(134 days)
No
The device description mentions a "filtering algorithm" and a "table lookup operation" for temperature conversion, which are standard signal processing and data retrieval techniques, not indicative of AI/ML. There is no mention of AI, ML, or related concepts in the document.
No.
The device is a thermometer used for measuring and monitoring temperature, which is a diagnostic function, not a therapeutic one.
No
This device is intended for measuring and monitoring human armpit temperature, which is a measurement function. While temperature can be a diagnostic indicator, the device itself only provides the measurement and does not interpret the results to make a diagnosis.
No
The device description explicitly states it is composed of a "Patch" and a "Mobile App". The "Patch" is a physical component containing a circuit board, NTC thermal resistor, and Bluetooth chip, which is essential for the temperature measurement function. This hardware component prevents it from being a software-only medical device.
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 armpit temperature. This is a measurement of a physiological parameter within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device measures temperature using a thermal resistor in contact with the skin. This is a physical measurement, not a chemical, biological, or immunological test performed on a sample.
- Lack of Sample Analysis: The description focuses on the collection and transmission of temperature data, not the analysis of a biological sample.
- Standards Compliance: The listed standards (ISO 10993, IEC 60601, ISO 80601) are relevant to medical devices that interact with the body or are used in a medical environment, but they are not specific to in vitro diagnostics. IVD devices typically comply with standards related to the analysis of biological samples.
In summary, the Wireless Thermometer is a medical device used for physiological monitoring, not an in vitro diagnostic device which analyzes samples outside of the body.
N/A
Intended Use / Indications for Use
The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. The system is intended for armpit temperature monitoring for persons with all ages.
The products can be used in hospital and at home.
Product codes
FLL
Device Description
The MCU chip in the wireless electronic thermometer collects the voltage value of the NTC thermal resistor, a thermo-sensitivity resistance, whose resistance will change according to temperature. After collecting and filtering algorithm, a resistance value data is obtained. After that, the Bluetooth chip performs a table lookup operation to find the Celsius temperature value corresponding to the resistance value. The temperature data is transmitted through the Bluetooth transmission to the compatible smart phone, in order to achieve the function of temperature measurement.
The wireless thermometer is composed of a Patch and a Mobile App.
-
Patch: One side of Patch is medical adhesive which is used to fix the patch on the armpit of patients. The other side is foam. There is a circuit board inside the patch. The patch is used for detecting of human body temperature and then transferred to Mobile App for display and further management. There is no display function on the patch, except for a indicator to indicating power on/off status.
Patches are single use only, and available in different configuration. The models ECH-b1-S, ECH-b1-M and ECH-b1-L all share the same design principles, materials, mechanism of actions. However they are different in size and intended patient. -
Mobile APP: The APP is intended for display and management of obtained human body temperature data.
The mobile APP is intended to be run on compatible smart phones with iOS operating system or Android operating system, including:
- iPhone 5, iPhone 5s, iphone 5C, iPhone 6, iPhone 6 Plus, iPhone 6s, iPhone 6s Plus, Iphone SE, iPhone 7, iPhone 7 Plus smart phone run on IOS 7.1 or advanced operation system or
- Nexus 5, Sumsang Galaxy S6, Huawei Mate 8 smart phone run on Android 4.4 or advanced operation system.
Its function includes:
- Patient management;
- Communication with Patch;
- Simultaneous display of temperature;
- Indication of low battery content of patch.
There is no alarming and interpretation feature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
armpit
Indicated Patient Age Range
all ages
Intended User / Care Setting
hospital and at 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 Biological evaluation of medical devices- Part 5: Tests for in vitro cvtotoxicitv
- 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 60601-1-2:2014, 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 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.
- IEC 60601-1-11:2010 Medical electrical equipment- Part 1-11:General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: +/- 0.2 °C for 25-45 °C
Predicate Device(s)
Reference Device(s)
Not Found
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
Tab #2 510(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: K170769
-
- Date of Preparation: 07/24/2017
-
- Sponsor Identification
ECH (ChangZhou) Medical Instrument Co., Ltd.
No.65 Huilin west road, zhouqu town, zhong lou District Changzhou city , Jiangsu Province ,213144
Establishment Registration Number: Not yet registered
Contact Person: Mr. Yuan Hu Position: deputy general manager Tel: +86-0519-88161606 Fax: +86-0519-83635058 Email: huyuan@ech-med.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Cindy Wang (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
1
-
- Identification of Proposed Device
Trade Name: Wireless Thermometer, Model(s): ECH-b1-L, ECH-b1-M, and ECH-b1-S
- Identification of Proposed Device
Common Name: Clinical electronic thermometer Model(s): ECH-b1-L, ECH-b1-M, ECH-b1-S
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:
The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. The system is intended for armpit temperature monitoring for persons with all ages.
- Intended Use Statement:
The products can be used in hospital and at home.
-
- Device Description
The MCU chip in the wireless electronic thermometer collects the voltage value of the NTC thermal resistor, a thermo-sensitivity resistance, whose resistance will change according to temperature. After collecting and filtering algorithm, a resistance value data is obtained. After that, the Bluetooth chip performs a table lookup operation to find the Celsius temperature value corresponding to the resistance value. The temperature data is transmitted through the Bluetooth transmission to the compatible smart phone, in order to achieve the function of temperature measurement.
- Device Description
The wireless thermometer is composed of a Patch and a Mobile App.
-
Patch: One side of Patch is medical adhesive which is used to fix the patch on the armpit of patients. The other side is foam. There is a circuit board inside the patch. The patch is used for detecting of human body temperature and then transferred to Mobile App for display and further management. There is no display function on the patch, except for a indicator to indicating power on/off status.
Patches are single use only, and available in different configuration. The models ECH-b1-S, ECH-b1-M and ECH-b1-L all share the same design principles, materials, mechanism of actions. However they are different in size and intended patient. -
Mobile APP: The APP is intended for display and management of obtained human body temperature data.
2
The mobile APP is intended to be run on compatible smart phones with iOS operating system or Android operating system, including:
- iPhone 5, iPhone 5s, iphone 5C, iPhone 6, iPhone 6 Plus, iPhone 6s, iPhone 6s Plus, Iphone SE, iPhone 7, iPhone 7 Plus smart phone run on IOS 7.1 or advanced operation system or
- Nexus 5, Sumsang Galaxy S6, Huawei Mate 8 smart phone run on Android 4.4 or advanced operation system.
Its function includes:
- Patient management;
- Communication with Patch;
- Simultaneous display of temperature;
- Indication of low battery content of patch.
There is no alarming and interpretation feature.
-
- Identification of Predicate Device(s)
510(k) Number: K143267 Product Name: TempTraq, Model TT-100
- Identification of Predicate Device(s)
-
Non-Clinical Test Conclusion 8.
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 Biological evaluation of medical devices- Part 5: Tests for in vitro cvtotoxicitv
-
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 60601-1-2:2014, 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 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.
-
IEC 60601-1-11:2010 Medical electrical equipment- Part 1-11:General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical system used in the home healthcare environment
3
9. Clinical Test Conclusion
No clinical study is included in this submission.
10. Substantially Equivalent (SE) Comparison
| Item | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Product Code | FLL | FLL | Similar |
| Regulation Number | 21 CFR 880.2910 | 21 CFR 880.2910 | Similar |
| Class | Clinical electronic thermometers | Clinical electronic thermometers | Similar |
| Intended Use | The Wireless Thermometer is a battery-operated electronic device with intended use of measuring and monitoring human armpit temperature continuously via wireless signal transmission of the measuring result. This system is intended for armpit temperature monitoring for persons with all ages. The products can be used in hospital and at home. | The wireless thermometer, model TT-100, is a battery-operated electronic device with intended use of measuring human body temperature precisely. This device is a single-use and intended for armpit temperature measurement of persons of all age. | Similar |
| Measurement Site | Under the armpit | Under the armpit | Similar |
| Features | Compatible with iOS or Android Mobile Device via Bluetooth connection | ||
| Display in mobile application, no display on device | Compatible with iOS or Android Mobile Device via wireless connection | ||
| Display in mobile application, no display on device | Similar | ||
| Component | Temperature Sensitive Sensor | ||
| Circuit Board | |||
| No Cable | |||
| Battery (button cell) | Temperature Sensitive Sensor | ||
| Circuit Board | |||
| No cable | |||
| Battery(button cell) | Similar | ||
| Working voltage | 3.0Vdc | 3.0 Vdc | Similar |
| Measurement range | 25.0~45.0 ℃ | 30~42.4 ℃ | Similar |
| Accuracy | $\pm$ 0.2 °C for 25-45 °C, | $\pm$ 0.1 °C for 30-42.4 °C, | Similar |
| Signal | |||
| transmission | Bluetooth Version 4.0 | Bluetooth Version 4.0 | Similar |
| Receiver | IOS 7.1 or later/ Android 4.4 | ||
| or later based smart phones | |||
| with Bluetooth® 4.0interface. | IOS 7.1 through 8.1 or | ||
| Android operating 4.3 | |||
| through 4.4 operating | |||
| system supportable smart | |||
| phones | Similar | ||
| Unit | °C or °F | °C or °F | Similar |
| Biocompatibility | Cytotoxicity |
Sensitization
Irritation | No Cytotoxicity
No sensitization
Negligible | Comply with ISO 10993-5
and ISO 10993-10
Similar |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC
60601-1 | Similar |
| EMC | Complied with IEC
60601-1-2 | Complied with IEC
60601-1-2 | Similar |
Table 1 Comparison of Technology Characteristics
4
The intended use, measurement range and accuracy of proposed device and predicate device are different. Intended use of the proposed device and predicate device are the same. The difference is only expression difference. The measurement range and accuracy of proposed device is different from that of the predicated device, but both the proposed device and predicated device comply with IEC 80601-2-56. Therefore, these differences will not affect the substantially equivalency concerning safety and effectiveness.
-
- 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
5
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 26, 2017
ECH (Changzhou) Medical Instrument Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd Room 405, Ziguang Mansion No.341 Shangcheng Road Shanghai. 200120 CHINA
Re: K170769
Trade/Device Name: Wireless Thermometer, Models: ECH-b1-L, ECH-b1-M, and ECH-b1-S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 26, 2017 Received: June 27, 2017
Dear Diana 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.
6
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 (reporting of medical devicerelated 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), 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/Resourcesfor You/Industry/default.htm.
Sincerely,
for Michael Ryan Acting 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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