Infrared Thermometer Model Number RN-50A,RN-50B

K200578 · Ningbo Ranor Medical Science & Technology Co., Ltd. · FLL · Jul 16, 2020 · General Hospital

Device Facts

• Record ID: K200578
• Device Name: Infrared Thermometer Model Number RN-50A,RN-50B
• Applicant: Ningbo Ranor Medical Science & Technology Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 16, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

Device Story

Hand-held, battery-powered (2xAA) non-contact infrared thermometer; models RN-50A and RN-50B. Device uses CMOS-compatible thermopile sensor to detect infrared energy radiated from patient forehead (3-5 cm distance). Sensor signal amplified and analyzed to calculate body temperature; results displayed on LCD. Used in home or clinical settings by patients or clinicians. Provides rapid (1s) temperature readings to assist in clinical assessment of fever or health status. Includes 60-set memory, buzzer, and auto-power-off features.

Clinical Evidence

Clinical study conducted per ASTM E1965-98 with 161 subjects across three age groups: infants (1-3 months, 3 months-1 year), children (1-5 years), and adults/children (>5 years). Each group included at least 35 subjects. Results demonstrated compliance with ASTM E1965-98 clinical accuracy requirements.

Technological Characteristics

Thermopile sensor; infrared radiation detection; 2xAA battery power; LCD display; ABS plastic enclosure. Conforms to ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and ASTM E1965-98. Biocompatibility per ISO 10993-5 and ISO 10993-10.

Indications for Use

Indicated for intermittent forehead temperature measurement in patients one month of age and older. Suitable for home and clinical 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

• Infrared Thermometer, Model DT-8836T, DT-8836P (K191251)

Submission Summary (Full Text)

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July 16, 2020

Ningbo Ranor Medical Science & Technology Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738,Shangcheng Rd., Pudong Shanghai 200120 China

Re: K200578

Trade/Device Name: Infrared Thermometer Model Number RN-50A.RN-50B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 10, 2020 Received: July 15, 2020

Dear Boyle 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/cdrl/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.

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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) 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 (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 ([e-mail]) or phone [phone] 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 Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K200578

Device Name Infrared Thermometer,RN-50A, RN-50B

Indications for Use (Describe)

The Infrared thermometer is a non-contact infrared thermometer intent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

| 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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# Tab #06 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR 807.92.

#### 1.0 submitter's Information

Name: Ningbo Ranor Medical Science & Technology Co., Ltd. Address: No. 127 Fenghui Road, Wangchun Industrial Park, Haishu District, Ningbo, China Tel: [phone] Fax: [phone] Contact: Emma Hu Date of Preparation: Jul.10,2020

### Designated Submission Correspondent

Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: [phone] Email: [e-mail]

### 2.0 Device Information

Trade name: Infrared Thermometer Common name: Infrared Thermometer Classification name: Clinical electronic thermometer Model(s): RN-50A,RN-50B

#### 3.0 Classification

Production code: FLL Regulation number: 21CFR 880.2910 Classification: Class II Panel: General Hospital

### 4.0 Predicate Device Information

Manufacturer: Shenzhen Calibeur Industries Co., Ltd. Infrared Thermometer, Model DT-8836T, DT-8836P Device: 510(k) number: K191251

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#### 5.0 Device Description

The Infrared Thermometer, Models RN-50A and RN-50B are hand-held device powered by 2*AA batteries and designed to measure human body temperature without contacting patient' forehead.

The Infrared Thermometers RN-50A and RN-50B measure the temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero will radiate a certain amount of infrared energy. According to the infrared energy and wavelength, the surface temperature of the object can be determined. The temperature of human forehead is relatively constant, so the temperature of human forehead can be measured according to this principle. The thermometer adopts a new CMOS compatible thermopile sensor with good sensitivity. The pressure difference generated by the sensor after receiving the infrared signal is amplified and analyzed then display on the LCD screen in digital form. The measurement distance of the subject device is 3~5 cm from the forehead.

The only differences among the RN-50A and RN-50B thermometers are size, weight, shape of enclosure.

#### 6.0 Indication for Use Statement

The Infrared thermometer is a non-contact infrared thermometer intended for the intermittent measurement of human body temperature from forehead for people of one month old and above. The device is reusable for home use and clinical use.

| Item | Subject Device<br>K200578 | Predicate Device<br>K191251 | Remark |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Type of<br>Thermometer | Infrared Thermometer<br>RN-50A,RN-50B | Infrared thermometer<br>DT-8836T, DT-8836P | -- |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | | | Same |
| Intended Use&<br>Indications for<br>use | The Infrared thermometer is a<br>non-contact infrared<br>thermometer intended for the<br>intermittent measurement of<br>human body temperature<br>from forehead for people of | The Infrared<br>thermometer is a<br>noncontact infrared<br>thermometer intended<br>for the intermittent<br>measurement of human | Different<br>1 |
| | one month old and above.<br>The device is reusable for<br>home use and clinical use. | body temperature from<br>forehead for people of<br>all ages. The device is<br>reusable for home use<br>and clinical use. | |
| Prescription/over-<br>the-counter use | over-the-counter use | over-the-counter use | Same |
| Measurement<br>technology | Infrared radiation detection<br>that converts a user's<br>forehead temperature<br>using the infrared energy<br>emitted in the area around<br>the user's forehead to a<br>reference site equivalent<br>temperature | Infrared radiation<br>detection that converts a<br>user's forehead<br>temperature using the<br>infrared energy emitted<br>in the area around the<br>user's forehead to a<br>reference site equivalent<br>temperature | Same |
| Measurement<br>place | Forehead | Forehead | Same |
| Measurement<br>Range | Forehead mode:<br>$32.0°C ~42.9°C$<br>(89.6 to 109.2 ° | Forehead mode:<br>$32.0°C ~42.5°C$<br>(89.6 to 108.5 ° F) | |
| Accuracy | Forehead mode:<br>$±0.2°C (0.4°F)$ within<br>$36.0°C ~ 39.0°C$<br>(96.8°F ~ 102.2°F),<br>$±0.3°C(0.5°F)$ other range | Forehead mode:<br>$±0.2°C (0.4°F)$ within<br>$35.0°C ~ 42.0°C$<br>(95.0°F ~ 107.6°F),<br>$±0.3°C(0.5°F)$ other<br>range | Different<br>2 |
| Display<br>resolution | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measurement<br>distance | 3~5 cm | ≤3cm | Different<br>3 |
| Response time | 1s | 1s | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Memory | 60 sets | 60 sets | Same |
| Buzzer | Yes | Yes | Same |
| Auto power-off<br>while no<br>operation | Yes | Yes | Same |
| Power supply | 2*AAA battery | 2 * 1.5V AAA | Same |
| Display screen | LCD | LCD | Same |
| Operation<br>Environment | $5.0°C~40.0°C(41°F~104°F)$ | $10~40°C (50°F ~104 °F)$<br>RH 15~95% | Different<br>4 |
| | 15%≤RH≤90%<br>70.0kPa-106.0kPa | | |
| Storage<br>Environment | -25.0℃~70.0°F<br><br>(-13°F~158°F)<br><br>RH≤95%<br>50.0kPa-106.0kPa | -25 ~+55°<br>(-13~+131°F)<br>RH:15~95% | |
| Dimension | RN-50A: 45*95*149mm<br>RN-50B: 40*87*137mm | 153.8*62.4*62.4 mm | -- |
| Weight | RN-50A: 131g<br>RN-50B: 120g | 96g | -- |
| Materials | User contacting materials are<br>ABS (Device Plastic Case,<br>Button & Battery Cover) | ABS | Same |
| Conformance<br>standard | ISO80601-2-56<br>(performance),<br>IEC60601-1(Safety),<br>IEC60601-1-2(EMC)<br>IEC 60601-1-11(Home use)<br>ASTM E1965-98 | ISO80601-2-56<br>(performance),<br>IEC60601-1(Safety),<br>IEC60601-1-2(EMC)<br>IEC 60601-1-11(Home<br>use)<br>ASTM E1965-98 | Same |
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | Same |

### 7.0 Comparison to the Predicate Device

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Analysis:

From the comparison table, the subject devices and predicate device have the same Intended use & Indications for Use, Measurement place, Display resolution, Display screen, Auto power-off while no operation and Conformance standard. There are slightly differences between the devices and predicate device as follows:

Different 1:The restriction in use for people of one month old and above, that is the subset patient population of the predicate device, thus no new safety and effectiveness concerns raised due to the difference.

Different 2: Both devices have different measurement range, but they have the same accuracy and the measurement range of subject devices meet the requirements of ASTME1965-98. The difference does not raise new performance questions.

Different 3: Measurement distance of the subject devices is 3-5cm, the predicate device's will be ≤3cm. Although the "measurement distance" of subject device is a little different from the predicate devices. The clinical trial

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report of the subject device demonstrates the device meets the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98 within the distance range, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.

Different 4: Both devices have slightly different Operation &Storage Environment, but the subject devices meet the requirements of IEC60601-1 and 80601-2-56.

In conclusion, these differences do not raise any new safety or performance questions.

#### 8.0 Non-Clinical Test Conclusion

#### Non-Clinical Performance Testing:

Non clinical tests were conducted to verify that the subject devices met all design specifications as were Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

- . IEC 60601-1: 2012 Medical Electrical Equipment - Part 1: General
Requirements for Basic Safety and essential performance

60601-1-2:2014 Medical electrical equipment - Part 1-2: OIEC . General

requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests

- ISO 80601-2-56: 2017+A1:2018 Medical electrical equipment Particular
requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.

●IEC ●IEC ●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

#### Biocompatibility Testing:

The biocompatibility evaluation for the RN-50A and RN-50B Infrared Thermometer were conducted in accordance with International Standards ISO 10993-1:2018, Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process, ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity, and ISO

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10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and sensitization

The testing conducted included the following:

- · Cytotoxicity
- · Irritation
- · Sensitization

### Software Information:

Software validation was conducted in accordance with a moderate level of concern designation in accordance with the FDA November 2005 document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

# 9.0 Clinical Accuracy Validation Test Conclusion

Clinical tests were conducted per ASTM E1965-98(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 161 subjects which were divided into three group age

ranges- A Infant group (Group A- (A1) 1 month up to 3 months; (A2)- 3 months up to 1 year), B Child group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 35 subjects.

Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).

#### 10.0 Conclusion

Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. And based on the performance testing and compliance with acceptable voluntary standards, we believe the Infrared Thermometer RN-50A and RN-50B are substantially equivalent to its predicate device in K191251.