Digital Thermometer

K161211 · Biocare Asia Corporation , Ltd. · FLL · Aug 29, 2016 · General Hospital

Device Facts

• Record ID: K161211
• Device Name: Digital Thermometer
• Applicant: Biocare Asia Corporation , Ltd.
• Product Code: FLL · General Hospital
• Decision Date: Aug 29, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

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 Story

Digital thermometer (models 1004/1005) measures body temperature using a thermistor sensor. Device requires a disposable probe cover for use. Thermistor resistance changes with temperature; an application-specific IC processes this signal to calculate temperature, which is displayed on an LCD. Features include predictive (8-10s) and non-predictive (60s) measurement modes, °F/°C switchable display, memory for 9 readings, and automatic shutoff. Elevated temperatures (>99.7°F/37.6°C) trigger a red backlight and audio beeps. Used by medical professionals or patients in clinical or home settings. Output provides immediate temperature feedback to assist in clinical decision-making regarding fever management.

Clinical Evidence

Bench testing only. Performance validated via accuracy and repeatability testing (n=120), demonstrating pooled clinical bias of -0.01 and repeatability of 0.058. Lab accuracy testing across 33.0°C–42.0°C water baths met ASTM E1112-00:2011 criteria. Additional testing included drop tests, operating/storage environment stress tests, electrical safety (IEC 60601-1), and EMC (IEC 60601-1-2). Biocompatibility confirmed per ISO 10993-5 and 10993-10.

Technological Characteristics

Thermistor-based temperature sensing; application-specific IC for signal processing; LCD display. Powered by 3.0V CR2032 battery. Flexible tip design. Materials include plastic housing and EVA film probe covers. Complies with IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, and ASTM E1112-00:2011. Non-sterile, single-use probe covers.

Indications for Use

Indicated for measuring body temperature in axillary, oral, or rectal sites for people of all ages in clinical, hospital, or home environments.

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

• Kingtech Digital Thermometer, TT1001 (K133111)

Reference Devices

• Clinical Electronic Thermometer, MC-246 (K091676)

Submission Summary (Full Text)

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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.

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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

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## 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)

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#### FOR FDA USE ONLY

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

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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

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

Phone: [phone] Fax: [phone]

www.bca-medical.com

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

#### ● Table I.1 Comparison Table

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

Phone: [phone] Fax: [phone]

www.bca-medical.com

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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.

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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

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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<br>temperature<br>(°C) | Maximum<br>calculated error<br>(°C) | E1112-00:2011<br>acceptance criteria<br>(°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 |

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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<br>E1112-00:2011 | Water bath<br>temperature<br>(°C) | Maximum<br>calculated error<br>(°C) | Acceptance<br>Criteria<br>(°C) | Verdict |
|------------------------------------------------------------------------------------------------------------------|-----------------------------------|-------------------------------------|--------------------------------|---------|
| Drop test:<br>Drop the subject<br>device from a<br>height of 1 m<br>onto the<br>hardwood with<br>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.

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#### 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<br>environment<br>1 | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (°C) | Acceptance<br>Criteria (°C) | Verdict |
|-------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 103 °F<br>(40°C)<br>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<br>environment<br>2 | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (oC) | Acceptance<br>Criteria (°C) | Verdict |
|-------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 103 °F<br>(40°C)<br>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<br>environment<br>3 | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (°C) | Acceptance<br>Criteria (°C) | Verdict |
|-------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 60.8 °F<br>(16°C)<br>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 |

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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<br>environment | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (°C) | Acceptance<br>Criteria (°C) | Verdict |
|-----------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 60.8 °F<br>(16°C)<br>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<br>environment<br>1 | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (°C) | Acceptance<br>Criteria (°C) | Verdict |
|-----------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| -13 °F<br>(-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 |

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#### 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<br>environment<br>2 | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (°C) | Acceptance<br>Criteria (°C) | Verdict |
|--------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| 130.9 °F<br>(55 °C )<br>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<br>environment | Water bath<br>temperature<br>(°C) | Maximum<br>calculated<br>error (°C) | Acceptance<br>Criteria (°C) | Verdict |
|-------------------------------------|-----------------------------------|-------------------------------------|-----------------------------|---------|
| <b>94.9 °F</b><br>(35 °C)<br>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

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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<br>range | The subject device shall<br>cover the minimum<br>measuring range from 35.5-<br>42 °C (95.9 – 109.2 °F) | The test range<br>covers 31.7 - 44.3<br>°C, and it meets the<br>acceptance criteria. | Pass |
| 2) | Digital<br>increment | The digital increment of the<br>indicating unit shall be 0.1<br>°C ( 0.1 °F) | The digital<br>increment of the<br>indicating unit is<br>inspected to be 0.1<br>°C (0.1 °F), and it<br>meets the<br>acceptance criteria. | Pass |
| 3) | Maximum<br>permissible<br>errors under<br>reference<br>conditions | The maximum permissible<br>error for the measuring<br>range 35.5 - 42.0 °C (95.9<br>- 107.6 °F) shall be 0.1 °C<br>within the ambient<br>temperature range from 18<br>- 28°C.<br>Outside the measuring<br>range of 35.5 - 42.0 °C<br>or outside the ambient<br>temperature range, the<br>maximum permissible<br>error shall not be<br>greater than twice the<br>specified value (0.2 °C). | The results are in<br>compliance with<br>the requirements of<br>Subclause 6.2.3,<br>and it meets the<br>acceptance criteria. | Pass |
| 4) | Time<br>Response | The test sample shall<br>display the correct<br>temperature reading within<br>60 seconds. | The result is in<br>compliance with<br>the requirements of<br>Subclause 6.2.4,<br>and it meets the<br>acceptance criteria. | Pass |
| 5) | Maximum<br>energy<br>dissipation | The maximum power<br>dissipation on probe shall<br>be 2 mW. | The result is in<br>compliance with<br>the requirements of<br>Subclause 6.2.5,<br>and it meets the<br>acceptance criteria. | Pass |
| 6) | Long term<br>stability | The maximum permissible<br>error shall comply with<br>Subclause 6.2.3 when<br>placing subject device into<br>temperature chamber for a<br>minimum of 288 hours at a<br>temperature of (55±2) °C. | The result is in<br>compliance with<br>the requirements of<br>Subclause 6.2.6,<br>and it meets the<br>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<br>no. | Test name | Acceptance criteria | Test results | Verdict |
|-------------|----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| 1) | Ambient<br>operating range | The maximum<br>permissible error shall<br>comply with Subclause<br>6.2.3. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.3.1, and it meets<br>the acceptance<br>criteria. | Pass |
| 2) | Effect of<br>storage | The maximum<br>permissible error shall<br>comply with Subclause<br>6.2.3. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.3.2, and it meets<br>the acceptance<br>criteria. | Pass |
| 3) | Thermal Shock | The maximum<br>permissible error<br>shall comply with | The result is in<br>compliance with | Pass |
| | | Subclause 6.2.3. | the requirements<br>of Subclause<br>6.3.3, and it meets<br>the acceptance<br>criteria. | |
| 4) | Humidity | The maximum<br>permissible error shall<br>comply with Subclause<br>6.2.3. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.3.4, and it meets<br>the acceptance<br>criteria. | Pass |
| 5) | Electromagnetic<br>compatibility | The maximum<br>permissible error shall<br>comply with Subclause<br>6.2.3. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.3.5, and it meets<br>the acceptance<br>criteria. | Pass |
| 6) | Mechanical<br>shock | The maximum<br>permissible error shall<br>comply with Subclause<br>6.2.3. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.3.6, and it meets<br>the acceptance<br>criteria. | Pass |
| 7) | Water resistance | The maximum<br>permissible error shall<br>comply with Subclause<br>6.2.3. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.3.7, and it meets<br>the acceptance<br>criteria. | |
| Item<br>no. | Test name | Acceptance criteria | Test results | Verdict |
| 1.1 | Voltage<br>limit<br>indication | *The subject device shall<br>automatically provide a<br>visual or auditory<br>warning when its supply<br>voltage is not within<br>specified limits.<br>*The device shall meet<br>the maximum permissible<br>error in Subclause 6.2.3<br>when the voltage is<br>within the specified<br>limits. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.4.1.1, and it<br>meets the<br>acceptance<br>criteria. | Pass |
| 1.2 | Indicating unit | *Numerical values on the<br>display shall be at least 4<br>mm in height.<br>* After power-on all<br>segments shall be<br>activated for at least 1<br>second. | *The numerical<br>values on the<br>display are<br>measured to be<br>more than 4 mm<br>in height.<br>* After power-on<br>all segments are<br>activated for at<br>least 1 second.<br>*The results<br>meet the<br>acceptance<br>criteria. | Pass |
| 1.3 | Functional<br>safety test | *The device shall<br>have a self-testing<br>routine. The correct<br>operation shall be<br>indicated by a given<br>display. | *The result is in<br>compliance with<br>the acceptance<br>criteria.<br>*Refer to | Pass |
| | | *The manufacturer<br>shall provide<br>information as to how<br>the self-testing<br>routine operates and<br>what display is to be<br>expected. | 1004/1005 user<br>manuals. | |
| 2) | Material | The device shall be free<br>from biological hazards. | *The result is in<br>compliance with<br>the acceptance<br>criteria.<br>*Refer to<br>Biocompatibility<br>information in<br>Section J of this<br>510(k)<br>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<br>no. | Test name | Acceptance criteria | Test results | Verdict |
|-------------|-------------------|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|---------|
| 1 | Electrical safety | The device shall comply<br>with the requirements of<br>EN 60601-1: 1990. | The result is in<br>compliance with<br>the requirements<br>of Subclause 6.5<br>and it meets the<br>acceptance<br>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<br>no. | Test name | Acceptance criteria | Test results | Verdict |
|-------------|---------------------------|------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------|
| | 1) | Thermometer | *Thermometers shall not<br>have sharp ends or angles<br>that could injure the user<br>or patient.<br>*The temperature probe<br>shall be smoothly<br>rounded in order to<br>prevent tissue damage<br>during use. | The result is in<br>compliance with<br>the requirements<br>of Subclause<br>6.6.1, and it<br>meets the<br>acceptance<br>criteria. |
| 2) | Resistance to<br>breakage | The thermometer with a<br>housing of glass shall<br>comply with Subclause<br>6.1.2.7 of prEN12470-1. | *The subject<br>devices have no<br>glass housing.<br>*This test is not<br>applicable to the<br>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.