Temperature Probe, Affinity Temperature Probe

K160091 · Medtronic, Inc. · FLL · May 20, 2016 · General Hospital

Device Facts

• Record ID: K160091
• Device Name: Temperature Probe, Affinity Temperature Probe
• Applicant: Medtronic, Inc.
• Product Code: FLL · General Hospital
• Decision Date: May 20, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

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 Story

Temperature probe consists of a thermistor sensor housed in a stainless steel sheath, connected to a 3-meter cable with a 6.35-mm phono plug. Device operates by measuring electrical resistance changes in the thermistor, which are equated to temperature changes. Used in clinical settings during extracorporeal circulation; operated by healthcare professionals. Input is thermal energy from blood; output is an electrical signal processed by a YSI tele-thermometer to display temperature. Benefits include continuous, real-time blood temperature monitoring to assist clinical decision-making during perfusion procedures.

Clinical Evidence

Bench testing only. No clinical data required. Performance testing included IEC 60601 electrical safety and EMC, temperature range accuracy, precision/repeatability, response time, life testing, and liquid ingress/chemical exposure testing. All tests passed.

Technological Characteristics

Thermistor-based sensor; stainless steel/brass probe tip; PVC cable; 6.35-mm phono plug. Energy source: electrical (passive resistance measurement). Connectivity: wired to YSI tele-thermometer. Compliance: IEC 60601-1 (Type CF).

Indications for Use

Indicated for continuous blood temperature monitoring in patients undergoing extracorporeal circulation using Medtronic devices.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Affinity Temperature Probe (K100645)

Reference Devices

• Temperature Probe (K831528)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> 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.<br>Medtronic Perfusion Systems<br>7611 Northland Drive<br>Minneapolis, MN 55428 |
| | Establishment Registration Number: 2184009 |
| Contact Persons: | Choua Thao<br>Regulatory Affairs Specialist<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail]<br><br>Alternate Contact:<br>Susan C. Fidler<br>Senior Regulatory Affairs Manager<br>Medtronic Perfusion Systems<br>Phone: [phone]<br>Fax: [phone]<br>Email: [e-mail] |
| Device Name and Classification<br>Trade Name: | Temperature Probe |
| Common Name: | Clinical Electronic Thermometer |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
| Product Classification: | Class II |

| Predicate Device<br>K100645 | Affinity Temperature Probe |
|-----------------------------|----------------------------|
| Reference Device<br>K831528 | Temperature Probe |

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### 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.

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

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.

## 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 impact<br>on operation of the device. |
| Use of PVC for cable | Testing demonstrated that the change in cable material had no<br>impact on the operation of the device. |
| Use of RTV (room temperature<br>vulcanization silicone) | Testing demonstrated that the change in adhesive had no<br>impact on the operation of the device. |
| Use of additional insulation sleeve | Testing demonstrated that the additional insulation sleeve did<br>not 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 –<br>K831528 | Reference II –<br>K831528 | Predicate - K100645 | Current Submission | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Element of<br>Comparison | Temperature Probe | Temperature Probe | Affinity Temperature<br>Probe | Temperature Probe | Substantially<br>Equivalent? |
| | FDA Clearance<br>30June1983 | FDA Clearance<br>30June1983 | FDA Clearance<br>14September2012 | | |
| Models | 1384 | TP | ATP210 | 1384, TP, ATP210 | |
| Indications for Use | Reusable temperature<br>probes are designed for<br>continuous temperature<br>measurement and<br>control with monitors<br>specifically designed for<br>use with the 400 Series<br>temperature. | The SciMed Model TP<br>Thermistor Probe is<br>intended to be used with<br>the SciMed Model TMA<br>Temperature Monitoring<br>Adapter and YSI Series<br>400 equipment. The<br>thermistor is housed in a<br>stainless steel probe, and<br>is connected to a ten foot<br>long shielded cable that is<br>terminated with a ¼ inch<br>phone plug. | The Affinity Temperature<br>Probe is intended for use<br>for continuous blood<br>temperature monitoring as<br>measured at a<br>temperature monitoring<br>adapter located within a<br>Medtronic extracorporeal<br>circulation device as<br>specified in the device's<br>Instructions for Use. The<br>Temperature Probe is<br>designed for use with a<br>YSI™ Tele-thermometer<br>to monitor and display<br>temperature. | The temperature probe is<br>intended for use for<br>continuous blood temperature<br>monitoring as measured at a<br>temperature monitoring<br>adapter located within a<br>Medtronic extracorporeal<br>circulation device as specified<br>in the device's instructions for<br>use. The temperature probe<br>is designed for use with a YSI<br>tele-thermometer to monitor<br>and display temperature. | Yes |
| Operating<br>Principle | A device that measures<br>differences in resistance<br>and equates that to<br>changes in temperature | A device that measures<br>differences in resistance<br>and equates that to<br>changes in temperature | A device that measures<br>differences in resistance<br>and equates that to<br>changes in temperature | A device that measures<br>differences in resistance and<br>equates that to changes in<br>temperature | Yes |
| Components | Reusable | Reusable | Reusable | Reusable | Yes |
| Element of<br>Comparison | Reference I –<br>K831528 | Reference II –<br>K831528 | Predicate - K100645 | Current Submission | Substantially<br>Equivalent? |
| | Temperature Probe | Temperature Probe | Affinity Temperature<br>Probe | Temperature Probe | |
| | FDA Clearance<br>30June1983 | FDA Clearance<br>30June1983 | FDA Clearance<br>14September2012 | | |
| Models | 1384 | TP | ATP210 | 1384, TP, ATP210 | |
| Sensor | Thermistor Sensor Tip | Thermistor Sensor Tip | Thermistor Sensor Tip | Thermistor Sensor Tip | Yes |
| Materials | • Thermistor<br>• Sensor Tip -<br>Stainless Steel,<br>Brass, Ceramic<br>• Cable - TPE (C-<br>Flex) and Copper<br>• Phono Plug -<br>Brass | • Thermistor Sensor<br>Tip - Stainless Steel,<br>Brass, Ceramic<br>• Cable - TPE (C-<br>Flex) and Copper<br>• Phono Plug - Brass | • Probe tip - Stainless<br>Steel, Brass,<br>Ceramic<br>• Cable - TPE (C-<br>Flex) and Copper<br>• Phono Plug - Brass | • Probe tip –<br>Stainless Steel and Brass<br>• Cable - PVC and Copper<br>• Phono Plug - Brass | Yes |
| Thermistor | Negative<br>Temperature<br>Coefficient (NTC)<br>Thermistor | Negative Temperature<br>Coefficient (NTC)<br>Thermistor | Negative Temperature<br>Coefficient (NTC)<br>Thermistor | Negative Temperature<br>Coefficient (NTC) Thermistor | Yes |
| Cable | PVC Insulated 2<br>conductor twisted<br>pair2 | PVC Insulated 2<br>conductor twisted pair | PVC Insulated 2<br>conductor twisted pair | PVC Insulated 2 conductor<br>twisted pair | Yes |
| Phono Plug | 6.35-mm (1/4-in)<br>phono plug | 6.35-mm (1/4-in) phono<br>plug | 6.35-mm (1/4-in) phono<br>plug | 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.