(58 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 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 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. 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.
This is a 510(k) premarket notification for a medical device (AVEA Ventilator), not a study report. Therefore, much of the requested information regarding acceptance criteria and study details for device performance, ground truth, and expert evaluation is not available in the provided text.
However, based on the submission, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It states generally that: "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."
The focus of this 510(k) is on modifications to an already cleared device, asserting substantial equivalence. The specific modifications are:
- "Software update encompasses a modification to the current . Non-Invasive ventilation previously cleared under K013642 of which allows for a particular mode on the Infant Flow Plus, Nasal CPAP."
- "This Nasal CPAP mode that is emulated is accomplished by a software modification only, utilizing existing AVEA hardware."
- "This Nasal CPAP mode is only for single level continuous positive airway pressure to nasal pronos."
Therefore, the "acceptance criteria" for this specific submission would implicitly be:
- The modified AVEA Ventilator, with the new Nasal CPAP software, performs equivalently to the predicate devices for continuous ventilation and specifically for the Nasal CPAP mode.
- The software modification does not adversely affect existing validated functionalities.
Given the nature of a ventilator, performance metrics would likely revolve around aspects such as:
- Accuracy of delivered pressure/volume/flow.
- Response time to patient effort.
- Safety alarms and limits.
- Biocompatibility (not directly covered by the software modification but generally a part of medical device approval).
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for any specific test set, nor the data provenance (country of origin, retrospective/prospective). The submission refers to "Performance testing" in a general sense.
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. Since this is an engineering performance assertion for a ventilator and not a diagnostic device relying on expert interpretation of images or signals, the concept of "ground truth" derived from expert consensus in that context is unlikely to apply directly in the same way. Performance testing for a ventilator typically involves engineering and physiological measurements rather than expert clinical consensus on data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/not provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving expert interpretation where disagreements need to be resolved for ground truth establishment. This is not the type of study described.
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. This is a ventilator device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This concept doesn't directly apply as the AVEA Ventilator is a device that interacts with a patient and is operated by trained clinical personnel. The "performance testing" mentioned would be for the device's functionality, which by its nature is "standalone" in terms of its mechanical and software operation, but in a real-world scenario, it's always "with human-in-the-loop" for patient management. The document states it is "servo-controlled, software-driven."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given the device type, "ground truth" would likely be derived from:
- Engineering specifications and validated measurement equipment (e.g., flow sensors, pressure transducers) for evaluating the ventilator's physical outputs.
- Physiological models or test lung systems to simulate patient conditions.
- Compliance with recognized standards (e.g., ISO standards for ventilators).
However, the specific methods are not detailed in the provided text.
8. The sample size for the training set
Not applicable. This device is not described as utilizing a machine learning model that requires a distinct "training set" in the context of AI/ML. The software modification is likely a rule-based or control-algorithm update, not an autonomously learning system.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a machine learning training set.
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SEP 2 0 2006
| ManufacturingSite: | VIASYS Respiratory Care Inc1100 Bird Center DrivePalm Springs, CA 92262 | ||
|---|---|---|---|
| Contact: | Tom Gutierrez (760) 778-7255 (phone); (760) 883-7181 (fax) | ||
| Summary Date | August 28, 2006 | ||
| Device TradeName: | AVEA Ventilator | ||
| DeviceCommon/Classification Name: | Classification name: 868.5895 Continuous Ventilator, 73 CBK | ||
| EstablishmentRegistrationNumber | 2021710 | ||
| Device Class: | Class II | ||
| ClassificationPanel: | Anesthesiology | ||
| Predicate Device: | The predicate devices are: | ||
| 510K | Product | Manufacturer | |
| 1 | K031745 | Infant Flow Plus Infant CPAPSystem(Trade Name: SIPAP System) | VIASYS RespiratoryCare Inc |
| 2 | K970460 | 840 Ventilator with Neo Mode Option | Tyco Puritan Bennett |
| DeviceDescription: | The AVEA is a servo-controlled, software-driven ventilator. It has adynamic range of breathing gas delivery that provides for neonatalthrough adult patients. Its graphical user interface module (UIM) has aflat panel color LCD with real time charting and digital monitoringcapabilities, a touch screen for interaction, membrane keys and a dialfor changing settings and operating parameters. It also has an internalgas delivery system with servo controlled active inhalation andexhalation functions. Using internal batteries this provides inter-hospital transport as well as back up capability due to loss of ACpower. The AVEA may be configured as a conventional ventilator ornon-invasive positive pressure ventilator (NPPV). It has beendesigned to function using commonly available accessories. |
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K062093 AVEA Ventilator 510(k) Special
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The AVEA is intended to provide continuous respiratory support in an Intended Use: 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.
Substantial The AVEA Ventilator is the same device as the AVEA Ventilator, which Equivalence was cleared for market under 510(k) K013642 and K022674.
Modifications to the AVEA Ventilator are associated with this submittal
- Software update encompasses a modification to the current . Non-Invasive ventilation previously cleared under K013642 of which allows for a particular mode on the Infant Flow Plus, Nasal CPAP.
- . This Nasal CPAP mode that is emulated is accomplished by a software modification only, utilizing existing AVEA hardware.
- . This Nasal CPAP mode is only for single level continuous positive airway pressure to nasal pronos.
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, .
Page B3
- 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 (mean NCPAP ventilation) to the predicate device(s).
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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Public Health Service
Image /page/2/Picture/11 description: The image shows the logo for the U.S. Department of Health and Human Services (HHS). The logo features a stylized caduceus, which is a symbol often associated with medicine and healthcare. The caduceus is depicted with three lines forming a shape resembling a stylized bird or abstract human figure. The words "HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 0 2006
Mr. Tom Gutierrez Regulatory Affairs Manager Viasys Respiratory Care, Incorporated 1100 Bird Center Drive Palm Springs, California 92262
Re: K062093
Trade/Device Name: AVEA Ventilator Regulation Number: 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 31, 2006 Received: September 1, 2006
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. 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 l'ederal 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Chiu Lin, Ph.D.
Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication For Use
510(k) Number (if known):
Device Name:
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 adult, ... . . . pediatric, and neonatal patients. It should only be operated by properly trained clinical personnel, under the direction of a physician.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
(21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Anesthesiology, General Hospital, Infection Control, Dental Devices | Page __ of __ |
| 510(k) Number: | K062093 |
(Posted November 13, 2003)
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K062093 AVEA Ventilator 510(k) Special
§ 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).