Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a simple electronic thermometer using a thermistor and LCD display, with no mention of AI or ML capabilities.

Therapeutic

No.
The device measures body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.

Diagnostic

Yes

The device measures body temperature, which is a physiological parameter used to assess the health status of an individual. Measuring body temperature can help identify fever or hypothermia, which are indicators of various medical conditions, thus serving a diagnostic purpose.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a hand-held electronic thermometer comprised of a thermistor sensor, PCB, LCD, ABS outer material, and stainless steel tip, all of which are hardware components.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
Device Function: The COCET Digital Thermometer measures body temperature directly from the armpit (axillary). It does not analyze a sample taken from the body.
Intended Use: The intended use is to measure body temperature, which is a physiological measurement, not an in vitro diagnostic test.

Therefore, based on the provided information, the COCET Digital Thermometer is a medical device, but it falls under the category of a clinical thermometer for body temperature measurement, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes (comma separated list FDA assigned to the subject device)

FLL

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 electronic thermometer, it comprised of an electronic thermo resistor (thermistor) sensor connected to printed circuit board(PCB) with liquid crystal display(LCD) user readout. The outer material of thermometer is made of ABS and the measuring tip is stainless steel. The thermometer using a temperature sensor to output an electrical signal, and then converting the current signal into a liquid crystal digital display temperature. The thermometers are powered by LR41 battery. The battery can be replaced.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

armpit (axillary)

Indicated Patient Age Range

adult

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Tests:
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 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.

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K120004

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 880.2910 Clinical electronic thermometer.

(a)
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.(b)
Classification. Class II (performance standards). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter, subject to the limitations in § 880.9 and the following conditions for exemption:(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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.

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.

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/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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
No.380 Ningkang East Road, Yueqing City 325600 Zhejiang Province
China
Phone: 086-577-55775583
E-mail: zelong_858@126.com
Contact Person: Zelong Cao
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 )
Common Name: Clinical electronic thermometer
Regulation Number: 21 CFR 880.2910
Regulation Name: Clinical electronic thermometer
Classification: Class II
Product Code: FLL |
| 3. | Predicate Device: | K120004, DIGITAL THERMOMETER (Models: YT301/ YT302/ YT303)
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
electronic thermometer, it comprised of an electronic thermo resistor
(thermistor) sensor connected to printed circuit board(PCB) with liquid
crystal display(LCD) user readout. The outer material of thermometer is
made of ABS and the measuring tip is stainless steel. The thermometer
using a temperature sensor to output an electrical signal, and then
converting the current signal into a liquid crystal digital display
temperature. The thermometers are powered by LR41 battery. The
battery can be replaced. |
| 5. | Indications for 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. |

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

4

| Feature | Kangfu Medical Equipment
Factory Models: KFT-01/ KFT-
02/ KFT-03/ KFT-04/ KFT-05/
KFT-06/ KFT-07/ KFT-08/ KFT-
09/ KFT-10 | CHINA (Shenyang) Med-
land Imp/Exp Corp.,Ltd
YT301/ YT302/ YT303 | Discussion |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| 510(k) Number | K182652 | K120004 | Different |
| Indications for 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. | The Digital Thermometer is
used for the measurement
and monitoring of human
body temperature. Body
temperature can be
measured with the Digital
Thermometer by oral,
axillary (under the arm) and
rectal methods. The device
is for adult and pediatric
use. | Different |
| thermometer type | under arm | oral, axillary (under the
arm) and rectal. | Different |
| components | Electronic thermo
resistor(thermistor) sensor
Printed circuit board(PCB)
Liquid crystal display(LCD)
Outer
Tip | Electronic thermo
resistor(thermistor) sensor
Printed circuit board(PCB)
Liquid crystal display(LCD)
Outer
Tip | Same |
| principal of operation | Using a temperature sensor to
output an electrical signal, and
then converting the current
signal into a liquid crystal
digital display temperature | Using a temperature sensor
to output an electrical
signal, and then converting
the current signal into a
liquid crystal digital display
temperature | Same |
| Temperature Measurement
Technology | NTC Thermistor Resistance
Technique | NTC Thermistor Resistance
Technique | Same |
| Key Temperature
Sensor | NTC Thermistor | NTC Thermistor | Same |
| Power requirements | 1xLR41 battery
Standard voltage 1.5V,
termination voltage 0.9V.
Discharge with 1K discharge
resistor, sustainable discharge
for 670 hours. Working | 1xLR41 battery | Same |
| capacity 28mAh, weight 0.61g.
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)
+/- 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)
+/- 0.2 °C(±0.4°F) in the rest measuring range | Same |
| Biocompatibility | Comply with ISO 10993-1
ISO10993-5
ISO 10993-10 | Comply with ISO 10993-1
ISO10993-5
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 |

5

Discussion:

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

COCET DIGITAL
THERMOME	KFT-07	same	127mm×
19mm ×
11.5mm	Stainless
steel
ABS plastic
cabinet
(White
code:WH
Blue
code:BU)
COCET DIGITAL
THERMOME	KFT-08	same	127.5mm ×
19mm ×
11.5mm	ABS plastic
cabinet
(White
code:WH
Blue
code:BU),
Stainless
steel
COCET DIGITAL
THERMOME	KFT-09	same	127mm ×
19mm ×
11.5mm	ABS plastic
cabinet
(White
code:WH
Blue
code:BU),
Stainless
steel
COCET DIGITAL
THERMOME	KFT-10	same	127.5mm ×
19mm ×
11.5mm	ABS plastic
cabinet
(White
code:WH
Blue
code:BU),
Stainless
steel

6

7

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

8

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.