IR Ear/Forehead thermometer, which includes models DX6635, DX6637, TH1081 and TH1091, are a hand-held, reusable, battery operated device that can measures human body temperature by two ways:

On forehead, the skin temperature on people's forehead
In ear, the tymperature in people's ear
The working principle based on infrared sensor technology. It utilizes infrared technology to receive infrared energy emitted from the eardrum or the surface of the object and convert to a voltage. The voltage value is responsible with the different temperature between the target object and infrared sensor. Then MCU will convert this value to digital data by an analog to digital (A/D) circuit. This data will be changed to the finalized temperature data by algorithms and displayed on LCD.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the IR Ear/Forehead thermometer, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Reference)	Device Performance (Model: DX6635, DX6637, TH1081, TH1091)
Accuracy (35.5℃ ~ 42.0℃)	±0.2℃ (0.4℉)
Accuracy (Other range)	±0.3℃ (0.5℉)
Measurement Temperature Range	32.0℃ ~ 42.9℃ (89.6℉ ~ 109.2℉)
Ambient Range (Ear)	10℃ ~ 40℃ (50.0℉ ~ 104.0℉)
Ambient Range (Forehead)	15℃ ~ 40℃ (59.0℉ ~ 104.0℉)
Storage Range	-20℃ ~ 55℃ (-4℉ ~ 131℉)
Applicable Standards Conformance	ASTM E1965-98 (2003), IEC 60601-1, IEC 60601-1-2

Note: The provided text primarily focuses on demonstrating substantial equivalence to a predicate device and conformance to standards rather than detailing a specific clinical study with granular raw performance data. The "Reported Device Performance" in the table reflects the specified accuracy and operational ranges claimed for the device, which are presented as being equivalent to the predicate device and in conformance with relevant standards.

2. Sample Size Used for the Test Set and Data Provenance:

The provided document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective) for clinical performance. The focus of this 510(k) summary is on substantial equivalence to a predicate device through technological characteristics and adherence to recognized standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts to establish a ground truth for a test set. This type of information would typically be found in a detailed clinical study report, which is not provided in this 510(k) summary.

4. Adjudication Method for the Test Set:

The document does not describe any adjudication method for a test set. This suggests that a multi-reader or expert-adjudicated test set in the traditional sense was not performed or at least not detailed in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, the document does not indicate that a multi-reader multi-case (MRMC) comparative effectiveness study was done. The submission relies on demonstrating substantial equivalence to a predicate device and conformance to standards, rather than proving improved human reader performance with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was Done:

The document describes the device as a "hand-held, reusable, battery operated device that can measures human body temperature" and the working principle is "based on infrared sensor technology." This is a hardware device with an embedded algorithm for temperature conversion. The performance evaluation presented is intrinsically standalone in the sense that the device itself, functioning autonomously to measure temperature, is the subject of conformity to standards. There's no explicit mention of a separate "algorithm-only" performance study distinct from the device's overall operation. The device is the algorithm in this context.

7. The Type of Ground Truth Used:

The ground truth for this device's performance is implicitly based on established metrological standards and physical measurements rather than clinical outcomes or expert consensus on interpretations. The reliance on standards like ASTM E1965-98 (2003) for "Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature" implies that the device's accuracy claims are benchmarked against reference thermometers or controlled temperature environments as defined by these standards.

8. The Sample Size for the Training Set:

The document does not provide any information regarding a training set sample size. This is a medical device that measures temperature using infrared technology, not a machine learning or AI algorithm that typically requires a large training dataset for model development in the way one might think of image recognition or diagnostic AI. The "algorithms" mentioned are for converting voltage to digital temperature data, likely based on known physics and calibration data, not iterative machine learning from a vast dataset.

9. How the Ground Truth for the Training Set was Established:

As there is no mention of a training set in the context of machine learning, there is no information on how a ground truth for such a set was established. The device relies on established physical principles and calibration against known temperature references (as per standards like ASTM E1965-98) during its manufacturing and design, rather than learning from labeled training data.

Summary

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File No: WMI-04-JR-T-FDA-05 Version: 1.I

JUL 2.2 2010

510(k) SUMMARY

IR Ear/Forehead thermometer, K (

Date of Submission: 01/20/2009 Submitter's Name: Shenzhen Dongdixin Technology Co., Ltd. Address: No.3bldვ. xiliyangguang industrial estae xilixiaobaimang Nanshan district Shenzhen, China 518108 Telephone: +86(755) 27652471 Fax: +86(755) 27652674 info@dundex.com E-mail: microcong@gmail.com Contact: Zhigang Zhao

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Proposed Device:

File No: WMI-04-IR-T-FDA-05 Version: 1.1

Trade Name: IR Ear/Forehead thermometer Classification Name: Clinical electronic thermometer Regulation Number: 21 CFR 880.2910 Product Code: FLL Device Class: II

1. Predicate Device:

Legally Marketed Device:	Infrared Thermometer Model:FDIR-VI
510(k) Number:	K052849
Manufacturer:	FAMIDOC TECHNOLOGY CO., LTD

3. Description of Proposed Device:

IR Ear/Forehead thermometer, which includes models DX6635, DX6637, TH1081 and TH1091, are a hand-held, reusable, battery operated device that can measures human body temperature by two ways:

On forehead, the skin temperature on people's forehead �
In ear, the tympanic temperature in people's ear �

The working principle based on infrared sensor technology. It utilizes infrared technology to receive infrared energy emitted from the eardrum or the surface of the object and convert to a voltage. The voltage value is responsible with the different temperature between the target object and infrared sensor. Then MCU will convert this value to digital data by an analog to digital (A/D) circuit. This data will be changed to the finalized temperature data by algorithms and displayed on LCD.

4. Proposed Device Intended for Use Statement:

Device Name:

IR Ear/Forehead thermometer, Model: DX6635, DX6637, TH1081, TH1091

Indications for Use:

The device is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.

Technological Characteristics and Substantial Equivalence ડ.

Section 05-Page 2 of 3

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Caretalk®

File No: WMI-04-IR-T-FDA-05 Version: 1.1

Both the IR Ear/Forehead thermometer and the Predicate device thermometer have the same intended use and fundamental technology. A side-by-side comparison of the IR Ear/Forehead thermometer and the cited predicate devices is included in the 510(k) submission. The IR Ear/Forehead thermometer is substantially equivalent to the technological features as the predicate devices.

	1 20 - 2 8 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2 - 2	New device 1 8 8 1 1 1 1 1 1 1 1 1 1r :	Predicate device ==========
	510K#	K	K052849
2	Device Name	IR Ear/Forehead thermometer Mode:	InfraredThermometerMode:
		DX6635, DX6636, TH1081, TH1091	FDIR-V1
3	Manufacturer	Shenzhen Dongdixin	FAMIDOC TECHNOLOGY Co., Ltd
		Technology Co., Ltd.
4	Measurement temp range	32.0~42.9℃	32.0~42.9℃
		(89.6~109.2°F)	(89.6~109.2°F)
S	Accuracy	35.5℃ (95.9ºF ) ~42.0℃ (107.6ºF )	35.5℃(95.9°F)~42℃(107.6°F)
		±0.2℃ (0.4℃ ) , Other ±0.3℃ (0.5℃ )	±0.2℃(0.4℃),Other ±0.3℃(0.5℃
હ	Ambient range	10℃~~ 40℃ (50.0°F~104.0°F) for Ear	10℃~ 40℃ (50.0°F~104.0°F)
		15℃~ 40℃ (59.0℃~104.0℃)for
		Forehead
7	Storage range	-20℃~ 55℃ (-47~~ 131°F)	-25℃~ 55℃ (-137~~131°Г)
8	Display type	LCD	LCD
ਰੇ	Activation	Scan button	Scan button
10	Power requirements	3V DC	3V DC
11	Classification	Clinical Electronic thermometer	Clinical Electronic thermometer
		Class II 21 CFR 880.2910	Class II 21 CFR 880.2910

Basic technological characteristics, new device vs. Predicate device

6. Performance Summary:

The device conforms to applicable standards included ASTM E1965-98 (2003), IEC 60601-1, and IEC 60601-1-2 requirements.

7. Conclusions:

IR Ear/Forehead thermometer, which includes models DX6635,DX6637,TH1081 and TH1091, has the same intended use and similar technological characteristics as the predicate device. Moreover, bench testing, safety report and Risk Analysis Report documentation supplied in this submission demonstrates that the difference in their technological characteristics do not raise any new question of safety or effectiveness. Thus, the IR Ear/Forehead thermometer is substantially equivalent to the predicate device.

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Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in bold, black font. The text is centered and appears to be a title or heading. The words are all capitalized and evenly spaced.

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

Shenzhen Dongdixin Technology Company, Limited C/O Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories, Incorporated 333 Pfingsten Road Northbrook, Illinois 60062

JUL 2-2 2010

Re: K100488

Trade/Device Name: IR Ear/Forehead Thermometer, Model: DX6635, DX6637, TH1081, TH1091 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: June 30, 2010 Received: July 15, 2010

Dear Mr. Devine:

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.

Image /page/3/Picture/10 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized human figure with three arms reaching upwards, representing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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Page 2- Mr. Devine

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 device-related 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOTfices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

Antony V. Watt

Anthony D. Watson, B.S., M.S., M.B.A. Diréctor Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and

Radiological Health

Enclosure

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File No: WMI-04-LT3000-FDA-04 Version: 1.1

Indications for Use

510(k) Number (

Device Name:

IR Ear/Forehead thermometer, Model: DX6635, DX6637, TH1081, TH1091

Indications for Use:

The device is intended for the intermittent measurement and monitoring of human body temperature by consumers in the home.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _ ✓ _ (21 CFR 801 Subpart C)

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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Light Music for RZC July 22, 2010

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K100488

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.