(139 days)
Not Found
No
The description focuses on basic temperature measurement and transmission via Bluetooth, with no mention of AI/ML terms or functionalities.
No
Explanation: The device is an electronic thermometer intended for measuring and monitoring human body temperature. Its function is diagnostic/monitoring, not therapeutic.
No
Measuring body temperature is a monitoring function, not a diagnostic one. While changes in body temperature can be indicators of illness, the thermometer itself does not diagnose a condition; it merely provides a data point. The "Intended Use" clearly states it is for "measuring and monitoring human body temperature," which supports this non-diagnostic function.
No
The device description explicitly states it is a "handheld device with battery power supply" and incorporates a "temperature sensitive sensor," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure and monitor human body temperature. This is a direct measurement of a physiological parameter within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device description confirms it's a thermometer for measuring body temperature. It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the accuracy and safety of the thermometer itself, not on the performance of a diagnostic test on a sample. The mention of ISO 10993 standards relates to the biocompatibility of the device in contact with the body, which is relevant for medical devices but not specifically for IVDs.
IVD devices are designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This electronic thermometer does not perform such analysis.
N/A
Intended Use / Indications for Use
Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures.
The proposed device is available in two models, which are WT1 and WT2.
Similarities between models:
a. Both of them incorporate a temperature sensitive sensor
b. Both of them can measure and monitor human body temperature under arm;
c. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature;
Differences between models:
a. WT1 has an automatic power on/off feature;
b. WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for measuring and monitoring;
c. WT2 can be used with a designated probe cover;
d. WT2 can be used for measurement of oral temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally and/or under arm
Indicated Patient Age Range
adult, pediatric and infant
Intended User / Care Setting
healthcare facility and home.
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 tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
- IEC 60601-1-2:2007/(R)2012, 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 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Guangdong Biolight Meditech Co., Ltd % Ms. Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K152739
Trade/Device Name: Electronic Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: January 25, 2016 Received: February 1, 2016
Dear Ms. Hong:
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. 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.
1
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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152739
Device Name
Electronic Thermometer, Model WT1 and WT2
Indications for Use (Describe)
Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.
| Type of Use (Select one or both, as applicable) | Research Use Only (21 CFR 201.3 Subject to Transition) For In-Vitro Diagnostic Use (21 CFR 809 Subject to Transition) |
|---|---|
| ------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------- |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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3
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.
The assigned 510(k) Number: K152739
-
- Date of Preparation: 1/25/2016
-
- Sponsor Identification
Guangdong Biolight Meditech Co., Ltd
Innovation First Road, Technology Innovation Coast Zhuhai, Guangdong, 519085, China
Establishment Registration Number: 3007305624
Contact Person: Ms. Liang, Jing Position: R&D Director Tel: +86-756-3399967 Fax: +86-756-3399989 Email: liang j@blt.com.cn
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Mr. Lee Fu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 240-238-7587 Email: info@mid-link.net
4
4. Identification of Proposed Device
Trade Name: Electronic Thermometer Common Name: Clinical electronic thermometer Model(s): WT1, WT2
Regulatory Information
Classification Name: Clinical electronic thermometer Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital
Intended Use Statement:
Electronic Thermometer is intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home.
Device Description
The proposed device, Electronic Thermometer, is a handheld device with battery power supply, intended for measuring and monitoring human body temperature orally and/or under arm for adult, pediatric and infant. It can be used in healthcare facility and home. There is no specific use of this device other than temperature measurements, including conversion of temperatures.
The proposed device is available in two models, which are WT1 and WT2.
Similarities between models:
- a. Both of them incorporate a temperature sensitive sensor
- Both of them can measure and monitor human body temperature under arm; b.
- C. Neither the WT1 nor WT2 has display function, the measured or monitored temperature will be transmitted to a mobile application, Temp Sitter, installed under iOS system via the blue tooth to display the measured and monitored temperature;
Differences between models:
- WT1 has an automatic power on/off feature; a.
- WT1 can be used with an adhesive tape, which could be fix the thermometer under arm for b. measuring and monitoring;
- WT2 can be used with a designated probe cover; c.
- WT2 can be used for measurement of oral temperature. d.
5
-
- Identification of Predicate Device(s)
510(k) Number: K132514 Product Name: Kinsa Smart Thermometer
- Identification of Predicate Device(s)
-
Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: -
ISO 10993-5:2009/(R) 2014, Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
-
ISO 10993-10:2010, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
-
IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance.
-
IEC 60601-1-2:2007/(R)2012, 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 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
-
- Clinical Test Conclusion
No clinical study is included in this submission.
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- Substantially Equivalent (SE) Comparison
Table 1 Comparison of Technology Characteristics
- Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device |
|---|---|---|
| Product Code | FLL | FLL |
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 |
| Intended Use | Electronic Thermometer is | |
| intended for measuring and | ||
| monitoring human body | ||
| temperature orally and/or under | ||
| arm for adult, pediatric and infant. | ||
| It can be used in healthcare | ||
| facility and home. | The Kinso Smart Thermometer is | |
| intended to measure the human body | ||
| temperature orally, rectally, or under | ||
| the arm, and the devices are reusable | ||
| for clinical or home use on people of | ||
| all ages | ||
| Measurement Site | orally and/or under arm | orally, rectally, or under the arm |
| Feature | Compatible with iOS Mobile | |
| Device via | Compatible with iOS Mobile Device | |
| via |
6
| wireless connection | wire connection | |
|---|---|---|
| Display in mobile application, no | ||
| display on device | Display in mobile application, no | |
| display on device | ||
| Component | Temperature Sensitive Sensor | Temperature Sensitive Sensor |
| Plastic Housing | Plastic Housing | |
| Circuit Board | Circuit Board | |
| No Cable | Cable | |
| Battery (button cell) | Mobile Device Power Supply | |
| Accessories | Adhesive tape (WT1) | No |
| Container (WT1) | No | |
| Probe cover (WT2) | No | |
| Range | $25.00°C~45.00°C$ | $35.00°C~42.00°C$ |
| Accuracy | $±0.1°C$ $25.00°C~34.99°C$ | Not Claimed |
| $±0.05°C$ $35.00°C~38.50°C$ | $±0.1°C$ $35.00°C~42.00°C$ | |
| $±0.1°C$ $38.51°C~45.00°C$ | ||
| Precision | 4 numeric digits displayed in 0.01 | |
| degree increments | 4 numeric digits displayed in 0.01 | |
| degree increments | ||
| Response Time | 5 minutes | 15 seconds |
| Unit | °C and °F | °C and °F |
| Patient contact | ||
| materials | Stainless Steel, S216 | |
| Polycarbonate (PC), 2458 | ||
| Silicone, TPE | ||
| Non-Woven Cloth | ||
| Medical Melt Adhesive | Stainless Steel | |
| Thermoplastic rubber | ||
| Acrylonitrile butadiene styrene | ||
| Biocompatibility | No Cytotoxicity | |
| No Sensitization | ||
| Irritation-negligible | Comply with ISO 10993-5 and ISO | |
| 10993-10 | ||
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 |
Discussion of Main Differences:
The proposed device can only measure orally and/or under arm, however, the predicate device can additionally measure rectal temperature. The intended sites have been communicated in the user manual, and this will not affect the intended use of the device; the proposed device connects with the iOS device through wireless method, however, the predicate device connects the iOS device through cable. Risk analysis and associated verification has been performed that the wireless feature is acceptable; In addition, the proposed device has a longer response time, however, this time is still acceptable and communicated in the User Manual.
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- Substantially Equivalent (SE) Conclusion
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.
- Substantially Equivalent (SE) Conclusion