Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description details a standard infrared thermometer that converts heat into a temperature value using software, but there is no mention of AI, ML, or related concepts. The performance studies focus on standard clinical and technical metrics, not AI/ML model performance.

Therapeutic

No
The device is indicated for "intermittent measurement and monitoring of human body temperature," which is a diagnostic or monitoring function, not a therapeutic one. It does not treat, cure, mitigate, or prevent disease.

Diagnostic

No

The device is an infrared ear thermometer for measuring human body temperature, which is a measurement device, not a diagnostic device. While temperature can be a symptom, the device itself simply provides a measurement and does not interpret or diagnose conditions.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the device includes hardware components such as an infrared detector, probes, plastic enclosures, buttons, and a battery cover. While software is used to convert the heat into a temperature value, the device is not solely software.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are 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 Ear Thermometers described measure body temperature by detecting infrared radiation directly from the eardrum and surrounding tissues. This is a direct measurement of a physiological parameter within the body, not an analysis of a specimen taken from the body.

The device is a medical device, specifically a thermometer, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.It's intended for use on people of all ages.

Product codes

FLL

Device Description

The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover.

The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

auditory canal, ear canal, eardrum (tympanic membrane)

Indicated Patient Age Range

people of all ages

Intended User / Care Setting

consumers in a home use environment.

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)

Performance testing was conducted to validate and verify that Infrared Electronic Thermometers, models ET-101D and ET-101H met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.

Electrical Safety and performance requirements:

AAMI/ANSI ES60601-1:2055/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment
. ISO 80601-2-56:2099 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ASTM E1965-98(Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
ASTM E1104-98(Reapproved 2009) Standard Specification for clinical thermometer probe . covers and sheaths

Home-used medical equipment requirements and environmental test:

IEC 60601-1-11:2010 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
Electromagnetic compatibility requirements:
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Biocompatibility Evaluation for patient contacting components:
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

Guidance Document:

Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic ● thermometers
The software/firmware 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.

Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082192

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 31, 2016

Sejoy Electronics & Instruments Co., Ltd. Ren Yunhua General Manager Building 2, No. 202, Zhenzhong Road, West Lake Economy & Technology Zone Hangzhou, 310030 CHINA

Re: K153146

Trade/Device Name: Infrared Ear Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: February 25, 2016 Received: February 29, 2016

Dear Ren Yunhua:

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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina Kiang -S

for Erin I. Keith, M.S. 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) K153146

Device Name Infrared Ear Thermometers ET-101D,ET-101H

Indications for Use (Describe)

Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment.It's intended for use on people of all ages.

Type of Use (Select one or both, as applicable)

Research Use Only (21 CFR 201.128) and/or
Over-The-Counter Use (21 CFR 201.66) and/or

__ 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: K153146 Date Prepared: 2015.11.22

I. Submitter:

Name: Sejoy Electronics & Instruments Co., Ltd. Add.: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou, China 310030 Contact Person: Yunhua Ren Phone: +86-571-81957767 Fax: +86-571-81957750 Email: renyh@sejoy.com

II. Device:

Trade Name: Infrared Ear Thermometer, Including models: ET-101D,ET-101H Common Name: Infrared Ear Thermometer Classification name: Clinical Electronic Thermometer

Classification Information: Product Code: FLL- Clinical Electronic Thermometer Device Class: II Panel: 80 Regulation number: 880.2910

III.Predicate Device Information:

Infrared Ear Thermometer ET-101A, K082192 The predicate device is manufactured by Sejoy Electronics & Instruments Co., Ltd.

IV. Device Description:

The Infrared Ear Thermometers, models ET-101D and ET-101H are electronic thermometers using an infrared detector (thermopile detector) to detect body temperature from the auditory canal. The thermometer's operation is based on measuring the natural thermal radiation emanating from the tympanic membrane and the adjacent surfaces of the patient.

Both thermometer models include probes, which are used to measure ear canal temperature, plastic enclosures enclosing the display window as well as buttons and a battery cover. The disposable probe cover of ET-101H is optional when measuring temperature while ET-101D does not utilize a disposable probe cover.

The Infrared Ear Thermometers measure temperature by reading infrared radiation emitting from the eardrum tissue. The small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues give off heat. The thermometer converts the heat into a temperature value using software.

4

V. Intended use / Indication for Use:

Infrared Ear Thermometers, models ET-101D and ET-101H are indicated for the intermittent measurement and monitoring of human body temperature by consumers in a home use environment. It is intended for use on people of all ages.

SE Comparisons	SUBJECT DEVICE :	PREDICATE DEVICE:	Comparison Result	Remark
	Infrared Ear Thermometer
Model:ET-101D、ET-101H
Manufacturer:
SEJOY ELECTRONICS &
INSTRUMENTS CO., LTD	Infrared Ear Thermometer
ET-101A (K082192)
Manufacturer:
SEJOY ELECTRONICS &
INSTRUMENTS CO., LTD	Identical	/
Thermometer type	Infrared Ear Thermometer
Product code: FLL		Identical	/
Measuring Site:	Ear canal		Identical	/
Reference Body
Site:	Oral (This thermometer converts the ear temperature to display
its "oral equivalent")		Identical	/
Intended use(s)	Indicated for the intermittent measurement and monitoring of human body
temperature by consumers in a home use environment.It's intended for use on
people of all ages.		Identical	/
Operation mode	Ear mode(Adjusted mode)		Identical	/
Components
& Materials	ET-101H
Case: ABS
Probe: Stainless steel & ABS
Probe Cover: PE

VI. Comparison of Technological Characteristics with the Predicate Device

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| Measurement range | ET-101D | $32.0°C~~43.0°C (89.6°F~~109.4°F)$ | $32.0°C~~43.0°C (89.6°F~~109.4°F)$ | Similar | Meet the
requirement
of ASTM
E1965-98 |
|----------------------------------------------|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|------------------------------------------------|
| | | Ear mode:
$28.0°C~~43.0°C (82.4°F~~109.4°F)$ | | | |
| | ET-101H | Object mode:
$-20°C~~100°C(-4°F~~212°F)$
Room temperature:
$0°C~~50°C (32°F~~122°F)$ | | | |
| | Operating
temperature range | ET-101D | $10°C~~40°C (50°F~~104°F)$ , 15%85
%RH, non-condensing
Atmospheric Pressure:
800hPa ~ 1060hPa | $10°C40°C (50°F104°F)$ , 15%85%RH, non-condensing
Atmospheric Pressure:
800hPa ~ 1060hPa | Identical |
| ET-101H | | Ear/Object mode:
$10°C40°C(50°F104°F)$ , 15%85
%RH, non-condensing
Atmospheric Pressure:
800hPa ~ 1060hPa | | | |
| Storage and
transportation
environment | | | $-25°C55°C(-13°F131°F)$ , 15%95%RH,non-condensing
Atmospheric Pressure:800hPa ~ 1060hPa | | Identical |
| Precision
(Laboratory accuracy) | ET-101D | $±0.2°C (0.4°F)$ during $35.0°C42.0°C (95.0°F107.6°F)$ at
$15°C~~35°C (59.0°F~~95.0°F)$
Operating temperature range
$±0.3°C (0.5°F)$ for other measuring
and operating
temperature range | $±0.2°C (0.4°F)$ during $35.0°C~~42.0°C (95.0°F~~107.6°F)$ at | | |
| | | | | | |
| | | | | | |
| | | | | | |
| | ET-101H | Ear mode:
$±0.2°C$ ( $0.4°F$ ) during operating temperature range
$35.5°C~~42.0°C$ ( $95.9°F~~107.6°F$ ) at $15°C~~35°C$ ( $59.0°F~~95.0°F$ ) operating temperature range
$±0.3°C$ ( $0.5°F$ ) for other measuring and operating temperature range
Object mode:
$±4%$ or $±2°C$ ( $4°F$ ) whichever is greater
Room temperature: $±2°C$ ( $±4°F$ ) | $15°C~~35°C$ ( $59.0°F~~95.0°F$ ) $±0.3°C$ ( $0.5°F$ ) for other measuring and operating temperature range | Similar | / |
| Biocompatibility | | Complied with the biocompatible requirements of FDA. | | Identical | / |
| | ET-101D | No accessory | Storage Case,Probe Cover | Different | / |
| Accessories | ET-101H | Storage Case, Probe Cover | Storage Case, Probe Cover | Identical | / |
| Response time | | Approximately 1 Second | | Identical | / |
| | ET-101D | Approx. 1 year/3000 readings | Approx. 1 year/3000 readings | Identical | / |
| Battery Life | ET-101H | Approx. 1 year/6000 readings | Approx. 1 year/3000 readings | Similar | / |
| Clinical Accuracy | ET-101D | Clinical bias: $0.07°C$ ( $0.1°F$ )
Clinical repeatability: 0.11( $0.2°F$ )
Limits of agreement: $0.76°C$ ( $1.4°F$ ) | Clinical bias: $0.12°C$ ( $0.2°F$ )
Clinical repeatability:
0.12( $0.2°F$ )
Limits of agreement
: $0.8°C$ ( $1.4°F$ ) | Similar | / |
| | ET-101H | Clinical bias: $0.08°C$ ( $0.14°F$ )
Clinical repeatability: 0.13( $0.23°F$ )
Limits of agreement: $0.76°C$ ( $1.31°F$ ) | | | |
| | ET-101D | One CR2032 battery | One CR2032 battery | Different | / |
| Power Sources | ET-101H | Two AAA batteries | One CR2032 battery | Different | / |

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Probe Cover	ET-101D	NO	YES	Different	/
	ET-101H	Optional	YES	Similar	/
Low Battery Detection		YES		Identical	/
Automatic Power-Off		YES		Identical	/
Beep Alarm		YES		Identical	/
°C/°F Switchable		YES		Identical	/
Object temperature
mode	ET-101D	NO	NO	Identical	/
	ET-101H	YES	NO	Different	/
Ambient temperature
mode	ET-101D	NO	NO	Identical	/
	ET-101H	YES	NO	Different	/
Real time clock	ET-101D	NO	NO	Identical	/
	ET-101H	YES	NO	Different	/
Room Temperature	ET-101D	NO	NO	Identical	/
	ET-101H	YES	NO	Different	/
Backlight function	ET-101D	One color	NO	Different	/
	ET-101H	Three colors in ear mode and one
color in object mode	NO	Different	/
Memory	ET-101D	10 sets	10 sets	Identical	/
	ET-101H	Each 10 sets memories for ear
and object measurements	10 sets	Similar	/
Probe cover
automatic detection
function	ET-101D	NO	NO	Identical	/
	ET-101H	YES	NO	Different	/

Summary of technological characteristics / performance

The Infrared Ear Thermometer, Model ET-101D, ET-101H have substantially equivalent indications for use and technological characteristics as the predicate device.

1. ET-101D,ET-101H have the same intended use/indication for use as the predicate device.
1. The same technologies and test principles are used in the ET-101D and ET-101H thermometers as the predicate device.
1. The identified differences in technological characteristics do not raise new or different questions of safety and effectiveness than the predicate devices.
1. Although some specifications are slightly different than the predicate device, ET-101A, changes have been verified and validated as part of performance testing and safety /EMC testing and are included as part of this submission. Performance information and evidence of compliance to recognized standards demonstrate the device is substantially equivalent to the predicate devices.

Based upon the intended use, and upon the similarity of materials, product configuration and administration, it can be concluded the Infrared Ear Thermometer, Model ET-101D and ET-110H devices are substantially equivalent to the identified predicate device.

VII. Performance Data

The following performance data were provided in support of the substantial equivalence determination:

Performance testing was conducted to validate and verify that Infrared Electronic Thermometers, models ET-101D and ET-101H met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.

7

Electrical Safety and performance requirements:

AAMI/ANSI ES60601-1:2055/(R)2012 and C1:2009/(R)2012 and A2:2010/(R)2012 Medical Electrical Equipment
. ISO 80601-2-56:2099 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ASTM E1965-98(Reapproved 2009) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
ASTM E1104-98(Reapproved 2009) Standard Specification for clinical thermometer probe . covers and sheaths

Home-used medical equipment requirements and environmental test:

IEC 60601-1-11:2010 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
Electromagnetic compatibility requirements:
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic ● safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests
Biocompatibility Evaluation for patient contacting components:
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

Guidance Document:

Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic ● thermometers
The software/firmware 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.

Discussion of Animal Tests Performed: No animal testing was performed.

Discussion of Clinical Tests Performed:

Clinical evaluation of Infrared Ear Thermometers was conducted by Sejoy Electronics & Instruments Co., Ltd in compliance with ISO 80601-2-56 and ASTME1965.

VIII. Conclusions:

The non-clinical data support the safety of the device and the hardware and software verifications and validation demonstrate that the Infrared Ear Thermometers, models: ET-101D and ET-101H should perform as intended in the specified use conditions. Based on the information provided in this submission, the Infrared Ear Thermometers, models: ET-101H are substantially equivalent to the predicate thermometer ET-101A.