(86 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 indicated for the delivery of air, oxygen or a helium-oxygen combination (Heliox).
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 a range of user interface 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.
The provided text describes the 510(k) summary for the AVEA Ventilator. It focuses on the device's intended use, its substantial equivalence to predicate devices, and a brief description of testing.
Here's an analysis of the available information regarding acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The submission does not explicitly provide a table of acceptance criteria with corresponding performance metrics. Instead, it states:
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Device meets its performance requirements. | "Performance testing of alams, controls and monitors verified that the AVEA Ventilator meets it's performance requirements." |
| Device is substantially equivalent to legally marketed predicate devices in the United States. | "Performance testing of alams, controls and monitors verified...that this device is substantially equivalent to medical devices currently legally marketed in the United States." The submission also argues for substantial equivalence based on: - Same indicated use - Similar indication as heliox predicate - Same operating principle - Same basic ventilator design (except for heliox connector) - Manufactured and packaged utilizing the same basic processes. |
Missing Information:
- Specific numerical performance requirements for "alarms, controls, and monitors" are not detailed. For example, acceptable ranges for pressure, volume, flow, response times for alarms, accuracy of delivered gas mixes, etc., are not provided.
- The actual measured performance values from the testing are not presented.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given text. The device is a ventilator, not an imaging or diagnostic device requiring expert interpretation for ground truth. The "ground truth" (or functional verification) would be against engineering specifications and physical measurements, rather than expert consensus on medical images or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given text. As this is a ventilator and not a diagnostic device relying on expert interpretation, an adjudication method in the traditional sense (e.g., for medical image reading) would not be applicable. The "adjudication" would be against engineering standards and test pass/fail criteria.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a multi-reader, multi-case comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices where human readers interpret medical images or data. The AVEA Ventilator is a treatment device, not a diagnostic one involving human interpretation of AI output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone medical device (a ventilator), but it's not an AI algorithm in the context typically discussed for standalone performance studies (e.g., deep learning models making diagnoses). The "performance testing" described involved the device functioning independently, but it's not an AI algorithm in the modern sense. The device does provide "continuous respiratory support," implying its operation without constant direct human intervention once set up, which could be considered "standalone" in its functional capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the nature of the device (a ventilator), the "ground truth" for performance testing would likely be:
- Engineering specifications and standards: The device's output (e.g., delivered volume, pressure, flow rates, alarm functionality, response times) would be compared against predefined engineering and medical device standards.
- Physical measurements: Using calibrated equipment to measure the actual performance parameters (e.g., gas flow, pressure, oxygen concentration) produced by the ventilator.
The text does not explicitly state the type of ground truth, but implicitly it relates to verifying compliance with performance requirements for "alarms, controls, and monitors."
8. The sample size for the training set
This information is not applicable and not provided. The AVEA Ventilator, described as a "servo-controlled, software-driven ventilator," from 2002, predates the widespread use of machine learning/AI models that would require "training sets" in the modern sense. Its software likely operates based on programmed logic and control algorithms rather than learned patterns from a "training set."
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no indication of a training set being used in the context of machine learning/AI for this device.
{0}------------------------------------------------
02
11
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturing Site: | Bird Products Corporation1100 Bird Center DrivePalm Springs, CA 92262 |
|---|---|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 778-7274 (fax) |
| Summary Date | July 24, 2002 |
| Device Trade Name: | AVEA Ventilator |
| DeviceCommon/Classification Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| EstablishmentRegistration 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 with7100 Ventilator Anesthesia System DATEX-OHMEDA | |
| OHMEDA EXCEL 3000 AnesthesiaGas System OHMEDA | |
| HOPE Nebulizer B&B Medical Technologies | |
| Device Description: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamicbreathing gas delivery that provides for neonatal through adult patients. Itsmodule 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
§ 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).