(114 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-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.
The provided document describes the FDA 510(k) clearance for an Infrared Thermometer (Models RN-60A, RN-60B). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a novel device meets specific performance criteria against a predefined standard of care.
Therefore, the information required to fully describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML medical device (as implied by the detailed questions about sample size for training/test sets, expert adjudication, MRMC studies, etc.) is largely not applicable (N/A) to this specific device (an infrared thermometer) or the type of 510(k) submission described.
However, I can extract the relevant performance data for the infrared thermometer and discuss the "acceptance criteria" and "study" as presented in the document for this traditional medical device.
Key points from the document regarding "acceptance criteria" and "study":
- Acceptance Criteria: For this device, the primary "acceptance criteria" are compliance with established performance standards for infrared thermometers, specifically ASTM E1965-98 (Reapproved 2016), and demonstrating substantial equivalence to a predicate device (Shenzhen Calibeur Industries Co., Ltd. Infrared Thermometer, Model DT-8836T, DT-8836P, K191251).
- Study Proving Acceptance: A "clinical accuracy validation test" was conducted per ASTM E1965-98.
Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for a non-AI device:
1. A table of acceptance criteria and the reported device performance
For a traditional device like a thermometer, "acceptance criteria" are typically defined by recognized standards and "reported device performance" demonstrates adherence to these.
| Criterion Type | Acceptance Criteria (from ASTM E1965-98 as referenced) | Reported Device Performance (as stated in comparison) |
|---|---|---|
| Accuracy | Specified by ASTM E1965-98 | Forehead mode: USD ±0.2°C (0.4°F) within (96.8°F ~ 102.2°F), USD ±0.3°C (0.5°F) when <36.0°C (96.8°F) and >39.0°C (102.2°F). (The document states the device "complied with the requirement of ASTM E1965-98 (2016)" which implies this accuracy was met.) |
| Measurement Range | Specified by ASTM E1965-98 | Forehead mode: 32.0°C ~42.9°C (89.6 to 109.2 ° F). (The document notes this is different from the predicate but states "the measurement range of subject devices meet the requirements of ASTME1965-98.") |
| Response Time | Not explicitly stated as an acceptance criterion | 1 second |
| Measurement Distance | Not explicitly stated as an acceptance criterion | 3~5 cm (The document notes this is different from the predicate but states "the performance test result of subject device shows the accuracy meets the requirements within the distance range.") |
| Operational and Storage Environment | Specified by IEC60601-1 and ISO80601-2-56 | Operation: 5.0°C |
| Safety and EMC | Compliance with IEC 60601-1, IEC 60601-1-2 | Non-clinical tests demonstrated compliance with IEC 60601-1:2012, IEC 60601-1-2:2014, and IEC 60601-1-11:2015. |
| Biocompatibility | Compliance with ISO 10993-5, ISO 10993-10 | Tests confirmed compliance with ISO 10993-5:2009 and ISO 10993-10:2010. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: A clinical study included a minimum of 178 subjects. These subjects were divided into three age groups:
- Group A1: 1 month up to 3 months
- Group A2: 3 months up to 1 year
- Group B: greater than 1 to 5 years old
- Group C: Above 5 years old
- Each group had at least 30 subjects.
- Data Provenance: Not explicitly stated (e.g., country of origin). The submission is from a Chinese company (Ningbo Ranor Medical Science & Technology Co., Ltd.) and the correspondent is in Shanghai. The study design is described as a "randomization, simple blind homologous control, pairing design of clinical investigation." It is not specified if it was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. For an infrared thermometer, "ground truth" for body temperature measurement typically involves a highly accurate reference thermometer (e.g., a rectal thermometer for core body temperature) used in a clinical setting, rather than expert interpretation of images or data. The document does not mention the use of experts in this capacity.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. This concept is primarily relevant for studies involving human interpretation (e.g., radiologists reading images). For a thermometer's accuracy study, the "ground truth" is typically a direct physiological measurement, and adjudication methods like 2+1 are not applicable.
5. 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
- N/A. This is a traditional thermometer device, not an AI/ML device. Therefore, no MRMC study involving human readers or AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, in concept. The "clinical accuracy validation test" described for the thermometer is essentially a standalone performance evaluation of the device itself against a reference standard, without human-in-the-loop assistance for measurement interpretation (as the device provides a direct digital readout). There is no "algorithm" in the AI/ML sense, but the device's internal processing to convert infrared signals to temperature is tested.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the clinical accuracy validation test would be established using a highly accurate reference thermometer (e.g., a rectal thermometer or other core body temperature measurement device) as per the requirements of ASTM E1965-98. The document specifically states "Clinical tests were conducted per ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature," which outlines the methodology for ground truth establishment.
8. The sample size for the training set
- N/A. This is a hardware device (infrared thermometer) with no mention of machine learning or deep learning algorithms that would require a "training set" in the context of AI.
9. How the ground truth for the training set was established
- N/A. As no training set for AI was used.
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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.
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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 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
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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)
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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
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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 DeviceK200471 | Predicate DeviceK191251 | Remark |
|---|---|---|---|
| Type ofThermometer | Infrared ThermometerRN-60A,RN-60B | Infrared thermometerDT-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 foruse | The Infrared thermometer isa non-contact infraredthermometer intended fortheintermittentmeasurement of humanbody temperature from | The Infraredthermometer is a non-contact infraredthermometer intendedfor the intermittentmeasurement of human | Different1 |
| forehead for people of onemonth 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 |
| Measurement technology | Infrared radiation detectionthat converts a user'sforehead temperature usingthe infrared energy emittedin the area around the user'sforehead to a reference siteequivalent temperature | Infrared radiationdetection that converts auser's foreheadtemperature using theinfrared energy emitted inthe area around theuser's forehead to areference site equivalenttemperature | Same |
| Measurement place | Forehead | Forehead | Same |
| Measurement Range | Forehead mode:$32.0°C ~42.9°C$(89.6 to 109.2 ° F) | Forehead mode:$32.0°C ~42.5°C$(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 $<36.0°C$ (96.8°F)and $>39.0°C$ (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$<35.0°C$ (95.0 °F) and$>42.0°C$ (107.6°F) | Different2 |
| Display resolution | $0.1°C(0.1°F)$ | $0.1°C(0.1°F)$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measurement distance | 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-off while no operation | 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 |
| StorageEnvironment | $-25.0℃ | $-25~+55°$$(-13~+131°F)$RH:15~95% | |
| Dimension | RN-60A:4670182mmRN-60B:4264185mm | 153.862.462.4 mm | -- |
| Weight | RN-60A:82gRN-60B:80g | 96g | -- |
| 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 |
| Patient contactmaterials | ABS | ABS | Same |
| Biocompatibility | ISO 10993-5ISO 10993-10 | ISO 10993-5ISO 10993-10 | 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 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.
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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 different does not raise new performance questions.
Different 3: Measurement distance of the subject devices is 3-5cm, the predicate device's is ≤3cm. But the performance test result of subject device shows the accuracy meets the requirements within the distance range. The different does not raise new performance questions.
Different 4: Both devices have slightly different Operation & Storage Environment, but the subject devices meet the requirements of IEC60601-1 and ISO80601-2-56. The different does not raise new performance questions.
8.0 Non-Clinical Test Conclusion
Non-clinical data:
Non-clinical tests were conducted to verify that the subject devices met all design specifications. 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
●IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General
requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
- ISO 80601-2-56:2017+A1:2018 Medical electrical equipment Particular
requirements for the basic safety and essential performance of clinical thermometers for body temperature measurement.
●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
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-
· ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests
for in vitro cytotoxicity -
ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests
for irritation and skin sensitization
Software verification and validation testing:
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", dated May 11, 2005.
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 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).
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 comformance with acceptable voluntary standards, we believe the Infrared Thermometer RN-60A and RN-60B 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.