(219 days)
Not Found
No
The description mentions "microprocessor control" and "electromechanical system" but does not include any terms or descriptions indicative of AI or ML technology.
Yes
The device is a ventilator, which is used to provide mechanical ventilatory support for individuals, directly assisting with a vital bodily function to treat respiratory conditions.
No
The device is a ventilator, which provides mechanical ventilatory support. Its purpose is to deliver gas and control exhalation, not to diagnose a condition.
No
The device description explicitly details numerous hardware components, including a turbine gas delivery system, electromechanical systems (flow delivery, exhalation, safety, inspiratory hold valve), pressure transducers, converters, processors, solenoid valves, and a power system. This indicates it is a hardware device with integrated software, not a software-only medical 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 individuals who require mechanical ventilation." This describes a device that directly supports a patient's breathing, not a device used to examine specimens from the human body to provide information for diagnosis, monitoring, or compatibility.
- Device Description: The description details a system that controls airflow to and from a patient's lungs. It involves pneumatic and electronic systems that manage breathing parameters. This aligns with the function of a ventilator, not an IVD device.
- No mention of analyzing biological specimens: The text does not mention the collection, analysis, or examination of any biological samples (blood, urine, tissue, etc.). IVD devices are specifically designed for these purposes.
Therefore, the TBird VELA Ventilator is a life-support device used for mechanical ventilation, 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 individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the supervision 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)
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 SVGA and Touchscreen. 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 and the Watchoog and Piardware Padin Monitorer - The Porton of external battery pack. errergy tron the RO into input, the interrial battery, and the 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 supervision of a physician; 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.
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
MAR 1 7 2004
| Manufacturing Site: | Bird Products Corporation
1100 Bird Center Drive
Palm Springs, CA 92262 |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 778-7274 (fax) |
| Summary Date | August 11, 2000 |
| Device Trade Name: | TBird VELA Ventilator |
| Device
Common/Classification 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 K020746 TBIRD VELA Ventilator Bird Products Corporation
2 K013642 AVEA Ventilator Bird Products Corporation
3 K981072 Esprit Respironics |
| 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 th
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 SVGA and Touchscreen. 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, |
Converter, wo Digital to Androg Onlyonors. The Power System conditions and controls.
and the Watchdog and Hardware Fault Monitors. The Power System conditions and controls and the Watchoog and Piardware Padin Monitorer - The Porton of external battery pack. errergy tron the RO into input, the interrial battery, and the operates from this source, as well as recharging the internal battery.
1
The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical Intended Use: I he TBIRG VEEN Ventilate is individuals who require mechanical ventilation. The ventilatory support for the baro of internation for use by qualified, trained personnel under ventilator is a restholou modioally, 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 VELA Ventilator, which was cleared for market under 510(k) K020746. The name of the device was changed to the TBird VELA.
Modifications to the TBird VELA Ventilator are associated with this submittal
- Addition of the mode PRVC / Vsync .
- Addition the mode APRV / BiPhasic .
- Addition of dual limb non-invasive ventilation (NPPV) as a mode .
- Remove the mode VAPS and re-implement it as Machine Volume �
- Add leak Compensation .
- Change the nebulizer on time from a fixed 60 minutes to user settable time from 1 to . 60 minutes.
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 .
- 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized eagle with three wavy lines emanating from its body.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 7 2004
Mr. Tom Gutierrez Regulatory Affairs Manager Bird Products Corp. 1100 Bird Center Drive Palm Springs, CA 92262
Re: K032451
TBird Vela Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (two) Product Code: CBK Dated: December 22, 2003 Received: December 24, 2003
Dear Mr. Gutierrez:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject 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 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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours!
fthwh
for,
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510 (k) Number (if known):__K03245| __________________________________________________________________________________________________________________________________________
Page ________ 1 ___ of _______________________________________________________________________________________________________________________________________________________
Device Name: ___ TBird VELA Ventilator
Indication For Use:
The TBird VELA Ventilator is intended to provide continuous or intermittent mechanical The TBIRG VED . VORMARE . Internatividuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel ventilator to a roothere a ntvsician. Specifically, the ventilator is applicable for adult and ander the unionton of a 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.
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital,
Infection Control, Dental Devices
| 510(k) Number: | K032451 |
|---|---|
| ---------------- | --------- |
| Prescription Use | ✓ | OR | Over-The-Counter Use | |
|---|---|---|---|---|
| (Per 21 cfr 801.109) | (Optional Format 1-2-96) |