General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities.
Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface.
Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the auralcanal.

The device is single use and for use by licensed healthcare practitioners only. The probes are designed to interface with DeRoyal- branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport. Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

Device Description

The DeRoyal Temperature Monitoring Probe is used for routine patient temperature monitoring. Each probe is single use and contains a wire set with a blue connector at the proximal end and a thermistor chip at the distal end. The thermistor passively modifies the electrical current traveling through the probe. The connector interfaces with a cable that is connected to an independent temperature monitor used to display the temperature readings.

There are three probe configurations included in this submission:

1. An adult skin temperature sensor that consists of the wire set with an adhesive probe cover that is applied to the patient's intact skin for monitoring of skin surface temperature.
1. A tympanic temperature probe that consists of the wire set with a foam ear plug that is inserted into the aural canal for monitoring of core body temperature.
1. A general purpose temperature probe that consists of the wire set enclosed in a tube that may be inserted into the esophageal, rectal, or nasopharyngeal cavities for monitoring of core body temperature.

All probes are individually packaged. The tympanic configuration is non-sterile. The other two configurations are sold sterile. The probes are designed to interface with DeRoyal-branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport, Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device: the DeRoyal Temperature Monitoring Probe. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets an algorithm's acceptance criteria through a study with a test set, ground truth, or expert readers.

Therefore, the provided text does not contain the information required to populate the fields related to an AI/ML algorithm's acceptance criteria and study proving performance. The document is a regulatory submission for a physical thermometer probe, detailing its characteristics, intended use, and comparison to predicate devices, along with the physical tests performed (biocompatibility, electrical safety, accuracy, etc.) to ensure its safety and effectiveness.

Here's why the requested information about AI/ML acceptance criteria and studies is not present:

Device Type: The device in question is a "DeRoyal Temperature Monitoring Probe," which is a physical clinical electronic thermometer. It measures temperature directly using a thermistor. It is not an AI/ML powered device that would process data or images to provide a diagnosis or prediction.
Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, often by comparing technical characteristics and showing adherence to relevant performance standards (e.g., ISO for accuracy and safety). This does not involve large-scale data studies with ground truth established by experts or MRMC studies that are typical for AI/ML device clearances.
"Acceptance Criteria" in this context: For this type of device, "acceptance criteria" generally refer to the performance specifications (e.g., accuracy within a certain range like ±0.2°C, operating conditions) and safety requirements (biocompatibility, electrical safety) that the device must meet, often defined by recognized national or international standards (e.g., ISO 80601-2-56 for medical thermometers). The study that "proves" these are met involves physical testing of the device prototypes or production samples against these standards, not clinical data studies with expert ground truth.

To directly answer your request based on the provided document, the following points can be extracted, while acknowledging that many of your specific questions are not applicable to this type of regulatory submission:

A table of acceptance criteria and the reported device performance:
- "Study" Name: Summary of Performance Tests (as described in the document)
- Device Under Test: DeRoyal Temperature Monitoring Probe (General Purpose, Adult Skin Sensor, Tympanic configurations)

Characteristic	Acceptance Criteria (Predicate Performance / Standard Requirement)	Reported Device Performance (Reference)
Rated Output Range	25°C to 45°C (from Predicate K925791)	25°C to 45°C (Stated for Proposed Device, matching predicate).
Accuracy	±0.2°C (from Predicate K925791)	±0.2°C (Stated for Proposed Device, matching predicate). "Accuracy and time response testing according to ISO 80601-2-56 was performed to ensure the proposed device completed its essential performance safely and effectively. ... All testing was performed on final, finished products manufactured with the proposed modification. The test results met the requirements of the aforementioned standards and demonstrate that the proposed modification does not impact the safety or efficacy of the device." (Page 12)
Operating Conditions	25°C to 45°C (from Predicate K925791)	25°C to 45°C (Stated for Proposed Device, matching predicate).
Biocompatibility	Must meet ISO 10993-1, ISO 10993-5, ISO 10993-10 requirements.	"The following biocompatibility tests were performed on final, finished products manufactured with the proposed change: cytotoxicity, skin sensitization, and irritation. This testing was performed on each of the three configurations contained within this submission... The test results met the requirements of the aforementioned standards..." (Page 12)
Electrical Safety	Must meet IEC 60601-1 and IEC 60601-1-2 requirements.	"Testing according to IEC 60601-1 and IEC 60601-1-2 was performed to ensure the change in the encapsulation did not affect the electrical safety of the device... A leakage current test also was performed after submerging the device in solution to ensure the encapsulation method is effective... The test results met the requirements of the aforementioned standards..." (Page 12)
Sterilization	Ethylene Oxide for sterile versions, Non-sterile for tympanic.	"Sterilized with Ethylene Oxide" (General Purpose, Adult Skin Sensor), "Non-sterile" (Tympanic Probe) - Matches predicate and implied acceptance.
Storage Conditions	-25°C to +55°C (from Predicate K925791)	-25°C to +55°C (Stated for Proposed Device, matching predicate).

Sample size used for the test set and the data provenance:
- The document refers to "final, finished products manufactured with the proposed modification" being tested (Page 12), implying physical samples of the device. Specific sample sizes for each test (e.g., how many probes were tested for accuracy or biocompatibility) are not provided in this summary, which is common for a 510(k) summary.
- Data Provenance: This is not a data study in the sense of patient data. The testing described is laboratory-based performance and safety testing of the manufactured device. There is no information on country of origin for the test data, or if it was retrospective or prospective, as these terms are not applicable to this type of device testing.
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):
- Not applicable. This is a physical thermometer, not an AI/ML algorithm that requires expert human interpretation or ground truth labeling from clinical data. The "ground truth" for a thermometer is a calibrated reference thermometer or standard against which its readings are compared, or specific standardized tests for biocompatibility and electrical safety.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There is no adjudication method described as it's not a clinical data review or AI/ML output review.
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 is a physical medical device (thermometer probe), not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. No algorithm is being submitted for standalone performance evaluation. The device is a direct measurement instrument.
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not applicable in the AI/ML context. For the accuracy testing, the "ground truth" would be the known, precisely controlled temperatures in a laboratory setting, measured by a validated reference standard. For biocompatibility and electrical safety, the "ground truth" is adherence to the specified limits and test methodologies outlined in the referenced ISO and IEC standards.
The sample size for the training set:
- Not applicable. This device does not have a "training set" as it is not an AI/ML model.
How the ground truth for the training set was established:
- Not applicable. No training set exists for this device.

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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the name. The text reads "U.S. FOOD & DRUG ADMINISTRATION".

December 23, 2020

DeRoyal Industries, Inc. Sarah Bennett Senior Regulatory Affairs Specialist 200 DeBusk Lane Powell, Tennessee 37849

Re: K200631

Trade/Device Name: DeRoyal Temperature Monitoring Probe Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 23, 2020 Received: November 24, 2020

Dear Sarah Bennett:

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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,

CAPT Alan M. Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K200631

Device Name

DeRoyal Temperature Monitoring Probe

Indications for Use (Describe)

The DeRoyal Temperature Monitoring Probe is used for routine of the patient's core body or skin surface temperature.

The probe is offered in the following three configurations :

General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities.
Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface.
Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the auralcanal.

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

Image /page/3/Picture/1 description: The image features the logo for "DeRoyal®". The logo consists of a stylized blue swoosh that curves over the text "DeRoyal". The "®" symbol is present to the right of the word "DeRoyal", indicating that it is a registered trademark.

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

Date prepared:	November 23, 2020
510(k) Owner:	DeRoyal Industries, Inc.200 DeBusk LanePowell, TN 37849Owner/Operator #1044833
510(k) Contact:	Sarah BennettSenior Regulatory Affairs SpecialistP: 865-362-6112F: 865-362-3741sabennett@deroyal.com
Contract Manufacturer:	DeRoyal Cientifica de LatinoamericaS.R.L.Global ParkBox 180-3006, 602 ParkwayLa Aurora, Heredia Heredia, CostaRica 146DeRoyal Industries, Inc.185 Richardson WayMaynardville, TN 37807
Trade Name:	DeRoyal Temperature MonitoringProbe
Common Name:	Temperature Monitoring Probe
Classification Name:	Thermometer, Electronic, Clinical
Device Product Code:	FLL
Regulatory Class:	Class II
Classification Panel:	General Hospital
Regulation Number:	21 CFR 880.2910
Predicate Devices:	Exac-Temp & Clini-Temp Probe w/Temperature Sensor [K925791] –Primary PredicateExac-Temp & Clini-TempTympanic Probe [K925792]

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Image /page/4/Picture/0 description: The image features the logo for "DeRoyal". The logo consists of a stylized, curved blue shape resembling a checkmark or a swoosh, positioned to the left of the company name. The text "DeRoyal" is written in a blue, sans-serif font, with the registered trademark symbol appearing next to the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

Reference Devices:

Skin Surface Temperature Sensor [K925006]

Skin Sensor Probe, General Purpose Probe, Tympanic Probe [K101244]

Esophageal/Rectal Temperature Probe [K140134]

Disposable Temperature Probe [K181967]

Device Description

There are three probe configurations included in this submission:

1. An adult skin temperature sensor that consists of the wire set with an adhesive probe cover that is applied to the patient's intact skin for monitoring of skin surface temperature.
1. A tympanic temperature probe that consists of the wire set with a foam ear plug that is inserted into the aural canal for monitoring of core body temperature.
1. A general purpose temperature probe that consists of the wire set enclosed in a tube that may be inserted into the esophageal, rectal, or nasopharyngeal cavities for monitoring of core body temperature.

Intended Use

The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature.

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Summary of Technological Characteristics

Characteristic	Configuration	Proposed Device	Predicate 510(k)	Predicate Device	Differences
Indications for Use	General Purpose	The DeRoyalTemperatureMonitoring Probe isused for routinemonitoring of thepatient's core body orskin surfacetemperature.	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	The Exac-TempGeneral PurposeTemperature Probe is tobe used for routinemonitoring ofanesthetized patients byinserting the probe intothe esophagus orrectum.	The Indications for Usehave been updated forthe proposed device toinclude the referencebody site andmeasuring site asdefined by ISO 80601-2-56 and the intendedtreatment populationand compatiblemonitors as requestedby the FDA.
	Adult Skin Sensor	The probe is offered inthe following threeconfigurations:- General PurposeTemperature Probe forroutine monitoring ofthe core bodytemperature in adultand pediatric patientsby insertion into thenasopharyngeal,esophageal, or rectalcavities;- Adult SkinTemperature sensor forroutine monitoring ofskin temperature byapplication of theprobe's adhesive coverto an adult patient'sskin surface.- TympanicTemperature Probe forroutine monitoring ofthe core bodytemperature in adultand pediatric patients	K925006 – Exac-TempSkin SurfaceTemperature Sensor	The Exac-Temp SkinSurface TemperatureSensor is to be used forroutine monitoring of apatient's skin surface.
	Tympanic Probe		K925792 – Exac-Temp& Clini-TempTympanic Probe	The Exac-TempTympanic TemperatureProbe is to be used forroutine monitoring ofthe patient temperatureusing the aural canal(ear canal or theexternal auditorymeatus).

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Prescription Only	General Purpose	Yes	K925791 - Exac-Temp & Clini-Temp Probe w/ Temp. Sensor	Yes	Same
	Adult Skin Sensor		K925006 - Exac-Temp Skin SurfaceTemperature Sensor
	Tympanic Probe		K925792 - Exac-Temp & Clini-TempTympanic Probe
Mode of Operation	General Purpose	Direct Mode	K925791 - Exac-Temp & Clini-Temp Probe w/ Temp. Sensor	Direct Mode	Same
	Adult Skin Sensor		K925006 - Exac-Temp Skin SurfaceTemperature Sensor
	Tympanic Probe		K925792 - Exac-Temp & Clini-TempTympanic Probe

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Measuring Site	General Purpose	Rectum, Esophagus,Nasopharynx	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Esophagus, Rectum	DeRoyal intends to addthe nasopharynx to theGeneral Purpose Probeas a measuring site. ISO80601-2-56 definesmeasuring site as the"part of the patientwhere the temperatureis measured." The FDAhas cleared three510(k)s for temperatureprobes that utilize thenasopharynx as ameasuring site inaddition to theesophagus and rectum:K101244, K140134,and K181967.
	Adult Skin Sensor	Skin Surface	K925006 – Exac-TempSkin SurfaceTemperature Sensor	Skin Surface	Same
	Tympanic Probe	Auditory Canal	K925792 - Exac-Temp& Clini-TempTympanic Probe	Auditory Canal	Same
Reference Body Site	General Purpose	Core Body	K925791 - Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Core Body	Same
	Adult Skin Sensor	Skin Surface	K925006 - Exac-TempSkin SurfaceTemperature Sensor	Skin Surface	Same
	Tympanic Probe	Core Body	K925792 – Exac-Temp& Clini-TempTympanic Probe	Core Body	Same
Use Environment	General Purpose	Hospital	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Hospital	Same
	Adult Skin Sensor		K925006 – Exac-TempSkin SurfaceTemperature Sensor

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	Tympanic Probe		K925792 - Exac-Temp& Clini-TempTympanic Probe
Rated Output Range	General Purpose	25°C to 45°C	K925791 - Exac-Temp& Clini-Temp Probe w/Temp. Sensor	25°C to 45°C	Same
	Adult Skin Sensor		K925006 - Exac-TempSkin SurfaceTemperature Sensor
	Tympanic Probe		K925792 - Exac-Temp& Clini-TempTympanic Probe
Accuracy	General Purpose	$\u00b10.2°C$	K925791 - Exac-Temp& Clini-Temp Probe w/Temp. Sensor	$\u00b10.2°C$	Same
	Adult Skin Sensor		K925006 - Exac-TempSkin SurfaceTemperature Sensor
	Tympanic Probe		K925792 - Exac-Temp& Clini-TempTympanic Probe
Operating Conditions	General Purpose	25°C to 45°C	K925791 - Exac-Temp& Clini-Temp Probe w/Temp. Sensor	25°C to 45°C	Same
	Adult Skin Sensor		K925006 - Exac-TempSkin SurfaceTemperature Sensor
	Tympanic Probe		K925792 - Exac-Temp& Clini-TempTympanic Probe
Design	General Purpose	Wire set with athermistor chip at thedistal end and a blueconnector at theproximal end. The wireset is enclosed in a tubethat may be insertedinto the application site.	K925791 - Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Wire set with athermistor chip at thedistal end and a blueconnector at theproximal end. The wireset is enclosed in a tubethat may be insertedinto the application site.	Same
	Adult Skin Sensor	Wire set with a	K925006 - Exac-Temp	Wire set with a	Same

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	thermistor chip at the distal end and a blueconnector at the proximal end. Anadhesive probe coverapplies the device to thepatients' skin.	Skin SurfaceTemperature Sensor	thermistor chip at the distal end and a blueconnector at the proximal end. Anadhesive probe coverapplies the device to thepatients' skin.
Tympanic Probe	Wire set with athermistor chip at the distal end and a blueconnector at the proximal end. A foamear plug is used toinsert the device intothe patient's auralcanal.	K925792 – Exac-Temp& Clini-TempTympanic Probe	Wire set with athermistor chip at the distal end and a blueconnector at the proximal end. A foamear plug is used toinsert the device intothe patient's auralcanal.	Same
Materials	General Purpose	Tube: PVCWire: Copper with PVCinsulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: UV-curedadhesive	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Tube: PVCWire: Copper with PVCinsulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: PVC and epoxyglue
	Adult Skin Sensor	Cover: Adhesive foamWire: Copper with PVCinsulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: UV-curedadhesive	K925006 - Exac-TempSkin SurfaceTemperature Sensor	Cover: Adhesive foamWire: Copper with PVCinsulationThermistor: CeramicConnector: PVC-molded brassStrain Relief: PVCCap: PVC and epoxyglue
	Tympanic Probe	Ear Plug: Foam and/orcotton ballWire: Copper with PVCinsulationThermistor: Ceramic	K925792 – Exac-Temp& Clini-TempTympanic Probe	Ear Plug: Foam and/orcotton ballWire: Copper with PVCinsulationThermistor: Ceramic

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		Connector: PVC-molded brassStrain Relief: PVCCap: UV-curedadhesive		Connector: PVC-molded brassStrain Relief: PVCCap: PVC and epoxyglue	Safety and EMC testingalso were performed onthe proposed device andare contained withinSection 17. The resultsof this testing supportthe proposed device'ssafety andeffectiveness.
Use of a Probe Cover	General Purpose	No	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	No	Same
	Adult Skin Sensor	Yes	K925006 - Exac-TempSkin SurfaceTemperature Sensor	Yes	Same
	Tympanic Probe	No	K925792 – Exac-Temp& Clini-TempTympanic Probe	No	Same
Nature of Body Contact	General Purpose	Mucosal Membrane	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Mucosal Membrane	Same
	Adult Skin Sensor	Intact Skin	K925006 - Exac-TempSkin SurfaceTemperature Sensor	Intact Skin	Same
	Tympanic Probe	Intact Skin	K925792 — Exac-Temp& Clini-TempTympanic Probe	Intact Skin	Same
Duration of Contact	General Purpose	Limited (≤ 24 hours)	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Limited (≤ 24 hours)	Same
	Adult Skin Sensor	Prolonged (≥ 24 hours)	K925006 - Exac-TempSkin SurfaceTemperature Sensor	Prolonged (≥ 24 hours)	Same
	Tympanic Probe	Prolonged (≥ 24 hours)	K925792 – Exac-Temp& Clini-TempTympanic Probe	Prolonged (≥ 24 hours)	Same
Sterilization	General Purpose	Sterilized with EthyleneOxide	K925791 - Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Sterilized with EthyleneOxide	Same

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Adult Skin Sensor	Sterilized with Ethylene Oxide	K925006 – Exac-TempSkin SurfaceTemperature Sensor	Sterilized with Ethylene Oxide	Same
Tympanic Probe	Non-sterile	K925792 – Exac-Temp& Clini-TempTympanic Probe	Non-sterile	Same
Storage Conditions	General Purpose	-25°C to +55°C	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	-25°C to +55°C	Same
Adult Skin Sensor		K925006 – Exac-TempSkin SurfaceTemperature Sensor
Tympanic Probe		K925792 – Exac-Temp& Clini-TempTympanic Probe
Reusable or Disposable	General Purpose	Disposable	K925791 – Exac-Temp& Clini-Temp Probe w/Temp. Sensor	Disposable	Same
Adult Skin Sensor		K925006 – Exac-TempSkin SurfaceTemperature Sensor
Tympanic Probe		K925792 – Exac-Temp& Clini-TempTympanic Probe

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Image /page/12/Picture/0 description: The image contains the logo for DeRoyal. The logo features a stylized blue swoosh above the company name, also in blue. The word "DeRoyal" is written in a serif font, with a registered trademark symbol next to the word "Royal".

Corporate 200 DeBusk Lane Powell, TN 37849 USA 865.938.7828 800.251.9864 www.deroyal.com

Summary of Performance Tests

The proposed device has been tested and/or evaluated according to the following standards: ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 80601-2-56, IEC 60601-1, and IEC 60601-1-2.

The following biocompatibility tests were performed on final, finished products manufactured with the proposed change: cytotoxicity, skin sensitization, and irritation. This testing was performed on each of the three configurations contained within this submission.

Testing according to IEC 60601-1 and IEC 60601-1-2 was performed to ensure the change in the encapsulation did not affect the electrical safety of the device. Accuracy and time response testing according to ISO 80601-2-56 was performed to ensure the proposed device completed its essential performance safely and effectively. A leakage current test also was performed after submerging the device in solution to ensure the encapsulation method is effective.

All testing was performed on final, finished products manufactured with the proposed modification. The test results met the requirements of the aforementioned standards and demonstrate that the proposed modification does not impact the safety or efficacy of the device.

Conclusion

The results of performance testing demonstrate the DeRoyal Temperature Monitoring Probe is substantially equivalent to the predicates. With the exception of the proposed change to the encapsulation method, the proposed device is identical to the predicate devices, which have been on the market since 1994. Therefore, the proposed device is substantially equivalent to the predicate.

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.