(295 days)
Not Found
No
The description details standard infrared sensing and processing with an internal microcontroller, without mentioning any AI/ML algorithms or training/test data characteristics indicative of such technology.
No.
A therapeutic device is used to treat a disease or condition, whereas this device is intended only for measurement of human body temperature.
No
The device is an infrared thermometer intended for "intermittent measurement of human body temperature from the forehead." While temperature measurement can be an indicator for various conditions, the device itself doesn't analyze the temperature or other data to provide a diagnosis of a disease or condition. It simply provides a measurement.
No
The device description explicitly lists multiple hardware components including a thermopile sensor, integrated circuits, LCD display, buttons, and batteries. This indicates it is a physical device with embedded software, not a software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. These tests are performed outside of the living body (in vitro).
- Device Function: The Infrared Thermometer (Model: IR8807) measures human body temperature from the forehead using infrared technology. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
The description clearly states its purpose is to measure body temperature from the forehead, which is a non-invasive, in-vivo measurement.
N/A
Intended Use / Indications for Use
The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Infrared Thermometer (Model: IR8807) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The Infrared Thermometer (Model: IR8807) has a forehead measurement mode and an object measurement mode.
The Infrared Thermometer (Model: IR8807), consists of the following parts:
- a) Thermopile Sensor
- b) Application-Specific Integrated Circuitry
- c) Erasable Programmable Read-Only Memory Integrated Circuit
- d) Capacitance-touch Integrated Circuit
- e) LCD display
- f) 2 buttons (Scan button, Setting button,)
- q) 2 x 1.5V AAA dry batteries
The operation principle is based on infrared sensor technology. The sensor in the thermometer detects the infrared energy, and the device processes the data to body temperature result with its internal microcontroller unit. It operates in an adjusted mode.
The main functions of Infrared Thermometer (Model: IR8807) are as followings:
- Forehead temperature measure functions
- Wide range of temperature readings: from 32.0ºC to 42.9ºC (89.6ºF ~ 109.2ºF)
- The measurement results can be displayed in either °C or °F units
- The LCD display showing clear measurement result.
- Memory data reading/removal function: The device can store a total of 32 groups of memorable values. All memory values can be removed after the battery is removed
- Low battery indicator
- Buzzer reminder function
- Users can set temperature alarm value
- Environment or object temperature measurement function
The reference body site of the output temperature is Oral.
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 ages except for neonates/newborns.
Intended User / Care Setting
Not Found
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 Test:
Clinical tests were conducted on Model: IR8807. 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 tests evaluated 169 subjects which were divided into three age groups: infant (less than 1 year), children (1 to 5 years old) and adult (greater than 5 years old). No less than 50 subjects in each group and 30% of them had temperature equaling or exceeding 37.5 °C. Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
Software Verification and Validation Test:
According to Software Safety Classification of IEC 62304, the infrared forehead thermometer IR8807 software shall be Class B. The Infrared Thermometer (model: IR8807) display data about the patient's body temperature supported by the software. According to the software unit level test, integration test and system level test, we hereby certify that all the functions those support the infrared forehead thermometer system specifications are proper. The Infrared Thermometer (model: IR8807) can be used safely and effectively to measure body temperature.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Forehead mode:±0.2°C , for range 35.0°C ~ 42.0°C
±0.3°C, outside this temperature range
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.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.
July 21, 2023
Shen Zhen Rong Feng Technology Co., Ltd Iris Fung Regulation Manager 3/F R Building ShaSi Industrial Park, Shajing Town BaoAn district Shenzhen, Guangdong China
Re: K223037
Trade/Device Name: Infrared Thermometer, Model: IR8807 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: June 18, 2023 Received: June 20, 2023
Dear Iris Fung:
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,
Porsche Bennett
Porsche Bennett For David Wolloscheck, Ph.D. 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) K223037
Device Name Infrared Thermometer, Model: IR8807
Indications for Use (Describe)
The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.
| 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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510(k) Summary-K223037
This summary of 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter Information
Sponsor Company Name: SHEN ZHEN RONG FENG TECHNOLOGY CO., LTD
- Address: 3/F R building ShaSi Industrial Park, ShajingTown, BaoAndistrict, ShenZhen � city, GuangDong Province, China
- Phone: +86-13715151187 � Fax: +86-020-82591255
- Contact Person (including title): Hong Xiao Lan (Engineer) �
- E-mail: 844352259@qq.com �
Application Correspondent: SHEN ZHEN RONG FENG TECHNOLOGY CO., LTD
Address: 3/F R building ShaSi Industrial Park, Shajing Town, BaoAn district, ShenZhen city,
GuangDong Province, China
- � Contact Person: Iris Fung
- Tile: Requlation Manager �
- Tel: +86-13211147965 �
- � Email: mdc-fs@foxmail.com; med-jl@foxmail.com
- Summary Prepared Date � July 21, 2023
- Subject Device Information: 2.
- � Type of 510(k) submission: Traditional
- � Common Name: Infrared Thermometer
- Trade Name: Infrared Thermometer, Model: IR8807 �
- Classification Name: Clinical Electronic Thermometer �
- Review Panel: General Hospital �
- � Product Code: FLL
- Regulation Number: 21 CFR 880.2910 �
- Regulation Class: 2 �
Predicate Device Information: 3.
- 510(k) number: K173048 �
- � Sponsor: Dongguan SIMZO Electronic Technology Co., Ltd.
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- Trade Name: Non-contact Forehead Thermometer, Model: HW-2/HW-3/HW-3/HW-4 /HW-� 4S/HW-302/HW-303
- Common Name: Infrared Thermometer �
- Review Panel: General Hospital �
- � Product Code: FLL
- Regulation Number: 21 CFR 880.2910 �
- Requlation Class: 2 �
Device Description 4.
The Infrared Thermometer (Model: IR8807) is an electronic thermometer using an infrared sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to a temperature value. The Infrared Thermometer (Model: IR8807) has a forehead measurement mode and an object measurement mode.
The Infrared Thermometer (Model: IR8807), consists of the following parts:
- a) Thermopile Sensor
- b) Application-Specific Integrated Circuitry
- c) Erasable Programmable Read-Only Memory Integrated Circuit
- d) Capacitance-touch Integrated Circuit
- e) LCD display
- f) 2 buttons (Scan button, Setting button,)
- q) 2×1.5V AAA dry batteries
The operation principle is based on infrared sensor technology. The sensor in the thermometer detects the infrared energy, and the device processes the data to body temperature result with its internal microcontroller unit. It operates in an adjusted mode.
The main functions of Infrared Thermometer (Model: IR8807) are as followings:
- Forehead temperature measure functions �
- Wide range of temperature readings: from 32.0ºCto 42.9ºC (89.6ºF ~ 109.2ºF) �
- The measurement results can be displayed in either °Cor °F units �
- The LCD display showing clear measurement result. �
- Memory data reading/removal function: The device can store a total of 32 groups of � memorable values. All memory values can be removed after the battery is removed
- Low battery indicator �
- Buzzer reminder function �
- Users can set temperature alarm value �
- Environment or object temperature measurement function � The reference body site of the output temperature is Oral.
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5. Indications for use
The Infrared Thermometer (Model: IR8807) is intended for the intermittent measurement of human body temperature from the forehead. It is a non-contact clinical thermometer and intended for use on people of all ages except for neonates/newborns.
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Manufacturer | SHEN ZHEN RONG FENG | ||
| TECHNOLOGY CO., LTD. | Dongguan SIMZO Electronic | ||
| Technology Co.Ltd. | – | ||
| 510 (k) Number | K223037 | K173048 | – |
| Product Name | Infrared Thermometer | Non-contact Forehead | |
| Thermometer | – | ||
| Models | Model: IR8807 | HW-2/HW-2S/HW-3/HW-4 | |
| /HW-4S/HW-302/HW- | |||
| 303 | Note 1 | ||
| Intended Use | The Infrared Thermometer (Model: | ||
| IR8807) is intended for the | |||
| intermittent measurement of human | |||
| body temperature from the forehead. | |||
| It is a non-contact clinical | |||
| thermometer and intended for use | |||
| on people of all ages except for | |||
| neonates/newborns. | The Non-contact Forehead | ||
| Thermometer is an infrared | |||
| thermometer intended for the | |||
| intermittent measurement of | |||
| human body temperature in | |||
| people of all ages. | Note 1 | ||
| Sensor | Infrared Sensor | Infrared Sensor | Same |
| Measurement | |||
| Mode | Forehead measurement Mode | Forehead measurement Mode | Same |
| Measurement | |||
| contact type | Non-contact type | Non-contact type | Same |
| Measurement | |||
| type | Adjusted | Adjusted | Same |
| Measurement | |||
| method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement | |||
| time | ≤3S | 1S | Note 2 |
| Measurement | |||
| Distance | 2-5cm | HW-2/HW-2S/HW-3/HW-302/ | |
| HW-303:5-8cm HW-4/HW- | |||
| 4S:1-2cm | Note 3 | ||
| Measuring | |||
| Range | 32°C ~ 42.9°C | Forehead mode: 35.5°C | |
| ~42.9°C (95.9°F | |||
| ~109.2°F) | Note 4 | ||
| Accuracy | Forehead mode:±0.2°C , for | ||
| range 35.0°C ~ 42.0°C | |||
| ±0.3°C, outside this temperature | |||
| range | Forehead mode: | ||
| ±0.2°C (0.4°F) within 35.5°C | |||
| ~42.9°C | |||
| (95.9°F~109.2°F), | |||
| ±0.3°C(0.5°F) other range | Note 5 | ||
| Display | |||
| Resolution | 0.1°C/0.1°F | 0.1°C/0.1°F | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Comparison |
| High | |||
| temperature | |||
| indication | Yes | Yes | Same |
| Buzzer | Yes | Yes | Same |
| Display screen | LCD | LCD | Same |
| Auto power-off | |||
| while no | |||
| operation | Yes | Yes | Same |
| °C/°Fswitchable | Yes | Yes | Same |
| Memory | 32 sets | HW-2/2S:32 | |
| sets HW- | |||
| 3/4/4S: 1 set | |||
| HW-302/303:64 Sets | Note 6 | ||
| Power Supply | 2 x AAA batteries | 2 x AAA | Same |
| Operating | |||
| Conditions | Temperature: 10°C ~ 40°C Relative | ||
| humidity: ≤85% RH | Temperature: 10~40°C | ||
| Relative humidity: ≤85% | |||
| RH | Same | ||
| Storage | |||
| Conditions | Temperature: -20°C ~55°C Relative | ||
| humidity: ≤93%RH, non- | |||
| condensing | Temperature: -25°C- +55°C | ||
| Relative humidity: ≤90% | Note 7 | ||
| Dimension | 182(L) x 54(W) x 47(H) mm | 9315341mm | Note 8 |
| Weight | Approximately 125 g | 90-125 g | Note 8 |
| Conformance | |||
| standard | EN60601-1(Safety), | ||
| IEC60601-1-2(EMC) | |||
| ASTME1965-98(performance) | EN60601- | ||
| 1(Safety), | |||
| IEC60601-1- | |||
| 2(EMC) | |||
| ASTME1965-98(performance) | Same | ||
| Biocompatibility | ISO 10993-10 Skin Irritation test ISO | ||
| 10993-10Skin Sensitization test | |||
| ISO 10993-5 Vitro Cytotoxicity test | ISO 10993-10 Skin Irritation | ||
| test ISO 10993-10Skin | |||
| Sensitization test | |||
| ISO 10993-5 Vitro Cytotoxicity | |||
| test | Same | ||
| Sensor and | |||
| patient contact | |||
| materials | Infrared Sensor ABS | ||
| plastic shell | Infrared Sensor | ||
| ABS plastic shell | Same |
Comparison to Predicate Device 6.
6
Note 1
The Intended Use of subject device and predicate device is non-contact measurement of human body temperature from the forehead. The target population of the subject device is a subset of the predicate. This difference does not raise new or different questions of safety and effectiveness.
Note 2
Measurement time of the subject device is ≤3 seconds, the predicate device is 1 second. Both the subject and predict devices comply with ASTM E 1965-98. It is demonstrated that Page 4 of 7
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the measure time does not affect the measurement accuracy. This difference does not raise new or different questions of safety and effectiveness.
Note 3
Measurement distance of the subject devices is 2-5cm, the predicate device measurement distance is 5- 8cm (models HW-2/HW-2S/HW-3/HW-302/ HW-303) or 1-2cm (models HW-4/HW-4S). Performance testing of the of the subject device demonstrates the accuracy meets the requirements within the distance range. The difference does not raise new or different questions of safety and effectiveness.
Note 4
Both devices have different measurement ranges; however, the measurement range of the subject device meets the requirements of ASTME1965-98. Therefore, the difference does not raise new or different questions of safety and effectiveness.
Note 5
Both devices have different accuracy requirements ; however, the measurement accuracy of the subject device and the predicate device meet the requirements of ASTME1965-98. Performance testing was conducted on the subject device according to ASTM E1965-98. Therefore, the difference does not raise new or different questions of safety and effectiveness.
Note 6
The memory capacity of the subject device is the same as the predicate device model: HW-2/2S. The memory capacity is only an auxiliary function. Software verification and validation testing conducted on the subject device demonstrates that the difference does not raise any new or different safety and effectiveness questions.
Note 7
There is a difference between the storage conditions of the predicate device and the subject device; however, both devices comply with IEC60601-1-11 and ASTM E1965-98. Therefore, the difference does not raise new or different questions of safety and effectiveness.
Note 8
There is a difference between the dimensions and weight of the predicate device and the subject device, however, the differences do not affect the safety and effectiveness as the subject device demonstrated adequate performance to requirements.
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7. Test Summary - Non-Clinical Test
The subject device conforms to applicable standards that include:
- � ASTM E 1965-98:2016 Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
- � IEC 60601-1:2012, Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance
- � IEC 60601-1-2:2014, Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility
- � IEC 62304:2006+AMD1:2015 Medical Device Software - Software Life Cycle Processes
- � IEC60601-1-11:2015 medical electrical equipment - part 1-11: general requirements for basic safety and essential performance - collateral standard: requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
- � ISO 10993-5:2009, Biological evaluation of medical devices --Part 5: Testsfor In Vitro cytotoxicity,
- � ISO 10993-10:2010, Biological evaluation of medical devices -- Part 10: Tests for irritation and skin sensitization
Summary of Clinical Test 8.
Clinical tests were conducted on Model: IR8807. 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 tests evaluated 169 subjects which were divided into three age groups: infant (less than 1 year), children (1 t o 5 years old) and adult (greater than 5 years old). No less than 50 subjects in each group and 30% of them had temperature equaling or exceeding 37.5 °C.
Based on the result, the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
9. Summary of software verification and validation Test
According to Software Safety Classification of IEC 62304, the infrared forehead thermometer IR8807 software shall be Class B. The Infrared Thermometer (model: IR8807) display data about the patient's body temperature supported by the software. According to the software unitlevel test, integration test and system level test, we hereby certify that all the functions those support the infrared forehead thermometer system specifications are proper. The Infrared Thermometer (model: IR8807) can be used safely and effectively to measure body temperature.
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10. Conclusion
After analyzing the intended use, technological characteristics, verification and validation testing, it can be concluded that the differences between the subject and predicate device do not raise any new or different questions of safety and effectiveness. Therefore, subject device, Infrared Thermometer, Model: IR8807 is substantially equivalent to the predicate device, Noncontact Forehead Thermometer, Model: HW-2/HW-2S/HW-3/HW-4 /HW-4S/HW-302/HW-303, cleared under K173048.