(167 days)
No
The device description and performance studies focus on basic temperature sensing technology (thermistor) and standard medical device testing, with no mention of AI or ML.
No.
The device is solely for monitoring temperature and does not provide any therapeutic intervention or treatment.
No
The device measures temperature, which is a physiological parameter, but it does not diagnose a disease or condition; it provides data for monitoring purposes.
No
The device description clearly states that the device consists of a physical probe with a thermistor and a connector, which are hardware components. It is a physical medical device used for temperature measurement.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device function: The Sterile Disposable Temperature Probe directly measures the temperature of the patient's body (core or skin) through physical contact. It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to "monitor core temperature or skin temperature," which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device falls under the category of a patient monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
-
Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
-
Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable which is also included in the submission as an accessory. These probes have a skin or core contact with a patient.
These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.
Products are packed individually into a paper pouch in sterile condition.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body cavity (esophageal or rectal cavities), Skin surface
Indicated Patient Age Range
adult and pediatric
Intended User / Care Setting
licensed healthcare practitioners
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 following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
The biocompatibility evaluation for the proposed Temperature Probes was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Rectal Irritation (Body cavity Temperature Probe only)
- Oral mucosa Irritation (Body cavity Temperature Probe only)
The Sterile Disposable temperature probe is considered surface/mucosal contacting for a duration of not exceed 24 hours.
Non-clinical data:
Non-clinical testing has been conducted to verify that the Sterile Disposable Temperature Probe meets all design specifications which support the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the targeted device complies with the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- Stability and performance test of the skin temperature probe for 24hrs continues use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: ± 0.1°C/0.2°F in the range 25°C/77°F to 45°C/113°F
± 0.2°C/0.4°F in the range 0°C/32°F to 24.9°C/76.8°F and 45.1°C/113.2°F to 50°C/122°F
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.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 shows the logo of the U.S. Food and 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 1, 2022
Shenzhen Envisen Industry Co., Ltd % Kevin Wang Consultant Shenzhen Chonconn Medical Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, Guangdong 518067 China
Re: K212945
Trade/Device Name: Sterile Disposable Temperature Probe/Model: TGMS-1691 and TSMS-1191 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 26, 2022 Received: January 28, 2022
Dear Kevin Wang:
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
1
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 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 (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 medical devices and radiation-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,
Gang Peng for Payal Patel Assistant 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
Indications for Use
510(k) Number (if known) K212945
Device Name
Sterile Disposable temperature probe/Model: TGMS-1691 and TSMS-1191
Indications for Use (Describe)
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
-
Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
-
Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
| 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
"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."
FORM FDA 3881 (6/20)
Type of Use (Select one or both, as applicable)
3
510(K) Summary for K212945
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 2022/2/25
Submission sponsor 1.
Name: Shenzhen Envisen Industry Co., Ltd. Address: Block 1, Room 201, 301, 401, 40 Jianlong Street, Baoan Community, Yuanshan Town, Longgang District, Shenzhen, P.R. China Contact person: Ailsa Huang Title: Management Representative E-mail: ailsa.huang@envisen.com Tel: +86 0755 88827227
2. Submission correspondent
Name: Shenzhen Chonconn Medical Device Consulting Co., Ltd. Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P.R. China Contact person: Kevin Wang E-mail: kevin@chonconn.com Tel: +86-755 33941160
| Trade/Device Name | Sterile Disposable Temperature Probe |
|---|---|
| Model | TGMS-1691 and TSMS-1191 |
| Common Name | Temperature Probe |
| Regulatory Class | Class II |
| Regulation Number | 21CFR 880.2910 |
| Regulation Name | Clinical Electronic Thermometer |
| Product Code | FLL |
Subject Device Information 3.
Predicate Device 4.
-
- DeRoyal Industries, Inc., DeRoyal Temperature Monitoring Probe under K200631.
Device Description ട്.
Sterile Disposable Temperature Probes are used during patient temperature measurement. These probes consist of a phone plug connector on the adapter cable end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor by using an interconnect cable which is also included in the submission as an accessory. These probes
4
have a skin or core contact with a patient.
These temperature probes are typically used with Mindray uMEC10, which was cleared under K171901.
Products are packed individually into a paper pouch in sterile condition.
6. Indications for use
The Sterile Disposable Temperature Probe is to be used with Mindray uMEC10 to monitor core temperature or skin temperature. The device is for use by licensed healthcare practitioners only.
The probe is offered in the following two configurations:
-
Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities.
-
Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface.
| Features | Configuration | Subject Device
Sterile
Disposable
Temperature
Probe
K212945 | Predicate Device
DeRoyal
Temperature
Monitoring Probe
K200631 | Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Classification
Name | Body cavity
Skin contact | Temperature
Probe | Temperature
Probe | Same |
| Product Code | Body cavity
Skin contact | FLL | FLL | Same |
| Regulation
Number | Body cavity
Skin contact | 880.2910 | 880.2910 | Same |
| Panel | Body cavity
Skin contact | General
Hospital | General Hospital | Same |
| Class | Body cavity
Skin contact | II | II | Same |
| Indications for
Use | Body cavity
Skin contact | The
Sterile
Disposable
Temperature
Probe is to be
used with
Mindray
uMEC10 to | The DeRoyal
Temperature
Monitoring Probe
is used for routine
monitoring of the
patient's core body
or skin surface | Different
1 |
| | monitor core temperature. temperature or skin temperature. The device is for use by licensed healthcare practitioners only. The probe is offered in the following two configurations: - Body cavity Temperature Probe TGMS-1691 for monitoring of the core temperature in adult and pediatric patients by insertion into the esophageal or rectal cavities. - Skin contact Temperature Probe TSMS-1191 for monitoring of skin temperature by application of the probe's adhesive cover to an adult and pediatric patient's skin surface. | 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. | |
| Application
Population | Body cavity
Skin contact | adult and
pediatric | adult and pediatric
adult | Same
Different 2 |
| Prescription
Only | Body cavity
Skin contact | Yes | Yes | Same |
| Mode of
operation | Body cavity
Skin contact | Direct mode | Direct mode | Same |
| Measure site | Body cavity
Skin contact | Rectum,
Esophagus
Skin Surface | Rectum,
Esophagus,
Nasopharynx
Skin Surface | Different 3
Same |
| Sensor | Body cavity
Skin contact | Thermistor
which is
sensitive to
temperature
change. | Thermistor which
is sensitive to
temperature
change. | Same |
| Reference Body
Site | Body cavity
Skin contact | Core Body
Skin Surface | Core Body
Skin Surface | Same |
| Principle of
operation | Body cavity
Skin contact | Thermistor
resistance based | Thermistor
resistance based | Same |
| | | on the metal
conductor increase
with temperature
decrease, and
the linear
changes to the
characteristics
of the
temperature
measurement. | on the metal
conductor increase
with temperature
decrease, and the
linear changes to
the characteristics
of the temperature
measurement. | |
| Rated
Range | Body cavity
Skin contact | 0-50°C
(32°F- 122°F) | 25-45°C | Different 4 |
| Accuracy | Body cavity
Skin contact | $\pm$ 0.1°C/0.2°F in
the range
25°C/77°F to
45°C/113°F
$\pm$ 0.2°C/0.4°F in
the range
0°C/32°F to
24.9°C/76.8°F
and
45.1°C/113.2°F
to 50°C/122°F | $\pm$ 0.2°C | |
| Operating
Conditions | Body cavity
Skin contact | 5°C to
40°C(41°F to
104°F)
20% to 85%RH, | 25°C to 45°C
\ | Different 5 |
| storage
conditions | Body cavity
Skin contact | -20 to 55°C (-
-4°F to 131°F),
10% to 93%RH, | -25°C to +55°C
\ | Different 6 |
| diameter | Body cavity | 3mm | 3mm,4mm | Same |
| Length | Body cavity
Skin contact | 0.75m
0.95m | \ | Different 7 |
| Design | Body cavity | Wire set with a
phone plug
connector on the
adapter cable
end and a
thermistor on | Wire set with a
thermistor chip at
the distal end and a
blue connector at
the proximal end.
The wire set is | Same |
| | | | | |
| | | the patient end.
The wire set is
enclosed in a
tube that may be
inserted into the
application site. | enclosed in a tube
that may be
inserted into the
application site. | |
| | Skin contact | Wire set with a
phone plug
connector on the
adapter cable
end and a
thermistor on
the patient end.
An adhesive
probe cover
applies the
device to the
patients' skin. | Wire set with a
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. | Same |
| Materials | Body cavity | PVC Connector
and Tube Cable
(PVDF
Material) | Tube: PVC
Wire: Copper with
PVC insulation
Thermistor:
Ceramic
Connector: PVC
molded brass
Strain Relief: PVC
Cap: UV-cured
adhesive | Different 8 |
| | Skin contact | Cover: Release
liner:(PET) and
Foam(aluminum
foil/PET) with
3M glue
Wire: Copper
with PVDF
insulation
Thermistor:
Ceramic
Connector: PVC
molded brass
Strain Relief: | Cover: Adhesive
foam
Wire: Copper with
PVC insulation
Thermistor:
Ceramic
Connector: PVC
molded brass
Strain Relief: PVC
Cap: UV-cured
adhesive | |
| | | PVC
Cap:
stainless
steel and epoxy
glue | | |
| Biocompatibility | Body cavity | Cytotoxicity
complied with
ISO 10993-5 | Cytotoxicity
complied with ISO
10993-5
Sensitization
complied with ISO
10993-10
Irritation complied
with ISO 10993-
10 | Same |
| | Skin contact | Sensitization
complied with
ISO 10993-10
Irritation
complied with
ISO 10993-10 | | Same |
| Sterilization | Body cavity | Sterilized with
Ethylene
Oxide | Sterilized with
Ethylene
Oxide | Same |
| | Skin contact | Sterilized with
Ethylene
Oxide | Sterilized with
Ethylene
Oxide | Same |
| Disposable | Body cavity
Skin contact | Yes | Yes | Same |
Comparison to the Predicate Device 7.
5
6
7
8
9
Different
The subject device has the same Intended use as the predicate device. However, there is some differences in the indications for use.
Predicate K200631 General purpose probe has one more application site nasopharyngeal compared with the subject body cavity probe. The esophageal and rectal cavities measurement sites of the subject body cavity temperature probe and predicate device general purpose temperature probe are the same. The measurement site of the subject body cavity temperature probe is a subset of the predicate device. The difference does not raise any new safety and effective questions.
Predicate K200631 skin probe is only appliable to adult while the subject skin probe is applicable to adult and pediatric. However, the skin contact probe design meets design requirements and is complied with ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions.
The compatible monitors of proposed devices are different from the predicate device. The validate testing was conducted in accordance with the ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions.
Different 2
Predicate K200631 skin probe is only appliable to adult while the subject skin probe is applicable to adult and pediatric. However, the skin contact probe design meets design
10
requirements and is complied with ISO 80601-2-56 standard. The difference does not raise any new safety and effective questions.
Different 3
K200631 General purpose probe has one more application site nasopharyngeal compared with the subject body cavity probe. The application site of the subject device is the subset of the predicate device and complies with ISO 80601-2-56 standard, the difference does not raise any new safety and effective questions.
Different 4
Although the measurement range and accuracy of the subject devices are different form the predicate device, the design meets the design requirement. The subject devices are complied with ISO 80601-2-56 standard. Therefore, the difference does not raise any new safety and effective questions.
Different 5
The operating conditions of the subject devices are different from the predicate device. According to ISO 80601-2-56, a clinical thermometer shall operate in normal use over the ranges of an ambient temperature operating range from 15℃ to 40℃. The ambient temperature of the subject device covers this range, it has also been tested according to ISO 80601-2-56, which has proved that the subject device functions well under specified ambient temperature environment.
Different 6
The storage temperature is the same while the humidity range information of the predicate is not available. However, the validation test was conducted according to ISO 80601-2-56 standard, which has proved that the subject device functions well under specified humidity environment.
Different 7
The information of the predicate is not available. However, the validation test was conducted according to ISO 80601-2-56 standard and the difference does not raise any new safety and effective questions.
Different 8
There are some differences in the materials used in the subject devices and the predicate devices. A biocompatibility testing was performed on the subject products. Electrical Safety and EMC testing also were performed on the subject devices. The results of the testing demonstrate the subject devices comply with ISO 10993-5 and ISO 10993-10 standard and the difference does not raise any new safety and effective questions.
Performance Data 8.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
11
The biocompatibility evaluation for the proposed Temperature Probes was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests:
- Cytotoxicity
- Sensitization
- Irritation
- Rectal Irritation (Body cavity Temperature Probe only)
- Oral mucosa Irritation (Body cavity Temperature Probe only)
The Sterile Disposable temperature probe is considered surface/mucosal contacting for a duration of not exceed 24 hours.
Non-clinical data
Non-clinical testing has been conducted to verify that the Sterile Disposable Temperature Probe meets all design specifications which support the conclusion that it's Substantially Equivalent (SE) to the predicate devices. The testing results demonstrate that the targeted device complies with the following standards:
- IEC 60601-1-2005+CORR.1:2006+CORR.2:2007+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56:2017+A1:2018 Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
- Stability and performance test of the skin temperature probe for 24hrs continues use.
9. Conclusion
Based on the performance testing, comparison and analysis, the proposed subject devices are substantially equivalent to the predicate device.