(197 days)
No
The device description and performance studies focus on standard infrared temperature measurement technology and clinical accuracy testing, with no mention of AI or ML algorithms for data processing or interpretation.
No
The device is intended for measuring human body temperature, which is a diagnostic tool, not a therapeutic intervention. It helps in identifying a condition (fever) but does not treat it.
No.
A diagnostic device typically identifies or characterizes a disease or condition. This device is an infrared thermometer, intended only for measuring body temperature, which is a physiological parameter, not a diagnosis in itself.
No
The device description explicitly states it is a "handheld device" and lists hardware components such as an infrared sensor, signal receiving processor, buttons, buzzer, LCD display, and batteries.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- This device directly measures a physiological parameter (body temperature) from the human body (forehead and ear) using infrared heat. It does not analyze a biological specimen.
The description clearly indicates it's a device for measuring body temperature directly from the patient, which falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.
Product codes
FLL
Device Description
The Infrared Thermometer, model E201, is a light weight, handheld and reusable infrared thermometer that measures temperatures for people of all ages by detecting infrared energy radiated from the forehead and auditory canal in the homecare environment. It uses 3.0V alkaline batteries and can be operated continuously.
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features:
- The device is intended to be used in the homecare environment;
- The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries;
-
- Switching between °C and °F;
-
- Multi-functional, can measure ear and forehead temperature;
- The 32 sets measurement data can be stored, the user can view the previous measurement results;
-
- Low battery indication, and auto shut-down within 30s.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared
Anatomical Site
forehead and auditory canal
Indicated Patient Age Range
people of all ages
Intended User / Care Setting
consumers in homecare environment.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Accuracy Testing:
Study type: Clinical accuracy study and repeatability testing
Sample size: 150 subjects (50 subjects in each age group: 0-1 year, 1-5 years, and older than 5 years)
Key results: The accuracy of the E201 infrared thermometer is within acceptable scope specified in standard ISO 81061-2-56. The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements per the referenced standards. The reference body site of the infrared thermometer is oxter. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature.
Non-clinical performance tests conducted:
- Electric safety testing (IEC 60601-1: 2005/A1; 2012) - Passed
- EMC testing (IEC 60601-1-2:2014) - Passed
- Electric safety for medical device used in the home healthcare environment (IEC 60601-1-11:2015) - Passed
- Performance testing (ISO 80601-2-56:2017, ASTM E1965-98:2016) - Passed
- Biocompatibility testing (ISO 10993-1:2018, ISO 10993-5: 2009, ISO 10993-10: 2010) - Passed
- Software verification and validation: Software documentation consistent with moderate level of concern. All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring accuracy:
±0.3°C(32.0°C34.9°C)42.0°C)
±0.2°C (35.0°C
±0.3°C (42.1°C~43.0°C)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
Bioland Technology Ltd Eric Tan Regulatory Engineer No. A6B7 (Block G) ShangRong Industrial Zone. No. 5 Baolong Road Shenzhen, 518116 CN
Re: K213011
Trade/Device Name: Infrared Thermometer (model: E201) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: March 7, 2022 Received: March 7, 2022
Dear Eric Tan:
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.
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
1
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 mediation-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.
Payal Patel 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
2
Indications for Use
510(k) Number (if known) K213011
Device Name Infrared Thermometer (model: E201)
Indications for Use (Describe)
The Infrared Thermometer (model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary - K213011
A. Applicant
Name: Bioland Technology Ltd.
Address: No. A6B7 (Block G) Shangrong Industrial Zone, No.5 Baolong Road, Baolong Community Longgang District, 518116 Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA
Tel: +86 755 3690 0999 Fax: +86 755 3329 6299 Contact person: Eric Tan E-mail: regulator-b@@bioland.com.cn Date of summary prepared: 2021.12.29
B. Subject device
Trade name: Infrared Thermometer Model: E201 Classification name: Clinical Electronic Thermometer Review Panel: General Hospital Product Code: FLL Regulation number: 880.2910 Device class: Class 2 Code of Federal Regulations: 21CFR 880.2910
C. Predicate Device
Device name: Infrared Thermometer Model MD-H30 510(K) number: K191570 Manufacturer: Guangzhou Berrcom Medical Device Co., Ltd.
D. Indications for Use
The Infrared Thermometer(model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment.
E. Device Description
The Infrared Thermometer, model E201, is a light weight, handheld and reusable infrared thermometer that measures temperatures for people of all ages by detecting infrared energy radiated from the forehead and auditory canal in the homecare environment. It uses 3.0V alkaline batteries and can be operated continuously.
4
To measure body temperature, the probe of the thermometer is inserted into a patient's outer ear canal or put onto the skin of a patient's forehead mode, the thermometer must keep 1-5 cm distance with the forehead of patient, a probe cover is not needed for the forehead and ear mode. The reference body site of E201 infrared thermometer is oxter (axillary). The device has the following features:
-
The device is intended to be used in the homecare environment;
-
The device is mainly composed of infrared sensor(Thermopile), signal receiving processor, buttons, buzzer, LCD display. It is powered by 2*1.5 AAA batteries;
-
- Switching between °C and °F;
-
- Multi-functional, can measure ear and forehead temperature;
- The 32 sets measurement data can be stored, the user can view the previous measurement results;
-
- Low battery indication, and auto shut-down within 30s.
F. Principle Operation
The Infrared Thermometer measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. All the temperature in nature above absolute zero (-273°C or -459.4°F) objects will radiate infrared, and the radiation of infrared energy and temperature is proportional to the relationship. Using this relationship, an object's temperature can be calculated by measuring its infrared intensity.
| Comparison items | Subject Device | Predicate Device | Remarks |
|---|---|---|---|
| Manufacturer | Bioland Technology Ltd | Guangzhou Berrcom Medical | |
| Device Co., Ltd. | N/A | ||
| Model | E201 | MD-H30 | N/A |
| Classification | II | II | Same |
| Product code | FLL | FLL | Same |
| Classification name | Thermometer, electronic, clinical | Thermometer, electronic, clinical | Same |
| Regulation No. | 880.2910 | 880.2910 | Same |
| 510(K) number | K213011 | K191570 | N/A |
| Intended Use | The Infrared Thermometer is a | ||
| non-sterile, reusable, handheld device. | |||
| It can be used by consumers in | |||
| homecare environment. It is intended | |||
| for measuring human body | |||
| temperature for people of all ages by | |||
| detecting infrared heat from the | |||
| forehead and auditory canal | The infrared thermometer is intended | ||
| for the intermittent measurement of | |||
| body temperature from the auditory | |||
| canal or central forehead skin surface | |||
| on people of all ages. It can be used | |||
| by consumers in the household | |||
| environment and by healthcare | |||
| providers | Same | ||
| Measurement method | Infrared radiation detection | Infrared radiation detection | Same |
| Comparison items | Subject Device | Predicate Device | Remarks |
| Measurement Site | indirect mode use : Forehead | ||
| direct mode use: Auditory canal | indirect mode use : Forehead | ||
| direct mode use: Auditory canal | Same | ||
| Measurement range | 32.0~43.0 °C | ||
| (89.6 °F ~109.4 °F) | 32.0~43.0 °C | ||
| (89.6 °F ~109.4 °F) | Same | ||
| Display precision | 0.1 °C / °F | 0.1 °C / °F | Same |
| °C / °F unit switchable | Yes | Yes | Same |
| Measuring accuracy | ±0.3°C(32.0°C~34.9°C) | ||
| ±0.2°C (35.0°C~42.0°C) | |||
| ±0.3°C (42.1°C~43.0°C) | ±0.2°C (35.0°C~42.0°C) | ||
| ±0.3°C for other range | Same | ||
| Power Source | AAA*2, DC 3V | AAA*2, DC 3V | Same |
| Low battery indication | Yes | Yes | Same |
| Display | LCD Display | LCD Display | Same |
| Operating | |||
| Environment | |||
| Condition | 15~40°C, RH≤85% (non-condense) | 10~40°C, RH≤95% (non-condense) | Different |
| Note 1 | |||
| Storage Environment | |||
| Condition | -20~55°C, RH≤93% (non-condense) | -20~55°C, RH≤95% (non-condense) | Different |
| Note 1 | |||
| Contact type | Contact/non contact | Contact/non contact | Same |
| Sensor | Thermopile | Thermopile | Same |
| Reference body site | Oxter | Not applicable | Same |
| Target population | People of all ages | People of all ages | Same |
| Use Environment | Homecare environment | Household environment | Same |
| Patient Age | People of all ages | People of all ages | Same |
| Measure time | 1s | 1s | Same |
| Measurement | |||
| distance (indirect | |||
| mode use) | 1~5cm for forehead mode | 1~5cm for forehead mode | Same |
| Memory Set | 32 sets | 20 sets | Different |
| Note 2 | |||
| Reusable/non-resuabl | |||
| e | Reusable | Reusable | Same |
| Use of probe cover | No | No | Same |
| Sensor | Thermopile | Thermopile | Same |
| Measurement | |||
| type | indirect mode use : Forehead | ||
| direct mode use: Auditory canal | indirect mode use : Forehead | ||
| direct mode use: Auditory canal | Same | ||
| Display type | LCD | LCD | Same |
| Patient contact | |||
| materials | ABS | ABS | Same |
| Comparison items | Subject Device | Predicate Device | Remarks |
| Biocompatibility | ISO 10993-5: 2009 | ISO 10993-5: 2009 | Same |
| ISO 10993-10: 2010 | ISO 10993-10: 2010 | ||
| EMC | IEC 60601-1-2: 2014 | IEC 60601-1-2: 2014 | Same |
| Electrical Safety | IEC 60601-1: 2005/A1; 2012 | IEC 60601-1: 2005/A1; 2012 | Same |
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | Same |
| ASTM E1965-98 | ASTM E 1965-98 |
G. Substantial Equivalence table
5
6
Note 1: The operating and storage environment condition is a little different between the subject device and predicate device, the subject device has passed the testing according to standard ASTM E1965-98 and ISO 80601-2-56, and the predicate device also conforms to the requirement of standard ISO 80601-2-56 and ASTM E1965-98. At the same time, we indicate the operating and storage environment condition on the user manual and gift-box. Therefore, the difference of declared standards has no influence on safety and effectiveness of product.
Note 2: The purpose of memory function is intended to store and view the previous measurement data. The function has been verified during software verification. The difference does not raise any issues on the device safety and effectiveness.
H. Predicate Device Comparison
The subject device and the predicate device both have same intended use, measuring range, measuring accuracy and contact materials, they both use infrared radiation detection method to detect human forehead temperature and some technical parameters are the same. Thus, it can be concluded that the subject device is substantially equivalent to the predicate devices.
| 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 | |||
| FDA Recognition number: 19-4 | The subject device complies | ||
| with the applicable requirements | |||
| set forth in the referenced | |||
| electric safety standard. | 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 | |||
| compatibility - Requirements and tests | |||
| FDA Recognition number: 19-8 | The subject device complies | ||
| with the applicable requirements | |||
| set forth in the referenced | |||
| standard. | Pass | ||
| Electric safety for | |||
| medical device | |||
| used in the home | IEC 60601-1-11:2015 Medical electrical | ||
| equipment - General requirements for basic | |||
| safety and essential performance - Part 1-11: | The subject device complies | ||
| with the applicable requirements | |||
| set forth in the referenced | Pass | ||
| Testing name | Referenced standard | Summary result | Verdict |
| healthcare | |||
| environment | Collateral Standard: Requirements for medical | ||
| electrical equipment and medical electrical | |||
| systems used in the home healthcare | |||
| environment. | |||
| FDA Recognition number: 19-14 | standard. | ||
| 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. | |||
| FDA Recognition number: 6-421 | |||
| ASTM E1965-98:2016 Standard Specification | |||
| for Infrared Thermometers for Intermittent | |||
| Determination of Patient Temperature | |||
| FDA Recognition number: 6-125 | The subject device complies | ||
| with the applicable requirements | |||
| set forth in the referenced | |||
| performance standard. | Pass | ||
| Biocompatibility | |||
| testing | ISO 10993-1:2018 Biological evaluation of | ||
| medical devices -- Part 1: Evaluation and | |||
| testing within a risk management process | |||
| FDA Recognition number: 2-258 | |||
| ISO 10993-5: 2009 Biological evaluation of | |||
| medical devices -- Part 5: Tests for In Vitro | |||
| cytotoxicity | |||
| FDA Recognition number: 2-245 | |||
| ISO 10993-10: 2010 Biological evaluation of | |||
| medical devices -- Part 10: Tests for irritation | |||
| and delayed-type hypersensitivity | |||
| FDA Recognition number: 2-174 | The subject device complies | ||
| with the applicable requirements | |||
| set forth in the referenced | |||
| biological evaluation standard. | Pass |
-Non-clinical test
7
Software verification and validation
Software documentation consistent with moderate level of concern is submitted in this 510(k). All software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. The software verification and validation were conducted in accordance with the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," dated May 11, 2005. The test results demonstrated the software function met the requirements.
J. Clinical Accuracy Testing
8
The clinical accuracy study for the E201 infrared thermometer was performed to determine the clinical accuracy. The study includes 150 subjects, the three groups of subjects being tested were: 1) 01 year old, 2) children between 15 years old, and 3) over 5 years old. For each age group, the ratio of febrile subjects was more than 30% and less than 50%. The reference body site of infrared thermometer is oxter. The study excluded subjects with medical conditions such as inflammation at the measuring sites and subjects using medications known to affect body temperature. The clinical accuracy test results showed that the accuracy of the E201 infrared thermometer is within acceptable scope specified in standard ISO 81061-2-56.
| Name of
clinical
testing | Referenced standard | Summary of
testing | Reference
body site | Patient population
(age groups,
number of subjects | Verdict |
|---------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|------------------------------------------------------------------------------------------------------------|---------|
| Clinical
accuracy
and
repeatability
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.
FDA Recognition
number: 6-421 | The methods and
criteria of clinical
accuracy and
repeatability testing
had been clinically
assessed to meet
the requirements
per the referenced
standards. | Oxter | 50 subjects in each
age group: 0-1 year,
1-5 years and older
than 5 years (Total
150 subjects) | Pass |
The clinical accuracy test information of subject device E201 as following:
K. Conclusion
Non-clinical performance and clinical accuracy tests were conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission, the subject device E201 infrared thermometer is substantially equivalent to the predicate device.