BIRD AVEA VENTILATOR

K022674 · Bird Products Corp. · CBK · Nov 6, 2002 · Anesthesiology

Device Facts

• Record ID: K022674
• Device Name: BIRD AVEA VENTILATOR
• Applicant: Bird Products Corp.
• Product Code: CBK · Anesthesiology
• Decision Date: Nov 6, 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 (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).

Device Story

Servo-controlled, software-driven ventilator; provides respiratory support for neonatal, pediatric, and adult patients. Inputs: air, oxygen, or heliox gas sources. Operation: internal gas delivery system with active inhalation/exhalation control; configured as conventional or noninvasive positive pressure ventilator (NPPV). Interface: flat panel display, membrane keys, and dial for parameter adjustment. Used in institutional healthcare environments by trained clinical personnel under physician direction. Output: controlled gas delivery to patient; monitors alarms and ventilation parameters. Benefits: provides flexible, continuous respiratory support.

Clinical Evidence

Bench testing only. Performance testing of alarms, controls, and monitors verified that the device meets performance requirements.

Technological Characteristics

Servo-controlled, software-driven ventilator. Features flat panel display, membrane keys, and dial interface. Supports air, oxygen, and heliox delivery. Internal gas delivery system with active inhalation/exhalation functions. Configurable for conventional or noninvasive positive pressure ventilation (NPPV).

Indications for Use

Indicated for continuous respiratory support in institutional settings for adult, pediatric, and neonatal patients requiring air, oxygen, or heliox delivery. Contraindications not specified.

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

• BIRD AVEA Ventilator (K013642)
• DATEX-OHMEDA AESTIVA/5 with 7100 Ventilator Anesthesia System
• OHMEDA EXCEL 3000 Anesthesia Gas System
• HOPE Nebulizer B&B Medical Technologies

Submission Summary (Full Text)

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K022674/

02

11

# 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

| Manufacturing Site: | Bird Products Corporation<br>1100 Bird Center Drive<br>Palm Springs, CA 92262 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tom Gutierrez [phone] (phone); [phone] (fax) |
| Summary Date | July 24, 2002 |
| Device Trade Name: | AVEA Ventilator |
| Device<br>Common/Classificati<br>on Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| Establishment<br>Registration Number | 2021710 |
| Device Class: | Class II |
| Classification Panel: | Anesthesiology |
| Predicate Device: | The predicate devices are: |
| | BIRD AVEA Ventilator Bird Products Corporation |
| | DATEX-OHMEDA AESTIVA/5 with<br>7100 Ventilator Anesthesia System DATEX-OHMEDA |
| | OHMEDA EXCEL 3000 Anesthesia<br>Gas System OHMEDA |
| | HOPE Nebulizer B&B Medical Technologies |
| Device Description: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic<br>breathing gas delivery that provides for neonatal through adult patients. Its<br>module provides maximum flexibility with simple operator interaction. It has |

c range of user interface ction. It has a flat panel module provides maximally with simple operator interaction. It has a nat parti interaction, membrane keys and a dial for changing settings and operating parameters. It also has an internal gas delivery system with servo controlled active inhalation and exhalation functions. The AVEA may be configured as a conventional ventilator or noninvasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.

D2

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## 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (Continued)

The AVEA is intended to provide continuous respiratory support in an institutional health Intended Use: 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.

Substantial The modified AVEA Ventilator is the same device as the AVEA Ventilator, which was Equivalence cleared for market under 510(k) K013642, except for the addition of a heliox connector and associated conforming labeling changes.

> The modified AVEA Ventilator have the following similarities to those which previously received 510(k) concurrence:

- have the same indicated use. .
- have similar indication as heliox predicate ●
- use the same operating principle, ●
- incorporate the same basic ventilator design with the exception of the modifications . identified above.
- . are manufactured and packaged utilizing the same basic processes.

In summary, the AVEA Ventilator described in this submission is, in our opinion, substantially equivalent to the predicate device(s).

Summary of Testing and Validation:

Performance testing of alams, controls and monitors verified that the AVEA 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/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are black and are set against a white background. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the profiles.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

#### 6 2002 NOV

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Bird Products Corporation C/O Mr. Jeffrey K. Shapiro Hogan & Hartson 555 Thirteenth Street, NW Washington, D.C. 20004-1109

Re: K022674

Trade/Device Name: AVEA Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 12, 2002 Received: August 12, 2002

Dear Mr. Shapiro:

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.

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.

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Page 2 - Mr. Shapiro

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/cdrh/dsma/dsmamain.html

Sincerely yours

Timo A. Ulatowski 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):____________________________________________________________________________________________________________________________________________________ Page 1 1

Device Name:

Indication For Use:

The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 cfr 801.109) OR

F.H. Westheimer

eneral Hospital.

510(k) Number: K022674

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

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69929/0001 - 1583935 v1