(44 days)
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.
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.
The provided text is a 510(k) summary for the AVEA Ventilator's optional Disposable Expiratory Filter / Water Trap. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device performance claim through a clinical study with specific acceptance criteria.
The key points from the document regarding "acceptance criteria" and "study" are:
- Acceptance Criteria: The device is considered to meet acceptance criteria if it is "substantially equivalent in terms of BFE / VFE and resistance performance" to the predicate device (Clear-Guard II, K990949) and "has the same indicated use as the reusable existing filter / water trap" (integral to the AVEA Ventilator, K013642).
- Study: "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."
This 510(k) summary does not provide the kind of detailed clinical study information (e.g., sample sizes, ground truth establishment, expert qualifications, MRMC studies) that would typically be associated with a device making a new performance claim or AI algorithm. It is a "substantial equivalence" review for a modification (an optional disposable filter) to an already cleared ventilator.
Therefore, the requested table and detailed information mostly cannot be extracted because the provided document does not contain that level of detail for this type of submission.
Here's a breakdown of what can be inferred or stated from the text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantially equivalent in BFE (Bacterial Filtration Efficiency) / VFE (Viral Filtration Efficiency) performance to predicate device (Clear-Guard II - K990949). | Not explicitly quantified in this document, but the submission concludes that it "is substantially equivalent in terms of BFE / VFE" to the predicate. |
| Substantially equivalent in resistance performance to predicate device (Clear-Guard II - K990949). | Not explicitly quantified in this document, but the submission concludes that it "is substantially equivalent in terms of ... resistance performance" to the predicate. |
| Has the same indicated use as the reusable existing filter / water trap (integral to AVEA Ventilator, K013642). | Stated: "Has the same indicated use as the reusable existing filter / water trap which is integral to the AVEA Ventilator approved under K013642." The intended use remains unchanged. |
| Meets performance requirements at both Component Level and System Level. | Stated: "Verification and Validation Testing demonstrated that the AVEA Disposable Expiratory Filter / Water Trap meets its performance requirements at both: Component Level and System Level." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. The document refers to "Verification and Validation Testing" but does not break down the specific sample sizes used for BFE/VFE or resistance testing.
- Data Provenance: Not specified. It's likely laboratory testing rather than patient data, given the nature of the filter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable as this is not a diagnostic device involving expert interpretation or ground truthing of clinical data in the traditional sense. Performance is based on physical and biological filtration efficiency measurements.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable for the type of testing described (performance testing of a filter).
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, an MRMC study was not done. This device is a ventilator filter, 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
- No, this is a hardware device (filter), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is the measured performance metrics (BFE, VFE, resistance) against established engineering standards and the performance of the predicate device. It's not clinical "ground truth" derived from patient outcomes or expert consensus.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
| Manufacturer: | Cardinal Health 20722745 Savi Ranch ParkwayYorba 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 AVEAVentilator, 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 thatprovides for neonatal through adult patients. Its revolutionary userinterface module (UIM) provides maximum flexibility wit6h simpleoperator interaction. It has a flat panel color LCD with real time graphicdisplays and digital monitoring capabilities, a touch screen for easyinteraction, membrane keys and a dial for changing settings andoperating parameters. A precision gas delivery engine with servocontrolled active inhalation and exhalation improves performance overprevious generations.The only design change is an optional Disposable Expiratory Filter /Water Trap to be used exclusively with the AVEA Ventilator. |
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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)
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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.
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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
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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:
Page _ 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).