AVEA VENTILATOR

K062093 · Viasys Respiratory Care, Inc. · CBK · Sep 20, 2006 · Anesthesiology

Device Facts

• Record ID: K062093
• Device Name: AVEA VENTILATOR
• Applicant: Viasys Respiratory Care, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 20, 2006
• Decision: SESE
• Submission Type: Special
• 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.

Device Story

AVEA is a servo-controlled, software-driven ventilator for neonatal through adult patients. Device features a graphical user interface (UIM) with flat panel color LCD, touch screen, and physical controls for parameter adjustment. Internal gas delivery system provides active inhalation and exhalation. Device supports conventional ventilation and non-invasive positive pressure ventilation (NPPV). Software update enables a nasal CPAP mode, emulating Infant Flow Plus functionality using existing hardware. Used in hospitals for respiratory support; operated by trained clinicians. Provides real-time charting and digital monitoring. Internal batteries allow for inter-hospital transport and backup during AC power loss. Output assists clinicians in managing patient ventilation, potentially improving respiratory outcomes.

Clinical Evidence

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

Technological Characteristics

Servo-controlled, software-driven ventilator. Features flat panel color LCD, touch screen, membrane keys, and dial. Internal gas delivery system. Battery-powered for transport. Software-based control system. No specific material standards or connectivity protocols (e.g., DICOM) detailed.

Indications for Use

Indicated for continuous respiratory support in institutional settings for adult, pediatric, and neonatal patients. Prescription use only; must 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

• Infant Flow Plus Infant CPAP System (SIPAP System) (K031745)
• 840 Ventilator with Neo Mode Option (K970460)

Reference Devices

• AVEA Ventilator (K013642)
• AVEA Ventilator (K022674)

Submission Summary (Full Text)

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K062093

SEP 2 0 2006

| Manufacturing<br>Site: | VIASYS Respiratory Care Inc<br>1100 Bird Center Drive<br>Palm Springs, CA 92262 | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------|
| Contact: | Tom Gutierrez [phone] (phone); [phone] (fax) | | |
| Summary Date | August 28, 2006 | | |
| Device Trade<br>Name: | AVEA Ventilator | | |
| Device<br>Common/Classific<br>ation Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK | | |
| Establishment<br>Registration<br>Number | 2021710 | | |
| Device Class: | Class II | | |
| Classification<br>Panel: | Anesthesiology | | |
| Predicate Device: | The predicate devices are: | | |
| | 510K | Product | Manufacturer |
| 1 | K031745 | Infant Flow Plus Infant CPAP<br>System<br>(Trade Name: SIPAP System) | VIASYS Respiratory<br>Care Inc |
| 2 | K970460 | 840 Ventilator with Neo Mode Option | Tyco Puritan Bennett |
| Device<br>Description: | The AVEA is a servo-controlled, software-driven ventilator. It has a<br>dynamic range of breathing gas delivery that provides for neonatal<br>through adult patients. Its graphical user interface module (UIM) has a<br>flat panel color LCD with real time charting and digital monitoring<br>capabilities, a touch screen for interaction, membrane keys and a dial<br>for changing settings and operating parameters. It also has an internal<br>gas delivery system with servo controlled active inhalation and<br>exhalation functions. Using internal batteries this provides inter-<br>hospital transport as well as back up capability due to loss of AC<br>power. The AVEA may be configured as a conventional ventilator or<br>non-invasive positive pressure ventilator (NPPV). It has been<br>designed to function using commonly available accessories. | | |

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K062093 AVEA Ventilator 510(k) Special

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

Substantial The AVEA Ventilator is the same device as the AVEA Ventilator, which Equivalence was cleared for market under 510(k) K013642 and K022674.

Modifications to the AVEA Ventilator are associated with this submittal

- Software update encompasses a modification to the current . Non-Invasive ventilation previously cleared under K013642 of which allows for a particular mode on the Infant Flow Plus, Nasal CPAP.
- . This Nasal CPAP mode that is emulated is accomplished by a software modification only, utilizing existing AVEA hardware.
- . This Nasal CPAP mode is only for single level continuous positive airway pressure to nasal pronos.

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

- have the same indicated use, ●
- use the same ventilation operating principle, .

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- 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 AVEA Ventilator described in this submission is, in our opinion, substantially equivalent (mean NCPAP ventilation) to the predicate device(s).

Summary of Testing and Validation:

Performance testing 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.

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Public Health Service

Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a shape resembling a stylized bird or abstract human figure. The words "HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP 2 0 2006

Mr. Tom Gutierrez Regulatory Affairs Manager Viasys Respiratory Care, Incorporated 1100 Bird Center Drive Palm Springs, California 92262

Re: K062093

Trade/Device Name: AVEA Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 31, 2006 Received: September 1, 2006

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. 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 l'ederal 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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

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):

Device Name:

Indications 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.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
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| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | Page __ of __ |
| 510(k) Number: | K062093 |

(Posted November 13, 2003)

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K062093 AVEA Ventilator 510(k) Special