(86 days)
Not Found
No
The summary describes a servo-controlled, software-driven ventilator with standard features and controls. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
Yes
The device is a ventilator intended to provide continuous respiratory support, which is a therapeutic function.
No
The text explicitly states the AVEA is "intended to provide continuous respiratory support." There is no mention of it being used to diagnose conditions or process diagnostic information. Its function is to deliver air, oxygen, or a helium-oxygen combination.
No
The device description explicitly states it has an "internal gas delivery system with servo controlled active inhalation and exhalation functions," which are hardware components.
Based on the provided information, the AVEA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the AVEA is for providing continuous respiratory support to patients. This is a direct interaction with the patient's respiratory system, not the examination of specimens derived from the human body.
- Device Description: The description details a ventilator, a device that assists breathing. This aligns with respiratory support, not in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any processes typically associated with in vitro diagnostics.
IVD devices are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening. The AVEA's function is to directly support a patient's breathing, which falls under the category of a therapeutic or life-support device, not an IVD.
N/A
Intended Use / Indications for Use
The AVEA is intended to provide continuous respiratory support in an institutional health 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. The AVEA is indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).
Product codes
CBK
Device Description
The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic breathing gas delivery that provides for neonatal through adult patients. Its 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.
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 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
02
11
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturing Site: | Bird Products Corporation
1100 Bird Center Drive
Palm Springs, CA 92262 |
|-------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 778-7274 (fax) |
| Summary Date | July 24, 2002 |
| Device Trade Name: | AVEA Ventilator |
| Device
Common/Classificati
on 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: |
| | BIRD AVEA Ventilator Bird Products Corporation |
| | DATEX-OHMEDA AESTIVA/5 with
7100 Ventilator Anesthesia System DATEX-OHMEDA |
| | OHMEDA EXCEL 3000 Anesthesia
Gas System OHMEDA |
| | HOPE Nebulizer B&B Medical Technologies |
| Device Description: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic
breathing gas delivery that provides for neonatal through adult patients. Its
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
1
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
2
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.
3
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 (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
4
. 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)
3
B1
69929/0001 - 1583935 v1