(115 days)
Not Found
No
The device description details standard electronic components for temperature measurement and display, with no mention of AI/ML algorithms or data processing beyond basic sensor input.
No
This device is intended to measure human body temperature (diagnosis), not to treat any condition.
Yes
The device is a digital forehead thermometer, which measures human body temperature to provide information that can be used for diagnosis (e.g., detecting fever), therefore classifying it as a diagnostic device.
No
The device description explicitly lists hardware components such as a probe with thermister sensor, PC board, LCD display, plastic body, power key, buzzer, and batteries.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure human body temperature using the forehead. This is a direct measurement of a physiological parameter of the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The description details components for measuring temperature directly from the skin surface. There is no mention of reagents, sample handling, or analysis of biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analysis of biological samples (blood, urine, etc.)
- Detection of specific substances or markers in samples
- Use of reagents or assays
In summary, the device is a thermometer, which is a medical device used for direct physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.
Product codes
FLL
Device Description
The Digital Forehead Thermometers, Model KD-2201 & KD-2210, consist of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature.
The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing rapidly. The electronic signal was transferred to ASIC circuit on PC board through sensor on probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement. All components assemble on the plastic main body. There is only one ON/OFF button to power on of off the device. The buzzer may sound during operation or end of the temperature measuring. The device is powered by DC voltage of two AAA type batteries
Press the power button may turn on the thermometer and the full screen of LCD will be displayed for two seconds with a "beep-beep" sound and flashing hourglass icon. After that, LCD will be displayed the measuring scale "C or "[r" and the hourglass icon disappeared. Then, the thermometer is ready for measurement. Place the probe to the temple and let the sensor touching patient's skin gently. The thermometer will start measuring automatically. Six seconds later, a "beep-beep" sound will be heard and the reading will be displayed when measuring completed. For the next measurement, wait for the hourglass stop flashing and disappeared before place the probe to patient's temple again. Press power button again may turn off the thermometer or the thermometer will turn off itself in one minute if not use.
The compact, small and light-weight design, the K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, enable 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
forehead
Indicated Patient Age Range
adult or pediatric patients
Intended User / Care Setting
Not Found
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 Digital Forehead Thermometers, KD-2201 & KD-2210, are complied with voluntary standards includes ASTM E 1112-00 and EN 12470-3.
The recognized consensus standards for safety of medical electrical equipment: IEC 60601-1 with amendments for safety and IEC 60601-1-2 for electromagnetic compatibility are complied.
Guidance documents included the "FDA Guidance on the Content of Premarket Notification 510(k) submissions for Clinical Electronic Thermometers".
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
APR - 4 2011
EXHIBIT 1
510(k) SUMMARY
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.
The assigned 510(k) number is: _K103617
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: November 30, 2010
2. Name of Device:
K-jump Health Co., Ltd. Digital Forehead Thermometer, Model KD-2201 & DK-2210
Regulation Number: 21 CFR 880.2910 Regulation Name: Thermometer, Electronic, Clinical Regulatory Class: II Product Code: FLL
3. Predicate Device Information:
- K070491, Digital Forehead Thermometer, Model KD-2200, K-jump Health Co., Ltd., । Taipei, Taiwan
4. Device Description:
1
EXHIBIT 1
The Digital Forehead Thermometers, Model KD-2201 & KD-2210, consist of a probe with thermister sensor and stainless steel plate, a PC board with ASIC circuits, a LCD display, a plastic main body, an ON/OFF power key, a buzzer and two AAA type batteries for the determination of human body temperature.
The tip of probe is made with a thermister sensor and stainless steel plate which may sense the temperature changing rapidly. The electronic signal was transferred to ASIC circuit on PC board through sensor on probe. The LCD displays the predictive temperature or last temperature recorded and warning information during measurement. All components assemble on the plastic main body. There is only one ON/OFF button to power on of off the device. The buzzer may sound during operation or end of the temperature measuring. The device is powered by DC voltage of two AAA type batteries
Press the power button may turn on the thermometer and the full screen of LCD will be displayed for two seconds with a "beep-beep" sound and flashing hourglass icon. After that, LCD will be displayed the measuring scale "C or "[r" and the hourglass icon disappeared. Then, the thermometer is ready for measurement. Place the probe to the temple and let the sensor touching patient's skin gently. The thermometer will start measuring automatically. Six seconds later, a "beep-beep" sound will be heard and the reading will be displayed when measuring completed. For the next measurement, wait for the hourglass stop flashing and disappeared before place the probe to patient's temple again. Press power button again may turn off the thermometer or the thermometer will turn off itself in one minute if not use.
The compact, small and light-weight design, the K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, enable to provide safe and reliable results and offers a very good clinical accuracy for human body temperature measurement.
5. Intend Use:
K-jump Health Co, Ltd. Digital Forehead Thermometers, Model KD-2201 & KD-2210, are intended to measure the human body temperature using the forehead as measurement site. They can be used with adult or pediatric patients.
6. Comparison to Predicate Devices:
Page 2 of 4
2
The subject device is substantially equivalent to the predicate devices, K070491, Digital Forehead Thermometer Model KD-2200. The substantial equivalence chart is provided as follows:
and the comments of the comments of the comments of the comments of the comments of
| Characteristics | Subject Devices
KD-2201 | Subject Devices
KD-2210 | Predicate Device
(KD-2200, K#070491) |
|---------------------------|--------------------------------------------------------------|------------------------------|--------------------------------------------------------------------|
| Sensor Type | Thermister | | Thermister |
| Number of Sensor | One (Skin Temperature
Sensor) | | Two (Skin & Ambient
Temperature Sensors) |
| Microcontroller | Sonix SN8P1919 | | Sonix SN8P1909 |
| Measuring Range | $35.0℃42.0℃$107.6°F) | | $32.2°C - 43.3°C$
(95.5°F
(90°F - 109.9°F) |
| Display Resolution | 0.1°C (0.1°F) | | 0.1°C (0.1°F) |
| C/F Switchable | Yes | | Yes |
| Measuring
accuracy | ±0.1°C (35.0°C~42.0°C) | | ±0.1°C 34.0°C - 42.0°C
(93.2°F - 107.6°F)
±0.2°C other range |
| Display | LCD display | | LCD display |
| Measurement Site | Temporal artery area of
forehead | | Temporal artery area of
forehead |
| Key | One button | | One button |
| Memory | Nine sets | | One set (Nine sets optional) |
| 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 |
| Operating
condition | 10℃ ~ 40℃ (50°F - 104.0°F)
15-95% RH, non-condensing. | | 16℃ ~ 40℃ (60.8°F -
104.0°F)