(329 days)
No
The summary describes a standard digital thermometer that transmits data via Bluetooth to a mobile app. There is no mention of AI, ML, or any complex data processing beyond basic temperature measurement and transmission. The performance studies focus on standard electrical and safety standards, not AI/ML model validation.
No.
The device is solely intended for measurement and monitoring of temperature, and does not provide any treatment or therapy.
Yes
Explanation: The device is intended for the measurement and monitoring of temperature, which is a key vital sign used for diagnostic purposes. While it measures a single parameter, the information gathered (body temperature) is crucial for identifying potential illnesses or conditions, thus assisting in diagnosis.
No
The device description explicitly states it is a "Digital Thermometer" and mentions hardware components like a thermistor and Bluetooth connectivity, which are integral to its function of measuring temperature. The software (GuardiAngel App) is used for transmission and display, but the core measurement is performed by the hardware.
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. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The described device is a digital thermometer that measures body temperature. It does this by directly interacting with the human body (oral or axillary).
- Lack of Sample Analysis: The device does not analyze any biological samples taken from the body. It measures a physical parameter (temperature) directly.
Therefore, since the device measures a physical parameter directly from the body and does not analyze biological samples, it falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
FLL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral or axillary
Indicated Patient Age Range
adult , pediatric and infant
Intended User / Care Setting
doctor or consumers in the hospital or home.
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
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 60601-1 Medical 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
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
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 & 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.
1
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 |
4
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 Digital
Thermometer (Model:
BT-A41CN-BT) (K160308) | Predicate Device:
Electronic Thermometer,
Model WT1 and WT2
(K152739) |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | FLL | FLL | FLL |
| Regulation
number | 21 CFR 880.2910 | 21 CFR 880.2910 | 21 CFR 880.2910 |
| Manufacturer | Fudakang Industrial
Co., Ltd | Fudakang Industrial Co., Ltd | Guangdong Biolight
Meditech Co., Ltd |
| Intended Use | Digital thermometers
(Model: TP-100, TP-300,
TP-200, TP-500,
TP-400, 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 | Fudakang Bluetooth Digital
thermometer (Model:
BT-A41CN-BT) is intended for
the measurement and
monitoring of oral, axillary, and
rectal temperature of adults via a
thermistor. The device is for use
of a doctor or lay consumers in
the hospital or home. The result
of measurement can be
transmitted to smart mobile
device (cell phone, iPad) while
displayed on the LCD. | Electronic Thermometer is
intended for measuring and
monitoring human body
temperature orally and/or
under arm for adult, pediatric
and infant. It can be used in
healthcare facility and home. |
| | | | |
| | Bluetooth
enabled | | |
| | smart mobile device | | |
| | (cell phone, iPad) with | | |
| | GuardiAngel
App | | |
| | installed. | | |
| Thermometer
type | Digital thermometer | Digital thermometer | Digital thermometer |
| Sensor | Thermistor | Thermistor | Thermistor |
| Power
requirements | 1x3V Lithium battery | 1.5V button battery | Button cell |
| Battery life | Approx. 100 hours for
continuous operation or
approx.18 months
while used 10 minutes
per day. | Approx. 100 hours for continuous
operation. | Not available |
| Signal
processing and
display | Internal software and
display on smart phone | Internal software and display on
smart phone as well as LCD | Display in mobile application,
no display on device |
| Signal
transmission | Bluetooth 4.0 | Bluetooth 4.1 | Bluetooth 4.0 |
| Receiver
(mobile
terminal) | iOS or Android mobile
device | iOS or Android mobile device | iOS Mobile Device |
| Valid
transmission
distance | 10 meters | 10 meters | Not available |
| Measuring
range | 32.0-42.9℃( 89.6-109.
2°F ) | 32.0-42.9℃( 89.6-109.2℃) | 25.00°C45.00°C |34.99°C |
| | ±0.1℃ 35.0-39.0℃ | ±0.1℃ 35.0-39.0℃ (±0.2℃ | ±0.1°C 25.00°C
| Accuracy | (±0.2°F 95.0-102.2°F) | 95.0-102.2°F ) | ±0.05°C 35.00°C38.50°C |40°C; 15% to 85%RH | Not available |
| | ±0.2℃ the rest | ±0.2℃ the rest | ±0.1℃ 38.51℃45.00℃ |40°C; 15% to
| Temperature
unit | °C or °F | °C or °F | °C or °F |
| Operation
environment | 5
85%RH | 5
| Storage
environment | -2055°C; ≤85%RH | -2055°C; ≤85%RH | Not available |
| Skin-contacting
components | Housing, probe, tapes,
holders and silicone
patches | Housing, probe | Housing, probe, tapes |
| Materials of | Housing: ABS, liquid | Housing: ABS, silicone rubber | Stainless Steel, S216 |
| skin-contacting
components | silicone rubber
Probe: Stainless steel 304
Medical Tape:
Polyethylene
Silicone patch: Silicone
rubber mixture
Holder: ABS | Probe: stainless steel 304 | Polycarbonate (PC), 2458
Silicone, TPE
Non-Woven Cloth
Medical Melt Adhesive |
Substantial Equivalence Comparison 6.
5
Version: A/2
6
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
7
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.