(133 days)
Not Found
No
The device description and performance studies focus on standard infrared thermometry principles and clinical validation against a predicate device, with no mention of AI or ML algorithms for temperature measurement or analysis.
No.
The device is an infrared thermometer for measuring body temperature, which is a diagnostic tool, not a therapeutic one. It does not provide treatment or alleviate symptoms.
No
The device is an infrared thermometer for measuring body temperature, which is a measurement device, not a diagnostic device that identifies diseases or conditions.
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, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health. This testing is done outside of the body (in vitro).
- This Device's Function: The Infrared Thermometer measures human body temperature directly from the forehead. It does not analyze any specimens 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 (comma separated list FDA assigned to the subject device)
FLL
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.
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy: Forehead mode: ±0.2°C (0.4°F) within 36.0°C ~ 39.0°C (96.8°F ~ 102.2°F), ±0.3°C(0.5°F) other range
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration. The Department of Health & Human Services logo is on the left and features a stylized human figure. The FDA logo is on the right and features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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.
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 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: 86-574-89258788 Fax: 86- 574-88219485 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: +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-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
4
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
K200578 | Predicate Device
K191251 | Remark |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------|
| Type of
Thermometer | Infrared Thermometer
RN-50A,RN-50B | Infrared thermometer
DT-8836T, DT-8836P | -- |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | | | 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 forehead for people of | The Infrared
thermometer is a
noncontact infrared
thermometer intended
for the intermittent
measurement of human | Different
1 |
| | 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$40.0°C(41°F
(89.6 to 109.2 ° | Forehead mode:
$32.0°C 42.5°C$5 cm | ≤3cm | Different
(89.6 to 108.5 ° F) | |
| Accuracy | Forehead mode:
$±0.2°C (0.4°F)$ within
$36.0°C ~ 39.0°C$
(96.8°F ~ 102.2°F),
$±0.3°C(0.5°F)$ other range | Forehead mode:
$±0.2°C (0.4°F)$ within
$35.0°C ~ 42.0°C$
(95.0°F ~ 107.6°F),
$±0.3°C(0.5°F)$ other
range | 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
3 |
| Response time | 1s | 1s | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Memory | 60 sets | 60 sets | Same |
| Buzzer | Yes | Yes | Same |
| Auto power-off
while no
operation | Yes | Yes | Same |
| Power supply | 2*AAA battery | 2 * 1.5V AAA | Same |
| Display screen | LCD | LCD | Same |
| Operation
Environment | $5.0°C104°F)$ | $1040°C (50°F 104 °F)$95% | Different
RH 15
4 |
| | 15%≤RH≤90%
70.0kPa-106.0kPa | | |
| Storage
Environment | -25.0℃~70.0°F
(-13°F~158°F)
RH≤95%
50.0kPa-106.0kPa | -25 +55°+131°F)
(-13
RH:15~95% | |
| Dimension | RN-50A: 4595149mm
RN-50B: 4087137mm | 153.862.462.4 mm | -- |
| Weight | RN-50A: 131g
RN-50B: 120g | 96g | -- |
| Materials | User contacting materials are
ABS (Device Plastic Case,
Button & Battery Cover) | ABS | Same |
| Conformance
standard | ISO80601-2-56
(performance),
IEC60601-1(Safety),
IEC60601-1-2(EMC)
IEC 60601-1-11(Home use)
ASTM E1965-98 | ISO80601-2-56
(performance),
IEC60601-1(Safety),
IEC60601-1-2(EMC)
IEC 60601-1-11(Home
use)
ASTM E1965-98 | Same |
| Biocompatibility | ISO 10993-5 | ISO 10993-5 | Same |
7.0 Comparison to the Predicate Device
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6
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
7
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
8
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.