Infrared thermometer

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. April 3, 2019 Shenzhen Pango Electronic Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China Re: K182597 Trade/Device Name: Infrared thermometer, Model: PG-IRT1601, PG-IRT1602, PG-IRT1603 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 27, 2019 Received: March 6, 2019 Dear Ms. Diana Hong: 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. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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}------------------------------------------------ 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 comprehensive regulatory information about medical devices and radiation-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, Sapana Patel -S for 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) K182597 Device Name Infrared Thermometer, PG-IRT1601, PG-IRT1602 and PG-IRT1603 Indications for Use (Describe) PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal. PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages. 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}------------------------------------------------ # 510(k) Summary This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92. The assigned 510(k) Number: K182597 - 1. Date of Preparation: 03/19/2019 - 2. Sponsor Identification ## Shenzhen Pango Electronic Co ., Ltd No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, 518115, China Establishment Registration Number: 3006792041 Contact Person: Youjian Xie Position: Technical Director Tel: +86-755-33825988-301 Fax: +86-755-33825989 Email: xie you jian@163.com #### 3. Designated Submission Correspondent Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person) # Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net {4}------------------------------------------------ #### 4. Identification of Proposed Device Trade Name: Infrared thermometer Common Name: Clinical electronic thermometer Model(s): PG-IRT1601, PG-IRT1602 and PG-IRT1603 ### Regulatory Information Classification Name: Clinical electronic thermometer Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital ### Indications for Use Statement: PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal. PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages. ### Device Description The proposed device includes 3 models, which are PG-IRT1602 and PG-IRT1603. It includes infrared thermometers and is intended for people of all age. The proposed device, Infrared Ear Thermometers, Model PG-IRT1601, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal. The proposed device, Infrared Skin Thermometers, Model PG-IRT1602, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 3cm~5cm. The proposed device, Infrared Ear/Forehead Thermometer, Model PG-IRT1603, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal or forehead. The distance of the measurement is 3~5cm while measuring the forehead temperature. ### Principle of operation The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human {5}------------------------------------------------ body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display. - Identification of Predicate Devices 5. Predicate Device 1 510(k) Number: K152748; Device Name: Braun Thermoscan® PRO 6000 Ear Thermometer Predicate Device 2 510(k) Number: K163516; Device Name: Braun No Touch + Forehead NTF3000 Thermometer; - Non-Clinical Test Conclusion 6. Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: - > 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 - > IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (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. - > 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. - A ASTM E1965-98 (R 2016), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements. {6}------------------------------------------------ #### 7. Clinical Test Conclusion Controlled human clinical studies were conducted on 3 models of proposed device with predicates in accordance with ASTM E1965-98, clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer. The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device. Total 130 subjects and three age groups, including age 0~1 (50 subjects), age 1~5 (40 subjects) and age above 5 (40 subjects) are included in each clinical study, the amounts of male subjects are the same with that of female subjects, including febrile and afebrile persons. Compared statistical result of clinical bias and clinical repeatability of two comparison groups, the results of proposed device are not being inferior to that of predicate device. The result of proposed device was not inferior to that of predicate device, and the proposed device complies with ASTM E1965-98. #### 8. Substantially Equivalent (SE) Comparison | ITEM | Proposed device | Predicate Device 1 | Predicate Device 2 | Remark | |------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | | | K152748 | K163516 | | | Product Code | FLL | FLL | FLL | Same | | Regulation<br>Number | 21 CFR 880.2910 | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | | Intended Use | PG-IRT1601 Infrared<br>Ear Thermometer is<br>intended to measure<br>human body<br>temperature by<br>measuring ear canal.<br>PG-IRT1602 Infrared<br>Forehead<br>Thermometer is<br>intended to measure<br>human body<br>temperature by<br>measuring forehead.<br>PG-IRT1603 Infrared<br>Ear/Forehead<br>Thermometer is<br>intended to measure<br>human body | The Braun<br>Thermoscan® PRO<br>6000 Ear<br>Thermometer is<br>indicated for the<br>intermittent<br>measurement and<br>monitoring of human<br>body temperature for<br>patients of all ages in<br>a professional use<br>environment. The<br>probe cover is used<br>as a sanitary barrier<br>between the infrared<br>thermometer and the<br>ear canal. | The Braun No Touch<br>Forehead +<br>NTF3000<br>Thermometer is a<br>non-sterile, reusable<br>clinical thermometer<br>intended for the<br>intermittent<br>determination of<br>human body<br>temperature in a<br>touch and no touch<br>mode on the center<br>of the forehead as<br>the measurement site<br>on people of all<br>ages. | Discussion<br>1 | | | temperature<br>by<br>measuring ear canal<br>or forehead.<br>The device can be<br>used on people of all<br>ages. | | | | | Measurement<br>Site | Forehead and/or<br>eardrum | Eardrum | Forehead | Same | | Principle of<br>Operation | Non-contacting,<br>Infrared Temperature<br>Measurement | Non-contacting,<br>Infrared Temperature<br>Measurement | Contacting or<br>non-contacting,<br>Infrared Temperature<br>Measurement | Same | | Ear Mode | | | | | | Range | 34.0°C-43.0°C | 32.0°C-42.9°C | / | Discussion<br>2 | | Accuracy | ±0.2 °C at 35.0 °C<br>-42.0°C<br>Others ±0.3 °C | ±0.2°C at<br>35.5°C-42.0°C<br>Others ±0.3°C | / | Same | | Forehead Mode | | | | | | Measurement<br>distance | 3~5cm | / | Unknown | Discussion<br>2 | | Range | 34. 0°C-43.0°C | / | 34.4°C-42.2°C | Discussion<br>2 | | Accuracy | ±0.2 °C at 35.0 °C<br>-42.0°C<br>Others ±0.3°C | / | ±0.2°C at<br>35.0°C-42.0°C<br>±0.3°C at<br>31.0°C-35.0°C<br>Above 42.0°C<br>±0.3°C | Same | | Display type | LCD | LCD | LCD | Same | | Activation | Scan button | Scan button | Scan button | Same | | Power<br>requirements | Two pieces of 1.5V<br>AAA (number seven)<br>batteries | Two AA Alkaline<br>Batteries or Custom<br>Nickel Metal<br>Hydride Battery Pack | Two AA batteries | Discussion<br>3 | | Safety | Complied with IEC<br>60601-1 | Complied with IEC<br>60601-1 | Complied with IEC<br>60601-1 | Same | | EMC | Complied with IEC<br>60601-1-2 | Complied with IEC<br>60601-1-2 | Complied with IEC<br>60601-1-2 | Same | | Performance | Complied with ISO<br>80601-2-56 | Complied with ISO<br>80601-2-56 | Complied with ISO<br>80601-2-56 | Same | | | Complied with<br>ASTM E 1965 -98<br>(2003) | Complied with<br>ASTM E 1965 -98<br>(2003) | Complied with<br>ASTM E 1965 -98<br>(2003) | Same | | Patient-contact<br>Materials | Shell Material: ABS<br>lens: PMMA<br>Button: High density<br>polyethylene<br>(HDPE)<br>Color additives | Common Materials-<br>including an impact<br>resistant casing.<br>Biocompatible<br>metals and resins. | Patient contacting<br>materials include<br>ABS (device<br>housing / handle and<br>power button) and<br>TPR (temperature<br>button and nose /<br>forehead touch<br>bumper). | Discussion<br>4 | | Biocompatibility | Complied with ISO<br>10993-5 | Complied with ISO<br>10993-5 | Complied with ISO<br>10993-5 | Same | | | Complied with ISO<br>10993-10 | Complied with ISO<br>10993-10 | Complied with ISO<br>10993-10 | Same | Table 1 Comparison of Technology Characteristics {7}------------------------------------------------ {8}------------------------------------------------ ### Discussion 1 The proposed device includes three models which respectively measure temperature by ear, by forehead and by ear or forehead. Predicate device 1 supports ear mode, and predicate device 2 supports forehead mode. The indications of proposed device can be covered by predicate 1 and 2. And the proposed device is also intended for people of all age, which is the same with predicates. The difference does not raise different safety and effectiveness issues. ### Discussion 2 The measurement ranges and distance of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of performance identified in the standards. The difference does not raise different performance questions. #### Discussion 3 The batteries of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of electrical safety identified in the standards. The difference does not raise different safety and effectiveness issues. ### Discussion 4 The patient-contact materials of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of biocompatibility identified in the standards. The difference does not raise different safety and effectiveness issues. {9}------------------------------------------------ #### Substantially Equivalent (SE) Conclusion 9. Based on the performance testing, comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.