(525 days)
Flight 60 Ventilator K130171
Trilogy 100 K083526
No
The description mentions a "microprocessor controlled ventilator" and "electrically controlled compressor," which are standard components of modern medical devices and do not inherently indicate the presence of AI/ML. There are no mentions of AI, ML, deep learning, or related terms in the provided text.
Yes
Explanation: The device, a ventilator, provides mechanical ventilation support to patients, which is a therapeutic intervention aimed at treating or managing a medical condition.
No
Explanation: The device is a ventilator, which is used for mechanical ventilation support, not for diagnosing medical conditions. Its purpose is to provide respiratory support, not to identify or monitor specific diseases or conditions.
No
The device description explicitly details hardware components such as a microprocessor, electrical boards (Main, Power, Communication), an electrically controlled compressor (pump), and an electrically controlled proportional solenoid for the exhalation valve. This indicates it is a physical device with integrated software, not a software-only medical device.
Based on the provided text, 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 describes a device used on a patient to support a physiological function (breathing).
- Device Description: The description details the mechanical and electrical components involved in delivering air to a patient's lungs. It talks about compressors, valves, and control systems, all related to direct patient support.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening. The description of the FLIGHT 60 Ventilator does not mention any interaction with patient specimens or any analytical function performed on them.
Therefore, the FLIGHT 60 Ventilator is a medical device used for direct patient care, not an in vitro diagnostic device.
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 1bs).
The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is sutable 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: 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. 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 limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
The purpose of this 510(k) is to allow for the addition of a blower type compressor instead of the piston type compressor.
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
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.
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
Design and verification activities were performed on the FLIGHT 60 as a result of the risk analysis and product requirements. 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. Specifically, FLIGHT 60 was designed and tested in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- . IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (2005), including US national deviations
- . ISO 80601-2-12: Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators (2011); and
- . IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: Electromagnetic Compatibility - Requirements and Tests (2007):
- o ESD contact discharge and air discharge test levels were replaced by 8 kV and 15 kV, respectively.
- Radiated immunity test level was 30 V/m. o
- Magnetic field immunity test level was 30 A/m o
Flight 60 was subjected to environmental tests and was tested for Volatile Organic Compounds (VOC) by EPA test TO-15 and for particles by EPA's PM 2.5. All tests confirmed the product met the predetermined acceptance criteria. Testing also included non-clinical side-by-side waveform performance test, in which the waveform characteristics of Flight 60 were compared to those of Trilogy 100 (K083526) and to Flight 60 (K130171). Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy and patient trigger reliability and synchrony. The comparison of the recorded waveforms supports the claim that FLIGHT 60 is substantially equivalent to the predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Flight 60 Ventilator K130171
Reference Device(s)
Trilogy 100 K083526
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 30, 2016
Flight Medical Innovations Ltd. % Bosmat Friedman Regulatory Affairs Consultant MJ RAC 1208-12 Rockford Rd, Toronto. ON M2R 3A2 Canada
Re: K143035 Trade/Device Name: Flight 60® Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II Product Code: CBK. NOU Dated: March 1, 2016 Received: March 2, 2016
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.
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Tejashri Purohit-Sheth, M.D.
Tejashri Purohit-Sheth, M.D. Clinical Deputy Director DAGRID/ODE/CDRH FOR
Erin I. Keith, M.S. 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K143035
Device Name FLIGHT60® Ventilator
Indications for Use (Describe)
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 pediatic (i.e., infant, child and adolescent) patients, greater than or equal to 5kg (11 1bs).
The FLIGHT 60 Ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician; it is sutable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) SUMMARY [as required by section 807.92(c)] FLIGHT 60 Ventilator
510(k) Number K143035
1. SUBMITTER
Applicant's Name:
Flight Medical Innovations Ltd. 7 Hatnufa Street Petach Tikva 4951025 Tel: (972) 3-6731660 Fax: (972) 3-6731690
Company Contact:
Yael Spielmann, RA & QA Manager yaels@flight-medical.com
Contact Person:
Bosmat Friedman Regulatory Affairs Consultant, MJ RAC 1208-12 Rockford Rd. Toronto, ON, M2R 3A2, Canada Phone: 647-975-3974; Fax: 647-427-1946; bosmat@pushmed.com
Date Prepared:
March 23, 2016
2. DEVICE
Trade Name: FLIGHT 60 Ventilator
Classification Name: Continuous Ventilator
Classification:
Name: Continuous ventilator Product Code: CBK Regulation No: 868.5895 Class: 2
4
Classification Panel: Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID) Respiratory Devices Branch (RPDB)
and
Name: Continuous, Ventilator, Home Use Product Code: NOU Regulation No: 868.5895 Class: 2 Classification Panel: Office of Device Evaluation (ODE) Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices (DAGRID) Respiratory Devices Branch (RPDB)
3. PREDICATE DEVICES
Main Predicate:
- Flight 60 Ventilator K130171 ●
Secondary Predicates:
- Trilogy 100 K083526 ●
4. 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. 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.
Flight 60 Ventilator Traditional 510(k)
5
A comprehensive alarm system is built-in to alert the user to violations of set limits. The alarm system alerts the care giver by activating the audible alarm, screen display and the LED indicator.
The purpose of this 510(k) is to allow for the addition of a blower type compressor instead of the piston type compressor.
INDICATIONS FOR USE ನ.
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.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The suggested modification to the Flight 60 has been tested and validated. No new issues of safety or effectiveness have been identified as a result of this change. A comparison of FLIGHT 60's technological characteristics with the predicate devices is presented in the table below:
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| DEVICE
NAME
| SUBJECT | FLIGHT 60 (REVISED) | FLIGHT 60 | TRILOGY 100 |
|---|---|---|---|
| MANUFACTURER | Flight Medical Innovations Ltd. | Flight Medical Innovations Ltd. | Respironics Inc. |
| 510(K) NUMBER | K130171 | K083526 | |
| PRODUCT CODE | CBK, NOU | CBK, NOU | CBK |
| 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 | ||
| 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 Philips 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). | |||
| PHYSICAL | |||
| DIMENSIONS | 11.641 x 11.457 x 9.803 | ||
| (295mm x 291 mm x 249 mm) | 11.641 x 11.457 x 9.803 | ||
| (295mm x 291 mm x 249 mm) | 16.68cm x 28.45cm x 23.52cm | ||
| USER INTERFACE | Touch screen with alpha numeric | ||
| data | Touch screen with alpha numeric | ||
| data | Control buttons, display screen | ||
| CONTROL BUTTONS | Touch screen function & buttons | Touch screen function & buttons | Buttons control panel |
| MECHANICAL | |||
| SYSTEM | Blower type compressor | Piston type compressor | Blower type compressor |
| POWER SUPPLY AC | 100-240V | ||
| 50-60Hz | 100-240V | ||
| 50-60Hz | 100-240V | ||
| 50-60Hz | |||
| EXTERNAL DC | 12-30 V | 12-30 V | 12/14.4 V |
| INTERNAL BATTERY | Li- ion battery, 12V 5.2Ah | Li- ion battery, 12V 5.2Ah | Li- ion battery, 14.4V 4176mAh |
| BACK-UP BATTERY | Li-ion, 14.8V 2.6Ah | Li-ion, 14.8V 2.6Ah | Li- ion battery, 14.4V 4176mAh |
| AVAILABLE MODES | Volume/pressure/PRVC control | ||
| ACMV | |||
| Volume/pressure/PRVC control | |||
| SIMV + pressure support | |||
| SPONT + pressure support | |||
| Bilevel, MVG, VtG | Volume/pressure/PRVC control | ||
| ACMV | |||
| Volume/pressure/PRVC control | |||
| SIMV + pressure support | |||
| SPONT + pressure support | |||
| Bilevel, MVG, VtG | Volume/pressure control ACMV, | ||
| Volume/pressure control SIMV + | |||
| pressure support | |||
| CPAP (bilevel) | |||
| Bilevel, ST AVAPS, AVAPS | |||
| MANDATORY | |||
| BREATH CONTROLS | Volume/pressure control | ||
| Flow/Pressure/time trigger | Volume/pressure control | ||
| Flow/Pressure/time trigger | Volume/pressure control | ||
| Flow trigger | |||
| SPONTANEOUS | |||
| BREATH SUPPORT | Pressure support | ||
| Cycle variables: flow or time | Pressure support | ||
| Cycle variables: flow or time | Pressure support | ||
| Cycle variables: flow | |||
| BASIC PRESSURE | |||
| CONTROL | Pressure targeted waveform | Pressure targeted waveform | Pressure targeted waveform |
| BASIC FLOW | |||
| CONTROL | Descending/Square flow waveform | Descending/Square flow waveform | Ramp (=Descending )/Square |
| Flow Pattern | |||
| ALARMS | AC Disconnection, Low Battery, | ||
| Empty Battery, Patient | |||
| Disconnection | AC Disconnection, Low Battery, | ||
| Empty Battery, Patient | |||
| Disconnection | AC Power Disconnect, Low | ||
| Battery, Battery Depleted, Circuit | |||
| Disconnect | |||
| Non-invasive | |||
| positive | |||
| pressure | |||
| ventilation | |||
| (NPPV) | Yes | Yes | Yes |
| Reusable | |||
| exhalation valve | Yes | Yes | Yes |
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As can be seen in the table above, the Revised Flight 60 has the same technological characteristics as the predicate Flight 60, with the exception of its compressor The same as Trilogy 100's compressor. Altogether, the technological characteristics of the Revised Flight 60 are substantially equivalent to the predicate Flight 60 or the Trilogy 100 (compressor type only). Thus, the comparison of the Revised Flight 60 to its predicate devices do not raise new safety and effectiveness concerns.
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7. PERFORMANCE DATA
Design and verification activities were performed on the FLIGHT 60 as a result of the risk analysis and product requirements. 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. Specifically, FLIGHT 60 was designed and tested in accordance with the applicable requirements in relevant FDA guidance documents and international standards including:
- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)
- . IEC 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Basic Safety and Essential Performance (2005), including US national deviations
- . ISO 80601-2-12: Medical Electrical Equipment - Part 2-12: Particular Requirements for Basic Safety and Essential Performance of Critical Care Ventilators (2011); and
- . IEC 60601-1-2: Medical Electrical Equipment - Part 1-2: Electromagnetic Compatibility - Requirements and Tests (2007):
- o ESD contact discharge and air discharge test levels were replaced by 8 kV and 15 kV, respectively.
- Radiated immunity test level was 30 V/m. o
- Magnetic field immunity test level was 30 A/m o
Flight 60 was subjected to environmental tests and was tested for Volatile Organic Compounds (VOC) by EPA test TO-15 and for particles by EPA's PM 2.5. All tests confirmed the product met the predetermined acceptance criteria. Testing also included non-clinical side-by-side waveform performance test, in which the waveform characteristics of Flight 60 were compared to those of Trilogy 100 (K083526) and to Flight 60 (K130171). Characteristics tested included flow, pressure and volume waveforms, ventilation control parameter accuracy and patient trigger reliability and synchrony. The comparison of the recorded waveforms supports the claim that FLIGHT 60 is substantially equivalent to the predicate devices.
8. 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 device without raising any new safety and effectiveness concerns.