Fever Garde

K191978 · Hubdic Co., Ltd. · FLL · Dec 18, 2020 · General Hospital

Device Facts

• Record ID: K191978
• Device Name: Fever Garde
• Applicant: Hubdic Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Dec 18, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Device is a battery-operated, wearable, contact electronic thermometer for armpit temperature monitoring. Sensor uses heat-sensitive resistance to measure temperature; software calculates temperature factoring in room temperature. Data transmitted via Bluetooth (2.4G) to mobile device running H-Health application at 20-second intervals. Application displays temperature, provides alerts for user-set high/low thresholds, and monitors connection status. Used in home settings by patients or caregivers. Healthcare providers review data via mobile device to support clinical decision-making for non-urgent monitoring. Benefits include continuous, non-invasive temperature tracking.

Clinical Evidence

No clinical data. Bench testing only. Performance verified via laboratory accuracy testing (34-42°C range, ±0.1°C accuracy), response time (171.3s heating, 113.8s cooling), adhesion testing, and wireless connectivity/data transfer validation. Biocompatibility confirmed per ISO 10993-1, -5, and -10. Electrical safety and EMC testing performed per IEC 60601-1 and IEC 60601-1-2.

Technological Characteristics

Wearable contact thermometer; silicone and acrylate materials. Sensing principle: resistance change with heat. Energy: 3.7V Lithium-polymer rechargeable battery. Connectivity: Bluetooth BLE 4.2+. Standards: ISO 10993, IEC 60601-1, IEC 60601-1-2, ISO 80601-2-56. Software level of concern: moderate.

Indications for Use

Indicated for non-urgent ambulatory continuous armpit body temperature monitoring in patients 29 days and older in a home environment.

Regulatory Classification

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.

Special Controls

(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.

Predicate Devices

• Fever Scout™Continuous Monitoring Thermometer (K181013)

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# 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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# 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

3) Tel : [phone]

4) Fax :[phone]

5) Contact person : Peter Chung, 412-512-8802

6) Contact person address : 300, Atwood Street, Pittsburgh, PA, 15213, USA

7) Date Prepared: December. 08, 2020

# 2. Device Information

- 1) Trade Name: Fever Garde, Model HMT-100
- 2) Common Name : Bluetooth Wearable Thermometer
- 3) Classification Name : Clinical Electronic Thermometer

4) Product Code : FLL

- 5) RegulationNumber: 21 CFR 880.2910
- 6) Class of device: Class II
- 7) 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.

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#### 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<br>Fever Scout™Continuous<br>Monitoring Thermometer | Substantially<br>Equivalent or<br>Not<br>Substantially<br>Equivalent |
|------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| 510(k) Number | K191978 | K181013 | N/A |
| Common Name | Bluetooth Wearable<br>thermometer | Armpit thermometer | N/A |
| Trade Name | Fever Garde, Model HMT-<br>100 | Fever Scout™Continuous<br>Monitoring Thermometer | N/A |
| Manufacturer | HuBDIC Co., Ltd. | VivaLNK Inc. | N/A |
| Product<br>Classification | II | II | Same |
| Indications for use | The Bluetooth Wearable<br>Thermometer, model HMT-<br>100 is a battery-operated<br>electronic device with an<br>intended use of measuring<br>human armpit temperature<br>and transmitting wireless<br>signal of the measuring<br>results to a mobile device,<br>monitoring armpit body<br>temperature for home use.<br>This product is a non-<br>invasive and re-usable<br>electronic device for<br>multiple patients at home.<br>This product is intended<br>for non-urgent ambulatory<br>continuous armpit body<br>temperature monitoring<br>from ages 29 days and<br>older. | The wireless Fever Scout<br>Continuous Monitoring<br>thermometer is a non-<br>invasive and re-usable<br>electronic device for<br>home use. This product in<br>intended for non-urgent<br>ambulatory continuous<br>armpit body temperature<br>monitoring from ages 29<br>days and older | Similar 1 |
| Display Use<br>Specification | Apple device and Android<br>device display | Apple device and Android<br>device display | Same |
| Working Voltage | 3.7 V DC | 3.0 V DC | Different 1 |
| Battery | Lithium-polymer<br>Rechargeable Battery 3.7V | MS Lithium Rechargeable<br>Battery 3.0V | Different 2 |
| Measurement Range | 34~42°C | 35~42°C | Similar 2 |
| Accuracy | ±0.1°C | ±0.1°C From 37~39°C<br>±0.2°C From 35~37°C and<br>39~42°C | Same |
| Signal Transmission | Wireless 2.4G<br>Bluetooth BLE | Wireless 2.4G<br>Bluetooth BLE | Same |
| Contact area | Skin(Surface device) | Skin(Surface device) | Same |
| Contact duration | A-Limited(<24hours) | A-Limited(<24hours) | Same |
| Receiver | Bluetooth: 4.2+/ IOS system:<br>IOS 8.0+/ Android system:<br>5.0(lollipop)+) | Wireless 2.4G<br>Bluetooth BLE enabled<br>smart devices running<br>Apple devices:<br>iPhone 5S+ or later, and<br>iOS 8.0 or later, and<br>Android device: 4.3 or<br>later. | Different 3 |
| Anatomical<br>Application | Axillary(armpit)<br>temperature measuring<br>and monitoring | Axillary(armpit)<br>temperature measuring<br>and monitoring | Same |
| Principle of<br>operation | The Sensor detects heat<br>and measures the<br>temperature using a<br>resistance that changes<br>with heat. Displays the<br>highest temperature among<br>consecutive temeprature<br>readings. | The Sensor detects heat<br>and measures the<br>temperature using a<br>resistance that changes<br>with heat. Displays the<br>highest temperature<br>among consecutive<br>temeprature readings. | Same |
| Re-useable Band | Re-useable Band | Re-useable Band | Same |
| Device major<br>components | Contact Skin<br>Band | Contact Skin<br>Band | Same |
| Patient contain<br>materials | Silicone and Acrylate | Silicone and Acrylate | Same |
| Specification<br>including operation<br>environment<br>temperature and<br>humidity level | 10~40°C/15~90% | 10~40°C/15~85% | Different 4 |
| Transmission<br>distance | 3~5m | 4.9ft | Different 5 |
| Response time | 170 Seconds | 8 minutes | Different 6 |
| Biocompatibility | Conformed to ISO 10993-1,<br>ISO10993-5,and<br>ISO10993-10 | Conformed to ISO 10993-<br>1, ISO 10993-5, and ISO<br>10993-10 | Same |
| Electrical Safety | Conformed to IEC 60601-1 | Conformed to IEC 60601-<br>1 | Same |
| Electromagnetic<br>Compatibility | Conformed to IEC 60601-1-<br>2 | Conformed to IEC 60601-<br>1-2 | Same |

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#### • Similar 1

The indications for use of the subject device Fever Garde, Model HMT- 100 is similar to the predicate device. Both subjectdevice and predicate contain characteristics of data transferring, battery-operated and home use. The indications for use of the subject device includes these characteristics but not described in the predicate device. The difference does not affect safety and effectiveness.

#### • Similar 2

The measuring range of the subject device and the predicate device is similar. The measuring range of the subject device is 1℃ wider that complies with performance standard. It does not affect safety and effectiveness.

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• Different 1

The rated voltage is 0.7V higher than the predicatedevice, but the IEC60601-1 electric sfety test was conducted, and it does not affect safety and effectiveness.

• Different 2

Although the battery specifications are different, the subject device has passed the IEC60601 - 1 test and it does not affect safety and effectiveness.

• Different 3

Reciever's specifications are different, the subject passed the test according to EN 300 328 and EN 62479 standards, and it does not affect safety and effectiveness.

• Different 4:

The operating temperature is the same. but the operating humidity is different. The operating humidity range of the subject device is wider than the predicate device. The performance test was conducted within the operating environment for the subject device. The difference does not affect safety and effectiveness.

• Different 5:

The monitoring distance of the subject device is longer than the predicate device. The subject device passed the test according to the standards of EN 300 328 and EN 62479, and it does not affect safety and effectiveness.

• Different 6:

The response time of the subject device is shorter than the predicate. The subject device has been tested for response time according to IEC60601-1. The difference does not affect safety and effectiveness.

| No. | Test Identification | Test method | |
|-----|---------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-------------------------|
| | | Test Criteria | Test result |
| 1 | Evaluation and Testing | ISO 10993-1: Evaluation and testing | Pass |
| 2 | Cytotoxicity MEM Elution<br>Method (Cytotoxicity) | ISO10993-5: Tests for Cytotoxicity, in vitro Methods | |
| | | Cytotoxicity: 0<br>Interpretation: Noncytotoxic | Not cytotoxic<br>(Pass) |
| 3 | Sensitization | ISO 10993-10: Test for Irritation and sensitization 6.2 Maximization<br>sensitization test | |
| | | Grading scale: 0<br>Patch test reaction: No visible<br>change | No evidence<br>(Pass) |
| 4 | Acute Intracutaneous<br>Reactivity | ISO10993-10: Test for Irritation and sensitization<br>5.4 Intracutaneous reactivity test | |
| | | The requirements of the test are met<br>If the difference between the test<br>sample and the vehicle blank mean<br>score is 1.0 or less | No evidence<br>(Pass) |

#### 7. Non-Clinical Testing

- 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 Page4 / 5

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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

| No. | Title | Results summary |
|-----|-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Display | Measured value displayed |
| 2 | Charging operation | Device not operating |
| 3 | Communication failure | Notification indicated |
| 4 | Temperature<br>notification | High and Low indication displayed |
| 5 | Internal battery status | Internal battery status displayed |
| 6 | Laboratory Accuracy | Rated Output Range: 34~42°C<br>Equation(0.1°C) |
| 7 | Time Response-heating<br>transient time | 171.3 Seconds |
| 8 | Time Response-cooling<br>transient time | 113.8 Seconds |
| 9 | Movement test | |
| 9-1 | Before the test | Within 30s without moving the sample,<br>H-Health application alarm sounded |
| 9-2 | During the test | While the sample was moving, H-Health<br>application alarm not sounded |
| 9-3 | After the test | Within 30s without moving the sample,<br>H-Health application alarm sounded |
| 10 | Adhesion Test | The product was attached to the armpit<br>with an adhesive band for 24 hours and<br>checked to ensure that it did not fall. |
| 11 | Monitoring Distance<br>Test | After moving the product and mobile<br>device to a distance of 3m, it was<br>confirmed that the connection was not<br>disconnected for 24 hours, and the<br>product and mobile device were not<br>disconnected for all participants. |
| 12 | Data Transfer Test | After attaching the product, it was<br>checked the body temperature data<br>was transmitted to all participants. |

#### Software Verification and Validation Testing

Software verification and validation testingwere 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." The software of the subject device was considered as a "moderate" level of concern.

#### Cybersecurity Testing

Cybersecurity testing was performed for the subject device. This testing confirmed that appropriate information security controls are implemented to preserve the integrity, confidentiality, and availability of its information based on considerations of 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".

#### 8. Conclusion:

Based on the performance testing, comparison, and analysis, the substantially equivalent to the predicate device.