The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

Device Description

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement.

Features and benefits:

Fully enclosed sensor helps ensure patient safety
Satin Slip™ finish for easy insertion ●
Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

1. Tube Blue
1. Sleeve GP
1. Thermistor Assembly
1. Slurry Mixture

The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A".

A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device.

Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.

AI/ML Overview

The provided text is a 510(k) summary for the Mon-a-Therm™ General Purpose Temperature Probe 400TM. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on benchtop performance testing and adherence to relevant standards. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts for image analysis.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, and studies involving human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies, are not applicable or described in this document.

However, based on the provided text, I can infer the acceptance criteria for the temperature probe's performance and what demonstrates that the device meets those criteria for certain aspects, primarily focusing on its temperature measurement accuracy.

Here's a breakdown of the available information:

Implied Acceptance Criteria and Reported Device Performance for the Mon-a-Therm™ General Purpose Temperature Probe 400TM

Since this is a thermal probe and not an AI/ML device, the acceptance criteria are not for diagnostic performance metrics like sensitivity, specificity, or AUC, but instead for physical and performance characteristics of a temperature measurement device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that the subject device (Mon-a-Therm™) has been updated to align with the latest regulation EN ISO 80601-2-56:2017, which expanded the required temperature range.

Acceptance Criteria Category	Specific Criteria (from EN ISO 80601-2-56:2017)	Reported Device Performance
Temperature Output Range	34°C to 42°C	Meets this expanded range.
Temperature Accuracy	±0.2°C within the primary range (likely 35°C to 42°C as per older standard's primary range implied)	Maintains a deviation of no more than ±0.2°C.
Temperature Accuracy	±0.3°C in the extended range (likely 34°C to < 35°C)	Maintains a deviation of no more than ±0.3°C.
Biocompatibility	Compliance with ISO 10993-1:2018, ISO 10993-23:2021 standards for "Surface Medical device, Mucosal Membrane" with "Prolonged contact, 24 hrs to 30 days"	Demonstrated compliance through adherence to the specified ISO 10993 series standards.
Safety	Compliance with IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 & EN 60601-1:2006/A2:2021	Demonstrated compliance ("General requirements for basic safety and essential performance").
Safety and Performance	Compliance with ISO 80601-2-56:2017 + A1: 2018 & EN ISO 80601-2-56:2017 + A1:2020	Demonstrated compliance ("Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement").
Electromagnetic Compatibility	Compliance with IEC 60601-1-2:2014 + AMD1:2020 & EN 60601-1-2:2015 + A1:2021	Demonstrated compliance ("Electromagnetic disturbances – Requirements and tests").
Usability	Compliance with IEC 62366-1:2015 + AMD1:2020 & EN 62366-1:2015 + A1:2020; IEC 60601-1-6:2010 + A1:2013 + A2:2020 & EN 60601-1-6:2010 + A1:2013 + A2:2021	Demonstrated compliance ("Application of usability engineering to medical devices," and "Usability" collateral standard).
Sterilization	Compliance with ISO 11135-1:2014 + A1:2018 & EN ISO 11135:2014 + A1:2019 (Ethylene Oxide) & EN 556-1:2001 (Sterile designation)	Demonstrated compliance. The device is packaged individually as a sterile, single-use device.
Material Impact (PVC variations)	Non-compromise of temperature accuracy due to PVC material changes (blue, opaque, semi-rigid, DEHP/Phthalate-free, RoHS3 compliant PVC vs. clear, 73 Shore A PVC in predicate).	"Verification Test Report for Temperature Accuracy and Storage Temperature" confirmed that the PVC variations do not compromise temperature accuracy.

2. Sample size used for the test set and the data provenance:

The document mentions "Bench Performance Testing" and specifically a "Verification Test Report for Temperature Accuracy and Storage Temperature" for assessing the impact of PVC material changes on temperature accuracy.
However, no specific sample sizes (number of probes tested) are provided for these bench tests.
Data Provenance: This is not explicitly stated in terms of country of origin but is implied to be internal testing conducted by Covidien, Ilc, which is located in Boulder, CO, USA. The testing is described as validation and verification testing, which is typically prospective for new product development.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. This is a temperature probe, not an AI/ML device requiring clinical expert interpretation for ground truth. Ground truth for temperature accuracy is established via calibrated reference thermometers and controlled environmental conditions.

4. Adjudication method for the test set:

Not applicable. No expert adjudication process is described or relevant for this type of device testing.

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:

Not applicable. This device is a temperature probe, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

Not applicable. There is no "algorithm only" performance for this device in the context of AI/ML. The device's "standalone" performance refers to its accuracy and other physical characteristics measured against established standards.

7. The type of ground truth used:

For temperature accuracy, the ground truth is established by calibrated reference standards/thermometers in controlled environments, as per the requirements of standards like EN ISO 80601-2-56.
For biocompatibility, safety, EMC, usability, and sterilization, the "ground truth" is compliance with the specific requirements and test methods outlined in the cited international standards (e.g., ISO 10993 series, IEC 60601 series).

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable. No training set for machine learning.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 20, 2024

Covidien Angelica Medina Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, Colorado 80301

Re: K240077

Trade/Device Name: Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 16, 2024 Received: July 19, 2024

Dear Angelica Medina:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

David Walloschek

David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors

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OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K240077

Device Name

Mon-a-Therm™ General Purpose Temperature Probe 400TM (90050, 90044)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
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K240077 - Mon-a-Therm™ General Purpose Temperature Probe 400TM 510(k) Summary

This summary of 510(k) safety and effectiveness information for the Mon-a-Therm™ General Purpose Temperature Probe 400TM is submitted in accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with the requirements of 21 CFR §807.92.

SUBMITTER INFORMATION

Submitted By:

Covidien, Ilc 6135 Gunbarrel Avenue Boulder, CO 80301

Date Prepared: August 20th, 2024

Contact Person:

Official Correspondent: Anqelica Medina, Requlatory Affairs Specialist Phone: 303-319-5125 Email: angelica.medina@medtronic.com

Secondary Correspondent: Greeshma Kayala, Regulatory Affairs Director

Phone: (303) 579-1718 Email: greeshma.kayala@medtronic.com

DEVICE

Trade Name:	Mon-a-Therm™ General Purpose Temperature Probe 400TM
Common Name:	Clinical electronic thermometer
Classification Regulation:	880.2910
Classification Name:	Clinical Electronic Thermometer
Regulatory Class:	Class II
Product Code:	FLL
Review Panel:	General Hospital

PREDICATE DEVICE

Predicate Manufacturer:	Mallinckrodt Critical Care
Predicate Trade Name:	Hi-Lo Temp® General Purpose Temperature Probe
Predicate 510(k):	K874514

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Medtronic

DEVICE DESCRIPTION

The subject device of this premarket 510(k) notification is referred to as the Mon-a-Therm™ General Purpose Temperature Probe 400TM throughout this submission.

Features and benefits:

Fully enclosed sensor helps ensure patient safety
Satin Slip™ finish for easy insertion ●
Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

Image /page/5/Picture/9 description: The image shows a collection of radioactive seeds used in brachytherapy, a type of radiation therapy. The seeds are small, cylindrical objects attached to thin, flexible wires. These seeds are implanted directly into or near a tumor to deliver a high dose of radiation while minimizing exposure to surrounding healthy tissue. The seeds appear to be grouped together, possibly for storage or preparation before implantation.

Figure 1: Illustration of subject device Mon-a-Therm™ General Purpose Temperature Probe 400TM

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

Image /page/5/Picture/13 description: The image shows a diagram of a catheter with four different labels. The catheter is labeled with the word "catheter" and has an arrow pointing to the length of the catheter. The numbers 1, 2, 3, and 4 are used to label different parts of the catheter.

Figure 2: Illustration of Subject Device Components

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Image /page/6/Picture/0 description: The image shows the word "Medtronic" in blue font. The font is a sans-serif font and the letters are closely spaced together. The background of the image is white. The word is the logo of the medical technology company Medtronic.

1. Tube Blue
1. Sleeve GP
1. Thermistor Assembly
1. Slurry Mixture

Image /page/6/Figure/8 description: This image shows a technical drawing of a thermistor. The overall length of the thermistor is 18 3/4. Detail A shows a close up of the end of the thermistor, which is sealed in a tube with a maximum length of 3/8.

Figure 3: Structure of Subject Device

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Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors

Product Code	Cable Length	Monitor Compatibility	MonitorConnector
502-0400A	16 feet/4.87m
502-0410A	10 feet/3.05m	Most patient monitors using series400 thermistor sensors, such asMindray Passport2™* Monitor	1/4 inch, rightangle phono plug
502-0405A	16 feet/4.87m
502-0415A	10 feet/3.05m	Siemens Monitor series SC	7 pinconnector
502-0401A	16 feet/4.87m
502-0411A	10 feet/3.05m	HP or Philips Monitors such asPhilips Intellivue™* Monitor	2 pinconnector

Image /page/7/Figure/4 description: The image shows a patient monitor connected to a temperature probe. The patient monitor displays the temperature as XX.X degC. A reusable cable connects the temperature module to the Mon-a-Therm General Purpose Temperature Probe 400TM.

Figure 4: Illustration of Patient Monitor Compatibility

INDICATIONS FOR USE

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Medtroi

Technological Characteristics

The Mon-a-Therm™ General Purpose Temperature Probe 400TM and its predicate device, utilize the same indications for use, intended purpose, target population, user base and environmental conditions. Compared to the predicate device, the subject device maintains consistency in terms of performance specifications such as measurement range, accuracy, and shelf life.

The subject and predicate device originally adhered to the EN ISO 80601-2-56:2012 standard, requiring a temperature output range of 35°C to 42°C. However, a subsequent standard revision (EN ISO 80601-2-56:2017) expanded the required range to 34°C to 42°C. The subject device meets the stringent accuracy requirements of the newer standard, maintaining a deviation of no more than ±0.2°C within the primary range and ±0.3°C in the extended range. While the predicate device complies with the older standard, the subject device has been updated to align with the latest regulations.

The subject and predicate device utilize PVC material for their tube and sleeve components. though the materials differ in composition. The predicate device employs a clear. 73 Shore A PVC material. In contrast, the subject device features a blue, opaque, semi-rigid PVC material. Notably, the subject device's PVC formulation is not made with DEHP or Phthalates and adheres to RoHS3 compliance standards.

The subject and predicate device utilize PVC material for their tube and sleeve components, though the materials differ in composition. The predicate device employs a clear, 73 Shore A PVC material. In contrast, the subject device features a blue, opaque, semi-rigid PVC material. Notably, the subject device's PVC formulation is not made with DEHP or Phthalates and adheres to RoHS3 compliance standards.

To assess the impact of PVC material used in the tube and sleeve components, temperature accuracy testing was performed on both the subject and predicate device. The results from "Verification Test Report for Temperature Accuracy and Storage Temperature" confirmed that the PVC variations do not compromise temperature accuracy.

These differences do not raise concerns regarding the safety or effectiveness of the subject device when compared to the predicate device as concluded in the Mon-a-Therm General Purpose Temperature Probe Verification and Validation Summary Test Plan and Summary report which demonstrates that these modifications do not have any adverse impact on the performance of the device. Refer to Bench Performance Testing in the below table.

Consequently, it can be affirmed that the Mon-a-Therm™ General Purpose Temperature Probe 400TM is substantially equivalent to the predicate. Hi-Lo Temp® General Purpose Temperature Probe.

PERFORMANCE DATA

The following performance data were provided to support the substantial equivalence determination with the predicate device.

Bench Performance Testing

The following benchtop performance testing was provided to support the substantial equivalence determination with the predicate device.

Covidien IIc

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Bench TestCategory	Guidance/Standard
Safety	IEC 60601-1:2005 + AMD1:2012 + AMD2:2020 & EN 60601-1:2006/A22021General requirements for basic safety and essential performance
Safety andperformance	ISO 80601-2-56:2017 + A1: 2018 & EN ISO 80601-2-56:2017 + A1:2020Particular requirements for basic safety and essential performance ofclinical thermometers for body temperature measurement.
ElectromagneticCompatibility	IEC 60601-1-2:2014 + AMD1:2020 & EN 60601-1-2:2015 + A1:2021General requirements for basic safety and essential performance –Collateral Standard: Electromagnetic disturbances – Requirements andtests.
Usability	IEC 62366-1:2015 + AMD1:2020 &EN 62366-1:2015 + A1:2020Application of usability engineering to medical devicesIEC 60601-1-6:2010 + A1:2013 + A2:2020 & EN 60601-1-6:2010 +A1:2013 + A2:2021General requirements for basic safety and essential performance –Collateral standard: Usability.
Biocompatibility	ISO 10993-1:2018 & EN ISO 10993-1:2020Biological evaluation of medical devices — Evaluation and testing withina risk management process.ISO 10993-23:2021 & EN ISO 10993-23:2021Biological evaluation of medical devices — Part 23: Tests for irritation.Device Classification:Contact Type - Surface Medical device, Mucosal MembraneContact Duration - Prolonged contact, 24 hrs to 30 daysTarget Population - Adults, Pediatric and Neonates
Sterilization	ISO 11135-1:2014 + A1:2018 & EN ISO 11135:2014 + A1:2019Sterilization of health care products – Ethylene Oxide.EN 556-1:2001Sterilization of medical devices. Requirements for medical devices to bedesignated "STERILE". Requirements for terminally sterilized medicaldevices.

Animal Performance Testing

Not applicable. No animal performance testing was required to demonstrate device safety and effectiveness.

Covidien Ilc

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Clinical Performance Testing

Not applicable. No clinical performance testing was required to demonstrate device safety and effectiveness.

CONCLUSIONS

Results from comprehensive verification and validating testing demonstrate that the Mon-a-Therm™ General Purpose Temperature Probe 400TM and Hi-Lo Temp® General Purpose Temperature Probe are substantially equivalent with respect to material, technological and performance characteristics.

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.