K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.

Device Description

The Digital Forehead Thermometers, Model KD-2201 & KD-2210, consist of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature.

AI/ML Overview

The acceptance criteria and study proving device performance are as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance (KD-2201 & KD-2210)
Accuracy (Measuring accuracy)	±0.1°C (35.0°C ~ 42.0°C)

2. Sample Size for the Test Set and Data Provenance:
The document does not explicitly state the sample size used for the test set in terms of the number of measurements or subjects. Rather, it refers to compliance with voluntary standards.
The provenance of data is not specified in terms of country of origin or whether it was retrospective or prospective, as clinical trials were deemed unnecessary.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. The ground truth was established through compliance with recognized performance standards (ASTM E 1112-00 and EN 12470-3), not through expert consensus derived from a clinical test set.

4. Adjudication Method for the Test Set:
Not applicable, as there was no expert adjudication process for establishing ground truth in this non-clinical performance evaluation.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not performed. The device is a standalone thermometer, and the evaluation focused on its intrinsic accuracy against standards rather than its performance with or without AI assistance for human readers.

6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop):
Yes, a standalone performance evaluation was conducted. The devices were tested for compliance with recognized performance standards (ASTM E 1112-00 and EN 12470-3). These standards typically involve testing the device's accuracy and other performance characteristics under controlled conditions, without human interpretation as part of the core performance metric.

7. Type of Ground Truth Used:
The ground truth was established by recognized performance standards for clinical electronic thermometers: ASTM E 1112-00 and EN 12470-3. These standards define the acceptable limits for accuracy and other performance parameters.

8. Sample Size for the Training Set:
Not applicable. The document describes a medical device (a thermometer), not an AI/machine learning algorithm, and therefore there is no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for an AI/machine learning algorithm.

Summary

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APR - 4 2011

EXHIBIT 1

510(k) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

The assigned 510(k) number is: _K103617

1. Submitter's Identification:

K-jump Health Co., Ltd. No. 56 Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien, 248, Taiwan Tel: +886-2-22991378 Fax: +886-2-22331386

Contact: Mr. Jason Cheng Date Summary Prepared: November 30, 2010

2. Name of Device:

K-jump Health Co., Ltd. Digital Forehead Thermometer, Model KD-2201 & DK-2210

Regulation Number: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL

3. Predicate Device Information:

K070491, Digital Forehead Thermometer, Model KD-2200, K-jump Health Co., Ltd., । Taipei, Taiwan

4. Device Description:

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EXHIBIT 1

The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing rapidly. The electronic signal was transferred to ASIC circuit on PC board through sensor on probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement. All components assemble on the plastic main body. There is only one ON/OFF button to power on of off the device. The buzzer may sound during operation or end of the temperature measuring. The device is powered by DC voltage of two AAA type batteries

Press the power button may turn on the thermometer and the full screen of LCD will be displayed for two seconds with a "beep-beep" sound and flashing hourglass icon. After that, LCD will be displayed the measuring scale "C or "[r" and the hourglass icon disappeared. Then, the thermometer is ready for measurement. Place the probe to the temple and let the sensor touching patient's skin gently. The thermometer will start measuring automatically. Six seconds later, a "beep-beep" sound will be heard and the reading will be displayed when measuring completed. For the next measurement, wait for the hourglass stop flashing and disappeared before place the probe to patient's temple again. Press power button again may turn off the thermometer or the thermometer will turn off itself in one minute if not use.

The compact, small and light-weight design, the K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, enable to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.

5. Intend Use:

6. Comparison to Predicate Devices:

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The subject device is substantially equivalent to the predicate devices, K070491, Digital Forehead Thermometer Model KD-2200. The substantial equivalence chart is provided as follows:

and the comments of the comments of the comments of the comments of the comments of

Characteristics	Subject DevicesKD-2201	Subject DevicesKD-2210	Predicate Device(KD-2200, K#070491)
Sensor Type	Thermister		Thermister
Number of Sensor	One (Skin TemperatureSensor)		Two (Skin & AmbientTemperature Sensors)
Microcontroller	Sonix SN8P1919		Sonix SN8P1909
Measuring Range	$35.0℃~~42.0℃$(95.5°F~~107.6°F)		$32.2°C - 43.3°C$(90°F - 109.9°F)
Display Resolution	0.1°C (0.1°F)		0.1°C (0.1°F)
C/F Switchable	Yes		Yes
Measuringaccuracy	±0.1°C (35.0°C~42.0°C)		±0.1°C 34.0°C - 42.0°C(93.2°F - 107.6°F)±0.2°C other range
Display	LCD display		LCD display
Measurement Site	Temporal artery area offorehead		Temporal artery area offorehead
Key	One button		One button
Memory	Nine sets		One set (Nine sets optional)
Power source	Two 1.5V AAA batteries		Two 1.5V AA batteries
Low batteryIndication	Replace the battery if the lowbattery indication appears		Replace the battery if the lowbattery indication appears
Operatingcondition	10℃ ~ 40℃ (50°F - 104.0°F)15-95% RH, non-condensing.		16℃ ~ 40℃ (60.8°F -104.0°F)< 95% RH, non-condensing
Storage condition	-25℃ ~ 50℃ (-13°F - 122°F)15-95% RH, non-condensing		-25℃ ~ 55℃ (-13°F - 131°F)< 95% RH, non-condensing
Dimension	105x46x44 mm	127x33x29mm	92x45x35 mm
Weight	73g (includingbatteries)	46g (includingbatteries)	55g (including batteries)

7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:

The following performance testing was conducted:

· The Digital Forehead Thermometers, KD-2201 & KD-2210, are complied with voluntary
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standards includes ASTM E 1112-00 and EN 12470-3.

· The recognized consensus standards for safety of medical electrical equipment: IEC 60601-1 with amendments for safety and IEC 60601-1-2 for electromagnetic compatibility are complied.
· Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(k) submissions for Clinical Electronic Thermometers".

8. Discussion of Clinical Tests Performed:

The subject devices are modified from the predicative device, Mode KD-2200. They use the same technical and design principle and have the same intended use. The differences between them are slightly. The ASTM E 1112-00 and EN 12470-3 test reports show the subject devices meet the all necessary requirements. The performance of subject and predicative devices are the same. Base on above discussion the clinical test is not necessary for the subject devices.

9. Conclusions:

K-jump Health Co., Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, have the same intended use and similar characteristics as the predicate device. Moreover, the subject device demonstrates product safety by successful completion of testing to the IEC60601-1 standard and electromagnetic standard, IEC 60601-1-2. The performance test demonstrates the KD-2201 & KD-2210 meet the ASTM E 1112-00 and EN 12470-3 standards and concludes that any differences in their characteristics do not rise any safety and effectivness issues.

From the above information we conclude the the subject devices, KD-2201 & KD-2210, are substantially equivalent to the predicate device, KD-2200.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name arranged in a circular pattern around a stylized emblem. The emblem consists of a series of three curved lines that resemble a stylized human figure or a symbol representing health and well-being.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

Mr. Jason Cheng Regulatory Affairs K - Jump Health Company, Limited No. 56, Wu Kung 5th Road Wu Ku Industrial Park Taipei Hsien China (Taiwan) 248

APR - 4 2011

Re: K103617

Trade/Device Name: Digital Forehead Thermometer, Model KD-2201 & KD-2210 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 3, 2011 Received: March 7, 2011

Dear Mr. Cheng:

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.

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Page 2- Mr. Cheng

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 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), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers. International and Consumer Assistance 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 yours,

for 2

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices

Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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Indications for Use Statement

Page of

510(k) Number (if known): K103617

Device Name: K-jump Health Co., Ltd. Digital Forehead Thermometer, Model KD-2201 & KD-2210

Indications for Use:

Prescription Use (Per 21 CFR 801 Subpart D) OR . Over-The Counter Use _ × (21 CFT 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

4/1/14

Division Sign-Off) . ivision of Anesthesiology, General Hospital ifection Control, Dental Devices

510(k) Number: K103617

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.