(181 days)
No
The description focuses on basic infrared sensing and electronic signal processing, with no mention of AI/ML algorithms for temperature interpretation or other functions.
No
The device is an infrared thermometer intended for body temperature measurement, which is a diagnostic function, not a therapeutic one. It measures a condition but does not treat or alleviate it.
No
The device is an infrared thermometer, which measures body temperature. While temperature can be an indicator of health, the device itself does not diagnose a medical condition or disease. It provides a measurement, not a diagnosis.
No
The device description explicitly states it uses an "infrared probe (Thermopile)" and processes electronic signals to display temperature on an "LCD," indicating it is a hardware device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Infrared Thermometer measures body temperature by detecting infrared radiation emitted from the body's surface (specifically the forehead). It does not analyze samples taken from the body.
- Intended Use: The intended use is for body temperature measurement, which is a direct measurement of a physiological parameter, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Infrared Thermometer is intended for body temperature measurement 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 subject device uses infrared probe 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. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.
The subject device intends to detect the temperature of patients of all ages.
The subject device includes 2 series: ThermoFlash and MyThermo. The ThermoFlash thermometers contain 5 models: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, while MyThermo thermometer contains one model BW-CX10. They all have the following basic functions:
- Sound alarm if temperature is exceeded. -
- LCD back-lighted digital screen. -
- Data displayed in Celsius or Fahrenheit. -
- Automatic stop (energy saver). -
- Small, convenient, easy to use. -
Their differences are in appearance and functions. The LX-26E and LX-360 are same in functions, while LX-260TE and LX-361T contain additional language function, BW-CX10 and PRO LX-261E contain additional rechargeable function, and BW-CX10 contains additional Bluetooth function.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared radiation
Anatomical Site
Forehead
Indicated Patient Age Range
Infants and adults, all ages
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
The clinical performance test protocol and data analysis followed the requirements of ASTM E1965-98 (2009). The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965-98 (2009).
Summary of Performance Studies
Study type: Nonclinical tests, Clinical accuracy test, Biological Evaluation, Battery Safety, Battery Transportation Safety, QoS testing, Wireless coexistence.
Tests conducted: Electric Safety (IEC 60601-1:2012), EMC (IEC 60601-1-2:2014, 47 CFR PART 15 Subpart C), Electric Safety for medical device used in the home healthcare environment (IEC 60601-1-11 Edition 1.0 2010-04), Basic Safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56 First Edition 2009-10-01), Clinical accuracy (ASTM E1965-98 (Reapproved 2009)), Biological Evaluation (ISO 10993-1:2009), In vitro Cytotoxicity (ISO 10993-5:2009), irritation and skin sensitization (ISO 10993-10: 2010), Battery Safety (IEC 62133 Edition 2.0 2012-12), Battery transportation Safety (UN 38.3), QoS testing (47 CFR PART 15 Subpart B, 47 CFR PART 15 Subpart C), Wireless coexistence (47 CFR PART 15 Subpart B, 47 CFR PART 15 Subpart C, EN 300328 V1.8.1).
Key results: All tests passed, indicating that the device complies with the requirements of the standards and is acceptable to measure patient's temperature.
Key Metrics
Measuring accuracy: +/- 0.2℃ in Body mode
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.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter of the circle. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 21, 2016
Nexmed Technology Co., Ltd c/o Ms. Elena Lu Consultant Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre Shenzhen, 518101 CHINA
Re: K160816
Trade/Device Name: Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: August 15, 2016 Received: August 22, 2016
Dear Ms. Elena Lu:
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.
1
Page 2 - Ms. Elena Lu
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang
-s
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
2
Indications for Use
510(k) Number (if known) K160816
Device Name
Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)
Indications for Use (Describe)
Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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Version:A/0
VOL 05 510(k) Summary
5.1 Administrative Information
| Date of Summary prepared | Aug., 31, 2016 |
|---|---|
| Manufacturer information | Nexmed Technology Co., Ltd. |
| 2 Floor Of No.1 Building, Jia An Technological | |
| Industrial Park, 67 District, Bao An, Shenzhen, | |
| Guangdong, China 518101 | |
| Contact person: Ellen Xu | |
| Phone: +86-755-2948 1701 | |
| Fax: +86-755-8525 8461 | |
| E-mail: ellen@nxm-tech.com | |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Address: Room 2032, International Mayors | |
| Communication Centre, NO. 55 Shizhou middle | |
| road , Nanshan District, Shenzhen | |
| Contact person: Ms. Elena Lu; Mr. Field Fu | |
| E-Mail: elena@cefda.com; cefda13485@163.com |
registration number
5.2 Device Information
| Type of 510(k)
| submission: | Traditional |
|---|---|
| Trade Name: | Infrared Thermometer |
| Model: | LX-26E, LX-260TE, PRO LX-261E, LX-360, LX- |
| 361T, BW-CX10 | |
| Classification name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
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Version:A/0
| Device Class: | II |
|---|---|
| Regulation Number: | 880. |
2910
5.3 Predicate Device Information
| Sponsor: | Shenzhen Jumper Medical Equipment Co., Ltd. |
|---|---|
| Device: | Non-contact Infrared Thermometer |
| 510(K) Number: | K131243 |
5.4 Device Description
The subject device uses infrared probe 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. The infrared probe (Thermopile) can recognize it and transfer to the proper electronic signal. The electronic signal can be processed in the Infrared Thermometer to convert to the temperature reading, which is displayed on the LCD. Therefore, the subject device is able to measure the temperature of a person by the energy the person emits.
The subject device intends to detect the temperature of patients of all ages.
The subject device includes 2 series: ThermoFlash and MyThermo. The ThermoFlash thermometers contain 5 models: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, while MyThermo thermometer contains one model BW-CX10. They all have the following basic functions:
- Sound alarm if temperature is exceeded. -
- LCD back-lighted digital screen. -
- Data displayed in Celsius or Fahrenheit. -
- Automatic stop (energy saver). -
- Small, convenient, easy to use. -
Their differences are in appearance and functions. The LX-26E and LX-360 are same in functions, while LX-260TE and LX-361T contain additional language function, BW-CX10 and PRO LX-261E contain additional rechargeable function, and BW-CX10 contains additional Bluetooth function.
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5.5 Intended Use/ Indications for Use
Infrared Thermometer is intended for body temperature measurement for infants and adults without contact to human body. It can be used by consumers in household environment and doctor in clinic as reference.
5.6 Technological characteristics of the subject device compared to the predicate device
| Items | Predicate Device
(K131243), Jumper | Subject Device | Remarks |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| 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. | Infrared Thermometer is
intended for body
temperature measurement
for infants and adults
without contact to human
body. It can be used by
consumers in household
environment and doctor in
clinic as reference. | Same |
| Measurement
method | Infrared radiation
detection | Infrared radiation detection | Same |
| Measurement
mode | Forehead measure mode | Body mode, also is
forehead measurement
mode | Same |
| Measuring range | Forehead temperature
mode: 32.2℃ - 43.3℃
(90.0℉ - 109.9℉) | Body mode: 30°to 43℃
(86.0℉ to 109.4℉) | Similar |
| Display
resolution | 0.1℃ (0.1℉) | 0.1 ℃/0.1 ℉ | Same |
| C/F switchable | Yes | Yes | Same |
| Measuring
accuracy | Forehead temperature
mode:
$ \pm $ 0.2℃ (0.4℉) | +/- 0.2℃ in Body mode | Same |
| Display | LCD display | LCD display | Same |
| Measurement
distance | 1-6cm | 2-5cm | Similar |
| Items | Predicate Device
(K131243), Jumper | Subject Device | Remarks |
| Memory | 20 sets | LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T: 32 sets;
BW-CX10: It does not memory any data, and the data are transferred to the mobile phone app for memory. | Similar |
| Power source | Two 1.5V AAA batteries | LX-26E, LX-260TE: two 1.5V AA batteries;
LX-360, LX-361T: two 1.5V AAA batteries;
PRO LX-261E, BW-CX10: 3.7V Lithium battery | Different
(Note 01) |
| Low battery indication | Yes | Yes | Same |
| Waterproof | No | No, IP22 | Different
(Note 02) |
| Dimension | 145 x 60 x 50mm | LX-26E:
102.5mm×42.3mm×155mm
LX-260TE:
102mm×38mm×160.8mm
PRO LX-261E:
102.5mm×38mm×158mm (without base)
156mm×66.6mm×177mm (with base)
LX-360, LX-361T:
162.5mm×59mm×29.8mm (without base)
172.5mm×60.35mm×60.35 mm (with base)
BW-CX10:
60.7 x 37.4 x 96.3 mm | Different
(Note 03) |
| Items | Predicate Device
(K131243), Jumper | Subject Device | Remarks |
| Weight | 180g | LX-26E: 177g (with battery)
130.2g (without battery)
LX-260TE: 179.4g (with
batteries)
132.6g (without battery)
PRO LX-261E: 193.2g
(without base)
406.6g (with base)
LX-360, LX-361T: 135g with
base and battery
112g with base no battery
97g without battery or base
BX-CX10: 177g (with
battery) | Different
(Note 03) |
| Operating
condition | 10℃ -40℃, in vitro
cytotoxicity | |
| irritation and
skin
sensitization | ISO 10993-10: 2010, Biological evaluation of
medical devices - Part 10: Tests for irritation and
skin sensitization | Pass |
| Battery Safety | IEC 62133 Edition 2.0 2012-12, Secondary cells
and batteries containing alkaline or other non-acid
electrolytes - Safety requirements for portable
sealed secondary cells, and for batteries made
from them, for use in portable applications | Pass |
| Battery
transportation
Safety | UN 38.3, the Fifth Revised Edition Amendment 2
of the Recommendations on the Transport of
Dangerous Goods, Manual of Test and Criteria
(ST/SG/AC.10/11/Rev.5/Amend.2/Section 38.3) | Pass |
| QoS testing | 47 CFR PART 15 Subpart B, Radio Frequency
Devices Subpart B – Unintentional Radiators;
47 CFR PART 15 Subpart C, Radio Frequency
Devices Subpart C – Intentional Radiators | Pass |
| Wireless
coexistence | 47 CFR PART 15 Subpart B, Radio Frequency
Devices Subpart B – Unintentional Radiators;
47 CFR PART 15 Subpart C, Radio Frequency
Devices Subpart C – Intentional Radiators;
EN 300328 V1.8.1, 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;
Harmonized EN covering the essential
requirements of article 3.2 of the R&TTE Directive | Pass |
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5.8 Brief discussion of clinical tests
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| Nexmed Technology Co., Ltd. | |
|---|---|
Version:A/0
The clinical performance test protocol and data analysis followed the requirements of ASTM E1965-98 (2009). The test report showed the clinical performance of subject device complied with the requirements of ASTM E1965-98 (2009). It is acceptable to measure patient's temperature.
5.9 Conclusions
Based on the above information, we conclude the subject device, Infrared Thermometer, is substantially equivalent to the predicate device.