MODIFICATION TO AVEA VENTILATOR

K073069 · Viasys Respiratory Care, Inc. · CBK · Jan 25, 2008 · Anesthesiology

Device Facts

• Record ID: K073069
• Device Name: MODIFICATION TO AVEA VENTILATOR
• Applicant: Viasys Respiratory Care, Inc.
• Product Code: CBK · Anesthesiology
• Decision Date: Jan 25, 2008
• 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.

Device Story

AVEA is a servo-controlled, software-driven ventilator for neonatal, pediatric, and adult patients. It provides conventional or non-invasive positive pressure ventilation (NPPV). The device features a graphical user interface (UIM) with a flat-panel color LCD, touch screen, and physical controls for parameter adjustment. It includes an internal gas delivery system with active inhalation/exhalation functions and internal batteries for inter-hospital transport. The device integrates a capnometry monitor and an onboard barometric pressure sensor for compensation. Used in hospitals by trained clinicians; output includes real-time charting and digital monitoring of respiratory parameters. Clinicians use this data to manage patient ventilation, potentially improving respiratory outcomes through precise gas delivery and monitoring.

Clinical Evidence

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

Technological Characteristics

Servo-controlled, software-driven ventilator. Features: flat-panel color LCD, touch screen, internal gas delivery system, internal batteries. Includes capnometry monitoring and barometric pressure sensor. Connectivity: real-time charting and digital monitoring. Sterilization: not specified.

Indications for Use

Indicated for continuous respiratory support in institutional settings for adult, pediatric, and neonatal patients. 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

• Respironics NICO (K982499)
• Maquet Servo-I (K022132)
• Cosmo Plus 8000 (K963380)

Submission Summary (Full Text)

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K073069

JAN 25 2008

| 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 3,-2007 |
| 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:<br>Respironics NICO K982499 Maquet Servo-I K022132 Cosmo Plus 8000 K963380 |
| Device<br>Description: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic<br>range of breathing gas delivery that provides for neonatal through adult<br>patients. Its graphical user interface module (UIM) has a flat panel color LCD<br>with real time charting and digital monitoring capabilities, a touch screen for<br>interaction, membrane keys and a dial for changing settings and operating<br>parameters. It also has an internal gas delivery system with servo controlled<br>active inhalation and exhalation functions. Using internal batteries this<br>provides inter-hospital transport as well as back up capability due to loss of<br>AC power. The AVEA may be configured as a conventional ventilator or non-<br>invasive positive pressure ventilator (NPPV). It has been designed to<br>function using commonly available accessories. |

AVEA Capnometry Monitor and Onboard Barometric Pressure Sensor 510K

:

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

> Modifications to the AVEA Ventilator are associated with this submittal are as follows:

- . Capnometry monitor operation
- . Provisions for barometric pressure compensation operation

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,
- 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 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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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with healthcare, with a double helix-like design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## JAN 25 2008

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

Re: K073069

Trade/Device Name: AVEA Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: October 29, 2007 Received: October 30, 2007

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 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 (OS) 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.

Smitte Y. Michael Omd

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): /くのフ3069

AVEA Ventilator 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 _____________________________________________________________________________________________________________________________________________________________

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Concurrence of CDRH C Vice Avaluation (ODE)

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page of 510(k) Number:

(Posted November 13, 2003)

AVEA Capnometry Monitor and Onboard Barometric Pressure Sensor 510K

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