(79 days)
The Breas Vivo 40 is designed for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. The CPAP function is intended to deliver continuous positive airway pressure therapy for the treatment of obstructive sleep apnea. The Breas Vivo 40 shall only be used by patients with spontaneous breathing. The Breas Vivo 40 is not intended for life-sustaining applications or for transport of critical care patients. The Breas Vivo 40 is intended for non-invasive use.
The Vivo 40 is a pressure-supported and pressure-controlled ventilator with a CPAP function intended for spontaneous breathing patients who require long-term support by mechanical ventilation during night and part of the day. 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 Vivo 40 can be used in clinical settings (e.g., hospitals, sleep laboratories, sub-acute care institutions) and home environments. It must always be prescribed by a licensed physician. It is not intended for life support applications or for transport of critical care patients. The therapy delivered by the Breas Vivo 40 System can be either: 1) Pressure Controlled Ventilation (PCV) or 2) Pressure Support Ventilation (PSV) or 3) 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 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 housing are 7.2 × 9.1 × 8.9 inches, and the device weighs 8.9 pounds.
The Breas Vivo 40 System is a ventilator. The 510(k) summary does not include specific acceptance criteria values or detailed performance results in the format requested. Instead, it broadly states that the device passed various tests and met its stated performance specifications.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Test/Specification | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Non-clinical Performance | Capable of meeting stated performance specifications; all Risk Analysis issues addressed. | "The device passed all tests." |
| Comparative Testing to Predicate Devices | Substantial equivalence with predicate devices regarding Wave-form performance, Work of Breathing, and Pressure Dynamic regulation. | "This bench-testing confirmed that the Breas Vivo 40 System is substantial equivalent with regards to Wave-form performance as well as Work of Breathing and Pressure Dynamic regulation." |
| Electrical Safety (per IEC 601-1) | Compliance with IEC 601-1 requirements. | "The device passed all tests." |
| Safety and Essential Performance (per ISO 10651-6) | Compliance with ISO 10651-6 requirements. | "The device passed all tests." |
| Safety and Performance (per ISO 17510-1) | Compliance with ISO 17510-1 requirements. | "The device passed all tests." |
| Electromagnetic Compatibility (EMC) | Compliance with EMC testing requirements. | "The device passed all tests." |
| Mechanical Safety | Compliance with mechanical safety testing requirements. | "The device passed all tests." |
| Environmental Testing | Compliance with environmental testing requirements. | "The device passed all tests." |
| Functional Testing | Compliance with functional testing requirements. | "The device passed all tests." |
| Particle Matter Testing | Compliance with particle matter testing requirements. | "The device passed all tests." |
| Software Documentation and Testing (per FDA Guidance) | Documented and tested in accordance with FDA's "Guidance for the content of Premarket Submissions for Software Contained in Medical Devices." | "The device passed all tests." |
2. Sample size used for the test set and the data provenance:
- The document describes bench testing, meaning the tests were conducted in a laboratory setting, not on human subjects.
- The sample size for the test set (number of devices tested for each category) is not specified in the provided summary.
- The data provenance is not explicitly stated beyond being non-clinical testing performed by the manufacturer, Breas Medical AB, which is based in Sweden.
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 applicable as the summary describes non-clinical, bench testing of the device's physical and functional performance against technical standards and predicate devices. No human experts were used to establish a "ground truth" for diagnostic or clinical evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable as the summary describes non-clinical, bench testing. Adjudication methods are typically used in clinical studies for human interpretation or diagnosis.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The device is a ventilator, and the testing described is non-clinical bench testing, not a study involving human readers or AI assistance.
- The document explicitly states: "Clinical studies were not required to support a substantial equivalence determination."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable in the context of this device. The Breas Vivo 40 System is a physical medical device (ventilator) with embedded software, not a standalone diagnostic algorithm. The software itself was documented and tested for compliance with FDA guidance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical bench testing, the "ground truth" was established by technical standards, engineering specifications, and the performance characteristics of legally marketed predicate devices. This is not a clinical ground truth like pathology or outcomes data.
8. The sample size for the training set:
- This is not applicable. The device is a ventilator, not a machine learning model that requires a training set of data.
9. How the ground truth for the training set was established:
- This is not applicable as there is no training set for this device.
§ 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).