This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all age ranges. The measured temperature correlates to axillary temperature.

Device Description

This device is an electronic infrared digital forehead thermometer. It scans the forehead area for temperature of the arterial blood supply under the skin. The thermometer displays the results digitally as well as by talking, between 35℃ (95ºF) and 42.2ºC (108ºF). This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift. HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.

AI/ML Overview

Please note that the provided text is a 510(k) summary for a forehead thermometer, focusing on demonstrating substantial equivalence to a predicate device. It does not contain an independent clinical study with a detailed acceptance criterion table, performance metrics, sample sizes, expert involvement, or MRMC studies as typically found for more complex AI/ML-based medical devices.

Therefore, many of the requested sections below will indicate "Not Applicable" or "Not Provided in the Document" as the 510(k) summary (at least the provided snippets) does not detail such information.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The provided 510(k) summary does not include an explicit table of acceptance criteria with reported numerical performance values for the IR Forehead Thermometer (HV-T36). Instead, it relies on demonstrating substantial equivalence to a predicate device (FT101 Forehead Infrared Digital Thermometer, K020433) across various technological characteristics.

The "Comparison result" column in the table indicates "Similar" or "Identical" for most characteristics which implies that the device performs equivalently to the predicate, but specific performance metrics are not quantified in this document.

Acceptance Criteria Category	Reported Device Performance (Summary from Document)
Indications for Use	Identical to predicate device
Target Population	Identical to predicate device
Design	Similar to predicate device
Materials	Similar to predicate device
Performance	Similar to predicate device
Sterility	Similar to predicate device
Biocompatibility	Similar to predicate device
Mechanical Safety	Similar to predicate device
Chemical Safety	Not Applicable (Implies no chemical components requiring assessment)
Anatomical Sites	Identical to predicate device
Human Factors	Similar to predicate device
Energy Used/Delivered	Similar to predicate device
Compatibility	Similar to predicate device
Where Used	Identical to predicate device
Standards Met	Similar to predicate device
Electrical Safety	Similar to predicate device
Thermal Safety	Similar to predicate device
Radiation Safety	Similar to predicate device

Study that proves the device meets the acceptance criteria:

The document states: "This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)". The "study" here is essentially the analysis detailed in Paragraph 14, which is a comparative analysis of technological characteristics against the predicate device. It does not describe a new clinical performance study the manufacturer conducted, but rather a justification of equivalence based on design and intended use alignment.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not provided. The provided 510(k) summary does not detail a separate test set, sample size, or data provenance as it relies on demonstrating equivalence through comparison of technical specifications, not independent performance testing against a specific dataset.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not provided. Since no independent test set or ground truth establishment is described in the provided text, information about experts is not relevant.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not provided.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a standalone electronic thermometer, not an AI-assisted diagnostic tool that would involve human readers.

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

Yes, this is a standalone device. The device itself (HV-T36 IR Forehead Thermometer) performs its function autonomously to measure and display temperature. The 510(k) process here focuses on ensuring its performance is similar to previously cleared devices.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not provided directly for the new device. For a thermometer, "ground truth" during development or validation typically refers to a reference temperature measured by a highly accurate, calibrated device. The 510(k) summary, however, relies on the assumption that the predicate device's performance aligns with established accuracy standards, and the new device is "similar" in performance.

8. The sample size for the training set

Not applicable / Not provided. This type of thermometer does not typically involve a "training set" in the context of machine learning or complex algorithms. Its design and calibration are based on established physics and engineering principles for infrared thermometry.

9. How the ground truth for the training set was established

Not applicable / Not provided.

Summary

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510(k) Summary

As Required by 21 section 807.92 ( c )

Mansour Consulting LLC 1-Submitter Name:

1308 Morningside Park Dr 2-Address: Alpharetta, GA 30022 USA
(770) 777- 4146 3-Phone:
(678) 623- 3765 4-Fax:

5-Contact Person: Jay Mansour

6-Date summary prepared: August 21*, 2003

7-Device Trade or Proprietary Name: IR FOREHEAD THERMOMETER, HV-T36
8-Device Common or usual name: Forehead Electronic Thermometer
Clinical Electronic Thermometer 9-Device Classification Name:
10-Substantial Equivalency is claimed against the following device:
FT101 Forehead Infrared Digital Thermometer, manufactured by IDT Technology . Limited and distributed in US by Oregon Scientific. 510k # K020433

11-Description of the Device:

This device includes also display of current date and time. Range of date display falls within Gregorian calendar year 1901~2099, time display includes 12 hours shift or 24 hours shift.

HV-T36 stores up to 30 sets of measurement records. Each set has a maximum storage time of 30 days. Temperature is stored together with measuring date and time of measurement.

12-Intended use of the device:

13-Safety and Effectiveness of the device:

This device is safe and effective as the other predicate device cited above. This is better expressed in the tabulated comparison (Paragraph 14 below)

14-Summary comparing technological characteristics with other predicate device:

Image /page/0/Picture/22 description: The image shows an oval shape with the text "PAGE 10" written inside. The text is handwritten in a simple, slightly messy style. The oval shape is outlined in black, and the text is also in black.

K032612-

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Please find below a tabulated comparison supporting that this device is substantially equivalent to other medical devices in commercial distribution. Also, Equivalency overview chart path is attached. Indeed, this device is SIMILAR to the predicate device.

FDA file reference number	510k # K020433
Attachments inside notification submission file	510k summary print out
TECHNOLOGICAL CHARACTERISTICS	Comparison result
Indications for use	Identical
Target population	Identical
Design	Similar
Materials	Similar
Performance	Similar
Sterility	Similar
Biocompatibility	Similar
Mechanical safety	Similar
Chemical safety	Not Applicable
Anatomical sites	Identical
Human factors	Similar
Energy used and/or delivered	Similar
Compatibility with environment and other devices	Similar
Where used	Identical
Standards met	Similar
Electrical safety	Similar
Thermal safety	Similar
Radiation safety	Similar

PAGE 11

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Image /page/2/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with three distinct head profiles, suggesting a focus on people and health.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 9 2004

Oriental Inspiration Limited C/O Mr. Jay Mansour Mansour Consulting LLC 1308 Morningside Park Drive Alpharette, Georgia 30022

Re: K032612

Trade/Device Name: IR Forehead Thermometer, HV-T36 Regulation Number: 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: December 1, 2003 Received: December 4, 2003

Dear Mr. Mansour

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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. Mansour

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Chiu-Ling, Ph.D.

Chiu Lin. Ph.D. Director 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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Page I of 1

510(k) Number (if known): //326/2

Device Name: IR FOREHEAD THERMOMETER, HV-T36

Indications for Use:

This device is an over-the-counter, non-sterile, reusable, infrared clinical electronic thermometer intended for the intermittent measurement and assessment of the skin forehead temperature of humans of all ages. The measured temperature correlates to axillary temperature

/ Over-the-Counter

Prescriptum

Clus-Ps

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

510(k) Number: K032622

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

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Concurence of CDRH, Office of Device Evaulation (ODL)

(Optional Format 3-10-98)

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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.