(329 days)
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.
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.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets those criteria:
Device: Digital Thermometer (Models: TP-100, TP-300, TP-400, TP-500, BT-A31A-BT)
Manufacturer: Fudakang Industrial Co., Ltd.
K Number: K172121
Based on the provided text, the device is a Digital Thermometer intended for measuring and monitoring oral or axillary temperature in adults, pediatric patients, and infants. It transmits measurements via Bluetooth to a smartphone or iPad with the GuardiAngel App installed.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance specifications and the standards the device claims to meet. The reported device performance is directly stated or implied by the assertion of compliance with these standards and the comparison to predicate devices.
| Acceptance Criteria (from text) | Reported Device Performance (from text) |
|---|---|
| Intended Use: Measurement and monitoring of oral or axillary temperature for adult, pediatric and infant via thermistor by doctor or consumers in the hospital or home. Transmission of results via Bluetooth (BLE) to a Bluetooth-enabled smart mobile device (cell phone, iPad) with GuardiAngel App installed. | The "Digital Thermometer (Model: TP-100, TP-300, TP-200, TP-500, TP-400, BT-A31A-BT) has similar indications for use and technological characteristics as the predicate device" (K152739), which includes measuring human body temperature orally and/or under arm for adult, pediatric and infant. Measures are transmitted via Bluetooth to a smart mobile device with GuardiAngel App. This indicates the device meets its stated intended use. |
| Measuring Range: 32.0-42.9℃ (89.6-109.2°F) | Device performance matches this range: 32.0-42.9℃ (89.6-109.2°F) |
| Accuracy: • ±0.1℃ for 35.0-39.0℃ (±0.2°F for 95.0-102.2°F)• ±0.2℃ for the rest of the range | Device performance matches this accuracy: • ±0.1℃ for 35.0-39.0℃ (±0.2°F for 95.0-102.2°F)• ±0.2℃ for the rest of the range |
| Wireless Connectivity: Connects to iOS and Android devices via Bluetooth. | The targeted device connects to iOS device and Android device through wireless method. "Risk analysis and associated verification (include cybersecurity test, FCC test and wireless verification) have been performed that the wireless feature is acceptable." This implies the device meets the functional requirements for wireless connectivity to both platforms. Specific standards for wireless communication (CFR 47 FCC PART 15 Subpart C section 15.247, ETSI EN301 489-1, ETSI EN 301 489-17, ETSI EN 300 328) were met. |
| Biocompatibility: Skin-contacting components (Housing, probe, tapes, holders, silicone patches) must be biocompatible. | "The biocompatibility test reports for the different materials have been provided to determine the biocompatibility of the subject device." Tested according to ISO 10993-5 (In Vitro Cytotoxicity) and ISO 10993-10 (Irritation and Skin Sensitization). The implication is that the device meets the biocompatibility requirements. |
| Electrical Safety: Compliance with general requirements for basic safety and essential performance. | Complies with IEC 60601-1 (Medical electrical equipment –Part 1: General requirements for basic safety and essential performance) and IEC 60601-1-11 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). |
| Electromagnetic Compatibility (EMC): Compliance with EMC standards. | Complies with IEC 60601-1-2 (Collateral standard: electromagnetic compatibility). |
| Clinical Thermometer Specific Performance: Compliance with particular requirements for basic safety and essential performance of clinical thermometers. | Complies with 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). |
| Software Verification and Validation: Software requirements met; hazards mitigated. | "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." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "Clinical study: Not applicable." This indicates that no clinical study involving human subjects or a test set of data with specific sample sizes was conducted or reported for this 510(k) submission. The device's performance was evaluated through non-clinical studies and testing against established standards, as well as a comparison to predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Given that no clinical study was performed, there was no test set with ground truth established by experts in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the established specifications and limits defined by the relevant international standards (e.g., ISO 80601-2-56 for accuracy) and internal design specifications. The experts involved would be the engineers and quality assurance personnel responsible for conducting these tests and verifying compliance. Their qualifications are not specified in this document.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a digital thermometer, not an AI-powered diagnostic imaging system requiring human readers or interpretation of complex cases. Therefore, an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This refers to the performance of the device itself (the algorithm) independent of human intervention. The non-clinical studies described, such as verification of accuracy, electrical safety, EMC, and compliance with ISO 80601-2-56 for clinical thermometers, are essentially standalone performance evaluations of the device and its internal software (algorithm). The device measures temperature and transmits it; the "algorithm" here is the embedded software that processes the thermistor data into a temperature reading. The document indicates that "all software requirement specifications are met and all software hazards have been mitigated."
7. The Type of Ground Truth Used
The ground truth used for the device's technical performance and safety was primarily based on:
- Established Standards: International and national standards (e.g., IEC 60601-1, ISO 80601-2-56, FCC regulations) that define acceptable performance limits, safety requirements, and electromagnetic compatibility.
- Design Specifications: Internal specifications set by the manufacturer for parameters like measuring range and accuracy.
- Predicate Device Performance: The performance of legally marketed predicate devices (K160308 and K152739) served as a benchmark for substantial equivalence, implying that the proposed device should perform at least as well in relevant aspects.
- Biocompatibility Testing: Chemical and biological assays (ISO 10993-5, ISO 10993-10) directly testing the device's materials for adverse reactions.
8. The Sample Size for the Training Set
Not applicable. As this device is a "Digital Thermometer" and not an AI/ML-driven diagnostic tool that learns from data, there is no "training set" in the conventional machine learning sense. The device's performance is based on its hardware design, thermistor technology, and pre-programmed software.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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 |
|---|---|
| ----------------------------------------------------------- | --------------------------------------------------------------------- |
| | 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. | +86 769 81098181 |
| Fax No. | +86 769 81098187 |
| Contact person | Bob Yu |
| Contact person's e-mail | bobyu@fudakang.com |
| 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. | +86-755-86069197 |
| Contact person | Field Fu; Christy Young; |
| Contact person's e-mail | christy@cefda.com; field@cefda.com |
| 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:Digital Thermometer | Predicate Device:Fudakang Bluetooth DigitalThermometer (Model:BT-A41CN-BT) (K160308) | Predicate Device:Electronic Thermometer,Model WT1 and WT2(K152739) |
|---|---|---|---|
| Product Code | FLL | FLL | FLL |
| Regulationnumber | 21 CFR 880.2910 | 21 CFR 880.2910 | 21 CFR 880.2910 |
| Manufacturer | Fudakang IndustrialCo., Ltd | Fudakang Industrial Co., Ltd | Guangdong BiolightMeditech Co., Ltd |
| Intended Use | Digital thermometers(Model: TP-100, TP-300,TP-200, TP-500,TP-400, BT-A31A-BT)is intended for themeasurement andmonitoring of oral oraxillary for adult ,pediatric and infanttemperature viathermistor by doctor orconsumers in thehospital or home. Theresult of measurementand monitoring will betransmitted viaBluetooth (BLE) to | Fudakang Bluetooth Digitalthermometer (Model:BT-A41CN-BT) is intended forthe measurement andmonitoring of oral, axillary, andrectal temperature of adults via athermistor. The device is for useof a doctor or lay consumers inthe hospital or home. The resultof measurement can betransmitted to smart mobiledevice (cell phone, iPad) whiledisplayed on the LCD. | Electronic Thermometer isintended for measuring andmonitoring human bodytemperature orally and/orunder arm for adult, pediatricand infant. It can be used inhealthcare facility and home. |
| Bluetoothenabled | |||
| smart mobile device | |||
| (cell phone, iPad) with | |||
| GuardiAngelApp | |||
| installed. | |||
| Thermometertype | Digital thermometer | Digital thermometer | Digital thermometer |
| Sensor | Thermistor | Thermistor | Thermistor |
| Powerrequirements | 1x3V Lithium battery | 1.5V button battery | Button cell |
| Battery life | Approx. 100 hours forcontinuous operation orapprox.18 monthswhile used 10 minutesper day. | Approx. 100 hours for continuousoperation. | Not available |
| Signalprocessing anddisplay | Internal software anddisplay on smart phone | Internal software and display onsmart phone as well as LCD | Display in mobile application,no display on device |
| Signaltransmission | Bluetooth 4.0 | Bluetooth 4.1 | Bluetooth 4.0 |
| Receiver(mobileterminal) | iOS or Android mobiledevice | iOS or Android mobile device | iOS Mobile Device |
| Validtransmissiondistance | 10 meters | 10 meters | Not available |
| Measuringrange | 32.0-42.9℃( 89.6-109.2°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℃ | |
| Temperatureunit | °C or °F | °C or °F | °C or °F |
| Operationenvironment | 5~40°C; 15% to85%RH | 5~40°C; 15% to 85%RH | Not available |
| Storageenvironment | -20~55°C; ≤85%RH | -20~55°C; ≤85%RH | Not available |
| Skin-contactingcomponents | Housing, probe, tapes,holders and siliconepatches | Housing, probe | Housing, probe, tapes |
| Materials of | Housing: ABS, liquid | Housing: ABS, silicone rubber | Stainless Steel, S216 |
| skin-contactingcomponents | silicone rubberProbe: Stainless steel 304Medical Tape:PolyethyleneSilicone patch: Siliconerubber mixtureHolder: ABS | Probe: stainless steel 304 | Polycarbonate (PC), 2458Silicone, TPENon-Woven ClothMedical 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.
§ 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.