(113 days)
The Vivo 40 is an assist ventilator intended to augment the breathing of spontaneously breathing adult patients >66 lbs (>30 kg) suffering from respiratory failure, respiratory insufficiency, or obstructive sleep apnea.
The Vivo 40 is not intended to provide the total ventilatory requirements of the patient.
The Vivo 40 is intended to be used for both invasive and non-invasive applications.
The Vivo 40 is intended to be operated by qualified and trained personnel.
The Vivo 40 is intended for use in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments.
The Vivo 40 must always be prescribed by a licensed physician.
The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneously breathing patients to augment the breathing.
In the treatment of chronic respiratory failure, positive airway pressure ventilation is well established and common practice as a mean to assure sufficient gas exchange. There are a number of devices legally marketed in the United States for this application.
The therapy delivered by the Breas Vivo 40 System can be either:
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- Pressure Controlled Ventilation (PCV) or
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- Pressure Support Ventilation (PSV) or
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- Constant Positive Airway Pressure (CPAP)
The Vivo 40 airflow is delivered via a single lumen outlet tube that may be connected to various non-invasive and invasive patient interfaces, such as nasal masks. To minimize CO2 rebreathing, masks or other interfaces permitting a leak flow of at least 12 liters/minute at the output pressure setting of 4 cmH20 are recommended.
The Vivo 40 has an auto-switching power supply that facilitates use in conjunction with international travel (100 - 240 VAC). It can also be used with an external 12.5/ 24 VDC power source when AC mains line voltage is not available.
The outer dimensions of the Vivo 40 housine are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.
This document describes the Breas Vivo 40 ventilator with a new "Target Volume" feature, seeking 510(k) clearance from the FDA. The submission largely relies on predicate device comparison and bench testing rather than extensive clinical studies.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Equivalence to Predicate Devilce(Breas Vivo 40 without Target Volume and Respironics BiPAP AVAPS) | Substantial equivalence in: |
- Pressure stability
- Dynamic pressure regulation
- Waveform performance
- Target volume feature | Bench testing confirmed substantial equivalence for:
- Wave-form performance
- Work of Breathing
- Pressure Dynamic regulation
- Target Volume feature |
| Safety and Effectiveness | As safe and effective as therapy without the Target Volume feature. | Clinical article attached (Appendix 12) supporting the use of volume-controlled ventilation in combination with pressure-controlled ventilation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not applicable. The primary evidence presented is bench testing and a single clinical article, not a clinical study with a defined patient test set for the device itself.
- Data Provenance:
- Bench Testing: Performed by Breas Medical AB (Sweden). This is retrospective as it's testing a modification to an existing device.
- Clinical Article: Referencing "one clinical article" provided in Appendix 12. The provenance (country of origin, retrospective/prospective) of this article's data is not specified in the provided text.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. As no clinical study with a patient test set for the device was performed by Breas Medical, there were no experts used to establish ground truth for such a test set. The bench testing relies on engineering standards and measurements, not expert human assessment. The cited clinical article would have its own ground truth establishment methods, but these are not for the device's specific performance in this submission.
4. Adjudication Method for the Test Set
- Not applicable. No human-involved test set requiring adjudication was conducted by Breas Medical for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
- No. An MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing has been performed by Breas Medical."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, in a sense, standalone performance testing was done in the form of "bench testing." The "Target Volume" feature is a software-based algorithm that adjusts pressure. The bench tests evaluated the performance of this algorithm (and the integrated device) in a controlled environment, without human intervention in the device's operation during the tests.
7. The Type of Ground Truth Used
- Bench Testing: The ground truth for bench testing is established by engineering specifications, physical principles, and measurement standards for ventilator performance (e.g., precise pressure and flow measurements, waveform analysis, tidal volume delivery).
- Clinical Article: The ground truth for the cited clinical article (not part of Breas Medical's direct testing) would depend on the study's design, but typically in clinical ventilation studies, it could involve physiological measurements (e.g., blood gas analysis, lung mechanics), patient outcomes, or expert clinical assessment.
8. The Sample Size for the Training Set
- Not applicable. The Vivo 40 with the Target Volume feature is a medical device, not an AI/ML algorithm that is "trained" on a dataset in the conventional sense. Its "training" or development would involve engineering design, simulation, and iterative hardware/software development and testing, not a labeled training dataset.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as there is no "training set" in the context of AI/ML for this device. The development of the device's control algorithms would be based on established physiological models, control theory, and engineering principles, with validation through simulations and bench testing.
§ 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).