(288 days)
No
The device description and intended use focus on a passive thermistor and its interface with existing temperature monitors, with no mention of AI or ML.
No.
The device is used for routine monitoring of the patient's core body or skin surface temperature. It does not treat, mitigate, or cure any condition.
No
Explanation: The device is a temperature monitoring probe used for "routine monitoring" of temperature. While temperature monitoring is often part of a diagnostic process, the monitor itself does not diagnose a condition, but rather provides data for a healthcare practitioner to interpret.
No
The device description clearly states it is a physical probe with a wire set, connector, and thermistor chip, which are hardware components.
Based on the provided text, the DeRoyal Temperature Monitoring Probe is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The DeRoyal Temperature Monitoring Probe directly measures the patient's body temperature (core or skin surface) by being placed in or on the body. It does not analyze a specimen taken from the body.
- Intended Use: The intended use clearly states "routine monitoring of the patient's core body or skin surface temperature." This is a direct physiological measurement, not an analysis of a biological sample.
Therefore, the DeRoyal Temperature Monitoring Probe falls under the category of a general medical device used for physiological monitoring, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DeRoyal Temperature Monitoring Probe is used for routine monitoring 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 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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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:
-
- 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.
-
- 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.
-
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasopharyngeal, esophageal, rectal cavities, skin surface, aural canal
Indicated Patient Age Range
Adult and pediatric patients
Intended User / Care Setting
licensed healthcare practitioners only. 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
The results of performance testing demonstrate the DeRoyal Temperature Monitoring Probe is substantially equivalent to the predicates.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/-0.2°C
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K925006, K101244, K140134, K181967
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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)
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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:
-
- 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.
-
- 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.
-
- 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 | | | |
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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.