(167 days)
Not Found
No
The device description details a simple thermistor-based temperature measurement system using a microcontroller, which is standard digital thermometer technology and does not indicate the use of AI or ML. The document explicitly states "Mentions AI, DNN, or ML: Not Found".
No
The device is a digital thermometer, which measures body temperature. While temperature measurement can aid in diagnosis, the device itself does not provide therapy or treatment.
Yes
The device, a digital thermometer, measures body temperature which is a physiological parameter used to identify or monitor medical conditions.
No
The device description explicitly mentions hardware components like a thermistor, microcontroller unit, LCD screen, stainless steel, and ABS, which are integral to its function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Digital Thermometer measures body temperature by directly contacting the body (oral or axillary). It does not analyze samples taken from the body.
- Intended Use: The intended use is to measure body temperature, which is a direct physiological measurement, not an analysis of a biological sample.
Therefore, this device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.
Product codes
FLL
Device Description
The Digital Thermometer utilizes measured thermistor resistance and a microcontroller unit to determine and display human body temperature. Changes in the probe temperature due to oral or auxiliary contact correspond to changes in resistance. The probe Temperature values are digitally displayed on an LCD screen in 0.2 degrees Fahrenheit increments. The measurements do not account for a probe cover. The user contacting materials are Stainless steel and Acrylonitrile Butadiene Styrene (ABS).
The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the samebasic functions:
- Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement
- Data displayed in Celsius -
- Automatic stop (energy saver) -
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral or axillaries (under arms)
Indicated Patient Age Range
all ages
Intended User / Care Setting
consumers in a household environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Performance tests protocols were performed in accordance with applicable standards and FDA quidance documents. The results of the tests demonstrate the compliance to applicable thermometer standards and FDA quidance documents which are list below, and demonstrate the performance of new devices is equivalent to the predicate devices.
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-11 Edition 1.0 2010-04, 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 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement.
ISO 10993-1:2009, Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing Within a Risk Management Process.
ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
FDA Guidance: Reprocessing Medical Devices in Health Care Settings -Validation Methods and Labeling.
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/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three human profiles incorporated into its design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 6, 2017
Guangzhou Jinxinbao Electronic Co., Ltd Ms. Elly Xu Consultant Manager Shenzhen Joyantech Consulting Co., Ltd. Room 1122, International Mayors Communication Centre NO.55 Shizhou middle road Nanshan District, Shenzhen, 518101 TAIWAN
Re: K163603
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 25, 2017 Received: May 08, 2017
Dear Elly Xu:
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.
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
1
Page 2 - Elly Xu
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 (reporting of medical devicerelated 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Tina Kiang
-s
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163603
Device Name Digital Thermometer
Indications for Use (Describe)
Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.
Type of Use (Select one or both, as applicable)
] Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K163603 510(k) Summary
This 510(K) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
1. Administrative Information
| Date of Summary
| prepared | May 31, 2017 |
|---|---|
| Manufacturer | |
| information | Company title: |
| Guangzhou Jinxinbao Electronic Co., Ltd. | |
| Company address: | |
| No.38 Huanzhen Xi Road, Dagang Town, | |
| Nansha Distric, Guanzhou, | |
| Guangdong,China 511470 | |
| Contact person: Mowu Zhu | |
| Phone: +86-020-34938449 | |
| Fax: +86-020-34936960 | |
| E-mail: jxb_qc_moo@jxb-htb.net | |
| Submission | |
| Correspondent | Shenzhen Joyantech Consulting Co., Ltd. |
| Room 1122, International Mayors | |
| Communication Centre, NO. 55 Shizhou middle | |
| road , Nanshan District, Shenzhen | |
| Contact person: Ms. Elly Xu; Mr. Field Fu | |
| E-Mail: elly@cefda.com; cefda13485@163.com | |
| Image: logo |
2. Device Information
| Type of 510(k)
| submission: | Traditional |
|---|---|
| Trade Name: | Digital Thermometer |
| Model: | DT001, DT007, DT008 |
| Classification name: | Clinical Electronic Thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
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II Device Class: Regulation Number: | 880.2910
3. Predicate Device Information
Fudakang Industrial Co., Ltd Sponsor: Device: Digital Thermometer BT-A11CN, BT-A21CN, BT-A41CN Model: 510(K) Number: K101387
4. Device Description
The Digital Thermometer utilizes measured thermistor resistance and a microcontroller unit to determine and display human body temperature. Changes in the probe temperature due to oral or auxiliary contact correspond to changes in resistance. The probe Temperature values are digitally displayed on an LCD screen in 0.2 degrees Fahrenheit increments. The measurements do not account for a probe cover. The user contacting materials are Stainless steel and Acrylonitrile Butadiene Styrene (ABS).
The Digital Thermometer includes 3 models: DT001, DT007 and DT008. The differences of these models are in appearance and specifications. All of them have the samebasic functions:
- Precision of 0.1℃ for measurements between 35℃ and 39℃ for measurement
- Data displayed in Celsius -
- Automatic stop (energy saver) -
5. Indications for Use
Digital Thermometer is intended to measure the body temperature either oral or axillaries (under arms) and to be used by consumers in a household environment. The device is intended for repeatable use by one patient. It is intended for use on people of all ages.
5
6. Technological characteristics of the proposed device compared to the predicate device
| Predicate Device (K101387), | |||
|---|---|---|---|
| ltems | Fudakang Digital | Subject Device | Remarks |
| Thermometer | |||
| Indication for | |||
| Use | Intended for measurement | ||
| and monitoring of human body | |||
| temperature by doctor or | |||
| consumers in the hospital or | |||
| home. | |||
| BT-A11CN, BT-A21CN and | |||
| BT-A41CN can be used in | |||
| axillary measurement, oral | |||
| measurements and rectal | |||
| measurement. | Digital | ||
| Thermometer is | |||
| intended to | |||
| measure the body | |||
| temperature either | |||
| oral or axillaries | |||
| (under arms) and to | |||
| be used by | |||
| consumers in | |||
| a household | |||
| environment. The | |||
| device is intended | |||
| for repeatable | |||
| use by one patient. | |||
| It is intended for | |||
| use on people of all | |||
| ages. | See | ||
| explanation | |||
| below | |||
| Use environment | Clinical or home | Home use | Same |
| Components | Sensor, buzz film, housing, | ||
| stainless steel cap, LCD | |||
| display, measurement control | |||
| module | Sensor, buzz film, | ||
| housing, stainless | |||
| steel probe, LCD | |||
| display, | |||
| measurement | |||
| control | |||
| module(MCU) | Same | ||
| Sensor | Thermistor | Thermistor | Same |
| Power | |||
| requirements | Battery | 1.5V d.c | Same |
| Material used | Housing: ABS | ||
| Probe: Stainless steel | Housing: ABS | ||
| Probe: Stainless | |||
| steel | Same | ||
| Measure range | 32°C ~42.9°C | 32°C ~42.9°C | Same |
| Operating mode | Direct mode | Direct mode | Same |
| Measuring | |||
| accuracy | 35.0°C | ||
| ±0.1°C between | |||
| to | |||
| 39.0°С; | |||
| The rest: ±0.2ºC | ±0.1°C | ||
| between | |||
| 36.0°C to 39.0°C; | |||
| The rest: ±0.2℃ | See | ||
| explanation | |||
| below | |||
| Response time | 60s | 30s | See |
| explanation | |||
| below | |||
| Items | Predicate Device (K101387), | ||
| Fudakang Digital | |||
| Thermometer | Subject Device | Remarks | |
| Biocompatibility | Comply with ISO 10993- | ||
| 5:2009, ISO 10993-10:2010 | Comply with ISO | ||
| 10993-5:2009, ISO | |||
| 10993-10:2010 | Same | ||
| Electric safety | |||
| and EMC | IEC 60601-1, IEC 60601-1-2, | ||
| IEC 60601-1-11:2010 | IEC 60601-1, IEC | ||
| 60601-1-2, IEC | |||
| 60601-1-11:2010 | Same | ||
| Performance | ASTM E1112 | ASTM E1112, | |
| ISO 80601-2-56. | Same |
6
The predicate device and subject device indications for use are not identical in language. The predicate device provides a list of models and can be used for obtaining a rectal temperature reading and the subject device identifies the user populations. The differences in technology between the subject and the predicate device are the measuring range of subject device meet the maximum error of ±0.1℃, temperature range from 37℃ to 39℃, which is stated in standard ASTM E 1112. Also, the subject device has a shorter response time in obtaining and displaying the temperature measurement on the LCD display. These minor differences in indications for use, and differences in technology do not raise different questions of safety and effectiveness.
7. Brief discussion of the nonclinical tests
All nonclinical testing performed on new devices is to demonstrate the substantial equivalence to the predicate devices. Performance tests protocols were performed in accordance with applicable standards and FDA quidance documents. The results of the tests demonstrate the compliance to applicable thermometer standards and FDA quidance documents which are list below, and demonstrate the performance of new devices is equivalent to the predicate devices.
IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance.
IEC 60601-1-2:2014, Medical Electrical Equipment - Part 1-2: General
7
Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests.
IEC 60601-1-11 Edition 1.0 2010-04, 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 First Edition 2009-10-01, Medical Electrical Equipment - Part 2-56: Particular Requirements for Basic Safety and Essential Performance of Clinical Thermometers for Body Temperature Measurement.
ISO 10993-1:2009, Biological Evaluation of Medical Devices -- Part 1: Evaluation and Testing Within a Risk Management Process.
ISO 10993-5:2009, Biological Evaluation of Medical Devices -- Part 5: Tests for In Vitro Cytotoxicity.
ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization.
FDA Guidance: Reprocessing Medical Devices in Health Care Settings -Validation Methods and Labeling.
8. Clinical tests
Substantial equivalence does not depend on the clinical test data as the subject and predicate device both have thermistors utilized in direct mode and clinical testing is not required.
9. Conclusions
Based on device comparison analysis and non-clinical performance bench testing, the proposed device is substantially equivalent to legally marketed predicate device.