The temperature probe is intended for use for continuous blood temperature monitoring as measured at a temperature monitoring adapter located within a Medtronic extracorporeal circulation device as specified in the device's instructions for use. The temperature probe is designed for use with a YSI tele-thermometer to monitor and display temperature.

Device Description

The temperature probe devices are intended for use with the temperature monitoring adapter of compatible Medtronic devices and the YSI™ tele-thermometer 1. The probe has a thermistor sensor housed in a stainless steel sheath connected to a 3-m (10-ft) cable, terminating with a 6.35-mm (1/4-in) phono plug.

AI/ML Overview

This refers to a 510(k) premarket notification for a Class II medical device, specifically a "Temperature Probe" (Product Code: FLL). The document details the device's characteristics and its comparison to predicate devices, along with performance testing to demonstrate substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" with numerical values. Instead, it lists performance tests and their "Pass" results, indicating the device met the requirements established for each test. The acceptance criteria for each test would be the specific requirements or standards defined prior to testing, which the device passed.

Test Description	Reference Standard/Requirement (Implicit Acceptance Criteria)	Reported Device Performance
IEC 60601	Ensures compliance with IEC 60601 electrical safety and Electromagnetic compatibility (EMC).	Pass
Temperature Range	Ensures performance at extreme temperature ranges.	Pass
Ambient Temperature Environment	Ensures performance at normal temperature ranges.	Pass
Accuracy	Accuracy over the entire specified temperature range.	Pass
Precision and Repeatability	Precision and repeatability of measurements over the specified temperature range with effects of air currents.	Pass
Time	Time required for the device to obtain a steady state reading.	Pass
Life Testing	Meets requirements for the expected life of the probe.	Pass
Liquid Ingress and Chemical Exposure Testing	Meets Ingress Protection and cleaning requirements.	Pass

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the exact sample size for each performance test. It states "Bench testing was used to demonstrate the performance characteristics," implying laboratory-based testing rather than clinical data from human subjects. There is no information regarding the country of origin of data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable. The device is a temperature probe, and its performance (e.g., accuracy, precision) is typically established through objective measurements against traceable standards in a laboratory setting, not by human expert opinion or interpretation of data in the same way an AI diagnostic tool would be evaluated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., medical image reading) where there might be disagreement among experts. For performance testing of a physical device like a temperature probe, objective measurements against established standards are used, not subjective adjudication.

5. 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

There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study is relevant for AI-assisted diagnostic tools involving human readers, which is not the case for this temperature probe.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This information is not applicable in the context of an AI algorithm. However, the performance tests listed in the table (e.g., accuracy, precision, life testing) assess the standalone performance of the device itself in a controlled environment, without human intervention beyond setting up the test conditions.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance tests mentioned, the "ground truth" would be established by:

Traceable standards: For accuracy and temperature range tests, the device's readings would be compared against highly accurate and calibrated reference thermometers.
Defined specifications/requirements: For other tests like life testing, ingress protection, or time to steady state, the ground truth is whether the device meets pre-defined engineering and safety specifications.
International standards: Compliance with IEC 60601 suggests adherence to internationally recognized electrical safety and EMC benchmarks.

8. The sample size for the training set

This information is not applicable. The temperature probe is a physical device, not an AI algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable, as there is no training set for a physical device.

Summary

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

May 20, 2016

Medtronic, Inc. Choua Thao Regulatory Affairs Specialist 7611 Northland Dr. Brooklyn Park, Minnesota 55428

Re: K160091

Trade/Device Name: Temperature Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 19, 2016 Received: April 20, 2016

Dear Choua Thao:

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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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 of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -

for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K160091

Device Name Temperature Probes

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary K160091

Date Prepared:	May 12, 2016
Submitter:	Medtronic, Inc.Medtronic Perfusion Systems7611 Northland DriveMinneapolis, MN 55428
	Establishment Registration Number: 2184009
Contact Persons:	Choua ThaoRegulatory Affairs SpecialistMedtronic Perfusion SystemsPhone: 763.514.9842Fax: 763.367.8360Email: choua.thao@medtronic.comAlternate Contact:Susan C. FidlerSenior Regulatory Affairs ManagerMedtronic Perfusion SystemsPhone: 763.514.9839Fax: 763.367.8360Email: susan.c.fidler@medtronic.com
Device Name and ClassificationTrade Name:	Temperature Probe
Common Name:	Clinical Electronic Thermometer
Regulation Number:	880.2910
Product Code:	FLL
Product Classification:	Class II

Predicate DeviceK100645	Affinity Temperature Probe
Reference DeviceK831528	Temperature Probe

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Device Description

The temperature probes meet the requirements of IEC 60601-1 when connected to a temperature monitor Class I or Class II device of type "CF."

Indications for Use

Comparison to Predicate and Reference Devices

A comparison of the proposed temperature probes to the currently marketed predicate devices (K831528 and K100645) indicates the following similarities:

Same operating principle
Same fundamental technological characteristics .
- o Substantially equivalent overall device design
- Substantially equivalent materials o
- o Same energy source
Substantially equivalent intended use/indications .

The following technological differences exist between the subject and predicate devices. The subject devices contain the following:

Differences	Impact Discussion
Use of lead free solder	Testing demonstrated that the change in solder had no impacton operation of the device.
Use of PVC for cable	Testing demonstrated that the change in cable material had noimpact on the operation of the device.
Use of RTV (room temperaturevulcanization silicone)	Testing demonstrated that the change in adhesive had noimpact on the operation of the device.
Use of additional insulation sleeve	Testing demonstrated that the additional insulation sleeve didnot negatively impact the operation of the device.

1 YSI is a trademark of YSI Incorporated.

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The following is a comparison table of the proposed temperature probes to the currently marketed predicate devices. The temperature probe devices are substantially equivalent.

	Reference I –K831528	Reference II –K831528	Predicate - K100645	Current Submission
Element ofComparison	Temperature Probe	Temperature Probe	Affinity TemperatureProbe	Temperature Probe	SubstantiallyEquivalent?
	FDA Clearance30June1983	FDA Clearance30June1983	FDA Clearance14September2012
Models	1384	TP	ATP210	1384, TP, ATP210
Indications for Use	Reusable temperatureprobes are designed forcontinuous temperaturemeasurement andcontrol with monitorsspecifically designed foruse with the 400 Seriestemperature.	The SciMed Model TPThermistor Probe isintended to be used withthe SciMed Model TMATemperature MonitoringAdapter and YSI Series400 equipment. Thethermistor is housed in astainless steel probe, andis connected to a ten footlong shielded cable that isterminated with a ¼ inchphone plug.	The Affinity TemperatureProbe is intended for usefor continuous bloodtemperature monitoring asmeasured at atemperature monitoringadapter located within aMedtronic extracorporealcirculation device asspecified in the device'sInstructions for Use. TheTemperature Probe isdesigned for use with aYSI™ Tele-thermometerto monitor and displaytemperature.	The temperature probe isintended for use forcontinuous blood temperaturemonitoring as measured at atemperature monitoringadapter located within aMedtronic extracorporealcirculation device as specifiedin the device's instructions foruse. The temperature probeis designed for use with a YSItele-thermometer to monitorand display temperature.	Yes
OperatingPrinciple	A device that measuresdifferences in resistanceand equates that tochanges in temperature	A device that measuresdifferences in resistanceand equates that tochanges in temperature	A device that measuresdifferences in resistanceand equates that tochanges in temperature	A device that measuresdifferences in resistance andequates that to changes intemperature	Yes
Components	Reusable	Reusable	Reusable	Reusable	Yes
Element ofComparison	Reference I –K831528	Reference II –K831528	Predicate - K100645	Current Submission	SubstantiallyEquivalent?
	Temperature Probe	Temperature Probe	Affinity TemperatureProbe	Temperature Probe
	FDA Clearance30June1983	FDA Clearance30June1983	FDA Clearance14September2012
Models	1384	TP	ATP210	1384, TP, ATP210
Sensor	Thermistor Sensor Tip	Thermistor Sensor Tip	Thermistor Sensor Tip	Thermistor Sensor Tip	Yes
Materials	• Thermistor• Sensor Tip -Stainless Steel,Brass, Ceramic• Cable - TPE (C-Flex) and Copper• Phono Plug -Brass	• Thermistor SensorTip - Stainless Steel,Brass, Ceramic• Cable - TPE (C-Flex) and Copper• Phono Plug - Brass	• Probe tip - StainlessSteel, Brass,Ceramic• Cable - TPE (C-Flex) and Copper• Phono Plug - Brass	• Probe tip –Stainless Steel and Brass• Cable - PVC and Copper• Phono Plug - Brass	Yes
Thermistor	NegativeTemperatureCoefficient (NTC)Thermistor	Negative TemperatureCoefficient (NTC)Thermistor	Negative TemperatureCoefficient (NTC)Thermistor	Negative TemperatureCoefficient (NTC) Thermistor	Yes
Cable	PVC Insulated 2conductor twistedpair2	PVC Insulated 2conductor twisted pair	PVC Insulated 2conductor twisted pair	PVC Insulated 2 conductortwisted pair	Yes
Phono Plug	6.35-mm (1/4-in)phono plug	6.35-mm (1/4-in) phonoplug	6.35-mm (1/4-in) phonoplug	6.35-mm (1/4-in) phono plug	Yes

Comparison Table – Indications for Use and Physical Specification

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² Two 24 gauge wires twisted around each other throughout the length of the cable.

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Summary of Performance Data

Bench testing was used to demonstrate the performance characteristics of the temperature probe devices. Clinical testing was not required to establish substantial equivalence.

The following performance tests were conducted:

Test	Description	Result
IEC 60601	Ensures the temperature probes meet the requirements of IEC 60601 electrical safety and Electromagnetic compatibility (EMC).	Pass
Temperature Range	Ensures the temperature probes meet the requirements of the system at the extreme temperature ranges.	Pass
Ambient Temperature Environment	Ensures the temperature probes meet the requirements of the system at the normal temperature ranges.	Pass
Accuracy	Accuracy over the entire temperature range specified for the device.	Pass
Precision and Repeatability	Precision and repeatability of measurements over the temperature range specified with the effects of air currents, over the entire temperature range specified.	Pass
Time	Indicate the time required for the device to obtain a steady state reading.	Pass
Life Testing	Ensures the temperature probes meet the requirements of the expected life of the probe.	Pass
Liquid Ingress and Chemical Exposure Testing	Ensures the temperature probes meet the Ingress Protection and cleaning requirements.	Pass

Conclusion

Medtronic has determined that the temperature probe devices described in this submission has shown to be substantially equivalent to the predicate devices.

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
Identification. A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(1) Device is not a clinical thermometer with telethermographic functions;
(2) Device is not a clinical thermometer with continuous temperature measurement functions; and
(3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.