INFINITY GAMMA / GAMMAXL, INFINITY VISTA

• K Number: K053484
• Device Name: INFINITY GAMMA / GAMMAXL, INFINITY VISTA
• Manufacturer: Draeger Medical Systems, Inc.
• Date Cleared: 2006-02-22 ( 69 days)
• Product Code: MHX
• Regulation Number: 870.1025
• Type: Special
• Panel: CV
• Reference & Predicate Devices: K042656 , K033600 , K040188 , K041087

Intended Use

This devices are capable of monitoring:

• Heart Rate .
• Respiration Rate .
• Invasive Pressure .
• Non-Invasive Pressure .
• Arrhythmia .
• Temperature ◆
• Arterial oxygen saturation .
• Pulse rate
• central apnea .
• end-tidal CO2* .
• ST Segment Analysis .

This device will produce visual and audible alarms if any of these parameters vary beyond presel linits and I mo do roo alarin recordings. The devices will connect to R50 recorders either directly or via the Infinity network.

When a GammaXL is connected to a SCIO* module sampled breathing gases from adults and pediatrics can be displayed. The gas module continuously measures the content of CO2, N2O, O2 and one of the anestheic agents, Halothane, Isoflurane, Enflurane, Sevoflurane in any mixture and communicates real time and derived gas information to the GammaXL.

The device is intended to be used in an environment where patient care is provided by Healthcare Professionals, i.e. physicians, nurses, and technicians, trained on the use of the device, who will determine when use of the device is indicated, based upon their professional assessment of the patient's medical condition.

The devices are intended for use in the Adult, Pediatric and Neonatal populations, with the exception of Arrhythmia and ST Segment Analysis which are not intended for the neonatal population.

• not available with Infinity Vista

Device Description

The intent of this 510(k) is to describe modifications for the Infinity Gamma/GammaXL and Vista monitors, including Pacer Fusion mode, three new versions of the Scio gas module, and Draeger's Masimo SET pod.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Infinity Gamma Series VF6 Monitors) and does not contain information about acceptance criteria or a study proving the device meets said criteria.

The submission is for modifications to an existing device, and it states: "Verification and validation testing performed indicates that the modifications implemented in the VF6 release of the Gamma series monitors are as safe and effective as previous versions and have not altered the fundamental technology of the device(s)."

However, it does not provide details of what "verification and validation testing" entailed, what the acceptance criteria for that testing were, or what the reported performance was against those criteria.

Therefore, I cannot extract the requested information regarding acceptance criteria and performance from the given text.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.