(87 days)
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 a servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its graphical user interface module (UIM) has a flat panel color LCD with real time charting and digital monitoring capabilities, a touch screen for 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. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of AC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using commonly available accessories.
The provided text does not contain the information requested for acceptance criteria and the study that proves the device meets the acceptance criteria.
The document is a 510(k) premarket notification summary for modifications to the AVEA Ventilator, specifically the addition of a capnometry monitor and onboard barometric pressure sensor. While it mentions "Performance testing verified that the AVEA Ventilator meets it's performance requirements," it does not provide any specific criteria, reported performance values, or details about the studies conducted.
Therefore, I cannot populate the table or answer the specific questions about sample size, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set information.
{0}------------------------------------------------
JAN 25 2008
| ManufacturingSite: | VIASYS Respiratory Care Inc1100 Bird Center DrivePalm Springs, CA 92262 |
|---|---|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 831-7181 (fax) |
| Summary Date | August 3,-2007 |
| Device TradeName: | AVEA Ventilator |
| DeviceCommon/Classification Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| EstablishmentRegistrationNumber | 2021710 |
| Device Class: | Class II |
| ClassificationPanel: | Anesthesiology |
| Predicate Device: | The predicate devices are:Respironics NICO K982499 Maquet Servo-I K022132 Cosmo Plus 8000 K963380 |
| DeviceDescription: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamicrange of breathing gas delivery that provides for neonatal through adultpatients. Its graphical user interface module (UIM) has a flat panel color LCDwith real time charting and digital monitoring capabilities, a touch screen forinteraction, membrane keys and a dial for changing settings and operatingparameters. It also has an internal gas delivery system with servo controlledactive inhalation and exhalation functions. Using internal batteries thisprovides inter-hospital transport as well as back up capability due to loss ofAC power. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed tofunction using commonly available accessories. |
AVEA Capnometry Monitor and Onboard Barometric Pressure Sensor 510K
:
{1}------------------------------------------------
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.
{2}------------------------------------------------
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.
{3}------------------------------------------------
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 (240) 276-0115. 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 (800) 638-2041 or (301) 443-6597 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
{4}------------------------------------------------
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 _____________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
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
Page B2
§ 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).