Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard infrared temperature sensing technology and does not mention AI or ML.

Therapeutic

No
The device is an infrared thermometer used to detect body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.

Diagnostic

No

The device is an infrared thermometer used to detect human body temperature, which is a measurement device, not a diagnostic one.

SaMD (Software as a Medical Device)

No

The device description clearly outlines hardware components like a lens, detector, and the process of converting radiant power to an electrical signal, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

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

Here's why:

IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
FT-100A Function: The FT-100A Electronic thermometer measures body temperature by detecting infrared radiation emitted from the forehead. This is a non-contact measurement performed on the living body. It does not involve analyzing samples taken from the body.

Therefore, based on the provided information, the FT-100A is a medical device, but it falls under the category of a non-invasive thermometer rather than an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to be used on forehead to detect body temperature. The FT-100A is intended for home use.

Product codes

FLL

Device Description

The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body.

The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.

There are some specific limitations to the use of the FT-100A.

It is suggested that a control measurement using a conventional thermometer is recommended in the following cases if the reading is surprisingly low, for new-born infants up to 100 days old or for children under three years of age who have a weakened immune system or who react unusually in the presence or absence of fever

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Infrared

Anatomical Site

forehead

Indicated Patient Age Range

patients of all ages

Intended User / Care Setting

home use.

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

A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months-,

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

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Image /page/0/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be part of a single, flowing design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

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

August 24, 2016

Hangzhou Universal Electronic Co., Ltd. c/o Mr. Charlie Mack IRC 7808 Rush Creek Drive Pasco. Washington 99301

Re: K160802

Trade/Device Name: Infrared Forehead Thermometer, FT-100A Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 16, 2016 Received: July 20, 2016

Dear Mr. Mack:

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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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 (OS) 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

Tina Kiang, Ph.D. Acting 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) K160802

Device Name Infrared forehead thermometer, FT-100A

Indications for Use (Describe)

The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to detect body temperature. The FT-100A is intended for home use.

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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510(k) Summary K160802

This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.

Date: March 5, 2016

Company and Correspondent making the submission:

Name - Hangzhou Universal Electronic Co., Ltd. Address – 38 Yangjiatang, Sandun, Westlake District, Hangzhou City Zhejiang Province, China 310030 Tel: 86-755-86213939 Fax: 86-571-89905288 Contact - Mr. Jiaqiang Wan General Manager Email - charliemack@irc-us.com

2. Device :

Trade/proprietary name: FT-100a Common Name : Clinical electronic thermometer Classification Name : thermometer, electronic, clinical

3. Predicate Devices :

| Manufacturer | Predicate Device | 510(k)
Number | Submitted Device |
|-------------------------------------|----------------------------------------------------------------|------------------|-----------------------------------------------|
| TaiDoc
Technology
Corporation | NEXUS IR30 NON-
CONTACT INFRARED
FOREHEAD
THERMOMETER | K122221 | Infrared Forehead
Thermometer, FT-
100A |

4. Classifications Names & Citations :

21CFR 880.2910, FLL, Clinical electronic thermometer

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5. Description :

The Universal Infrared Forehead Thermometer, Model FT-100A is a non-contact thermometer which infers temperature from the blackbody radiation emitted from the patient. Temperature is calculated from the knowledge of the amount of infrared energy emitted from the human body.

The design consists of a lens to focus the infrared thermal radiation on to a detector, which converts the radiant power to an electrical signal that can be displayed in units of temperature after being compensated for ambient temperature. This permits temperature measurement from a distance without contact with the object to be measured.

There are some specific limitations to the use of the FT-100A.

It is suggested that a control measurement using a conventional thermometer is recommended in the following cases if the reading is surprisingly low, for new-born infants up to 100 days old or for children under three years of age who have a weakened immune system or who react unusually in the presence or absence of fever

6. Indication for use:

The FT-100A Electronic thermometer is an Infrared thermometer which uses an infrared sensor to detect human body temperature of patients of all ages. It is intended to be used on forehead to detect body temperature. The FT-100A is intended for home use.

Comparison with predicate device:

Hangzhou Universal Electronic Co., Ltd. believes that the Infrared Forehead Thermometer, FT-100A is substantially equivalent to the (K122221) Nexus Ir30 Non-Contact Infrared Forehead Thermometer (TaiDoc Technology Corporation).

There are differences between the Indications For Use between the predicate TaiDoc Technology Corporation device and the submitted Hangzhou FT-100A device. The difference is simply different grammatical approaches to state that the same point. Both Indication For Use statements state the intended use is to take body temperature from an Infrared device on the same patient population in the same environment.

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Content	New Device	Predict Device
Device Name	Infrared forehead thermometer, FT-100A	Nexus IR30 Thermometer (TD-1265)
Manufacturer	Hangzhou Universal Electronic Co., Ltd.	TaiDoc Technology Corporation
510(K)	N/A	K122221
Indication for Use	The FT-100A Electronic thermometer is an
Infrared thermometer which uses an infrared
sensor to detect human body temperature of
patients of all ages. It is intended to be used on
forehead to detect body temperature. The
FT-100A is intended for home use.	Nexus IR30 Thermometer is an electronic
thermometer using an infrared sensor to
detect human body temperature from the
surface of human skin without contact. It is
for use on people of all ages (infants,
children, adolescents, and adults) in the
homecare environment.
Temperature unit	Same	°C or °F
Measurement range	Same	Forehead:
32.0°C to 43.0°C (89.6°F to 109.4°F)
Object:
0°C to 100°C (32°F to 212°F)
Operating temperature	Same	16°C to 40°C (60.8°F to 104°F)
Operating humidity	85% RH or less	95% RH or less
Storage temperature	Same	-25°C to 55°C (-13°F to 131°F)
Storage humidity	Same	95% RH or less
Accuracy	FOR BODY MODE: Same as predict device
± 0.2°C (±0.4°F) from 36.0°C (96.8°F) to
39.0°C (102.2°F)
± 0.3°C (±0.5°F) from 32.0°C (89.6°F) to
35.9°C (96.6°F) and from 39.1°C (102.4°F) to
43.0°C ( 109.4°F)

FOR OBJECT MODE:
± 4°C (±7.2°F) from 0°C (32°F) to 4.9°C
(40.8°F)
± 1°C (±2°F) from 5.0°C (32°F) to 60.0°C
(140.0°F)
± 4°C (±7.2°F) from 60.1°C (140.1°F) to
100°C (199.9°F) | FOR BODY MODE:
±0.2°C (±0.36°F) from 36.0°C (96.8°F) to
39.0°C (102.2°F)
±0.3°C (±0.54°F) from 32.0°C (89.6°F) to
35.9°C (96.6°F) and from 39.1°C
(102.4°F) to 43.0°C (109.4°F)

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8. Safety and Performance Data:

| Test Report File

No.	Test	Standards	Result
SDWH-
M201502527-1	In vitro cytotoxicity with 10%
FBS	ISO 10993-5:2009	Pass
SDWH-
M201502527-2	Skin sensitization 0.9%SC	ISO 10993-10:2010	Pass
SDWH-
M201502527-3	Skin sensitization sesame oil	ISO 10993-10:2010	Pass
SDWH-
M201502527-4	Skin irritation 0.9%SC	ISO 10993-10:2010	Pass
SDWH-
M201502527-5	Skin irritation sesame oil	ISO 10993-10:2010	Pass
EED33H000003-2	General requirements for
basic safety and essential
performance	ANSI/AAMI ES60601-1:
2005/(R)2012 and C1:2009/(R)2012
and A2:2010/(R)2012	Pass
EED32H000003	EMC TEST	IEC 60601-1-2:2007	Pass
GF20150815001	Particular requirement for
basic safety and essential
performance of
clinical thermometers for
body temperature
Measurement	ISO 80601-2-56:2009	Pass
GF20150518001	Standard specification for
infrared thermometers for
intermittent determination of
patient temperature	ASTM E1965-98(Reapproved 2009)	Pass

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1. Clinical: A clinical investigation was performed to evaluate the clinical accuracy and clinical repeatability on the following three age groups: 0-12 months-