(140 days)
No
The device description focuses on a simple thermistor-based temperature measurement and does not mention any AI or ML components or functions.
No
The device is a diagnostic tool designed for continuous temperature monitoring, not for treating or preventing a disease or condition.
No
The device is a temperature probe used to continuously measure a patient's skin or internal body temperature. While temperature monitoring is a fundamental part of patient assessment, this device itself only collects data and does not interpret that data to provide a diagnosis of a disease or condition. It is a measurement tool, not a diagnostic one.
No
The device description explicitly states it is composed of a plug, cable, and temperature sensing probe, which are hardware components. It also describes physical interaction with the patient's body (pasting under the axilla or insertion into cavities).
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 for diagnosis, monitoring, or screening.
- Device Function: The Disposable Temperature Probe directly measures the patient's body temperature (skin, oral, rectal, nasopharyngeal cavity). It does not analyze a specimen taken from the body.
- Intended Use: The intended use is to continuously measure the patient's temperature, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device 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 Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.
The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all been tested and evaluated for biocompatibility.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin, patient's oral, rectal, nasopharyngeal cavity
Indicated Patient Age Range
Adult and pediatric patient
Intended User / Care Setting
professionals
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)
Non-clinical testings have been conducted to verify that the Disposable Temperature Probe meets all design specifications which supports 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, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
- 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. (General Plastic Surgery/General Hospital)
The body-contacting components of this device are sticker and probe which have been demonstrated conformance to the following standards. - ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- ISO 10993-10. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- Cleaning validation and disinfection validation have been conducted based on the following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Temperature range: 25°C-45°C
Accuracy: ±0.1°C (25°C - 45°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.
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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 10, 2018
Shenzhen Launch Electrical Co., LTD % Tracy Che Registered Engineer Feiying Drug & Medical Consulting Technical Service Group B-3F-3005, Bldg.1, Southward Ruifeng Business Center, No. 22 Guimiao Road Shenzhen, Guangdong, 518000 China
Re: K181967
Trade/Device Name: Disposable Temperature Probe. Model: TAS03-14. TAS03-15. TAS03-16. TAS03-17 (body surface type); TAE03-09S, TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 8, 2018 Received: November 13, 2018
Dear Tracy Che:
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
1
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Sapana Patel -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K181967
Device Name
Disposable Temperature Probe/ Model: TAS03-14, TAS03-16, TAS03-17 (body surface type); TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S (celomic type)
Indications for Use (Describe)
The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.
The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.
Type of Use (Select one or both, as applicable)
| 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
510 (k) Summary
This "510(k) Summary" is submitted in accordance with requirements of Title 21, CFR Section 807.92.
K181967
(1) Applicant information
| 510 (k) owner's name: | SHENZHEN LAUNCH ELECTRICAL CO., LTD |
|---|---|
| ----------------------- | ------------------------------------- |
| Address: | NO. F Building, Zhonggangxing Industrial Estate, Zhangge
Community, Guanlan Street, Longhua New District, Shenzhen,
China |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Contact person: | Jiaan Huang |
| Phone number: | +86-755-29532401 |
| Fax number: | +86-755-29532483 |
| Email: | yuanhe@cnlaunch.com |
| Date of summary prepared: | 2018.12.07 |
(2) Proprietary name of the device
| Trade name/Model: | Disposable Temperature Probe/ Model: TAS03-14, TAS03-15,
TAS03-16, TAS03-17 (body surface type); TAE03-09S,
TAE03-10S, TAE03-11S, TAE03-12S, TAE03-13S, TAE03-14S,
TAE03-15S, TAE03-16S (celomic type) |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Regulation name: | Clinical electronic thermometer |
| Regulation number: | 21 CFR 880.2910 |
| Product code | FLL |
| Review panel: | General hospital |
| Regulation class: | Class II |
(3) Predicate and reference device
- 彩 Predicate device
| Sponsor | Dräger Medical GmbH |
|---|---|
| Device Name and Model | Temperature Probes (General purpose/ Skin) |
| 510(k) Number | K121999 |
| Product Code | FLL |
| Regulation Number | 21 CFR 880.2910 |
| Regulation Class | II |
4
| Sponsor | Starboard Medical, LLC | Welch Allyn, Incorporated |
|---|---|---|
| Device Name and Model | Esophageal/Rectal | |
| Temperature Probe | SureTemp® Plus | |
| 510(k) Number | K140134 | K030580 |
| Product Code | BZT, FLL | FLL |
| Regulation Number | 21 CFR 868.1920 | |
| 21 CFR 880.2910 | 21 CFR 880. 2910 | |
| Regulation Class | II | II |
- Reference device જુન
(4) Description/ Design of device
The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all
(5) Indications for use
been tested and evaluated for biocompatibility.
The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.
The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.
| Component of
Device Requiring
Biocompatibility | Material of
Component | Body Contact Category
(ISO 10993-1) | Contact Duration
(ISO 10993-1) |
| ------------------------------------------------------ | -------------------------- | ---------------------------------------- | ----------------------------------- |
|---|
(6) Materials
5
| Sticker | Foam | Surface-contacting device:
Intact skin | Note 5:
Although the predicate device is intended for patient skin temperature measurement, the reference devices are intended for temperature measurement via nasopharynx and oral route. The method of measurement do not raise new or different questions of safety or effectiveness.
(8) Non-clinical studies and tests performed
Non-clinical testings have been conducted to verify that the Disposable Temperature Probe meets all design specifications which supports 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:
- A IEC 60601-1, Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2. Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements and tests
-
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. (General Plastic Surgery/General Hospital)
The body-contacting components of this device are sticker and probe which have been demonstrated conformance to the following standards.
-
ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity
- A ISO 10993-10. Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
Cleaning validation and disinfection validation have been conducted based on the following FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."
(9) Conclusion
Based on the above analysis and tests performed, it can be concluded that the performance and function of Disposable Temperature Probe is Substantially Equivalent (SE) to the predicate device.