Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French

Q: Who is the manufacturer of Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

Deroyal Industries, Inc. filed the 510(k) submission for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (K193027).

Q: What is the FDA product code for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

BZT. It is classified under 21 CFR 868.1920 as a Class 2 device in the Anesthesiology panel.

Q: What is the regulatory pathway for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

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

Q: What are the predicate devices for Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

DeBusk Temperature Systems Esophageal Stethoscope (K925789).

Q: Who can help prepare an FDA 510(k) submission like Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French?

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.

K193027 · Deroyal Industries, Inc. · BZT · Apr 2, 2020 · Anesthesiology

Device Facts

Record ID	K193027
Device Name	Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French
Applicant	Deroyal Industries, Inc.
Product Code	BZT · Anesthesiology
Decision Date	Apr 2, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 868.1920
Device Class	Class 2

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.

Device Story

Device is a sterile, single-use esophageal stethoscope with integrated temperature sensor. Input: acoustic signals from heart/respiratory sounds and thermal energy from esophageal environment. Operation: stethoscope tube with distal cuff transmits acoustic sounds to proximal ear piece; internal thermistor chip modifies electrical current based on temperature. Output: acoustic sounds for clinician auscultation and electrical signal for external temperature monitor. Used in hospital settings by clinicians during anesthesia. Benefits: enables simultaneous core temperature monitoring and auscultation in anesthetized patients.

Clinical Evidence

Bench testing only. Evaluated per ISO 10993-1 (biocompatibility), ISO 80601-2-56 (accuracy/time response), IEC 60601-1 (electrical safety), and IEC 60601-1-2 (EMC). Acoustic responsiveness and leakage current tests confirmed the modified encapsulation method maintains device performance and safety. Accuracy is ± 0.2°C.

Technological Characteristics

Materials: PVC tube/cuff, copper wire, ceramic thermistor, K-Resin ear piece, molded brass connector. Sensing: Thermistor-based temperature measurement. Connectivity: Wired connection to external monitor. Sterilization: Ethylene oxide. Sizes: 9, 12, 18, 24 French. Sensors: 400 or 700 series.

Indications for Use

Indicated for routine monitoring of core body temperature, heart sounds, and respiratory sounds in anesthetized patients via esophageal insertion.

Regulatory Classification

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.

Predicate Devices

DeBusk Temperature Systems Esophageal Stethoscope (K925789)

Related Devices

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K092716 — ESOPHAGEAL STETHOSCOPE · Truer Medical, Inc. · Sep 17, 2009
K973839 — DISPOSABLE ESOPHAGEAL STETHOSCOPE · Catheter Research, Inc. · Mar 19, 1998
K062020 — LIFESOUND ESOPHAGEAL STETHOSCOPE · Novamed, LLC · Sep 5, 2006
K982193 — ESOPHAGEAL STETHOSCOPE · Shore Medical, Inc. · Sep 1, 1998

Submission Summary (Full Text)

{0}------------------------------------------------ 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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K193027 #### Device Name Esophageal Stethoscope with Temperature Sensor Indications for Use (Describe) 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. | 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 Paperwork 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 Paperwork 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 OMB number." {3}------------------------------------------------ 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 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 | | Trade Name: | Esophageal Stethoscope with Temperature Sensor | | Common Name: | Esophageal Stethoscope with Temperature Sensor | | Classification Name: | Stethoscope, Esophageal, with Electrical Conductors | | Device Class: | Class II | | Device Product Code: | BZT | | Regulation Number: | 21 CFR 868.1920 | | Classification Panel: | Anesthesiology | | Predicate Devices: | DeBusk Temperature Systems Esophageal Stethoscope [K925789] | {4}------------------------------------------------ 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 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. ## 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 Esophageal Stethoscope with Temperature Sensor | DeBusk Temperature Systems Esophageal Stethoscope (K925789) | |------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for 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. | The EXAC-TEMP Esophageal Stethoscope with temperature sensor is to be used for routine monitoring of temperature, as well as for heart and respiratory sounds, in an anesthetized patient by inserting the stethoscope tube into the esophagus. | | Prescription Only | Yes | Yes | #### Summary of Technological Characteristics {5}------------------------------------------------ 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 of Operation | Direct according to ISO 80601-2-56 | Direct according to ISO 80601-2-56 | |------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Measuring Site | Esophagus | Esophagus | | Reference Body Site | Core body temperature | Core body temperature | | Use Environment | Hospital | Hospital | | Design | A wire set inserted into a plastic tube with a blue cuff at the distal end. The wire set has a thermistor chip at the distal end and a blue connector at the proximal end. | A wire set inserted into a plastic tube with a blue cuff at the distal end. The wire set has a thermistor chip at the distal end and a blue connector at the proximal end. | | Materials | Tube – PVC Cuff – PVC Wire – Copper with PVC insulation Thermistor - Ceramic Ear Piece - K-Resin Connector – PVC- molded brass Strain Relief – PVC Cap - UV-Curing Adhesive | Tube – PVC Cuff – PVC Wire - Copper with PVC insulation Thermistor - Ceramic Ear Piece - K-Resin Connector - PVC- molded brass Strain Relief - PVC Cap - PVC and epoxy glue | | Accuracy | $\pm$ 0.2°C | $\pm$ 0.2°C | | Sterilization | Sterilized with ethylene oxide | Sterilized with ethylene oxide | | Biocompatibility | ISO 10993-1 compliant | ISO 10993-1 compliant | ## 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 {6}------------------------------------------------ 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.