(513 days)
Not Found
No
The description details standard sensor technology, data transmission, and basic calculation/alerting logic, with no mention of AI/ML terms or concepts.
No.
The device is solely for monitoring body temperature and does not provide any therapeutic intervention.
No
Explanation: This device is a thermometer used for measuring and monitoring armpit temperature. It does not provide a medical diagnosis based on the temperature readings, but rather outputs the temperature measurement, which can then be used by a user or healthcare professional for diagnostic purposes.
No
The device description explicitly states it is a "Bluetooth Wearable Thermometer" which is a "contact electronic thermometer using a sensor to measure armpit temperature." It also mentions "hardware components" and "electrical safety" testing, indicating it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Bluetooth Wearable Thermometer measures body temperature directly from the armpit. It does not analyze a sample taken from the body.
- Intended Use: The intended use is to measure and monitor human armpit temperature, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device, specifically a thermometer, but not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use.
This product is a non-invasive and re-usable electronic device for multiple patients at home.
This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
Product codes
FLL
Device Description
The Bluetooth Wearable Thermometer is a contact electronic thermometer using a sensor to measure armpit temperature. The Sensor detects heatand measures the temperature using a resistance that changes with heat. Displays the highest temperatureamong consecutive temeprature readings. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device.
This product is in conjunction with the App, and information can be checked through a mobile device.
Application Name: H-Health
The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
human armpit
Indicated Patient Age Range
29 days and older.
Intended User / Care Setting
Home 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Evaluation and Testing: ISO 10993-1: Evaluation and testing, Pass
- Cytotoxicity MEM Elution Method (Cytotoxicity): ISO10993-5: Tests for Cytotoxicity, in vitro Methods, Cytotoxicity: 0, Interpretation: Noncytotoxic, Not cytotoxic (Pass)
- Sensitization: ISO 10993-10: Test for Irritation and sensitization 6.2 Maximization sensitization test, Grading scale: 0, Patch test reaction: No visible change, No evidence (Pass)
- Acute Intracutaneous Reactivity: ISO10993-10: Test for Irritation and sensitization 5.4 Intracutaneous reactivity test, The requirements of the test are met If the difference between the test sample and the vehicle blank mean score is 1.0 or less, No evidence (Pass)
- IEC60601-1 Medical electrical equipment Part1: Generalrequirementsfor safety and essential performance
- IEC60601-1 Medical electrical equipment Part1-6 – General requirements for safety and essential performance - Collateral Standard: Usability
- IEC60601-1 Medical electrical equipment Part1-11 - General requirements for safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- ISO80601-2-56 Medical electrical equipment – Part2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- IEC60601-1-2 Medicalelectrical equipment General requirements for basic safety and essential performance collateral standard Electromagnetic compatibility Requirements and tests
Test Results Summary:
- Display: Measured value displayed
- Charging operation: Device not operating
- Communication failure: Notification indicated
- Temperature notification: High and Low indication displayed
- Internal battery status: Internal battery status displayed
- Laboratory Accuracy: Rated Output Range: 34~42°C, Equation(0.1°C)
- Time Response-heating transient time: 171.3 Seconds
- Time Response-cooling transient time: 113.8 Seconds
- Movement test: Before the test, Within 30s without moving the sample, H-Health application alarm sounded; During the test, While the sample was moving, H-Health application alarm not sounded; After the test, Within 30s without moving the sample, H-Health application alarm sounded
- Adhesion Test: The product was attached to the armpit with an adhesive band for 24 hours and checked to ensure that it did not fall.
- Monitoring Distance Test: After moving the product and mobile device to a distance of 3m, it was confirmed that the connection was not disconnected for 24 hours, and the product and mobile device were not disconnected for all participants.
- Data Transfer Test: After attaching the product, it was checked the body temperature data was transmitted to all participants.
Software Verification and Validation Testing: Conducted in accordance with FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software was considered a "moderate" level of concern.
Cybersecurity Testing: Performed to confirm appropriate information security controls are implemented based on FDA's Guidance for Industry and FDA Staff, "Guidance for Industry and Food and Drug Administration Staff: Contentof Premarket Submissions for Management of Cybersecurity in Medical Devices".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 18, 2020
HuBDIC Co., Ltd. % Peter Chung President Plus Global 300 Atwood Pittsburgh, Pennsylvania 15213
Re: K191978
Trade/Device Name: Fever Garde, Model: HMT-100 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 16, 2020 Received: November 16, 2020
Dear Peter 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/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
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
CAPT Alan Stevens Acting Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K191978
Device Name Fever Garde, Model: HMT-100
Indications for Use (Describe)
The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use.
This product is a non-invasive and re-usable electronic device for multiple patients at home.
This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring 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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3
510(k) Summary
510(k) Summarv
K191978
[as required by 807.92(c)]
1. Applicant
1 ) Company : HuBDIC Co., Ltd.
2 ) Address : 301, 53, jeonpa-ro, Manan-gu, Anyang-si, Gyeonggi-do Korea, 14084
-
Tel : +82-31-441-8637
-
Fax :+82-31-442-4994
-
Contact person : Peter Chung, 412-512-8802
-
Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA
-
Date Prepared: December. 08, 2020
2. Device Information
-
- Trade Name: Fever Garde, Model HMT-100
-
- Common Name : Bluetooth Wearable Thermometer
-
- Classification Name : Clinical Electronic Thermometer
- Product Code : FLL
-
- RegulationNumber: 21 CFR 880.2910
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- Class of device: Class II
-
- Panel : General Hospital
3. The legally marketed device to which we are claiming equivalence:
K181013, Fever Scout™Continuous Monitoring Thermometer
4. Device description :
The Bluetooth Wearable Thermometer is a contact electronic thermometer using a sensor to measure armpit temperature. The Sensor detects heatand measures the temperature using a resistance that changes with heat. Displays the highest temperatureamong consecutive temeprature readings. Its software performs a calculation that factors in room temperature, and then a calculated temperature is displayed on the mobile device.
This product is in conjunction with the App, and information can be checked through a mobile device.
Application Name: H-Health
The control unit transmits the measurement data to the application wirelessly through the antenna at intervals of 20 seconds. The application displays the corresponding data on a mobile device. In addition, the application alerts the user by sound or vibration when the temperature is below the user-set minimum temperature or above the maximum temperature.
5. Indications for Use:
The Bluetooth Wearable Thermometer, model HMT-100 is a battery-operated electronic device with an intended use of measuring human armpit temperature and transmitting wireless signal of the measuring results to a mobile device, monitoring armpit body temperature for home use. This product is a non-invasive and re-usable electronic device for multiple patients at home. This product is intended for non-urgent ambulatory continuous armpit body temperature monitoring from ages 29 days and older.
4
6. Comparison of technological characteristics with the predicate device
The comparison of features and operation principles between the subject device Fever Garde (HMT-100) and predicate device Fever Scout™Continuous Monitoring Thermometer is listed as follows:
| Proprietary | Subject Device | Predicate Device
Fever Scout™Continuous
Monitoring Thermometer | Substantially
Equivalent or
Not
Substantially
Equivalent |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) Number | K191978 | K181013 | N/A |
| Common Name | Bluetooth Wearable
thermometer | Armpit thermometer | N/A |
| Trade Name | Fever Garde, Model HMT-
100 | Fever Scout™Continuous
Monitoring Thermometer | N/A |
| Manufacturer | HuBDIC Co., Ltd. | VivaLNK Inc. | N/A |
| Product
Classification | II | II | Same |
| Indications for use | The Bluetooth Wearable
Thermometer, model HMT-
100 is a battery-operated
electronic device with an
intended use of measuring
human armpit temperature
and transmitting wireless
signal of the measuring
results to a mobile device,
monitoring armpit body
temperature for home use.
This product is a non-
invasive and re-usable
electronic device for
multiple patients at home.
This product is intended
for non-urgent ambulatory
continuous armpit body
temperature monitoring
from ages 29 days and
older. | The wireless Fever Scout
Continuous Monitoring
thermometer is a non-
invasive and re-usable
electronic device for
home use. This product in
intended for non-urgent
ambulatory continuous
armpit body temperature
monitoring from ages 29
days and older | Similar 1 |
| Display Use
Specification | Apple device and Android
device display | Apple device and Android
device display | Same |
| Working Voltage | 3.7 V DC | 3.0 V DC | Different 1 |
| Battery | Lithium-polymer
Rechargeable Battery 3.7V | MS Lithium Rechargeable
Battery 3.0V | Different 2 |
| Measurement Range | 3442°C | 3542°C | Similar 2 |
| Accuracy | ±0.1°C | ±0.1°C From 3739°C37°C and
±0.2°C From 35
39~42°C | Same |
| Signal Transmission | Wireless 2.4G
Bluetooth BLE | Wireless 2.4G
Bluetooth BLE | Same |
| Contact area | Skin(Surface device) | Skin(Surface device) | Same |
| Contact duration | A-Limited(