(46 days)
Not Found
No
The description mentions "microprocessor control" and an "electromechanical system" with various electronic components and subsystems, but there is no mention of AI, ML, or related concepts. The focus is on traditional control systems and hardware.
Yes
The device is a ventilator, which provides mechanical ventilatory support for individuals requiring assistance with breathing, directly treating a medical condition.
No
Explanation: The TBIrd VELA Ventilator is described as a device that provides mechanical ventilatory support, which is a treatment, not a diagnostic function. Its components and functions are geared towards delivering breathing assistance to patients.
No
The device description explicitly details a complex electromechanical system with numerous hardware components, including a turbine gas delivery system, microprocessor control, pneumatic systems, electronic systems, pressure transducers, solenoid valves, and power systems. This is clearly not a software-only device.
Based on the provided text, the TBird VELA 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 ventilatory support for the care of individuals who require mechanical ventilation." This describes a life support device that directly interacts with a patient's respiratory system.
- Device Description: The description details a "turbine gas delivery system along with microprocessor control" and pneumatic and electronic systems that control airflow to and from the patient. This aligns with the function of a ventilator.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
Therefore, the TBird VELA Ventilator is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
73 CBK
Device Description
The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.
The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.
This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.
The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of three Alarm Setpoint Displays, seven Control Setpoint Displays, up to forty-eight Message Display characters, up to twentyfive Discrete Indicators, and a bargraph style Manometer. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC line input, the internal battery, and the optional external battery pack. When energy is available from the AC line, the ventilator operates from this source, as well as recharging the internal battery.
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 patients weighing at least 10 kg (22 lbs.)
Intended User / Care Setting
qualified, trained personnel under the direction of a physician. The ventilator is suitable for use in institutional and transport settings.
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)
Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K950484, K920113, K973646, K911336
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
APR 2 2002
| Manufacturing Site: | Bird Products Corporation
1100 Bird Center Drive
Palm Springs, CA 92262 | 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS | |
|-------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------------|---------------------------|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 778-7274 (fax) | | |
| Summary Date | August 11, 2000 | | |
| Device Trade Name: | TBird VELA Ventilator | | |
| Device
Common/Classificati
on Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK | | |
| Establishment
Registration Number | 2021710 | | |
| Device Class: | Class II | | |
| Classification Panel: | Anesthesiology | | |
| Predicate Device: | The predicate devices are: | | |
| | 1 K950484 | TBIRD AVS | Bird Products Corporation |
| | 2 K920113 | Bird Graphics Monitor | Bird Products Corporation |
| | 3 K973646 | Bird Sentry Blender | Bird Products Corporation |
| | 4 K911336 | Bird Nebulizer Synchronizer | Bird Product Corporation |
Device Description:
The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessor control to provide support for pediatric to adult patients. Capable of delivering clinically advanced modes of ventilation like Pressure Support with an internal battery or AC power the TBird VELA Ventilator has an extensive patient range.
The TBird VELA Ventilator ventilator pneumatic system is an electromechanical system comprised of four major subsystems, each containing several components. These systems include the flow delivery system, the exhalation system, the safety system and the inspiratory hold valve.
This electromechanical system controls all inspiratory flow to the patient. The exhalation system controls the flow of gas from the patient's lungs during the exhalation phase. The mechanical safety system ensures that the patient can breath spontaneously from room air and that the patient pressure is limited to a maximum value in the event of a ventilator malfunction. When activated, the inspiratory hold valve blocks flow between the flow delivery system and the patient.
The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems, each containing numerous components. These subsystems include the Graphical User Interface System, the Power System, the Main Controller System, Exhalation, and Flow Delivery systems. The Display System is comprised of three Alarm Setpoint Displays, seven Control Setpoint Displays, up to forty-eight Message Display characters, up to twentyfive Discrete Indicators, and a bargraph style Manometer. The Main Controller System is comprised of three Pressure Transducers, an Analog-to-Digital Converter, two Digital-to-Analog Converters, the Input-Output Processor, Solenoid Valves, and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls energy from the AC line input, the internal battery, and the optional external battery pack. When energy is available from the AC line, the ventilator operates from this source, as well as recharging the internal battery.
1
Intended Use:
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
Substantial Equivalence The TBird VELA Ventilator is the same device as the TBird AVS Ventilator, which was cleared for market under 510(k) K950484. The name of the device was changed to the TBird VELA.
Modifications to the TBird VELA Ventilator are associated with this submittal
- . Graphical User Interface (GUI) touch-screen/display
- t OXYGEN monitor
- . Nebulizer high pressure gas source.
- Exhalation flow sensor was also modified to incorporate a direct hard wire . connection
The modified TBird VELA Ventilator have the following similarities to those which previously received 510(k) concurrence:
- . have the same indicated use,
- . use the same ventilation operating principle,
- incorporate the same basic ventilator design with the exception of modifications . described in this submittal.
- . incorporate the same basic electronic control system with the exception of modifications described within this submittal.
- . are manufactured and packaged utilizing the same basic processes.
- In summary, the TBird VELA Ventilator described in this submission is, in our opinion, . substantially equivalent to the predicate device(s).
Summary of Testing and Validation:
Performance testing verified that the TBird VELA Ventilator meets it's performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States.
D3
2
Image /page/2/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with outstretched arms, surrounded by a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top and left side of the circle.
APR 2 2 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Tom Gutierrez Bird Products Corporation 1100 Bird Center Drive Palm Springs, CA 92262
Re: K020746
TBird VELA Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: Class II (two) Product Code: 73 CBK Dated: February 29, 2002 Received: April 1, 2002
Dear Mr. Guitierrez:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becaused the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 10 use surved in the encreativent of 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, de rices that hat to been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may ; therefore, maxis of the Act include requirements for annual registration, listing of general voltarely pro resuring practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it 11 your de roo to such 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.
3
Page 2 - Mr. Tom Gutierrez
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 toast of advised that I DPT of issuaires complies with other requirements of the Act that I Dr has made a aown regulations administered by other Federal agencies. You must or any I catal statutes and regarients, including, but not limited to: registration and listing (21 Comply with an the rice of requirements, is, good manufacturing practice requirements as set CFK i at 607); laboring (21 CFR Part 820); and if applicable, the electronic rorth in the quality by bections (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will and h yourse FDA finding of substantial equivalence of your device to a legally prematicated predicated. The Pro macinssification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire specific advices for in vitro diagnostic devices), please contact the Office of additionally 21 OF F Far 8646. Additionally, for questions on the promotion and advertising of Compinance at (301) 591-1010 ffice of Compliance at (301) 594-4639. Also, please note the your devices, preads "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation chitited, Tribbiananing oresponsibilities under the Act may be obtained from the Other general mionmation on your new and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510 (k) Number (if known):
Page _________________________________________________________________________________________________________________________________________________________________________
Device Name: ___ TBird VELA Ventilator
Indication For Use:
The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical The TDIrd VEEX Ventifator is intonecise players mechanical ventilation. The ventilatory Support for the ours of marmatic or use by qualified, trained personnel ventifator is a restificied modiour dovice iffically, the ventilator is applicable for adult and under the direction of a priyelland 10 kg (22 lbs.), who require the following general pediatho putionto weighing 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Division of Cardiovascular & Respiratory Devices
510(k) Number 4020746
| Prescription Use | ✓ | OR | Over-The-Counter Use _________ |
|---|---|---|---|
| (Per 21 cfr 801.109) | (Optional Format 1-2-96) |