The FEMON Banana Thermometer is a battery operated electronic device with intended use of measuring human body temperature. This device is intended for armpit temperature measurement from ages 29 days and older.

Device Description

The FEMON Banana Thermometer is a thermometer composed of a body patch to be directly attached to the patient's skin on armpit. The temperature information is then to be retrieved from the patch to the mobile phone application via Bluetooth.

AI/ML Overview

The FEMON Banana Thermometer is intended for armpit temperature measurement for patients aged 29 days and older.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Accuracy (°C): ±0.1°C between 35°C and 42°C	±0.1°C: 35~42°C

Important Note: The provided document states that the subject device's accuracy criteria are ±0.1°C for the entire range of 35-42°C, which is different and stricter than the predicate device's accuracy criteria (±0.1°C for 37-39°C and ±0.2°C for 35-37°C and 39-42°C). However, the document does not explicitly state an "acceptance criteria" but rather reports the device's performance. For the purpose of this table, the reported device performance for accuracy is assumed to be the acceptance criterion it aims to meet.

2. Sample size used for the test set and the data provenance:

The document states that "Clinical Accuracy Performance Testing (per ISO80601-2-56)" was performed. However, it does not specify the sample size used for this test set or the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not provided in the document for the clinical accuracy testing.

4. Adjudication method for the test set:

This information is not provided in the document for the clinical accuracy testing.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

No, an MRMC comparative effectiveness study is not mentioned in the provided document. The study performed was a clinical accuracy performance test for the device itself against a standard, not a comparison of human readers with and without AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Yes, a standalone performance study was done in the form of "Clinical Accuracy Performance Testing (per ISO80601-2-56)." This tests the device's accuracy in measuring temperature directly, without human interpretation or intervention in the measurement process itself.

7. The type of ground truth used:

The ground truth for the clinical accuracy performance testing was established by following the "ISO80601-2-56" standard. This standard typically dictates methods for determining the true or reference temperature, often involving a reference thermometer or a calibrated temperature bath to provide the gold standard for comparison.

8. The sample size for the training set:

This information is not applicable or not provided. The FEMON Banana Thermometer is an electronic thermometer, not an AI/machine learning algorithm that requires a training set in the conventional sense. Its performance is validated through direct measurement accuracy testing.

9. How the ground truth for the training set was established:

This information is not applicable as there is no training set for an electronic thermometer in the context of an AI/ML algorithm.

Summary

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January 22, 2019

Life Science Technology Inc. % Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA Inc. 690 Roosevelt Irvine, California 92620

Re: K180767

Trade/Device Name: FEMON Banana Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 19, 2018 Received: December 21, 2018

Dear Priscilla Chung:

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/cfpmp/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

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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 (QS) 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

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Indications for Use

510(k) Number (if known) K180767

Device Name FEMON Banana Thermometer

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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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

(K180767)

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

Date: January 22, 2019

1. 510K Applicant / Submitter:

Life Science Technology Inc. Suite B-1207, Gangseo Hangang Xi Tower, Yangcheon-ro 401, Gangseo-gu, Seoul, South Korea, 07528 Tel: +82-70-8620-8021

2. Submission Contact Person

LK Consulting Group USA, Inc. 690 Roosevelt, Irvine CA 92620 Priscilla Juhee Chung Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com

3. Device

Proprietary Name: FEMON BananaThermometer .
. Common Name: Electronic Thermometer
Classification: Class II (21 CFR 880.2910), Clinical Electronic Thermometer .
Product Code: FLL .

4. Predicate Device

. Primary Predicate Device: Fever Scout by VivaLink (K162137)

5. Description:

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8. Indications for Use

9. Substantial Equivalence Discussion:

The subject device, FEMON Banana Thermometer, has same intended use as the predicate device, and employs similar technology. The differences in the indications for use statement do not raise any different questions of safety or effectiveness.

The differences in technology do not raise different questions of safety and effectiveness. Like the predicate, the subject device functions to transmit continuous measurements of body temperature wirelessly to a mobile app. The device utilizes an adhesive that was evaluated for biocompatibility.

The technical specifications such as display device, working voltage, signal transmission, and receiver between the subject device and the predicate device are similar. The performance specifications such as measurement and accuracy range are similar as well.

The difference is that the subject device has 4 measurement interval options, whereas, the predicate device has only one option. The interval options of the subject device are offered to save battery life and also to choose intensive monitoring. This difference does not raise different questions in safety and performance because the user can choose the interval option for each situation.

	Subject Device	Primary Predicate Device
Device Name	FEMONBanana Thermometer	Fever Scout
Manufacturer	LIFE SCIENCETECHNOLOGY Inc.	VivaLink
510(k) Number	K180767	K162137
Product Code	FLL	FLL
Indications forUse	The FEMON Banana Thermometeris a battery operated electronicdevice with intended use ofmeasuring human body temperature.This device is intended for armpittemperature measurement forpatients from ages 29 days andolder.	The wireless Fever ScoutContinuousMonitoring thermometer is anoninvasive and re-usableelectronic device for home use.This product is intended for non-urgent ambulatory continuous armpitbody temperaturemonitoring from ages 29 days andolder.
Display UseSpecification	iOS device displayand Android devicedisplay	iOS device display
Working Voltage	3.0V DC	3.0V DC
Battery	3.0v Lithium Button Cell	MS Lithium Rechargeable Battery3.0V
Reusability	Yes	Yes
MeasurementRange (°C)	35~ 42°C	35~ 42°C
Accuracy (°C)	±0.1°C: 35~42°C	±0.1°C: 37 ~39°C.±0.2°C: 35 ~ 37°C and 39~42°C
TemperatureUnit	°C or °F	°C or °F
SignalTransmission	Wireless 2.4GBluetooth BLE	Wireless 2.4GBluetooth BLE
Receiver	Wireless 2.4G Bluetooth BLEenabled smart devices runningApple operating system iOS 9+ orAndroid operating system 4.4+	Wireless 2.4G Bluetooth BLEenabled smart devices running Appleoperating systemiPhone 5S+ or newer.
OperatingCondition	5~40°C15-90% RH	10~40°C15-85% RH
AnatomicalApplication	Armpit peel-and-stickcontact thermometersensor	Armpit peel-and-stickcontact thermometersensor
TemperatureMeasurementInterval	• Fever Check option for intensivemonitoring: continuousmeasurement every second for 20secs.• Continuous transmitter measuresbody temperature every 5seconds (default setting). User canchange the setting to 30 secondsor 60 seconds.	Continuous transmittermeasures bodytemperature every 15seconds
StandardConformance	IEC 60601-1,IEC 60601-1-2,IEC 60601-1-6,ISO 80601-2-56,ISO 10993-1,ISO 10993-5,ISO 10993-10	IEC 60601-1,IEC 60601-1-2,ISO 10993-1,ISO 10993-5,ISO 10993-10

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10. Performance Tests

The following performance testing was included to support a determination of substantial equivalence of the device to the predicate:

Clinical Accuracy Performance Testing (per ISO80601-2-56) ●
. The EMC and Electrical Safety Testing (per IEC 60601-1 and IEC 60601-1-2
Software Verification and Validation Testing in according with FDA Guidance for ● Software in Medical Devices
Biocompatibility Tests (Cytotoxicity, Sensitization, Irritation) per ISO 10993. ●

The test results of the above tests performed on the subject device supported that it is substantially equivalent to the predicate device.

11. Conclusions:

Based on the information provided in this premarket notification, Life Science Technology Inc. concludes that the FEMON Banana Thermometer is substantially equivalent to the predicate device as described herein in.

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.