TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR

K103802 · GE Healthcare Finland Oy · DQA · Aug 2, 2011 · Cardiovascular

Device Facts

• Record ID: K103802
• Device Name: TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR; TRUSIGNAL R SPO2 PEDITIP SENSOR
• Applicant: GE Healthcare Finland Oy
• Product Code: DQA · Cardiovascular
• Decision Date: Aug 2, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2700
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

TS-SP3-GE The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds) TS-SP3-MC The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds) TS-SP-D The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

Device Story

TruSignal® SpO2 PediTip Sensors are reusable pulse oximeter sensors designed for continuous, non-invasive monitoring of arterial oxygen saturation and pulse rate. Sensors connect to compatible patient monitors to provide real-time physiological data. Operation involves optical sensing of blood oxygenation; device transforms light absorption signals into SpO2 and pulse rate values. Used in clinical settings by healthcare professionals. Device benefits include reliable, continuous monitoring for pediatric patients (15-30 kg). Output is displayed on connected patient monitors to assist clinicians in patient assessment and decision-making. The PediTip sensor utilizes identical optical and electrical components to the predicate TruSignal® FingerTip sensors, with modifications only to the sensor head geometry to accommodate pediatric anatomy.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing and identical electro-optical components to the predicate device (K101871).

Technological Characteristics

Reusable pulse oximeter sensor; optical sensing principle; identical electro-optical components to predicate K101871; modified sensor head geometry for pediatric use; connects to patient monitors; no internal software/firmware (passive sensor).

Indications for Use

Indicated for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring in pediatric patients weighing 15-30 kg (33-66 pounds).

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 FingerTip Sensors (K101871)
• Philips M1 192A Reusable SpO2 sensor (K882609)

Submission Summary (Full Text)

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1103802

GE Healthcare _

510(k) Premarket Notification Submission

#### 510(k) Summary

In accordance with 21 CFR 807.92 the following summary of information is provided: Date: 22-December-2010 GE Healthcare, (GE Healthcare Finland Oy) Submitter: Kuortaneenkatu 2 FIN-00510 Helsinki, Finland Primary Contact Person: Tommi Jokiniemi RA Leader GE Healthcare, (GE Healthcare Finland Ov) Tel [phone] fax [phone] Secondary Contact Person: Tatja Pasanen RA Leader GE Healthcare, (GE Healthcare Finland Oy) Tel [phone] fax [phone] Device: Trade Name: TruSignal® SpO2 PediTip Sensor Common/Usual Name: Pulse Oximeter Sensors Classification Names: 21CFR870.2700 Product Code: DQA Predicate Device(s): K101871 TruSignal® SpO2 FingerTip Sensors K882609 Philips M1 192A Reusable SpO2 sensor Device Description: Pulse oximeter sensors connecting to patient monitors Intended Use: TS-SP3-GE The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds) TS-SP3-MC The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

TS-SP-D

The sensor is a reusable sensor intended for use for continuous

Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

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GE Healthcare __

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510(k) Premarket Notification Submission

non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

Technology: The TruSignal® SpO2 PediTip Sensors employ the same fundamental scientific technology as its predicate devices. They are identical to the predicate device TruSignal® SpO2 FingerTip Sensors except for the sensor head geometry. All optical and electrical components of the sensors are identical to the predicate device TruSignal® SpO2 FingerTip Sensors.

> To demonstrate sensor geometry did not have an adverse effect on the performance of the products, the products were tested for safety, mechanical durability, electromagnetic compatibility, current transfer ratio and crosstalk. As the proposed devices performed equal or better in all of these areas, the performance of the proposed device is at least equal to the predicate device TruSignal® SpO2 FingerTip Sensors.

#### Summary of Non-Clinical Tests: Determination of Substantial Equivalence:

The TruSignal® SpO2 PediTip Sensors and their applications comply with voluntary standards as detailed in Section 9 of this premarket submission. The following quality assurance measures were applied to the development of the system:

- . Risk Analysis
- . Requirements Reviews
- . Design Reviews
- . Testing on unit level (Module verification)
- Integration testing (System verification) .
- . Performance testing (Verification)
- Safety testing (Verification) .
- . Simulated use testing (Validation)

## Summary of Clinical Tests:

The subject of this premarket submission, TruSignal® SpO2 PediTip Sensors, did not require clinical studies to support substantial equivalence.

has identical This sensor materials and electro-ontical components and equivalent sensor characteristics, thus the clinical data from TruSignal FingerTip SpO2 Sensor K101871 applies to this sensor as well.

Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

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# GE Healthcare

. . .

ﺎ ﺗﻘ

510(k) Premarket Notification Submission

- GE Healthcare considers the TruSignal® SpO2 PediTip Sensors Conclusion: to be as safe, as effective, and performance is substantially equivalent to the predicate device TruSignal® SpO2 FingerTip Sensors.
·Confidential and Privileged. This document confidential and privileged trade screts and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Ms. Tatja Pasanen Regulatory Affairs Leader GE Healthcare Finland OY Kuortaneekatu 2 FIN-00510 Helsinki, Finland

AUG - 2 2011

Re: K103802

Trade/Device Name: TruSignal® SpO2 PediTip Sensors Regulation Number: 21 CFR 870.2700 Regulation Name: Oximeter Regulatory Class: II Product Code: DQA Dated: July 25, 2011 Received: July 27, 2011

Dear Ms. Pasanen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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# Page 2 - Ms. Pasanen

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/ CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem /default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerelv vours.

Nh for

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology. General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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GE Healthcare .. 510(k) Premarket Notification Submission

510(k) Number (if known):

Device Name: TruSignal® SpO2 PediTip Sensors

Indications for Use:

### TS-SP3-GE

The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

#### TS-SP3-MC

The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

# TS-SP-D

The sensor is a reusable sensor intended for use for continuous non-invasive arterial oxygen saturation (SpO2) and pulse rate monitoring. Patient weight range: 15-30 kg (33-66 pounds)

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
L. Shulter

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K103802

Confidential and Privileged. This document contains confidential and privileged trade secrets and other information of General Electric Co. and as such may not be disclosed to others not employed by General Electric Co. All rights reserved