(155 days)
Not Found
No
The device description and performance studies focus on passive sensing and standard electrical/acoustic measurements, with no mention of AI or ML algorithms for data processing or interpretation.
No.
Explanation: The device is used for monitoring core body temperature and heart/respiratory sounds, which are diagnostic/monitoring functions, not therapeutic interventions.
No
The device is used for routine monitoring of core body temperature, as well as heart and respiratory sounds. It gathers physiological data rather than diagnosing a specific disease or condition.
No
The device description clearly outlines physical components such as a plastic tube, cuff, wire set, thermistor chip, and connectors, indicating it is a hardware device with integrated sensors.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Device Function: The DeRoyal Esophageal Stethoscope with Temperature Sensor is used to monitor core body temperature and heart/respiratory sounds directly within the patient's body (in vivo) by inserting it into the esophagus. It does not analyze specimens taken from the body.
The device is a monitoring device used for physiological measurements within the patient, not for diagnostic testing of biological samples.
N/A
Intended Use / 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.
Product codes
BZT
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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 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.
Key Metrics
Accuracy: +/- 0.2°C
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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)
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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] |
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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
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.