Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a direct measurement of infrared radiation and a simple conversion ("ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature"). There is no mention of AI, ML, or complex algorithms that would suggest their use. The performance studies focus on standard clinical metrics for thermometers.

Therapeutic

No
The device is described as a thermometer intended for the determination of human body temperature, not for therapeutic purposes. It measures temperature but does not treat any condition.

Diagnostic

No

Explanation: The device is a thermometer intended for the intermittent determination of human body temperature. While temperature can be a diagnostic indicator, the device itself only measures temperature and is not described as performing diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a hand-held device powered by batteries and includes hardware components like a lens and detector to measure infrared radiation.

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).
Device Function: The HeTaiDa non-contact infrared body thermometers measure human body temperature by detecting infrared radiation emitted from the forehead. This is a direct measurement of a physiological parameter on the living body, not a test performed on a sample taken from the body.

The device description and intended use clearly indicate that it is a thermometer for measuring body temperature externally, which falls under the category of a general medical device, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.

Product codes

FLL

Device Description

The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The thermometers HTD8818A, HTD8816C and HTD8808C infer 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 thermometer design consists 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. This permits temperature measurement from a distance without contact with the object to be measured.

The three models HTD8818A,HTD8816C,HTD8808C are bundled in this one 510k submission based on the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission. The HTD8818A, HTD8816C, HTD8808C thermometers present scientific and regulatory issues that can be addressed during one review. Their indications for use, safety and performance data, biocompatibility, clinical evaluation data, and electromagnetic compatibility data are identical. The only differences among the HTD8818A, HTD8816C, HTD8808C thermometers are size, weight, shape of enclosure, printed circuit board (PCB) layout and measuring distances.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Forehead

Indicated Patient Age Range

all ages

Intended User / Care Setting

clinical and home use environment

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 (study type, sample size, AUC, MRMC, standalone performance, key results)

A clinical investigation was performed to evaluate the clinical bias, clinical accuracy and clinical repeatability. The four groups of subjects being tested were:
(1) 0 3 months, (2) 3 months 1 year old, (3) 1 5 years old, and (4) >5 years older.
Each group of subjects underwent a series of temperature measurement at their forehead using HTD8818A, HTD8816C and HTD8808C non-contact infrared body thermometers. All the subject groups also underwent a series of temperature measurement using a reference contact clinical electronic thermometer BT-21H, which temperatures were measured in the axillary of patients. These temperature measurements were then each compared to the temperature measurements taken by the HeTaiDa non-contact infrared body thermometers. The clinical bias, clinical accuracy and clinical repeatability of the HeTaiDa-thermometers are calculated to be -0.027, ±0.14, and 0.07, respectively, which are within the clinically acceptable range as required by ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009). These clinical results indicate that the HeTaiDa non-contact infrared thermometers produce effective and accurate temperature measurements.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Clinical bias: -0.027
Clinical accuracy: +/-0.14
Clinical repeatability: 0.07

Predicate Device(s)

K160802

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

0

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1

K171888

5. 510(k) Summary

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

Date: July 15th, 2018

1. Company making the submission: Name - HeTaiDa Technology Co., Ltd Address - 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. Tel: 86-13923426692 Contact – Tom ZhenGuang Chen General Manager Email - tomchen@hetaida.com.cn
1. U.S. Correspondent and Contact Name: Elliot Medical Solutions Address: 18586 Parkland Drive, Shaker Heights, Ohio, 44122, U.S.A. Contact: Roman Huang General Manager Tel: 216-262-0962 Email: support@elliotmd.com
1. Device Name: Non-contact Infrared Body Thermometer Trade name: HeTaiDa-Thermometer Models: HTD8818A,HTD8816C,HTD8808C Common Name: Clinical electronic thermometer Classification Name: Thermometer, electronic, clinical Regulatory Class: II Product Code: FLL Type of 510(k) submission: Traditional
1. Predicate Device.

| Manufacturer | Predicate
Device | 510(k)
number |
|--------------------------------------------------|--------------------------------------------------------|------------------|
| Hangzhou
Universal
Electronic Co.,
Ltd. | Non-contact
infrared Body
thermometer
FT-100A | K160802 |

2

1. Description.
  The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient' forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.

The thermometers HTD8818A, HTD8816C and HTD8808C infer 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 thermometer design consists 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. This permits temperature measurement from a distance without contact with the object to be measured.

The three models HTD8818A,HTD8816C,HTD8808C are bundled in this one 510k submission based on the Guidance for Industry and FDA Staff; Bundling Multiple Devices or Multiple Indications in a Single Submission. The HTD8818A, HTD8816C, HTD8808C thermometers present scientific and regulatory issues that can be addressed during one review. Their indications for use, safety and performance data, biocompatibility, clinical evaluation data, and electromagnetic compatibility data are identical. The only differences among the HTD8818A, HTD8816C, HTD8808C thermometers are size, weight, shape of enclosure, printed circuit board (PCB) layout and measuring distances.

1. Indication for use.
  The HeTaiDa non-contact infrared body thermometers HTD8818A,HTD8816C, HTD8808C are non-sterile, reusable thermometers intended for the intermittent determination of human body temperature measured at the patients' forehead without contact. The devices are intended for use on people of all ages. The HTD8818A, HTD8816C, HTD8808C are intended for use in clinical and home use environment.
1. Similarities/Differences between the subject and predicate device.

| Element of

Comparison	Subject Device(s)	Predicate Device	Comparison
Type of
Thermometer	Non-Contact Infrared
forehead thermometer
(Models: HTD8818A
HTD8816C
HTD8808C)	Non-contact Infrared
forehead thermometer,
(model: FT-100A)	Identical

3

510(k)	N/A	K160802	N/A
Indication for Use	The HeTaiDa electronic
thermometers
HTD8818A, HTD8816C
and HTD8808C are
infrared thermometers
which use 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 HTD8818A,
HTD8816C and
HTD8808C are intended
for use in the clinical and
homecare environment.	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 and clinical
use.	Identical
Temperature unit	°C or °F	°C or °F	Identical
Measurement
Range	Forehead:
34°C to 42.9°C (93.2°F to
109.2°F)
Surface (Object):
0°C to 100°C (32°F to
212°F)	Forehead:
32°C to 43°C (89.6°F
to 109.4°F)
Object:
0°C to 100°C (32°F to
212°F)	Similar
Operating
Temperature	15°C to 35°C (59°F to
95°F)	16°C to 40°C (60.8°F
to 104°F)	Similar
Operating
humidity	85% RH or less	95% RH or less	Similar
Storage
temperature	-20°C to 55°C (-4°F to
131°F)	-25°C to 55°C (-13°F
to 131°F)	Similar
Storage humidity	93% RH or less	95% RH or less	Similar
Accuracy	FOR BODY MODE:
34.0~34.9°C: ±0.3°C
(93.2-94.8°F: ±0.5°F);
35.0~42.0°C: ±0.2°C
(95.0-107.6°F: ±0.4°F);
42.1~42.9°C: ±0.3°C
(107.8-109.2°F: ±0.5°F);

FOR SURFACE MODE:
± 2°C (± 3.6 °F) | FOR BODY MODE:
±0.2°C (±0.4°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)

4

1. Comparison of Technological Characteristics with Predicate Device.
  The technological characteristics of the HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers and the predicate device (FT-100A) are similar. Both convert user's forehead temperature using the infrared energy emitted in the area around the user's forehead to a reference site equivalent temperature. The differences between the HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers and the predicate device FT-100 do not raise different questions of safety and effectiveness. The HeTaiDa Technology Co., Ltd believes that the noncontact infrared body thermometers HTD8818A, HTD8816C, HTD8808C are substantially equivalent to the (K160802) non-contact infrared body thermometer FT-100A of Universal Electronic Co., Ltd.

5

9. Safety and Performance Data.

Bench Data are listed in Table as below.

| Model | Bench Tests | Standards | Results | Report
File No. |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|---------|-----------------------------|
| HTD8818A
HTD8808C
HTD8816C | General requirements
for basic safety and
essential performance | IEC 60601-1:2005
(Third Edition) +
CORP. 1:2006 +
CORP. 2:2007 +
A1:2012 | Pass | GZME160
500034301
-01 |
| | 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 | IEC 60601-1-11 (First
Edition): 2010 | Pass | GZME160
500034302
-01 |
| | General requirements
for basic safety and
essential performance

Collateral Standard:
Electromagnetic
compatibility | IEC 60601-1-2:2014 | Pass | GZME170
100001901 |
| | EMC TEST | CFR 47 FCC Part 15,
Subpart B, Class B
2016 | Pass | NTC17051
46FV00 |
| | Particular
requirements for
basic safety and
essential performance
of clinical
thermometers for
body temperature
measurement | ISO 80601-2-56:2009
(First Edition) for use
in conjunction with
IEC 60601-1:2005
(Third edition) | Pass | GZME160
500034303
-01 |
| | Standard
specification for
infrared
thermometers for
intermittent
determination of
patient temperature | ASTM E1965-98
(Reapproved 2009) | Pass | GZME170
100001801 |

6

Biocompatibility data are listed in Table as below.

| Model | Biocompatibility
Tests of Final
Finished Device | Standards | Results | Report File No. |
|----------------------------------|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------------------------------------------------------|
| HTD8818A
HTD8808C
HTD8816C | In vitro
cytotoxicity with
10% FBS | ISO 10993-5:2009:
Biological
evaluation of
medical devices:
part 5: Tests for in
vitro cytotoxicity | Pass | SDWH-
M201800599-1
(HTD8808C),
SDWH-
M201800600-1
(HTD8816C),
SDWH-
M201800601-1
(HTD8818A) |
| | Skin sensitization
0.9%SC | ISO 10993-10,
Biological
evaluation of
medical device -
Part 10: Tests for
irritation and skin
sensitization. | Pass | SDWH-
M201800599-2
and -3
(HTD8808C), |
| | Skin sensitization
Cotton seed oil | | | SDWH-
M201800600-2
and -3
(HTD8816C),
SDWH-
M201800601-2
and -3
(HTD8818A) |
| | Skin irritation
0.9%SC | ISO 10993-10,
Biological
evaluation of
medical device -
Part 10: Tests for
irritation and skin
sensitization. | Pass | SDWH-
M201800599-4
and -5
(HTD8808C),
SDWH-
M201800600-4
and -5
(HTD8816C),
SDWH-
M201800601-4
and -5
(HTD8818A) |
| | Skin irritation
Cotton seed oil | | | |

7

A clinical investigation was performed to evaluate the clinical bias, clinical accuracy and clinical repeatability. The four groups of subjects being tested were:

(1) 0 3 months, (2) 3 months 1 year old, (3) 1 5 years old, and (4) >5 years older.
Each group of subjects underwent a series of temperature measurement at their forehead using HTD8818A, HTD8816C and HTD8808C non-contact infrared body thermometers. All the subject groups also underwent a series of temperature measurement using a reference contact clinical electronic thermometer BT-21H, which temperatures were measured in the axillary of patients. These temperature measurements were then each compared to the temperature measurements taken by the HeTaiDa non-contact infrared body thermometers. The clinical bias, clinical accuracy and clinical repeatability of the HeTaiDa-thermometers are calculated to be -0.027, ±0.14, and 0.07, respectively, which are within the clinically acceptable range as required by ISO 80601-2-56:2009 and ASTM 1965-68 (Reapproved 2009). These clinical results indicate that the HeTaiDa non-contact infrared thermometers produce effective and accurate temperature measurements.

The design of the submitted device specifications is substantially the same as the predicate, with minor difference in the operating temperature and humidity range, and storage temperature and humidity range.

11. Conclusions.

The HeTaiDa non-contact infrared body thermometers HTD8818A, HTD8816C and HTD8808C have similar intended use, principle of operation, and similar technological characteristics as the predicate device identified. Performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. Thus, in accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part807 and based on the information provided in this premarket notification, HeTaiDa Technology Co., Ltd. concludes that the Infrared Forehead Thermometers HTD8818A, HTD8816C, HTD8808C are substantially equivalent to predicate device.

End.

8

Image /page/8/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there 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, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

July 23, 2018

Hetaida Technology Co., Ltd % Roman Huang Elliiot Medical Solutions 18586 Parkland Drive Shaker Heights, Ohio 44122

Re: K171888

Trade/Device Name: Non-contact infrared body thermometer, HTD8818A, HTD8816C, and HTD8808C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 15, 2018 Received: July 6, 2018

Dear Roman Huang:

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.

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 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);

9

Page 2 - Roman Huang

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 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