(256 days)
Not Found
No
The summary describes a standard non-contact infrared thermometer and does not mention any AI or ML components or capabilities. The performance studies reference standard thermometer validation protocols.
No
The device is a non-contact thermometer intended to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not provide treatment or promote healing.
Yes
The device is described as measuring human body temperature, and temperature measurement is a common diagnostic tool used to identify conditions such as fever, which can indicate illness. The intended use for both consumers and doctors further supports its diagnostic application.
No
The device description explicitly states it is a "compact, small and light-weight device, which is powered by a battery and can be connected to a smartphone through headphone jack". This indicates a physical hardware component is part of the medical device, not just software running on a general-purpose computing platform.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: This device measures human body temperature without contact to the human body. It detects infrared radiation emitted from the body's surface (likely the forehead, based on the measurement range).
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the body. It directly measures a physical property (temperature) from the body's surface.
Therefore, because the device does not perform tests on samples taken from the body, it falls outside the definition of an In Vitro Diagnostic device. It is a medical device used for a direct physiological measurement.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
children and adults
Intended User / Care Setting
consumers in household environment and doctor in clinics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The performance of the Non-contact Thermometer is verified and validated to comply with following recognized standards.
-
- 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.
-
- 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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.
5. Indications for Use
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.
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May 1, 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 Infrare
nermometer |
|-----------------------|-------------------------------|-----------------------------------|
| 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°F109.9°F) | 32.2℃43.3℃, (90.0°F109.9°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℃ (50.0104°F) | 10℃40℃ (50.0104°F) |
| | 15%-95% RH | 15%-95% RH |
| Storage condition | -20℃55℃ (-13.0131°F) | -20℃55℃ (-13.0131°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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2
8. Performance Summary
The performance of the Non-contact Thermometer is verified and validated to comply with following recognized standards.
-
- 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.
- ANSI/AAMI ES60601-1:2005 Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance
-
- 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.
- ANSI/AAMI/IEC 60601-1-2:2007 Medical Electrical Equipment Part 1-2: General Requirements for Safety; Electromagnetic Compatibility
-
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.
3
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.
4
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:
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.
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:
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.
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:_