(180 days)
Not Found
No
The summary describes a standard infrared thermometer using a thermopile sensor and basic temperature conversion. There is no mention of AI, ML, or any complex algorithms beyond simple temperature calculation.
No
The device is an infrared thermometer used to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
No
A diagnostic device is one used to identify the nature or cause of a disease or condition. While the device measures body temperature, which can be an indicator of health status, it does not, on its own, provide a diagnosis of a disease or condition. It provides a measurement, which a healthcare professional might then use as part of a diagnostic process, but the device itself isn't performing the diagnosis.
No
The device description clearly states that the devices are "handheld instruments" and are "powered by AAA 1.5Vx2 Alkaline batteries," indicating they are hardware devices. While one model can transmit data to a mobile application, the core function of temperature measurement is performed by the physical thermometer.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The infrared thermometers described measure human body temperature by detecting infrared thermal energy emitted from the eardrum or forehead. This is a direct measurement of a physiological parameter from the body itself, not an analysis of a specimen taken from the body.
- Intended Use: The intended use is to take human body temperature, which is a vital sign measurement, not an in vitro diagnostic test.
Therefore, the function and intended use of these infrared thermometers fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Infrared thermometers (JPD-FR400 and JPD-FR402) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
Product codes
FLL
Device Description
The infrared thermometers (JPD-FR400, JPD-FR402) are handheld instruments which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD. And, the results measured by JPD-FR400 can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application "Angel Doctor" installed on a mobile device using the iOS system or the Android system. The thermometers, which are powered by AAA 1.5Vx2 Alkaline batteries, can be used for all age groups except for babies under three months.
A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Eardrum, forehead
Indicated Patient Age Range
all age groups except for babies under three months
Intended User / Care Setting
professional use and home use
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 is conducted according to ASTM E 1965-98 (Reapproved 2009). The test report showed the clinical performance of proposed devices complied with the requirements of ASTM E 1965-98 (Reapproved 2009).
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
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is the Department of Health & Human Services logo, and on the right, there is the FDA logo. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
March 14, 2018
Shenzhen Jumper Medical Equipment Co., Ltd. % Field Fu Shenzhen Joyantech Consulting Co., Ltd Room 1122, International Mayors Communication Centre, NO. 55 Shizhou Middle Road Shenzhen, Guangdong, GD755 CHINA
Re: K172795
Trade/Device Name: Non-contact Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 2, 2018 Received: February 8, 2018
Dear Field Fu:
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.
2
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 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.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Version: A/0
510(k) Summary
Contact Details 1.
1.1 Applicant information
| Applicant Name | Shenzhen Jumper Medical Equipment Co., Ltd. |
|---|---|
| Address | Address: D Building, No. 71, Xintian Road, Fuyong Street, Baoan, |
| Shenzhen, Guangdong, China | |
| Phone No. | +86-755-26696279 |
| Fax No. | |
| Contact person | Rambo Yang |
| Contact person's e-mail | yanggang@jumper-medical.com |
| Date Prepared | Aug.30, 2017 |
| Website | www.jumper-medical.com |
1.2 Submission Correspondent
| Shenzhen Joyantech Consulting Co., Ltd | |
|---|---|
| Room 1122, International Mayors Communication Centre, NO. 55 | |
| Shizhou middle road , Nanshan District, Shenzhen | |
| 卓远天成 | |
| Phone No. | +86-755-86069197 |
| Contact person | Field Fu; Crean Bai |
| Contact person's e-mail | crean@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
| 2. Device information | |
| Trade name | Non-contact Infrared Thermometer |
| Common name | Infrared Thermometer |
| Model | JPD-FR400, JPD-FR402 |
| Classification | II |
| Classification name | Thermometer, Electronic, Clinical |
| Product code | FLL |
| Regulation No. | 880.2910 |
| 3. Legally Marketed Predicate Device | |
| Trade Name | Thermo Pal Infrared Ear Thermometer, Model no.: ETH-101 |
| 510(k) Number | K112189 |
| Product Code | FLL |
| Manufacturer | Digio2 International Co., LTD. |
| Trade Name | Non-Contact Thermometer |
| 510(k) Number | K131243 |
| Product Code | FLL |
| Manufacturer | Shenzhen Jumper Medical Equipment Co., Ltd. |
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Version: A/0
Device Description 4.
The infrared thermometers (JPD-FR400, JPD-FR402) are handheld instruments which can measure human body's temperature either via the eardrum or the forehead for clinical or home use. The results can be displayed on LCD. And, the results measured by JPD-FR400 can be transmitted to mobile device (i.e. iPhone) with Bluetooth and the application "Angel Doctor" installed on a mobile device using the iOS system or the Android system. The thermometers, which are powered by AAA 1.5Vx2 Alkaline batteries, can be used for all age groups except for babies under three months.
A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the eardrum or the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or F .
5. Intended Use/Indication for Use
The Infrared thermometers (JPD-FR400 and JPD-FR402) take human body temperature via the eardrum or forehead. They apply to all age groups except for babies under three months. Both devices apply to both professional use and home use.
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Version: A/0
Substantial Equivalence Comparison 6.
| Item | Proposed Device:
Infrared Thermometer
JPD-FR400/402 | Predicate Device 1:
Thermo Pal Infrared Ear
Thermometer, Model no.:
ETH-101 | Predicate Device 2:
Non-Contact
Thermometer
JPD-FR100 | Comments | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----|
| 510(k) Number | Pending | K112189 | K131243 | / | |
| Product Code | FLL | FLL | FLL | Same | |
| Intended Use &Indications for use | The Infrared thermometers
(JPD-FR400, JPD-FR402)
take human body
temperature via the eardrum
or forehead. They apply to
all age groups except for
babies under three months.
Both devices apply to both
professional use and home
use. | The Thermo Pal Infrared Ear
Thermometer (Model no.:
ETH-101) is infrared
thermometer intended for the
intermittent measurement of
human body temperature in
people of all ages. | 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. | Different
Note 01 | |
| Regulation Number: | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same | |
| Measurement mode | Ear and Forehead
measurement mode | Ear measurement mode | Forehead measurement
mode | For ear
measurement mode,
same as Predicate
device 1;
For forehead
measurement mode,
same as Predicate
device 2; | |
| Item | Proposed Device:
Infrared Thermometer
JPD-FR400/402 | Predicate Device 1:
Thermo Pal Infrared Ear
Thermometer, Model no.:
ETH-101 | Predicate Device 2:
Non-Contact
Thermometer
JPD-FR100 | Comments | |
| Measurement range | Forehead temperature
mode:
$0.0℃100.0℃$212.0 °F
/32.0°F
Ear temperature mode:
$0.0℃100.0℃$212.0 °F | Ear canal mode:
/32.0°F
$3243℃$109.5°F ) | Forehead temperature
(89.6
mode:
$32.2℃43.3℃$109.9°F ) | Different
(90.0°F
Note 02 | |
| Auto power-off while no operation | Yes | Yes | Yes | Same | |
| °C/°F can be switchable | Yes | Yes | Yes | Same | |
| Working Ambient Temperature
Environment | Operating environment:
Temperature: $10℃40℃$102.2°F
(50°F-104°F)
Humidity: 15%-95% RH,
non-condensing
Atmospheric pressure:
86kPa–106 kPa
Storage condition:
Ambient Temperature: -20°C
to 55°C (-4°F-131°F)
Relative Humidity: 0-95%
RH, non-condensing
Atmospheric pressure: 50kPa | 1. Operating: $10℃40℃$39°C
2. Storage: -20℃50℃ | 1. Operation: $10℃$ 40°C,
80% RH,
non-condensing
2. Storage and
transportation:
Temperature:-10°C to
60°C
Humidity: 0 - 95%
RH, non-condensing | Similar | |
| Item | Proposed Device:
Infrared Thermometer
JPD-FR400/402 | Predicate Device 1:
Thermo Pal Infrared Ear
Thermometer, Model no.:
ETH-101 | Predicate Device 2:
Non-Contact
Thermometer
JPD-FR100 | Comments | |
| | to 106kPa | | | | |
| Accuracy | 1) ±0.2°C (±0.4°F)
36.0°C-39.0°C/96.8°F-1
02.2°F
2) ±0.3°C (±0.5°F) from
32.0°C-35.9°C/89.6°F-9
6.7°F
3) ±0.3°C (±0.5°F)
39.1°C-42.2°C/102.3°F-
108.0°F | ±0.2°C, 36
±0.3°C, the rest
(±0.4°F, 96.8
±0.5°F, the rest) | Forehead temperature
mode:
±0.2 °C (±0.4 °F) | For the forehead
temperature mode:
same as Predicate
Device 2.
For the ear canal
temperature mode:
same as Predicate
Device 1. | |
| Display Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | 0.1°C/0.1°F | Same | |
| Measurement distance | 1-5cm | / | 1-6cm | Similar with
Predicate Device 2. | |
| Power supply | 2×1.5Vdc AAA Alkaline
batteries | Two 1.5Vdc Alkaline
Manganese batteries (AAA) | 2×1.5Vdc AAA Alkaline
batteries | Same | |
| Low power indication | Yes | Yes | Yes | Same | |
| Display screen | LCD | LCD | LCD | Same | |
| Memory | 20 sets | Unknown | 20 sets | Same as Predicate
Device 2. | |
| Bluetooth function | JPD-FR400, yes,
JPD-FR402, no. | No | No | For JPD-FR400,
different
Note 03 | |
| Item | Proposed Device:
Infrared Thermometer
JPD-FR400/402 | Predicate Device 1:
Thermo Pal Infrared Ear
Thermometer, Model no.:
ETH-101 | Predicate Device 2:
Non-Contact
Thermometer
JPD-FR100 | Comments | |
| Waterproof | IP22 | No | No | Different
Note 04 | |
| Conformance
standard
/guidance | Electric safety and
EMC | AAMI ANSI
ES60601-1:2005/(R)2012+
A1:2012
IEC 60601-1-2: 2014
IEC 60601-1-11:2015 | IEC 60601-1
IEC 60601-2
IEC 60601-1-11 | IEC
60601-1:1988+A1:1991+
A2:1995
IEC 60601-1-2:2007
IEC 60601-1-11:2010 | SE |
| | Risk management | ISO 14971:2007 | ISO 14971 | ISO 14971:2007 | SE |
| | Biocompatibility | ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:20 | ISO 10993-1
ISO 10993-5
ISO 10993-10 | ISO 10993-1:2009
ISO 10993-5:2009
ISO 10993-10:2010 | SE |
| | Performance | ASTM E 1965-98
(Reapproved 2009)
ISO 80601-2-56: 2009 | ASTM E1965: 2003 | ASTM E 1965-98(2009) | SE |
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8
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9
Discussion:
Note 01:
For the ear canal measurement mode, the subject devices' intended population is smaller than that of Predicate device 1.
For the forehead measurement mode, the subject devices' intended population is smaller than that of Predicate device 2.
Note 02:
The subject devices' measuring range is larger than that of both predicate device 1 and predicate device 2. Due to the subject devices also apply to measuring the environmental temperature, so their measuring range is larger.
Note 03:
JPD-FR400 has passed FCC, EN301489-1, EN301489-17, EN 300328 and wireless coexistence test.
Note 04:
The subject device has passed the IEC60601-1 and the IEC60601-1-11 test.
Non-clinical Performance Testing 7.
The performance data in compliance with the following standard were provided in support of the substantial equivalence determination.
AAMI ANSI ES60601-1:2005/(R)2012 And A1:2012: Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-1-2:2014: Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests:
IEC 60601-1-11:2015: Medical Electrical Equipment - Part 1-11: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Requirements For Medical Electrical Equipment And Medical Electrical Systems Used In The Home Healthcare Environment;
ISO 80601-2-56 First Edition 2009-10-01: Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement;
ISO 10993-5:2009: Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity;
ISO 10993-10:2010: Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization;
ASTM E 1965-98 (Reapproved 2009): Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature;
EN 300 328 : Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques;
ETSI EN 301 489-1: Electromagnetic compatibilityand Radio spectrum Matters (ERM);ElectroMagnetic Compatibility (EMC)standard for radio equipment and services;Part 1: Common technical requirements:
10
Proposed product: Infrared Thermometer Version: A/0
ETSI EN 301 489-17: Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmission Systems;
8. Clinical performance
The clinical performance test is conducted according to ASTM E 1965-98 (Reapproved 2009). The test report showed the clinical performance of proposed devices complied with the requirements of ASTM E 1965-98 (Reapproved 2009).
9. Conclusions
The infrared thermometer JPD-FR400 and JPD-FR402 have the similar intended use with the predicated device 1 on ear canal mode and have the similar intended use with the predicate device 2 on forehead mode, the non-clinical performance tests and the clinical tests demonstrated adequate performance. The Infrared Thermometer JPD-FR400 and JPD-FR402 are substantially equivalent to the predicate devices, K112189 and K131243.