ELECTRONIC THERMOMETER

K131210 · Shenzhen Pump Medical System Co., Ltd. · FLL · Mar 18, 2014 · General Hospital

Device Facts

• Record ID: K131210
• Device Name: ELECTRONIC THERMOMETER
• Applicant: Shenzhen Pump Medical System Co., Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Mar 18, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

It is intended for use in measuring human body temperature (Armpit or Oral).

Device Story

Electronic thermometer (Models TF3100, TF3101, TF3102) measures human body temperature; utilizes thermistor sensor to convert temperature into electronic signal; signal processed and displayed on LCD; device powered by 3.7V rechargeable lithium battery; intended for clinical or home use; provides digital temperature readout to user; aids in monitoring body temperature for clinical decision-making.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical safety (IEC 60601-1), performance (ASTM E1112-00), environmental testing (IEC 60601-1-11), EMC (EN 60601-1-2), and biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Thermistor-based sensing; ABS plastic and stainless steel construction; 3.7V rechargeable lithium battery; LCD display; IP22 water-proof rating; temperature range 32.00°C–42.00°C; accuracy 0.05°C (35.30°C–39.00°C) and 0.1°C otherwise; 0.01°C resolution; 5-minute response time; standards: IEC 60601-1, ASTM E1112-00, IEC 60601-1-11, EN 60601-1-2, ISO 10993.

Indications for Use

Indicated for measuring human body temperature via armpit or oral sites in 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 thermometer Model MT Series (K062784)

Submission Summary (Full Text)

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

#### K131210

# 510(k) Summary

### 1. Applicant

| Applicant Name: | SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
|-----------------|-----------------------------------------------------------------------------------------------------------------------------|
| Address: | 2/F West, M-7 Sinosteel Building, Maqueling Estate,<br>Hi-Tech Industrial Park, Nanshan District,<br>Shenzhen 518057, China |

Contact person:

| Name: | Xie Qiongyu |
|----------------|--------------------|
| Phone numbers: | 86-0755-26710795 |
| Fax numbers: | 86-0755-26012025 |
| E-mail: | [e-mail] |
| Date Prepared: | 2013-04-20 |

## 2. Device information

- Trade name: Electronic Thermometer .
- Model No.: TF3100, TF3101, TF3102 .
- Classification name: Thermometer, electronic, clinical (per CER 880.2910) .
- . Class: 2
- . Requlation Medical Specialty : General Hospital
- . Review Panel: General Hospital
- Product code: FLL- Clinical Electronic Thermometer .
- Regulation Description: Clinical electronic thermometer .
- Regulation Number: 880.2910

Indications for Use: It is intended for use in measuring temperature in the human body (Armpit or Oral).

#### Predicates

Digital thermometer Model MT Series K-number: K062784 Product Code: FLL

# Indications for Use:

The devices Model MT series (MT-201, MT-301, MT-402, and MT-403) 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.

Manufacture: SEJOY ELECTRONICS & INSTRUMENTS CO., LTD.

{1}------------------------------------------------

# 4. Description of the device

The body temperature is converted into electronic signal by the temperature sensor, and then the electronic signal is converted into LCD digital display.

The Electronic Thermometers TF3100, TF3101 and TF3102 have the same basic principles, main function, performance and intended use, and they are consistent in product structure and material.

| ELEMENT OF<br>COMPARISON | Electronic Thermometer<br>Model No.: TF3100, TF3101,<br>TF3102<br>Manufacture: SHENZHEN PUMP<br>MEDICAL SYSTEM CO., LTD. | Digital thermometer MT Series<br>(K062784)<br>Manufacture: SEJOY ELECTRONICS<br>& INSTRUMENTS CO., LTD. |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| thermometer type | TF3100, TF3101, TF3102 | MT-301 |
| intended use(s) | It is intended for use in measuring<br>temperature in the human body<br>(Armpit or Oral). | The devices Model MT series<br>(MT-201, MT-301, MT-402, and<br>MT-403) are intended to measure the<br>human body temperature in regular<br>mode orally, rectally or under the<br>arm, and the devices are reusable for<br>clinical or home use on people of all<br>ages. |
| components | Temperature sensor, liquid crystal display, battery and circuit of motherboard | |
| sensor | Thermistor | |
| signal processing and<br>display | Using the resistance change of thermal resistor to detect body temperature,<br>and displayed through the LCD. | |
| power requirements | DC3.7V Rechargeable Lithium<br>Battery | One 1.5 V Button Battery model LR 41 |
| Materials | ABS plastic and stainless steel | |
| temperature range | $32.00°C ~ 42.00°C$ | $32.00°C - 42.90°C$ |
| ambient temperature<br>environment | $+5°C~+40°C$ | $10°C ~ 35°C$ |
| accuracy | $0.05°C(35.30°C ~ 39.00°C)$<br>$0.1°C( < 35.30°C or > 39.00°C )$ | $±0.1°C,35.5°C - 42.0°C$<br>$±0.2°C under 35.5°C or over 42.0°C$ |
| precision and<br>repeatability | 4 numerical digits, display in 0.01<br>degree increments | 4 numerical digits, display in 0.01<br>degree increments |
| Response time | 5 minutes | 5 minutes |
| Water-proof | IP22 | IP22 |

# 5. Comparison to Predicate Devices

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

Comparing to the predicate, the subject devices used same the Measuring Principle, same electrical measurement technologic and same measurement site (Measuring on Armpit or Oral). The subject devices do not constitute a new intended use.

As a result, the subject device is Substantially Equivalent (SE) to the predicate which is US legally market device.

#### 6. Discussion of Non-Clinical Tests Performed for Determination of Substantial

#### Equivalence

Laboratory testing was conducted to validate and verify that Electronic Thermometer met all requirements of related international standards, including electrical safety, EMC, biocompatibility, specification. Results of these tests demonstrate compliance to the requirements of the bellow consensus standards.

| Standard: |
|------------------------------------------------------------------|
| Electrical Safety and performance requirements: |
| IEC 60601-1 |
| ASTM E1112-00 |
| Home-used medical equipment requirements and Environmental test: |
| IEC 60601-1-11 |
| Electromagnetic Compatibility Requirements: |
| EN 60601-1-2 |
| Biocompatibility Evaluation for the part contacted to patient |
| ISO 10993-5, ISO 10993-10 |

#### 7. Clinical Evaluation

Clinical evaluation of Electronic Thermometers has been conducted by SHENZHEN PUMP MEDICAL SYSTEM CO., LTD.

## 8. Conclusion

As stated above, the Electronic Thermometer (Models: TF3100, TF3101 and TF3102) have the same intended use and similar technological characteristics as the cleared devices of the digital thermometer MT series (K062784).

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

Moreover, the Electronic Thermometer (Models: TF3100, TF3101 and TF3102) comply with the appropriate medical device standards. Verification and validation test reports contained in this submission demonstrate that any differences in their characteristics do not raise any new questions of safety or effectiveness.

Furthermore, those engineering differences do not affect the intended use or alter the fundamental scientific technology of the cleared devices of the digital thermometer MT series (K062784).

As a result, Electronic Thermometers (Models: TF3101 and TF3102) are safety and effective, and substantially equivalent to the earlier identified predicate devices.

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

Image /page/4/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered.

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular fashion around the caduceus symbol.

Public Health Service

Food and Drug Administration 0903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

#### March 18, 2014

SHENZHEN PUMP MEDICAL SYSTEM Company, Limited C/O Ivy Chen Shenzhen Huatongwei International Inspection Co., Ltd. Keji Nan No.12 Road, Hi-tech Park Shenzhen, Guangdong 518057 CHINA

Re: K131210

Trade/Device Name: Electronic Thermometer, Models TF3100, TF3101, TF3102 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 27, 2013 Received: March 13, 2014

Dear Ms. Chen:

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.

|

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

Page 2 - Ms. Chen

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); 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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/Medical/Devices/Safety/Reportal?roblem/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 Small Manufacturers. International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

# Mary S. Runner -S

Erin 1. Keith. M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

#### Indications for Use

510(k) Number (if known) K131210

# Device Name

Electronic Thermometer, Models TF3100, TF3101, TF3102

Indications for Use (Describe)

(Armpit or Oral) . It is intended for use in measuring human body temperature

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

Image /page/6/Figure/11 description: The image shows a document with the header "FOR FDA USE ONLY". It indicates the concurrence of the Center for Devices and Radiological Health (CDRH) and includes a digital signature by Richard C. Chapman. The signature date is specified as 2014.03.18 at 09:36:56 with a time zone offset of -04'00'.

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

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."