K Number
K232473
Device Name
Infrared Thermometer: Model YJ600
Date Cleared
2024-02-09

(177 days)

Product Code
Regulation Number
880.2910
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.
Device Description
Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.
More Information

Not Found

No
The summary describes a standard infrared thermometer and does not mention any AI or ML components or capabilities. The performance studies focus on clinical repeatability and accuracy against established standards, not on the performance of an AI/ML algorithm.

No.

A therapeutic device is used to treat or cure a disease or condition. This device is an infrared thermometer, which is used for the intermittent measurement of body temperature, indicating a diagnostic function rather than a therapeutic one.

No
The device is an infrared thermometer, which measures body temperature. While temperature can be an indicator of health, the device itself does not provide a diagnosis of a disease or condition; it only provides a measurement. Its intended use is for intermittent measurement of body temperature, not for diagnosing.

No

The device description explicitly states it is composed of hardware components including an infrared probe, main circuit board, LCD display, and housing.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The Infrared Thermometer measures body temperature from the forehead. This is a direct measurement of a physiological parameter from the body's surface, not a test performed on a sample taken from the body.
  • Intended Use: The intended use is for "intermittent measurement of body temperature from the forehead." This aligns with a general medical device for monitoring a vital sign, not an IVD for analyzing a biological sample.

Therefore, the Infrared Thermometer described is a medical device, but it does not fall under the category of an In Vitro Diagnostic.

N/A

Intended Use / Indications for Use

Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Infrared radiation detection

Anatomical Site

Forehead

Indicated Patient Age Range

all ages

Intended User / Care Setting

consumers in the household environment and by health care providers.

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

This study included 200 subjects (the age range include 0 up to 3 months to one year, older than one year to five years, older than five years, detail groups as below)

Age groupAge RangeNumberGender distribution
GenderNumberPercentage
A0 up to 3 months50Female2244%
Male2856%
B3 months to one year50Female2346%
Male2754%
Colder than one year to five years50Female2856%
Male2244%
Dolder than five years50Female2856%
Male2244%

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

The non-clinical testing for Infrared Thermometer: Model YJ600 was performed to demonstrate verification testing in conformance with the acceptance criteria of test methods and recognized consensus standards.

YJ600 was tested to ISO 80601-2-56:2017/Amd 1:2018 Medical electrical equipment --Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement — Amendment 1 and ASTM E1965-98(Reapproved 2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature.

This study included 200 subjects (the age range include 0 up to 3 months to one year, older than one year to five years, older than five years, detail groups as below)

According to the results, Infrared thermometer: Model YJ600 clinical repeatability of each age group are in the range of plus or minus 0.3℃, meets the clinical repeatability requirement plus or minus 0.3℃ of ISO 80601-2-56:2017+A1:2018 and ASTM E1965-98(Reapproved 2016) standards.

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.

K200471

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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

February 9, 2024

Zhuhai Yueja Medical Device Technology Co.,Ltd. Feng Yan Department manager Room 201, Building 2, No.2 Liushi Road Tangjiawan Town, High-tech Zone Zhuhai, Guangdong 519000 China

Re: K232473

Trade/Device Name: Infrared Thermometer: Model YJ600 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 11, 2024 Received: January 11, 2024

Dear Feng Yan:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

1

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (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.

Porsche Bennett

Porsche Bennett For David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn,

2

General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

3

Indications for Use

510(k) Number (if known) K232473

Device Name Infrared Thermometer: Model YJ600

Indications for Use (Describe)

Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

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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K232473- 510(k) Summary

  • Device Submitter: Zhuhai Yueja Medical Device Technology Co.,Ltd. Room 201, Building 2, No.2 Liushi Road, Tangjiawan Town, High-tech Zone, Zhuhai, 519000, China
  • Contact Person: Feng Yan Department Manager Phone: +86-18826906029 E-mail: fengy@myzr.com.cn Date Prepared February 9, 2024

l Subject Device

Trade Name of Device:Infrared Thermometer:
Model YJ600
Regulation Number:21 CFR 880.2910
Product Code:FLL
Regulation Name:Clinical Electronic Thermometer
Common nameElectronic Thermometer
Regulatory ClassII
Review PanelGeneral Hospital

II Predicate Device

510k NumberK200471
Trade Name of Device:Infrared
Thermometer, Model:
RN-60A, RN-60B
Regulation Number:21CFR 880.2910
Regulation Name:Clinical electronic thermometer
Regulatory ClassII
Product Code:FLL

III Device Descriptions

Infrared Thermometer is mainly composed of infrared probe components, main circuit board components, LCD display components and housing components. The Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. Infants and children cannot operate the thermometer; it is recommended that adults take the measurement. The Infrared Thermometer can be used by consumers in the household environment and by healthcare providers. The operator

5

should be an adult with relevant experience. The operator can replace the battery, transmit data, and measure temperature.

IV Indications for use

Infrared Thermometer is intended for the intermittent measurement of body temperature from the forehead on people of all ages. It can be used by consumers in the household environment and by health care providers.

V Technological Characteristics Comparison

VI-1: Comparison of Subject and Predicate Devices

| Device
Characteristic | Subject Device | Predicate Device
(K200471) | Discussion |
|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Type of
Thermometer | Infrared Thermometer:
Model YJ600 | Infrared
Thermometer,
Model:
RN-60A, RN-60B | - |
| Product Code | FLL | FLL | Same |
| Regulation No. | 21 CFR 880.2910 | 21 CFR 880.2910 | Same |
| Class | II | II | Same |
| Indications for Use | Infrared Thermometer is
intended for the intermittent
measurement of body
temperature from
forehead on people of all
ages. It can be used by
Consumers in
household environment and
by health care providers. | The Infrared
thermometer is a
non-contact infrared
thermometer
intended for
intermittent
the measurement of
all human body
temperature from
the forehead for
people of one month
old and above. The
device is reusable for
home use and
clinical use. | Different 1 |
| Patient population | All ages | One month old
and above | Different 2 |
| Operation Principle | According to the
characteristics of natural
objects, all objects with
temperatures higher | The Infrared
Thermometers
RN-60A and RN-60B
measure the | Different 3 |
| | | | |
| | zero (-273.15 °C ) are constantly emitting infrared capabilities to surrounding space. Its radiation characteristics, radiation energy and wavelength distribution are closely related to the surface temperature of the object. The human body, like other organisms, radiates infrared energy around itself, and its wavelength is generally 9-14µm, which is in the infrared band of 0.76-100 μ m. Because the light in this wavelength range is not absorbed by air, the infrared radiation from human body has nothing to do with the environmental impact, but only with the energy released by human body. | temperature by using the principle of receiving infrared. An object with a temperature higher than absolute zero and 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 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. | |
| Prescription/over-the-counter use | over-the-counter use | over-the-counter use | Same |
| Measurement technology | Infrared radiation detection that converts a user's forehead temperature using | Infrared radiation detection that converts a user's | Same |
| | the infrared energy emitted
in the area around the user's
forehead to a reference site
equivalent temperature. | forehead
temperature
using
the infrared energy
emitted in the area
around the user's
forehead to a
reference site
equivalent
temperature. | |
| Measurement site | Forehead | Forehead | Same |
| Measurement Range | $22.0 °C42.9 °C$ | Forehead mode:
$32.0°C 42.9°C$
(89.6 to 109.2 ° F) | Different 4 |
| Accuracy | $±0.3°C$ | Forehead mode:
$±0.2°C (0.4°F)$ within
(96.8°F ~
102.2°F), $±0.3°C(0.5°$
F) when $
$39.0°C$ (102.2°F) | Different 5 |
| Display resolution | $0.1°C$ | $0.1°C(0.1°F)$ | Same |
| C/F switchable | Yes | Yes | Same |
| Measurement distance | 1-3 cm | 3
5 cm | Different 6 |
| Measurement time | 2s | 1s | Different 7 |
| Sensor type | high precision infrared
sensor | Thermopile | Different 8 |
| Memory | 32 sets | 60 sets | Different 9 |
| Buzzer | Yes | Yes | Same |
| Auto power-off while no
operation | Yes | Yes | Same |
| Power supply | 2 AAA size batteries | 2*AAA battery | Same |
| Display screen | LCD | LCD | Same |
| Operation Environment | +15°C
+40C RH4mm. | Pass |
| | 5.3 Prompt function | | In the body temperature mode, when the measured value of the thermometer is lower than $22.0°C$ , there should be a prompt sound "Di di" twice and "LO" should be displayed; when the measured value is higher than $42.9°C$ , a prompt sound " Beep" twice and display "HI" | Pass |
| | 5.4
Low | The
battery
of the
voltage | Pass | |
| | voltage | thermometer is lower than 2.5±0.2V. | | |
| | prompt | " icon flashes on
When the " | | |
| | function | | | |
| | | the screen, it means that the battery | | |
| | | is low and needs to be replaced. | | |
| | 5.5 Mode | a) The thermometer should have a | Pass | |
| | | temperature measurement mode. | | |
| | | The
calibration
mode
b)
for | | |
| | | calibration purposes
shall
be | | |
| | | obtained by a conversion technique | | |
| | | directly sets the infrared
that | | |
| | | thermometer to this mode. | | |
| 6 Function and | 6.1
Unit | The thermometer has a temperature | Pass | |
| performance | switching | unit switching function, which can | | |
| test | function | switch between "℃" and "F". | | |
| | 6.2 Sound | a) In body temperature mode, when | Pass | |

Table VII-1: Performance testing was conducted on the subject device

10

11

| Prompt
Function | the measurement result is in the
range of 22° C to 37.4°C, a green
backlight will be displayed and a short
sound will arise.
b) In body temperature mode, when
the measurement result is in the
range of 37.5° C to 38.4° C, an orange
backlight will be displayed and 1 long
sound + 3 short sounds will arise.
c) In body temperature mode, when
the measurement result is in the
range of 38.5° C to 42.9° C, a red
backlight will be displayed and 1 long
sound + 5 short sounds will arise. | |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 6.3
Measuring
time | The thermometer should complete
the temperature measurement within
2s. | Pass |

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| | 6.4
Memory
query | 32 groups of local data can be queried. | Pass |
|-------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 7. Cleaning and disinfection test | | After the thermometer is cleaned/disinfected according to the instructions in the instruction manual, it shall meet the requirements of 6.3.1. | Pass |
| 8. Self-inspection function test | | All LCDs on the screen should be fully displayed every time the thermometer is turned on. | Pass |
| 9. Automatic shutdown function test | | In standby mode, when there is no button action, it will automatically shut down within 20 seconds. | Pass |
| 10. Instruction Manual Inspection | | The instructions for use of the thermometer shall at least include the following: | Pass |

| 11.
Electrical
safety inspection | 11.1 | a) Temperature display range,
temperature unit, maximum allowable
error, normal working and storage
conditions.
b) Conversion method between
calibration mode and body
temperature mode;
c) The clinical accuracy or clinical
bias of the subject population, body
part and thermometer. | Case Leakage Current and Patient
Leakage Current: | Pass | | | | | | |
|----------------------------------------|------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|------|--|--|--|--|--|--|
| | | | Test item Normal
status Case leakage
current