K Number

Device Name

Infrared thermometer

Manufacturer

Shenzhen Pango Electronic Co., Ltd

Date Cleared

2019-04-03

(195 days)

Product Code

FLL

Regulation Number

880.2910

Intended Use

PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal. PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead. PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead. The device can be used on people of all ages.

Device Description

The proposed device includes 3 models, which are PG-IRT1602 and PG-IRT1603. It includes infrared thermometers and is intended for people of all age. The proposed device, Infrared Ear Thermometers, Model PG-IRT1601, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal. The proposed device, Infrared Skin Thermometers, Model PG-IRT1602, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 3cm~5cm. The proposed device, Infrared Ear/Forehead Thermometer, Model PG-IRT1603, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal or forehead. The distance of the measurement is 3~5cm while measuring the forehead temperature.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K152748, K163516

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a standard infrared thermometer.

Therapeutic

No
The device is described as an infrared thermometer intended to measure human body temperature. It performs a diagnostic function (measuring temperature) rather than providing therapy or treatment.

Diagnostic

The device is an infrared thermometer intended to measure human body temperature. While temperature can be an indicator, the device itself only measures a physiological parameter and does not diagnose a condition or disease.

SaMD (Software as a Medical Device)

The device description explicitly states that the proposed device includes infrared thermometers which are hand-held, reusable, and battery-powered, indicating a hardware component.

IVD (In Vitro Diagnostic)

Based on the provided information, 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.
Device function: The described device is an infrared thermometer that measures human body temperature by sensing infrared radiation from the ear canal or forehead. It does not perform any tests on samples taken from the body.
Intended Use: The intended use is to measure human body temperature, which is a direct measurement of a physiological parameter, not an analysis of a biological sample.

Therefore, while it is a medical device, it falls under a different classification than In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The device can be used on people of all ages.

Product codes (comma separated list FDA assigned to the subject device)

FLL

Device Description

The proposed device includes 3 models, which are PG-IRT1602 and PG-IRT1603. It includes infrared thermometers and is intended for people of all age.

The proposed device, Infrared Ear Thermometers, Model PG-IRT1601, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal.

The proposed device, Infrared Skin Thermometers, Model PG-IRT1602, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring forehead. The distance of the measurement is 3cm~5cm.

The proposed device, Infrared Ear/Forehead Thermometer, Model PG-IRT1603, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal or forehead. The distance of the measurement is 3~5cm while measuring the forehead temperature.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Ear canal, Forehead

Indicated Patient Age Range

all ages

Intended User / Care Setting

Not Found

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

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Controlled human clinical studies were conducted on 3 models of proposed device with predicates in accordance with ASTM E1965-98, clinical bias, clinical uncertainty and clinical repeatability have been evaluated per clinical validation for infrared thermometer. The clinical trial results verify that the clinical accuracy of the proposed device is not inferior to that of predicate device.

Total 130 subjects and three age groups, including age 0~~1 (50 subjects), age 1~~5 (40 subjects) and age above 5 (40 subjects) are included in each clinical study, the amounts of male subjects are the same with that of female subjects, including febrile and afebrile persons. Compared statistical result of clinical bias and clinical repeatability of two comparison groups, the results of proposed device are not being inferior to that of predicate device. The result of proposed device was not inferior to that of predicate device, and the proposed device complies with ASTM E1965-98.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K152748, K163516

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

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

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA acronym with the agency's name on the right. The symbol on the left is a stylized representation of human services. To the right of the symbol is a blue square containing the acronym "FDA" in white letters. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.

April 3, 2019

Shenzhen Pango Electronic Co., Ltd % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai. 200120 China

Re: K182597

Trade/Device Name: Infrared thermometer, Model: PG-IRT1601, PG-IRT1602, PG-IRT1603 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 27, 2019 Received: March 6, 2019

Dear Ms. Diana Hong:

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 avare 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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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,

Sapana Patel -S

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

Indications for Use

510(k) Number (if known)

K182597

Device Name

Infrared Thermometer, PG-IRT1601, PG-IRT1602 and PG-IRT1603

Indications for Use (Describe)

The device can be used on people of all ages.

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

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K182597

1. Date of Preparation: 03/19/2019
1. Sponsor Identification

Shenzhen Pango Electronic Co ., Ltd

No. 25, 1st Industry Zone, Fenghuang Road, Xikeng Village, Henggang Town, Longgang District, Shenzhen, Guangdong, 518115, China

Establishment Registration Number: 3006792041

Contact Person: Youjian Xie Position: Technical Director Tel: +86-755-33825988-301 Fax: +86-755-33825989 Email: xie you jian@163.com

3. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Mr. Chengyu Wang (Alternative Contact Person)

Mid-Link Consulting Co., Ltd

P.O. Box 120-119, Shanghai, 200120, China

Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net

4. Identification of Proposed Device

Trade Name: Infrared thermometer Common Name: Clinical electronic thermometer Model(s): PG-IRT1601, PG-IRT1602 and PG-IRT1603

Regulatory Information

Classification Name: Clinical electronic thermometer Classification: Class II Product Code: FLL Regulation Number: 21 CFR 880.2910 Review Panel: General Hospital

Indications for Use Statement:

PG-IRT1601 Infrared Ear Thermometer is intended to measure human body temperature by measuring ear canal.

PG-IRT1602 Infrared Forehead Thermometer is intended to measure human body temperature by measuring forehead.

PG-IRT1603 Infrared Ear/Forehead Thermometer is intended to measure human body temperature by measuring ear canal or forehead.

The device can be used on people of all ages.

Device Description

The proposed device includes 3 models, which are PG-IRT1602 and PG-IRT1603. It includes infrared thermometers and is intended for people of all age.

The proposed device, Infrared Ear Thermometers, Model PG-IRT1601, is hand-held, reusable, battery powered device, which is intended to measure human body temperature by measuring ear canal.

Principle of operation

The proposed device uses a temperature sensor, which can detect the object temperature (OBJ) [human

body temperature], environment temperature (NTC) and temperature of sensor itself (AMB); these temperatures are then transfer to electronic signal and amplified; and then it is transferred to digital signal by AD module (signal conversion module) in MCU (Microcontroller Unit) of the proposed device. MCU will calculate the body temperature based on OBJ, NTC and AMB, and then transfer to screen for display.

Identification of Predicate Devices 5.
Predicate Device 1 510(k) Number: K152748; Device Name: Braun Thermoscan® PRO 6000 Ear Thermometer

Predicate Device 2 510(k) Number: K163516; Device Name: Braun No Touch + Forehead NTF3000 Thermometer;

Non-Clinical Test Conclusion 6.
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) medical electrical equipment - part 1: general requirements for basic safety and essential performance.
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility -Requirements And Tests.
ISO 80601-2-56 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements For Basic Safety And Essential Performance Of Clinical Thermometers For Body Temperature Measurement.
A ASTM E1965-98 (R 2016), Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.

7. Clinical Test Conclusion

8. Substantially Equivalent (SE) Comparison

ITEM	Proposed device	Predicate Device 1	Predicate Device 2	Remark
		K152748	K163516
Product Code	FLL	FLL	FLL	Same
Regulation
Number	21 CFR 880.2910	21 CFR 880.2910	21 CFR 880.2910	Same
Intended Use	PG-IRT1601 Infrared
Ear Thermometer is
intended to measure
human body
temperature by
measuring ear canal.
PG-IRT1602 Infrared
Forehead
Thermometer is
intended to measure
human body
temperature by
measuring forehead.
PG-IRT1603 Infrared
Ear/Forehead
Thermometer is
intended to measure
human body	The Braun
Thermoscan® PRO
6000 Ear
Thermometer is
indicated for the
intermittent
measurement and
monitoring of human
body temperature for
patients of all ages in
a professional use
environment. The
probe cover is used
as a sanitary barrier
between the infrared
thermometer and the
ear canal.	The Braun No Touch
Forehead +
NTF3000
Thermometer is a
non-sterile, reusable
clinical thermometer
intended for the
intermittent
determination of
human body
temperature in a
touch and no touch
mode on the center
of the forehead as
the measurement site
on people of all
ages.	Discussion
1
	temperature
by
measuring ear canal
or forehead.
The device can be
used on people of all
ages.
Measurement
Site	Forehead and/or
eardrum	Eardrum	Forehead	Same
Principle of
Operation	Non-contacting,
Infrared Temperature
Measurement	Non-contacting,
Infrared Temperature
Measurement	Contacting or
non-contacting,
Infrared Temperature
Measurement	Same
Ear Mode
Range	34.0°C-43.0°C	32.0°C-42.9°C	/	Discussion
2
Accuracy	±0.2 °C at 35.0 °C
-42.0°C
Others ±0.3 °C	±0.2°C at
35.5°C-42.0°C
Others ±0.3°C	/	Same
Forehead Mode
Measurement
distance	3~5cm	/	Unknown	Discussion
2
Range	34. 0°C-43.0°C	/	34.4°C-42.2°C	Discussion
2
Accuracy	±0.2 °C at 35.0 °C
-42.0°C
Others ±0.3°C	/	±0.2°C at
35.0°C-42.0°C
±0.3°C at
31.0°C-35.0°C
Above 42.0°C
±0.3°C	Same
Display type	LCD	LCD	LCD	Same
Activation	Scan button	Scan button	Scan button	Same
Power
requirements	Two pieces of 1.5V
AAA (number seven)
batteries	Two AA Alkaline
Batteries or Custom
Nickel Metal
Hydride Battery Pack	Two AA batteries	Discussion
3
Safety	Complied with IEC
60601-1	Complied with IEC
60601-1	Complied with IEC
60601-1	Same
EMC	Complied with IEC
60601-1-2	Complied with IEC
60601-1-2	Complied with IEC
60601-1-2	Same
Performance	Complied with ISO
80601-2-56	Complied with ISO
80601-2-56	Complied with ISO
80601-2-56	Same
	Complied with
ASTM E 1965 -98
(2003)	Complied with
ASTM E 1965 -98
(2003)	Complied with
ASTM E 1965 -98
(2003)	Same
Patient-contact
Materials	Shell Material: ABS
lens: PMMA
Button: High density
polyethylene
(HDPE)
Color additives	Common Materials-
including an impact
resistant casing.
Biocompatible
metals and resins.	Patient contacting
materials include
ABS (device
housing / handle and
power button) and
TPR (temperature
button and nose /
forehead touch
bumper).	Discussion
4
Biocompatibility	Complied with ISO
10993-5	Complied with ISO
10993-5	Complied with ISO
10993-5	Same
	Complied with ISO
10993-10	Complied with ISO
10993-10	Complied with ISO
10993-10	Same

Table 1 Comparison of Technology Characteristics

Discussion 1

The proposed device includes three models which respectively measure temperature by ear, by forehead and by ear or forehead. Predicate device 1 supports ear mode, and predicate device 2 supports forehead mode. The indications of proposed device can be covered by predicate 1 and 2. And the proposed device is also intended for people of all age, which is the same with predicates. The difference does not raise different safety and effectiveness issues.

Discussion 2

The measurement ranges and distance of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of performance identified in the standards. The difference does not raise different performance questions.

Discussion 3

The batteries of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of electrical safety identified in the standards. The difference does not raise different safety and effectiveness issues.

Discussion 4

The patient-contact materials of proposed device are different from that of predicate device. However, the proposed device has been demonstrated to comply with the requirements of biocompatibility identified in the standards. The difference does not raise different safety and effectiveness issues.

Substantially Equivalent (SE) Conclusion 9.

Based on the performance testing, comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.