Infrared Thermometer (Model: LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T, BW-CX10)

{0}------------------------------------------------ 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Version:A/0 # VOL 05 510(k) Summary K160816 ## 5.1 Administrative Information | Date of Summary prepared | Aug., 31, 2016 | |--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer information | Nexmed Technology Co., Ltd.<br>2 Floor Of No.1 Building, Jia An Technological<br>Industrial Park, 67 District, Bao An, Shenzhen,<br>Guangdong, China 518101<br>Contact person: Ellen Xu<br>Phone: +86-755-2948 1701<br>Fax: +86-755-8525 8461<br>E-mail: ellen@nxm-tech.com | | Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: Room 2032, International Mayors<br>Communication Centre, NO. 55 Shizhou middle<br>road , Nanshan District, Shenzhen<br>Contact person: Ms. Elena Lu; Mr. Field Fu<br>E-Mail: elena@cefda.com; cefda13485@163.com | # registration number ## 5.2 Device Information | Type of 510(k)<br>submission: | Traditional | |-------------------------------|-------------------------------------------------------------| | Trade Name: | Infrared Thermometer | | Model: | LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-<br>361T, BW-CX10 | | Classification name: | thermometer, electronic, clinical | | Review Panel: | General Hospital | | Product Code: | FLL | {4}------------------------------------------------ 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. {5}------------------------------------------------ #### 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<br>(K131243), Jumper | Subject Device | Remarks | |------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------| | Indications for<br>use | The non-contact infrared<br>thermometer, model JPD-<br>FR100, can measure<br>body temperature for<br>infants and adults without<br>contact to human body. It<br>can be used by<br>consumers in household<br>environment and doctor<br>in clinic as reference. | Infrared Thermometer is<br>intended for body<br>temperature measurement<br>for infants and adults<br>without contact to human<br>body. It can be used by<br>consumers in household<br>environment and doctor in<br>clinic as reference. | Same | | Measurement<br>method | Infrared radiation<br>detection | Infrared radiation detection | Same | | Measurement<br>mode | Forehead measure mode | Body mode, also is<br>forehead measurement<br>mode | Same | | Measuring range | Forehead temperature<br>mode: 32.2℃ - 43.3℃<br>(90.0℉ - 109.9℉) | Body mode: 30°to 43℃<br>(86.0℉ to 109.4℉) | Similar | | Display<br>resolution | 0.1℃ (0.1℉) | 0.1 ℃/0.1 ℉ | Same | | C/F switchable | Yes | Yes | Same | | Measuring<br>accuracy | Forehead temperature<br>mode:<br>$ \pm $ 0.2℃ (0.4℉) | +/- 0.2℃ in Body mode | Same | | Display | LCD display | LCD display | Same | | Measurement<br>distance | 1-6cm | 2-5cm | Similar | | Items | Predicate Device<br>(K131243), Jumper | Subject Device | Remarks | | Memory | 20 sets | LX-26E, LX-260TE, PRO LX-261E, LX-360, LX-361T: 32 sets;<br>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;<br>LX-360, LX-361T: two 1.5V AAA batteries;<br>PRO LX-261E, BW-CX10: 3.7V Lithium battery | Different<br>(Note 01) | | Low battery indication | Yes | Yes | Same | | Waterproof | No | No, IP22 | Different<br>(Note 02) | | Dimension | 145 x 60 x 50mm | LX-26E:<br>102.5mm×42.3mm×155mm<br>LX-260TE:<br>102mm×38mm×160.8mm<br>PRO LX-261E:<br>102.5mm×38mm×158mm (without base)<br>156mm×66.6mm×177mm (with base)<br>LX-360, LX-361T:<br>162.5mm×59mm×29.8mm (without base)<br>172.5mm×60.35mm×60.35 mm (with base)<br>BW-CX10:<br>60.7 x 37.4 x 96.3 mm | Different<br>(Note 03) | | Items | Predicate Device<br>(K131243), Jumper | Subject Device | Remarks | | Weight | 180g | LX-26E: 177g (with battery)<br>130.2g (without battery)<br>LX-260TE: 179.4g (with<br>batteries)<br>132.6g (without battery)<br>PRO LX-261E: 193.2g<br>(without base)<br>406.6g (with base)<br>LX-360, LX-361T: 135g with<br>base and battery<br>112g with base no battery<br>97g without battery or base<br>BX-CX10: 177g (with<br>battery) | Different<br>(Note 03) | | Operating<br>condition | 10℃ -40℃, <95%RH,<br>no-condensing | 15℃ ~ 40℃<br>10%RH ~ 85%RH | Similar | | Bluetooth | No | LX-26E, LX-260TE, PRO<br>LX-261E, LX-360, LX-361T:<br>No<br>BW-CX10: Yes | Different<br>(Note 04) | | Patient contact<br>materials | ABS and TPE | ABS with colorants (yellow,<br>green, blue, dark blue,<br>aqua, purple and white) and<br>PC | Different<br>(Note 05) | | Cleaning | The probe tip and lens<br>are cleaned and<br>disinfected by 70°<br>alcohol. | The probe tip and protective<br>glass over the lens are<br>cleaned and disinfected by<br>70°alcohol. | Similar | | Biocompatibility | Comply with ISO 10993-<br>5:2009, ISO 10993-<br>10:2010 | Comply with ISO 10993-5:<br>2009, ISO 10993-10: 2010 | Similar | | Electric Safety<br>and EMC | IEC 60601-1:<br>1988+A1:1991+A2:1995,<br>IEC 60601-1-2: 2007, IEC<br>60601-1-11:2010 | IEC 60601-1:<br>2005+CORR.1<br>(2006)+CORR.2 (2007), IEC<br>60601-1-2: 2007, IEC<br>60601-1-11: 2010, ISO<br>80601-2-56: 2009. | Similar | | ltems | Predicate Device<br>(K131243), Jumper | Subject Device | Remarks | | Performance | ASTM E1965-98 (2009) | ASTM E1965-98 (2009),<br>ISO 80601-2-56: 2009. | Similar | {6}------------------------------------------------ Nexmed Technology Co., Ltd. Subject product: Infrared Thermometer Version:A/0 {7}------------------------------------------------ Nexmed Technology Co., Ltd. Subject product: Infrared Thermometer Version:A/0 {8}------------------------------------------------ Nexmed Technology Co., Ltd. Subject product: Infrared Thermometer Version:A/0 #### Note 01: PRO LX-261E and BW-CX10 have passed over charge tests, IEC 62133 tests and UN38.3 tests. #### Note 02: The subject devices have passed IEC 60601-1 and IEC 60601-1-11 safety test. #### Note 03: The subject devices have passed IEC 60601-1, IEC 60601-1-11 safety test, IEC 60601-1-2 EMC test and ISO 80601-2-56 performance test. #### Note 04: BW-CX10 has passed 47 CFR PART 15 Subpart B, 47 CFR PART 15 Subpart C and EN 300328 Tests. ### Note 05: The patient contact materials had passed the Biocompatibility Test. The subject device and the predicate device have the same intended use and similar technological characteristics, they both use infrared radiation detection method to detect human body forehead temperature. Their design is compact, small and light-weight. They are same in measuring accuracy, and similar in measuring range. For the subject device, the model BW-CX10 contains Bluetooth function. However, information contained in this submission demonstrates that any differences in their characteristics do not raise any new questions. Thus, the subject device is substantially equivalent to the predicate devices. ### 5.7 Brief discussion of the nonclinical tests The nonclinical tests of the Infrared Thermometer are listed as below table: {9}------------------------------------------------ Version:A/0 | Tests | Test Standards | Results | |-----------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Electric Safety | IEC 60601-1:2012 Medical electrical equipment -<br>Part 1: General requirements for basic safety and<br>essential performance | Pass | | EMC | IEC 60601-1-2:2014, Medical electrical<br>equipment - Part 1-2: General requirements for<br>basic safety and essential performance -<br>Collateral Standard: Electromagnetic compatibility<br>- Requirements and tests;<br>47 CFR PART 15 Subpart C, Radio Frequency<br>Devices Subpart C - Intentional Radiators | Pass | | Electric Safety<br>for medical<br>device used in<br>the home<br>healthcare<br>environment | IEC 60601-1-11 Edition 1.0 2010-04, Medical<br>electrical equipment - Part 1-11: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Requirements<br>for medical electrical equipment and medical<br>electrical systems used in the home healthcare<br>environment | Pass | | Basic Safety<br>and essential<br>performance<br>of clinical<br>thermometers<br>for body<br>temperature<br>measurement | ISO 80601-2-56 First Edition 2009-10-01, Medical<br>electrical equipment - Part 2-56: Particular<br>requirements for basic safety and essential<br>performance of clinical thermometers for body<br>temperature measurement | Pass | | Clinical<br>accuracy | ASTM E1965-98 (Reapproved 2009): Standard<br>Specification for Infrared Thermometers for<br>Intermittent Determination of<br>Patient Temperature | Pass | | Biological<br>Evaluation | ISO 10993-1:2009, Biological evaluation of<br>medical devices - Part 1: Evaluation and testing<br>within a risk management process | Pass | | In vitro | ISO 10993-5:2009, Biological evaluation of<br>medical devices - Part 5: Tests for in vitro<br>cytotoxicity | Pass | | Tests | Test Standards | Results | | Cytotoxicity | medical devices - Part 5: Tests for <i>in vitro</i><br>cytotoxicity | | | irritation and<br>skin<br>sensitization | ISO 10993-10: 2010, Biological evaluation of<br>medical devices - Part 10: Tests for irritation and<br>skin sensitization | Pass | | Battery Safety | IEC 62133 Edition 2.0 2012-12, Secondary cells<br>and batteries containing alkaline or other non-acid<br>electrolytes - Safety requirements for portable<br>sealed secondary cells, and for batteries made<br>from them, for use in portable applications | Pass | | Battery<br>transportation<br>Safety | UN 38.3, the Fifth Revised Edition Amendment 2<br>of the Recommendations on the Transport of<br>Dangerous Goods, Manual of Test and Criteria<br>(ST/SG/AC.10/11/Rev.5/Amend.2/Section 38.3) | Pass | | QoS testing | 47 CFR PART 15 Subpart B, Radio Frequency<br>Devices Subpart B – Unintentional Radiators;<br>47 CFR PART 15 Subpart C, Radio Frequency<br>Devices Subpart C – Intentional Radiators | Pass | | Wireless<br>coexistence | 47 CFR PART 15 Subpart B, Radio Frequency<br>Devices Subpart B – Unintentional Radiators;<br>47 CFR PART 15 Subpart C, Radio Frequency<br>Devices Subpart C – Intentional Radiators;<br>EN 300328 V1.8.1, Electromagnetic compatibility<br>and Radio spectrum Matters(ERM); Wideband<br>transmission systems; Data transmission<br>equipment operating in the 2.4 GHz ISM band<br>and using wide band modulation techniques;<br>Harmonized EN covering the essential<br>requirements of article 3.2 of the R&TTE Directive | Pass | {10}------------------------------------------------ Version:A/0 # 5.8 Brief discussion of clinical tests {11}------------------------------------------------ | 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.