(133 days)
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.
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.
The provided document is a 510(k) premarket notification for an Infrared Thermometer (Models RN-50A, RN-50B). It describes the device, its intended use, a comparison to a predicate device, and the non-clinical and clinical testing performed to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for the infrared thermometer are primarily based on its accuracy and adherence to specific standards.
| Acceptance Criterion | Reported Device Performance (as stated or implied) |
|---|---|
| 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" (Page 5) "the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." (Page 9) |
| Measurement Range (Forehead mode) | "$32.0°C ~42.9°C (89.6 to 109.2 °F)$" (Page 5) "the measurement range of subject devices meet the requirements of ASTME1965-98." (Page 6) |
| Measurement Distance | "3~5 cm from the forehead." (Page 5) "the clinical trial 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" (Page 7) |
| Compliance with ISO 80601-2-56 | "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." (Page 9) "the device meets the clinical accuracy requirements of the standards ISO 80601-2-56 and ASTM E1965-98 within the distance range" (Page 7) |
| Compliance with ASTM E1965-98 | "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature." (Page 9) "the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)." (Page 9) |
| Biocompatibility | Tested and compliant with ISO 10993-1, -5, -10 regarding Cytotoxicity, Irritation, and Sensitization. (Page 8-9) |
| Electrical Safety (IEC 60601-1) | Complies with IEC 60601-1: 2012 (Page 7) |
| Electromagnetic Compatibility (IEC 60601-1-2) | Complies with IEC 60601-1-2:2014 (Page 7) |
| Home Healthcare Environment (IEC 60601-1-11) | Complies with IEC 60601-1-11:2015 (Page 7) |
| Software Validation (Moderate Level of Concern) | Software validation conducted in accordance with FDA guidance. (Page 9) |
Study Details:
The document describes a "Clinical Accuracy Validation Test" as the primary study to prove the device meets acceptance criteria for accuracy.
-
Sample Size Used for the Test Set and Data Provenance:
- Sample Size: "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." (Page 9)
- Data Provenance: Not explicitly stated, but given the manufacturer's address (Ningbo, China) and the correspondent's address (Shanghai, China), it can be inferred the study was likely conducted in China. The document does not specify if it was retrospective or prospective, but clinical trials are typically prospective.
-
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This information is not provided in the document. For a thermometer, the "ground truth" would typically come from a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature, or a calibrated black-body source for non-contact measurements), not human experts.
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Adjudication Method for the Test Set:
- This is not applicable as the "test set" here refers to patient measurements compared to a reference standard, not images requiring expert interpretation and adjudication.
-
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:
- This is not applicable to this device. An infrared thermometer measures temperature; it does not involve human readers interpreting images or AI assistance.
-
If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This is not applicable in the traditional sense of an "algorithm" in AI. The device itself is the "standalone" entity that measures temperature. Its performance is evaluated against a clinical standard.
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The Type of Ground Truth Used:
- The ground truth for the clinical accuracy validation test was derived from a reference standard as defined by ASTM E1965-98 (Reapproved 2016). This standard outlines procedures for determining the accuracy of infrared thermometers against a "core body temperature" reference, often involving concurrent measurements with highly accurate methods like rectal thermometers in a controlled clinical setting. While not explicitly stated as "rectal" or "oral" in this document, adherence to the ASTM standard implies the use of a validated, highly accurate measurement method as the ground truth.
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The Sample Size for the Training Set:
- This device is a physical thermometer, not a machine learning model that requires a distinct "training set." The concept of a "training set" is not applicable here. The 161 subjects are for the validation of the device's accuracy.
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How the Ground Truth for the Training Set Was Established:
- As there is no "training set" in the context of an AI/ML model for this device, this question is not applicable. The device's design and calibration would have been based on physics principles and engineering, not data-driven training.
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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 (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
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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 DeviceK200578 | Predicate DeviceK191251 | Remark |
|---|---|---|---|
| Type ofThermometer | Infrared ThermometerRN-50A,RN-50B | Infrared thermometerDT-8836T, DT-8836P | -- |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | Same | ||
| Intended Use&Indications foruse | The Infrared thermometer is anon-contact infraredthermometer intended for theintermittent measurement ofhuman body temperaturefrom forehead for people of | The Infraredthermometer is anoncontact infraredthermometer intendedfor the intermittentmeasurement of human | Different1 |
| one month old and above.The device is reusable forhome use and clinical use. | body temperature fromforehead for people ofall ages. The device isreusable for home useand clinical use. | ||
| Prescription/over-the-counter use | over-the-counter use | over-the-counter use | Same |
| Measurementtechnology | Infrared radiation detectionthat converts a user'sforehead temperatureusing the infrared energyemitted in the area aroundthe user's forehead to areference site equivalenttemperature | Infrared radiationdetection that converts auser's foreheadtemperature using theinfrared energy emittedin the area around theuser's forehead to areference site equivalenttemperature | Same |
| Measurementplace | Forehead | Forehead | Same |
| MeasurementRange | Forehead mode:$32.0°C ~42.9°C$(89.6 to 109.2 ° | Forehead mode:$32.0°C ~42.5°C$(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),$±0.3°C(0.5°F)$ otherrange | Different2 |
| Displayresolution | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measurementdistance | 3~5 cm | ≤3cm | Different3 |
| Response time | 1s | 1s | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Memory | 60 sets | 60 sets | Same |
| Buzzer | Yes | Yes | Same |
| Auto power-offwhile nooperation | Yes | Yes | Same |
| Power supply | 2*AAA battery | 2 * 1.5V AAA | Same |
| Display screen | LCD | LCD | Same |
| OperationEnvironment | $5.0°C | $10~40°C (50°F | Different4 |
| 15%≤RH≤90%70.0kPa-106.0kPa | |||
| StorageEnvironment | -25.0℃ | -25 | |
| Dimension | RN-50A: 4595149mmRN-50B: 4087137mm | 153.862.462.4 mm | -- |
| Weight | RN-50A: 131gRN-50B: 120g | 96g | -- |
| Materials | User contacting materials areABS (Device Plastic Case,Button & Battery Cover) | ABS | Same |
| Conformancestandard | 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(Homeuse)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.
§ 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.