Wireless Intelligent Thermometer by Shenzhen Jumper Medical Equipment Co.,Ltd.

The Thermometer is a non- invasive and re-usable electronic device for home use. The thermometer is intended for nonurgent ambulatory continuous left chest body temperature monitoring from ages 29 days and older.

Device Description

Wireless Intelligent Thermometer

AI/ML Overview

This document is a 510(k) clearance letter for the Jumper Wireless Intelligent Thermometer (K182437). It doesn't contain a detailed description of the acceptance criteria or the specific study that proves the device meets those criteria.

However, based on the nature of the device (a clinical electronic thermometer) and standard regulatory practices for such devices, we can infer the likely type of acceptance criteria and study that would have been performed.

Inferred Acceptance Criteria and Study Information (Based on common practices for clinical thermometers):

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (Inferred)	Reported Device Performance (Inferred; from a successful 510(k) submission, it implies meeting these)
Accuracy (Temperature measurement)	ISO 80601-2-56:2017 or similar standard for clinical thermometers. Typically, this involves limits on measurement error (e.g., ±0.1°C to ±0.3°C depending on the temperature range and measurement site). The predicate device's performance would also have served as a benchmark.	The device would have demonstrated accuracy within the specified limits of the relevant standard and/or comparable to the predicate device.
Precision/Reproducibility	Repeat measurements under identical conditions should yield consistent results, typically quantified by standard deviation or coefficient of variation.	Demonstrated high precision and reproducibility according to standard testing methods.
Response Time	The time taken for the thermometer to display a stable temperature reading.	Met the required response time for clinical thermometers.
Drift	The change in readings over prolonged use or storage.	Demonstrated minimal drift over time and under various storage conditions.
Environmental Performance	Performance within specified operating (e.g., temperature, humidity) and storage conditions.	Maintained accuracy and functionality across the specified environmental ranges.
Biocompatibility	ISO 10993 series. For patient-contacting parts (even indirect skin contact for a surface thermometer).	Met biocompatibility requirements to ensure no adverse biological reactions.
Electrical Safety	IEC 60601 series.	Complied with relevant electrical safety standards.
EMC (Electromagnetic Compatibility)	IEC 60601-1-2.	Demonstrated compliance with EMC standards, indicating it does not interfere with or is not affected by other electronic devices.

Study Description (Inferred for a Clinical Electronic Thermometer):

The study alluded to in a 510(k) submission for a thermometer would typically be a performance validation study, often comparing the new device against a legally marketed predicate device or a highly accurate reference standard.

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: For a clinical thermometer, the "test set" would typically refer to the number of subjects (persons) on whom the thermometer was tested and/or the number of temperature measurements taken.
- Inferred: Likely involves a statistically significant number of subjects (e.g., several dozens to hundreds, possibly across different age groups if applicable, as the device is for "ages 29 days and older"). The sample size would be determined to ensure sufficient statistical power to detect equivalence or non-inferiority to the predicate device or a reference standard based on the accuracy criteria.
Data Provenance:
- Inferred: Most likely prospective clinical testing conducted in a controlled environment (e.g., a clinic or lab) or in a relevant home-use setting simulating real-world conditions. The country of origin for such testing would typically be where the manufacturer is based or a region where clinical trials can be efficiently and ethically conducted (e.g., China, or possibly a country with regulatory alignment).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Inferred: For a thermometer, "ground truth" for temperature is typically established by highly accurate, calibrated reference thermometers or established clinical methods. It would not typically involve "experts" in the sense of clinicians interpreting images or diagnoses.
- "Experts" (Metrology Technicians/Clinicians): The "experts" would be the skilled technicians or clinical staff responsible for operating the reference thermometer, performing the measurements correctly, ensuring calibration, and recording data accurately. Their qualifications would involve training in metrology and clinical measurement techniques.

4. Adjudication Method for the Test Set

Inferred: Adjudication methods like "2+1" or "3+1" are primarily for subjective assessments (e.g., image interpretation). For objective measurements like temperature, there is no "adjudication" of the ground truth itself in that sense.
- Method: Instead, the method would involve direct comparison of the device's readings against a highly accurate, calibrated reference thermometer or against the predicate device's readings. Statistical methods (e.g., Bland-Altman analysis, regression analysis) would be used to compare agreement and bias.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

Inferred: No, an MRMC study is highly unlikely for a clinical electronic thermometer. MRMC studies are specific to diagnostic devices where multiple human readers interpret medical images or data. Temperature measurement is an objective, automated process once the device is in place.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

Inferred: Yes, the fundamental performance testing of a thermometer (its accuracy, precision, response time) is inherently a standalone assessment of the device's measurement capabilities. While human interaction is needed to place the thermometer, the temperature reading itself is generated by the device's sensors and algorithms. The device's performance would be evaluated purely on its ability to accurately and consistently measure temperature. "Human-in-the-loop" would primarily refer to usability aspects, not the core measurement function's accuracy.

7. The Type of Ground Truth Used

Inferred: The ground truth for temperature measurement is typically established using:
- Reference Standard Instruments: Highly accurate, calibrated thermometers (e.g., mercury-in-glass thermometers traceable to national standards, or precise electronic reference thermometers).
- Established Clinical Methods: Simultaneous measurement using the device under test and a cleared/approved clinical thermometer on the same subject or body site.

8. The Sample Size for the Training Set

Inferred: For a device like a thermometer, there isn't typically a "training set" in the sense of machine learning algorithms that learn from labeled data. The thermometer's underlying measurement principle is based on physics and calibrated sensors, not a trained AI model.
If there are any digital signal processing or adaptive algorithms (e.g., for noise reduction or artifact rejection) that might be considered "AI," these would likely be developed and validated internally using lab data, simulations, and possibly limited human data, but not a formally defined "training set" as seen in diagnostic AI.
Most Likely: No distinct "training set" for the core temperature measurement function.

9. How the Ground Truth for the Training Set Was Established

Inferred: Since there's unlikely a formal "training set" in the AI/ML sense:
- Any internal development or calibration of sensor parameters or basic signal processing would rely on physical models, laboratory measurements with highly accurate reference instruments, and engineering specifications.
- If any adaptive algorithms exist, the "ground truth" for their development would similarly come from controlled experiments using reference measurements.

Summary

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May 5, 2019

Shenzhen Jumper Medical Equipment Co.,Ltd. % Reanny Wang Manager Shenzhen Reanny Medical Devices Management Consulting Co., Ltd. Room 2012#. Gebu commercial building, Hongxing community, Songgang Street Baoan District Shenzhen, Guandong 518000 China

Re: K182437

Trade/Device Name: Wireless Intelligent Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 14, 2019 Received: April 2, 2019

Dear Reanny 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.

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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.htm); 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,

for Tina Kiang, Ph.D. 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

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Indications for Use

510(k) Number (if known) K182437

Device Name Wireless Intelligent Thermometer

Indications for Use (Describe)

Prescription Use (Part 21 CFR 801 Subpart D)

|X Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 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.