The Infrared thermometers (JPD-FR400 and JPD-FR402) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.

Device Description

The infrared thermometers (JPD-FR400, JPD-FR402) are handheld instruments which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD. And, the results measured by JPD-FR400 can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application "Angel Doctor" installed on a mobile device using the iOS system or the Android system. The thermometers, which are powered by AAA 1.5Vx2 Alkaline batteries, can be used for all age groups except for babies under three months. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F .

AI/ML Overview

This document describes the premarket notification for a non-contact infrared thermometer (models JPD-FR400, JPD-FR402). The information provided pertains to the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to previously marketed devices.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

Key Takeaways:

This submission is for a medical device (non-contact infrared thermometer), not an AI/ML diagnostic device. Therefore, many of the requested categories related to AI performance (e.g., ground truth establishment for training, MRMC studies, human-in-the-loop performance, expert consensus) are not applicable.
The primary method for demonstrating acceptance and substantial equivalence is through compliance with recognized performance standards for clinical thermometers and non-clinical testing.
A clinical performance test was conducted, which is crucial for proving the accuracy of a thermometer.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from recognized standards like ASTM E 1965-98. The document does not present a formal table of "acceptance criteria" vs. "reported performance" in the typical AI/ML sense (e.g., sensitivity, specificity thresholds). Instead, it states that the device's performance complied with the requirements of the standards.

However, we can infer some key performance criteria and the device's reported capabilities from the "Substantial Equivalence Comparison" table and "Non-clinical Performance Testing" section.

Feature / Performance Metric	Acceptance Criteria (from Predicate/Standards)	Reported Device Performance (JPD-FR400/402)
Accuracy	Predicate 1 (Ear): ±0.2°C (36-39°C), ±0.3°C (rest); Predicate 2 (Forehead): ±0.2°C	1) ±0.2°C (±0.4°F) for 36.0°C-39.0°C/96.8°F-102.2°F 2) ±0.3°C (±0.5°F) from 32.0°C-35.9°C/89.6°F-96.7°F 3) ±0.3°C (±0.5°F) for 39.1°C-42.2°C/102.3°F-108.0°F (Comment in table: "For the forehead temperature mode: same as Predicate Device 2. For the ear canal temperature mode: same as Predicate Device 1.")
Measurement Range	Predicate 1 (Ear): 32-43°C; Predicate 2 (Forehead): 32.2-43.3°C	Forehead: 0.0°C-100.0°C; Ear: 0.0°C-100.0°C (Note 02: "The subject devices' measuring range is larger than that of both predicate device 1 and predicate device 2. Due to the subject devices also apply to measuring the environmental temperature, so their measuring range is larger.")
Display Resolution	0.1°C/0.1°F	0.1°C/0.1°F
Measurement Mode	Predicate 1: Ear; Predicate 2: Forehead	Ear and Forehead measurement mode (Matches both predicates)
Auto Power-off	Yes	Yes
°C/°F Switchable	Yes	Yes
Working Ambient Temp.	Predicate 1: 10-40°C; Predicate 2: 10-40°C	10°C-40°C
Electrical Safety	AAMI ANSI ES60601-1:2005/(R)2012+A1:2012; IEC 60601-1:1988+A1:1991+A2:1995	Compliance stated.
EMC	IEC 60601-1-2: 2014 / 2007; ETSI EN 301 489-1; ETSI EN 301 489-17	Compliance stated, including specific tests for Bluetooth functionality (JPD-FR400).
Home Healthcare Env.	IEC 60601-1-11:2015 / 2010	Compliance stated.
Risk Management	ISO 14971:2007	Compliance stated.
Biocompatibility	ISO 10993-1:2009; ISO 10993-5:2009; ISO 10993-10:2010	Compliance stated.
Clinical Performance	ASTM E 1965-98 (Reapproved 2009) requirements	"The test report showed the clinical performance of proposed devices complied with the requirements of ASTM E 1965-98 (Reapproved 2009)."
Waterproof	Predicate 1/2: No	IP22 (Different from predicates, but indicates better performance/feature and passed IEC60601-1 and IEC60601-1-11 test.)
Bluetooth Function	Predicate 1/2: No	JPD-FR400: Yes (Passed FCC, EN301489-1, EN301489-17, EN 300328, wireless coexistence test.) JPD-FR402: No.

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

Sample Size: The document explicitly states: "The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009)." This standard specifies the methodology for clinical accuracy testing of infrared thermometers. While the exact number of subjects or measurements is not explicitly stated in this summary document, adherence to ASTM E 1965-98 implies a sufficient sample size as mandated by that standard.
Data Provenance: Not explicitly stated (e.g., country of origin). The document is a 510(k) submission from Shenzhen Jumper Medical Equipment Co., Ltd. in China. Given the manufacturer's location, the testing was likely conducted in China.
Retrospective or Prospective: Unspecified, but clinical performance testing for medical device approval is typically prospective to ensure controlled conditions and data collection.

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

This category is not applicable in the context of this device. A non-contact infrared thermometer directly measures temperature. The "ground truth" for thermometer accuracy is established by comparing the device's readings against a highly accurate reference thermometer, typically in a controlled clinical setting or using a black body calibrator. It does not rely on subjective expert interpretation like radiological images.

4. Adjudication Method for the Test Set

Not applicable. As above, the "truth" is a physical measurement, not a subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a standalone medical device (thermometer), not an AI-based diagnostic tool that assists human readers.

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

Yes, in effect. The device's primary function is to provide an objective temperature reading, acting as a standalone measurement tool. The "clinical performance test" evaluates the device's accuracy in a clinical setting without human interpretation impacting the reading itself. The performance is assessed based on how closely its readings match reference measurements.

7. The Type of Ground Truth Used

Reference Thermometer Readings / Clinical Patient Temperatures: The ground truth for a clinical thermometer's accuracy is established by comparing its readings to known, accurate body temperatures obtained via a reference method (e.g., rectal thermometer or an established highly accurate clinical thermometer) in subjects, or by using precisely controlled temperature sources (e.g., black body calibrators) for calibration and laboratory accuracy testing. The text states "The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009)," which details how this ground truth is established (e.g., using a reference thermometer to perform simultaneous or near-simultaneous measurements on subjects).

8. The Sample Size for the Training Set

Not applicable / Unknown: This device is a traditional infrared thermometer. It is not an AI/ML device that undergoes "training" on a data set in the way a deep learning model would. Its "training" or calibration would involve engineering and manufacturing processes to ensure its sensor and algorithms accurately convert infrared radiation to temperature readings according to physical principles.

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

Not applicable: As discussed above, this is a traditional medical device, not an AI/ML model requiring a distinct "training set" with established ground truth in the AI sense. Its "ground truth" for manufacturing calibration would involve highly accurate laboratory temperature references.

Summary

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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

March 14, 2018

Shenzhen Jumper Medical Equipment Co., Ltd. % Field Fu Shenzhen Joyantech Consulting Co., Ltd Room 1122, International Mayors Communication Centre, NO. 55 Shizhou Middle Road Shenzhen, Guangdong, GD755 CHINA

Re: K172795

Trade/Device Name: Non-contact Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 2, 2018 Received: February 8, 2018

Dear Field 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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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); 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.

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.

For comprehensive regulatory information about mediation-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,

Tina Kiang, Ph.D. 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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510(k) Summary

Contact Details 1.

1.1 Applicant information

Applicant Name	Shenzhen Jumper Medical Equipment Co., Ltd.
Address	Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan,
	Shenzhen, Guangdong, China
Phone No.	+86-755-26696279
Fax No.
Contact person	Rambo Yang
Contact person's e-mail	yanggang@jumper-medical.com
Date Prepared	Aug.30, 2017
Website	www.jumper-medical.com

1.2 Submission Correspondent

Shenzhen Joyantech Consulting Co., Ltd
Room 1122, International Mayors Communication Centre, NO. 55
Shizhou middle road , Nanshan District, Shenzhen

卓远天成
Phone No.	+86-755-86069197
Contact person	Field Fu; Crean Bai
Contact person's e-mail	crean@cefda.com; field@cefda.com
Website	http://www.cefda.com
2. Device information
Trade name	Non-contact Infrared Thermometer
Common name	Infrared Thermometer
Model	JPD-FR400, JPD-FR402
Classification	II
Classification name	Thermometer, Electronic, Clinical
Product code	FLL
Regulation No.	880.2910
3. Legally Marketed Predicate Device
Trade Name	Thermo Pal Infrared Ear Thermometer, Model no.: ETH-101
510(k) Number	K112189
Product Code	FLL
Manufacturer	Digio2 International Co., LTD.

Trade Name	Non-Contact Thermometer
510(k) Number	K131243
Product Code	FLL
Manufacturer	Shenzhen Jumper Medical Equipment Co., Ltd.

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Device Description 4.

A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F .

5. Intended Use/Indication for Use

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Substantial Equivalence Comparison 6.

Item	Proposed Device:Infrared ThermometerJPD-FR400/402	Predicate Device 1:Thermo Pal Infrared EarThermometer, Model no.:ETH-101	Predicate Device 2:Non-ContactThermometerJPD-FR100	Comments
510(k) Number	Pending	K112189	K131243	/
Product Code	FLL	FLL	FLL	Same
Intended Use &Indications for use	The Infrared thermometers(JPD-FR400, JPD-FR402)take human bodytemperature via the eardrumor forehead. They apply toall age groups except forbabies under three months.Both devices apply to bothprofessional use and homeuse.	The Thermo Pal Infrared EarThermometer (Model no.:ETH-101) is infraredthermometer intended for theintermittent measurement ofhuman body temperature inpeople of all ages.	The non-contact infraredthermometer, modelJPD-FR100, can measurebody temperature forinfants and adults withoutcontact to human body. Itcan be used by consumersin household environmentand doctor in clinic asreference.	DifferentNote 01
Regulation Number:	21CFR 880.2910	21CFR 880.2910	21CFR 880.2910	Same
Measurement mode	Ear and Foreheadmeasurement mode	Ear measurement mode	Forehead measurementmode	For earmeasurement mode,same as Predicatedevice 1;For foreheadmeasurement mode,same as Predicatedevice 2;
Item	Proposed Device:Infrared ThermometerJPD-FR400/402	Predicate Device 1:Thermo Pal Infrared EarThermometer, Model no.:ETH-101	Predicate Device 2:Non-ContactThermometerJPD-FR100	Comments
Measurement range	Forehead temperaturemode:$0.0℃~~100.0℃$/32.0°F~~212.0 °FEar temperature mode:$0.0℃~~100.0℃$/32.0°F~~212.0 °F	Ear canal mode:$32~~43℃$(89.6~~109.5°F )	Forehead temperaturemode:$32.2℃~~43.3℃$(90.0°F~~109.9°F )	DifferentNote 02
Auto power-off while no operation	Yes	Yes	Yes	Same
°C/°F can be switchable	Yes	Yes	Yes	Same
Working Ambient TemperatureEnvironment	Operating environment:Temperature: $10℃~40℃$(50°F-104°F)Humidity: 15%-95% RH,non-condensingAtmospheric pressure:86kPa–106 kPaStorage condition:Ambient Temperature: -20°Cto 55°C (-4°F-131°F)Relative Humidity: 0-95%RH, non-condensingAtmospheric pressure: 50kPa	1. Operating: $10℃~40℃$2. Storage: -20℃~50℃	1. Operation: $10℃~$ 40°C,80% RH,non-condensing2. Storage andtransportation:Temperature:-10°C to60°CHumidity: 0 - 95%RH, non-condensing	Similar
Item	Proposed Device:Infrared ThermometerJPD-FR400/402	Predicate Device 1:Thermo Pal Infrared EarThermometer, Model no.:ETH-101	Predicate Device 2:Non-ContactThermometerJPD-FR100	Comments
	to 106kPa
Accuracy	1) ±0.2°C (±0.4°F)36.0°C-39.0°C/96.8°F-102.2°F2) ±0.3°C (±0.5°F) from32.0°C-35.9°C/89.6°F-96.7°F3) ±0.3°C (±0.5°F)39.1°C-42.2°C/102.3°F-108.0°F	±0.2°C, 36~~39°C±0.3°C, the rest(±0.4°F, 96.8~~102.2°F±0.5°F, the rest)	Forehead temperaturemode:±0.2 °C (±0.4 °F)	For the foreheadtemperature mode:same as PredicateDevice 2.For the ear canaltemperature mode:same as PredicateDevice 1.
Display Resolution	0.1°C/0.1°F	0.1°C/0.1°F	0.1°C/0.1°F	Same
Measurement distance	1-5cm	/	1-6cm	Similar withPredicate Device 2.
Power supply	2×1.5Vdc AAA Alkalinebatteries	Two 1.5Vdc AlkalineManganese batteries (AAA)	2×1.5Vdc AAA Alkalinebatteries	Same
Low power indication	Yes	Yes	Yes	Same
Display screen	LCD	LCD	LCD	Same
Memory	20 sets	Unknown	20 sets	Same as PredicateDevice 2.
Bluetooth function	JPD-FR400, yes,JPD-FR402, no.	No	No	For JPD-FR400,differentNote 03
Item	Proposed Device:Infrared ThermometerJPD-FR400/402	Predicate Device 1:Thermo Pal Infrared EarThermometer, Model no.:ETH-101	Predicate Device 2:Non-ContactThermometerJPD-FR100	Comments
Waterproof	IP22	No	No	DifferentNote 04
Conformancestandard/guidance	Electric safety andEMC	AAMI ANSIES60601-1:2005/(R)2012+A1:2012IEC 60601-1-2: 2014IEC 60601-1-11:2015	IEC 60601-1IEC 60601-2IEC 60601-1-11	IEC60601-1:1988+A1:1991+A2:1995IEC 60601-1-2:2007IEC 60601-1-11:2010	SE
	Risk management	ISO 14971:2007	ISO 14971	ISO 14971:2007	SE
	Biocompatibility	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:20	ISO 10993-1ISO 10993-5ISO 10993-10	ISO 10993-1:2009ISO 10993-5:2009ISO 10993-10:2010	SE
	Performance	ASTM E 1965-98(Reapproved 2009)ISO 80601-2-56: 2009	ASTM E1965: 2003	ASTM E 1965-98(2009)	SE

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Discussion:

Note 01:

For the ear canal measurement mode, the subject devices' intended population is smaller than that of Predicate device 1.

For the forehead measurement mode, the subject devices' intended population is smaller than that of Predicate device 2.

Note 02:

The subject devices' measuring range is larger than that of both predicate device 1 and predicate device 2. Due to the subject devices also apply to measuring the environmental temperature, so their measuring range is larger.

Note 03:

JPD-FR400 has passed FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test.

Note 04:

The subject device has passed the IEC60601-1 and the IEC60601-1-11 test.

Non-clinical Performance Testing 7.

The performance data in compliance with the following standard were provided in support of the substantial equivalence determination.

AAMI ANSI ES60601-1:2005/(R)2012 And A1:2012: 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:

IEC 60601-1-11:2015: Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;

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;

ISO 10993-5:2009: 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;

ASTM E 1965-98 (Reapproved 2009): Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature;

EN 300 328 : Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;

ETSI EN 301 489-1: Electromagnetic compatibilityand Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1: Common technical requirements:

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Proposed product: Infrared Thermometer Version: A/0

ETSI EN 301 489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems;

8. Clinical performance

The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009). The test report showed the clinical performance of proposed devices complied with the requirements of ASTM E 1965-98 (Reapproved 2009).

9. Conclusions

The infrared thermometer JPD-FR400 and JPD-FR402 have the similar intended use with the predicated device 1 on ear canal mode and have the similar intended use with the predicate device 2 on forehead mode, the non-clinical performance tests and the clinical tests demonstrated adequate performance. The Infrared Thermometer JPD-FR400 and JPD-FR402 are substantially equivalent to the predicate devices, K112189 and K131243.

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.