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The Breas HA01 is a humidifier intended to humidify gases delivered to a patient with a Breas CPAP device or a bilevel ventilator constructed to use an internal mask leak and no active exhalation valve.

The HA01 is a humidifier that only can be used together with Breas breathing therapy equipment. such as iSleep or Viyo. It uses pass-over humidification to humidify the air delivered to the patient. It consists of the following major components: 1 Water container - a sealed container with a water capacity of 400 ml. It has one inlet port where the air from the ventilator enters the humidifier and one 22 mm standard conical male outlet port where various non-invasive patient interfaces, such as nasal masks may be connected. It has a detachable lid that is removed when filling water in the container. The water container is attached to other Breathing therapy equipment, such as iSleep or Vivo when in use. Dimensions: W × H × D148 × 155 × 98 mm Weight; 260 g (empty container) 2 Electronic heating unit that via a heating plate heats the water container. Power. 12-30 V DC. max 40 W. is supplied from the Breas breathing therapy unit that the humidifier is connected to. The output from the HA01 unit is controlled by software included in the attached Breas unit. This software, which is a modularized part of the connected unit, controls temperature and it includes alarm supervision.

The provided text describes a 510(k) premarket notification for a medical device, the Breas HA01 humidifier. It outlines the device's technical specifications and the testing performed to demonstrate its substantial equivalence to a predicate device. However, it does not contain the kind of detailed information typically found in a clinical study report regarding acceptance criteria, device performance, ground truth establishment, or sample sizes related to AI/algorithm performance.

Here's a breakdown of why it's not possible to extract the requested information from this document:

• This is a 510(k) summary, not a clinical study report. 510(k) submissions focus on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing and comparison of technological characteristics and intended use. They are generally not focused on clinical efficacy studies or detailed performance metrics against specific acceptance criteria in the same way a PMA or de novo submission might require.
• The device is a medical device (humidifier), not an AI/algorithm-driven device. The document refers to "software included in the attached Breas unit" that "controls temperature and it includes alarm supervision," but this is supervisory software for a physical medical device, not an AI or algorithm that would require a test set, ground truth established by experts, or MRMC studies.
• Clinical studies were explicitly stated as NOT required. The document states, "Clinical studies were not required to support a substantial equivalence determination." This confirms that no such clinical performance study, as typically described in the request, was conducted or submitted for this specific notification.

Therefore, I cannot provide the requested information because it is not present in the provided text. The questions are geared toward AI/algorithm performance studies, which were not performed or reported for this device in this submission.

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