The Non-contact Thermometer is intended to measure the human body temperature for children and adults without contact to human body. It can be used by consumers in household environment and doctor in clinics as reference.

Device Description

The Non-contact Thermometer is a compact, small and light-weight device, which is powered by a battery and can be connected to a smartphone through headphone jack, for detecting body temperature without contact to human body. The measured temperature will be displayed on the screen of a smartphone.

AI/ML Overview

The provided document describes a 510(k) premarket notification for a Non-contact Thermometer (K120711). The primary method for proving the device meets acceptance criteria is through demonstrating substantial equivalence to a predicate device (K102947) and compliance with recognized standards.

Here's an analysis of the acceptance criteria and the study (or lack thereof) that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the predicate device's performance specifications and industry standards.

Acceptance Criteria	Reported Device Performance	Notes
Measurement Method	Infrared radiation detection	Identical to predicate device. This is a characteristic, not a performance metric that directly needs to be met with a numerical value.
Measuring Range	Forehead Mode: 32.2℃~~43.3℃ (90.0°F~~109.9°F)	Identical to predicate device.
C/F Switchable	Yes	Identical to predicate device.
Display Resolution	0.1℃ (0.1°F)	Identical to predicate device.
Measuring Accuracy	Forehead Mode: ±0.2°C (0.4°F)	Identical to predicate device. This is a critical performance acceptance criterion. The document states compliance with ASTM E1965-98, which sets a "maximum permissible laboratory error" (this likely corresponds to the ±0.2°C).
Low Battery Detection	Yes	Identical to predicate device.
Operating Condition	Temperature: 10℃~~40℃ (50.0~~104°F); Humidity: 15%-95% RH	Identical to predicate device.
Storage Condition	Temperature: -20℃~~55℃ (-13.0~~131°F); Humidity: 15%-95% RH	Identical to predicate device.
General Safety (Electrical, Mechanical, Temperature, Faults)	Complies with ANSI/AAMI ES60601-1:2005	The device has been "verified and validated to comply" with this standard, indicating it meets the safety requirements outlined in the standard. This is an acceptance criterion for safety.
Electromagnetic Compatibility (EMC)	Complies with ANSI/AAMI/IEC 60601-1-2:2007	The device has been "verified and validated to comply" with this standard, including radiated emission, ESD, radiated RF immunity, and magnetic field immunity. This is an acceptance criterion for EMC.
Infrared Thermometer Standard Compliance	Complies with ASTM E1965-98	The device has been "verified and validated to comply" with this standard, which covers aspects like displayed temperature range, maximum permissible laboratory error, ambient conditions, low power supply operation, display, human interface, and construction. This standard directly addresses key performance attributes of infrared thermometers.

Detailed Study Information (Based on provided text)

The document primarily relies on design validation and compliance with established standards rather than a specific clinical study with human subjects for novel performance claims.

Sample size used for the test set and data provenance:
This information is not provided in the document. The filing states the device "complies" and is "verified and validated," but it does not detail the specific test set size (e.g., number of temperature measurements, number of subjects) or the provenance (e.g., country of origin, retrospective/prospective) of any data collected to demonstrate compliance with ASTM E1965-98, which would typically involve testing on physical samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The document does not describe a clinical study relying on expert-established ground truth. Compliance with ASTM E1965-98 would typically involve metrology experts and calibrated reference devices, but specific details are absent.
Adjudication method for the test set:
This information is not provided. As there's no mention of a clinical study with multiple observers, adjudication methods like 2+1 or 3+1 are not applicable here.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
No, an MRMC comparative effectiveness study was not done. This device is a standalone thermometer, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The entire premise of this submission is for a standalone device (a thermometer). The "performance" described is the standalone performance of the device itself (its accuracy, operating range, etc.) in meeting established standards. There's no separate "algorithm only" component vs. "human-in-the-loop," as the human interacts directly with the device to take a measurement. The "study" (or validation) conducted would have been to verify the device's accuracy against a known reference temperature source during testing, as per ASTM E1965-98.
The type of ground truth used:
The ground truth for performance (specifically temperature accuracy) would have been established through calibrated reference standards and laboratory testing in accordance with ASTM E1965-98. For safety and EMC, the ground truth is adherence to the technical specifications and test methodologies defined in the respective IEC/ANSI/AAMI standards.
The sample size for the training set:
This information is not applicable/not provided. This device is a hardware product with embedded firmware/sensors for a direct physical measurement. It is not an AI/machine learning device that requires a "training set" in the conventional sense.
How the ground truth for the training set was established:
This information is not applicable/not provided, as there is no "training set" for this type of device.

Summary

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510(k) Summary of Safety and Effectiveness

Submitter

K-jump Health Co., Ltd.

No. 56. Wu Kung 5th Rd. New Taipei Industrial Park New Taipei City 24890, Taiwan

Contact: JM Lin, Regulatory Affairs Representative +886-2-2299-1378 ext. 237 Phone: Fax: +886-2-2299-1385 jm(a)kjump.com.tw (preferred) Email:

2. Name of Device

Common/Usual Name: Non-contact Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL

3. Predicate Device

Device Name	510(k) Number	Decision Date
K-jump Health Co., Ltd.Non-Contact Infrared Thermometer,Model KI-8280	K102947	2/25/2011

4. Device Description

5. Indications for Use

તું

May 1, 2012

NOV 1 9 2012

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6. Technological Characteristics

The Non-contact Thermometer uses an infrared sensor to detect the infrared energy radiated from objects. As the intensity of the radiated energy will depend on the temperature of the air, solid, liquid or human body, the detected infrared energy can be acquired and calculated to temperature reading. The technological characteristics of Noncontact Thermometer have no difference with predicate device.

7. Comparison to Predicate Device

The Non-contact Thermometer is substantially equivalent to the predicate devices, K102947, the Non-contact infrared Thermometer. The comparison of their technological characteristics is summarized in the table below.

Characteristics Art	( Non-contact Thermometer (	Non-contact Infrarenermometer
510(k) Number	K120711	K102947
Intended Use	Similar	Similar
Technology
Measurement method	Infrared radiation detection	Infrared radiation detection
Function
Measuring Range	Forehead Mode	Forehead Mode
	32.2℃~~43.3℃,(90.0°F~~109.9°F)	32.2℃~~43.3℃, (90.0°F~~109.9°F)
C/F Switchable	Yes	Yes
Performance
Display Resolution	0.1℃ (0.1 °F)	0.1℃ (0.1 °F)
Measuring accuracy	Forehead Mode, ±0.2°C (0.4°F)	Forehead Mode, ±0.2℃(0.4°F).
Low battery detection	Yes	Yes
Environmental
Operating condition	10℃~~40℃ (50.0~~104°F)	10℃~~40℃ (50.0~~104°F)
	15%-95% RH	15%-95% RH
Storage condition	-20℃~~55℃ (-13.0~~131°F)	-20℃~~55℃ (-13.0~~131°F)
	15%-95% RH	15%-95% RH
Power	One CR2032	Two AAA batteries
Physical
Dimensions	59 x 22 x 61 mm	138 x 90 x 45 mm
Weight	25g (with battery)	125g (with batteries)

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8. Performance Summary

The performance of the Non-contact Thermometer is verified and validated to comply with following recognized standards.

1. ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
  The Non-contact Thermometer complies with to applicable ANSI/AAMI ES60601-1 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions.
1. ANSI/AAMI/IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
  The Non-contact Thermometer complies with applicable ANSVAAMI/IEC 60601-1-2 requirements including radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, and power frequency magnetic field immunity test.
3: ASTM E1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
The Non-contact Thermometer complies applicable ASTM E1965-98 requirements including displayed temperature range, maximum permissible laboratory error, ambient conditions, low power supply operation, display and human interface, constructions.

9. Conclusions

The Non-contact Thermometer has the similar intended use, same fundamental scientific technology, similar technological characteristics with the predicate device. Moreover, both devices comply with similar safety and performance standards. All information described above can demonstrate the Non-contact Thermometer is substantial equivalent to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

November 19, 2012

Mr. JM Lin

Regulatory Affairs Representative K-Jump Health Company, Limited Number 56, Wu Kung 5th Road New Taipei Industrial Park New Taipei City, Taiwan 24890

Re: K120711

Trade/Device Name: Non-Contact Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: October 30, 2012 Received: October 31, 2012

Dear Mr. Lin:

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. Lin

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,

Evilla " " " " " = " =

DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, cn=Anthony D. Watson. 0.9.2342.19200300.100.1.1=1300 092402

Anthony D. Watson, B.S., M.S., M.B.A. 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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K-jump®

Indications for Use

510(k) Number (if known): 112-07 U

Device Name: Non-contact Thermometer

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Kwame O. Ulmer ---------------------------------------------------------------------------------------------------------------------------------------------------------------

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

Page 1 of 1

510(k) Number: K120711

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Image /page/6/Picture/0 description: The image shows the logo for K-Jump. The logo is in black and features a stylized lowercase "k" connected to the word "jump". A registered trademark symbol is present to the right of the word "jump".

Indications for Use

K120711 510(k) Number (if known):_

Device Name: Non-contact Thermometer

Indications For Use:

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rhd C. Chay 0 11/9/12

(Division Sign-Off) (Division Sign-Only Division Control, Dental Devices

Page 1 of __ 1

x 120711 510(k) Number:_

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.