(427 days)
The SERVO-U ventilator system is:
- intended for respiratory support, monitoring and treatment of neonatal, pediatric and adult patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
For NAVA and Edi monitoring, it is in addition intended:
- to provide monitoring of the patient's breathing drive
- to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
- for use on all patients with no contraindication for insertion/exchange of a nasogastric tube
The SERVO-n ventilator system is:
- intended for respiratory support, monitoring and treatment of neonatal and pediatric patients
- to be used only by healthcare providers
- to be used only in professional healthcare facilities and for transport within these facilities
For NAVA and Edi monitoring, it is in addition intended:
- to provide monitoring of the patient's breathing drive
- to improve synchrony between the ventilator system and patient when the electrical signal from the brain to the diaphragm is active
- for use on all patients with no contraindication for insertion/exchange of a nasogastric tube
The SERVO-U/n 2.1 is available in two models, SERVO-U and SERVO-n. The SERVO-U/n 2.1 consists of a Patient Unit where gases are mixed and administered, and a User Interface where the settings are made and ventilation is monitored. The SERVO-U/n 2.1 is based on the cleared predicate device SERVO-U/n 1.1 (K151814), with some improvements. The ventilation modes in the SERVO-U/n 2.1 are similar as in the predicate device, even though the standard configurations of available modes and optional modes differ between the devices, i.e. SERVO-U, SERVO-n and the cleared predicate device SERVO-U/n 1.1. The ventilator delivers controlled or supported breaths to the patient, with constant flow, constant pressure or pressure proportional to the Edi signal (the electrical activity of the diaphragm) of the patient, using a set oxygen concentration. SERVO-U/n contains a dedicated controller circuit for the Aerogen Pro and Solo nebulizers (included as standard). Accessories for CO2 monitoring and flow and pressure measurements at the Y piece (Y sensor) are integrated as options. The SERVO-U/n Ventilator System will produce visual and audible alarms if any parameter varies beyond pre-set or default limits and produce alarm recordings. The system contains provisions for battery modules to supply the system in the case of mains power failure or during intra-hospital transport.
The provided text is a 510(k) summary for the SERVO-U/n Ventilator System 2.1. It details the device's intended use and compares it to a predicate device, CERVO-U/n 1.1. However, it does not describe an AI/algorithm-driven device performance study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Instead, the document states: "No clinical investigation has been performed since it has been concluded based on literature data, state of the art knowledge and applicable product standards that SERVO-U/n 2.1 has no new clinical aspects or risks which are not already discussed and evaluated in the 510(k) submission for the cleared predicate device SERVO-U/n 1.1 (K151814)."
Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/algorithm-driven device, as no such study is presented or referenced in the provided text.
The document primarily focuses on demonstrating substantial equivalence to a predicate device through:
- Comparison of Intended Use: States it's identical.
- Comparison of Technology Characteristics: Details improvements and changes from the predicate without introducing AI components.
- Non-clinical Testing and Performance: Lists design verification activities (code review, unit tests, system tests, regression testing, etc.), compliance with product standards (e.g., ANSI/AAMI, IEC, ISO), and biocompatibility evaluation.
The key takeaway is that the clearance for the SERVO-U/n Ventilator System 2.1 is based on its substantial equivalence to a previous version and adherence to recognized standards, not on an AI performance study.
§ 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).