Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36

K153149 · Sejoy Electronics & Instruments Co., Ltd. · FLL · May 27, 2016 · General Hospital

Device Facts

• Record ID: K153149
• Device Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36
• Applicant: Sejoy Electronics & Instruments Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: May 27, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Digital Thermometers MT series 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.

Device Story

MT series digital thermometers measure human body temperature via thermistor resistance changes. Non-predictive models provide direct readings; predictive models (MT-4726, MT-4735) use a proprietary algorithm to estimate balanced temperature in 5-10 seconds. Devices consist of sensor, housing, stainless steel cap, LCD, and control module. Used in clinical or home environments by patients or clinicians. Output displayed on LCD; aids in fever detection and clinical decision-making. Predictive models automatically revert to regular mode if prediction fails. Powered by 1.5V or 3.0V batteries; some models include backlight and color-coded temperature indicators.

Clinical Evidence

Clinical accuracy evaluation conducted for predictive models MT-4726 and MT-4735 per ISO 80601-2-56:2009, clause 201.102. Non-predictive models relied on bench testing and substantial equivalence to predicates.

Technological Characteristics

Thermistor-based sensing; ABS housing; stainless steel probe cap. Predictive models use proprietary software algorithms. Standards: AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, ISO 80601-2-56, ASTM E1112, ISO 10993-5/10. Power: 1.5V or 3.0V DC. Connectivity: None. Sterilization: Not specified (reusable device).

Indications for Use

Indicated for human body temperature measurement (oral, rectal, or axillary) in clinical or home settings for patients of all ages.

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 Thermometers Models MT-4119 and MT-4320 (K110776)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three heads facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 27, 2016

Sejoy Electronics & Instruments Co., Ltd. Mr. Ren Yunhua General Manager Building 2, No. 202, Zhenzhong Road West Lake Economy & Technology Zone Hangzhou, 310030 CHINA

Re: K153149

Trade/Device Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-36 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: April 15, 2016 Received: May 13, 2016

Dear Mr. Yunhua:

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.

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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 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 yours,

Tina Kiang -

for Erin I. Keith, M.S. 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) K153149

#### Device Name

Digital Thermometer, Models MT-1027, MT-4127, MT-4333, MT-4326, MT-4726, MT-4726, MT-4735, MT-09, MT-30, MT-31, MT-36

#### Indications for Use (Describe)

The Digital Thermometers MT series 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.

| 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) | <div> </div> |

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Image /page/3/Picture/0 description: The image shows the logo for SEJOY. The logo is blue and has a yellow triangle above the "J". The letters are bold and easy to read. The logo is simple and modern.

世佳电子有限公司 Sejoy Electronics & Instruments Co.,Ltd.

# 510(k) Summary

The assigned 510(k) number is: K153149

### 1. Date Prepared:

May 25, 2016

### 2. Submitter's Identification:

Name: Sejoy Electronics & Instruments Co., Ltd. Address: Building 2, No.202, Zhenzhong Road, West Lake Economy & Technology Zone, Hangzhou, China 310030 Contact Person: Yunhua Ren Phone: [phone] Fax: [phone] Email: [e-mail]

### 3. Name of the Device:

Trade Name: Digital Thermometer, Models MT-1027, MT-4127, MT-1032, MT-4132, MT-4333, MT-4326, MT-4726, MT-4335, MT-4735, MT-09, MT-30, MT-31, MT-રેસ

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: 21 CFR 880.2910

#### 5. Predicate Device Information:

Digital Thermometers Models MT-4119 and MT-4320 manufactured by SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.

510(k) number: K110776

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

The Digital Thermometers MT series 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.

The intended uses/ indication for use of the Digital Thermometers, models: MT series are Identical to the predicate devices, Digital Thermometers, models: MT-4119, MT-4320.

#### 7. Device Description:

Models MT-1027, MT-4127, MT-4132, MT-4132, MT-4335, MT-4335, MT-4326, MT-09, MT-30, MT-31, and MT-36 are non-predictive digital thermometers. Models MT-4726 and MT-4735 are predictive digital thermometers.

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Both predictive and non-predictive models include a sensor, buzz films, housing, a stainless steel cap, a LCD display, and a measurement control module. The thermometers include a dustproof case as an accessory.

Additionally, both models do not need to be used in conjunction with a disposable probe cover when taking temperature.

#### 8. Principles of Operation:

The basic principle of the MT series digital thermometers is that a change in thermistor resistance is caused by a change in temperature. The resistance is measured by a microcontroller unit, so that changes in temperature will correspond to changes in resistance.

Compared to the non-predictive thermometers, the following is a description of the predictive thermometer models MT-4726 and MT-4735:

The predictive thermometer models display the temperature results in a short period of time. The displayed temperature is equivalent to the balanced temperature after 5 minutes according to the proprietary algorithm. Therefore, users only need about 5 seconds to take temperature readings. The measurement time may vary depending on the anatomical site of the temperature reading; however the measurement time should remain between 5-10 seconds. If the predictive temperature cannot be measured, the device will take the actual temperature (regular mode) automatically.

### 9. Modifications to Predicate Device:

The subject device models have each been altered in at least one of the following ways as noted in the table below:

-Addition of predictive algorithm for Models MT-4735 and MT-4726

-New battery type to support added backlight feature

- -Modification of labeling including cleaning/disinfection instructions
- -Temperature associated color light indication with updated labeling
- -Thermometer response time
- -Battery life

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| Technological<br>Characteristics<br>of Comparison | Subject Device: | Predicate Device<br>Model MT-4119<br>(K110776): | Predicate Device<br>Model MT-4320<br>(K110776) | Comparison<br>on<br>Result | Remark | |
|---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-----------------------------------------------------------------------|-------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Digital<br>thermometers | Models:<br>MT-1027,MT-4127,MT-1032,MT-<br>4132,MT-4333,MT-4326,MT-<br>4726,MT-4335, MT-4735,MT-09,MT-<br>30,MT-31,MT-36 | Model: MT-4119<br>(Rigid tip thermometer) | Model: MT-4320<br>(Flexible tip<br>thermometer) | / | / | |
| Intended use/<br>Indication for Use | Measuring the human body temperature in regular mode orally, rectally or under the arm, and the<br>devices are reusable for clinical or home use on people of all ages. | | | Identical | / | |
| Components | Sensor, buzz film, housing, stainless steel cap, LCD display, measurement control module. | | | Identical | / | |
| Accessory | Dustproof case | | | Identical | / | |
| Sensor | Thermistor | | | Identical | / | |
| Power<br>Requirements | MT-1027,MT-4127<br>MT-1032,MT-4132<br>MT-4333,MT-<br>4326, MT-<br>4335,MT-09, MT-<br>30,MT-31,<br>MT-4726,MT-4735 | 1.5V d.c (LR41 or<br>SR41,UCC392)<br>3.0V d.c(CR2032) | 1.5V d.c (LR41 or SR41,UCC392) | Similar | Change in<br>battery type<br>from 1.5V<br>d.c. (LR41 or<br>SR41,UCC392)<br>to 3.0V d.c.<br>(CR2032) | |
| Backlight function | MT-1027,MT-4127<br>MT-1032,MT-4132<br>MT-4333,MT-4326,<br>MT-4335,MT-09,<br>MT-30,MT-31,<br>MT-36 | No backlight function | No backlight function | | Identical | / |
| | MT-4726,MT-4735 | Yes | No backlight function | | Different | / |
| Material used | MT-1027,MT-4127<br>MT-1032,MT-4132<br>MT-09,MT-30,<br>MT-31<br>MT-4333,MT-4326,<br>MT-4726,MT-4335,<br>MT-4735,MT-36 | Housing: ABS<br>Probe: Stainless<br>steel | Housing: ABS<br>Probe: Stainless steel | Housing: ABS<br>Flexible tip: TPE<br>Probe: Stainless steel | Identical | Flexible tip<br>thermometers<br>are identical to<br>MT-4320 and<br>rigid tip<br>thermometers<br>are identical to<br>MT-4119 |
| Measure range | MT-1027,MT-4127<br>MT-1032,MT-4132<br>MT-4326,MT-4335,<br>MT-4333,MT-09,<br>MT-30,MT-31,<br>MT-36<br>MT-4726,MT-4735 | 32°C~42.9°C<br>(90°F~109.9°F) | 32°C~42.9°C<br>(90°F~109.9°F) | | Similar | Meet the<br>requirement of<br>ASTM E1112 |
| | MT-1027,MT-4127<br>MT-1032,MT-4132<br>MT-4333,MT-4326, | | Direct Mode | | | |
| Operating mode | MT-4335,MT-09,<br>MT-30,MT-31,<br>MT-36 | Direct Mode | | Similar | / | |
| | MT-4726,MT-4735 | Adjusted mode :<br>Oral mode/<br>Rectal mode/<br>Underarm mode<br>Direct Mode:<br>Bath mode | | | / | |
| Accuracy | $±0.1°C$ between $35.5°C$ to $42.0°C$ ( $±0.2°F,95.9°F-107.6°F$ ),<br>$±0.2°C$ under $35.5°C$ or over $42.0°C$ ( $±0.4°F$ under $95.9°F$ or over $107.6°F)$ | | | Identical | / | |
| Humidity range | 15%~95%,non-condensing | | | Identical | / | |
| Storage | Temperature: $-20℃~55℃$ ( $-4°F~131°F$ ) | | | Identical | / | |
| Environment | Humidity:15% ~95% RH; Atmospheric Pressure:800hPa ~ 1060hPa | | | Identical | / | |
| Color-temperature<br>light indicators | MT-4132,MT-4333 | Different colored lights | | Different | / | |
| | MT-4335,MT-4735<br>MT-4726,MT-4326 | corresponding to<br>different temperatures. | No this function | | / | |
| | MT-1027,MT-4127<br>MT-1032, MT-09,<br>MT-30,MT-31,<br>MT-36 | | No this function | Identical | / | |
| Response time | MT-4326,MT-4127<br>MT-4132,MT-4333<br>MT-4335,MT-30 | <45s | <45s | Identical | / | |
| | MT-1027 MT-1032 | <60s | <45s | Similar | / | |
| | MT-09,MT-31 | | | | | |
| | MT-4726,MT-4735<br>MT-36 | <10s | <45s | Similar | / | |
| | MT-1027,MT-4127 | | | | | |
| Software | MT-1032,MT-4132 | | | | | |
| | MT-4333,MT-4335 | No software | No software | Identical | / | |
| | MT-4326,MT-09, MT- | | | | | |
| | 30,MT-31, MT-36 | | | | | |
| | MT-4726,MT-4735 | Have software | No software | Different | / | |
| Battery life | MT-1027,MT-4127 | | | | Battery life | |
| | MT-1032,MT-4132 | | | | changes from | |
| | MT-4333,MT-4335 | | | Similar | approx 200 hours | |
| | MT-4326,MT-09, MT- | Approx 200 hours | Approx 200 hours | | to approx | |
| | 30,MT-31, MT-36 | | | | 40 hours | |
| | MT-4726,MT-4735 | Approx 40 hours | | | | |
| Biocompatibility | Complied with the biocompatible requirements of FDA | | | Identical | / | |
| Labeling | Updated cleaning/disinfection instructions,<br>Updated MR Safety labeling | | Outdated cleaning/disinfection instructions and MR<br>Safety labeling | Different | / | |
| Where used | Clinical or home | | | Identical | / | |
| Number of | | | | Identical | / | |
| readings stored in | Display of temperature last measured | | | | | |
| Memory | | | | | | |
| Precision and | 3 numerical digits, display in 0.1 degree increments | | | Identical | / | |
| repeatability | | | | | | |
| Reference<br>Standards | AAMI / ANSI ES60601-1,IEC 60601-1-2, IEC 60601-1-11,ISO 80601-2-56, ASTM E1112, ISO<br>10993-5, ISO 10993-10 | | | Identical | / | |

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### 10. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence:

The Sponsor performed a risk assessment based on the changes made to their predicate device and determined that the following non-clinical testing was necessary to demonstrate that the changes did not introduce any new risks to the subject device.

Laboratory testing was conducted to validate and verify that the thermometers continued to meet all requirements of related international standards, including electrical safety, EMC, software, biocompatibility, and cleaning/disinfection. Results of these tests demonstrated compliance to the requirements of the below consensus standards and FDA Guidance documents. Software validation testing was only performed for predictive Models MT-4726 and MT-4735.

### Electrical Safety and Performance:

AAMI / ANSI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and, A2:2010/(R)2012:

AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, and C1:2009/(R)2012 and A2:2010/(R)2012;

ISO 80601-2-56:2009;

ASTM E1112-00(Reapproved 2011)

Medical Electrical Equipment and medical Electrical Systems Used in the Home Healthcare Environment:

IEC 60601-1-11:2010

### Electromaqnetic Compatibility:

IEC 60601-1-2:2007

IEC 60601-1-2:2014

### Biocompatibility:

ISO 10993-5:2009

ISO 10993-10:2010

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# Cleaning/Disinfection/Reprocessing:

ASTM E2314 -03(2014)

FDA Guidance: Reprocessing Medical Devices in Health Care Settings -Validation Methods and Labeling

## Software:

EN 60601-1-4:2000 General Requirements for safety - Collateral Standard: Programmable electrical medical system

General Principles of Software Validation – Final Guidance for Industry and FDA Staff

### Clinical Electronic Thermometers Guidance:

Guidance on the content of Premarket Notification[510(k)] Submission for clinical electronic thermometers

### 11. Discussion of Clinical Tests Performed:

In order to demonstrate that the subject device did not introduce any new risks in comparison to the subject device a clinical accuracy evaluation has been conducted according to clause 201.102 of ISO 80601-2-56:2009 for predictive models MT-4726 and MT-4735.

### 12. Conclusions:

Based on the information provided in this submission, the subject digital thermometer MT series is substantially equivalent to the predicate models MT-4119 and MT-4320. The devices are as safe and as effective as the predicate device models.