AVEA

K013642 · Bird Products Corp. · CBK · May 22, 2002 · Anesthesiology

Device Facts

• Record ID: K013642
• Device Name: AVEA
• Applicant: Bird Products Corp.
• Product Code: CBK · Anesthesiology
• Decision Date: May 22, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Intended Use

The AVEA is intended to provide continuous respiratory support in an institutional health care environment. It may be used on adult, pediatric, and neonatal patients. Properly trained clinical personnel, under the direction of a physician should only operate it.

Device Story

AVEA is a servo-controlled, software-driven ventilator providing respiratory support for neonatal, pediatric, and adult patients. Device features internal gas delivery system with active inhalation and exhalation functions; configurable as conventional or non-invasive positive pressure ventilator (NPPV). User interface includes flat panel color LCD, touch screen, membrane keys, and dial for parameter adjustment; provides real-time charting and digital monitoring. Used in institutional healthcare environments (e.g., hospitals) by trained clinical personnel. Output allows clinicians to monitor patient respiratory status and adjust ventilation settings to provide life support. Benefits include flexible, precise gas delivery across diverse patient populations.

Clinical Evidence

Bench testing only. Performance testing and analysis verified that the AVEA Ventilator meets its performance requirements and is substantially equivalent to legally marketed predicate devices.

Technological Characteristics

Servo-controlled, software-driven ventilator. Features internal gas delivery system, flat panel color LCD, touch screen, membrane keys, and dial interface. Supports conventional and non-invasive positive pressure ventilation (NPPV).

Indications for Use

Indicated for continuous respiratory support in institutional settings for adult, pediatric, and neonatal patients. To be operated by trained clinical personnel under physician direction.

Regulatory Classification

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.

Predicate Devices

• 840 (K970460)
• EVITA 4 (K961687)
• SERVO VENTILATOR 300 (K902859)
• Bear Cub 750 PSV (K992788)
• Bear 1000es (K983981)
• VIP Gold/Sterling (K993449)
• DATEX-OHMEDA AESTIVA/5 with 7100 Ventilator Anesthesia System (K000706)

Submission Summary (Full Text)

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MAY 22 2002

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Manufacturing<br>Site: | Bird Products Corporation<br>1100 Bird Center Drive<br>Palm Springs, CA 92262 |
|----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tom Gutierrez [phone] (phone)<br>[phone] (fax) |
| Summary<br>Date | October 27, 2001 |
| Device Trade<br>Name: | AVEA Ventilator |
| Device<br>Common/<br>Classification<br>Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| Establishment<br>Registration<br>Number | 2021710 |
| Device Class: | Class II |
| Classification<br>Panel: | Anesthesiology |
| Device<br>Description: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range of<br>breathing gas delivery that provides for neonatal through adult patients. Its user interface<br>module provides maximum flexibility with simple operator interaction. It has a flat panel color<br>LCD with real time charting and digital monitoring capabilities, a touch screen for interaction,<br>membrane keys and a dial for changing settings and operating parameters. It also has an<br>internal gas delivery system with servo controlled active inhalation and exhalation functions. |

exhalation functions. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

The AVEA is intended to provide continuous respiratory support in an institutional health care Intended environment. It may be used on adult, pediatric, and neonatal patients. Properly trained Use: clinical personnel, under the direction of a physician should only operate it.

The intended use of the AVEA Ventilator is the same basic intended use as that for standard, Substantial Equivalence predicate device currently marketed critical care ventilator. The basic design of this device is similar to those of the predicate devices. The technical characteristics of the AVEA Ventilator do not introduce new questions of safety or effectiveness of critical care ventilators. The labeling associated with the AVEA Ventilator is similar information as that predicate device. The predicate devices used for substantial equivalence determination are as follows:

| | 510(k) Number | Trade or proprietary or model name | Manufacturer |
|---|---------------|------------------------------------------------------------------|---------------------------|
| 1 | K970460 | 840 | Puritan Bennett |
| 2 | K961687 | EVITA 4 | Drager |
| 3 | K902859 | SERVO VENTILATOR 300 | SIEMENS |
| 4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems |
| 5 | K983981 | Bear 1000es | Bear Medical Systems |
| 6 | K993449 | VIP Gold/Sterling | Bird Products Corporation |
| 7 | K000706 | DATEX-OHMEDA AESTIVA/5 with 7100<br>Ventilator Anesthesia System | DATEX: OHMEDA |

Performance testing and analysis will have verified that the AVEA Ventilator meets its Summary of Testing and performance requirements and that this device is substantially equivalent to medical devices Validation: currently legally marketed in the United States prior to market release.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 2 2002

Mr. Tom Gutierrez Bird Products Corp. 1100 Bird Center Drive Palm Springs, CA 92262-8099

Re: K013642

Avea Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (two) Product Code: 73 CBK Dated: (not dated) Received: March 12, 2002

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrl/dsma/dsmamain.html

Sincerely yours,

Deak Tullh

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): KO13642

Device Name:

. . . Indication For Use:

The AVEA is intended to provide continuous respiratory support in an institutional health THE AVES Intendou to provide out may be used on adult, pediatric, and neonatal Care Chrimonnent (C.g. nooptate). They be operated by properly trained clinical personnel, under the direction of a physician.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Division of Cardiovascular & Respiratory Devices | |
|--------------------------------------------------|---------|
| 510(k) Number | K013642 |

| Prescription Use | <div style="text-align:center;">✓</div> | OR | Over-The-Counter Use |
|------------------|-----------------------------------------|----|----------------------|
|------------------|-----------------------------------------|----|----------------------|

(Per 21 cfr 801.109)
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