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 Description

Pulse oximeter sensors connecting to patient monitors

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the TruSignal® SpO2 PediTip Sensors, based on the provided text:

Important Note: The provided document states that clinical studies were NOT required for this device to support substantial equivalence. Instead, the manufacturer relied on the non-clinical tests and the established equivalence of materials and electro-optical components to a predicate device. Therefore, many of the typical questions regarding clinical study design (sample size, expert qualifications, adjudication, MRMC studies, ground truth for training data) do not apply directly to this specific submission.

Acceptance Criteria and Reported Device Performance

Since clinical studies were not performed, specific acceptance criteria in terms of SpO2 accuracy (e.g., A_rms values) are not explicitly stated for the device itself in this submission. Instead, the acceptance criteria focused on demonstrating equivalence to the predicate device in non-clinical tests.

Acceptance Criteria Category	Reported Device Performance
Safety	Performed equal to or better than the predicate device.
Mechanical Durability	Performed equal to or better than the predicate device.
Electromagnetic Compatibility	Performed equal to or better than the predicate device.
Current Transfer Ratio	Performed equal to or better than the predicate device.
Crosstalk	Performed equal to or better than the predicate device.
Substantial Equivalence	Concluded to be as safe, as effective, and performance is substantially equivalent to the predicate device (TruSignal® SpO2 FingerTip Sensors, K101871).

Study Information (Non-Clinical Equivalence Demonstration)

As mentioned, no clinical studies were conducted for the TruSignal® SpO2 PediTip Sensors in this submission. The "study" described is a series of non-clinical tests to demonstrate that the new sensor geometry did not adversely affect performance compared to its predicate device. This approach is based on the fact that the new device has identical materials and electro-optical components to the predicate.

Sample size used for the test set and the data provenance:
- Test Set Size: Not applicable in terms of patient data. The "test set" here refers to the device units subjected to non-clinical tests. The exact number of units is not specified, but it would have been a sample of the TruSignal® SpO2 PediTip Sensors.
- Data Provenance: Not applicable for patient data. The non-clinical tests would have been performed by GE Healthcare, likely at their R&D or manufacturing facilities. The specific country of origin for these tests is not explicitly stated in the provided text, but the submitter is GE Healthcare Finland Oy.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. As no clinical studies were performed, there was no need for experts to establish ground truth from patient data. The "ground truth" for the non-clinical tests would be the established performance characteristics of the predicate device against which the new device was compared.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No clinical data requiring adjudication by experts.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a pulse oximeter sensor, not an AI-assisted diagnostic tool requiring human reader studies.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. This device is a sensor. Its standalone performance was evaluated through the non-clinical tests (safety, mechanical durability, etc.) to ensure it functioned as expected on its own and comparably to the predicate.
The type of ground truth used:
- For the non-clinical tests, the "ground truth" was derived from predefined engineering specifications, regulatory standards, and the known performance characteristics of the legally marketed predicate device (TruSignal® SpO2 FingerTip Sensors, K101871).
The sample size for the training set:
- Not applicable. There is no AI/machine learning algorithm involved that would require a training set in the typical sense.
How the ground truth for the training set was established:
- Not applicable for the same reasons as above.

Summary

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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 +358-10-394 6561 fax +358-9-2726532 Secondary Contact Person: Tatja Pasanen RA Leader GE Healthcare, (GE Healthcare Finland Oy) Tel +358-10-394 2243 fax +358-9-2726532 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.

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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 (800) 638-2041 or (301) 796-7100 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

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).