(305 days)
Not Found
No
The summary describes a standard electronic thermometer that transmits data via Bluetooth. There is no mention of AI, ML, or any algorithms that would suggest the use of such technologies for temperature measurement or analysis.
No.
The device's stated intended use is solely for measuring human body temperature, not for treating or preventing any disease or condition.
No
The device is a thermometer used for measuring body temperature, which is a physiological measurement, not a diagnosis of a disease or condition.
No
The device description explicitly states it is composed of a body patch and retrieves temperature information from the patch, indicating a hardware component is included.
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 body (in vitro).
- FEMON Banana Thermometer Function: The FEMON Banana Thermometer measures human body temperature directly from the skin (armpit). It does not analyze any biological samples taken from the body.
Therefore, based on the provided information, the FEMON Banana Thermometer is a medical device used for temperature measurement, but it does not fit the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
armpit
Indicated Patient Age Range
29 days and older
Intended User / Care Setting
Over-The-Counter Use
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
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue.
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
1
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)
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.
| 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
(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:
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.
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8. Indications for Use
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 for patients from ages 29 days and older.
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 | FEMON | |
| Banana Thermometer | Fever Scout | |
| Manufacturer | LIFE SCIENCE | |
| TECHNOLOGY Inc. | VivaLink | |
| 510(k) Number | K180767 | K162137 |
| Product Code | FLL | FLL |
| Indications for | ||
| Use | 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 for | ||
| patients from ages 29 days and | ||
| older. | The wireless Fever Scout | |
| Continuous | ||
| Monitoring thermometer is a | ||
| noninvasive and re-usable | ||
| electronic device for home use. | ||
| This product is intended for non- | ||
| urgent ambulatory continuous armpit | ||
| body temperature | ||
| monitoring from ages 29 days and | ||
| older. | ||
| Display Use | ||
| Specification | iOS device display | |
| and Android device | ||
| display | iOS device display | |
| Working Voltage | 3.0V DC | 3.0V DC |
| Battery | 3.0v Lithium Button Cell | MS Lithium Rechargeable Battery |
| 3.0V | ||
| Reusability | Yes | Yes |
| Measurement | ||
| Range (°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 | ||
| Temperature | ||
| Unit | °C or °F | °C or °F |
| Signal | ||
| Transmission | Wireless 2.4G | |
| Bluetooth BLE | Wireless 2.4G | |
| Bluetooth BLE | ||
| Receiver | Wireless 2.4G Bluetooth BLE | |
| enabled smart devices running | ||
| Apple operating system iOS 9+ or | ||
| Android operating system 4.4+ | Wireless 2.4G Bluetooth BLE | |
| enabled smart devices running Apple | ||
| operating system | ||
| iPhone 5S+ or newer. | ||
| Operating | ||
| Condition | 5~40°C | |
| 15-90% RH | 10~40°C | |
| 15-85% RH | ||
| Anatomical | ||
| Application | Armpit peel-and- | |
| stick | ||
| contact thermometer | ||
| sensor | Armpit peel-and- | |
| stick | ||
| contact thermometer | ||
| sensor | ||
| Temperature | ||
| Measurement | ||
| Interval | • Fever Check option for intensive | |
| monitoring: continuous | ||
| measurement every second for 20 | ||
| secs. | ||
| • Continuous transmitter measures | ||
| body temperature every 5 | ||
| seconds (default setting). User can | ||
| change the setting to 30 seconds | ||
| or 60 seconds. | Continuous transmitter | |
| measures body | ||
| temperature every 15 | ||
| seconds | ||
| Standard | ||
| Conformance | 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.