Digital Thermometer

K163518 · Joytech Healthcare Co. , Ltd. · FLL · Sep 19, 2017 · General Hospital

Device Facts

• Record ID: K163518
• Device Name: Digital Thermometer
• Applicant: Joytech Healthcare Co. , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Sep 19, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended 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.

Device Story

Digital thermometers for body temperature measurement; oral, rectal, or axillary sites. Device comprises temperature sensor, integrated circuit (IC), LCD, and buzzer. Sensor resistance changes with temperature; IC converts resistance to frequency to calculate temperature. Output displayed on LCD. Used in clinical or home environments by patients or clinicians. Provides temperature readings to assist in health monitoring and clinical decision-making.

Clinical Evidence

Clinical performance testing conducted per ISO 80601-2-56. Bench testing verified compliance with electrical safety (AAMI/ANSI ES60601-1), EMC (IEC 60601-1-2), and biocompatibility (ISO 10993-5/10). Software/firmware validated per FDA guidance.

Technological Characteristics

Materials: Stainless Steel, TPE, ABS. Sensing: Resistance-based temperature sensor. Energy: 1.5V (LR41/SR41) or 3.0V (CR2032/CR1225) button batteries. Connectivity: Standalone. Standards: ISO 80601-2-56, IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 10993-5/10.

Indications for Use

Indicated for human body temperature measurement (oral, rectal, or axillary) in clinical or home settings for all ages. DMT-455 indicated for oral use only in children <4 years. All pediatric use requires adult supervision.

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

• Digital Thermometer, DMT series (K153149)

Submission Summary (Full Text)

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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

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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 [phone] or [phone] 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 [phone] or [phone] 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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# 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: [phone]

Fax: [phone]

Email: [e-mail]

#### 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

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K163518

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<br>(Model:MT-4132、MT-4726) | Comparison<br>Result |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------|
| Indication for use | DMT series(except DMT-455) are<br>intended to measure the human<br>body temperature in regular mode<br>orally, rectally or under the arm. And<br>the devices are reusable for clinical<br>or home use on people of all ages.<br><br>DMT-455 is intended to measure<br>temperature orally, and the device is<br>reusable for clinical or home use for<br>children less than 4 years old. | Measuring the human body<br>temperature in regular mode orally,<br>rectally or under the arm, and the<br>devices are reusable for clinical or<br>home use on people of all ages. | Similar |
| Measurement Site | DMT series (except DMT-455):<br>orally, rectally or under the arm<br><br>DMT-455:orally | orally, rectally or under the arm | Similar |
| Range | DMT series (except DMT-47XX):<br>32℃~42.9℃(90°F~109.9°F) | MT-4132:<br>32℃~42.9℃(90°F~109.9°F) | Identical |
| | DMT-4735,DMT-4726:<br>32℃~42.9℃ (89.6°F ~109.2°F ) | MT-4726:<br>32℃~42.9℃ (89.6°F ~109.2°F ) | Identical |
| | DMT-4737:35.5℃~42.0℃ | MT-4132: | Different |
| | (96.0°F -109.0°F) | 32°C~42.9°C(90°F~109.9°F) | |
| Accuracy | ±0.1°C between 35.5°C to 42.0°C<br>(±0.2°F ,95.9°F-107.6°F),<br>±0.2°C under 35.5°C or over 42.0°C<br>(±0.4°Funder 95.9°For over 107.6 °F | ±0.1°C between 35.5°C to<br>42.0°C (±0.2°F,95.9°F -107.6°F),<br>±0.2°C under 35.5°C or over 42.0°C<br>(±0.4°F under 95.9°F or over<br>107.6°F) | Identical |
| Display resolution | DMT series(except DMT-301,<br>DMT-3032,DMT-3033,DMT-4737):<br>0.1 C/0.1 F | 0.1 C/0.1 F | Identical |
| | DMT-301,DMT-3032,DMT-3033:<br>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<br>steel cap, LCD display,<br>measurement control module. | Sensor, buzz film, housing, stainless<br>steel cap, LCD display, measurement<br>control module. | Identical |
| Operating Range | Temperature: 41°F~104°F (5°C~<br>40°C)<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure : 700hPa ~<br>1060hPa | Temperature: 41°F~104°F (5°C~<br>40°C)<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure : 700hPa ~<br>1060hPa | Identical |
| Storage and<br>Transportation<br>Condition | Temperature:-4°F~131°F (-20°C<br>~55°C)<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure : 700hPa ~<br>1060hPa | Temperature:-4°F~131°F (-20°C<br>~55°C)<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure: 700hPa ~<br>1060hPa | Identical |
| | One 1.5 V DC. button battery (size<br>LR41or SR41, UCC 392) | MT-4132:One 1.5 V DC. button<br>battery (size LR41or SR41, UCC<br>392) | Identical |
| Battery Type | DMT-4726,DMT-4735:<br>One 3.0V CR2032 battery | MT-4726:One 3.0V CR2032 battery | Identical |
| | DMT-4737:<br>One 3.0V CR1225 battery | MT-4726:One 3.0V CR2032 battery | Different |
| Biocompatibility | Comply with ISO 10993-5 and ISO<br>10993-10 | Comply with ISO 10993-5 and ISO<br>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

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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.