(192 days)
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
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 kevs 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.
The provided document is a 510(k) summary for the AVEA Ventilator, focusing on modifications for Volume Guarantee and Nasal Intermittent Positive Pressure Ventilation. It states that "Performance testing 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." However, it does not provide specific details about the acceptance criteria or the study that proves the device meets those criteria, as requested in the prompt.
Therefore, I cannot provide a complete answer to your request based on the provided text. The document confirms that performance testing was done, but it omits the actual results and methodology of that testing.
Here's what I can extract and what is missing based on your request:
1. Table of acceptance criteria and the reported device performance:
- Missing from the document. The document states that performance testing "verified that the AVEA Ventilator meets its performance requirements," but it does not list these requirements (i.e., acceptance criteria) or the specific reported device performance against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing from the document. The document mentions "Performance testing" but does not specify the sample size, data provenance, or whether it was retrospective or prospective.
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):
- Not applicable / Missing from the document. This type of information is typically relevant for AI/ML-based diagnostic devices where a "ground truth" needs to be established, often by human experts reviewing medical images or patient data. The AVEA Ventilator is a mechanical ventilator, and its performance testing would likely involve engineering and physiological measurements rather than expert review for "ground truth." Therefore, this information is not relevant in the context of this device or is completely absent.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Missing from the document. Similar to point 3, adjudication methods are usually for resolving discrepancies in expert interpretations, which is not relevant for a mechanical ventilator's performance testing.
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:
- Not applicable / Missing from the document. An MRMC study is relevant for diagnostic AI tools involving human readers. This is not applicable to a mechanical ventilator like the AVEA Ventilator.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Missing from the document. This question is also focused on AI/ML algorithms. The AVEA Ventilator has software that implements Volume Guarantee and Nasal Intermittent Mandatory Ventilation, which are automated functions. The document states "software implement Volume Guarantee which is the automated requlation of inspiratory pressure," implying standalone algorithmic function within the device. However, the performance study details for these automated functions are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Missing from the document. As mentioned in point 3, the concept of "ground truth" in the context of expert review is unlikely to apply to the performance testing of a mechanical ventilator. The ground truth for such a device would typically be derived from engineering specifications, established physiological parameters, and direct measurement against those standards. The specific methods are not detailed.
8. The sample size for the training set:
- Not applicable / Missing from the document. A "training set" typically refers to data used to train an AI/ML model. While the ventilator has "software-driven" functions, the document does not suggest an AI/ML model that would require a distinct training set in the conventional sense. The "training" would be more akin to software development and verification/validation against specifications.
9. How the ground truth for the training set was established:
- Not applicable / Missing from the document. For the reasons stated in points 7 and 8, this information is not provided and likely not relevant in the AI/ML context.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| ManufacturingSite: | CareFusion22745 Savi Ranch ParkwayYorba Linda, CA 92887Tel. (714)922-7615 |
|---|---|
| Contact: | Farokh Etemadieh (714) 922-7615 (phone); (714) 922-7615 (fax) |
| Summary Date | May 12, 2011 |
| Device TradeName: | AVEA Ventilator |
| DeviceCommon/Classification Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK |
| EstablishmentRegistrationNumber | 2050001 |
| Device Class: | Class II |
| ClassificationPanel: | Anesthesiology |
| Predicate Device: | The predicate devices are: |
| 1. K083693: 840 Ventilator (Covidien)2. K974176: Baby log 8000 (Drager Inc.) |
The AVEA is a servo-controlled, software-driven ventilator. It has a Device dynamic range of breathing gas delivery that provides for neonatal Description: 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 kevs 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.
AVEA Volume Guarantee / Nasal intermittent positive pressure ventilation
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Intended Use:
The AVEA is intended to provide continuous respiratory support in an institutional health care environment (e.g. hospitals). It may be used on neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
Substantial Equivalence:
The AVEA Ventilator is the same device as the AVEA Ventilator, which was cleared for market under 510(k) K013642, K022674, K062093, K073069, and K081837.
Modifications to the AVEA Ventilator associated with this submittal:
The purpose of this traditional 510K submission is to request authorization for enhancement to the AVEA Ventilator applicable only to changes that are necessary to software implement Volume Guarantee which is the automated requlation of inspiratory pressure to achieve a Clinician specified target tidal volume, and is applicable to TCPL and PRESSURE modes of Ventilation and Nasal Intermittent Mandatory Ventilation which is a time-triggered time-cycled mode of pressure control Ventilation provided via nasal prongs on cannula.
All other AVEA requirements shall remain unchanged.
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, .
- 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 (Volume Guarantee and Nasal intermittent positive pressure ventilation) to the predicate devices.
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.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Farokh Etemadieh Senior Regulatory Affairs Associate CareFusion 22745 Savi Ranch Parkway Yorba Linda, California 92887
MAY 1 2 2011
Re: K103211 Trade/Device Name: AVEA Ventilator Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: May 6, 2011 Received: May 11, 2011
Dear Mr. Etemadieh:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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. Etemadieh
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Ph for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and
Radiological Health
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Indications for Use
510(k) number (if known): K103211
Device Name: AVEA Ventilator
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 neonatal through adult patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
Prescription Use ✔ AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE OF NEEDED)
L. Schulther
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devices
510(k) Number: K103211
Page 1 of ____________________________________________________________________________________________________________________________________________________________________
§ 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).