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.

AI/ML Overview

The provided document is a 510(k) Summary for an Infrared Thermometer. It describes the device's indications for use, design, and the testing conducted to demonstrate its substantial equivalence to predicate devices. However, this document does not contain the detailed acceptance criteria and study results in the format requested. Specifically, it talks about clinical and non-clinical tests verifying compliance with standards like ASTM E1965-98, but it does not provide:

A table of specific numerical acceptance criteria for performance metrics (e.g., accuracy +/- X degrees C) and the reported device performance against those specific criteria.
The exact sample size used for the test set in the clinical study (it states 130 subjects for each clinical study, implying 3 studies for the 3 models, but doesn't break down by test set vs. training set or specific age groups for overall "clinical study" rather than a dedicated "test set").
Data provenance beyond "clinical trial results."
Details on expert involvement, ground truth establishment methods (beyond "clinical validation"), or adjudication methods.
Any information regarding MRMC studies, standalone AI performance, or training set details.

The document focuses on demonstrating compliance with recognized standards and similarity to predicate devices, rather than providing raw performance data against predefined acceptance criteria for a novel AI/algorithm. This is typical for a 510(k) submission for a non-AI medical device like a thermometer, where compliance with performance standards and safety is key for substantial equivalence.

Therefore, I cannot provide the information in the requested format based on the text provided. The document is a regulatory submission for a simple medical device (infrared thermometer), not an AI algorithm.

If this were a submission for an AI/ML device, the content would have to include the specific details you've asked for because the performance evaluation of AI is very different from that of a basic electronic thermometer.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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}------------------------------------------------

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

{5}------------------------------------------------

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.

{6}------------------------------------------------

7. Clinical Test Conclusion

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.

8. Substantially Equivalent (SE) Comparison

ITEM	Proposed device	Predicate Device 1	Predicate Device 2	Remark
		K152748	K163516
Product Code	FLL	FLL	FLL	Same
RegulationNumber	21 CFR 880.2910	21 CFR 880.2910	21 CFR 880.2910	Same
Intended Use	PG-IRT1601 InfraredEar Thermometer isintended to measurehuman bodytemperature bymeasuring ear canal.PG-IRT1602 InfraredForeheadThermometer isintended to measurehuman bodytemperature bymeasuring forehead.PG-IRT1603 InfraredEar/ForeheadThermometer isintended to measurehuman body	The BraunThermoscan® PRO6000 EarThermometer isindicated for theintermittentmeasurement andmonitoring of humanbody temperature forpatients of all ages ina professional useenvironment. Theprobe cover is usedas a sanitary barrierbetween the infraredthermometer and theear canal.	The Braun No TouchForehead +NTF3000Thermometer is anon-sterile, reusableclinical thermometerintended for theintermittentdetermination ofhuman bodytemperature in atouch and no touchmode on the centerof the forehead asthe measurement siteon people of allages.	Discussion1
	temperaturebymeasuring ear canalor forehead.The device can beused on people of allages.
MeasurementSite	Forehead and/oreardrum	Eardrum	Forehead	Same
Principle ofOperation	Non-contacting,Infrared TemperatureMeasurement	Non-contacting,Infrared TemperatureMeasurement	Contacting ornon-contacting,Infrared TemperatureMeasurement	Same
Ear Mode
Range	34.0°C-43.0°C	32.0°C-42.9°C	/	Discussion2
Accuracy	±0.2 °C at 35.0 °C-42.0°COthers ±0.3 °C	±0.2°C at35.5°C-42.0°COthers ±0.3°C	/	Same
Forehead Mode
Measurementdistance	3~5cm	/	Unknown	Discussion2
Range	34. 0°C-43.0°C	/	34.4°C-42.2°C	Discussion2
Accuracy	±0.2 °C at 35.0 °C-42.0°COthers ±0.3°C	/	±0.2°C at35.0°C-42.0°C±0.3°C at31.0°C-35.0°CAbove 42.0°C±0.3°C	Same
Display type	LCD	LCD	LCD	Same
Activation	Scan button	Scan button	Scan button	Same
Powerrequirements	Two pieces of 1.5VAAA (number seven)batteries	Two AA AlkalineBatteries or CustomNickel MetalHydride Battery Pack	Two AA batteries	Discussion3
Safety	Complied with IEC60601-1	Complied with IEC60601-1	Complied with IEC60601-1	Same
EMC	Complied with IEC60601-1-2	Complied with IEC60601-1-2	Complied with IEC60601-1-2	Same
Performance	Complied with ISO80601-2-56	Complied with ISO80601-2-56	Complied with ISO80601-2-56	Same
	Complied withASTM E 1965 -98(2003)	Complied withASTM E 1965 -98(2003)	Complied withASTM E 1965 -98(2003)	Same
Patient-contactMaterials	Shell Material: ABSlens: PMMAButton: High densitypolyethylene(HDPE)Color additives	Common Materials-including an impactresistant casing.Biocompatiblemetals and resins.	Patient contactingmaterials includeABS (devicehousing / handle andpower button) andTPR (temperaturebutton and nose /forehead touchbumper).	Discussion4
Biocompatibility	Complied with ISO10993-5	Complied with ISO10993-5	Complied with ISO10993-5	Same
	Complied with ISO10993-10	Complied with ISO10993-10	Complied with ISO10993-10	Same

Table 1 Comparison of Technology Characteristics

{7}------------------------------------------------

{8}------------------------------------------------

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.

{9}------------------------------------------------

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.

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.