Non-conact Infrared Themometer, model JPD-FR 100, can measure for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

Device Description

The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, solid, liquid or gas. The intensity of the emitted energy depends on the temperature of the object and the infrared sensor can recognize it to transfer to the proper electronic signal. The electronic signal can be processed in the subject device to convert to the temperature reading. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits. The predicated device KI-8280, use the same detection principle to measure the patient's temperature.

The subject device also use the focusing design to collect the infrared emitted from nearby area of patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. The subject device intended to detect the temperature of patients. The temperature is converted to the oral temperature. The temperature reading shown in the device display after measuring is the patient's oral temperature.

The compact, small and light-weight design, the Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.

AI/ML Overview

The medical device in question is a Non-contact Infrared Thermometer, Model JPD-FR100.

Here's an analysis of the provided text for acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The primary acceptance criterion mentioned is compliance with the ASTM E1965-98 (2009) standard for infrared thermometers.

Acceptance Criteria (from ASTM E1965)	Reported Device Performance (JPD-FR100)
Measurement Accuracy (forehead temperature mode)	±0.2°C (0.4°F)

Further details about the specific accuracy requirements within ASTM E1965 for different temperature ranges, as well as repeatability and other performance metrics, are not explicitly detailed in the provided summary. However, the study "complied with the requirements of ASTM E1965."

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

Sample Size: The document does not explicitly state the sample size used for the clinical test set. It mentions "the clinical performance test protocol and data analysis followed the requirements of ASTM E 1965."
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). ASTM E1965 specifies clinical testing, implying prospective data collection on human subjects, but the location is not provided.

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

Not applicable. For a thermometer, the "ground truth" for temperature measurement is typically established using a reference thermometer or a controlled environment, not through expert human interpretation. The ASTM E1965 standard defines the methodology for this.

4. Adjudication Method for the Test Set

Not applicable. Temperature measurement through a device like a thermometer does not involve human adjudication in the way medical image analysis or diagnostic studies do. The ground truth is a direct measurement.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices where human readers interpret results, and the AI's impact on their performance is evaluated. For a thermometer, the device provides a direct measurement, and human interpretation is not the primary factor of interest in its performance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The document states: "The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965. It is acceptable to measure patient's temperature." This indicates that the device's accuracy was assessed independently against the ASTM standard.

7. Type of Ground Truth Used

The ground truth used for the clinical performance test would be simultaneous measurements from a calibrated reference thermometer as per the methodology defined in ASTM E1965. The standard dictates how to compare the device's readings to highly accurate ground truth measurements.

8. Sample Size for the Training Set

Not applicable. The device is a non-contact infrared thermometer, which is a sensor-based measurement device. It does not employ machine learning or AI models that would require a "training set" in the conventional sense. Its function is based on physical principles of infrared radiation detection.

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

Not applicable, as there is no training set for this type of device.

Summary

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VOL 05 510(k) Summary

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

The assigned 510(k) number is: K131243

NOV 1 2 2013

1.0 Information of Submitter and Correspondent

Submitter's Information:

Shenzhen Jumper Medical Equipment Co., Ltd.

Address: 5th Floor, Building No.34, Baoyuan Industrial Zone, Xixiang Street, Baoan District,

Shenzhen 518102, Guangdong Province, P.R. China

Phone: +86-755-26692192

Fax:

Contact Person: Mr. Yi Hui

E-mail: info@jumper-medical.com

Submission correspondent's information:

Shenzhen ZYTC Consulting Co., Ltd. Address: 4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District, Shenzhen, Guangdong, China. Contact person: Mr. Field.Fu E-mail: cefda13485@163.com

2.0 Device Information

Type of 510(k) submission:	Traditional
Trade Name:	Non-contact Infrared Thermometer
Model:	JPD-FR100
Classification name:	thermometer, electronic, clinical
Review Panel:	General Hospital
Product Code:	FLL
Device Class:	II
Regulation Number:	880.2910

3.0 Predicate Device Information

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Sponsor: K-jump Health Co., Ltd. Non-contact Infrared Thermometer, model KI-8280 Device: 510(K) Number: K102947

4.0 Device Description

5.0 Intended Use

The non-contact infrared thermometer, model JPD-FR100, can measure body temperature for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.

6.0 Performance Summary

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Non-contact Infrared Thermometer, model JPD-FR100 was conforms to the following standards:

. IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
. IEC 60601-1-11:2010, Medical electrical equipment - General requirements for basic safety and essential performance - Part 1-11: Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
. ASTM E1965-98 (2009), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
IEC 62304:2006, Medical device software Software life cycle processes. ◆
ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing � within a risk management process. 2009
◆ ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. 2009
ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for � imitation and delayed-type hypersensitivity
ISO 14971:2007, Medical devices Application of risk management to medical devices. �

7.0 Comparison to predicate device and conclusion

The subject device is substantially equivalent to predicate devices, K102947, Kl-8280. The substantial equivalence chart is provided as follows:

Characteristics	Subject Device	Predicate Device
Device name	Non-contact InfraredThermometer	Non-contact InfraredThermometer
Model	JPD-FR100	KI-8280
K number	Pending	K102947
Manufacturer	Shenzhen Jumper MedicalEquipment Co., Ltd.	K-jump Health Co., Ltd.
Measurement method	Infrared radiation detection	Infrared radiation detection

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Shenzhen Jumper Medical Equipment Co., Ltd.

VOL_005:001_510K Summary

Version:A/1

Measurement mode	Forehead measure mode	Forehead and surfacemeasure mode
Measuring range	Forehead temperature mode:$32.2°C-43.3°C (90.0°F-109.9°F)$ ;	Forehead temperature mode:$32.0°C-42.2°C (89.6°F-107.9°F)$ ;Surface temperature mode:$0.0°C-100°C (32°F-212°F)$ ;
Display resolution	$0.1°C (0.1°F)$	$0.1°C (0.1°F)$
C/F switchable	Yes	Yes
Measuring accuracy	Forehead temperature mode:$±0.2°C(0.4°F)$ ;	Forehead temperature mode:$±0.2°C(0.4°F)$ ;Surface temperature mode:$±1°C(1.8°F)$
Display	LCD display	LCD display
Measurement distance	1-6cm	3-8cm
Key	Two button (Foreheadmeasure, temperature unitshift)	Two button (On/off, Memory)
Memory	20 sets	10 sets
Power source	Two 1.5V AAA batteries	Two 1.5V AAA batteries
Low battery indication	Yes	Yes
Waterproof	No	No
Dimension	145×60×50mm	138×90×45mm
Weight	180g	125g(including batteries)
Operating condition	$10°C-40°C (50°F-104°F)$ , <95%RH no-condensing	$10°C-40°C (50°F-104°F)$ , <95%RH no-condensing

8.0 Clinical Tests Performed

The clinical performance test protocol and data analysis followed the requirements of ASTM E 1965. The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965. It is acceptable to measure patient's temperature.

9.0 Conclusions

Non-contact Infrared Thermometer, Model JPD-FR100, has 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 IEC 60601-1 standard and

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electromagnetic standard IEC 60601-1-2. The performance test demonstrates the JPD-FR100 meets the ASTM E 1965 and concludes that any differences in their characteristics do not raise any safety and effectiveness issues.

From the above information we conclude the subject device, JPD-FR100, is substantially equivalent to the predicate devices, KI-8280.

10.0 Summary prepared date

November 11, 2013

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 12, 2013

Shenzhen Jumper Medical Equipment Company, Limited C/O Mr. Field Fu Shenzhen ZYTC Consulting Company, Limited 40 Floor, Jinhui Building, Nanhai Boulevard Nanshen District, Shenzhen, Guandong CHINA 518052

Re: K131243

Trade/Device Name: Non-contact Infrared Thermometer. Model JPD-FR100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 10, 2013 Received: November 5, 2013

Dear Mr. Fu:

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. Fu

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 (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/McdicalDevices/Safety/ReportaProblem/default.hun 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.

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Kwame Ulmer M.S. Acting Division 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) K131243

Device Name

Non-contact Infrared Thermometer, Model JPD-FR100

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.

THE ATTACT COLLECT FOR FOR FOR FOR FOR FOR THE SEARNERS AT TOTAL CONTINUE TO THE FORT IS A CATE ・・・ Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Richard C. Chapman 2013.11.12 15:08:21 -05'00'

Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.

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.