(219 days)
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 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 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 energy from the AC input, the internal battery, and the option of external battery pack. The ventilator operates from this source, as well as recharging the internal battery.
The provided document, K032451, is for a medical device (TBird VELA Ventilator) and details modifications to an already cleared device. It primarily focuses on demonstrating substantial equivalence to predicate devices and verifying performance requirements.
Therefore, the requested information regarding acceptance criteria, study details, expert involvement, and specific ground truth methodologies for an AI device is not applicable to this submission. This document describes a ventilator, which is a hardware medical device, not an AI/ML-driven software device.
Specifically:
- A table of acceptance criteria and the reported device performance: Not applicable. The document states "Performance testing verified that the TBird VELA Ventilator meets its performance requirements," but does not present a table of specific acceptance criteria or quantitative performance metrics in the way one would for an AI model. The verification is at a system level for a hardware device.
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. This refers to a clinical study for an AI algorithm, not the engineering performance verification of a ventilator.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. This pertains to AI model evaluation, not hardware device performance.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This pertains to AI model evaluation.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This pertains to AI model evaluation, specifically human-in-the-loop performance.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This pertains to AI model evaluation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. This pertains to AI model evaluation.
- The sample size for the training set: Not applicable. This pertains to AI model training.
- How the ground truth for the training set was established: Not applicable. This pertains to AI model training.
The document indicates that "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." This implies that internal engineering and functional tests were conducted to ensure the device performs as intended and meets relevant safety and effectiveness standards for a ventilator, likely against established benchmarks for similar devices. However, the specific details of these performance requirements and test outcomes are not provided in this summary.
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MAR 1 7 2004
| Manufacturing Site: | Bird Products Corporation1100 Bird Center DrivePalm 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 |
| DeviceCommon/Classification Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| EstablishmentRegistration Number | 2021710 |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
| Predicate Device: | The predicate devices are:1 K020746 TBIRD VELA Ventilator Bird Products Corporation2 K013642 AVEA Ventilator Bird Products Corporation3 K981072 Esprit Respironics |
| Device Description: | The TBird VELA Ventilator employs a turbine gas delivery system along with microprocessorcontrol to provide support for pediatric to adult patients. Capable of delivering clinicallyadvanced modes of ventilation like Pressure Support with an internal battery or AC power thTBird VELA Ventilator has an extensive patient range.The TBird VELA Ventilator ventilator pneumatic system is an electromechanical systemcomprised of four major subsystems, each containing several components. These systemsinclude the flow delivery system, the exhalation system, the safety system and the inspiratoryhold valve.This electromechanical system controls all inspiratory flow to the patient. The exhalationsystem controls the flow of gas from the patient's lungs during the exhalation phase. Themechanical safety system ensures that the patient can breath spontaneously from room airand that the patient pressure is limited to a maximum value in the event of a ventilatormalfunction. When activated, the inspiratory hold valve blocks flow between the flow deliverysystem and the patient.The TBird VELA Ventilator ventilator electronic system is comprised of several subsystems,each containing numerous components. These subsystems include the Graphical UserInterface System, the Power System, the Main Controller System, Exhalation, and FlowDelivery systems. The Display System is comprised of SVGA and Touchscreen. The MainController System is comprised of three Pressure Transducers, an Analog-to-DigitalConverter, 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.
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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
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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.
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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
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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) |
§ 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).