(44 days)
No
The summary describes a servo-controlled, software-driven ventilator with a user interface and gas delivery system. There is no mention of AI or ML in the device description, intended use, or performance studies. The only design change mentioned is a disposable filter/water trap.
Yes
The device is a ventilator, which provides respiratory support, directly treating or managing a patient's breathing difficulties.
No
The device is a ventilator, designed to provide respiratory support, not to diagnose medical conditions.
No
The device description clearly states it is a "servo-controlled, software-driven ventilator" and details hardware components like a user interface module, LCD, touch screen, membrane keys, dial, and a precision gas delivery engine. It also mentions a physical accessory, the Disposable Expiratory Filter / Water Trap. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided text, the AVEA Ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "continuous respiratory support." This is a life-support function directly applied to a patient, not a test performed on a sample taken from a patient.
- Device Description: The description details a mechanical ventilator with gas delivery and user interface components. There is no mention of analyzing biological samples or performing diagnostic tests.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring substances in these samples.
- Providing information for diagnosis, monitoring, or screening.
The device is a therapeutic device used to assist breathing, not a diagnostic device used to analyze samples.
N/A
Intended Use / Indications for Use
The AVEA Ventilator 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 be operated by properly trained clinical personnel, under the direction of a physician.
This is the same intended use as previously cleared for AVEA under K013642, K022674, and K062093. There is no change to the AVEA intended use.
Product codes
CBK
Device Description
The AVEA Ventilator is a fourth generation servo-controlled, software-driven ventilator. It has a dynamic range of breathing gas delivery that provides for neonatal through adult patients. Its revolutionary user interface module (UIM) provides maximum flexibility wit6h simple operator interaction. It has a flat panel color LCD with real time graphic displays and digital monitoring capabilities, a touch screen for easy interaction, membrane keys and a dial for changing settings and operating parameters. A precision gas delivery engine with servo controlled active inhalation and exhalation improves performance over previous generations.
The only design change is an optional Disposable Expiratory Filter / Water Trap to be used exclusively with the AVEA Ventilator.
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 (e.g. hospitals)
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
Verification and Validation Testing demonstrated that the AVEA Disposable Expiratory Filter / Water Trap meets its performance requirements at both: Component Level and System Level, and, that this device is substantially equivalent to medical devices currently legally marketed in the United States.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturer: | Cardinal Health 207
22745 Savi Ranch Parkway
Yorba Linda, CA 92887-4668 | AUG 13 2008 |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| Contact: | Andre von Muller 714-283-8472 (Phone/Fax) | |
| Summary date: | June 20, 2008 | |
| Device Trade Name: | AVEA Ventilator | |
| Device Common/
Classification Name: | Continuous Ventilator | |
| Regulation Number: | 868.5895 | |
| Product Code: | CBK | |
| Device Class: | II | |
| Classification Panel: | Anesthesiology | |
| Predicate Device: | The predicate devices used on this optional disposable Filter are:
• Existing reusable filter assembly (Which is part of the AVEA
Ventilator, cleared under K013642)
• Intersurgical: Clear Guard II - K990949 | |
| Device Description: | The AVEA Ventilator is a fourth generation servo-controlled, software-
driven ventilator. It has a dynamic range of breathing gas delivery that
provides for neonatal through adult patients. Its revolutionary user
interface module (UIM) provides maximum flexibility wit6h simple
operator interaction. It has a flat panel color LCD with real time graphic
displays and digital monitoring capabilities, a touch screen for easy
interaction, membrane keys and a dial for changing settings and
operating parameters. A precision gas delivery engine with servo
controlled active inhalation and exhalation improves performance over
previous generations.
The only design change is an optional Disposable Expiratory Filter /
Water Trap to be used exclusively with the AVEA Ventilator. | |
1
The AVEA Ventilator is intended to provide continuous respiratory Intended Use: support in an institutional health care environment (e.g. hospitals). It may be used on adult, pediatric, and neonatal patients. It should be operated by properly trained clinical personnel, under the direction of a physician.
This is the same intended use as previously cleared for AVEA under K013642, K022674, and K062093. There is no change to the AVEA intended use.
Substantial Equivalence:
The AVEA Ventilator remains the same in terms of intended use and fundamental scientific technology.
The optional AVEA Disposable Expiratory Filter / Water Trap has the following similarities to the existing reusable filter, currently used on the AVEA Ventilator, which previously received 510(k) concurrence:
- Is substantially equivalent in terms of BFE / VFE and resistance . performance to predicate device (Clear-Guard II) previously cleared under K990949
- Has the same indicated use as the reusable existing filter / water . trap which is integral to the AVEA Ventilator approved under K013642
In summary, the AVEA Disposable Expiratory Filter / Water Trap described in this submission is, in our opinion, substantially equivalent, in terms of safety, effectiveness, and performance, to the predicate device(s) currently in the market.
Verification and Validation Testing demonstrated that the AVEA Disposable Expiratory Filter / Water Trap meets its performance requirements at both: Component Level and System Level, and, that this device is substantially equivalent to medical devices currently legally marketed in the United States.
Summary of Testing_ Verification and Validation: (PERFORMANCE)
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Andre von Muller Regulatory Affairs Engineer Cardinal Health 207, Incorporated 22745 Savi Ranch Parkway Yorba Linda, California 92887-4668
AUG 1 3 2008
Re: K081837
Trade/Device Name: AVEA Disposable Expiratory Filter / Water Trap Regulation Number: 21 CFR 868.5895 Regulation Name: Continuous Ventilator Regulatory Class: II Product Code: CBK Dated: August 7, 2008 Received: August 8, 2008
Dear Mr. Muller:
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. Muller
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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Thiamuelt Ludms fore//
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
4
Indications for Use
510(k) Number (if known): -----------------
Device Name: __AVEA Disposable Expiratory Filter / Water Trap
Indications for Use: The AVEA Ventilator 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 be operated by properly trained clinical personnel, under the direction of a physician.
This is the same intended use as previously cleared for AVEA under K013642, K022674, and K062093. There is no change to the AVEA intended use.
Prescription Use
AND/OR Over the Counter Use (21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE- CONTINUE IN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
W. mclz fa m. Herbal
Division of Anesthesiology, General Hospital Infection Control. Dental Devices
Posted November 13, 2003)
837 510(k) Number:
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