(172 days)
Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead. The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead. The Infrared thermometer included DET-205,DET-305,DET-305,DET-306 and DET-215. DET-205 and DET-206 units are contact Infrared forehead thermometer,DET-305 and DET-306 units are non-contact Infrared forehead thermometer(measurement distance is 2~3cm), DET-215 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode. In addition,all models have voice function that used to broadcast the measurement temperature results after complete the measurement. It's working principle is that Microcontroller Unit sends voice commands to the voice integrated circuit and then broadcast the measurement temperature results that display on the LCD.The voice function is use English language and actives after each measurement completed.
The provided document is a 510(k) premarket notification for a medical device (Infrared Thermometers). It details the substantial equivalence of the subject device to legally marketed predicate devices, focusing on technical specifications and conformance to standards. However, it does not include the specific details typically found in a study proving a device meets acceptance criteria related to AI/ML performance, especially those involving human expert review, MRMC studies, or clear ground truth establishment for a test set. This document describes the validation of a traditional hardware thermometer, not an AI-powered device.
Therefore, many of the requested items (e.g., sample size for test set provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance for AI, training set details) are not applicable to this document as it concerns a non-AI/ML device.
Here's an attempt to extract the relevant information based on the document, noting where the requested information is absent or not applicable:
Device Type: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer
Models: DET-205, DET-206, DET-305, DET-306, DET-215
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for these thermometers are based on conformance to recognized standards, primarily ASTM E1965-98 for performance and ISO 80601-2-56 for general safety and essential performance of clinical thermometers. The key performance metric is accuracy of temperature measurement.
| Acceptance Criteria (from ASTM E1965-98 / ISO 80601-2-56 compliance) | Reported Device Performance (Accuracy) |
|---|---|
| Forehead mode: ±0.2℃ (0.4℉) during 35.5℃~42.0℃ (95.9℉~107.6℉) at 15℃~35℃ (59.0℉~95.0℉) operating temperature range | Meets the criteria: ±0.2℃ (0.4℉) during 35.5℃~42.0℃ (95.9℉~107.6℉) at 15℃~35℃ (59.0℉~95.0℉) operating temperature range |
| Forehead mode: ±0.3℃ (0.5℉) for other measuring and operating temperature range | Meets the criteria: ±0.3℃ (0.5℉) for other measuring and operating temperature range |
| Ear / Forehead mode (for DET-215): ±0.2°C (0.4°F) during 35.5°C | Meets the criteria: ±0.2°C (0.4°F) during 35.5°C |
| Ear / Forehead mode (for DET-215): ±0.3℃ (0.5°F) for other measuring and operating temperature range | Meets the criteria: ±0.3℃ (0.5°F) for other measuring and operating temperature range |
Additional Conformance Standards:
- IEC 60601-1:2012 (Safety)
- IEC 60601-1-2:2014 (EMC)
- ISO 10993-5:2009 (Biocompatibility - In Vitro cytotoxicity)
- ISO 10993-10:2010 (Biocompatibility - irritation and skin sensitization)
- IEC 60601-1-11:2015 (Home healthcare environment)
The document states that a clinical performance test protocol and data analysis were conducted as required by ASTM E1965-98 (2016), and "The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016)."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Clinical Tests: 165 subjects.
- Data Provenance: Not explicitly stated regarding country of origin, but the submitting company is based in China. The study is described as "clinical tests were conducted," implying a prospective study for the device's performance evaluation.
- Subject Groups: Infants (newborn to one year), Children (greater than one to five years), and Adults (greater than five years old).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not Applicable. For a traditional thermometer, "ground truth" for temperature measurement is typically established using highly accurate reference thermometers or through controlled calibration procedures traceable to national standards, not through human expert review or consensus as would be the case for AI image interpretation. The clinical study evaluates the device's reading against an established reference method.
4. Adjudication Method for the Test Set
Not Applicable. As "ground truth" is not established by human experts in this context, an adjudication method is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
No. This is a hardware thermometer, not an AI/ML device. Therefore, no MRMC comparative effectiveness study was conducted to evaluate human reader improvement with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not Applicable. This is a hardware device; there is no AI algorithm to evaluate in a standalone manner. The device's performance is intrinsically its "standalone" performance.
7. The Type of Ground Truth Used
The ground truth for temperature measurement would typically be established by:
- Comparison with a traceable reference thermometer (e.g., in a laboratory setting for accuracy testing against a known temperature).
- In the context of the "clinical performance test," it refers to the device's ability to accurately measure human body temperature as determined by standardized clinical protocols (e.g., comparison to rectal temperature as a gold standard in some contexts, or high-accuracy reference thermometers within a controlled clinical environment). The document explicitly states the test "complied with the requirement of ASTM E1965-98 (2016)," which outlines the methodology for clinical accuracy testing of infrared thermometers against a reference thermometer.
8. The Sample Size for the Training Set
Not Applicable. This is a hardware device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. No training set was used.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 29, 2018
JOYTECH Healthcare Co., Ltd. Yunhua Ren General Manager No. 365 Wuzhou Road, Yuhang Economic Development Zone Hangzhou City Zhejiang, 311100 China
Re: K181239
Trade/Device Name: Infrared Forehead Thermometer, Infrared Ear/Forehead Thermometer; Models: DET-205, DET-206, DET-305, DET-306, DET-215 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 29, 2018 Received: September 28, 2018
Dear Yunhua Ren:
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/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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Geeta K. Pamidimukkala -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K181239
Device Name
Infrared Thermometers DET-205,DET-206,DET-305,DET-306,DET-215
Indications for Use (Describe)
Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
| 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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510(k) Summary
The assigned 510(k) number is: K181239
1. Date Prepared: 2018.10.25
2. Submitter's Identification:
Name: JOYTECH Healthcare Co.,Ltd. Add.: No,365,Wuzhou Road,Yuhang Economic Development Zone, Hangzhou City,311100 Zhejiang,China Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: renyh@sejoy.com
Name of the Device: 3.
Device Name:Infrared Thermometer
Trade Name:Infrared Forehead Thermometer,Infrared Ear/Forehead Thermometer Including models:DET-205,DET-206,DET-305,DET-306,DET-215 Classification name:Clinical Electronic Thermometer
4. Classification Information:
Product Code: FLL Device Class: II Panel: 80 Regulation number:880.2910
Predicate Device Information: 5.
Non-contact Clinical Thermometer,Model THB0F(Radiant Innovation Inc,K121428)
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RII Multi-function Infrared Thermometer, Model TH52Z. (Radiant Innovation Inc, K162083)
Intended use / Indication for Use: 6.
Infrared Thermometer DET series are intended for the intermittent measurement of human body temperature by people of all ages. The devices are reusable for home use only.
7. Device Description:
The Infrared thermometers are hand-held, battery powered devices designed to measure human body temperature from the auditory canal or forehead. Its operation is based on measuring the natural thermal radiation from the tympanic membrane or forehead.
The thermometers use a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a thermopile collect, the infrared energy emitted from the forehead.
The Infrared thermometer included DET-205,DET-305,DET-305,DET-306 and DET-215. DET-205 and DET-206 units are contact Infrared forehead thermometer,DET-305 and DET-306 units are non-contact Infrared forehead thermometer(measurement distance is 2~3cm), DET-215 unit is multifunction infrared thermometer and it can be selected Ear mode or Forehead mode.
In addition,all models have voice function that used to broadcast the measurement temperature results after complete the measurement. It's working principle is that Microcontroller Unit sends voice commands to the voice integrated circuit and then broadcast the measurement temperature results that display on the LCD.The voice function is use English language and actives after each measurement completed.
8.Summary of technological characteristics of device compared to the predicate devices, see the table1 and table2
A comparison of key similarities and differences between the subject devices (Model DET-205,DET-206,DET-305,DET-306,DET-215) and the predicate devices (K121428 and K162083) is provided below.
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| able1-1 | 1 |
|---|---|
| --------------------- | --- |
| SE Comparison | Subject Device | Predicate device(PD) | Note | |
|---|---|---|---|---|
| 510k number | Model DET-205,DET-206,DET-305,DET-306 | Radiant THB0F | ||
| 510k number | Present application | K121428 | -- | |
| Regulationnumber | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | |
| Product Code | FLL | FLL | Same | |
| Intended Use/Indications for use | Infrared Thermometer DETseries are intended for theintermittent measurement ofhuman body temperature bypeople of all ages. The devicesare reusable for home use only. | The Non-contact ClinicalThermometer, Model THBOFis an infrared thermometerintended for the intermittentmeasurement of human bodytemperature in people of allages. | Similar | |
| Measure Method | Infrared radiation detection | Infrared radiation detection | Same | |
| MeasurementRange | Forehead mode:34.0℃~43.0℃(93.2℉~109.4℉) | Forehead mode:34 | Similar(Note1) | |
| Accuracy | Forehead mode:$ \pm 0.2℃ (0.4℉) during 35.5℃~42.0℃ (95.9℉~107.6℉)at 15℃~35℃ (59.0℉~95.0℉)operating temperature range\pm 0.3℃ (0.5℉) for othermeasuring and operatingtemperature range $ | Forehead mode:$ \pm 0.2℃ (0.4℉) within36 | Similar(Note1) | |
| Display | 0.1℃(0.1℉) | 0.1℃(0.1℉) | Same | |
| MeasurementPlace | Forehead | Forehead | Same | |
| MeasurementDistance | DET-205,DET-206DET-305,DET-306 | ForeheadContactNon-contact,2~3cm | 2-3cm | Different(Note3)Same |
| Response Time | Approximately 3 seconds | 1s | Similar(Note4) | |
| Sensor Type | Thermopile | Thermopile | Same | |
| Scale Selection | ℃/℉ | ℃/℉ | Same | |
| Display screen | LCD | LCD | Same | |
| Memory | Each 10 sets memories forforehead and objectmeasurements | 60 Sets | Different(Note4) | |
| Auto power off | Yes | Yes | Same |
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| while no operation | |||
|---|---|---|---|
| Buzzer | Yes | Yes | Same |
| Voice Function | Yes | Unknown | Different(Note4) |
| Power Source | DC3V(2×AAA battery) | DC3V(2×AAA battery) | Same |
| Patient Contactmaterial | Enclosure;ABSProbe:ABS & Glass | Enclosure;ABSProbe:ABS & Glass | Same |
| Biocompatibilitytesting | Cytotoxicity, Skin irritation,Skin sensitization | Cytotoxicity, Skin irritation,Skin sensitization | Same |
| Conformancestandard | ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)ASTM E1965-98ISO 10993-5 and ISO 10993-10(Biocompatibility) | ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)ASTM E1965-98ISO 10993-5 and ISO10993-10 (Biocompatibility) | Same |
Table 2
| SE Comparison | Subject Device | Pridicate Device | Note |
|---|---|---|---|
| Model DET-215 | Radiant Innovation Inc,Model:TH52Z | ||
| 510k number | Present application | K162083 | -- |
| Regulationnumber | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| Intended Use/Indications for use | Infrared Thermometer DETseries are intended for theintermittent measurement ofhuman body temperature bypeople of all ages. The devicesare reusable for home use only. | The RII Multi-function InfraredThermometer,Model TH52Z isintended for the intermittentmeasurement of human bodytemperatures.The device isintended for the use at homeby people of all ages includingneonates and it can beselected Ear mode orForehead mode. | Similar |
| Measure Method | Infrared radiation detection | Infrared radiation detection | Same |
| MeasurementRange | Ear/Forehead mode: 34.0°C | Ear / Forehead mode:34.0°C | Similar(Note1) |
| Accuracy | Ear/Forehead mode:±0.2°C (0.4°F) during 35.5°C | ±0.4°F (0.2°C) within95 | Similar(Note1) |
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| operating temperature range±0.3℃ (0.5°F) for othermeasuring and operatingtemperature range | |||
|---|---|---|---|
| Display | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Measurement Place | ForeheadEar | ForeheadEar | Same |
| Response Time | Ear mode/Object mode:Approx. 1sForehead: Approx. 3s | 1s | Similar(Note4) |
| Sensor Type | Thermopile | Thermopile | Same |
| Scale Selection | °C/°F | °C/°F | Same |
| Display screen | LCD | LCD | Same |
| Memory | Each 10 sets memories forear,forehead and objectmeasurements | 9 Sets | Different(Note4) |
| Auto power-offwhile no operation | Yes | Yes | Same |
| Buzzer | Yes | Yes | Same |
| Voice Function | Yes | Unknown | Different(Note4) |
| Power Source | DC3V(2 × AAA battery) | CR2032*1 | Different(Note2) |
| Biocompatibility | Cytotoxicity, Skin irritation,Skin sensitization | Cytotoxicity, Skin irritation,Skin sensitization | Same |
| Conformancestandard | ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)ASTM E1965-98ISO 10993-5 and ISO 10993-10(Biocompatibility) | ISO 80601-2-56(Performance)IEC 60601-1(Safety)IEC 60601-1-2(EMC)ASTM E1965-98ISO 10993-5 and ISO10993-10 (Biocompatibility) | Same |
Analysis
From the comparison table1 and table2, the subject devices and predicate devices have the similar Intended use & Indications for Use, same measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard. There are slightly differences between the devices and predicate devices as follows,through the verification and validation process, it has been shown that the differences do not raise new questions of safety and effectiveness.
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| Note1 | Measurement Range&Accuracy changes | The measurement range and accuracy of subjectdevices meet the requirements of ISO80601-2-56and ASTM E1965-98. |
|---|---|---|
| Note2 | Power Source | Meet the requirement of IEC 60601-1 |
| Note3 | Measurement Distancechanges | Meet the requirement of ISO 80601-2-56 clinical test |
| Note4 | Response Time changesfrom 1s to 3s | Our devices have longer response time to measurethe temperature,and all tests passed,so suchdifferent do not raise new performance questions. |
| Memory change from 60sets/9 sets to 10 sets | Software Validation Passed. | |
| Note4 | Add voice function | Software Validation Passed. |
9. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
Infrared Thermometers conforms to applicable standards that include:
- ◆ ASTM E 1965-98 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- ◆ 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
- . ISO 10993-5:2009, Biological evaluation of medical devices -- Part 5: Tests for In Vitro cytotoxicity,
-
- ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
- � IEC 60601-1-11:2015 medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for
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medical electrical equipment and medical electrical systems used in the home healthcare environment
- ◆ ISO 80601-2-56: 2009 Medical electrical equipment - part 2-56: particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
-
- The software verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
12. Discussion of Clinical Tests Performed:
Clinical tests were conducted on the DET-205,DET-206,DET-305,DET-306 and DET-215. The clinical tests evaluated 165 of subjects. Each model was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old.The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
13. Conclusions:
Based on the information provided in this submission, the submit Infrared Thermometers, models: DET-205,DET-206,DET-305,DET-306 and DET-215 are substantially equivalent to the predicate devices.
§ 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.