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K Number
K041223
Device Name
MODIFICATION TO SERVO-I VENTILATOR SYSTEM, MODEL 64 87 800 E407E
Manufacturer
MAQUET CRITICAL CARE AB
Date Cleared
2004-07-29

(80 days)

Product Code
CBK
Regulation Number
868.5895
Type
Traditional
Panel
AN
Reference & Predicate Devices
K040221,K010093
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Servo' Ventilator System is intended for treatment and monitoring of patients in the range of I ne or re Fentually with respiratory failure or respiratory insufficiency. Servo' is a ventilator neonales, thanks and datas will respiratery gain. I o realthcare facilities and for in-hospital transport.

Device Description

The ventilator is a platform with several selectable ventilation modes which monitor patients whom need respiratory assistance. The Non-Invasive Ventilation Option is a software controlled feature available on the Servo-i ventilator. The microprocessor control of this feature allows a larger range of flow capabilities designed to meet patient needs safely in a non-invasive application.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for a device, nor does it describe a study explicitly proving that the device meets such criteria. The document is primarily a 510(k) summary for a Special 510(k) submission regarding a "NIV option for Servo-i" ventilator and concerns its substantial equivalence to predicate devices.

Therefore, I cannot provide a response filling the requested table and sections as the information is not present in the provided text.

Specifically, the document focuses on:

  • Identifying the device and its manufacturer.
  • Listing predicate devices.
  • Briefly describing the device as a software-controlled feature for the Servo-i ventilator, designed to handle non-invasive ventilation with features like disconnect/leakage detection.
  • Stating that the intended uses and indications are largely the same as the unmodified Servo-i, with a minor change in the lower range for infant use with the NIV option.
  • The FDA letter confirms the substantial equivalence determination but does not delve into detailed performance acceptance criteria or study results demonstrating compliance with such criteria.

§ 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).