(114 days)
Not Found
No
The description details a standard infrared thermometer using a thermopile sensor and basic signal processing to determine temperature. There is no mention of AI, ML, or complex algorithms beyond standard signal amplification and analysis.
No.
The device is clearly described as an "Infrared thermometer intended for the intermittent measurement of human body temperature," which is a diagnostic function, not a therapeutic one. It measures temperature but does not treat any condition.
Yes
The device is intended for the intermittent measurement of human body temperature from the forehead, which is a diagnostic function to assess a person's health status.
No
The device description explicitly states it is a hand-held device powered by batteries and uses a thermopile sensor to receive infrared signals, indicating it is a hardware device with embedded software for processing and display.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- This Device's Function: The Infrared Thermometer described measures human body temperature directly from the forehead. It does not analyze any samples taken from the body. It is a non-invasive measurement of a physiological parameter.
Therefore, based on the provided information, the Infrared Thermometer is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / Indications for 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.
Product codes
FLL
Device Description
The Infrared Thermometer, Models RN-60A and RN-60B are hand-held device powered by 2*AAA batteries and designed to measure human body temperature without contacting patient' forehead.
The Infrared Thermometers RN-60A and RN-60B 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-60A and RN-60B thermometers are size, weight, shape of enclosure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
one month old and above
Intended User / Care Setting
home use and clinical use.
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 minimum of 178 subjects which were divided into three group age ranges- A Infants group (Group A1 - 1 month up to 3 months; Group A2 - 3 months up to 1 year), B Children group (greater than 1 to 5 years old) and C Over 5 years old (Above 5 years old). Each group at least has 30 subjects.
Based on the result, it is demonstrated the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
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 and 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.
June 19, 2020
Ningbo Ranor Medical Science & Technology Co., Ltd. % Mr. Boyle Wang Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K200471
Trade/Device Name: Infrared Thermometer, Model: RN-60A, RN-60B Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: May 18, 2020 Received: May 21, 2020
Dear Mr. 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/cdrh/cfdocs/cfpmr/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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Tina Kiang, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K200471
Device Name
Infrared Thermometer, Model: RN-60A, RN-60B
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)
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
Tab #06 510(k) Summary K200471
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: 86-574-89258788 Fax: 86- 574-88219485 Contact: Emma Hu Date of Preparation: May 28, 2020
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Infrared Thermometer Common name: Infrared Thermometer Classification name: Clinical electronic thermometer Model(s): RN-60A,RN-60B
3.0 Classification
Production code: FLL Regulation number: 21CFR 880.2910 Class II Classification: Panel: General Hospital
4.0 Predicate Device Information
Manufacturer: Shenzhen Calibeur Industries Co., Ltd. Device: Infrared Thermometer, Model DT-8836T, DT-8836P 510(k) number: K191251
4
5.0 Device Description
The Infrared Thermometer, Models RN-60A and RN-60B are hand-held device powered by 2*AAA batteries and designed to measure human body temperature without contacting patient' forehead.
The Infrared Thermometers RN-60A and RN-60B 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-60A and RN-60B 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
K200471 | Predicate Device
K191251 | Remark |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Type of
Thermometer | Infrared Thermometer
RN-60A,RN-60B | Infrared thermometer
DT-8836T,DT-8836P | -- |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | II | II | Same |
| Intended Use&
Indications for
use | The Infrared thermometer is
a non-contact infrared
thermometer intended for
the
intermittent
measurement of human
body temperature from | The Infrared
thermometer is a non-
contact infrared
thermometer intended
for the intermittent
measurement of human | Different
1 |
| | forehead for people of one
month old and above.
The device is reusable for
home use and clinical use. | body temperature from
forehead for people of
all ages. The device is
reusable for home use
and clinical use. | |
| Prescription/over-the-counter use | over-the-counter use | over-the-counter use | Same |
| Measurement technology | Infrared radiation detection
that converts a user's
forehead temperature using
the infrared energy emitted
in the area around the user's
forehead to a reference site
equivalent temperature | Infrared radiation
detection that converts a
user's forehead
temperature using the
infrared energy emitted in
the area around the
user's forehead to a
reference site equivalent
temperature | Same |
| Measurement place | Forehead | Forehead | Same |
| Measurement Range | Forehead mode:
$32.0°C ~42.9°C$
(89.6 to 109.2 ° F) | Forehead mode:
$32.0°C 42.5°C$5 cm |
(89.6 to 108.5 ° F) | |
| Accuracy | Forehead mode:
$±0.2°C (0.4°F)$ within
(96.8°F ~ 102.2°F),
$±0.3°C(0.5°F)$
when $39.0°C$ (102.2°F) | Forehead mode:
$±0.2°C (0.4°F)$ within
$35.0°C ~ 42.0°C$
(95.0°F ~ 107.6°F),
$±0.3°C(0.5°F)$ when
$42.0°C$ (107.6°F) | Different
2 |
| Display resolution | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measurement distance | 3