Digital Thermometer

K200599 · Joytech Healthcare Co. , Ltd. · FLL · Jul 8, 2020 · General Hospital

Device Facts

• Record ID: K200599
• Device Name: Digital Thermometer
• Applicant: Joytech Healthcare Co. , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Jul 8, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.

Device Story

Digital thermometer (DMT-4756) measures human body temperature via thermistor sensor. Device features foldable tip for rectal use; unfolded for oral/axillary use. Operates by measuring thermistor resistance changes processed by internal MCU. Provides 10-second predictive quick read and 30-second final reading. Used in clinical or home settings by patients or clinicians. Output displayed on integrated LCD. Includes beep alarm, unit switching, low battery detection, memory (10 readings), and auto-power off. Benefits include rapid, accurate temperature monitoring for all ages.

Clinical Evidence

Clinical testing conducted on 450 subjects across three age groups: infants (newborn to 1 year), children (>1 to 5 years), and adults (>5 years). Testing performed per ISO 80601-2-56 for all measurement sites. Results demonstrated compliance with performance requirements.

Technological Characteristics

Materials: ABS, TPE, stainless steel. Sensing: Thermistor. Energy: 3.0V CR2032 battery. Form factor: Handheld with foldable probe. Connectivity: None. Standards: ISO 80601-2-56, ASTM E1112, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 10993-5, ISO 10993-10.

Indications for Use

Indicated for human body temperature measurement in people of all ages, including children under 8 with adult supervision. Measurement sites include oral, rectal, and axillary. No specific contraindications listed.

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

• DMT-4726 (K183393)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue, followed by the words "U.S. FOOD & DRUG" in a larger font and "ADMINISTRATION" in a smaller font below it, also in blue.

July 8, 2020

Joytech Healthcare Co., Ltd Mr. Yunhua Ren General Manager No. 365, Wuzhou Road, Yuhang Economic Development Zone Hangzhou City 311100 Zhejiang China

Re: K200599

Trade/Device Name: Digital Thermometer, Model DMT-4756 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 5, 2020 Received: June 8, 2020

Dear Mr. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-devices/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance)and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K200599

Device Name Digital Thermometer, Model DMT-4756

Indications for Use (Describe)

The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all ages, including children under 8 with adult supervision.

| 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are some Chinese characters in blue.

# 510(k) Summary

The assigned 510(k) number is: K200599

- 1. Date Prepared: 2020.07.08
#### 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 Model: DMT-4756 Common Name: Digital Thermometer Classification name: Clinical Electronic Thermometer

### 4. Classification Information:

Product Code: FLL- Clinical Electronic Thermometer Device Class: II Panel: 80 Regulation number:880-2910

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. The word "JOYTECH" is in blue, except for the "T", which is in red. To the right of the word "JOYTECH" are three Chinese characters in blue.

#### Predicate Device Information: 5.

The Digital Thermometer DMT-4756 is substantially equivalent to the following device:

| 510k number | model | Product code | manufacturer |
|-------------|----------|--------------|------------------------------|
| K183393 | DMT-4726 | FLL | JOYTECH HEALTHCARE CO., LTD. |

#### Intended use / Indication for Use: 6.

The Digital Thermometer DMT-4756 is intended to measure the human body temperature in regular mode orally, rectally or under the arm, and the device is reusable for clinical or home use on people of all age, including children under 8 with adult supervision.

## 7. Device Description:

The digital thermometer DMT-4756 is hand held device which can measure human body's temperature orally, axillary (under the arm), and rectally. The results can be displayed on LCD.

The flexible tip is foldable,when the flexible tip folded, DMT-4756 is used to measure human body's temperature rectally, while the flexible tip unfolded, it is used to measure temperature orally and axillary (under the arm).

The digital thermometer have several functions,such as beep alarm,unit switchable, low battery detection,memories,backlight,auto power off functions.

DMT-4756 is a predictive digital thermometer. Users only need 10 seconds for predictive quick read and 30 seconds for final temperature readings.

### 8. Substantial Equivalence Comparison:

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for JOYTEC-11建拓. The text "JOYTEC" is in blue, with the "C" stylized with a red triangle. The "11建拓" is in blue and is to the right of the "JOYTEC" text.

| SE<br>Comparisons | Subject device K200599<br>DMT-4756 | Predicate device K183393<br>(Model:DMT-4726) | Comparison<br>Result |
|------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|
| Intended Use<br>/Indication for use | The Digital Thermometer DMT-4756 is<br>intended to measure the human body<br>temperature in regular mode orally,<br>rectally or under the arm, and the<br>device is reusable for clinical or home<br>use on people of all age, including<br>children under 8 with adult supervision | The Digital Thermometer DMT-4726 is<br>intended to measure the human body<br>temperature in regular mode orally,<br>rectally or under the arm. The device is<br>reusable for clinical or home use on<br>people of all ages, including children<br>under 8 with adult supervision. | Identical<br>(Only change<br>in model<br>number) |
| Fundamental<br>technology&<br>Operating<br>principle | A change of thermistor resistance,<br>caused by changes of temperature. The<br>resistance is measured by MCU, so<br>changes of temperature will correspond<br>to changes of resistance | A change of thermistor resistance,<br>caused by changes of temperature. The<br>resistance is measured by MCU, so<br>changes of temperature will correspond<br>to changes of resistance | Identical |
| Sensor | Thermistor | Thermistor | Identical |
| Signal processing<br>and display | -Internal firmware and local<br>LCD display | -Internal firmware and local<br>LCD display | Identical |
| Measurement<br>Site | orally, rectally or under the arm | orally, rectally or under the arm | Identical |
| Range | $32.0°C~43.9°C (89.6°F-111.0°F)$ | $32.0°C~43.9°C (89.6°F-111.0°F)$ | Identical |
| Accuracy | $±0.1°C$ 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<br>$42.0°C (±0.4°F$ under $95.9°F$ or over<br>$107.6°F)$ | $±0.1°C$ 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<br>$42.0°C (±0.4°F$ under $95.9°F$ or over<br>$107.6°F)$ | Identical |
| Display resolution | $0.1 °C/0.1 °F$ | $0.1 °C/0.1 °F$ | Identical |
| components | Sensor, buzz film, housing, stainless<br>steel cap, LCD display, measurement<br>control module. | Sensor, buzz film, housing, stainless<br>steel cap, LCD display, measurement<br>control module. | Identical |
| Memories | 10 memories | 10 memories | Identical |
| Material | ABS,TPE,Stainless steel | ABS,TPE,Stainless steel | Identical |
| Operating range | Temperature:<br>$41°F~104°F (5°C~40°C)$<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure :<br>700hPa ~ 1060hPa | Temperature:<br>$41°F~104°F (5°C~40°C)$<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure :<br>700hPa ~ 1060hPa | Identical |
| Construction | The probe is foldable into the body of the thermometer | Flexible Digital Thermometer | Different<br>(Note1) |
| Measurement method & time | 10s Predictive read<br>30s Final read. | Approximate 5 ~ 10s | Different<br>(Note 2) |
| Weight | Approx. 40 grams including battery | Approx. 23 grams including battery | Different<br>(Note3) |
| Thermometer Size | 10.6cm*3.2cm*2.5cm (L x W x H) | 13.5cm*3.4cm*1.7cm (L x W x H) | Different<br>(Note3) |
| LCD Size | 2.5cm*1.4cm | 2.7cm*2.1cm | Different<br>(Note3) |
| Color &Coding | White(R9003),<br>Green(P564C) | White(R9003),<br>Blue(P294C) | Different<br>(Note3) |
| Predictive mode | Yes | Optional | Different<br>(Note2) |
| Storage and transportation condition | Temperature:<br>-4°F~131°F (-20℃~55℃)<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure:<br>700hPa ~ 1060hPa | Temperature:<br>-4°F~131°F (-20℃~55℃)<br>Relative humidity: 15%~95%RH<br>Atmospheric Pressure:<br>700hPa ~ 1060hPa | Identical |
| Battery type | One 3.0V CR2032 battery | One 3.0V CR2032 battery | Identical |
| 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 |

{6}------------------------------------------------

### Analysis

From the comparison table, the subject device and predicate device(K183393) have the similar Intended use & Indications for Use, Measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard;

There are slightly differences between the subject device and predicate device(K183393) as follows and we have conducted the tests to verify that the differences do not raise new questions of safety and effectiveness,please see below::

| Note 1 | Add foldable<br>construction function | Performance testing shows the subject device<br>complies with standard ISO 80601-2-56. The<br>difference does not raise new questions of safety and<br>effectiveness |
|--------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | Measure time changed<br>from approximate<br>5~10s to “10 second<br>predictive quick read,30 | Performance test including clinical test shows the<br>subject device complies with performance standard.<br>The differences do not raise new questions of safety<br>and effectiveness |

{7}------------------------------------------------

Image /page/7/Picture/0 description: The image shows the logo for JOYTECH. The logo is in blue and red. To the right of the word JOYTECH is Chinese characters in blue.

| | second for final<br>temperature reading",<br>and predictive mode<br>changed from optional<br>to have this function | |
|--------|--------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 3 | Weight,Size,color<br>changed; | Biocompatibility test and performance bench test met<br>the requirements in the standards. The differences do<br>not raise new questions of safety and effectiveness |

## 9. Performance data

The following performance data were provided in support of the substantial equivalence determination:

Performance testing was conducted to validate and verify that Digital Thermometer, DMT-4756 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 80601-2-56:2017 · Medical electrical equipment Part 2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
- . ASTM E1112:00(Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

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 health care 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

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the logo for JOYTECH. The logo is blue and red. To the right of the word JOYTECH are three Chinese characters.

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.

#### 10. Discussion of Clinical Tests Performed:

The clinical tests were conducted on the DMT-4756 for each measurement site. The clinical tests evaluated 450 of subjects. The thermometer was evaluated in three groups 1) infants-newborn to one year; 2) children-greater than one to five years; and 3) adults-greater than five years old.The clinical performance test protocol and data analysis was conducted in accordance with ISO 80601-2-56. The test report showed the clinical performance of the subject device complied with the requirement of ISO 80601-2-56.

#### 11. Conclusions:

Based on the performance testing,comparison and analysis in the submission, the subject digital thermometer DMT-4756 are substantially equivalent to the predicate thermometer DMT-4726(K183393).