Digital Thermometer

K172121 · Fudakang Industrial Co., Ltd. · FLL · Jun 7, 2018 · General Hospital

Device Facts

• Record ID: K172121
• Device Name: Digital Thermometer
• Applicant: Fudakang Industrial Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jun 7, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

Digital thermometers (Model: TP-100, TP-300, TP-400, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth (BLE) to Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.

Device Story

Digital thermometer uses thermistor sensor to measure oral or axillary body temperature; device transmits data via Bluetooth 4.0 to smart mobile devices (iOS/Android) running GuardiAngel App. Used by clinicians or consumers in hospital or home. App displays temperature results; enables monitoring. Benefits include remote temperature tracking and digital record keeping. Device powered by 3V lithium battery; housing constructed from ABS and silicone rubber; probe made of stainless steel 304.

Clinical Evidence

No clinical data. Bench testing only, including performance verification per ISO 80601-2-56, electrical safety (IEC 60601-1), EMC (IEC 60601-1-2), home healthcare environment requirements (IEC 60601-1-11), and wireless/radio frequency compliance (FCC Part 15, ETSI standards). Biocompatibility testing performed per ISO 10993-5 and ISO 10993-10.

Technological Characteristics

Thermistor-based digital thermometer. Materials: ABS housing, stainless steel 304 probe, silicone rubber, polyethylene tape. Power: 3V lithium battery. Connectivity: Bluetooth 4.0 (BLE). Dimensions/form factor: Handheld. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-56, ISO 10993-5/10.

Indications for Use

Indicated for oral or axillary temperature measurement and monitoring in adults, pediatrics, and infants by clinicians or consumers in hospital or home settings.

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

• Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) (K160308)
• Electronic Thermometer, Model WT1 and WT2 (K152739)

Submission Summary (Full Text)

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June 7, 2018

Fudakang Industrial Co., Ltd % Field Fu Shenzhen Joyantech Consulting Co., Ltd NO. 55 Shizhou Middle Road Nanshan District, Shenzhen, GD755 CHINA

Re: K172121

Trade/Device Name: Digital Thermometer Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: April 28, 2018 Received: May 9, 2018

Dear Field Fu:

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. 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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tina Kiang -

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) K172121

Device Name Digital Thermometer

Indications for Use (Describe)

Digital thermometers (Model: TP-100, TP-300, TP-300, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.

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

| ☐ Research involving HHS-conducted or -supported research | ☒ Secondary Research involving HHS-conducted or -supported research |
|-----------------------------------------------------------|---------------------------------------------------------------------|
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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

#### 1. Contact Details

1.1 Applicant information

| Applicant Name | Fudakang Industrial Co., Ltd. |
|-------------------------|------------------------------------------------------------------|
| Address | No.8 Yinghe Road, Yuanjiangyuan Management Zone, Changping Town, |
| | Dongguan City, Guangdong 523560, China |
| Phone No. | [phone] |
| Fax No. | [phone] |
| Contact person | Bob Yu |
| Contact person's e-mail | [e-mail] |
| Date Prepared | July 4, 2017 |
| Website | http://www.fudakang.com/ |

# 1.2 Submission Correspondent

| Image: logo | Shenzhen Joyantech Consulting Co., Ltd |
|-------------------------|--------------------------------------------------------------|
| | Room 1122, International Mayors Communication Centre, NO. 55 |
| | Shizhou middle road , Nanshan District, Shenzhen |
| 卓远天成 | |
| Phone No. | [phone] |
| Contact person | Field Fu; Christy Young; |
| Contact person's e-mail | [e-mail]; [e-mail] |
| Website | http://www.cefda.com |

#### 2. Device information

-

| Trade name | Digital Thermometer |
|---------------------|----------------------------------------------|
| Common name | Digital Thermometer |
| Model | TP100, TP200, TP300, TP400, TP500,BT-A31A-BT |
| Classification | II |
| Classification name | Clinical Electronic Thermometer |
| Product code | FLL |
| Regulation No. | 880.2910 |
| | |

#### ర్లు Legally Marketed Predicate Device

| Trade Name | Fudakang Bluetooth Digital Thermometer (Model: BT-A41CN-BT) |
|---------------|-------------------------------------------------------------|
| 510(k) Number | K160308 |
| Product Code | FLL |
| Manufacturer | Fudakang Industrial Co., Ltd. |

| Trade Name | Electronic Thermometer, Model WT1 and WT2 |
|---------------|-------------------------------------------|
| 510(k) Number | K152739 |
| Product Code | FLL |

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Guangdong Biolight Meditech Co., Ltd Manufacturer

#### 4. Device Description

The Digital Thermometer is a general purpose thermometer is intended for oral or axillary temperature measurements of the human body. The thermometer should be used with a smart phone or other Bluetooth smart device on which the GuadiAngel app is installed. The thermometer communicates with the user's device through a Bluetooth connection.

#### Intended Use/Indication for Use 5.

Digital thermometers (Model: TP-100, TP-300, TP-400, TP-500, BT-A31A-BT) is intended for the measurement and monitoring of oral or axillary for adult , pediatric and infant temperature via thermistor by doctor or consumers in the hospital or home. The result of measurement and monitoring will be transmitted via Bluetooth (BLE) to Bluetooth enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed.

| Item | Proposed Device:<br>Digital Thermometer | Predicate Device:<br>Fudakang Bluetooth Digital<br>Thermometer (Model:<br>BT-A41CN-BT) (K160308) | Predicate Device:<br>Electronic Thermometer,<br>Model WT1 and WT2<br>(K152739) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FLL | FLL | FLL |
| Regulation<br>number | 21 CFR 880.2910 | 21 CFR 880.2910 | 21 CFR 880.2910 |
| Manufacturer | Fudakang Industrial<br>Co., Ltd | Fudakang Industrial Co., Ltd | Guangdong Biolight<br>Meditech Co., Ltd |
| Intended Use | Digital thermometers<br>(Model: TP-100, TP-300,<br>TP-200, TP-500,<br>TP-400, BT-A31A-BT)<br>is intended for the<br>measurement and<br>monitoring of oral or<br>axillary for adult ,<br>pediatric and infant<br>temperature via<br>thermistor by doctor or<br>consumers in the<br>hospital or home. The<br>result of measurement<br>and monitoring will be<br>transmitted via<br>Bluetooth (BLE) to | Fudakang Bluetooth Digital<br>thermometer (Model:<br>BT-A41CN-BT) is intended for<br>the measurement and<br>monitoring of oral, axillary, and<br>rectal temperature of adults via a<br>thermistor. The device is for use<br>of a doctor or lay consumers in<br>the hospital or home. The result<br>of measurement can be<br>transmitted to smart mobile<br>device (cell phone, iPad) while<br>displayed on the LCD. | Electronic Thermometer is<br>intended for measuring and<br>monitoring human body<br>temperature orally and/or<br>under arm for adult, pediatric<br>and infant. It can be used in<br>healthcare facility and home. |
| | | | |
| | Bluetooth<br>enabled | | |
| | smart mobile device | | |
| | (cell phone, iPad) with | | |
| | GuardiAngel<br>App | | |
| | installed. | | |
| Thermometer<br>type | Digital thermometer | Digital thermometer | Digital thermometer |
| Sensor | Thermistor | Thermistor | Thermistor |
| Power<br>requirements | 1x3V Lithium battery | 1.5V button battery | Button cell |
| Battery life | Approx. 100 hours for<br>continuous operation or<br>approx.18 months<br>while used 10 minutes<br>per day. | Approx. 100 hours for continuous<br>operation. | Not available |
| Signal<br>processing and<br>display | Internal software and<br>display on smart phone | Internal software and display on<br>smart phone as well as LCD | Display in mobile application,<br>no display on device |
| Signal<br>transmission | Bluetooth 4.0 | Bluetooth 4.1 | Bluetooth 4.0 |
| Receiver<br>(mobile<br>terminal) | iOS or Android mobile<br>device | iOS or Android mobile device | iOS Mobile Device |
| Valid<br>transmission<br>distance | 10 meters | 10 meters | Not available |
| Measuring<br>range | 32.0-42.9℃( 89.6-109.<br>2°F ) | 32.0-42.9℃( 89.6-109.2℃) | 25.00°C~45.00°C |
| | ±0.1℃ 35.0-39.0℃ | ±0.1℃ 35.0-39.0℃ (±0.2℃ | ±0.1°C 25.00°C~34.99°C |
| Accuracy | (±0.2°F 95.0-102.2°F) | 95.0-102.2°F ) | ±0.05°C 35.00°C~38.50°C |
| | ±0.2℃ the rest | ±0.2℃ the rest | ±0.1℃ 38.51℃~45.00℃ |
| Temperature<br>unit | °C or °F | °C or °F | °C or °F |
| Operation<br>environment | 5~40°C; 15% to<br>85%RH | 5~40°C; 15% to 85%RH | Not available |
| Storage<br>environment | -20~55°C; ≤85%RH | -20~55°C; ≤85%RH | Not available |
| Skin-contacting<br>components | Housing, probe, tapes,<br>holders and silicone<br>patches | Housing, probe | Housing, probe, tapes |
| Materials of | Housing: ABS, liquid | Housing: ABS, silicone rubber | Stainless Steel, S216 |
| skin-contacting<br>components | silicone rubber<br>Probe: Stainless steel 304<br>Medical Tape:<br>Polyethylene<br>Silicone patch: Silicone<br>rubber mixture<br>Holder: ABS | Probe: stainless steel 304 | Polycarbonate (PC), 2458<br>Silicone, TPE<br>Non-Woven Cloth<br>Medical Melt Adhesive |

#### Substantial Equivalence Comparison 6.

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Version: A/2

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Version: A/2

### Proposed product: Digital Thermometer

Discussion of the differences:

The Digital Thermometer (Model: TP-100, TP-200, TP-400, TP-500, BT-A31A-BT) has similar indications for use and technological characteristics as the predicate device:

Digital Thermometer has the same intended use as the predicate device (K152739) : to measure human body temperature orally and/or under arm for adult, pediatric and infant.

The same and/or similar technologies and parameters are used in digital thermometers as the predicate device. The identified differences in technological characteristics do not raise new or different questions of safety and effectiveness. Although some specifications are slightly different from the predicate device, the thermometer quality has been verified and validated as a part of performance testing and safety /EMC testing and the results are included as a part of this submission. Performance information and evidence of compliance to recognized standards demonstrate the device is substantially equivalent to the predicate device.

The targeted device may connect to iOS device and Android device through wireless method, but the predicate device can only connect to iOS device. Risk analysis and associated verification (include cybersecurity test, FCC test and wireless verification) have been performed that the wireless feature is acceptable.

Both devices use similar materials for construction and have direct skin surface contact. The biocompatibility test reports for the different materials have been provided to determine the biocompatibility of the subject device. Based upon the same intended use, similar materials for device construction, product specification and operation, as well as performance testing, it could be concluded that the Digital Thermometer (Model: TP-100, TP-200, TP-300, TP-500, BT-A31A-BT) is substantially equivalent to the predicate device.

#### 7. Non-clinical studies and tests performed

Non-clinical tests were conducted to verify that the targeted device meet all design specifications in order to demonstrate that it is Substantially Equivalent to the predicate device.

The test results demonstrate that the targeted device complies with the following standards: IEC 60601-1Medical electrical equipment –Part 1: General requirements for basic safety and essential performance

IEC 60601-1-2 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance -Collateral standard: electromagnetic compatibility

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IEC 60601-1-11 Medical electrical equipment –Part 1-11: General requirements for basic safety and essential performance -Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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 CFR 47 FCC PART 15 Subpart C section 15.247 under the operating frequency of 2402~2480MHz ETSI EN301 489-1 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment and services; Part 1: Common technical requirements

ETSI EN 301 489-17 Electromagnetic compatibility and Radio spectrum Matters (ERM); ElectroMagnetic Compatibility (EMC) standard for radio equipment; Part 17: Specific conditions for Broadband Data Transmitting Systems

ETSI EN 300 328 Electromagnetic compatibility and Radio spectrum Matters (ERM); Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques: Harmonized EN covering the essential requirements of article 3.2 of the R&TTE Directive

### Software verification and validation:

Software documentation consistent with moderate level of concern is submitted in this 510(k). System validation testing presented in this 510(k) demonstrates that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels.

### Bio-compatibility test:

The body-contacting components of this device were tested according to: ISO 10993-5 Biological Evaluation of Medical Devices—Tests for In Vitro Cytotoxicity ISO 10993-10 Biological Evaluation of Medical Devices- Tests for Irritation and Skin Sensitization

#### 8. Clinical study

Not applicable.

#### Conclusion 9.

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate devices.