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K Number
K111595
Device Name
NEUMOVENT GRAPHNET
Manufacturer
TECME S.A.
Date Cleared
2012-01-27

(234 days)

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

Model: Advance
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for patients from neonate/infant to adult. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Model: Neumovent GraphNet TS
Intended to provide continuous ventilation to patients respiratory support. The devices are intended for patients from pediatric to adult with an option for neonate/infant patients. The devices are intended to be used in hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Model: Neumovent GraphNet NEO
Intended to provide continuous ventilation to patients requiring respiratory support. The devices are intended for neonate/infant patient. The devices are intended to be used in hospital and hospital-type facilities and during hospital and hospital-type transport provided that electrical power and compressed gas are supplied.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) premarket notification FDA clearance letter for a continuous ventilator, the Neumovent GraphNet. It indicates that the device has been found substantially equivalent to predicate devices, but it does not contain any information regarding acceptance criteria, device performance studies, or clinical trial data.

Therefore, I cannot provide the requested information. The prompts about "acceptance criteria," "reported device performance," "sample sizes," "expert ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," and "training set details" are not addressed in this regulatory document.

§ 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).