(126 days)
No
The description focuses on a physical temperature probe with a thermistor sensor and cable, and mentions its use with a tele-thermometer. There is no mention of AI, ML, or any computational analysis of the temperature data beyond simple monitoring and display.
No.
Explanation: The device is a temperature probe for monitoring blood temperature within an extracorporeal circulation device. Its function is to measure and display temperature, which is a diagnostic or monitoring function, not a therapeutic one. It does not directly treat or alleviate a medical condition.
No
The device is a temperature probe that monitors and displays temperature, which is a measurement function, not a diagnostic one. It provides data for monitoring but does not interpret that data to identify a disease or condition.
No
The device description explicitly states the device is a "temperature probe" with 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." This describes physical hardware components, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: This device is a temperature probe used for continuous blood temperature monitoring within an extracorporeal circulation device. It measures the temperature of the blood flowing through the device.
- Lack of Analysis of Biological Samples: The device is measuring a physical parameter (temperature) of the blood as it circulates outside the body. It is not analyzing the biological composition or characteristics of the blood sample itself to diagnose or monitor a condition.
Therefore, while it interacts with blood, its function is to measure a physical property (temperature) in a real-time, continuous manner within a medical device, rather than performing an in vitro analysis of a biological sample for diagnostic purposes.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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."
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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:
- IEC 60601: Ensures the temperature probes meet the requirements of IEC 60601 electrical safety and Electromagnetic compatibility (EMC). Result: Pass
- Temperature Range: Ensures the temperature probes meet the requirements of the system at the extreme temperature ranges. Result: Pass
- Ambient Temperature Environment: Ensures the temperature probes meet the requirements of the system at the normal temperature ranges. Result: Pass
- Accuracy: Accuracy over the entire temperature range specified for the device. Result: 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. Result: Pass
- Time: Indicate the time required for the device to obtain a steady state reading. Result: Pass
- Life Testing: Ensures the temperature probes meet the requirements of the expected life of the probe. Result: Pass
- Liquid Ingress and Chemical Exposure Testing: Ensures the temperature probes meet the Ingress Protection and cleaning requirements. Result: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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.
1
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
2
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) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary K160091
| Date Prepared: | May 12, 2016 |
|---|---|
| Submitter: | Medtronic, Inc. |
| Medtronic Perfusion Systems | |
| 7611 Northland Drive | |
| Minneapolis, MN 55428 | |
| Establishment Registration Number: 2184009 | |
| Contact Persons: | Choua Thao |
| Regulatory Affairs Specialist | |
| Medtronic Perfusion Systems | |
| Phone: 763.514.9842 | |
| Fax: 763.367.8360 | |
| Email: choua.thao@medtronic.com |
Alternate Contact:
Susan C. Fidler
Senior Regulatory Affairs Manager
Medtronic Perfusion Systems
Phone: 763.514.9839
Fax: 763.367.8360
Email: susan.c.fidler@medtronic.com |
| Device Name and Classification
Trade Name: | Temperature Probe |
| Common Name: | Clinical Electronic Thermometer |
| Regulation Number: | 880.2910 |
| Product Code: | FLL |
| Product Classification: | Class II |
| Predicate Device
| K100645 | Affinity Temperature Probe |
|---|---|
| Reference Device | |
| K831528 | Temperature Probe |
4
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 |
| on operation of the device. | |
| Use of PVC for cable | Testing demonstrated that the change in cable material had no |
| impact on the operation of the device. | |
| Use of RTV (room temperature | |
| vulcanization silicone) | Testing demonstrated that the change in adhesive had no |
| impact on the operation of the device. | |
| Use of additional insulation sleeve | Testing demonstrated that the additional insulation sleeve did |
| not negatively impact the operation of the device. |
1 YSI is a trademark of YSI Incorporated.
5
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 of
Comparison | Temperature Probe | Temperature Probe | Affinity Temperature
Probe | Temperature Probe | Substantially
Equivalent? |
| | FDA Clearance
30June1983 | FDA Clearance
30June1983 | FDA Clearance
14September2012 | | |
| Models | 1384 | TP | ATP210 | 1384, TP, ATP210 | |
| Indications for Use | Reusable temperature
probes are designed for
continuous temperature
measurement and
control with monitors
specifically designed for
use with the 400 Series
temperature. | The SciMed Model TP
Thermistor Probe is
intended to be used with
the SciMed Model TMA
Temperature Monitoring
Adapter and YSI Series
400 equipment. The
thermistor is housed in a
stainless steel probe, and
is connected to a ten foot
long shielded cable that is
terminated with a ¼ inch
phone plug. | The Affinity 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. | 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. | Yes |
| Operating
Principle | A device that measures
differences in resistance
and equates that to
changes in temperature | A device that measures
differences in resistance
and equates that to
changes in temperature | A device that measures
differences in resistance
and equates that to
changes in temperature | A device that measures
differences in resistance and
equates that to changes in
temperature | Yes |
| Components | Reusable | Reusable | Reusable | Reusable | Yes |
| Element of
Comparison | Reference I –
K831528 | Reference II –
K831528 | Predicate - K100645 | Current Submission | Substantially
Equivalent? |
| | Temperature Probe | Temperature Probe | Affinity Temperature
Probe | Temperature Probe | |
| | FDA Clearance
30June1983 | FDA Clearance
30June1983 | FDA Clearance
14September2012 | | |
| 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 Sensor
Tip - Stainless Steel,
Brass, Ceramic
• Cable - TPE (C-
Flex) and Copper
• Phono Plug - Brass | • Probe tip - Stainless
Steel, 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 | Negative
Temperature
Coefficient (NTC)
Thermistor | Negative Temperature
Coefficient (NTC)
Thermistor | Negative Temperature
Coefficient (NTC)
Thermistor | Negative Temperature
Coefficient (NTC) Thermistor | Yes |
| Cable | PVC Insulated 2
conductor twisted
pair2 | PVC Insulated 2
conductor twisted pair | PVC Insulated 2
conductor twisted pair | PVC Insulated 2 conductor
twisted pair | Yes |
| Phono Plug | 6.35-mm (1/4-in)
phono plug | 6.35-mm (1/4-in) phono
plug | 6.35-mm (1/4-in) phono
plug | 6.35-mm (1/4-in) phono plug | Yes |
Comparison Table – Indications for Use and Physical Specification
6
² Two 24 gauge wires twisted around each other throughout the length of the cable.
7
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.