Infrared Thermometer
Device Facts
| Record ID | K172795 |
|---|---|
| Device Name | Infrared Thermometer |
| Applicant | Shenzhen Jumper Medical Equipment Co., Ltd. |
| Product Code | FLL · General Hospital |
| Decision Date | Mar 14, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.2910 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Handheld infrared thermometers (JPD-FR400, JPD-FR402) measure human body temperature via eardrum or forehead. Thermopile sensor detects infrared thermal energy emitted from target; converts energy into temperature reading (Celsius or Fahrenheit). Powered by two AAA alkaline batteries. JPD-FR400 includes Bluetooth for data transmission to mobile devices (iOS/Android) running 'Angel Doctor' application. Used in clinical or home settings by professionals or patients. Results displayed on LCD. Enables temperature monitoring; aids clinical decision-making by providing objective thermal data.
Clinical Evidence
Clinical performance testing conducted per ASTM E 1965-98 (Reapproved 2009). Results demonstrate compliance with standard requirements for clinical thermometers. No specific sample size or comparative statistical metrics (e.g., sensitivity/specificity) provided in summary.
Technological Characteristics
Handheld infrared thermometer; thermopile sensor; 2x 1.5V AAA alkaline batteries; LCD display; Bluetooth connectivity (JPD-FR400 only); IP22 ingress protection. Complies with ASTM E 1965-98, ISO 80601-2-56, ISO 10993-5/10 (biocompatibility), and IEC 60601-1/1-2/1-11 (safety/EMC).
Indications for Use
Indicated for human body temperature measurement via eardrum or forehead in all age groups, excluding infants under three months. Suitable for professional and home use.
Regulatory Classification
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.
Special Controls
(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.
Predicate Devices
Submission Summary (Full Text)
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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.
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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
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## 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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#### 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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### Substantial Equivalence Comparison 6.
| Item | Proposed Device:<br>Infrared Thermometer<br>JPD-FR400/402 | Predicate Device 1:<br>Thermo Pal Infrared Ear<br>Thermometer, Model no.:<br>ETH-101 | Predicate Device 2:<br>Non-Contact<br>Thermometer<br>JPD-FR100 | Comments | |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|----|
| 510(k) Number | Pending | K112189 | K131243 | / | |
| Product Code | FLL | FLL | FLL | Same | |
| Intended Use &Indications for use | The Infrared thermometers<br>(JPD-FR400, JPD-FR402)<br>take human body<br>temperature via the eardrum<br>or forehead. They apply to<br>all age groups except for<br>babies under three months.<br>Both devices apply to both<br>professional use and home<br>use. | The Thermo Pal Infrared Ear<br>Thermometer (Model no.:<br>ETH-101) is infrared<br>thermometer intended for the<br>intermittent measurement of<br>human body temperature in<br>people of all ages. | The non-contact infrared<br>thermometer, model<br>JPD-FR100, can measure<br>body temperature for<br>infants and adults without<br>contact to human body. It<br>can be used by consumers<br>in household environment<br>and doctor in clinic as<br>reference. | Different<br>Note 01 | |
| Regulation Number: | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same | |
| Measurement mode | Ear and Forehead<br>measurement mode | Ear measurement mode | Forehead measurement<br>mode | For ear<br>measurement mode,<br>same as Predicate<br>device 1;<br>For forehead<br>measurement mode,<br>same as Predicate<br>device 2; | |
| Item | Proposed Device:<br>Infrared Thermometer<br>JPD-FR400/402 | Predicate Device 1:<br>Thermo Pal Infrared Ear<br>Thermometer, Model no.:<br>ETH-101 | Predicate Device 2:<br>Non-Contact<br>Thermometer<br>JPD-FR100 | Comments | |
| Measurement range | Forehead temperature<br>mode:<br>$0.0℃~100.0℃$<br>/32.0°F~212.0 °F<br>Ear temperature mode:<br>$0.0℃~100.0℃$<br>/32.0°F~212.0 °F | Ear canal mode:<br>$32~43℃$<br>(89.6~109.5°F ) | Forehead temperature<br>mode:<br>$32.2℃~43.3℃$<br>(90.0°F~109.9°F ) | Different<br>Note 02 | |
| Auto power-off while no operation | Yes | Yes | Yes | Same | |
| °C/°F can be switchable | Yes | Yes | Yes | Same | |
| Working Ambient Temperature<br>Environment | Operating environment:<br>Temperature: $10℃~40℃$<br>(50°F-104°F)<br>Humidity: 15%-95% RH,<br>non-condensing<br>Atmospheric pressure:<br>86kPa–106 kPa<br>Storage condition:<br>Ambient Temperature: -20°C<br>to 55°C (-4°F-131°F)<br>Relative Humidity: 0-95%<br>RH, non-condensing<br>Atmospheric pressure: 50kPa | 1. Operating: $10℃~40℃$<br>2. Storage: -20℃~50℃ | 1. Operation: $10℃~$ 40°C,<br>80% RH,<br>non-condensing<br>2. Storage and<br>transportation:<br>Temperature:-10°C to<br>60°C<br>Humidity: 0 - 95%<br>RH, non-condensing | Similar | |
| Item | Proposed Device:<br>Infrared Thermometer<br>JPD-FR400/402 | Predicate Device 1:<br>Thermo Pal Infrared Ear<br>Thermometer, Model no.:<br>ETH-101 | Predicate Device 2:<br>Non-Contact<br>Thermometer<br>JPD-FR100 | Comments | |
| | to 106kPa | | | | |
| Accuracy | 1) ±0.2°C (±0.4°F)<br>36.0°C-39.0°C/96.8°F-1<br>02.2°F<br>2) ±0.3°C (±0.5°F) from<br>32.0°C-35.9°C/89.6°F-9<br>6.7°F<br>3) ±0.3°C (±0.5°F)<br>39.1°C-42.2°C/102.3°F-<br>108.0°F | ±0.2°C, 36~39°C<br>±0.3°C, the rest<br>(±0.4°F, 96.8~102.2°F<br>±0.5°F, the rest) | Forehead temperature<br>mode:<br>±0.2 °C (±0.4 °F) | For the forehead<br>temperature mode:<br>same as Predicate<br>Device 2.<br>For the ear canal<br>temperature mode:<br>same as Predicate<br>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<br>Predicate Device 2. | |
| Power supply | 2×1.5Vdc AAA Alkaline<br>batteries | Two 1.5Vdc Alkaline<br>Manganese batteries (AAA) | 2×1.5Vdc AAA Alkaline<br>batteries | Same | |
| Low power indication | Yes | Yes | Yes | Same | |
| Display screen | LCD | LCD | LCD | Same | |
| Memory | 20 sets | Unknown | 20 sets | Same as Predicate<br>Device 2. | |
| Bluetooth function | JPD-FR400, yes,<br>JPD-FR402, no. | No | No | For JPD-FR400,<br>different<br>Note 03 | |
| Item | Proposed Device:<br>Infrared Thermometer<br>JPD-FR400/402 | Predicate Device 1:<br>Thermo Pal Infrared Ear<br>Thermometer, Model no.:<br>ETH-101 | Predicate Device 2:<br>Non-Contact<br>Thermometer<br>JPD-FR100 | Comments | |
| Waterproof | IP22 | No | No | Different<br>Note 04 | |
| Conformance<br>standard<br>/guidance | Electric safety and<br>EMC | AAMI ANSI<br>ES60601-1:2005/(R)2012+<br>A1:2012<br>IEC 60601-1-2: 2014<br>IEC 60601-1-11:2015 | IEC 60601-1<br>IEC 60601-2<br>IEC 60601-1-11 | IEC<br>60601-1:1988+A1:1991+<br>A2:1995<br>IEC 60601-1-2:2007<br>IEC 60601-1-11:2010 | SE |
| | Risk management | ISO 14971:2007 | ISO 14971 | ISO 14971:2007 | SE |
| | Biocompatibility | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-10:20 | ISO 10993-1<br>ISO 10993-5<br>ISO 10993-10 | ISO 10993-1:2009<br>ISO 10993-5:2009<br>ISO 10993-10:2010 | SE |
| | Performance | ASTM E 1965-98<br>(Reapproved 2009)<br>ISO 80601-2-56: 2009 | ASTM E1965: 2003 | ASTM E 1965-98(2009) | SE |
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## 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:
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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.
