The Non-Contact Infrared Thermometer is an electronic thermometer using an infrared sensor (thermopile) to measure forehead temperature. Its operation is based on measuring the natural thermal radiation from the forehead and the adjacent surforms a calculation that factors in room temperature, and then a calculated temperature is displayed on the LCD.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Non-Contact Infrared Thermometer, based on the provided document:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by the accuracy specifications, which are implicitly the performance requirements for the device. The reported device performance is presented as its specifications. Since this is a 510(k) submission where the device is effectively the same as its predicate, the performance criteria are met by demonstrating the device has these specifications.

Characteristic	Acceptance Criteria (Specification)	Reported Device Performance (Value)
Measurement Method	Infrared measurement, Contactless measurement	Infrared measurement, Contactless measurement
Measurement Range	Object: 15.0°C ~ 60.0°CBody: 34.0°C ~ 42.5°C	Object: 15.0°C ~ 60.0°C Body: 34.0°C ~ 42.5°C
Accuracy (Object)	±2.0°C (for 15.0°C ~ 60.0°C)	±2.0°C (for 15.0°C ~ 60.0°C)
Accuracy (Body)	±0.3°C (for 34.0°C ~ 35.9°C)±0.2°C (for 36.0°C ~ 39.0°C)±0.3°C (for 39.1°C ~ 42.5°C)	±0.3°C (for 34.0°C ~ 35.9°C)±0.2°C (for 36.0°C ~ 39.0°C)±0.3°C (for 39.1°C ~ 42.5°C)
Humidity (FS-301)	20 ~ 90% RH (Operating Range)±10% (Accuracy for Humidity)	20 ~ 90% RH (Operating Range)±10% (Accuracy for Humidity)
Display Format	LCD display	LCD display
Display Unit	0.1°C	0.1°C
Power Idle Mode	After 60 seconds	After 60 seconds
Measurement Time	Less than 2 seconds	Less than 2 seconds
Battery Life	At least 5,000 measurements	At least 5,000 measurements
Weight	120g (without holder and batteries)	120g (without holder and batteries)
Safety & Compliance	IEC 60601-1, IEC 60601-1-2, IEC 60601-1-4, ISO 14971 (General requirements for medical electrical equipment safety, EMC, programmable systems, risk management)	The device "has been manufactured and tested to meet the following safety and effectiveness requirements" (listing the standards as fulfilled), indicating compliance (This is explicitly stated as being met, not just a goal)

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

The document does not specify a separate "test set" or a sample size beyond stating that the device "has been manufactured and tested to meet" the listed standards. This implies that the testing for these specifications was conducted, but the details of how many units were tested or what specific individuals were tested on are not provided.

The provenance of this data is not explicitly stated as retrospective or prospective, nor is a country of origin mentioned for any clinical testing. The core argument for substantial equivalence relies on the fact that the device is "exactly same as its predicate device (K101912)", meaning its performance is considered equivalent to the predicate's established performance.

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

This information is not provided in the document. Given that this is a thermometer and the key performance metrics are accuracy against defined temperature ranges, it's highly probable that ground truth would be established using NIST-traceable reference thermometers or controlled temperature environments, rather than expert human interpretation in a clinical context.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, the nature of thermometer testing typically involves direct measurement comparisons, not expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for image-based diagnostic devices where human readers interpret results, comparing their performance with and without AI assistance. This is not applicable to a non-contact infrared thermometer.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a standalone measurement device with no explicit "algorithm" in the sense of a complex AI or diagnostic algorithm that would require a separate standalone performance study. Its performance as an independent device is described by its accuracy specifications. The device includes a "calculation that factors in room temperature," but this is a standard engineering control, not an AI algorithm requiring a standalone study in the context of device approval.

7. The Type of Ground Truth Used

The ground truth used for verifying the accuracy of a non-contact infrared thermometer would typically be established by controlled laboratory conditions using calibrated reference thermometers (e.g., fluid baths, blackbody simulators) and/or potentially comparison with invasive core body temperature measurements in clinical studies. The document does not explicitly state the specific method of ground truth establishment, but it refers to meeting specific accuracy claims.

8. The Sample Size for the Training Set

No training set is referenced or relevant to this device. This device is a hardware measurement tool, not an AI/ML model that requires training data.

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

Not applicable, as there is no training set for this device.

Summary

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113-0361

510(k) Summary 5.

2 2013 APR

A. Submission date: 01/21/2013

B. Applicant:

Company name: HuBDIC Co., Ltd
Address: B-301, Taekwang-industrial Building, 191-1, Anyang 7-dong, Manan-gu, Anyang-si, Gyeonggi-do, Korea, 430-815.
TEL: +82-31-441-8637
FAX: +82-31-442-4994
EMAIL : sales@hubdic.com

B. Contact Person

Name: Matt Hansen
Address: 504 Bluegrass Drive, Canonsburg, PA15317, USA
Tel (US): 516 279 7207
Tel (Korea): +82 104 255 4562
E-mail: mbhans80@gmail.com

C. Proprietary and Established Names

· Common Name: Non-Contact Infrared Thermometer
Classification Name: Clinical Electronic Thermometer
Trade Names: 1. Thermofinder
- 2. Thermocare
Establishment Registration Number: 3008729744
Product Code and Classification Panel: FLL, 21 CFR 880.2910
Regulatory Classification: Class II

D. Predicate device: The Infrared Forehead Thermometer, FS-300&301 (K101912)

E. Intended use

The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.

F. Device Description

G. Technological Characteristics:

The Non-Contact Thermometer has the exact same technological characteristics as the predicate device. In fact, the predicate device is the same device with the same intended use, specifications, materials, etc. The only difference between the current device and its predicate is the 'Indication for Use', which will change from Rx to OTC. The specifications of the device are summarized below:

Measurement method	Infrared measurement, Contactless measurement
Measurement range	Object : 15.0°C ~ 60.0°CBody : 34.0°C ~ 42.5°C

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	Only FS-301 SpecificationsHumidity :20 ~ 90% RH
Accuracy	Object : 15.0°C~~60.0°C : ±2.0°CBody : 34.0°C~~35.9°C : ±0.3°C36.0°C~~39.0°C: ±0.2°C39.1°C~~42.5°C: ±0.3°C
	Only FS-301 SpecificationsHumidity : 20% ~ 90% : ±10%
Display format	LCD display
Display unit	0.1°C
Power idle mode	After 60 seconds
Measurement time	Less than 2 second
Battery	LR03(AAA) (2EA) at least 5,000 measurements
Weight	120g (without holder and batteries)

H. Performance (Safety and Effectiveness Information)

The Non-Contact Infrared Thermometer has been manufactured and tested to meet the following safety and effectiveness requirements:

IEC 60601-1: Medical Electrical Equipment Part 1: General Requirements for Safety, 1988; -Amendment 1, 1991-11, Amendment 2, 1995.
IEC 60601-1-2: Medical Electrical Equipment Part 1-2: General Requirements for Safety Collateral -Standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004); Edition 2.1 (Edition 2:2001 consolidated with Amendment 1:2004).
IEC 60601-1-4: Medical Electrical Equipment Part 1-4: General Requirements for Safety ---Collateral Standard: Programmable Electrical Medical Systems, Edition 1.1.
ISO 14971: Medical Devices Application of Risk Management to Medical Devices. .

I. Conclusion:

Technically the device is exactly same as its predicate device (K101912). The 510(k) changes its indication from Prescription (Rx) use to Over-The-Counter (OTC) use.

The performance tests demonstrate that the Non-Contact Infrared Thermometer is as safe, as effective and performs in a substantially equivalent manner to the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

Hubdic Company, Limited C/O Mr. David Yungvirt Responsible Third Party Official Pharmalink Technical Group, LLC 20 F Street, NW Washington, District of Columbia 20001 April 2, 2013

Re: K130361

Trade/Device Name: Infrared Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: March 16, 2013 Received: March 19, 2013

Dear Mr. Yungvirt:

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.

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Page 2 - Mr. Yungvirt

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/CDRH0ffices/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.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

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Anthony D. Watson, B.S., M.S., M.B.A. 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):_____________________________________________________________________________________________________________________________________________________

Device Name: Non-Contact Infrared Thermometer

Indications:

The Non-Contact Infrared Thermometer is intended for measurement and monitoring of human body temperature.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use X (21 CFR 807 Subpart C)

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Concurrence of CDRH. Office of Device Evaluation (ODE) Richard C. Chapman 2013.04.01 14:08:08 -04'00'

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

K130361 510(k) Number:

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.