(278 days)
Not Found
No
The device description details a simple temperature measurement process based on resistance changes and IC conversion, with no mention of AI or ML technologies. The performance studies focus on standard medical device testing and compliance with relevant standards, not AI/ML validation.
No.
The device is a digital thermometer used to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
Explanation: This device is a digital thermometer, which measures a physical parameter (temperature). While temperature can be an indicator of health, the device itself simply measures and displays a physical value and does not interpret this value to diagnose a disease or condition.
No
The device description explicitly lists hardware components: a temperature sensor, integrated circuit (IC), LCD display, and buzzer. This indicates it is a physical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Function: The Digital Thermometers DMT series directly measure the human body temperature. They do not analyze any specimens taken from the body.
- Intended Use: The intended use clearly states measuring "human body temperature" orally, rectally, or under the arm. This is a direct measurement of a physiological parameter, not an in vitro analysis.
Therefore, based on the provided information, the Digital Thermometers DMT series are not IVD devices. They are considered medical devices used for direct physiological measurement.
N/A
Intended Use / Indications for Use
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
Product codes
FLL
Device Description
The Digital Thermometers DMT series are used to measure the human body temperature in regular mode orally, rectally, or under the arm. They have the same test principles, performance specifications and intended use as the Predicate device. The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of the sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The calculated temperature is displayed on the LCD. The products have similar structural designs and the patient contacting materials are the same as the Predicate devices (Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
orally, rectally or under the arm
Indicated Patient Age Range
The devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
Intended User / Care Setting
clinical or home use
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
Performance testing was conducted to verify and validate that Digital Thermometers, DMT series met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.
Electrical Safety and performance requirements:
- . AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- ISO 80601-2-56:2009 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Home-used medical equipment requirements and environmental test:
-
· IEC 60601-1-11:2015 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
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
Biocompatibility Evaluation for patient contacting components:
- · ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Guidance Document:
• Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56.
Based on the performance testing and bench data the submit digital thermometers DMT series are substantially equivalent to the predicate thermometers, model: MT-4132 and MT-4726.
Key Metrics
Accuracy: ±0.1°C between 35.5°C to 42.0°C (±0.2°F ,95.9°F-107.6°F), ±0.2°C under 35.5°C or over 42.0°C (±0.4°Funder 95.9°For over 107.6 °F)
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.
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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure with three faces in profile. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 19, 2017
Joytech Healthcare Co., Ltd Yunhua Ren General Manager No. 365, Wuzhou Road Yuhang Economic Development Zone Hangzhou. 311100 China
Re: K163518
Trade/Device Name: Digital Thermometer, DMT Series Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 10, 2017 Received: August 21, 2017
Dear Yunhua Ren:
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 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
1
the quality systems (OS) 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,
Michael J. Ryan -S
for Tina Kiang, PhD 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) K163518
Device Name Digital Thermometer DMT series
Indications for Use (Describe)
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary(21 CFR §807.92)
The assigned 510(k) number is: K163518
1. Date Prepared: September 06, 2017
2. Submitter's Identification:
Name: JOYTECH HEALTHCARE CO. LTD.
Add.:No.365, Wuzhou Road, Yuhang Economic Development Zone,
Hangzhou city, 311100 Zhejiang,China
Contact Person: Yunhua Ren
Phone: +86-571-81957767
Fax: +86-571-81957750
Email: RENYH@SEJOY.COM
3. Name of the Device:
Trade Name: Digital Thermometer, DMT series
Models:DMT-101、DMT-411、DMT-301、DMT-102、DMT-202、DMT-412、DMT-423、 DMT-433、DMT-455、DMT-108、DMT-418、DMT-106、DMT-206、DMT-416、 DMT-427、DMT-437、DMT-4218、DMT-4318、DMT-1019、DMT-2019、 DMT-4119、DMT-4220、DMT-4320、DMT-4340、DMT-4343、DMT-4139、 DMT-2021、DMT-4121、DMT-209、DMT-1030、DMT-2030、DMT-4130、 DMT-1031、DMT-2031、DMT-4131、DMT-4226、DMT-4326、DMT-4726、 DMT-1027、DMT-2027、DMT-4127、DMT-1032、DMT-2032、DMT-3032、 DMT-4132、DMT-3033、DMT-4233、 DMT-4333、DMT-4235、DMT-4335、 DMT-4735、DMT-4236、DMT-4336、DMT-4737、DMT-4238、DMT-4338
Common Name: Digital Thermometer
Regulation number: 21 CFR §880.2910
Classification name: Clinical Electronic Thermometer
Regulation Class: II
Product Code: FLL
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4. Predicate Device Information:
The Digital Thermometers are substantially equivalent to the following devices:
Trade Name:Digital Thermometer, DMT series
510(k) Reference:K153149
Common Name:Digital Thermometer
Regulation Number:21 CFR §880.2910
Requlation Name: Clinical Electronic Thermometer
Requlatory Class:II
Product Code: FLL
Classification Panel: General Hospital
5. Indication for Use:
The Digital Thermometers DMT series(Except DMT-455) are intended to measure the human body temperature in regular mode orally, rectally or under the arm. The devices are reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.
The device model DMT-455 is intended to measure temperature orally, and the device is reusable for clinical or home use for children less than 4 years old with adult supervision.
6. Device Description:
The Digital Thermometers DMT series are used to measure the human body temperature in regular mode orally, rectally, or under the arm. They have the same test principles, performance specifications and intended use as the Predicate device. The Digital Thermometers DMT series consists of a temperature sensor, low power consumption integrated circuit (IC), LCD display, and buzzer. The resistance of the sensor changes with temperature and the IC converts the resistance to frequency and calculates the temperature according to the relation of resistance and frequency. The
5
calculated temperature is displayed on the LCD. The products have similar structural designs and the patient contacting materials are the same as the Predicate devices (Stainless Steel, TPE and Acrylonitrile Butadiene Styrene (ABS)).
7. Comparing to Predicate Device:
The subject devices and predicate devices have no characteristic differences which raise new questions of safety and effectiveness. All differences are verified as substantially equivalent through applicable standardized testing. For details please see the following table:
| SE Comparisons | Subject device | Predicate device K153149
(Model:MT-4132、MT-4726) | Comparison
Result |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indication for use | DMT series(except DMT-455) are
intended to measure the human
body temperature in regular mode
orally, rectally or under the arm. And
the devices are reusable for clinical
or home use on people of all ages.
DMT-455 is intended to measure
temperature orally, and the device is
reusable for clinical or home use for
children less than 4 years old. | Measuring the human body
temperature in regular mode orally,
rectally or under the arm, and the
devices are reusable for clinical or
home use on people of all ages. | Similar |
| Measurement Site | DMT series (except DMT-455):
orally, rectally or under the arm
DMT-455:orally | orally, rectally or under the arm | Similar |
| Range | DMT series (except DMT-47XX):
32℃42.9℃(90°F109.9°F) | MT-4132:
32℃42.9℃(90°F109.9°F) | Identical |
| | DMT-4735,DMT-4726:
32℃42.9℃ (89.6°F 109.2°F ) | MT-4726:
32℃42.9℃ (89.6°F 104°F (5°C109.2°F ) | Identical |109.9°F) | |
| | DMT-4737:35.5℃42.0℃ | MT-4132: | Different |42.9°C(90°F
| | (96.0°F -109.0°F) | 32°C
| Accuracy | ±0.1°C between 35.5°C to 42.0°C
(±0.2°F ,95.9°F-107.6°F),
±0.2°C under 35.5°C or over 42.0°C
(±0.4°Funder 95.9°For over 107.6 °F | ±0.1°C between 35.5°C to
42.0°C (±0.2°F,95.9°F -107.6°F),
±0.2°C under 35.5°C or over 42.0°C
(±0.4°F under 95.9°F or over
107.6°F) | Identical |
| Display resolution | DMT series(except DMT-301,
DMT-3032,DMT-3033,DMT-4737):
0.1 C/0.1 F | 0.1 C/0.1 F | Identical |
| | DMT-301,DMT-3032,DMT-3033:
0.01 °C/0.01°F | 0.1 C/0.1 F | Different |
| | DMT-4737:Analog Display | 0.1 C/0.1 F | Different |
| Components | Sensor, buzz film, housing, stainless
steel cap, LCD display,
measurement control module. | Sensor, buzz film, housing, stainless
steel cap, LCD display, measurement
control module. | Identical |
| Operating Range | Temperature: 41°F
40°C)
Relative humidity: 15%95%RH104°F (5°C
Atmospheric Pressure : 700hPa ~
1060hPa | Temperature: 41°F
40°C)
Relative humidity: 15%95%RH131°F (-20°C
Atmospheric Pressure : 700hPa ~
1060hPa | Identical |
| Storage and
Transportation
Condition | Temperature:-4°F
~55°C)
Relative humidity: 15%95%RH131°F (-20°C
Atmospheric Pressure : 700hPa ~
1060hPa | Temperature:-4°F
~55°C)
Relative humidity: 15%~95%RH
Atmospheric Pressure: 700hPa ~
1060hPa | Identical |
| | One 1.5 V DC. button battery (size
LR41or SR41, UCC 392) | MT-4132:One 1.5 V DC. button
battery (size LR41or SR41, UCC
392) | Identical |
| Battery Type | DMT-4726,DMT-4735:
One 3.0V CR2032 battery | MT-4726:One 3.0V CR2032 battery | Identical |
| | DMT-4737:
One 3.0V CR1225 battery | MT-4726:One 3.0V CR2032 battery | Different |
| Biocompatibility | Comply with ISO 10993-5 and ISO
10993-10 | Comply with ISO 10993-5 and ISO
10993-10 | Identical |
| Electrical Safety | Complied with IEC 60601-1 | Complied with IEC 60601-1 | Identical |
| EMC | Complied with IEC 60601-1-2 | Complied with IEC 60601-1-2 | Identical |
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8. Performance data
The performance data listed below is provided in support of the substantial equivalence determination.
Performance testing was conducted to verify and validate that Digital Thermometers, DMT series met all requirements of related international standards, including electrical safety, EMC, biocompatibility, software validation and product specifications. Results of these tests demonstrate compliance to the requirements of the below consensus standards.
Electrical Safety and performance requirements:
- . AAMI / ANSI ES60601-1:2005/(R)2012 And A1:2012,C1:2009/(R)2012 And A2:2010/(R)2012 Medical Electrical Equipment
- ISO 80601-2-56:2009 Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
Home-used medical equipment requirements and environmental test:
-
· IEC 60601-1-11:2015 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
Electromagnetic compatibility requirements: -
IEC 60601-1-2:2014 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
8
Biocompatibility Evaluation for patient contacting components:
- · ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
- ISO10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Guidance Document:
• Guidance on the content of Premarket Notifications [510(k)] Submissions for clinical electronic thermometers
The software/firmware verification and validation was provided in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005.
9. Discussion of Clinical Tests Performed:
The clinical performance test protocol and data analysis followed the requirements of ISO 80601-2-56.
Conclusions: 10.
Based on the performance testing and bench data the submit digital thermometers DMT series are substantially equivalent to the predicate thermometers, model: MT-4132 and MT-4726.