(142 days)
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.
The Advocate Non-Contact Infrared Thermometer, model EF001S, 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, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function.
Here's a breakdown of the acceptance criteria and study information for the Advocate Non-Contact Infrared Thermometer, Model EF001S, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the referenced standards, and the reported device performance is indicated by the "Pass" verdict for all tests. Specific numerical criteria are provided for measuring accuracy.
| Acceptance Criteria (from Referenced Standards) | Reported Device Performance |
|---|---|
| Electrical Safety | Complies with ANSI AAMI ES60601-1:2005 |
| EMC | Complies with IEC 60601-1-2:2014 |
| EMC | Complies with FCC 47 CFR Part 18, Subpart B |
| Performance (Clinical Thermometers) | Complies with ISO 80601-2-56:2017 |
| Biocompatibility | Complies with EN ISO 10993-1:2018 (same human-contacting materials as predicate) |
| Software Validation | Complies with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, issued on May 11, 2005" |
| Clinical Accuracy (Body Measurement Mode): | Meets requirements per ASTM E1965-98(2016) |
| 93.2 °F - 94.8 °F (34.0 °C - 34.8 °C) | ±0.5 °F / 0.3 °C |
| 95.0 °F - 107.6 °F (35.0 °C - 42.0 °C) | ±0.4 °F / 0.2 °C |
| 107.8 °F - 109.4 °F (42.1 °C - 43.0 °C) | ±0.5 °F / 0.3 °C |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set (Clinical Accuracy): 120 subjects
- 40 subjects in each age group: infants (0-1 year), children (1-5 years), and adults (>5 years).
- Data Provenance: The document does not explicitly state the country of origin or whether the study was retrospective or prospective. It only mentions "EF001 Clinical Test" and that it "had been clinically assessed."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The study description focuses on meeting the criteria of the referenced standards rather than on a ground truth established by experts in a typical diagnostic AI setting. For a thermometer, the "ground truth" for temperature measurement is typically a highly accurate reference thermometer measurement, not an expert's interpretation.
4. Adjudication Method for the Test Set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typically used for subjective diagnostic tasks involving human readers, which is not directly applicable to a thermometer's performance evaluation against a reference standard.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-assisted diagnostic tools where human interpretation is involved. The Advocate Non-Contact Infrared Thermometer is a direct measurement device; its performance is assessed against a technical standard for accuracy, not against human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, a standalone performance assessment was done. The device's accuracy was tested against the standards ASTM E1965-98(2016) and ISO 80601-2-56:2017 directly, without a human in the loop for the temperature measurement itself. The "Clinical Accuracy" testing evaluates the device's ability to accurately measure body temperature.
7. The Type of Ground Truth Used
- The ground truth for the clinical accuracy testing is implicitly the reference measurements of body temperature taken concurrently with the device being tested, as required by the ASTM E1965-98(2016) standard. This standard outlines procedures for evaluating the accuracy of infrared thermometers for intermittent determination of patient temperature, which involves comparing the device's readings to established, highly accurate temperature measurements.
8. The Sample Size for the Training Set
- This information is not provided as this is not an AI/machine learning device that typically involves a distinct training set. The "software validation report" mentioned relates to the device's embedded software functionality, not a learning algorithm trained on data.
9. How the Ground Truth for the Training Set was Established
- This information is not applicable as there is no mention of a training set for a learning algorithm. The software validation ensures the embedded software functions as intended and meets regulatory guidelines.
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September 5, 2019
BroadMaster Biotech, Corp. % Dr. Ke-Min Jen Contact Person Chinese-European Industrial Research Society No. 58. Fu-Chiun St Hsin-Chu City, 30067 Taiwan
Re: K191004
Trade/Device Name: Advocate Non-Contact Infrared Thermometer, Model EF001S Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: July 19, 2019 Received: August 6, 2019
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/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Alan Stevens Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K191004
Device Name
Advocate Non-Contact Infrared Thermometer, EF001S
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)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/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 "BROADMASTER" is the word "BIOTECH" in smaller letters. To the right of the words 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
510(k) Summary (Per 21 CFR 807.92)
510(k) number: K191004
| Trade or proprietary name | Advocate Non-Contact Infrared Thermometer,model EF001S |
|---|---|
| Common Name | Digital Thermometer |
| Classification Name | Clinical Electronic Thermometer |
| Class | 21 CFR 880.2910 |
| Panel | II |
| Product Code | 80 General Hospital |
| Owner/Operator | FLL |
| BroadMaster Biotech, Corp. | |
| 1F., 2F., No. 91, Xiyuan Rd., Zhongli Dist., TaoyuanCity 32057, Taiwan (R.O.C.) | |
| Tel: +886-3-451-7600 | |
| Fax: +886-3-451-9500 | |
| Website:www.broadmaster-biotech.com | |
| Date prepared | July 19, 2019 |
| Application Correspondent | Dr. Jen, Ke-MinROC Chinese-European Industrial Research SocietyNo. 58, Fu-Chiun St., Hsin-Chu City, 30067, TaiwanTel: +886-3-5208829Fax: +886-3-5209783Email: ceirs.jen@msa.hinet.net |
| Predicate Device | |
| Manufacturer: BroadMaster Biotech, Corp. | |
| Product name: Advocate Non-Contact Infrared Thermometer | |
| Model No: EF001A |
● 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 in blue and features the words "BROADMASTER" in large, bold letters. Below that, in smaller letters, is the word "BIOTECH". To the right of the words 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
● Descriptions:
The Advocate Non-Contact Infrared Thermometer, model EF001S, 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, , as shown in the following diagram.
The device has the following features: one-second measuring time, measuring Body or Ambient temperature, 12-memory recalls, "F/"C unit switchable, over range message (Hi/Lo), low battery indication, auto display for the last reading when power is on, auto shut-off when the device is idle for 60 seconds and voice function. When the device starts, "Please measure" in English or "Mira la temperature" in Spanish will be heard. When completes, the result will be heard in additional to the data display. The Advocate Non-Contact Infrared Thermometer, model EF001S, including the voice function, is not intended for use by the visually impaired individuals.
Image /page/4/Figure/5 description: The image shows two views of a thermometer. The left side of the image shows the front of the thermometer, which is red and black. The front of the thermometer has a display screen, a measuring button, and a power switch button. The right side of the image shows the back of the thermometer, which is black and has a probe, a body/ambient button, and a battery cover.
Components of EF001S
● 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 -3.94 inches(5-10 cm), the IR radiation sensor is activated, and the measurement will be taken instantly by detection of the infrared heat.
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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 word "BROAD" stacked on top of the word "MASTER". Below the word "MASTER" is the word "BIOTECH" in a smaller font. To the right of the word "BROAD" is a butterfly-like design.
BroadMaster Biotech, Corp. 1F, 100 St, 100 - 100 - 10 - 10 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 7 - 1 - 7 - 1 - 7 - 1 - 7 - 1 - Fax:+886-3-451-9500 Website: www.broadmaster-biotech.com
Substantial Equivalence Comparison Table ●
| Comparison Items | Predicate Device | Subject Device | Remarks |
|---|---|---|---|
| Applicant | BroadMaster Biotech, Corp. | BroadMaster Biotech, Corp. | Same |
| Proprietary (Trade) | Advocate Non-Contact Infrared | Advocate Non-Contact Infrared | Same |
| Name | Thermometer | Thermometer | |
| Model | EF001A | EF001S | Seriesmodel |
| 510(k) No. | K180355 | K191004 | -- |
| Classification Nameand RegulationNumber | thermometer, electronic, clinical21 CFR 880.2910 | thermometer, electronic, clinical21 CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| Device Class | II | II | Same |
| Intended uses | Advocate Non-Contact InfraredThermometer is a non-sterile, reusable,handheld device. It can be used byconsumers in homecare environment anddoctors in clinic as reference. It is intendedfor measuring human body temperature ofall ranges of people by detecting infraredheat from the forehead. | Advocate Non-Contact InfraredThermometer is a non-sterile, reusable,handheld device. It can be used byconsumers in homecare environment anddoctors in clinic as reference. It is intendedfor measuring human body temperature ofall ranges of people by detecting infraredheat from the forehead. | Same |
| Intended users | Lay user and professional | Lay user and professional | Same |
| Measurementmethod | 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 - 43 °C) | Body measurement mode:89.6 °F-109.4 °F (32 °C - 43 °C) | Same |
| Display resolution | 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:+0.5 °F / 0.3 °C(93.2 °F -94.8 °F, 34.0 °C-34.8ºC)±0.4 °F/0.2°C(95.0 °F -107.6 °F, 35.0 °C-42.0 °C)±0.5ºF/0.3ºC(107.8 °F-109.4°F, 42.1°C-43.0 °C) | Body measurement mode:±0.5 °F / 0.3 °C(93.2 °F -94.8 °F, 34.0 °C-34.8ºC)±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) | Same |
| Display | LCD display | LCD display | Same |
| Measurementdistance | 2-3.94 inch ( 5-10 cm) | 2-3.94 inch ( 5-10 cm) | Same |
| Memory set | 12 sets | 12 sets | Same |
| Power source | Two 1.5V AAA alkaline batteries | Two 1.5V AAA alkaline batteries | Same |
| Low batteryindication | Yes | Yes | Same |
| Degree of protection | IP20 | IP20 | Same |
| Operating condition | 50.0 °F- 104.0 °F (10.0 °C-40.0 °C)≤ 80% RH | 50.0 °F- 104.0 °F (10.0 °C-40.0 °C)≤ 80% RH | Same |
| Storage condition | -13.0 °F-131 °F (-25.0 °C-55.0 °C)≤ 95% RH | -13.0 °F-131 °F (-25.0 °C-55.0 °C)≤ 95% RH | Same |
| Cleaning method | The thermometer enclosure and probe canbe cleaned and disinfected by 70% alcohol. | The thermometer enclosure and probe canbe cleaned and disinfected by 70% alcohol. | Same |
| Human -contactingmaterials | Enclosure of red & black ABS, LCD Lens ofPMMA and Probe of Metals | Enclosure of red &black ABS, LCD Lens ofPMMA and Probe of Metals | Same |
| Biocompatibility | EN ISO 10993-5:2009 &ISO 10993-10:2010 | Complying EN ISO 10993-1:2009 | Same |
| Software | Software validation report | Revised software validation report | Different |
| Voice function | No | Yes, extra 5 voice hardware: U3, U3A, C10(10 uF), C13(0.1 uF) and Speaker | Different |
| EMC | IEC 60601-1-2:2014FCC 47 CFR Part 18, Subpart B | IEC 60601-1-2:2014FCC 47 CFR Part 18, Subpart B | Same |
| Electrical Safety | IEC 60601-1: 2005/A1:2012 | ANSI AAMI ES60601-1:2005IEC 60601-1: 2005/A1:2012 | Same |
| Performance | ASTM E1965-98(2016)ISO 80601-2-56:2017 | *Declaration of conformity to ASTME1965-98(2016)*Declaration of conformity to ISO80601-2-56:2017 | Same |
| РСВ | FR4 PCB | FR4 PCB | Same |
| Materials | Patient contacting materials is ABS (devicehousing / handle and button). | Patient contacting materials is ABS (devicehousing / handle and button). | Same |
| MCU | HYCON HY11P138-Bit RISC-like Mixed SignalMicrocontrollerEmbedded 4x20 LCD DriverLow Noise Amplifier18-Bit ADC | HYCON HY11P138-Bit RISC-like Mixed Signal MicrocontrollerEmbedded 4x20 LCD DriverLow Noise Amplifier18-Bit ADC | Same |
| Sensor | GE THERMOPILE IR SENSOR ZTP-148SR | GE THERMOPILE IR SENSOR ZTP-148SR | Same |
| LCD | TN LCD | TN LCD | Same |
| Speaker | Buzzer | Speaker | Different |
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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" in large, bold letters. Below the main text, the word "BIOTECH" is written in smaller letters. 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
● Comparison discussion
Because the subject device is almost identical to the predicate device, except for the voice function, we will discuss the differences raised by the existence of voice function for the subject device.
The software is different due to the addition of the voice function. However, software validation was performed and this difference of software did not raise any new or different questions of safety and effectiveness for the subject device.
The extra 5 hardware components used by EF001S due to addition of the voice function are voice ICs:U3, U3A, C10 (10 uF), C13 (0.1 uF) and Speaker. Thus, we subjected the subject
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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 words "BROADMASTER" in large, bold letters. Below "BROADMASTER" is the word "BIOTECH" in smaller letters. To the right of the word "BROAD" 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
device EF001S to meeting the provisions of Safety and EMC standards, i.e., ANSI AAMIES60601-1:2005, IEC 60601-1-2:2014, and FCC 47 CFR Part 18, Subpart B. This voice function is not intended for use by vision-impaired patients, and it is an auxiliary function for the lay users and medical professionals. So the voice function brings some convenience to the lay users and professionals. Regarding the extra 5 hardware components used by the subject device, there is no different or new safety and effectiveness questions.
Non-Clinical Testing ●
| Testing name | Referenced standard | Summary result | Verdict |
|---|---|---|---|
| Electric safety testing | ANSI AAMIES60601-1:2005Medical electrical equipment - Part 1:General requirements for basic safetyand essential performanceFDA recognition number: 19-4 | The subject device complies withthe applicable requirements setforth in the referenced electricsafety standard, ANSIAAMIES60601-1:2005. | Pass |
| EMC testing | IEC60601-1-2:2014 Medical electricalequipment - Part 1-2: Generalrequirements for basic safety andessential performance - CollateralStandard: Electromagneticdisturbances- Requirements and tests,FDA recognition number: 19-8 | The subject device complies withthe applicable requirements setforth in the referenced EMCstandard, IEC 60601-1-2:2014. | Pass |
| FCC 47 CFR Part 18: Industrial,Scientific, And Medical Equipment,Subpart B:Applications andAuthorizations | The subject device complies withthe applicable requirements setforth in the referenced EMCstandard, FCC 47 CFR Part 18. | Pass | |
| Performance testing | ISO 80601-2-56: 2017.Medical electrical equipment –Part 2-56: Particular requirements forbasic safety and essential performanceof clinical thermometers for bodytemperature measurementFDA recognition number: 6-403 | The subject device complies withthe applicable requirements setforth in the referencedperformance standard, ISO80601-2-56:2017. | Pass |
| Biocompatibility testing | EN ISO 10993-1:2018Biological evaluation of medicaldevices -- Part 1: Evaluation and testingwithin a risk management processFDA recognition number: 2-258 | The subject device EF001S hasthe same human-contactingmaterials as predicate deviceEF001A. There is no need toproceed the biocompatibilityevaluation according to EN ISO10993-1-2018 | Pass |
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Image /page/8/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 "BROAD" 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
| Revised SoftwareValidation Report | Guidance for the Content of PremarketSubmissions for Software Contained inMedical Devices, issued on May11,2005 | The software contained inthesubject devicecomplies with theapplicable requirements setforthin the referenced guidancedocument, “Guidance for theContentof PremarketSubmissions forSoftwareContained, issue done May 11,2005. | Pass |
|---|---|---|---|
| --------------------------------------- | ----------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------ |
● Clinical Testing
| Name ofclinicaltesting | Referenced standard | Summary of testing | Patientpopulation (agegroups,number ofsubjects) | Verdict |
|---|---|---|---|---|
| EF001ClinicalAccuracy | *ASTM E1965-98(2016)Standard Specification forInfrared Thermometers forIntermittent Determination ofPatient TemperatureFDA recognition number: 6-125 | The methods and criteria ofEF001 Clinical Test had beenclinically assessed to meet therequirements of clinicalaccuracy per the referencedstandards. | 40 subjects ineach age group,infants (0-1year), children(1-5 years) andadults (>5 years)(Total 120subjects) | Pass |
● Conclusion
Non-clinical performance and clinical 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, EF001S, is substantially equivalent to the predicate device, EF001A.
§ 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.