TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR

• K Number: K093881
• Device Name: TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR
• Manufacturer: GE HEALTHCARE FINLAND OY
• Date Cleared: 2010-03-12 ( 84 days)
• Product Code: DQA , DPZ
• Regulation Number: 870.2700
• Type: Special
• Panel: Anesthesiology
• Reference & Predicate Devices: K062576 , K040831 , K021955 , K992323
• Predicate For: K132696 , K250931

Intended Use

TS-F-D
The Finger Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range > 20 kg (> 44 pounds)

TS-E-D
The Ear Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The headband is single-patient use. Patient weight range > 10 kg (> 22 pounds)

TS-W-D
The Wrap Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are single-patient use. Patient weight range > 3 kg (> 6.6 pounds)

TS-SE-3
The Sensitive Skin Sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. The tape and foam wrap are singlepatient use. Patient weight range All patients

TS-AF-10 and TS-AF-25
The AllFit Sensor is a single-patient use adhesive sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range All patients

Trusignal SpO2 Interconnect cables
The Interconnect Cable is a reusable cable intended for use for all patients for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring when used with a compatible SpO2 sensor.

Device Description

Pulse oximeter sensors and interconnect cables connecting to patient monitors

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study details for the TruSignal® SpO2 Sensors and Interconnect Cables, based on the provided 510(k) summary:

1. Acceptance Criteria and Device Performance

Acceptance Criteria (Target)	Reported Device Performance
A_RMS (Accuracy Root Mean Square)

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).