(58 days)
No
The summary describes a servo-controlled, software-driven ventilator with a graphical user interface and internal gas delivery system. There is no mention of AI, ML, or related terms, nor any description of training or test sets typically associated with AI/ML development.
Yes
The device is a ventilator, which provides continuous respiratory support, directly treating a physiological function.
No
The device is described as a "servo-controlled, software-driven ventilator" intended to "provide continuous respiratory support". Its functions involve gas delivery and monitoring, which are therapeutic and supportive, not diagnostic.
No
The device description explicitly states it has an "internal gas delivery system with servo controlled active inhalation and exhalation functions" and "internal batteries," indicating significant hardware components beyond just software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- AVEA Function: The AVEA is a ventilator. Its purpose is to provide respiratory support by delivering breathing gas directly to the patient. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it provides "continuous respiratory support" and is used on patients, not on specimens.
- Device Description: The description focuses on the mechanics of gas delivery, user interface, and power supply, not on any analytical or diagnostic processes involving biological samples.
Therefore, based on the provided information, the AVEA is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
CBK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients.
Intended User / Care Setting
properly trained clinical personnel, under the direction of a physician.
institutional health care environment (e.g. hospitals).
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
SEP 2 0 2006
| Manufacturing
Site: | VIASYS Respiratory Care Inc
1100 Bird Center Drive
Palm Springs, CA 92262 | | |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|--------------------------------|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 883-7181 (fax) | | |
| Summary Date | August 28, 2006 | | |
| Device Trade
Name: | AVEA Ventilator | | |
| Device
Common/Classific
ation Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK | | |
| Establishment
Registration
Number | 2021710 | | |
| Device Class: | Class II | | |
| Classification
Panel: | Anesthesiology | | |
| Predicate Device: | The predicate devices are: | | |
| | 510K | Product | Manufacturer |
| 1 | K031745 | Infant Flow Plus Infant CPAP
System
(Trade Name: SIPAP System) | VIASYS Respiratory
Care Inc |
| 2 | K970460 | 840 Ventilator with Neo Mode Option | Tyco Puritan Bennett |
| Device
Description: | 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. | | |
:
Page B2
:
K062093 AVEA Ventilator 510(k) Special
1
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, .
Page B3
- 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.
2
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.
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 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 (240) 276-0120. 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.
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):
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) | |
|---|---|
| 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