Who is the manufacturer of DeRoyal Temperature Monitoring Probe?

Deroyal Industries, Inc. filed the 510(k) submission for DeRoyal Temperature Monitoring Probe (K200631).

What is the FDA product code for DeRoyal Temperature Monitoring Probe?

FLL. It is classified under 21 CFR 880.2910 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for DeRoyal Temperature Monitoring Probe?

510(k) clearance (submission type: Traditional).

What are the predicate devices for DeRoyal Temperature Monitoring Probe?

Exac-Temp & Clini-Temp Probe w/ Temperature Sensor (K925791); Exac-Temp & Clini-Temp Tympanic Probe (K925792).

Who can help prepare an FDA 510(k) submission like DeRoyal Temperature Monitoring Probe?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

DeRoyal Temperature Monitoring Probe

K200631 · Deroyal Industries, Inc. · FLL · Dec 23, 2020 · General Hospital

Device Facts

Record ID	K200631
Device Name	DeRoyal Temperature Monitoring Probe
Applicant	Deroyal Industries, Inc.
Product Code	FLL · General Hospital
Decision Date	Dec 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.2910
Device Class	Class 2
Attributes	Pediatric

Indications for Use

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

Device Story

Single-use temperature monitoring probe; consists of wire set with proximal blue connector and distal thermistor chip. Thermistor passively modifies electrical current based on temperature. Interfaces with DeRoyal-branded cables connected to YSI 400/700 series compatible monitors (e.g., Mindray, Philips, Siemens/Draeger, GE). Used in hospital settings by licensed healthcare practitioners. Three configurations: General Purpose (nasopharyngeal, esophageal, rectal), Adult Skin (adhesive cover), and Tympanic (foam ear plug). Output displayed on independent patient monitor; assists clinicians in routine core or skin temperature tracking. Benefits patient through continuous, accurate temperature monitoring.

Clinical Evidence

Bench testing only. No clinical data. Testing included biocompatibility (cytotoxicity, skin sensitization, irritation), electrical safety, EMC, leakage current, and temperature accuracy/response time per ISO 80601-2-56. Results confirmed the encapsulation modification does not impact safety or efficacy.

Technological Characteristics

Passive thermistor-based temperature sensing. Materials: PVC tubing/insulation, copper wire, ceramic thermistor, brass connector, UV-cured adhesive. Dimensions/form factor: wire set with specific distal interfaces (tube, adhesive cover, or foam plug). Connectivity: wired interface to YSI 400/700 compatible monitors. Sterilization: Ethylene Oxide (General Purpose/Skin) or non-sterile (Tympanic).

Indications for Use

Indicated for routine monitoring of core body or skin surface temperature in adult and pediatric patients. General Purpose probes are for nasopharyngeal, esophageal, or rectal use. Adult Skin sensors are for skin surface application. Tympanic probes are for aural canal use. For use by licensed healthcare practitioners only.

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

Exac-Temp & Clini-Temp Probe w/ Temperature Sensor (K925791)
Exac-Temp & Clini-Temp Tympanic Probe (K925792)

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)

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ #### 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. 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. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperw ork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperw ork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid 0MB number." {3}------------------------------------------------ # 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 Lane Powell, TN 37849 Owner/Operator #1044833 | | 510(k) Contact: | Sarah Bennett Senior Regulatory Affairs Specialist P: 865-362-6112 F: 865-362-3741 sabennett@deroyal.com | | Contract Manufacturer: | DeRoyal Cientifica de Latinoamerica S.R.L. Global Park Box 180-3006, 602 Parkway La Aurora, Heredia Heredia, Costa Rica 146 DeRoyal Industries, Inc. 185 Richardson Way Maynardville, TN 37807 | | Trade Name: | DeRoyal Temperature Monitoring Probe | | 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 Predicate Exac-Temp & Clini-Temp Tympanic Probe [K925792] | {4}------------------------------------------------ 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 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. - 2. 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. - 3. 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. ## Intended Use The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature. {5}------------------------------------------------ ### Summary of Technological Characteristics | Characteristic | Configuration | Proposed Device | Predicate 510(k) | Predicate Device | Differences | |---------------------|-------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | General Purpose | The DeRoyal Temperature Monitoring Probe is used for routine monitoring of the patient's core body or skin surface temperature. | K925791 – Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | The Exac-Temp General Purpose Temperature Probe is to be used for routine monitoring of anesthetized patients by inserting the probe into the esophagus or rectum. | The Indications for Use have been updated for the proposed device to include the reference body site and measuring site as defined by ISO 80601- 2-56 and the intended treatment population and compatible monitors as requested by the FDA. | | | Adult Skin Sensor | 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 | K925006 – Exac-Temp Skin Surface Temperature Sensor | The Exac-Temp Skin Surface Temperature Sensor is to be used for routine monitoring of a patient's skin surface. | | | | Tympanic Probe | | K925792 – Exac-Temp & Clini-Temp Tympanic Probe | The Exac-Temp Tympanic Temperature Probe is to be used for routine monitoring of the patient temperature using the aural canal (ear canal or the external auditory meatus). | | {6}------------------------------------------------ | Prescription Only | General Purpose | by insertion of the ear piece into the aural canal. 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. | Yes | K925791 - Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | Yes | Same | |-------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|--------------------------------------------------------|-------------|------| | | Adult Skin Sensor | | | K925006 - Exac-Temp Skin Surface Temperature Sensor | | | | | Tympanic Probe | | | K925792 - Exac-Temp & Clini-Temp Tympanic 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 Surface Temperature Sensor | | | | | Tympanic Probe | | | K925792 - Exac-Temp & Clini-Temp Tympanic Probe | | | {7}------------------------------------------------ | Measuring Site | General Purpose | Rectum, Esophagus, Nasopharynx | K925791 – Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | Esophagus, Rectum | DeRoyal intends to add the nasopharynx to the General Purpose Probe as a measuring site. ISO 80601-2-56 defines measuring site as the "part of the patient where the temperature is measured." The FDA has cleared three 510(k)s for temperature probes that utilize the nasopharynx as a measuring site in addition to the esophagus and rectum: K101244, K140134, and K181967. | |---------------------|-------------------|-----------------------------------|--------------------------------------------------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Adult Skin Sensor | Skin Surface | K925006 – Exac-Temp Skin Surface Temperature Sensor | Skin Surface | Same | | | Tympanic Probe | Auditory Canal | K925792 - Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | Skin Surface | Same | | | Tympanic Probe | Core Body | K925792 – Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | | | {8}------------------------------------------------ | | Tympanic Probe | | K925792 - Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | | | | | Tympanic Probe | | K925792 - Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | | | | | Tympanic Probe | | K925792 - Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | | | | | Tympanic Probe | | K925792 - Exac-Temp & Clini-Temp Tympanic Probe | | | | Design | General Purpose | Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. The wire set is enclosed in a tube that may be inserted into the application site. | K925791 - Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. The wire set is enclosed in a tube that may be inserted into the application site. | Same | | | Adult Skin Sensor | Wire set with a | K925006 - Exac-Temp | Wire set with a | Same | {9}------------------------------------------------ | | | thermistor chip at the distal end and a blue connector at the proximal end. An adhesive probe cover applies the device to the patients' skin. | Skin Surface Temperature Sensor | thermistor chip at the distal end and a blue connector at the proximal end. An adhesive probe cover applies the device to the patients' skin. | | |--|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | Tympanic Probe | Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. A foam ear plug is used to insert the device into the patient's aural canal. | K925792 – Exac-Temp & Clini-Temp Tympanic Probe | Wire set with a thermistor chip at the distal end and a blue connector at the proximal end. A foam ear plug is used to insert the device into the patient's aural canal. | Same | | | Materials | General Purpose | Tube: PVC Wire: Copper with PVC insulation Thermistor: Ceramic Connector: PVC- molded brass Strain Relief: PVC Cap: UV-cured adhesive | K925791 – Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | Tube: PVC Wire: Copper with PVC insulation Thermistor: Ceramic Connector: PVC- molded brass Strain Relief: PVC Cap: PVC and epoxy glue | | | | Adult Skin Sensor | Cover: Adhesive foam Wire: Copper with PVC insulation Thermistor: Ceramic Connector: PVC- molded brass Strain Relief: PVC Cap: UV-cured adhesive | K925006 - Exac-Temp Skin Surface Temperature Sensor | Cover: Adhesive foam Wire: Copper with PVC insulation Thermistor: Ceramic Connector: PVC- molded brass Strain Relief: PVC Cap: PVC and epoxy glue | | | | Tympanic Probe | Ear Plug: Foam and/or cotton ball Wire: Copper with PVC insulation Thermistor: Ceramic | K925792 – Exac-Temp & Clini-Temp Tympanic Probe | Ear Plug: Foam and/or cotton ball Wire: Copper with PVC insulation Thermistor: Ceramic | | | | | | | | {10}------------------------------------------------ | | | Connector: PVC- molded brass Strain Relief: PVC Cap: UV-cured adhesive | | Connector: PVC- molded brass Strain Relief: PVC Cap: PVC and epoxy glue | Safety and EMC testing also were performed on the proposed device and are contained within Section 17. The results of this testing support the proposed device's safety and effectiveness. | |------------------------|-------------------|------------------------------------------------------------------------------------|--------------------------------------------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 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-Temp Skin Surface Temperature Sensor | Yes | Same | | | Tympanic Probe | No | K925792 – Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | Intact Skin | Same | | | Tympanic Probe | Intact Skin | K925792 — Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | Prolonged (≥ 24 hours) | Same | | | Tympanic Probe | Prolonged (≥ 24 hours) | K925792 – Exac-Temp & Clini-Temp Tympanic Probe | Prolonged (≥ 24 hours) | Same | | Sterilization | General Purpose | Sterilized with Ethylene Oxide | K925791 - Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | Sterilized with Ethylene Oxide | Same | {11}------------------------------------------------ | Adult Skin Sensor | Sterilized with Ethylene Oxide | K925006 – Exac-Temp Skin Surface Temperature Sensor | Sterilized with Ethylene Oxide | Same | | |------------------------|--------------------------------|-----------------------------------------------------------|--------------------------------------------------------------|----------------|------| | Tympanic Probe | Non-sterile | K925792 – Exac-Temp & Clini-Temp Tympanic 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-Temp Skin Surface Temperature Sensor | | | | | Tympanic Probe | | K925792 – Exac-Temp & Clini-Temp Tympanic Probe | | | | | Reusable or Disposable | General Purpose | Disposable | K925791 – Exac-Temp & Clini-Temp Probe w/ Temp. Sensor | Disposable | Same | | Adult Skin Sensor | | K925006 – Exac-Temp Skin Surface Temperature Sensor | | | | | Tympanic Probe | | K925792 – Exac-Temp & Clini-Temp Tympanic Probe | | | | {12}------------------------------------------------ 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.

DeRoyal Temperature Monitoring Probe

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Technological Characteristics

Indications for Use

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DeRoyal Temperature Monitoring Probe

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