directly supports a patient's breathing, which is a life support function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the mechanical and electrical components of a ventilator, including a compressor, exhalation valve, and control systems. These are all related to delivering air to a patient, not analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
In summary, the Flight 60 Ventilator is a therapeutic medical device used for respiratory support, not a diagnostic device used to test samples outside of the body.
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 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.
Product codes
73 CBK, NOU
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.
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 10kg (22 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
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. A usability/human factors study was conducted where users were requested to use the ventilator and perform required tasks, which demonstrated that the ventilator's user interface is simple and easy to use. Comparison between the performance of the revised Flight 60 Ventilator with its predicate devices demonstrated substantial equivalence without raising new safety and/or effectiveness concerns.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for Flight Medical. The logo consists of a symbol on the left and the words "Flight Medical" on the right. The symbol is made up of three circles connected by lines, and the word "Medical" has a small circle with a "c" inside of it in the upper right corner.
510(K) SUMMARY FLIGHT 60 Ventilator 510(k) Number K111683
Date Prepared:
October 10, 2011
Applicant's Name:
Flight Medical Innovations Ltd. 13 Hamelacha Street North Industrial Park Lod 71520, Israel Tel: (972) 8-9235111 Fax:(972) 8-9236111
Contact Person:
Shoshana (Shosh) Friedman, RAC 1914 J N Pease Pl., Charlotte, NC 28262 Address: Telephone: 704-430-8695 or 704-899-0092 Fax: 704-899-0098 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
Anesthesiology
Predicate Devices:
1
Image /page/1/Picture/0 description: The image shows the logo for Flight Medical. The logo consists of a symbol on the left and the words "Flight Medical" on the right. The symbol is made up of three circles connected by lines, and the words "Flight Medical" are written in a simple, sans-serif font. There is a trademark symbol to the right of the word "Medical".
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 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
2
Image /page/2/Picture/0 description: The image shows the logo for Flight Medical. The logo consists of a symbol on the left and the text "Flight Medical" on the right. The symbol is made up of three circles connected by lines. The text "Flight Medical" is in a simple, sans-serif font, and there is a circled "C" trademark symbol in the upper right corner.
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.
abo and in the mostilator was subject to usability/human factors study in First I right of a sers were requested to use the ventilator, perform winch intended abore word required ack. The results of the study demonstrated that the ventilator's user interface is simple and easy to use for the potential users.
poochlar accr.
Additionally, comparison between the performance of the revised Flight 60 Ventilator (subject of this submission) with its predicate devices - the original Flight 60 and the Vela Ventilator – demonstrated that the Flight 60 Ventilator is substantially equivalent to it predicate devices without raising any new safety and/or effectiveness concerns.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol to the right and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a semi-circle around the symbol. The symbol is a stylized representation of a human figure, with three lines forming the body and head, and a wavy line forming the legs.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 3 1 2011
Flight Medical Limited C/O Ms. Shoshana Friedman Consultant Push-Med LLC 1914 JN Pease Place Charlotte, North Carolina 28262
Re: K111683
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: October 20, 2011 Received: October 26, 2011
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.
4
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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Luong
for Anthony D. Watson, R.S.
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
5
ATTACHMENT 1
INDICATIONS FOR USE STATEMENT
510(k) Number:_K111683
Device Name:
FLIGHT60® Ventilator
Indications for Use:
The FLIGHT 60 Ventilator is intended to provide continuous or intermittent The Firstil of volum support for the care of individuals who require mechanical ventilation Specifically, the FLIGHT 60 is applicable for adult mechanical vehicle (i.e., infant, child and adolescent) patients, greater than or equal to 10kg (22 lbs).
cquarter 1917 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
OR
Over the Counter Use__________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE ·CONTINUE ON ANOTHER PAGE IF NEEDED)
L. Schultheis
(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices
510(k) Number: K111683
Flight 60 Ventilator