COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10

K182652 · Kangfu Medical Equipment Factory · FLL · Nov 20, 2018 · General Hospital

Device Facts

• Record ID: K182652
• Device Name: COCET Digital Thermometer (Models KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10
• Applicant: Kangfu Medical Equipment Factory
• Product Code: FLL · General Hospital
• Decision Date: Nov 20, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2

Intended Use

COCET Digital Thermometer measures body temperature. This digital thermometer is used in the armpit (axillary) to take temperature measuring results. The device is for adult use.

Device Story

Hand-held electronic thermometer; utilizes NTC thermistor sensor to detect temperature; converts electrical signal via PCB to digital readout on LCD screen. Device used in home or clinical settings by adults for self-measurement or by clinicians. Powered by replaceable 1.5V LR41 battery. ABS plastic housing with stainless steel tip. Provides digital temperature display to user; assists in monitoring body temperature for health assessment.

Clinical Evidence

Bench testing only. Compliance with ISO 80601-2-56:2017 for clinical thermometer performance, IEC 60601-1 for electrical safety, and IEC 60601-1-2 for EMC. Biocompatibility testing performed per ISO 10993-1, including cytotoxicity (ISO 10993-5), skin irritation, and sensitization (ISO 10993-10).

Technological Characteristics

NTC thermistor resistance technique; ABS plastic housing; stainless steel tip; 1.5V LR41 battery power; LCD display. Standards: ISO 80601-2-56, IEC 60601-1, IEC 60601-1-2, ISO 10993-1/5/10.

Indications for Use

Indicated for adult patients for the measurement of body temperature via the axillary (armpit) route.

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 (Models: YT301/ YT302/ YT303) (K120004)

Submission Summary (Full Text)

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November 20, 2018

Kangfu Medical Equipment Factory Mr. Zelong Cao Quality Manager No. 380 Ningkang East Road Yueqing City, Zhejiang 325600 CHINA

Re: K182652

Trade/Device Name: COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-04/KFT-04/KFT-05/KFT-06/KFT-07/KFT-08/KFT-09/KFT-10) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 24, 2018 Received: September 24, 2018

Dear Mr. Zelong Cao:

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.

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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 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

> Sincerely, >Tina Kiang - S

Tina Kiang, Ph.D. 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) K182652

Device Name

COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-07/KFT-07/KFT-07/KFT-08/KFT-09/KFT-09/KFT-10)

Indications for Use (Describe)

COCET Digital Thermometer measures body temperature. This digital thermometer is used in the armpit (axillary) to take temperature measuring results. The device is for adult use.

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)

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# 510(k) SUMMARY

[Refer to 21 CFR §807.92]

## K182652

| 1. | Submitted by: | Kangfu Medical Equipment Factory<br>No.380 Ningkang East Road, Yueqing City 325600 Zhejiang Province<br>China<br>Phone: [phone]<br>E-mail: [e-mail]<br>Contact Person: Zelong Cao<br>Date Prepared: November 16, 2018 |
|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Trade Name: | COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/KFT-05/KFT-06/ KFT-07/ KFT-08/ KFT-09/KFT-10 )<br>Common Name: Clinical electronic thermometer<br>Regulation Number: 21 CFR 880.2910<br>Regulation Name: Clinical electronic thermometer<br>Classification: Class II<br>Product Code: FLL |
| 3. | Predicate Device: | K120004, DIGITAL THERMOMETER (Models: YT301/ YT302/ YT303)<br>Manufacturer: CHINA (Shenyang) Med-land Imp/Exp Corp., Ltd. |
| 4. | Device Description: | COCET Digital Thermometer (Models: KFT-01/KFT-02/KFT-03/KFT-04/ KFT-05/KFT-06/ KFT-07/KFT-08/ KFT-09/KFT-10) is a hand-held<br>electronic thermometer, it comprised of an electronic thermo resistor<br>(thermistor) sensor connected to printed circuit board(PCB) with liquid<br>crystal display(LCD) user readout. The outer material of thermometer is<br>made of ABS and the measuring tip is stainless steel. The thermometer<br>using a temperature sensor to output an electrical signal, and then<br>converting the current signal into a liquid crystal digital display<br>temperature. The thermometers are powered by LR41 battery. The<br>battery can be replaced. |
| 5. | Indications for Use: | COCET Digital Thermometer measures body temperature. This digital<br>thermometer is used in the armpit (axillary) to take temperature<br>measuring results. The device is for adult use. |

#### Predicate Device Comparison 6.

Table 1 Predicate Product Comparisons - COCET Digital Thermometer Models: KFT-01/ KFT-02/ KFT-03/ KFT-04/ KFT-05/ KFT-06/ KFT-07/ KFT-08/ KFT-09/ KFT-10

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| Feature | Kangfu Medical Equipment<br>Factory Models: KFT-01/ KFT-<br>02/ KFT-03/ KFT-04/ KFT-05/<br>KFT-06/ KFT-07/ KFT-08/ KFT-<br>09/ KFT-10 | CHINA (Shenyang) Med-<br>land Imp/Exp Corp.,Ltd<br>YT301/ YT302/ YT303 | Discussion |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K182652 | K120004 | Different |
| Indications for Use | COCET Digital Thermometer<br>measures body temperature.<br>This digital thermometer is<br>used in the armpit (axillary) to<br>take temperature measuring<br>results. The device is for adult<br>use. | The Digital Thermometer is<br>used for the measurement<br>and monitoring of human<br>body temperature. Body<br>temperature can be<br>measured with the Digital<br>Thermometer by oral,<br>axillary (under the arm) and<br>rectal methods. The device<br>is for adult and pediatric<br>use. | Different |
| thermometer type | under arm | oral, axillary (under the<br>arm) and rectal. | Different |
| components | Electronic thermo<br>resistor(thermistor) sensor<br>Printed circuit board(PCB)<br>Liquid crystal display(LCD)<br>Outer<br>Tip | Electronic thermo<br>resistor(thermistor) sensor<br>Printed circuit board(PCB)<br>Liquid crystal display(LCD)<br>Outer<br>Tip | Same |
| principal of operation | Using a temperature sensor to<br>output an electrical signal, and<br>then converting the current<br>signal into a liquid crystal<br>digital display temperature | Using a temperature sensor<br>to output an electrical<br>signal, and then converting<br>the current signal into a<br>liquid crystal digital display<br>temperature | Same |
| Temperature Measurement<br>Technology | NTC Thermistor Resistance<br>Technique | NTC Thermistor Resistance<br>Technique | Same |
| Key Temperature<br>Sensor | NTC Thermistor | NTC Thermistor | Same |
| Power requirements | 1xLR41 battery<br>Standard voltage 1.5V,<br>termination voltage 0.9V.<br>Discharge with 1K discharge<br>resistor, sustainable discharge<br>for 670 hours. Working | 1xLR41 battery | Same |
| capacity 28mAh, weight 0.61g.<br>Load resistance 22K | | | |
| Materials | ABS plastic cabinet (White and blue), Stainless steel | ABS plastic cabinet (White), Stainless steel | Different |
| Temperature range | 32.0 °C ~ 42.9 °C (90°F-109.2 °F) | 32.0 °C ~ 42.9 °C (90°F - 109.2 °F) | Same |
| Accuracy | +/- 0.1 °C(±0.2°F) from 35.5 °C to 42 °C(95.9°F-107.6°F)<br>+/- 0.2 °C(± 0.4 °F) in the rest measuring range | +/- 0.1 °C( ± 0.2 °F) from 35.5 °C to 42 °C(95.9°F-107.6 °F)<br>+/- 0.2 °C(±0.4°F) in the rest measuring range | Same |
| Biocompatibility | Comply with ISO 10993-1<br>ISO10993-5<br>ISO 10993-10 | Comply with ISO 10993-1<br>ISO10993-5<br>ISO 10993-10 | Same |
| Voluntary standards for Clinical Electronic Thermometers | Comply with ISO 80601-2-56 | Comply with ASTME1112-00 | Different |
| Medical Electrical Safety and EMC | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 | Same |

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Discussion:

1. Indications for Use is different from the description of the contrasting devices are measuring human body temperature, the predicate device is used orally, axillary (under the arm) and rectal for adult and pediatric, our COCET Digital Thermometer is only used under arm for adult, the difference does not raise performance questions.

2. Thermometer type: Our product COCET Digital Thermometer is only used in the armpit, the predicated device can be used orally , axillary (under the arm) and rectal, the difference does not raise performance questions.

3. Materials: The ABS plastic cabinet of predicate device only has white color, COCET Digital Thermometer has two color white and blue. However, it is conformed with ISO 10993 series standard. It can be proved in the biocompatibility testing report. The difference does not raise performance questions.

4. Voluntary standards for Clinical Electronic Thermometers: Electronic Thermometer comply with ASTME1112-00 and COCET Digital Thermometer comply with The ISO 80601-2-56, the two standards were meets FDA guidelines. The difference does not raise performance questions.

| Name | Model | principal of operation | Dimension | Materials |
|------------------------------|--------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------|----------------------------------------------------------------------------------------|
| COCET DIGITAL<br>THERMOMETER | KFT-01 | This digital thermometer is used in<br>the armpit (axillary) and using a<br>temperature sensor to output an<br>electrical signal, and then converting<br>the current signal into a liquid crystal<br>digital display temperature | 124.5mm ×<br>18mm×<br>9mm | ABS plastic<br>cabinet<br>(White<br>code:WH),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-02 | same | 120mm ×<br>16mm ×<br>9.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-03 | same | 127mm×<br>19mm ×<br>11.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-04 | same | 127.5mm ×<br>19mm ×<br>11.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-05 | same | 133mm ×<br>27.5mm ×<br>10mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-06 | same | 132mm ×<br>20mm ×<br>7.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU), |
| | | | | |
| COCET DIGITAL<br>THERMOME | KFT-07 | same | 127mm×<br>19mm ×<br>11.5mm | Stainless<br>steel<br>ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU) |
| COCET DIGITAL<br>THERMOME | KFT-08 | same | 127.5mm ×<br>19mm ×<br>11.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-09 | same | 127mm ×<br>19mm ×<br>11.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |
| COCET DIGITAL<br>THERMOME | KFT-10 | same | 127.5mm ×<br>19mm ×<br>11.5mm | ABS plastic<br>cabinet<br>(White<br>code:WH<br>Blue<br>code:BU),<br>Stainless<br>steel |

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#### 7. Non-clinical Tests

Safety and EMC:

Safety and EMC test was performed in according to the

- IEC 60601-1:2005+CORR.1:2006+CORR.2.2007+a1:2012 . Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-2 :2014 -

Medical electrical equipment - Part 1-2: General requirements for basic safety and essential

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performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests Biocompatibility:

Biocompatibility testing was performed to evaluate the biocompatibility of the contact materials in accordance with ISO 10993-1:2009, the device passed each biocompatibility test identified below:

- । Cytotoxicity testing in according to ISO 10993-5:2009 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- Skin irritation testing in according to ISO 10993-10:2010 Biological evaluation of medical devices--Part 5: Tests for in vitro cytotoxicity
- Sensitization testing in according to ISO 10993-10:2010 Biological evaluation of medical devices- । Part 5: Tests for in vitro cytotoxicity

#### Performance Data:

The following bench testing was conducted in order to support substantial equivalence:

- । 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.
### 8. Conclusion

Based on performance testing and compliance with voluntary standards demonstrate that the proposed device is substantially equivalent to the predicate device.