Digital Thermometer

• K Number: K161211
• Device Name: Digital Thermometer
• Manufacturer: BIOCARE ASIA CORPORATION LTD.
• Date Cleared: 2016-08-29 ( 123 days)
• Product Code: FLL
• Regulation Number: 880.2910

Intended Use

Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.

Device Description

The Digital Thermometers, 1004/1005, enable easy and accurate measuring over the body temperature range. It must be used in conjunction with a disposable probe cover when measuring temperature. From the construction point of view, the digital thermometer comprises of a thermistor for temperature sensing, a reference resistor for comparison of temperature, a buzzer for sounding effect, an application specified IC for calculating, and an LCD for displaying the measured temperature reading which the thermistor contacts and senses.

Predicate Devices

K133111

Reference Devices

K091676

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details standard electronic components for temperature measurement and display, with no mention of AI/ML terms or capabilities. The performance studies focus on accuracy and environmental factors, not algorithmic performance.

Therapeutic

No
The device is a digital thermometer, intended for measuring body temperature, not for treating any condition.

Diagnostic

No
The device measures body temperature, which is a physiological parameter, but it does not diagnose a disease or condition. Instead, the temperature reading is a piece of information that can be used by a medical professional to help make a diagnosis.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a thermistor, reference resistor, buzzer, application specified IC, and LCD, indicating it is a physical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
• Device Function: The Digital Thermometer described measures body temperature directly from the body (axillary, oral, or rectum). It does not analyze specimens taken from the body.
• Intended Use: The intended use clearly states measuring body temperature, not analyzing biological samples.

Therefore, this device falls under the category of a general medical device, specifically a clinical thermometer, rather than an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.

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

FLL

Device Description

The Digital Thermometers, 1004/1005, enable easy and accurate measuring over the body temperature range. It must be used in conjunction with a disposable probe cover when measuring temperature. From the construction point of view, the digital thermometer comprises of a thermistor for temperature sensing, a reference resistor for comparison of temperature, a buzzer for sounding effect, an application specified IC for calculating, and an LCD for displaying the measured temperature reading which the thermistor contacts and senses.

The Digital Thermometers, 1004/1005, are the electronic thermometers operated by a thermistor as the temperature sensor and an application specified IC for signal processing. The basic operation principle is that a change of thermistor, caused by changes of temperature, provides a signal to application specified IC. Application specified IC gets the sensor's signal, then processes the signal and calculates the result. After that, it displays the temperature result on an LCD display.

Features:

• Patient having an elevated temperature: indicated by red lit screen and audio beep when above 99.7 °F / 37.6 °C
• Measurement time: approximately 8-10 seconds (Predictive mode) and approximately 60 seconds (Non-predictive mode)
• LCD read-out with °F / °C switchable
• Flexible tip
• Automatic shutoff when idle for 180 sec
• Memory: The last reading is automatically displayed for 2 seconds when the unit is witched ON. Up to 9 sets of memory can be stored.
• Storage case & battery included

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

axillary, oral or rectum

Indicated Patient Age Range

people of all ages

Intended User / Care Setting

medical professionals in clinical and hospital environments or consumers in a home environment

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)

Summary of non-clinical testing

1) Electrical Safety, EMC and Biocompatibility Test

• IEC/ EN 60601-1 2012+ CORR.1 (2014) Medical electrical equipment Part 1: General requirements for basic safety and essential performance
• IEC/EN 60601-1-11:2010 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC/ EN 60601-1-2:2007+AC:2010 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
• ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

2) Performance Test

• Accuracy & repeatability test: The evaluation of test results showed the uncertainty and repeatability clinical bias were 0.09 and 0.058. It all met the minimum acceptable accuracies required by BS EN 12470-3:2000+A1:2009.

  • Sample size: 120 (for pooled clinical bias and repeatability evaluation)
  • The pooled clinical bias of subject device: -0.01 (+1.96 SD: 0.17, -1.96 SD: -0.20), Uncertainty: 0.09
  • The pooled clinical repeatability of subject device: 0.058

• Lab accuracy test: Per E1112-00:2011, temperatures tested at water bath temperatures of 33.0, 36.0, 38.0, 40.0, and 42.0 °C.

  • Maximum calculated error at all temperatures was 0.1 °C.
  • All results passed the E1112-00:2011 acceptance criteria.

• Display temperature range test: Verified the measuring display range of the subject device to be complied with ASTM E1112-00:2011 standard. The display measuring range of subject device is specified and validated to be from 32.0 to 42.9 ℃, which covers the required range of 35.5 - 41 °C (96.0 to 106.0 °F).

• Drop test: Dropped the subject device from a height of 1 m onto hardwood with two directions.

  • Water bath temperatures and maximum calculated errors were measured:
    • 33.0 °C: 0.1 °C error (Acceptance Criteria: ±0.3 °C) - Pass
    • 36.0 °C: 0.1 °C error (Acceptance Criteria: ±0.2 °C) - Pass
    • 38.1 °C: 0.1 °C error (Acceptance Criteria: ±0.1 °C) - Pass
    • 40.0 °C: 0.1 °C error (Acceptance Criteria: ±0.2 °C) - Pass
    • 42.0 °C: 0.1 °C error (Acceptance Criteria: ±0.3 °C) - Pass

• Operating environment test: Maximum errors within accuracy requirements specified in ASTM E1112-00:2011 for various operating environments.

  • 103 °F (40°C), 15% RH: All errors 0.1 °C, passed acceptance criteria.
  • 103 °F (40°C), 80% RH: Errors 0.1-0.2 °C, passed acceptance criteria.
  • 60.8 °F (16°C), 40% RH: All errors 0.1 °C, passed acceptance criteria.
  • 60.8 °F (16°C), 95% RH: All errors 0.1 °C, passed acceptance criteria.

• Storage environment test: Maximum errors within accuracy requirements specified in ASTM E1112-00:2011 for various storage environments.

  • -13 °F (-25 °C): All errors 0.1 °C, passed acceptance criteria.
  • 130.9 °F (55 °C), 15% RH: All errors 0.1 °C, passed acceptance criteria.
  • 94.9 °F (35 °C), 95% RH: All errors 0.1 °C, passed acceptance criteria.

• EN 12470-3:2000+A1:2009 Clinical thermometers compliance test:

  • Metrological requirements:
    • Measuring range: Test range 31.7 - 44.3 °C, met acceptance criteria (35.5 - 42 °C).
    • Digital increment: 0.1 °C (0.1 °F), met acceptance criteria.
    • Maximum permissible errors under reference conditions: Complied with requirements of Subclause 6.2.3, met acceptance criteria.
    • Time Response: Complied with requirements of Subclause 6.2.4, met acceptance criteria (correct temperature reading within 60 seconds).
    • Maximum energy dissipation: Complied with requirements of Subclause 6.2.5, met acceptance criteria (2 mW).
    • Long term stability: Complied with requirements of Subclause 6.2.6, met acceptance criteria.
  • Environmental requirements: All tests (Ambient operating range, Effect of storage, Thermal Shock, Humidity, Electromagnetic compatibility, Mechanical shock, Water resistance) conducted and results were in compliance with the respective subclauses and met acceptance criteria.
  • Construction requirements: The tables (Table I.7.c) are not included in the provided text but implied to have passed.
    • Voltage limit indication: Complied with requirements and met acceptance criteria.
    • Indicating unit: Numerical values on display > 4 mm height, all segments activated for at least 1 second after power-on. Met acceptance criteria.
    • Functional safety test: Self-testing routine present and compliant, information provided in user manual. Met acceptance criteria.
    • Material: Free from biological hazards, biocompatibility information referred in Section J of 510(k) submission. Met acceptance criteria.
  • Electrical safety: Complied with EN 60601-1: 1990 requirements. Met acceptance criteria.
  • Mechanical safety:
    • Thermometer: No sharp ends or angles, temperature probe smoothly rounded. Met acceptance criteria.
    • Resistance to breakage: Not applicable as device does not have glass housing.

Conclusion: The non-clinical tests demonstrate that the subject device performs as well as the predicate device.

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

• Uncertainty (clinical bias): 0.09
• Repeatability clinical bias: 0.058
• Accuracy:
  • Lab accuracy test (per E1112-00:2011): Maximum calculated error of 0.1 °C at 33.0, 36.0, 38.0, 40.0, and 42.0 °C.
  • For the range of 98 °F to 102.2 °F, the accuracy of the subject device is around ±0.18 °F.

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.

K133111

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.

K091676

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

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.

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

August 29, 2016

Biocare Asia Corporation Ltd. Ke-Min Jen 510k Contact Person No.260, Mayun Road, New District Suzhou, 215129 Jiangsu CHINA

Re: K161211

Trade/Device Name: Digital Thermometer, Model 1004/1005 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: II Product Code: FLL Dated: July 26, 2016 Received: August 2, 2016

Dear Ke-Min Jen:

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.

1

Page 2 - Ke-Min Jen

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

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

2

Indications for Use

510(k) Number (if known) K161211

Device Name Digital Thermometer, Model 1004 / 1005

Indications for Use (Describe)

Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for 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)

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

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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 PRAStaff(@fda.hhs.gov

"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

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

K161211

I. 510(k) Summary of Safety and Effectiveness (Per 21 CFR 807.92)

Trade or proprietary name	Digital Thermometer, model 1004/1005
Common Name	Digital Thermometer
Classification Name	Clinical Electronic Thermometer
21 CFR 880.2910
Class	II
Panel	80 General Hospital
Product Code	FLL
Owner/Operator	BIOCARE ASIA CORPORATION LTD.
NO.260, MAYUN ROAD, NEW DISTRICT
SUZHOU, JIANGSU, 215129, P.R.C.
Phone: [phone]
Fax: [phone]
www.bca-medical.com
Date prepared	August 22, 2016
510k Contact Person	Dr. Jen, Ke-Min
TEL: [phone]
FAX: [phone]
Email: [e-mail]
Predicate Device	Kingtech Enterprises Limited
KINGTECH Digital Thermometer, TT1001
K133111
Reference Device	Omron Healthcare, Inc.
Clinical Electronic Thermometer, MC-246
K091676

● Indications for Use:

Digital Thermometer is intended to measure body temperature in axillary, oral or rectum and to be used by medical professionals in clinical and hospital environments or consumers in a home environment. It is intended for use on people of all ages.

4

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

● Descriptions

The Digital Thermometers, 1004/1005, enable easy and accurate measuring over the body temperature range. It must be used in conjunction with a disposable probe cover when measuring temperature. From the construction point of view, the digital thermometer comprises of a thermistor for temperature sensing, a reference resistor for comparison of temperature, a buzzer for sounding effect, an application specified IC for calculating, and an LCD for displaying the measured temperature reading which the thermistor contacts and senses.

● Test Principle

The Digital Thermometers, 1004/1005, are the electronic thermometers operated by a thermistor as the temperature sensor and an application specified IC for signal processing. The basic operation principle is that a change of thermistor, caused by changes of temperature, provides a signal to application specified IC. Application specified IC gets the sensor's signal, then processes the signal and calculates the result. After that, it displays the temperature result on an LCD display.

● Features

• . Patient having an elevated temperature: indicated by red lit screen and audio beep when above 99.7 °F / 37.6 °C
• . Measurement time: approximately 8-10 seconds (Predictive mode) and approximately 60 seconds (Non-predictive mode)
• LCD read-out with °F / °C switchable
• Flexible tip
• I Automatic shutoff when idle for 180 sec
• . Memory: The last reading is automatically displayed for 2 seconds when the unit is witched ON. Up to 9 sets of memory can be stored.
• . Storage case & battery included

5

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

| Comparison

Items	Predicate Device (PD)	Subject Device
Applicant	Kingtech Enterprises Limited,	Biocare Asia Corporation Ltd.
Proprietary
(Trade) Name	Kingtech Digital Thermometer	Digital Thermometer
Model	TT1001	1004 / 1005
510(k) No.	K133111	K161211
Classification
Code	FLL, Class II,
21 CFR 880.2910	FLL, Class II,
21 CFR 880.2910
Similar characteristics
Intended uses	TT1001 Digital Thermometer is
intended to measure the body
temperature orally and to be used
by medical professionals in
clinical and hospital environments
and consumers in a home
environment. It is intended for
use on people of all ages.	Digital Thermometer is intended to
measure body temperature in
axillary, oral or rectum and to be
used by medical professionals in
clinical and hospital environments or
consumers in a home environment.
It is intended for use on people of all
ages.
Components	Temperature sensor, liquid crystal
display, battery and circuit board	Same components
Sensor	Thermistor	Same sensor type
Signal processing
and display	Using the resistance change of
thermal resistor to detect body
temperature and displayed
through the LCD.	Same technologies:
Same signal processing and LCD
display.
Elevated
temperature
indicator	Above 99.5 °F,
4 short beeps as Bi-Bi-Bi-Bi in 4
seconds	Above 99.7°F, rapid beeps and a red
backlight inform the patient,
Same audio beeps
Display
Resolution	0.1 °F	0.1 °F
Same display resolution:
Response time	60 sec	8-10 sec – predictive mode
60 sec – non predictive mode
Same response times under
non-predictive mode.
Reference
standard	EN 12470-3:2000+A1:2009
ASTM E1112-00:2011
IEC 60601-1:2005
IEC 60601-1-2:2007	EN 12470-3: 2000+A1:2009
ASTM E1112-00:2011
IEC 60601-1:2005
IEC 60601-1-11:2010
IEC 60601-1-2:2007
One more reference standard, IEC
60601-1-11
Used with
probe cover	YES	YES
Patient contacting
material
Biocompatibility	ISO 10993-5:2009
ISO 10993-10:2010	Non-sterile & single-use
510(k)-clearance probe cover with
the same biocompatibilities tests
Cleaning /
disinfection info	Cleaning & disinfecting the
device after each use with 75%
isopropyl alcohol	Same cleaning /disinfection process
Operating
temperature
and humidity	60.8 °F to 104 °F
95% RH or less	60.8 °F to 104°F
95% RH or less
Same operating conditions as PD
Different characteristics
Measurement site	Oral	Axillary, oral or rectum
2 more sites choices than PD.
Storage
temperature
and humidity	-13 °F to 131 °F
95% RH or less	-4 °F to 131 °F
95% RH or less
Different storage conditions.
Power
requirements	1.5V, LR41	3.0 V, CR2032
Same button-like batteries, but with
different voltages,
Measurement
range	89.6 °F to 111.2 °F	89.6 °F ~109.2 °F
Narrower measurement range than
PD
Accuracy	±0.2 °F for the range of 98 °F to
102.2 °F	±0.1 °C at 33.0 °C,
±0.1 °C at 36.0 °C
±0.1 °C at 38.0 °C,
±0.1 °C at 40.0 °C
±0.1 °C at 42.0 °C
They have slightly different
measurement accuracies, but they
all met the ASTM 1112-00:2011.
Weight
(w/ battery)	15g	30g
They have different weights.
Dimensions
(LWH) mm	118 x 20 x 12 mm	134.2 x 35.1 x 15.1 mm
They have different size dimensions.
Auto power off	Yes, when idle for 10 min	Yes, when idle for 3 min
Better performance of energy saving
function than PD
Patient contacting
material	Non-sterile & single-use probe
cover (PVC film)	Non-sterile & single-use
510(k)-clearance probe cover ( EVA
film)
Color (inks/ dyes)	Yes	Yes
Pigment (YELLOW Ferro1020)

● Table I.1 Comparison Table

6

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

7

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

Substantial Equivalence Discussion ●

• A claim of substantial equivalence is made to Kingtech Digital ● Thermometer TT1001 (K133111). The indications for use. the measurement principle and technologies are the same. There are no new concerns raised.
• The subject device has two more sites choices than PD, i.e. under arm or rectum sites. Since the accuracy performances under arm and rectum sites are validated by the relevant bench performance testing, there are no safety or effectiveness concerns raised.
• The storage temperature range of the subject device is different from those of PD, and the maximum storage humidity ranges of both devices are to be 95% RH or less. The storage conditions are confirmed to be effective and safe after we did the storage environment testing. If the user stores the subject device according to the prescribed storage conditions, there is no any concern raised.
• Both of them use the same button-like batteries but with different voltages. The battery information is shown in the user manual and on the device itself, and the users can replace and install a correct type battery without question. There is no concern raised.
• The slight differences of maximum measurement points 109.2 °F for the subject device are 2 degrees less than PD. Since these differences are so small, thev will not raise any new concern.
• The accuracies of the subject and predicate devices are different. The subject device passes the relevant accuracy testing, in which results show the accuracies as
  • ±0.1 °C at 33.0 °C. ±0.1 ºC at 36.0 ºC ±0.1 °C at 38.0 °C. ±0.1 °C at 40.0 °C ±0.1 °C at 42.0 °C

for different temperature ranges. PD has the same accuracy of ±0.2 °F for the range of 98 F to 102.2 F. For the range of 98 °F to 102.2 °F the accuracy of the subject device is around ±0.18 °F. So the differences of accuracies did not raise any concern.

• Weight of the subject device is 30g, and PD is 15g. Since most of the users are healthcare professional and the different weights will not pose any adverse events for the patients. There is no new concern raised.
• The size dimensions of the PD and subject devices are different. This is caused by the different designs of the main housing and electric board. There is no new concern raised.

8

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

• The instructions for cleaning & disinfecting the device after each use with 75% isopropyl alcohol are the same for subject and predicate devices. There is no new concern raised.
• The auto power off functions for the subject device is when idle for 180 sec and PD is 10 min idle. We can say the subject device has better performance of energy saving. There is no new concern raised.
• The color parts of subject and predicate devices are different due to the various colorants/dyes added. But subject and predicate devices are all required to be used with probe covers for patient-contacting materials. The patient-contacting materials are probe covers, not the various color parts. Especially, the probe cover used with the subject device is already 510(k) cleared (K102508). The patient-contacting materials all passed biocompatibilities testing, and the various probe covers and different color parts did not raise new safety and effectiveness concerns.

● Summary of non-clinical testing

1) Electrical Safety, EMC and Biocompatibility Test

• IEC/ EN 60601-1 2012+ CORR.1 (2014) Medical electrical equipment Part 1: General requirements for basic safety and essential performance
• IEC/EN 60601-1-11:2010 Medical electrical equipment Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
• IEC/ EN 60601-1-2:2007+AC:2010 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests
• ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
• ISO 10993-5:2009 Biological evaluation of medical devices -- Part 5: Tests for in vitro cytotoxicity
• ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization

9

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

2) Performance Test

• Accuracy & repeatability test: The evaluation of test results showed the uncertainty and repeatability clinical bias were 0.09 and 0.058. It all met the minimum acceptable accuracies required by BS EN 12470-3:2000+A1:2009.

Table I.2.a The pooled clinical bias and its standard deviation of subject device

Sample	The pooled	Bias+ 1.96	Bias -1.96	Uncertainty
size	clinical bias	SD	SD
120	-0.01	0.17	-0.20	0.09

Table I.2.b The pooled clinical repeatability of subject device

The pooled clinical repeatability evaluation	Sample size	Repeatability clinical bias
120	0.058

● Lab accuracy test

Table I.3 Lab accuracy test per E1112-00:2011

| Water bath
temperature
(°C) | Maximum
calculated error
(°C) | E1112-00:2011
acceptance criteria
(°C) | Verdict |
|-----------------------------------|-------------------------------------|----------------------------------------------|---------|
| 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| 42.0 | 0.1 | $\pm$ 0.3 | Pass |

10

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C. Phone: [phone] Fax: [phone] www.bca-medical.com

• Display temperature range test: Verify the measuring display range of subject device to be complied with ASTM E1112-00:2011 standard, which has the requirement of covering the minimum measuring range from 35.5 to 41 °C (96.0 to 106.0 °F), The display measuring range of subject device is specified and validated to be from 32.0« to 42.9 ℃, which covers the range of 35.5 - 41 °C.

● Drop test

| Per ASTM
E1112-00:2011 | Water bath
temperature
(°C) | Maximum
calculated error
(°C) | Acceptance
Criteria
(°C) | Verdict |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------------|--------------------------------|---------|
| Drop test:
Drop the subject
device from a
height of 1 m
onto the
hardwood with
two directions. | 33.0 | 0.1 | $\u00b10.3$ | Pass |
| | 36.0 | 0.1 | $\u00b10.2$ | Pass |
| | 38.1 | 0.1 | $\u00b10.1$ | Pass |
| | 40.0 | 0.1 | $\u00b10.2$ | Pass |
| | 42.0 | 0.1 | $\u00b10.3$ | Pass |

Table I.4 The greatest measurement errors after drop tests.

● Operating environment test

Table I.5. The maximum errors in the operating environmental test are within the requirements of the accuracy requirements specified in ASTM E1112-00:2011.

11

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

Table I.5.a.

| Operating
environment
1 | Water bath
temperature
(°C) | Maximum
calculated
error (°C) | Acceptance
Criteria (°C) | Verdict |
|-------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 103 °F
(40°C)
15% RH | 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| | 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| | 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 42.0 | 0.1 | $\pm$ 0.3 | Pass |

Table I.5.b.

| Operating
environment
2 | Water bath
temperature
(°C) | Maximum
calculated
error (oC) | Acceptance
Criteria (°C) | Verdict |
|-------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 103 °F
(40°C)
80% RH | 33.0 | 0.2 | ±0.3 | Pass |
| | 36.0 | 0.1 | ±0.2 | Pass |
| | 38.0 | 0.1 | ±0.1 | Pass |
| 40.0 | 40.0 | 0.1 | ±0.2 | Pass |
| | 42.0 | 0.1 | ±0.3 | Pass |

Table I.5.c.

| Operating
environment
3 | Water bath
temperature
(°C) | Maximum
calculated
error (°C) | Acceptance
Criteria (°C) | Verdict |
|-------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 60.8 °F
(16°C)
40% RH | 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| | 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| | 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 42.0 | 0.1 | $\pm$ 0.3 | Pass |

12

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

Table I.5.d.

| Operating
environment | Water bath
temperature
(°C) | Maximum
calculated
error (°C) | Acceptance
Criteria (°C) | Verdict |
|-----------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 60.8 °F
(16°C)
95% RH | 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| | 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| | 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 42.0 | 0.1 | $\pm$ 0.3 | Pass |

● Storage environment test

Table I.6. The maximum errors in the storage environmental test of subject device are within the requirements of the accuracy requirements specified in ASTM E1112-00:2011.

| Storage
environment
1 | Water bath
temperature
(°C) | Maximum
calculated
error (°C) | Acceptance
Criteria (°C) | Verdict |
|-----------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| -13 °F
(-25 °C) | 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| | 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| | 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 42.0 | 0.1 | $\pm$ 0.3 | Pass |

13

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

Table I.6.b.

| Storage
environment
2 | Water bath
temperature
(°C) | Maximum
calculated
error (°C) | Acceptance
Criteria (°C) | Verdict |
|--------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 130.9 °F
(55 °C )
15% RH | 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| | 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| | 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 42.0 | 0.1 | $\pm$ 0.3 | Pass |

Table I.6.c.

| Storage
environment | Water bath
temperature
(°C) | Maximum
calculated
error (°C) | Acceptance
Criteria (°C) | Verdict |
|-------------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 94.9 °F
(35 °C)
95% RH | 33.0 | 0.1 | $\pm$ 0.3 | Pass |
| | 36.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 38.0 | 0.1 | $\pm$ 0.1 | Pass |
| | 40.0 | 0.1 | $\pm$ 0.2 | Pass |
| | 42.0 | 0.1 | $\pm$ 0.3 | Pass |

• EN 12470-3:2000+A1: 2009 Clinical thermometers - Part 3: Performance of compact electrical thermometers (non-predictive and predictive) with maximum device". Table I.7.a - Table I.7.e show the compliance of the subject devices with the EN 12470-3:2000+A1:2009.

a) Metrological requirements

14

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

Table I.7.a.

Item no.	Test name	Acceptance criteria	Test results	Verdict
1)	Measuring
range	The subject device shall
cover the minimum
measuring range from 35.5-
42 °C (95.9 – 109.2 °F)	The test range
covers 31.7 - 44.3
°C, and it meets the
acceptance criteria.	Pass
2)	Digital
increment	The digital increment of the
indicating unit shall be 0.1
°C ( 0.1 °F)	The digital
increment of the
indicating unit is
inspected to be 0.1
°C (0.1 °F), and it
meets the
acceptance criteria.	Pass
3)	Maximum
permissible
errors under
reference
conditions	The maximum permissible
error for the measuring
range 35.5 - 42.0 °C (95.9

• 107.6 °F) shall be 0.1 °C
  within the ambient
  temperature range from 18
• 28°C.
  Outside the measuring
  range of 35.5 - 42.0 °C
  or outside the ambient
  temperature range, the
  maximum permissible
  error shall not be
  greater than twice the
  specified value (0.2 °C). | The results are in
  compliance with
  the requirements of
  Subclause 6.2.3,
  and it meets the
  acceptance criteria. | Pass |
  | 4) | Time
  Response | The test sample shall
  display the correct
  temperature reading within
  60 seconds. | The result is in
  compliance with
  the requirements of
  Subclause 6.2.4,
  and it meets the
  acceptance criteria. | Pass |
  | 5) | Maximum
  energy
  dissipation | The maximum power
  dissipation on probe shall
  be 2 mW. | The result is in
  compliance with
  the requirements of
  Subclause 6.2.5,
  and it meets the
  acceptance criteria. | Pass |
  | 6) | Long term
  stability | The maximum permissible
  error shall comply with
  Subclause 6.2.3 when
  placing subject device into
  temperature chamber for a
  minimum of 288 hours at a
  temperature of (55±2) °C. | The result is in
  compliance with
  the requirements of
  Subclause 6.2.6,
  and it meets the
  acceptance criteria. | Pass |

15

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone] www.bca-medical.com

b) Environmental requirements

Table I.7.b

| Item

no.	Test name	Acceptance criteria	Test results	Verdict
1)	Ambient
operating range	The maximum
permissible error shall
comply with Subclause
6.2.3.	The result is in
compliance with
the requirements
of Subclause
6.3.1, and it meets
the acceptance
criteria.	Pass
2)	Effect of
storage	The maximum
permissible error shall
comply with Subclause
6.2.3.	The result is in
compliance with
the requirements
of Subclause
6.3.2, and it meets
the acceptance
criteria.	Pass
3)	Thermal Shock	The maximum
permissible error
shall comply with	The result is in
compliance with	Pass
		Subclause 6.2.3.	the requirements
of Subclause
6.3.3, and it meets
the acceptance
criteria.
4)	Humidity	The maximum
permissible error shall
comply with Subclause
6.2.3.	The result is in
compliance with
the requirements
of Subclause
6.3.4, and it meets
the acceptance
criteria.	Pass
5)	Electromagnetic
compatibility	The maximum
permissible error shall
comply with Subclause
6.2.3.	The result is in
compliance with
the requirements
of Subclause
6.3.5, and it meets
the acceptance
criteria.	Pass
6)	Mechanical
shock	The maximum
permissible error shall
comply with Subclause
6.2.3.	The result is in
compliance with
the requirements
of Subclause
6.3.6, and it meets
the acceptance
criteria.	Pass
7)	Water resistance	The maximum
permissible error shall
comply with Subclause
6.2.3.	The result is in
compliance with
the requirements
of Subclause
6.3.7, and it meets
the acceptance
criteria.
Item
no.	Test name	Acceptance criteria	Test results	Verdict
1.1	Voltage
limit
indication	*The subject device shall
automatically provide a
visual or auditory
warning when its supply
voltage is not within
specified limits.
*The device shall meet
the maximum permissible
error in Subclause 6.2.3
when the voltage is
within the specified
limits.	The result is in
compliance with
the requirements
of Subclause
6.4.1.1, and it
meets the
acceptance
criteria.	Pass
1.2	Indicating unit	*Numerical values on the
display shall be at least 4
mm in height.

• After power-on all
  segments shall be
  activated for at least 1
  second. | *The numerical
  values on the
  display are
  measured to be
  more than 4 mm
  in height.
• After power-on
  all segments are
  activated for at
  least 1 second.
  *The results
  meet the
  acceptance
  criteria. | Pass |
  | 1.3 | Functional
  safety test | *The device shall
  have a self-testing
  routine. The correct
  operation shall be
  indicated by a given
  display. | *The result is in
  compliance with
  the acceptance
  criteria.
  *Refer to | Pass |
  | | | *The manufacturer
  shall provide
  information as to how
  the self-testing
  routine operates and
  what display is to be
  expected. | 1004/1005 user
  manuals. | |
  | 2) | Material | The device shall be free
  from biological hazards. | *The result is in
  compliance with
  the acceptance
  criteria.
  *Refer to
  Biocompatibility
  information in
  Section J of this
  510(k)
  submission | Pass |

16

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

17

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

c) Construction requirements

Table I.7.c.

18

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

d) Electrical safety

Table I.7.d.

| Item

no.	Test name	Acceptance criteria	Test results	Verdict
1	Electrical safety	The device shall comply
with the requirements of
EN 60601-1: 1990.	The result is in
compliance with
the requirements
of Subclause 6.5
and it meets the
acceptance
criteria.	Pass

19

NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.

Phone: [phone] Fax: [phone]

www.bca-medical.com

e) Mechanical safety

Table I.7.e.

| Item

no.	Test name	Acceptance criteria	Test results	Verdict
	1)	Thermometer	*Thermometers shall not
have sharp ends or angles
that could injure the user
or patient.
*The temperature probe
shall be smoothly
rounded in order to
prevent tissue damage
during use.	The result is in
compliance with
the requirements
of Subclause
6.6.1, and it
meets the
acceptance
criteria.
2)	Resistance to
breakage	The thermometer with a
housing of glass shall
comply with Subclause
6.1.2.7 of prEN12470-1.	*The subject
devices have no
glass housing.
*This test is not
applicable to the
subject device.	NA

● Conclusion

The conclusions drawn from the non-clinical tests demonstrate that the subject device performs as well as the predicate device identified in the submission. Thus the subject device is substantially equivalent to the predicate device.