(198 days)
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 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.
The provided text is a 510(k) summary for the AVEA Ventilator. It describes the device, its intended use, and states that performance testing and analysis verified the device meets its requirements and is substantially equivalent to legally marketed predicate devices. However, it does not contain the specific details required to complete your request: acceptance criteria, reported device performance metrics, and the specifics of a study proving those criteria were met.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about the study, as that information is not present in the provided document.
Here's a breakdown of what can be extracted and what cannot:
A. Information NOT present in the document:
- A table of acceptance criteria and the reported device performance: The document states "Performance testing and analysis will have verified that the AVEA Ventilator meets its performance requirements," but it does not list these specific requirements or the results.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as there's no mention of a diagnostic AI component requiring ground truth from experts. The device is a ventilator.
- Adjudication method: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not mentioned, and generally not applicable for a device like a ventilator.
- If a standalone study (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned, and not a typical study for a ventilator.
- The type of ground truth used: Not applicable in the context of a ventilator's performance validation.
- The sample size for the training set: Not applicable as no AI/algorithm training is explicitly described for a diagnostic purpose.
- How the ground truth for the training set was established: Not applicable.
B. Information that can be inferred or stated from the document:
- Study type: The document generally refers to "Performance testing and analysis" and "Validation" which are typical for medical device clearance processes to ensure the device performs as intended and is safe and effective. It's not a diagnostic AI study.
- Purpose of the study: To demonstrate that the AVEA Ventilator meets its performance requirements and is substantially equivalent to predicate devices.
- Predicate Devices: A list of 7 predicate ventilators from Puritan Bennett, Drager, SIEMENS, Bear Medical Systems, Bird Products Corporation, and DATEX-OHMEDA is provided.
In summary, the provided 510(k) summary for the AVEA Ventilator does not contain the detailed study results, acceptance criteria, or methodological specifics typically found in a clinical study report for an AI/diagnostic device that would allow me to populate your request. It primarily focuses on the regulatory submission process and substantial equivalence to existing devices.
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MAY 22 2002
1013642
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| ManufacturingSite: | Bird Products Corporation1100 Bird Center DrivePalm Springs, CA 92262 |
|---|---|
| Contact: | Tom Gutierrez (760) 778-7255 (phone)(760) 778-7274 (fax) |
| SummaryDate | October 27, 2001 |
| Device TradeName: | AVEA Ventilator |
| DeviceCommon/ClassificationName: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| EstablishmentRegistrationNumber | 2021710 |
| Device Class: | Class II |
| ClassificationPanel: | Anesthesiology |
| DeviceDescription: | The AVEA is a servo-controlled, software-driven ventilator. It has a dynamic range ofbreathing gas delivery that provides for neonatal through adult patients. Its user interfacemodule provides maximum flexibility with simple operator interaction. It has a flat panel colorLCD 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 aninternal 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.
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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 7100Ventilator 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.
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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.
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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
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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.
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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
§ 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).