The DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as heart and respiratory sounds in an anesthetized patient by inserting the stethoscope tube into the esophagus.

Device Description

The DeRoyal Esophageal Stethoscope with Temperature Sensor is inserted into the esophagus of anesthetized patients to monitor core body temperature as well as heart and respiratory sounds. The probe consists of a small diameter plastic tube upon which a blue cuff is placed. When inserted in the esophagus, the cuff facilitates transmission of sound to an ear piece attached at the proximal end of the tube. Additionally, a wire set is placed inside the plastic tube. This wire set contains a thermistor chip at the distal end that passively modifies the electrical current traveling through the probe. A blue connector at the proximal end of the wire set interfaces with a cable that is connected to an independent temperature monitor that is used to display the temperature readings.

The probe is sterile and individually packaged. It is available in 9, 12, 18, and 24 French sizes and may come with 400 or 700 series sensors. The stethoscope has a male luer fitting for attachment to standard ear pieces.

AI/ML Overview

The provided text describes a 510(k) submission for a medical device, the "DeRoyal Esophageal Stethoscope with Temperature Sensor". This submission is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

Crucially, this document is NOT about proving an AI/ML algorithm's performance. It's about a hardware medical device (a stethoscope with a temperature sensor). Therefore, many of the requested points, such as "multi reader multi case (MRMC) comparative effectiveness study," "standalone (i.e. algorithm only without human-in-the loop performance)," "ground truth for the test set," and "training set," are not applicable to this type of device submission.

The document discusses performance tests for manufacturing quality and safety, not for an AI model's diagnostic accuracy.

However, I can extract the relevant information regarding the device's acceptance criteria and the proofs provided within the scope of this hardware device submission.

Acceptance Criteria and Device Performance (for a Hardware Device)

The device in question is the DeRoyal Esophageal Stethoscope with Temperature Sensor. Its primary functions are:

Monitoring core body temperature.
Monitoring heart and respiratory sounds.

The submission aims to prove substantial equivalence to a predicate device, the DeBusk Temperature Systems Esophageal Stethoscope (K925789).

Here's a table summarizing the acceptance criteria (as implicitly defined by equivalence to the predicate and relevant standards) and the reported device performance:

Acceptance Criteria (Relevant to Hardware Device)	Reported Device Performance (Adherence to Standards/Predicate Equivalence)
Temperature Accuracy	$\pm$ 0.2°C (Matches predicate, tested per ISO 80601-2-56)
Stethoscope Functionality	Acoustic responsiveness tested; proposed change (encapsulation) did not affect stethoscope functions.
Material Biocompatibility	ISO 10993-1 compliant (Evaluated via biological risk assessment for proposed change; no new testing for non-patient contacting material).
Sterilization Method	Sterilized with ethylene oxide (Matches predicate).
Electrical Safety	Tested according to IEC 60601-1 and IEC 60601-1-2; leak current test performed. Met requirements.
Essential Performance	Accuracy and time response tested per ISO 80601-2-56; demonstrated safe and effective.
Mode of Operation	Direct according to ISO 80601-2-56.
Intended Use Environment	Hospital.
Sizes Available	9, 12, 18, and 24 French sizes; 400 or 700 series sensors.
Prescription Use	Yes (Matches predicate).

Study Details (Relevant to Hardware Device Testing)

Since this is a hardware device and not an AI/ML algorithm, many of the requested categories are not directly applicable. I will address the relevant ones and explicitly state when a category is not applicable for this context.

A table of acceptance criteria and the reported device performance: (Provided above)
Sample size used for the test set and the data provenance:
- Sample Size: The document repeatedly states "All testing was performed on a final, finished device manufactured with the proposed modification." It does not specify a quantitative sample size (e.g., N units). This is typical for engineering verification and validation of medical devices where tests are performed on a representative sample of finished products to ensure design specifications are met.
- Data Provenance: The testing was performed internally by the manufacturer (DeRoyal Industries, Inc.) or by contracted labs following specified standards (e.g., ISO, IEC). No information about "country of origin of the data" or "retrospective/prospective" studies in the clinical sense is provided as it's not a clinical trial of a diagnostic algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a hardware device; "ground truth" in the AI/ML sense (e.g., expert labels on images) is not established. Device performance is measured against established engineering standards (e.g., temperature accuracy to $\pm$ 0.2°C, electrical safety limits). The "ground truth" is typically defined by metrological standards and calibrated reference instruments.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for subjective interpretations (like medical image reading). Hardware device testing involves objective measurements against predefined specifications.
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 hardware medical device, not an AI/ML diagnostic system. No human reader studies or AI assistance are involved.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. There is no algorithm. The device's performance is inherently "standalone" in that its physical functions (temperature sensing, sound transmission) are tested directly.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For temperature accuracy, the "ground truth" would be established by measurements using a highly accurate, calibrated reference thermometer in a controlled environment (e.g., a water bath at a known temperature). For electrical safety, the "ground truth" refers to compliance with the limits set by standards like IEC 60601-1. For acoustic responsiveness, it would be measured against expected sound transmission properties. This is about physical properties and engineering standards, not medical diagnoses.
The sample size for the training set:
- Not Applicable. There is no AI/ML model, hence no training data or training set.
How the ground truth for the training set was established:
- Not Applicable. As there is no training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K193027

Trade/Device Name: Esophageal Stethoscope with Temperature Sensors Regulation Number: 21 CFR 868.1920 Regulation Name: Esophageal Stethoscope with Electrical Conductors Regulatory Class: Class II Product Code: BZT Dated: February 25, 2020 Received: February 27, 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 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

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devices or post-marketing 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 (QS) 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.

Todd Courtney Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K193027

Device Name

Esophageal Stethoscope with Temperature Sensor

Indications for Use (Describe)

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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DeRoyal Industries, Inc. Traditional 510(k) Submission – Esophageal Stethoscope with Temperature Sensor October 25, 2019

510(k) Summary

Date prepared:	October 25, 2019
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 146
Trade Name:	Esophageal Stethoscope withTemperature Sensor
Common Name:	Esophageal Stethoscope withTemperature Sensor
Classification Name:	Stethoscope, Esophageal, withElectrical Conductors
Device Class:	Class II
Device Product Code:	BZT
Regulation Number:	21 CFR 868.1920
Classification Panel:	Anesthesiology
Predicate Devices:	DeBusk Temperature SystemsEsophageal Stethoscope [K925789]

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Image /page/4/Picture/0 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the word "DeRoyal" in blue, with a registered trademark symbol next to it. The logo is simple and modern, with a clean design.

Device Description

Intended Use

The DeRoyal Esophageal Stethoscope with Temperature Sensor is to be used for routine monitoring of core body temperature, as well as heart and respiratory sounds, in an anesthetized patient by inserting the stethoscope tube into the esophagus.

Characteristic	DeRoyal EsophagealStethoscope withTemperature Sensor	DeBuskTemperatureSystems EsophagealStethoscope(K925789)
Indications forUse	The DeRoyalEsophagealStethoscope withTemperature Sensoris to be used forroutine monitoring ofcore bodytemperature, as wellas heart andrespiratory sounds, inan anesthetizedpatient by insertingthe stethoscope tubeinto the esophagus.	The EXAC-TEMPEsophagealStethoscope withtemperature sensor isto be used for routinemonitoring oftemperature, as wellas for heart andrespiratory sounds, inan anesthetizedpatient by insertingthe stethoscope tubeinto the esophagus.
PrescriptionOnly	Yes	Yes

Summary of Technological Characteristics

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Image /page/5/Picture/2 description: The image shows the logo for DeRoyal. The logo consists of a blue swoosh-like graphic on the left, followed by the word "DeRoyal" in blue, with a registered trademark symbol next to it. The logo is simple and modern, with a clean design.

Mode ofOperation	Direct according toISO 80601-2-56	Direct according toISO 80601-2-56
Measuring Site	Esophagus	Esophagus
Reference BodySite	Core bodytemperature	Core bodytemperature
Use Environment	Hospital	Hospital
Design	A wire set insertedinto a plastic tubewith a blue cuff at thedistal end. The wireset has a thermistorchip at the distal endand a blue connectorat the proximal end.	A wire set insertedinto a plastic tubewith a blue cuff at thedistal end. The wireset has a thermistorchip at the distal endand a blue connectorat the proximal end.
Materials	Tube – PVCCuff – PVCWire – Copper withPVC insulationThermistor - CeramicEar Piece - K-ResinConnector – PVC-molded brassStrain Relief – PVCCap - UV-CuringAdhesive	Tube – PVCCuff – PVCWire - Copper withPVC insulationThermistor - CeramicEar Piece - K-ResinConnector - PVC-molded brassStrain Relief - PVCCap - PVC andepoxy glue
Accuracy	$\pm$ 0.2°C	$\pm$ 0.2°C
Sterilization	Sterilized withethylene oxide	Sterilized withethylene oxide
Biocompatibility	ISO 10993-1compliant	ISO 10993-1compliant

Summary of Performance Tests

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

The following biocompatibility tests were performed on the predicate device: cytotoxicity, skin sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity. The proposed change was evaluated in a biological risk assessment, and it was determined that, because the change is to a non-patient contacting material that does not directly or indirectly contact tissue, it was unnecessary to perform new testing on a device manufactured with the proposed encapsulation method.

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

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Image /page/6/Picture/0 description: The image contains the logo for DeRoyal. The logo consists of a blue swoosh-like graphic above the text "DeRoyal" in blue. The "R" in DeRoyal has a registered trademark symbol next to it.

testing according to ISO 80601-2-56 were performed to ensure the proposed device performed its essential performance safely and effectively. A leakague current test also was performed after submerging the device in solution to ensure the encapsulation method is effective. Additionally, an acoustic responsiveness test was done to demonstrate the proposed change did not affect the stethoscope functions of the device.

All testing was performed on a final, finished device 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 Esophageal Stethoscope with Temperature Sensor do not raise different questions of safety or effectiveness. With the exception of the proposed change to the encapsulation method, the proposed device is identical to the predicate, which has been on the market since 1993. Therefore, the proposed device is substantially equivalent to the predicate.

Regulation Number and Section

§ 868.1920 Esophageal stethoscope with electrical conductors.

(a)
Identification. An esophageal stethoscope with electrical conductors is a device that is inserted into the esophagus to listen to a patient's heart and breath sounds and to monitor electrophysiological signals. The device may also incorporate a thermistor for temperature measurement.(b)
Classification. Class II (performance standards).