(198 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description focuses on traditional ventilator technology and software control.
Yes
The device "provides continuous respiratory support" and its intended use is to "provide continuous respiratory support in an institutional health care environment," which clearly indicates a therapeutic function.
No
The device is a ventilator, which provides respiratory support, not a diagnostic device which identifies or determines the presence of a medical condition or disease.
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. It also mentions a user interface module with a flat panel LCD, touch screen, membrane keys, and a dial, all of which are hardware.
Based on the provided information, the AVEA device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "provide continuous respiratory support." This is a therapeutic function, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The description details a ventilator, which is a life support device that assists with breathing. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
The AVEA is clearly described as a ventilator, which falls under the category of respiratory support devices, not in vitro diagnostics.
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.
Product codes
73 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 user interface module provides maximum flexibility with simple operator interaction. It 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. The AVEA may be configured as a conventional ventilator or non-invasive 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
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 and analysis will have verified that the AVEA Ventilator meets its performance requirements and that this device is substantially equivalent to medical devices currently legally marketed in the United States prior to market release.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K970460, K961687, K902859, K992788, K983981, K993449, K000706
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
MAY 22 2002
1013642
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 | October 27, 2001 |
| Device Trade
Name: | AVEA Ventilator |
| Device
Common/
Classification
Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| Establishment
Registration
Number | 2021710 |
| Device Class: | Class II |
| Classification
Panel: | Anesthesiology |
| 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 user interface
module provides maximum flexibility with simple operator interaction. It 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. |
exhalation functions. The AVEA may be configured as a conventional ventilator or non-invasive positive pressure ventilator (NPPV). It has been designed to function using most commonly available accessories.
8-1
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
The AVEA is intended to provide continuous respiratory support in an institutional health care Intended environment. It may be used on adult, pediatric, and neonatal patients. Properly trained Use: clinical personnel, under the direction of a physician should only operate it.
The intended use of the AVEA Ventilator is the same basic intended use as that for standard, Substantial Equivalence predicate device currently marketed critical care ventilator. The basic design of this device is similar to those of the predicate devices. The technical characteristics of the AVEA Ventilator do not introduce new questions of safety or effectiveness of critical care ventilators. The labeling associated with the AVEA Ventilator is similar information as that predicate device. The predicate devices used for substantial equivalence determination are as follows:
| 510(k) Number | Trade or proprietary or model name | Manufacturer | |
|---|---|---|---|
| 1 | K970460 | 840 | Puritan Bennett |
| 2 | K961687 | EVITA 4 | Drager |
| 3 | K902859 | SERVO VENTILATOR 300 | SIEMENS |
| 4 | K992788 | Bear Cub 750 PSV | Bear Medical Systems |
| 5 | K983981 | Bear 1000es | Bear Medical Systems |
| 6 | K993449 | VIP Gold/Sterling | Bird Products Corporation |
| 7 | K000706 | DATEX-OHMEDA AESTIVA/5 with 7100 | |
| Ventilator Anesthesia System | DATEX: OHMEDA |
Performance testing and analysis will have verified that the AVEA Ventilator meets its Summary of Testing and performance requirements and that this device is substantially equivalent to medical devices Validation: currently legally marketed in the United States prior to market release.
8-2
2
Image /page/2/Picture/0 description: The image shows the seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 2 2002
Mr. Tom Gutierrez Bird Products Corp. 1100 Bird Center Drive Palm Springs, CA 92262-8099
Re: K013642
Avea Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II (two) Product Code: 73 CBK Dated: (not dated) Received: March 12, 2002
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. Tom 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 (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/cdrl/dsma/dsmamain.html
Sincerely yours,
Deak Tullh
Donna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication For Use
510 (k) Number (if known): KO13642
Device Name:
. . . Indication For Use:
The AVEA is intended to provide continuous respiratory support in an institutional health THE AVES Intendou to provide out may be used on adult, pediatric, and neonatal Care Chrimonnent (C.g. nooptate). They be operated by properly trained clinical personnel, under the direction of a physician.
Page
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division of Cardiovascular & Respiratory Devices | |
|---|---|
| 510(k) Number | K013642 |
| Prescription Use | ✓ | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | ----------------------------------------- | ---- | ---------------------- |
(Per 21 cfr 801.109)
(Optional Format 1-2-96)1-3