BIRD TBIRD VELA VENTILATOR by BIRD PRODUCTS CORP.

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.

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.

AI/ML Overview

The manufacturer states 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."

However, this submission does not provide any specific acceptance criteria or detailed results of the performance testing. It only makes a general statement about meeting performance requirements and substantial equivalence.

Therefore, many of the requested details cannot be extracted from the provided text.

Here is a summary of what can and cannot be provided based on the given document:

1. A table of acceptance criteria and the reported device performance:

Acceptance Criteria	Reported Device Performance
Not specified in the document.	The document states: "Performance testing verified that the TBird VELA Ventilator meets it's performance requirements." No specific performance metrics or values are provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size for Test Set: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).

3. 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):

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not specified.

5. 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:

MRMC Study: Not mentioned or implied. The device is a ventilator, not an AI-assisted diagnostic tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This question is not entirely applicable in the context of a ventilator. The "performance testing" would likely refer to the device's functional performance in delivering ventilation according to its specifications, rather than an algorithm's diagnostic performance. No details are given about the methodology of this testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground Truth: Not specified. For a ventilator, "ground truth" would generally refer to established engineering standards, physiological measurements, and clinical outcomes for evaluating its performance. However, no details on how "performance requirements" were assessed are provided.

8. The sample size for the training set:

Sample Size for Training Set: Not applicable/not specified. Ventilators do not typically have "training sets" in the same way AI algorithms do. Their development involves engineering design, prototyping, and testing against specified performance criteria.

9. How the ground truth for the training set was established:

Ground Truth for Training Set: Not applicable/not specified. (See point 8).

In summary, the provided document is a 510(k) summary for a ventilator, focusing on its description, intended use, and substantial equivalence to predicate devices. It states that performance testing was conducted to verify that the device meets its requirements, but it does not provide any specific details about the acceptance criteria, study design, sample sizes, or results of that testing.

Summary

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APR 2 2002

K020746

Manufacturing Site:	Bird Products Corporation1100 Bird Center DrivePalm 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
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 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:

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Intended Use:

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.

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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.

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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

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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)

Regulation Number and Section

§ 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).