(336 days)
Not Found
No
The description details a standard infrared thermometer with basic features and no mention of AI/ML algorithms for temperature measurement or other functions.
No
The device is described as a thermometer intended for measuring human body temperature, not for treating or preventing disease.
No
Justification: A diagnostic device is used to identify the nature or cause of a disease or condition. This device is a thermometer, used for measuring body temperature, which is a physiological parameter, not for diagnosing a specific disease.
No
The device description explicitly lists hardware components such as a probe with an infrared sensor, LCD display, buttons, and an enclosure.
No, 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. This testing is performed outside of the body (in vitro).
- Device Function: The Advocate Non-Contact Infrared Thermometer measures body temperature by detecting infrared heat radiated from the forehead. This is a measurement taken on the body, not from a specimen taken from the body.
Therefore, based on the intended use and device description, this thermometer falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS.
The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, ºF/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
all ranges of people
Intended User / Care Setting
consumers in homecare environment and doctors in clinic
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Testing:
- Electric safety testing: IEC 60601-1:2005/A1:2012; The subject device complies with the applicable requirements set forth in the referenced electric safety standard, IEC 60601-1:2005. Verdict: Pass
- EMC testing: IEC 60601-1-2:2014; The subject device complies with the applicable requirements set forth in the referenced EMC standard, IEC 60601-1-2:2014. Verdict: Pass
- EMC testing: FCC 47 CFR Part 18; The subject device complies with the applicable requirements set forth in the referenced EMC standard, FCC 47 CFR Part 18. Verdict: Pass
- Performance testing: ASTM E1965-98(2016); The subject device complies with the applicable requirements set forth in the referenced performance standard, ASTM E1965-98(2016). Verdict: Pass
- Performance testing: ISO 80601-2-56: 2017; The subject device complies with the applicable requirements set forth in the referenced performance standard, ISO 80601-2-56:2017. Verdict: Pass
- Biocompatibility testing: ISO 10993-5:2009; The subject device complies with the applicable requirements set forth in the referenced biocompatibility standard, ISO 10993-5:2009. Verdict: Pass
- Biocompatibility testing: ISO 10993-10:2010 (Skin Irritation test); The subject device complies with the applicable requirements set forth in the referenced biocompatibility standard, ISO 10993-10:2010. Verdict: Pass
- Biocompatibility testing: ISO 10993-10:2010 (Sensitization test); The subject device complies with the applicable requirements set forth in the referenced biocompatibility standard, ISO 10993-10:2010. Verdict: Pass
- Software validation and verification test: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005; The software contained in the subject device complies with the applicable requirements set forth in the referenced guidance document, “Guidance for the Content of Premarket Submissions for Software Contained, issued on May 11, 2005. Verdict: Pass
Clinical Testing:
- Clinical test: The methods and criteria of EF001A Clinical Test had been assessed to meet the requirements of clinical accuracy per the referenced standards: ASTM E1965-98 (Reapproved 2016) Standard Specification for Infrared Thermometer For Intermittent Determination of Patient temperature. Patient population: 40 subjects in each age group, infants (0-1 year), children (1-5 years) and adults (>5 years) (Total 120 subjects). Result & Verdict: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Body measurement mode: ±0.5 °F / 0.3°C (93.2°F -94.8°F, 34.0°C-34.8°C), ±0.4°F/0.2°C (95.0°F -107.6°F, 35.0°C-42.0°C), ±0.5 °F/0.3 °C (107.8°F-109.4°F, 42.1°C-43.0°C)
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.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 10, 2019
BroadMaster Biotech, Corp. % Dr. Ke-Min Jen Chinese-European Industrial Research Society No. 58, Fu-Chiun St Hsin-Chu City, Taiwan 30067 China
Re: K180355
Trade/Device Name: Advocate Non-Contact Infrared Thermometer, Model: EF001A Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 30, 2018 Received: December 12, 2018
Dear Dr. 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmp/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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
1
statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Image /page/1/Picture/5 description: The image shows the name "Sapana Patel -S" in a large, bold, sans-serif font. The text is black against a white background. The name is likely a person's name, with "-S" possibly indicating an initial or a designation.
for 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K180355
Device Name
Advocate Non-Contact Infrared Thermometer, EF001A
Indications for Use (Describe)
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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."
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Image /page/3/Picture/0 description: The image contains the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" stacked on top of each other in a bold, sans-serif font. Below the words "BROADMASTER" is the word "BIOTECH" in a smaller font. To the right of the words is a stylized butterfly wing.
BroadMaster Biotech, Corp. 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057, Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com
510(k) Summary (Per 21 CFR 807.92) l. K180355
| Trade or proprietary name | Advocate Non-Contact Infrared Thermometer,
EF001A |
|---------------------------|--------------------------------------------------------------|
| Common Name | Digital Thermometer |
| Classification Name | Clinical Electronic Thermometer |
| | 21 CFR 880.2910 |
| Class | II |
| Panel | 80 General Hospital |
| Product Code | FLL |
| Owner/Operator | BroadMaster Biotech, Corp. |
| | 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., |
| | Taoyuan City 32057, Taiwan (R.O.C.) |
| | Tel: +886-3-451-7600 |
| | Fax: +886-3-451-9500
Website: www.broadmaster-biotech.com |
| Date prepared | December 28, 2018 |
| 510(k) Contact Person | Dr. Jen, Ke-Min |
| | Tel: +886-3-5208829 |
| | Fax: +886-3-5209783 |
| | Email: ceirs.jen@msa.hinet.net |
| U.S. agent | Shu-Chen Cheng |
| | ROC CHINESE-EUROPEAN INDUSTRIAL |
| | RESEARCH SOCIETY |
| | 2064 Tamarin Dr. |
| | Columbus, OH, 43235 |
| | Phone: (614) 588-8168 |
| | Email: ceirs.jen@msa.hinet.net |
| Predicate Device | |
| Manufacturer: | Intrinity Global Limited |
| Product name: | Non Contact Infrared Forehead Thermometer |
| Model No: | TVT-200, TVT-200 PLUS |
| 510(k) number: | K170662 |
● Indications for Use:
Advocate Non-Contact Infrared Thermometer is a non-sterile, reusable, handheld device. It can be used by consumers in homecare environment and doctors in clinic as reference. It is intended for measuring human body temperature of all ranges of people by detecting infrared heat from the forehead.
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Image /page/4/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is blue and features the words "BROADMASTER" in large, bold letters. Below the word "MASTER" is the word "BIOTECH" in smaller letters. To the right of the word "BROADMASTER" is a stylized image of a butterfly.
● Descriptions
The Advocate Non-Contact Infrared Thermometer model EF001A measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The device is composed of a Probe of metals with infrared sensor inside to detect the infrared energy, an LCD Display, a SCAN button to start measuring temperatures, a Power switch button to switch on or off the device, a Body/Ambient button to switch between two measuring modes, and an Enclosure of ABS.
The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, 9F/℃ unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, and auto shut-off when the device is idle for 60 seconds.
● Principle Operation
The Advocate Non-Contact Infrared Thermometer measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. As soon as the distance between the probe and the forehead is within 2 to 3.94 inches, the IR radiation sensor is activated, and the measurement will be taken instantly by detection of the infrared heat.
● Predicate Device Comparison Table
| Comparison Items | Predicate Device
Non Contact Infrared
Forehead Thermometer
Model TVT-200, TVT-
200 PLUS | Subject Device
Advocate Non-Contact
Infrared Thermometer
Model EF001A | Remarks |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Indications for use | Non Contact Infrared Forehead
Thermometer is a non-sterile,
reusable, handheld device. It can
be used by consumers in
homecare environment and
doctors in clinic as reference. It is
intended for measuring human
body temperature of all ranges of | Advocate Non-Contact Infrared
Thermometer is a non-sterile,
reusable, handheld device. It can
be used by consumers in homecare
environment and doctors in clinic
as reference. It is intended for
measuring human body
temperature of all ranges of people | Same |
| | people by detecting infrared heat
from the forehead. Website: www.broadmaster-biotech.com | by detecting infrared heat from the
forehead. | |
| Intended users | Lay user and professional | Lay user and professional | Same |
| Measurement method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement mode | Forehead measurement mode | Forehead measurement mode | Same |
| Measuring range | Body measurement mode:
89.6°F to 109.4°F (32°C to 43°C) | Body measurement mode:
89.6°F-109.4°F (32°C - 43°C) | Same |
| Displayresolution | 0.1°F/0.1°C | 0.1 °F / 0.1 °C | Same |
| °C/°F unit switchable | Yes | Yes | Same |
| Measuring accuracy | Body measurement mode:
±0.4°F/0.2°C
(89.6°F to 109.4°F, 32°C to 43°C) | Body measurement mode:
±0.5 °F / 0.3°C
(93.2°F -94.8°F,34.0°C-34.8°C)
±0.4°F/0.2°C
(95.0°F -107.6°F, 35.0°C-42.0°C)
±0.5 °F/0.3 °C
(107.8°F-109.4°F, 42.1°C-43.0°C) | Similar |
| Display | LCD display | LCD display | Same |
| Measurement distance | 0.39 inch (1 cm) | 2 - 3.94 inch (5-10 cm) | Different |
| Memory set | 16 sets | 12 sets | Similar |
| Power source | One 1.5V AAA alkaline battery | Two 1.5V AAA alkaline batteries | Similar |
| | | | |
| Low battery indication | Yes | Yes | Same |
| Degree of protection | IP22 | IP20 | Different |
| Patient contact materials
(colour coding) | Enclosure of pink, grey, orange
and purple ABS,
LCD Lens of PMMA and
Probe of Metals | Enclosure of red & black ABS,
LCD Lens of PMMA and
Probe of Metals | Same |
| Principle operation
information | Detection of infrared heat energy
from forehead | Detection of infrared heat energy
from forehead | Same |
| Operating condition | 59°F~ 104°F (15°C~ 40°C) ≤95%
RH | 50.0°F- 104.0°F (10.0°F-40.0°C)
≤ 80% RH | Similar |
| Storagecondition | Not available | -13.0°F-131°F (-25.0°F-55.0°C)
≤ 95%RH | Similar |
| Cleaning method | The thermometer enclosure and
the measuring probe are cleaned
and disinfected by 70% alcohol. | The thermometer enclosure and
probe can be cleaned and
disinfected by 70% alcohol. | Same |
| Biocompatibility | Comply with
ISO 10993-5:2009 &
ISO 10993-10:2010 | Comply with
ISO 10993-5:2009 &
ISO 10993-10:2010 | Same |
| Electrical Safety | IEC 60601-1:2005+CORR.1
(2006)+CORR.2(2007), | IEC 60601-1:2005/A1:2012 | Same |
| EMC | IEC 60601-1-2: 2014, | IEC60601-1-2:2014
FCC 47 CFR Part 18, Subpart B | Same |
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Image /page/5/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" in large, bold letters. Below the word "BROADMASTER" is the word "BIOTECH" in smaller letters. To the right of the word "BROADMASTER" is a stylized image of a butterfly.
BroadMaster Biotech, Corp.
1F., 2F., No. 91, Xiyuan Rd., Zoongli Dist.,
Taoyuan City 32057, Taiwan (Thongli Dist.,
Tel.:+886-3-451-7600
Fax: +886-3-451-7600
Website: +886-3-451-9500
Website: www.broa
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Image /page/6/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" stacked on top of each other in a bold, sans-serif font. Below the words "BROADMASTER" is the word "BIOTECH" in a smaller font. To the right of the words is a stylized image of a butterfly.
Comparison discussion: ●
The main differences between two devices are the measuring accuracy, measurement distance, memory set, power source, degree of ingress protection, operating conditions, and storage conditions. We discuss those differences as below,
- The measuring accuracy, ±0.4ºF/0.2ºC, in the range of 95.0ºF - 107.6ºF (35ºC -42°C) are the same for two devices. The range of 95.0°F - 107.6°F (35°C- 42°C) is the most possibly used range for the regular practice. The accuracy, ±0.5ºF/0.3ºC, in the ranges of 93.2°F - 94.8°F and 107.8°F - 109.4°F are different from those of the predicate device, but the accuracy ±0.5ºF /0.3ºC still complies with the requirements of section 5.4.1, ASTM E1965-98 (2016). This difference does not raise any different questions of safety or effectiveness for the subject device.
- The measurement distances between the probe and the forehead are different for the predicate and subject devices. They are 0.39 inch for the predicate device and 2 -3.94 inch for the subject device. The subject device's measurement distance is larger than the predicate device. It means the subject device can detect and receive the IR heat energy at a larger distance. As the measurement distance for the subject device is a range and is larger than the fixed value of the predicate device, the performance test complies with standard ASTM E1965-98. There are no safety and effectiveness concerns raised for the subject device due to the different measurement distance.
- The memory sets of the predicate device have 16 sets of temperature data and the subject device has12 sets of temperature data.. Since the memory sets are used for storing and recalling the temperature data taken previously by the users for reference, the different quantities of temperature data do not play a significant role in the usage for two devices. There are no safety and effectiveness concerns raised for the subject device due to this difference.
- . The difference of the power source is the quantity of the 1.5V AAA alkaline batteries used, and the difference results from the different electric circuit voltages requirements, i.e. 1.5V for predicate device and 3.0V for subject device. This difference is related with the electric circuit component designs, and there are no safety and effectiveness concerns raised.
- The ingress protection degrees for predicate device and subject devices are IP22 and IP20 respectively. The dust ingress protections for two devices are the same and the liquid ingress protections are different. The subject device passed the cleaning test in the ASTM E 1965-98(2016) section 5.6.5, so the different liquid ingress protection levels between both devices will not raise any safety and effectiveness concerns for the subject device.
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Image /page/7/Picture/0 description: The image shows the logo for Broadmaster Biotech. The logo is in blue and features the word "BROADMASTER" in large, bold letters. Below the word "BROADMASTER" is the word "BIOTECH" in smaller letters. To the right of the word "BROADMASTER" is a graphic of a butterfly.
- The operating conditions of two devices are different. The operating condition of the subject device is tested and validated to meet the requirements of ASTM E 1965-98 (2016), sections 5.6.1 & 5.6.2. Thus, the difference of operating conditions will not raise any safety and effectiveness concerns for the subject device.
- The storage conditions of the two devices are different. The storage condition of the subject device is tested and validated to meet the requirements of ASTM E 1965-98 (2016), section 5.6.4. Thus, the difference of the storage conditions will not raise any safety and effectiveness concerns for the subject device.
● Non-Clinical Testing:
| Testing name | Referenced standard | Summary result | Verdict |
|---|---|---|---|
| Electric safety | |||
| testing | IEC 60601-1:2005/A1:2012 | ||
| Medical electrical equipment |
- Part 1: General requirements
for basic safety and essential
performance | The subject device complies
with the applicable
requirements set forth in
the referenced electric
safety standard, IEC
60601-1:2005. | Pass |
| EMC testing | IEC 60601-1-2:2014
Medical electrical equipment - Part 1-2: General
requirements for basic safety
and essential performance -
Collateral Standard:
Electromagnetic disturbances - Requirements and tests | The subject device
complies with the
applicable requirements set
forth in the referenced
EMC standard, IEC
60601-1-2:2014. | Pass |
| EMC testing | FCC 47 CFR Part 18:
Industrial, Scientific, And
Medical Equipment,
Subpart B: Applications
and Authorizations | The subject device
complies with the
applicable requirements
set forth in the referenced
EMC standard, FCC 47
CFR Part 18. | Pass |
| | Website: www.broadmaster-biotech.com | | |
| Performance
testing | ASTM E1965-98(2016)
Standard Specification for
Infrared Thermometers for
Intermittent Determination of
Patient Temperature | The subject device
complies with the
applicable requirements set
forth in the referenced
performance standard,
ASTM E1965-98(2016). | Pass |
| Performance
testing | ISO 80601-2-56: 2017.
Medical electrical equipment
-- Part 2-56: Particular
requirements for basic safety
and essential performance of
clinical thermometers for
body temperature
measurement | The subject device
complies with the
applicable requirements set
forth in the referenced
performance standard, ISO
80601-2-56:2017. | Pass |
| Biocompatibility
testing | ISO 10993-5:2009
in vitro Cytotoxicity test | The subject device
complies with the
applicable requirements set
forth in the referenced
biocompatibility standard,
ISO 10993-5:2009. | Pass |
| Biocompatibility
testing | ISO 10993-10:2010
Skin Irritation test | The subject device
complies with the
applicable requirements set
forth in the referenced
biocompatibility standard,
ISO 10993-10:2010. | Pass |
| Biocompatibility
testing | ISO 10993-10:2010
Sensitization test | The subject device
complies with the
applicable requirements set
forth in the referenced
biocompatibility standard,
ISO 10993-10:2010. | Pass |
| Software
validation and
verification test | Guidance for the Content of
Premarket Submissions for
Software Contained in Medical | The software contained in
the subject device
complies with the | Pass |
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Image /page/8/Picture/0 description: The image contains the logo for Broadmaster Biotech. The logo is in blue and features the words "BROADMASTER" stacked on top of each other in a bold, sans-serif font. Below the words "BROADMASTER" is the word "BIOTECH" in a smaller font. To the right of the word "BROADMASTER" is a stylized image of a butterfly.
BroadMaster Biotech, Corp.
IF., 2F., No. 91, Xiyuan Rd., Zooma. Dist.,
Taoyuan City 32057, Taiwan (R.O.C.)
Taoyuan City 32057, Taiwan (R.O.C.)
Tel: +886-3-451-7600
Fax: +886-3-451-9500
9
Image /page/9/Picture/0 description: The image contains the logo for Broadmaster Biotech. The text "BROAD" is stacked on top of the text "MASTER" in a large sans-serif font. Below this is the text "BIOTECH" in a smaller font. To the right of the text is a stylized image of a butterfly.
BroadMaster Biotech, Corp.
1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., Taoyuan City 32057, Taiwan (R.O.C.) Tel:+886-3-451-7600 Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com
| Devices, issued on May 11,
2005 | applicable requirements set
forth in the referenced
guidance document,
“Guidance for the Content
of Premarket
Submissions for
Software Contained, issued
on May 11, 2005. |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
• Clinical Testing
| Name of
clinical
testing | Summary of testing | Referenced standard | Patient
population (age
groups,
number of
subjects) | Result
&
Verdict |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|------------------------|
| Clinical test | The methods and
criteria of EF001A
Clinical Test had been
assessed to meet the
requirements of
clinical accuracy per
the referenced
standards. | * ASTM E1965-98
(Reapproved 2016)
Standard Specification
for Infrared
Thermometer
For Intermittent
Determination of
Patient temperature | 40 subjects in
each age group,
infants (0-1
year), children
(1-5 years) and
adults (>5 years)
(Total 120
subjects) | Pass |
● Conclusion
Performance tests were conducted on the subject device and all tests met specified criteria. Based on the information provided in this submission the subject device, Advocate Non-Contact Infrared Thermometer, model EF001A, is substantially equivalent to the predicate device.