(195 days)
Not Found
No
The description focuses on basic infrared sensing and signal processing to convert detected energy into a temperature reading. There is no mention of AI or ML algorithms for data analysis, prediction, or learning.
No.
The device is a non-contact infrared thermometer used to measure body temperature and does not treat or prevent any disease or condition.
Yes.
This device is used to measure body temperature, which is a physiological parameter used in diagnosing medical conditions and monitoring health.
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.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: The Non-contact Infrared Thermometer, model JPD-FR 100, measures the temperature of the human body by detecting infrared radiation emitted from the forehead. It does not analyze any biological specimens taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical device used for direct measurement of a physiological parameter (temperature) on the body, not an IVD.
N/A
Intended Use / Indications for Use
The non-contact infrared thermometer, model JPD-FR100, 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 (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, 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 predicated device KI-8280, 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 patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. 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 Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
forehead
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The clinical performance test protocol and data analysis followed the requirements of ASTM E 1965. The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965. It is acceptable to measure patient's temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Version:A/l
VOL 05 510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR $807.92.
The assigned 510(k) number is: K131243
NOV 1 2 2013
1.0 Information of Submitter and Correspondent
Submitter's Information:
Shenzhen Jumper Medical Equipment Co., Ltd.
Address: 5th Floor, Building No.34, Baoyuan Industrial Zone, Xixiang Street, Baoan District,
Shenzhen 518102, Guangdong Province, P.R. China
Phone: +86-755-26692192
Fax:
Contact Person: Mr. Yi Hui
E-mail: info@jumper-medical.com
Submission correspondent's information:
Shenzhen ZYTC Consulting Co., Ltd. Address: 4th Floor, Jinhui Building, Nanhai BLVD, Nanshan District, Shenzhen, Guangdong, China. Contact person: Mr. Field.Fu E-mail: cefda13485@163.com
2.0 Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Non-contact Infrared Thermometer |
| Model: | JPD-FR100 |
| Classification name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Device Class: | II |
| Regulation Number: | 880.2910 |
3.0 Predicate Device Information
1
Sponsor: K-jump Health Co., Ltd. Non-contact Infrared Thermometer, model KI-8280 Device: 510(K) Number: K102947
4.0 Device Description
The Non-contact Infrared Thermometer, Model JPD-FR100, uses infrared sensor (thermopile) to detect the radiated infrared energy emitted by the object, 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 predicated device KI-8280, 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 patient's forehead. This mechanism make the subject device have the ability to detect the forehead temperature in the distance of 1-6cm. 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 Shenzhen Jumper Medical Equipment Co., Ltd. Non-contact Infrared Thermometer, model JPD-FR100, enables to provide safe and reliable result and offers a very good clinical accuracy for human body temperature measurements.
5.0 Intended Use
The non-contact infrared thermometer, model JPD-FR100, 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.
6.0 Performance Summary
VOL 05 Page 2 of 5
2
Version:A/l
Non-contact Infrared Thermometer, model JPD-FR100 was conforms to the following standards:
- . IEC 60601-1, Medical Electrical Equipment - Part 1: General Requirements for Safety, 1988+A1:1991+A2:1995
- IEC 60601-1-2, Medical electrical equipment Part 1-2: General requirements for basic . safety and essential performance - Collateral standard: Electromagnetic compatibility -Requirements and tests, 2007
- . IEC 60601-1-11:2010, Medical electrical equipment - General requirements for basic safety and essential performance - Part 1-11: Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
- . ASTM E1965-98 (2009), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.
- IEC 62304:2006, Medical device software Software life cycle processes. ◆
- ISO 10993-1, Biological evaluation of medical devices -- Part 1: Evaluation and testing � within a risk management process. 2009
- ◆ ISO 10993-5, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity. 2009
- ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for � imitation and delayed-type hypersensitivity
- ISO 14971:2007, Medical devices Application of risk management to medical devices. �
7.0 Comparison to predicate device and conclusion
The subject device is substantially equivalent to predicate devices, K102947, Kl-8280. The substantial equivalence chart is provided as follows:
| Characteristics | Subject Device | Predicate Device |
|---|---|---|
| Device name | Non-contact Infrared | |
| Thermometer | Non-contact Infrared | |
| Thermometer | ||
| Model | JPD-FR100 | KI-8280 |
| K number | Pending | K102947 |
| Manufacturer | Shenzhen Jumper Medical | |
| Equipment Co., Ltd. | K-jump Health Co., Ltd. | |
| Measurement method | Infrared radiation detection | Infrared radiation detection |
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Shenzhen Jumper Medical Equipment Co., Ltd.
VOL_005:001_510K Summary
Version:A/1
| Measurement mode | Forehead measure mode | Forehead and surface
measure mode |
|------------------------|------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Measuring range | Forehead temperature mode:
$32.2°C-43.3°C (90.0°F-109.9°F)$ ; | Forehead temperature mode:
$32.0°C-42.2°C (89.6°F-107.9°F)$ ;
Surface temperature mode:
$0.0°C-100°C (32°F-212°F)$ ; |
| Display resolution | $0.1°C (0.1°F)$ | $0.1°C (0.1°F)$ |
| C/F switchable | Yes | Yes |
| Measuring accuracy | Forehead temperature mode:
$±0.2°C(0.4°F)$ ; | Forehead temperature mode:
$±0.2°C(0.4°F)$ ;
Surface temperature mode:
$±1°C(1.8°F)$ |
| Display | LCD display | LCD display |
| Measurement distance | 1-6cm | 3-8cm |
| Key | Two button (Forehead
measure, temperature unit
shift) | Two button (On/off, Memory) |
| Memory | 20 sets | 10 sets |
| Power source | Two 1.5V AAA batteries | Two 1.5V AAA batteries |
| Low battery indication | Yes | Yes |
| Waterproof | No | No |
| Dimension | 145×60×50mm | 138×90×45mm |
| Weight | 180g | 125g(including batteries) |
| Operating condition | $10°C-40°C (50°F-104°F)$ ,