(15 days)
The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.
The provided FDA 510(k) clearance letter for the AIRO Suction Unit (AIRO-01) is for a powered suction pump. Such devices are typically evaluated based on their physical and functional performance rather than AI/ML algorithm performance.
Therefore, many of the requested categories related to AI/ML specific studies (like MRMC studies, sample sizes for AI training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.
Here's a breakdown of the available information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states the device was tested to ISO 10079-1 and ISO 10079-4, and all applicable clauses were successfully executed, meeting the established criteria. However, the specific quantitative acceptance criteria and detailed performance results are not explicitly provided in the excerpt. We can infer the performance from the device description and the ISO standards it complies with.
| Acceptance Criterion (Inferred from ISO 10079-1:2015 and device description) | AIRO Suction Unit (AIRO-01) Reported Performance |
|---|---|
| Vacuum Pressure Range: | 20-550 mmHg |
| Low Vacuum Level (≤ 150 mmHg / ≤ 20 kPa) compliance: | Compliant (device achieves a continuous range of vacuum pressures from 20 mmHg) |
| Medium Vacuum Level (150 - 450 mmHg / 20 - 60 kPa) compliance: | Compliant (device achieves a continuous range of vacuum pressures between 150-450 mmHg) |
| High Vacuum Level (≥ 450 mmHg / ≥ 60 kPa) compliance: | Compliant (device achieves a continuous range of vacuum pressures up to 550 mmHg) |
| **Low Flowrate Device (Free air flowrate |
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.