(172 days)
Not Found
No
The device description details standard infrared thermometry technology and a simple voice function based on a microcontroller and integrated circuit. There is no mention of AI, ML, or any complex algorithms that would suggest their use.
No
The device is described as an infrared thermometer intended for "intermittent measurement of human body temperature," which indicates a diagnostic rather than a therapeutic function.
No
This device is intended for the measurement of human body temperature. While temperature can be an indicator of illness, the device itself does not interpret the measurement to provide a diagnosis of a disease or condition.
No
The device description clearly outlines physical hardware components such as a thermopile sensor, thermistor, and a microcontroller unit, indicating it is a hardware device with integrated software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device function: The Infrared Thermometer DET series measures human body temperature by detecting infrared radiation emitted from the auditory canal or forehead. It does not analyze any biological specimens taken from the body.
- Intended Use: The intended use is for "intermittent measurement of human body temperature," which is a direct measurement of a physiological parameter, not an analysis of a sample.
Therefore, based on the provided information, the Infrared Thermometer DET series falls under the category of a medical device but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
auditory canal or forehead
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
home use only.
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 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).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
0
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.
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/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
2
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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3
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)
4
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.
5
| able
1
| 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 | -- | |
| Regulation | ||||
| number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same | |
| Product Code | FLL | FLL | Same | |
| Intended Use/ | ||||
| Indications for use | 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 Non-contact Clinical | |||
| Thermometer, Model THBOF | ||||
| is an infrared thermometer | ||||
| intended for the intermittent | ||||
| measurement of human body | ||||
| temperature in people of all | ||||
| ages. | Similar | |||
| Measure Method | Infrared radiation detection | Infrared radiation detection | Same | |
| Measurement | ||||
| Range | 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 | |
| Measurement | ||||
| Place | Forehead | Forehead | Same | |
| Measurement | ||||
| Distance | DET-205, | |||
| DET-206 | ||||
| DET-305, | ||||
| DET-306 | Forehead | |||
| Contact | ||||
| Non-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 for | |||
| forehead and object | ||||
| measurements | 60 Sets | Different | ||
| (Note4) | ||||
| Auto power off | Yes | Yes | Same |
6
| 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 Contact | |||
| material | Enclosure;ABS | ||
| Probe:ABS & Glass | Enclosure;ABS | ||
| Probe:ABS & Glass | Same | ||
| Biocompatibility | |||
| testing | Cytotoxicity, Skin irritation, | ||
| Skin sensitization | Cytotoxicity, Skin irritation, | ||
| Skin sensitization | Same | ||
| Conformance | |||
| standard | ISO 80601-2-56(Performance) | ||
| IEC 60601-1(Safety) | |||
| IEC 60601-1-2(EMC) | |||
| ASTM E1965-98 | |||
| ISO 10993-5 and ISO 10993-10 | |||
| (Biocompatibility) | ISO 80601-2-56(Performance) | ||
| IEC 60601-1(Safety) | |||
| IEC 60601-1-2(EMC) | |||
| ASTM E1965-98 | |||
| ISO 10993-5 and ISO | |||
| 10993-10 (Biocompatibility) | Same |
Table 2
| SE Comparison | Subject Device | Pridicate Device | Note |
|---|---|---|---|
| Model DET-215 | Radiant Innovation Inc, | ||
| Model:TH52Z | |||
| 510k number | Present application | K162083 | -- |
| Regulation | |||
| number | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| Intended Use/ | |||
| Indications for use | 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 RII Multi-function Infrared | ||
| Thermometer,Model TH52Z is | |||
| intended for the intermittent | |||
| measurement of human body | |||
| temperatures.The device is | |||
| intended for the use at home | |||
| by people of all ages including | |||
| neonates and it can be | |||
| selected Ear mode or | |||
| Forehead mode. | Similar | ||
| Measure Method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement | |||
| Range | 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 | |||
| at 15°C | ±0.4°F (0.2°C) within | ||
| 95 | |||
| ±0.5°F (0.3°C) for other | |||
| range | Similar | ||
| (Note1) |
7
| | operating temperature range
±0.3℃ (0.5°F) for other
measuring and operating
temperature range | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Display | 0.1°C (0.1°F) | 0.1°C (0.1°F) | Same |
| Measurement Place | Forehead
Ear | Forehead
Ear | Same |
| Response Time | Ear mode/Object mode:
Approx. 1s
Forehead: 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 for
ear,forehead and object
measurements | 9 Sets | Different
(Note4) |
| Auto power-off
while 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 |
| Conformance
standard | ISO 80601-2-56(Performance)
IEC 60601-1(Safety)
IEC 60601-1-2(EMC)
ASTM E1965-98
ISO 10993-5 and ISO 10993-10
(Biocompatibility) | ISO 80601-2-56(Performance)
IEC 60601-1(Safety)
IEC 60601-1-2(EMC)
ASTM E1965-98
ISO 10993-5 and ISO
10993-10 (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.
8
| Note1 | Measurement Range&
Accuracy changes | The measurement range and accuracy of subject
devices meet the requirements of ISO80601-2-56
and ASTM E1965-98. |
|-------|-------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note2 | Power Source | Meet the requirement of IEC 60601-1 |
| Note3 | Measurement Distance
changes | Meet the requirement of ISO 80601-2-56 clinical test |
| Note4 | Response Time changes
from 1s to 3s | Our devices have longer response time to measure
the temperature,and all tests passed,so such
different do not raise new performance questions. |
| | Memory change from 60
sets/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
9
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.