Infrared Thermometer Models: DT-8806S, DT-8807S

{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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. April 16, 2021 Shenzhen Everbest Machinery Industry Co., LTD % Kevin Wang Consultant Chonconn Medical Device Consulting Co., Ltd. Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District Shenzhen, 518067 Cn Re: K203170 Trade/Device Name: Infrared Thermometer, Models: DT-8806S, DT-8807S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 15, 2021 Received: March 15, 2021 # Dear Kevin Wang: 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 aware 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. 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 {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. 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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203170 Device Name Infrared Thermometer, Models: DT-8806S, DT-8807S ### Indications for Use (Describe) The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use. Type of Use (Select one or both, as applicable) | Registration Under Part 4 of STP 92-1 Select Sites | <input type="checkbox"/> | |----------------------------------------------------|-------------------------------------| | Coverage Under Part 4 of STP 92-1 Select Sites | <input checked="" type="checkbox"/> | __ 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}------------------------------------------------ ### Prepared in accordance with the requirements of 21 CFR Part 807.92 ## Prepared Date: March 11, 2021 #### 1. Submission sponsor Name: SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. Address: 19th Building, 5th Region, Baiwangxin Industrial Park, Songbai Rd., Baimang, Xili, Nanshan, Shenzhen, Guangdong, China 518108 Contact person: Deng Aiguo Title: Quality Manager E-mail: dengaiguo(acem-meter.com.cn #### 2. Submission correspondent Name: Chonconn Medical Device Consulting Co., Ltd. Address: Room 508, Block C, No. 1029 Nanhai Avenue, Nanshan District, Shenzhen, Guangdong, P. R. China 518067 Contact person: Kevin Wang E-mail: kevin(@chonconn.com Tel: +86-755 33941160 | 3. Subject Device Information | | |-------------------------------|--------------------------------------------------------| | Trade/Device Name | Infrared Thermometer | | Model | DT-8806S, DT-8807S | | Common Name | Infrared Thermometer | | Regulatory Class | Class II | | Classification | 21CFR 880.2910 / Clinical electronic thermometer / FLL | | Submission type | Traditional 510(K) | #### 2 Subiect Device Information #### Predicate Device 4. SHENZHEN EVERBEST MACHINERY INDUSTRY CO., LTD. Infrared thermometer Models: DT-8806, DT-8806H, Regulation 21 CFR 880.2910, Product Code FLL, under K 101736. #### 5. Device Description The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the central forehead for clinical or home use. The thermometers are powered by AAA 1.5 V×2 alkaline batteries. The results can be displayed on LCD. A thermopile sensor is employed to detect or monitor the infrared thermal energy emitted from the surface of the skin of the forehead, which is converted into temperature measurement with the unit of ℃ or ºF {4}------------------------------------------------ The Infrared thermometer included DT-8806S, DT-8807S. These two models are identical on hardware and software except the physical dimensions and appearance. #### Intended use & Indication for use 6. The Infrared thermometer is intended for the intermittent measurement of human body temperature from forehead for people of all ages. The device is reusable for home use and clinical use. | | Subject device<br>Infrared thermometer: DT-<br>8806S, DT-8807S | Predicate device K101736<br>Infrared thermometer: DT-<br>8806, DT-8806H | Note | |-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------| | Features | | | | | Regulation number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | | Product code | FLL | FLL | Same | | Intended Use &<br>Indications for use | The Infrared thermometer is<br>intended for the intermittent<br>measurement of human body<br>temperature from forehead for<br>people of all ages. The device is<br>reusable for home use and clinical<br>use. | Infrared Thermometer Model:<br>DT-8806H/DT-8806 Non-<br>contact body infrared<br>thermometer is designed for body<br>surface and forehead temperature<br>measurement for infants and<br>adults without contact to human<br>body. | Different (1) | | Measurement<br>Method | Infrared radiation detection,<br>adjusted mode | Infrared radiation detection,<br>adjusted mode | Same | | Measurement<br>Range | $32.0°C ~42.5°C$<br>(89.6 to 108.5 ° F) | $32.0°C ~42.5°C$<br>(89.6 to 108.5 ° F) | Same | | Accuracy | $±0.2°C (0.4°F) within$<br>$36.0°C ~ 39.0°C, (96.8°F ~$<br>$102.2°F),$<br>$±0.3°C(0.6°F) within$<br>$32°C ~35.9°C (89.6°F ~96.6°F)$<br>and $39.1°C~42.5°C (102.3°F$<br>$~108.5°F)$ | $±0.2°C (0.4°F) within$<br>$36.0°C ~ 39.0°C, (96.8°F ~$<br>$102.2°F),$<br>$±0.3°C(0.6°F) within$<br>$32°C ~35.9°C (89.6°F ~96.6°F)$<br>and $39.1°C~42.5°C (102.3°F$<br>$~108.5°F)$ | Same | | Display | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Same | | Measurement<br>distance | 8806S: 1 cm - 10 cm<br>8807S: 1 cm - 4 cm | 5 cm - 15 cm | Different (2) | | Measurement<br>place | Forehead<br>Surface | Forehead<br>Surface | Same | | Sensor type | Thermopile | Thermopile | Same | | Scale Selection | °C /°F | °C /°F | Same | | Memory | 32 sets | 32 sets | Same | | Features | Subject device<br>Infrared thermometer: DT-<br>8806S, DT-8807S | Predicate device K101736<br>Infrared thermometer: DT-<br>8806, DT-8806H | Note | | Buzzer | Yes | Yes | Same | | Auto<br>power-off<br>while no operation | Yes | Yes | Same | | Power supply | 2 * 1.5V AAA | 2 * 1.5V AAA | Same | | Display screen | LCD | LCD | Same | | Contact materials | ABS | ABS | Same | | Operation | 10~40°C (50°F ~104 °F) | 10~40°C (50°F ~104 °F) | Same | | Environment | RH ≤85% | RH ≤85% | Same | | Storage condition | 0 to 50°C (32 to 122°F)<br>RH ≤85% | 0 to 50°C (32 to 122°F)<br>RH ≤85% | Same | | Dimension | 128 * 74 * 36 mm | 149 * 77 * 43mm | --- | | Weight | 104.5 g | 172 g | --- | | Conformance<br>standard | ISO80601-2-56(performance),<br>IEC60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM E1965-98 | ISO80601-2-56(performance),<br>IEC60601-1(Safety),<br>IEC60601-1-2(EMC)<br>ASTM E1965-98 | Same | | Biocompatibility | Under the condition of this study<br>the device is non-cytotoxic, non-<br>sensitizing and non-irritating. | Under the condition of this study<br>the device is non-cytotoxic, non-<br>sensitizing and non-irritating. | | | Expected battery<br>life | 40000 times measure | 40000 times measure | | | Measuring time | 1 second | 1 second | | | Clinical accuracy | Meet the requirements of ISO<br>80601-2-56:2017, ASTM 1965-<br>98(2016) | Meet the requirements of ISO<br>80601-2-56:2017, ASTM 1965-<br>98(2016) | Same | #### 7. Comparison to the Predicate Device {5}------------------------------------------------ Justification of difference: Different (1): The description of the intended use is different. The population of the subject device is wider than the predicate device. The performance testing can demonstrate that the subject device can meet the requirement on this population. So, the different does not raise different questions of safety and effectiveness. The subject device is only used to measure the body temperature from forehead. The clinical study report can demonstrate this measuring site. So, the different does not raise different questions of safety and effectiveness. Different (2): The measurement distance is different. The performance testing can demonstrate that the subject device can meet the requirement on this measurement distance. So, the different does not raise different questions of safety and effectiveness. {6}------------------------------------------------ #### 8. Performance Data The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The biocompatibility evaluation for the Infrared thermometer was conducted in accordance with the FDA Guidance for Industry and Food and Drug Administration Staff: Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". The battery of testing included the following tests: - . Cytotoxicity - . Sensitization - . Irritation # Non-clinical data The Infrared thermometer has been tested according to the following standards: - IEC 60601-1: Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and essential performance - IEC 60601-1-2: 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: Medical electrical equipment – Particular requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement. - IEC 60601-1-11: 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 The test was selected to show substantial equivalence between the subject device and the predicate. ## Clinical data Clinical testing is conducted per ASTM E 1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature. This clinical study is a randomization, simple blind homologous control, pairing design of clinical investigation, consists of a minimum of 150 subjects, of which 1/3 are children and the rest 1/3 are adults (NOTE: Infants---newborn to one year; Children--- greater than one to five years; Adults--- greater than five years old.). The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ASTM E 1965-98 (Reapproved 2016). #### 9. Conclusion Based on the perf ormance testing, comparison and analysis provided it was concluded that the subject device, Infrared Thermometer, Models: DT-8806S, DT-8807S is substantially equivalent to the Infrared Thermometer, Models: DT-8806, DT-8806H cleared under K101736