TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR

K132696 · GE Healthcare Finland Oy · DQA · Sep 27, 2013 · Cardiovascular

Device Facts

• Record ID: K132696
• Device Name: TRUSIGNAL SPO2 ADULT AND PEDIATRIC ADHESIVE WRAP DISPOSABLE SENSOR
• Applicant: GE Healthcare Finland Oy
• Product Code: DQA · Cardiovascular
• Decision Date: Sep 27, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

TS-AAW-10 and TS-AAW-25 The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: > 20 kg (>44 pounds) TS-PAW-10 and TS-PAW-25 The Disposable Sensor is a single-patient use sensor intended for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds)

Device Story

TruSignal SpO2 Adult and Pediatric Disposable Sensors are single-patient use pulse oximetry sensors; used with standalone oximeters or modular patient monitors. Sensors contain LEDs (multiple wavelengths) and a photodetector; detect light attenuated by tissue. Resistor encodes LED wavelength for monitor calibration. Used in clinical settings (including step-down units); operated by healthcare professionals. Output (SpO2 and pulse rate) displayed on monitor; assists clinicians in patient status assessment and decision-making. Benefits include continuous, non-invasive monitoring of oxygenation and heart rate.

Clinical Evidence

Clinical verification performed via induced hypoxia studies on healthy adult volunteers (ages 19-31). Measured arterial hemoglobin saturation compared to CO-oximeter values. Results showed A_RMS < 2% during steady-state conditions (70-100% SpO2). Pediatric sensor equivalence supported by identical materials and electro-optical components to the adult sensor.

Technological Characteristics

Disposable pulse oximetry sensors; LED light source and photodetector; resistor-based wavelength encoding. Complies with IEC 60601-1, IEC 60601-1-2, ISO 9919, ISO 10993-1, IEC 60601-1-6, and IEC 62366. Connects to monitors via interconnect cables (TS-G3, TS-M3, TS-H3, TS-N3).

Indications for Use

Indicated for continuous non-invasive SpO2 and pulse rate monitoring in patients weighing 3-20 kg (pediatric) and >20 kg (adult).

Regulatory Classification

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.

Predicate Devices

• TruSignal SpO2 Allfit Sensor (K093881)

Submission Summary (Full Text)

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K132 bab

Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "g" and "e" intertwined within a circular border. The logo is in black and white.

GE Healthcare Finland Oy
Kuortaneenkatu 2, P.O. Box 900 ビ
Finland
T: [phone]
T: [phone]
F: [phone]
F: [phone]

## 510(k) Summary

In accordonce with 21 CFR 807.92 the following summary of information is provided:

| Date: | September 27, 2013 | |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Owner/Submitter: | GE Healthcare Finland Oy<br>Kuortaneenkatu 2<br>FIN-00510 Helsinki, Finland | |
| Primary Contact Person: | Joel Kent<br>Manager, Quality and Regulatory Affairs<br>GE Healthcare<br>Phone: [phone]<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Secondary Contact Person: | Rauno Ruoho<br>Regulatory Affairs Manager<br>GE Healthcare Finland Oy<br>Kuortaneenkatu 2<br>00510 Helsinki<br>Finland<br>Phone: + 358 10 394 3624<br>Fax: [phone]<br>E-mail: [e-mail] | |
| Device names (807.92(a)(2)): | Device Trade Name:<br>TruSignal® SpO2 Adult and Pediatric Adhesive Wrap Disposable<br>Sensors | |
| | Common/Usual Name:<br>Pulse Oximeter Sensors | |
| | Classification Names:<br>21 CFR 870.2700 Oximeter | |
| Product Code: | DOA | |
| Predicate Device(s)<br>(807.92(a)(3)): | TruSignal SpO2 Allfit Sensor cleared in K093881 TruSignal® Sensors<br>and Interconnect Cables | |
| Device Description<br>(807.92(a)(4)): | The TruSignal SpO2 Adult and Pediatric Disposable Sensors are used<br>together with standalone oximeters or modular patient monitors to<br>measure continuous non-invasive arterial oxygen saturation (SpO2)<br>and pulse rate monitoring. | |
| | The sensors are to be connected to a device using an interconnect<br>cable TS-G3, TS-M3, TS-H3 or TS-N3 (cleared in K093881). The<br>interconnect cable type depends on the monitor end connector of<br>the device. | |
| | The sensors contain light emitting diodes (LEDs) that emit light of<br>different wavelengths. The sensors also contain a photodetector for<br>detecting the emitted light after it has been attenuated by tissue. The<br>sensors further contain a resistor, which is used to encode the<br>wavelength of the LEDs used in the sensor. The resistor value is read<br>by the monitor to determine the calibration curve used for that<br>specific sensor. | |
| Intended Use (807.92(a)(5): | TS-AAW-10 and TS-AAW-25<br>The Disposable Sensor is a single-patient use sensor intended for<br>continuous non-invasive arterial oxygen saturation (SpO2) and pulse<br>rate monitoring. Patient weight range: > 20 kg (>44 pounds)<br>TS-PAW-10 and TS-PAW-25 | |
| | The Disposable Sensor is a single-patient use sensor intended for<br>continuous non-invasive arterial oxygen saturation (SpO2) and pulse<br>rate monitoring. Patient weight range: 3-20 kg (6.6-44 pounds) | |
| Technology<br>(807.92(a)(6)): | The TruSignal SpO2 Adult and Pediatric Disposable Sensors employ<br>the same fundamental scientific technology as their predicate device<br>TruSignal SpO2 Allfit Sensor K093881. | |
| | The following is an overview of the differences between the proposed<br>TruSignal SpO2 Adult and Pediatric Disposable Sensors and the<br>predicate device: | |
| | Patient Population Equivalent to the predicate device: Patient weight range has been changed from all patients of the predicate device to 3-20 kg (6.6-44 pounds) of the TS-PAW proposed device and > 20 kg (>44 pounds) of the TS-AAW proposed device. Applicable Electromagnetic Compatibility, Electrical safety, Usability, biocompatibility, engineering verification tests (such as cleaning, and material durability) and clinical performance testing test report show that the proposed device is as safe and effective as the predicate K093881. | |
| | | |
| Anatomical Sites<br>Equivalent to the predicate device:<br>Palm of the hand and side of the foot excluded from<br>0<br>the application sites.<br>Applicable Electromagnetic Compatibility, Electrical<br>0<br>safety, Usability, biocompatibility, engineering<br>verification tests (such as cleaning, and material<br>durability) and clinical performance testing test report<br>show that the proposed device is as safe and<br>effective as the predicate K093881<br>Environment of Use<br>Step down units added to the list of environments of<br>o<br>use of the proposed device. ESU removed from the list<br>of environments of use of the proposed device.<br>Applicable Electromagnetic Compatibility, Electrical<br>O<br>safety, Usability, biocompatibility, engineering<br>verification tests (such as cleaning, and material<br>durability) and clinical performance testing test report<br>show that the proposed device is as safe and<br>effective as the predicate K093881.<br>Sensor head<br>Geometry and dimensions<br>0<br>TS-AAW-10 and TS-AAW-25: Identical to the predicate<br>0<br>device.<br>TS-PAW-10, TS-PAW-25: Equivalent to the predicate<br>O<br>device: Geometry is identical to the predicate device.<br>The distance of the optical components have been<br>changed to be slightly less compared to the predicate<br>device to better fit the finger of the smaller pediatric<br>patients.<br>Applicable Electromagnetic Compatibility, Electrical<br>O<br>safety, Usability, biocompatibility, engineering<br>verification tests (such as cleaning, and material<br>durability) and clinical performance testing test report | | |
| show that the proposed device is as safe and<br>effective as the predicate K093881.<br>Equivalent to the predicate device in terms of<br>Materials<br>intended use.<br>Applicable Electromagnetic Compatibility, Electrical<br>o<br>safety, Usability, biocompatibility, engineering<br>verification tests (such as cleaning, and material<br>durability) and clinical performance testing test report | | |
| | show that the proposed device is as safe and<br>effective as the predicate K093881. | |
| | Electro-optical components Equivalent to the predicate<br>device:<br>• | |
| | • Identical LEDs, detector and leadframes. The color of<br>the sensor head have been changed from light pink<br>of the predicate device to white of the proposed<br>device. | |
| | • Applicable Electromagnetic Compatibility, Electrical<br>safety, Usability, biocompatibility, engineering<br>verification tests (such as cleaning, and material<br>durability) and clinical performance testing test report<br>show that the proposed device is as safe and<br>effective as the predicate K093881. |…