(155 days)
Not Found
No
The document describes a standard infrared thermometer and does not mention any AI or ML components or capabilities.
No.
The device is used for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
This device is an infrared thermometer, which measures body temperature. While temperature can be an indicator of health, the device itself simply measures a physiological parameter and does not provide a diagnosis of a disease or condition. The "Intended Use" explicitly states it's for "measuring human body temperature" and can be used "as reference," not for diagnosing.
No
The device description clearly states it is a "handheld and non-contact device" and a "light weight, handhold and non-contact Infrared Thermometer," indicating it is a physical hardware device that measures temperature.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to examine these samples outside of the body.
- This Device's Function: The description clearly states that this infrared thermometer measures human body temperature by detecting infrared heat from the forehead. This is a non-contact measurement taken on the body, not a test performed on a sample taken from the body.
Therefore, based on the provided information, this device falls under the category of a medical device, but not specifically an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Infrared Thermometer is a non-sterile, reusable, handheld and non-contact 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 one month of age and above by detecting infrared heat from the forehead.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Infrared Thermometer, Model E127, is a light weight, handhold and non-contact Infrared Thermometer that measures temperatures of people ages 1 month and above by detecting the infrared energy radiated directly from the forehead without physical contact from a measurement distance of 1-5cm. . It uses 3.0V alkaline batteries. The device can measure temperature in direct and adjusted mode.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared heat detection
Anatomical Site
forehead
Indicated Patient Age Range
one month of age and above
Intended User / Care Setting
Home care environment and doctors in clinic as reference.
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 and repeatability testing
The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards.
Patient population: 50 subjects in each age group, infants (0-1 year), children (1-5years) and adults (>5 years) (Total 150 subjects)
Verdict: Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measuring accuracy:
±0.3 °C (32.0 °C -34.9 °C)
±0.2 °C (35-42.0 °C)
±0.3 °C (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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
October 2, 2020
Bioland Technology Ltd. Yiging Feng R.A No. A6B7 (Block G), ShangRong Industrial Zone No. 5 Baolong Road Shenzhen, Guangdong 518116 China
Re: K201161
Trade/Device Name: Infrared Thermometer (E127) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: September 25, 2020 Received: September 28, 2020
Dear Yiqing Feng:
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
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/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 Payal Patel Acting 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K201161
25-84
Device Name Infrared Thermometer, E127
Indications for Use (Describe)
Infrared thermometer is a non-sterile, reusable, handheld and non-contact device. It can be used by consumers in home care environment and doctors in clinic as reference. It is intended for measuring human body temperature of one month of age and above 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.
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*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."
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3
K201161 510(k) Summary
A. 10/2/2020
B. 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: Yiging Feng E-mail: regulator-a@bioland.com.cn
ﻥ Subject device
Trade name: Infrared Thermometer Model: E127 Classification name: Clinical Electronic Thermometer Regulation Medical Specialty: General Hospital Product Code: FLL Regulation number: 880.2910 Device class: Class 2 Code of Federal Regulations: 21CFR 880.2910
D. Predicate Device
Device name: Advocate Non-Contact Infrared Thermometer 510K number: K191004 Manufacturer: BroadMaster Biotech, Corp.
ші Indication for use
The Infrared Thermometer is a non-sterile, reusable, handheld and non-contact 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 people one month of age and above by detecting infrared heat from the forehead.
Device Description ட்
The Infrared Thermometer, Model E127, is a light weight, handhold and non-contact Infrared Thermometer that measures temperatures of people ages 1 month and above by detecting the infrared energy radiated directly from the forehead without physical contact from a measurement distance of 1-5cm. . It uses 3.0V alkaline batteries. The device can measure temperature in direct and adjusted mode.
4
F. Principle Operation
The Infrared Thermometer measures temperatures of people by detecting the infrared energy radiated directly from the forehead without physical contact. The reference body site is the oxter (axillary). 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 | BroadMaster Biotech, Corp | N/A |
| Model | E127 | EF001S | 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 | K201161 | K191004 | N/A |
| Intended Use | Infrared Thermometer is a non- | ||
| sterile, reusable, handheld and | |||
| non-contact 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 one month of age | |||
| and above by detecting infrared | |||
| heat from the forehead. | 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. | Similar | ||
| Note 1 | |||
| Intended users | Lay user and professional | Lay user and professional | Same |
| Measurement | |||
| method | Infrared radiation detection | Infrared radiation detection | Same |
| Target | |||
| population | One month of age and above | All ranges of people | Similar |
| Note 1 | |||
| Measurement | |||
| Site | Forehead | Forehead | 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 | |||
| resolution | 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 (35-42.0 °C) | |||
| ±0.3 °C (42.1 °C -43.0 °C) | ±0.3 °C (32.0 °C -34.9 °C) | ||
| ±0.2 °C (35-42.0 °C) | |||
| ±0.3 °C (42.1 °C -43.0 °C) | Same | ||
| Measurement | |||
| distance | 1-5cm | 5-10cm | Different |
| Note 2 | |||
| Memory | 20 | 12 | Different |
| Note 3 | |||
| Power Source | AAA*2, DC 3V | Two 1.5V AAA alkaline | |
| batteries | Same | ||
| Low battery | |||
| indication | Yes | Yes | Same |
| Display | LCD Display | LCD Display | Same |
| Operating | |||
| Environment | |||
| Condition | 15~40°C, RH≤85% (non-condense) | 10 °C~40 °C, RH≤80% | Similar |
| Note 4 | |||
| Storage | |||
| Environment | |||
| Condition | -20~55°C, RH≤93% (non-condense) | -20~55°C, RH≤95% | Similar |
| Note 4 | |||
| Degree of | |||
| protection | IP22 | IP20 | Different |
| Note 5 | |||
| PCB | FR4 PCB | FR4 PCB | Same |
| Cleaning | |||
| method | The thermometer outer shell and | ||
| probe can be cleaned and | |||
| disinfected by 70% alcohol | The thermometer enclosure and | ||
| probe can be cleaned and | |||
| disinfected by 70% alcohol | Same | ||
| Patient contact | |||
| materials | ABS | ABS | Same |
| Biocompatibility | ISO 10993-5: 2009 | ||
| ISO 10993-10: 2010 | ISO 10993-5: 2009 | ||
| ISO 10993-10: 2010 | Same | ||
| 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: 2017 | ||
| ASTM E 1965-98: 2016 (clinical | |||
| accuracy) | ASTM E 1965-98: 2016 | ||
| ISO 80601-2-56: 2017 | Similar | ||
| Note 6 |
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Note 1: Target population of subject device is one month of age and above, target population of predicate device is all ranges of people; Compared to the predicate device, the target population of subject device is a little narrower, but this difference has no effect on safety and effectiveness of product.
Note 2: Due to the difference in software algorithm and temperature sensor, so the measurement distance between subject product and predicate product; But the measurement distance of subject product has been effectively verified by the clinical repeatability and accuracy, therefore, the difference of measurement distance has no influence on safety and effectiveness of product.
Note 3: Memory function is only used to store data and is not product-critical, so it has no effect on product safety and effectiveness.
Note 4: Compared to the predicate device, the operating temperature of subject device is narrower, the operating humidity of subject device is wider, and the Storage humidity of subject device is narrower, but the operating and storage condition of subject device has passed ISO 80601-2-56 and IEC 60601-1-11 testing. Therefore, the difference of operating and storage condition has no influence on safety and effectiveness of product.
Note 5: The subject device has passed IEC 60601-1 and IEC 60601-1-11 safety test. Therefore, the difference of degree of protection has no influence on safety and effectiveness of product.
Note 6: ISO 80601-2-56: 2017 is an international standard, the subject device and the predicate device have has passed ISO 80601-2-56: 2017 performance test. The subject device was tested per the requirements in ASTM E1965-98: 2016 for clinical accuracy. Therefore, the difference of declared performance standards has no influence on safety and effectiveness of product.
Predicate Device Comparison H.
The subject device and the predicate device have the same intended use and the similar technical parameters, they both use infrared radiation detection method to detect human body forehead temperature. They have same measuring range and measuring accuracy. Thus, the subject device is substantially equivalent to the predicate devices.
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| I. Non-clinical test | |||
|---|---|---|---|
| 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 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 complies with the | ||
| applicable requirements set | |||
| forth in the referenced EMC | Pass | ||
| Electric safety for | |||
| medical device | |||
| used in the home | |||
| Healthcare | |||
| environment | IEC 60601-1-11:2015 Medical electrical | ||
| equipment - General requirements for basic | |||
| safety and essential performance - Part 1-11: | |||
| Collateral Standard: Requirements for | |||
| medical electrical equipment and medical | |||
| electrical systems used in the home | |||
| healthcare environment. | The subject complies with the | ||
| applicable requirements set | |||
| forth in the referenced IEC | |||
| 60601-1-11:2015 | Pass | ||
| Performance | |||
| testing | 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. | |||
| FDA Recognition number: 6-403 | The subject 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 complies with the
applicable requirements set
forth in the referenced
biological evaluation standard. | Pass |
8
J. Clinical Testing
| Name of
clinical testing | Referenced standard | Summary of testing | 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:
6-403
ASTM E1965-98: 2016,
Standard Specification for
Infrared Thermometers for
Intermittent Determination of
Patient Temperature
FDA Recognition number: 6-
125 | The methods and criteria
of clinical accuracy and
repeatability testing had
been clinically assessed
to meet the requirements
of clinical accuracy per
the referenced
standards. | 50 subjects in each age
group, infants (0-1
year), children
(1-5years) and adults
(>5 years) (Total 150
subjects) | Pass |
K. Conclusion
Non-clinical performance and clinical tests were conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission the subject device, E127 infrared thermometer is substantially equivalent to the predicate device, EF001S.