Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.

Therapeutic

No.
The device is intended for the measurement of body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.

Diagnostic

No
The device is strictly for measuring body temperature, which is a vital sign measurement and not a diagnostic function.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "hand-held, battery powered device" that measures infrared energy, indicating it is a physical hardware 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 Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
This Device's Function: This device measures body temperature by detecting infrared energy emitted from the forehead. It does not analyze any biological specimens taken from the body.

Therefore, based on the provided information, this Infrared Forehead Thermometer is a medical device, but it falls under a different classification than an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

Product codes

FLL

Device Description

The Infrared Forehead Thermometer (Model IR-FT) is a hand-held, battery powered device designed to measure human body temperature. This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted from the forehead skin above the evebrows. The Forehead Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the reading of the body temperature with a forehead touch.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Infrared

Anatomical Site

Forehead

Indicated Patient Age Range

People of all ages.

Intended User / Care Setting

Clinical and home environments.

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

Clinical accuracy validation: A comparison study and clinical repeatability testing was performed on the following three age groups: 0-12 months, 12 months - 5 years - 5 years older in accordance with ISO 80601-2-56 to compare the Infrared Forehead Thermometer (Model IR-FT) with Vitreous thermometer. This clinical comparison study demonstrated that the temperatures obtained with the Infrared Forehead Thermometer (Model IR-FT) were highly related when compared to the Vitreous thermometer, the clinical bias with stated uncertainty and clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability, the results shows substantial equivalence.

Key Metrics

Not Found

Predicate Device(s)

K134043

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

October 18, 2019

Comper Chuangxiang (Beijing) Technology Co., Ltd. Han Du Official Correspondent Room 102-103 1st Floor, Building 4 No. 1 Kangding Street Daxing District, Beijing 100176 China

Re: K191668

Trade/Device Name: Infrared Forehead Thermometer (Model IR-FT) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 13, 2019 Received: September 13, 2019

Dear Han Du:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Geeta Pamidimukkala Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K191668

Device Name

Infrared Forehead Thermometer (Model IR-FT)

Indications for Use (Describe)

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intermittent determination of human body temperature through a touch on the center of the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

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

Prepared in accordance with the requirements of 21 CFR Part 807.92

Prepared Date: 18 October 2019

1. Submitter's Information

The submitter of this pre-market notification is:

Name:	Comper Chuangxiang (Beijing) technology Co., Ltd.
Address:	Room 102-103 1st Floor, Building 4 No.1 Kangding Street,
Daxing District Beijing, CHINA 100176
Contact person:	Han Du
Title:	Manager
E-mail:	registration@comper.com
Tel:	+86-10-57480968

2. Device Identification

Trade/Device Name:	Infrared Forehead Thermometer
Models:	IR-FT
Regulation Number:	21 CFR 880.2910
Regulation Name:	Clinical electronic thermometer
Regulation Class:	Class II
Product Code:	FLL

3. Predicate Device

510(K) number:	K134043
Device Name:	No Touch + Forehead Thermometer
Manufacturer:	KAZ USA, Inc.
Regulation Number:	21 CFR 880.2910
Regulation Name:	Clinical electronic thermometer
Regulation Class:	Class II
Product Code:	FLL

4. Device Description

The Infrared Forehead Thermometer (Model IR-FT) is a hand-held, battery powered device designed to measure human body temperature. This Forehead Thermometer takes the body temperature by measuring the infrared energy emitted from the forehead skin above the evebrows. The Forehead Thermometer adopts gentle-touch, user friendly and non-invasive measurement design. It instantly displays the reading of the body temperature with a forehead touch.

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5. Indication for use

This device is a non-sterile, reusable, contact Infrared Forehead Thermometer (Model IR-FT) intended for intermittent determination of human body temperature through a touch on the center of the forehead as the measurement site on people of all ages. The Infrared Forehead Thermometer (Model IR-FT) can be used in clinical and home environments.

6. Comparison of technological characteristics with the Predicate Device

Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table

Feature	Subject device	Predicate device	Discussion
510(k) Number	K191668	K134043
Indication for
use	This device is a non-
sterile, reusable, contact
Infrared Forehead
Thermometer (Model IR-
FT) intended for
intermittent determination
of human body
temperature through a
touch on the center of the
forehead as the
measurement site on
people of all ages. The
Infrared Forehead
Thermometer (Model IR-
FT) can be used in
clinical and home
environments.	The No Touch + Forehead
Thermometer (Model
NTF3000US) is a non-sterile,
reusable clinical
thermometer intended for the
intermittent determination of
human body temperature in
a touch and no touch on the
centre of the forehead as the
measurement site on people
of all ages.	The intended use is
similar to the predicate
device, however, the
subject device may be
used only in contact
mode. Additionally the
subject device defines
the use environment as
both clinical and home-
use.
Thermometer
type	Infrared forehead	Infrared forehead	Same
Components	The product is mainly
composed of a
temperature sensor, a
housing, a circuit board
and a battery
compartment.	The product is mainly
composed of a temperature
sensor, a housing, a circuit
board and a battery
compartment.	The same structure
Temperature
Measurement
Technology	The thermometer uses a
thermopile sensor with
integrated thermistor for
the target reading, a
thermistor mounted in the
head of the thermometer
for ambient temperature
readings, and an infrared	The thermometer uses a
thermopile sensor with
integrated thermistor for the
target reading, a thermistor
mounted in the head of the
thermometer for ambient
temperature readings, a
parabolic mirror to help focus	Similar, our device
have not a parabolic
mirror, but the
performance has been
verified according to
the ISO 80601-2-56
and ASTM E1965, the
result shows that our
	proximity sensor for
detection of contact use
and compensation of the
temperature reading.	the infrared energy emitted
from the forehead, and an
infrared proximity sensor for
detection of contact or non-
contact use and
compensation of the
temperature reading.	device has the same
specification to
predicate device.
Key
Temperature
Sensor	Thermopile Sensor
OTP-336 manufactured
by Oriental system
technology inc.	Thermopile Sensor	Same type, but
different manufacturer.
We performed the
performance test
according to the ISO
80601-2-56 and ASTM
D1965, therefore it do
not raise different
questions of safety and
effectiveness.
Power
requirements	D.C. 3 V (2 AAA dry
batteries)	D.C. 3 V (2 AAA dry
batteries)	Same
Materials	Patient contacting
materials include PC (Top
cover, battery cover,
chamber, button power)
and ABS+TPU (front
cover).	Patient contacting materials
include ABS (device housing
/ handle and power button)
and
TPR (temperature button and
nose / forehead touch
bumper).	Different, but both of
our device and
predicate device have
performed the
Biocompatibility test
according to the ISO
10993-1, both two
devices meet the
requirements of ISO

therefore it is
substantially equivalent
on Biocompatibility
risk. | |
| Temperature
range | 32.0°C ~43.0°C (89.6°F -
109.4°F) | 34.4°C to 42.2°C
(93.9°F to 108.0°F) | Our measurement
range is greater than
predicate device, but
we performed accuracy
test according to the
ASTM E1965 and ISO
80601-2-56, therefore
it is substantially
equivalent on
performance. | |
| | | | | |
| Accuracy for
body
temperature
measurement | ≤±0.2°C (0.4°F), for the
range 35°C -42°C (95°F -
107.6°F);
≤±0.3°C (0.5°F),for the
range 32°C -34.9°C
(89.6°F -94.8°F) and
42.1-43°C (107.8°F -
109.4°F). | ± 0.2°C / 0.36°F
35.0°C to 42.0°C
(95.0°F to 107.6°F);
± 0.3°C / 0.54°F
31.0°C to 35.0°C
(87.8°F to 95.0°F);
± 0.3°C / 0.54°F
Above 42.0°C
(Above 107.6°F) | Same | |
| | Resolution of
display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| | | Signal output
And display | LCD, Buzzer | LCD, Buzzer |
| | Biocompatibility | | ISO 10993-1 | ISO 10993-1 |
| Voluntary
standards
for Clinical
Electronic
Thermometers, | ISO 80601-2-56
ASTM E1965 | ASTM E 1965 and
ISO 80601-2-56 | Same | |
| | Medical
Electrical
Safety and
EMC | IEC 60601-1, IEC 60601-
1-2 | IEC 60601-1, IEC 60601-1-2 | Same |

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Comper Chuangxiang (Beijing) technology Co., Ltd

The required testing demonstrated that the differences do not raise new questions of safety and

effectiveness between the subject and the predicate device.

8. Performance Data

Non-clinical data

Cleaning Validation:

We performed the cleaning validation according to the method of instruction for use, the validation result shows that the method of cleaning meets the cleaning requirements.

Safety:

1. ANSI/AAMI ES60601-1:2005/(R)2012 AND A1:2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
1. AAMI/ANSI ES60601-1-2:2014 Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance -- Collateral Standard: Electromagnetic disturbances --Requirements and tests

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1. IEC 60601-1-11:2015 Medical electrical equipment Part 1-11: 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

Performance:

1. ISO 80601-2-56:2017 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
1. ASTM E1965-98(2016) Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

Clinical accuracy validation:

A comparison study and clinical repeatability testing was performed on the following three age groups: 0-12 months, 12 months - 5 years - 5 years older in accordance with ISO 80601-2-56 to compare the Infrared Forehead Thermometer (Model IR-FT) with Vitreous thermometer. This clinical comparison study demonstrated that the temperatures obtained with the Infrared Forehead Thermometer (Model IR-FT) were highly related when compared to the Vitreous thermometer, the clinical bias with stated uncertainty and clinical repeatability as defined in the ISO 80601-2-56 standard were within clinical acceptability, the results shows substantial equivalence.

Biocompatibility:

1. ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
1. ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro cytotoxicity
1. ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitization

The tests were selected to show substantial equivalence between the subject device and the predicate.

9. Conclusion

Based on the safety and performance testing and compliance with acceptable voluntary standard, we believe that the Infrared Forehead Thermometer (Model IR-FT) is substantially equivalent to the predicate device (K134043), and does not raise any new safety and effectiveness issues.