(144 days)
No
The description details a standard infrared thermometer technology based on detecting and converting infrared energy to a temperature reading. There is no mention of AI, ML, or any complex algorithms beyond basic signal processing and conversion. The performance studies are based on comparison to a digital thermometer, not on training or testing of an AI/ML model.
No
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
Explanation: The device measures body temperature, which is a physiological parameter used to identify or monitor a medical condition (e.g., fever).
No
The device description explicitly details hardware components like an infrared sensor (thermopile) and focusing design, indicating it is a physical device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening.
- This device measures body temperature in vivo (within the body) by detecting infrared radiation emitted from the skin surface. It does not analyze biological samples.
The description clearly states it's a "Non-Contact Infrared Thermometer" that measures "body temperature" by detecting "infrared energy emitted by the objects" (specifically, the human body). This is a direct measurement of a physiological parameter, not an in vitro analysis of a specimen.
N/A
Intended Use / Indications for Use
Non-Contact Infrared Thermometer, Model KI-8280, 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.
Product codes
FLL
Device Description
The Non-Contact Infrared Thermometer, Model KI-8280, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the objects, 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 predicate device, JXB Thermoflash, 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 object surface. This mechanism make the subject device have the ability to detect the object surface temperature in the distance of 3-8cm. 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 K-jump Health Co, Ltd. Non-Contact Infrared Thermometer, Model KI-8280, enables to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.
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
infants and adults
Intended User / Care Setting
consumers in household environment and doctor in clinic
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
The Non-Contact Infrared Thermometer, KI-8280, is complied with voluntary standards includes ASTM E1965 and EN 12470-5.
The recognized consensus standards for safety of medical electrical equipment: IEC 60601-1 with amendments for safety and IEC 60601-1-2 for eiectromagnetic compatibility are complied.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(k) submissions for Clinical Electronic Thermometers".
The clinical performance test protocol and data analysis is followed the requirements the ASTM E 1965. The test report shows the patient's temperature readings difference between digital thermometer and the subject device, KI-8280, are within acceptable range. It can conclude that the Non-Contact Infrared Thermometer, KI-8280, is acceptable to measure patient's temperature
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
EXHIBIT 1
510(k) SUMMARY
FEB 2 5 2011
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.
K102947 The assigned 510(k) number is:
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: September 30, 2010
2. Name of Device:
Non-Contact Infrared Thermometer, Model KI-8280
Regulation Number: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL
3. Predicate Device Information:
- K080759, ThermoFlash LX-26, JXB Co., Ltd., Guangzhou, China -
4. Device Description:
The Non-Contact Infrared Thermometer, Model KI-8280, uses infrared sensor
Page 1 of 4
1
EXHIBIT 1
(thermopile) to detect the radiated infrared energy emitted by the objects, 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 predicate device, JXB Thermoflash, 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 object surface. This mechanism make the subject device have the ability to detect the object surface temperature in the distance of 3-8cm. 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 K-jump Health Co, Ltd. Non-Contact Infrared Thermometer, Model KI-8280, enables to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.
5. Intend Use:
The non-contact infrared thermometer, Model KI-8280, 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. Comparison to Predicate Devices:
The subject device is substantially equivalent to the predicate devices, K080759, ThermoFlash LX-26. The substantial equivalence chart is provided as follows:
| Characteristics | K-jump Device
(Subject Device) | ThermoFlash LX-26
JXB Co., Ltd.
K#080759 |
|-----------------------|--------------------------------------------------------------------|----------------------------------------------------------------------------------|
| Measurement
method | Infrared radiation detection | Infrared radiation detection |
| Measuring Range | Forehead Mode:
$32.2°C43.3°C(90.0°F109.9°F)$
Surface Mode: | In body mode: $32°C - 42.9°C$
(90°F - 109°F)
In Surface Temp mode: $0°C ~$ |
2
| $0.0℃ | $60°C (32°F to 140°F)$ | |
|---|---|---|
| Display Resolution | $0.1°C (0.1°F)$ | $0.1°C (0.1°F)$ |
| C/F Switchable | Yes | Yes |
| Measuring | ||
| accuracy | Forehead Mode: | |
| $±0.2℃ (0.4°F)$ | ||
| Surface Mode: | ||
| $±1°C(1.8°F)$ | $±0.2℃ (0.4°F)$ range from 36 | |
| $-39.0℃ (93.2-102.2°F)$ | ||
| $±0.3℃ (0.5°F)$ range from 34 ~ | ||
| $35.9℃ (93.2~96.6°F) & 39 ~$ | ||
| $42.5℃ (102.2~108.5°F)$ | ||
| Display | LCD display | LCD display |
| Measurement | ||
| Distance | 3 - 8 cm | 5 - 8 cm |
| Key | Two button (On/Off, Memory) | Four button (measuring, Menu, |
| Setting*2) | ||
| Memory | 10 sets | 32 sets |
| Power source | Two 1.5V AAA batteries | Two 1.5V AA batteries |
| Low battery | ||
| Indication | Replace the battery if the low | |
| battery indication appears | Replace the battery if the low | |
| battery indication appears | ||
| Waterproof | No | No |
| Dimension | 138X90X45 mm | 196x150x50 mm |
| Weight | 125g (including batteries) | 220g |
| Operating | ||
| condition | $10℃~40℃ (50.0 ~ 104°F),$ |