(123 days)
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.
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.
This document is a 510(k) Summary of Safety and Effectiveness for the Digital Thermometer, Models 1004 & 1005, manufactured by Biocare Asia Corporation Ltd. It describes the device, its intended use, comparison to a predicate device, and the non-clinical testing performed to establish substantial equivalence.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is primarily assessed against the standards ASTM E1112-00:2011 and EN 12470-3:2000+A1:2009.
| Acceptance Criteria (Standard) | Reported Device Performance | Verdict |
|---|---|---|
| Accuracy (ASTM E1112-00:2011) | ||
| ±0.3 °C at 33.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.2 °C at 36.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.1 °C at 38.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.2 °C at 40.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| ±0.3 °C at 42.0 °C water bath temperature | Maximum calculated error: 0.1 °C | Pass |
| Accuracy (EN 12470-3:2000+A1:2009 - Maximum permissible errors under reference conditions) | ||
| 0.1 °C within 35.5 - 42.0 °C (ambient 18 - 28°C) | Results in compliance with Subclause 6.2.3 | Pass |
| 0.2 °C outside 35.5 - 42.0 °C or ambient temperature range | Results in compliance with Subclause 6.2.3 | Pass |
| Drop Test (ASTM E1112-00:2011) | ||
| Max error within specified accuracy limits for 1m drop | Max calculated error: 0.1 °C at all tested temperatures (33.0-42.0 °C) | Pass |
| Operating Environment Test (ASTM E1112-00:2011) | ||
| Max errors within specified accuracy limits at various temp/humidity | Max calculated errors within acceptance criteria (0.1-0.2 °C) | Pass |
| Storage Environment Test (ASTM E1112-00:2011) | ||
| Max errors within specified accuracy limits after storage conditioning | Max calculated errors within acceptance criteria (0.1 °C) | Pass |
| Measuring Range (EN 12470-3:2000+A1:2009) | ||
| Cover minimum 35.5 - 42 °C (95.9 – 109.2 °F) | Test range covers 31.7 - 44.3 °C | Pass |
| Digital Increment (EN 12470-3:2000+A1:2009) | ||
| 0.1 °C (0.1 °F) | Inspected to be 0.1 °C (0.1 °F) | Pass |
| Time Response (EN 12470-3:2000+A1:2009) | ||
| Display correct temperature within 60 seconds | Results in compliance with Subclause 6.2.4 | Pass |
| Maximum energy dissipation (EN 12470-3:2000+A1:2009) | ||
| Max 2 mW on probe | Results in compliance with Subclause 6.2.5 | Pass |
| Long term stability (EN 12470-3:2000+A1:2009) | ||
| Comply with Subclause 6.2.3 after 288 hrs at 55±2 °C | Results in compliance with Subclause 6.2.6 | Pass |
| Environmental Requirements (EN 12470-3:2000+A1:2009) | ||
| Ambient operating range, effect of storage, thermal shock, humidity, EMC, mechanical shock, water resistance: Accuracy to comply with Subclause 6.2.3 | All results in compliance with relevant subclauses (6.3.1-6.3.7) | Pass |
| Voltage limit indication (EN 12470-3:2000+A1:2009) | ||
| Auto visual/auditory warning for out-of-spec voltage; meet 6.2.3 accuracy | Results in compliance with Subclause 6.4.1.1 | Pass |
| Indicating unit (EN 12470-3:2000+A1:2009) | ||
| Numerical values >= 4mm height; all segments activated for >= 1 sec on power-on | Numerical values > 4mm; all segments activated for >= 1 sec | Pass |
| Functional safety test (EN 12470-3:2000+A1:2009) | ||
| Self-testing routine with correct operation indicated | Results in compliance; refer to user manual for details | Pass |
| Material (EN 12470-3:2000+A1:2009) | ||
| Free from biological hazards | Results in compliance; refer to biocompatibility info in Section J | Pass |
| Construction (EN 12470-3:2000+A1:2009) | ||
| Smooth surface, tip dimensions, absence of sharp edges, water resistance | All results in compliance with relevant subclauses | Pass |
| Electrical safety (EN 12470-3:2000+A1:2009) | ||
| Compliance with EN 60601-1:1990 | Results in compliance with Subclause 6.5 | Pass |
| Mechanical safety (EN 12470-3:2000+A1:2009) | ||
| No sharp ends/angles; probe smoothly rounded | Results in compliance with Subclause 6.6.1 | Pass |
| Resistance to breakage (for glass housing) | Not applicable to subject device (no glass housing) | NA |
2. Sample size used for the test set and the data provenance
- Test Set (Clinical Accuracy & Repeatability): 120 samples.
- Test Set (Lab Accuracy, Drop, Operating Environment, Storage Environment tests): The document does not explicitly state the number of devices tested for each of these bench tests, but implies multiple devices were tested to report the "maximum calculated error".
- Data Provenance: The document does not explicitly state the country of origin or whether the data is retrospective or prospective. Given that Biocare Asia Corporation Ltd. is located in Jiangsu, China, it is likely the testing was conducted in China. The clinical accuracy tests, with "pooled clinical bias" and "pooled clinical repeatability," suggest a clinical study was performed, which would be prospective in nature. The other performance tests are bench tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the device is a digital thermometer, and the ground truth for temperature measurement is established by calibrated reference standards (e.g., water baths, and for clinical accuracy, potentially reference thermometers). Experts are not typically involved in establishing the "ground truth" for physical measurements like temperature in this context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a digital thermometer as ground truth is based on physical scientific measurements with calibrated equipment, not subjective expert assessment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a digital thermometer, not an AI-powered diagnostic imaging device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is a standalone device in the sense that it provides a temperature reading without a human interpreting an algorithm's output. The "algorithm" here is the device's internal signal processing of the thermistor input. The performance tests (e.g., accuracy against reference temperatures) evaluate the standalone performance of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the performance tests (accuracy, repeatability, environmental robustness) is established by calibrated reference standards (e.g., water baths at precisely controlled temperatures) as defined by the mentioned international standards (ASTM E1112-00:2011, EN 12470-3:2000+A1:2009). For clinical accuracy, it would be a comparison to a highly accurate reference thermometer.
8. The sample size for the training set
Not applicable. This device is not an AI/machine learning model that requires a training set. It is a traditional electronic device based on physical principles.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)
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)
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 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 Thermometer21 CFR 880.2910 |
| Class | II |
| Panel | 80 General Hospital |
| Product Code | FLL |
| Owner/Operator | BIOCARE ASIA CORPORATION LTD.NO.260, MAYUN ROAD, NEW DISTRICTSUZHOU, JIANGSU, 215129, P.R.C.Phone: +86 (512) 6809-1772Fax: +86 (512) 6809-7761www.bca-medical.com |
| Date prepared | August 22, 2016 |
| 510k Contact Person | Dr. Jen, Ke-MinTEL: +886-3-5208829FAX: +886-3-5209783Email: ceirs.jen@msa.hinet.net |
| Predicate Device | Kingtech Enterprises LimitedKINGTECH Digital Thermometer, TT1001K133111 |
| Reference Device | Omron Healthcare, Inc.Clinical Electronic Thermometer, MC-246K091676 |
● 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: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
● 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: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
| ComparisonItems | 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 |
| ClassificationCode | FLL, Class II,21 CFR 880.2910 | FLL, Class II,21 CFR 880.2910 |
| Similar characteristics | ||
| Intended uses | TT1001 Digital Thermometer isintended to measure the bodytemperature orally and to be usedby medical professionals inclinical and hospital environmentsand consumers in a homeenvironment. It is intended foruse on people of all ages. | Digital Thermometer is intended tomeasure body temperature inaxillary, oral or rectum and to beused by medical professionals inclinical and hospital environments orconsumers in a home environment.It is intended for use on people of allages. |
| Components | Temperature sensor, liquid crystaldisplay, battery and circuit board | Same components |
| Sensor | Thermistor | Same sensor type |
| Signal processingand display | Using the resistance change ofthermal resistor to detect bodytemperature and displayedthrough the LCD. | Same technologies:Same signal processing and LCDdisplay. |
| Elevatedtemperatureindicator | Above 99.5 °F,4 short beeps as Bi-Bi-Bi-Bi in 4seconds | Above 99.7°F, rapid beeps and a redbacklight inform the patient,Same audio beeps |
| DisplayResolution | 0.1 °F | 0.1 °FSame display resolution: |
| Response time | 60 sec | 8-10 sec – predictive mode60 sec – non predictive modeSame response times undernon-predictive mode. |
| Referencestandard | EN 12470-3:2000+A1:2009ASTM E1112-00:2011IEC 60601-1:2005IEC 60601-1-2:2007 | EN 12470-3: 2000+A1:2009ASTM E1112-00:2011IEC 60601-1:2005IEC 60601-1-11:2010IEC 60601-1-2:2007One more reference standard, IEC60601-1-11 |
| Used withprobe cover | YES | YES |
| Patient contactingmaterialBiocompatibility | ISO 10993-5:2009ISO 10993-10:2010 | Non-sterile & single-use510(k)-clearance probe cover withthe same biocompatibilities tests |
| Cleaning /disinfection info | Cleaning & disinfecting thedevice after each use with 75%isopropyl alcohol | Same cleaning /disinfection process |
| Operatingtemperatureand humidity | 60.8 °F to 104 °F95% RH or less | 60.8 °F to 104°F95% RH or lessSame operating conditions as PD |
| Different characteristics | ||
| Measurement site | Oral | Axillary, oral or rectum2 more sites choices than PD. |
| Storagetemperatureand humidity | -13 °F to 131 °F95% RH or less | -4 °F to 131 °F95% RH or lessDifferent storage conditions. |
| Powerrequirements | 1.5V, LR41 | 3.0 V, CR2032Same button-like batteries, but withdifferent voltages, |
| Measurementrange | 89.6 °F to 111.2 °F | 89.6 °F ~109.2 °FNarrower measurement range thanPD |
| Accuracy | ±0.2 °F for the range of 98 °F to102.2 °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 °CThey have slightly differentmeasurement accuracies, but theyall met the ASTM 1112-00:2011. |
| Weight(w/ battery) | 15g | 30gThey have different weights. |
| Dimensions(LWH) mm | 118 x 20 x 12 mm | 134.2 x 35.1 x 15.1 mmThey have different size dimensions. |
| Auto power off | Yes, when idle for 10 min | Yes, when idle for 3 minBetter performance of energy savingfunction than PD |
| Patient contactingmaterial | Non-sterile & single-use probecover (PVC film) | Non-sterile & single-use510(k)-clearance probe cover ( EVAfilm) |
| Color (inks/ dyes) | Yes | YesPigment (YELLOW Ferro1020) |
● Table I.1 Comparison Table
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
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: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 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: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 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 bathtemperature(°C) | Maximumcalculated error(°C) | E1112-00:2011acceptance 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 |
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C. Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 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 ASTME1112-00:2011 | Water bathtemperature(°C) | Maximumcalculated error(°C) | AcceptanceCriteria(°C) | Verdict |
|---|---|---|---|---|
| Drop test:Drop the subjectdevice from aheight of 1 monto thehardwood withtwo 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: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 www.bca-medical.com
Table I.5.a.
| Operatingenvironment1 | Water bathtemperature(°C) | Maximumcalculatederror (°C) | AcceptanceCriteria (°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.
| Operatingenvironment2 | Water bathtemperature(°C) | Maximumcalculatederror (oC) | AcceptanceCriteria (°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.
| Operatingenvironment3 | Water bathtemperature(°C) | Maximumcalculatederror (°C) | AcceptanceCriteria (°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 |
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 www.bca-medical.com
Table I.5.d.
| Operatingenvironment | Water bathtemperature(°C) | Maximumcalculatederror (°C) | AcceptanceCriteria (°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.
| Storageenvironment1 | Water bathtemperature(°C) | Maximumcalculatederror (°C) | AcceptanceCriteria (°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 |
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
Table I.6.b.
| Storageenvironment2 | Water bathtemperature(°C) | Maximumcalculatederror (°C) | AcceptanceCriteria (°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.
| Storageenvironment | Water bathtemperature(°C) | Maximumcalculatederror (°C) | AcceptanceCriteria (°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
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Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 www.bca-medical.com
Table I.7.a.
| Item no. | Test name | Acceptance criteria | Test results | Verdict |
|---|---|---|---|---|
| 1) | Measuringrange | The subject device shallcover the minimummeasuring range from 35.5-42 °C (95.9 – 109.2 °F) | The test rangecovers 31.7 - 44.3°C, and it meets theacceptance criteria. | Pass |
| 2) | Digitalincrement | The digital increment of theindicating unit shall be 0.1°C ( 0.1 °F) | The digitalincrement of theindicating unit isinspected to be 0.1°C (0.1 °F), and itmeets theacceptance criteria. | Pass |
| 3) | Maximumpermissibleerrors underreferenceconditions | The maximum permissibleerror for the measuringrange 35.5 - 42.0 °C (95.9- 107.6 °F) shall be 0.1 °Cwithin the ambienttemperature range from 18- 28°C.Outside the measuringrange of 35.5 - 42.0 °Cor outside the ambienttemperature range, themaximum permissibleerror shall not begreater than twice thespecified value (0.2 °C). | The results are incompliance withthe requirements ofSubclause 6.2.3,and it meets theacceptance criteria. | Pass |
| 4) | TimeResponse | The test sample shalldisplay the correcttemperature reading within60 seconds. | The result is incompliance withthe requirements ofSubclause 6.2.4,and it meets theacceptance criteria. | Pass |
| 5) | Maximumenergydissipation | The maximum powerdissipation on probe shallbe 2 mW. | The result is incompliance withthe requirements ofSubclause 6.2.5,and it meets theacceptance criteria. | Pass |
| 6) | Long termstability | The maximum permissibleerror shall comply withSubclause 6.2.3 whenplacing subject device intotemperature chamber for aminimum of 288 hours at atemperature of (55±2) °C. | The result is incompliance withthe requirements ofSubclause 6.2.6,and it meets theacceptance criteria. | Pass |
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761 www.bca-medical.com
b) Environmental requirements
Table I.7.b
| Itemno. | Test name | Acceptance criteria | Test results | Verdict |
|---|---|---|---|---|
| 1) | Ambientoperating range | The maximumpermissible error shallcomply with Subclause6.2.3. | The result is incompliance withthe requirementsof Subclause6.3.1, and it meetsthe acceptancecriteria. | Pass |
| 2) | Effect ofstorage | The maximumpermissible error shallcomply with Subclause6.2.3. | The result is incompliance withthe requirementsof Subclause6.3.2, and it meetsthe acceptancecriteria. | Pass |
| 3) | Thermal Shock | The maximumpermissible errorshall comply with | The result is incompliance with | Pass |
| Subclause 6.2.3. | the requirementsof Subclause6.3.3, and it meetsthe acceptancecriteria. | |||
| 4) | Humidity | The maximumpermissible error shallcomply with Subclause6.2.3. | The result is incompliance withthe requirementsof Subclause6.3.4, and it meetsthe acceptancecriteria. | Pass |
| 5) | Electromagneticcompatibility | The maximumpermissible error shallcomply with Subclause6.2.3. | The result is incompliance withthe requirementsof Subclause6.3.5, and it meetsthe acceptancecriteria. | Pass |
| 6) | Mechanicalshock | The maximumpermissible error shallcomply with Subclause6.2.3. | The result is incompliance withthe requirementsof Subclause6.3.6, and it meetsthe acceptancecriteria. | Pass |
| 7) | Water resistance | The maximumpermissible error shallcomply with Subclause6.2.3. | The result is incompliance withthe requirementsof Subclause6.3.7, and it meetsthe acceptancecriteria. | |
| Itemno. | Test name | Acceptance criteria | Test results | Verdict |
| 1.1 | Voltagelimitindication | *The subject device shallautomatically provide avisual or auditorywarning when its supplyvoltage is not withinspecified limits.*The device shall meetthe maximum permissibleerror in Subclause 6.2.3when the voltage iswithin the specifiedlimits. | The result is incompliance withthe requirementsof Subclause6.4.1.1, and itmeets theacceptancecriteria. | Pass |
| 1.2 | Indicating unit | Numerical values on thedisplay shall be at least 4mm in height. After power-on allsegments shall beactivated for at least 1second. | The numericalvalues on thedisplay aremeasured to bemore than 4 mmin height. After power-onall segments areactivated for atleast 1 second.*The resultsmeet theacceptancecriteria. | Pass |
| 1.3 | Functionalsafety test | *The device shallhave a self-testingroutine. The correctoperation shall beindicated by a givendisplay. | *The result is incompliance withthe acceptancecriteria.*Refer to | Pass |
| *The manufacturershall provideinformation as to howthe self-testingroutine operates andwhat display is to beexpected. | 1004/1005 usermanuals. | |||
| 2) | Material | The device shall be freefrom biological hazards. | *The result is incompliance withthe acceptancecriteria.*Refer toBiocompatibilityinformation inSection J of this510(k)submission | Pass |
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
c) Construction requirements
Table I.7.c.
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
d) Electrical safety
Table I.7.d.
| Itemno. | Test name | Acceptance criteria | Test results | Verdict |
|---|---|---|---|---|
| 1 | Electrical safety | The device shall complywith the requirements ofEN 60601-1: 1990. | The result is incompliance withthe requirementsof Subclause 6.5and it meets theacceptancecriteria. | Pass |
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NO.260, MAYUN ROAD, NEW DISTRICT SUZHOU, JIANGSU, 215129, P.R.C.
Phone: +86 (512) 6809-1772 Fax: +86 (512) 6809-7761
e) Mechanical safety
Table I.7.e.
| Itemno. | Test name | Acceptance criteria | Test results | Verdict |
|---|---|---|---|---|
| 1) | Thermometer | *Thermometers shall nothave sharp ends or anglesthat could injure the useror patient.*The temperature probeshall be smoothlyrounded in order toprevent tissue damageduring use. | The result is incompliance withthe requirementsof Subclause6.6.1, and itmeets theacceptancecriteria. | |
| 2) | Resistance tobreakage | The thermometer with ahousing of glass shallcomply with Subclause6.1.2.7 of prEN12470-1. | *The subjectdevices have noglass housing.*This test is notapplicable to thesubject 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.
§ 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.