(315 days)
Not Found
No
The description focuses on standard infrared sensing and capacitance-based distance detection, with no mention of AI or ML algorithms for temperature calculation or other functions.
No.
The device is used to measure body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any condition.
Yes
Explanation: The device is an infrared thermometer that measures human body temperature, which is a physiological parameter used to assess health status and can indicate the presence of illness (e.g., fever). This falls under the definition of a diagnostic device as it provides information for detecting or monitoring a medical condition.
No
The device description explicitly lists multiple hardware components, including a thermopile sensor, integrated circuits, LED, batteries, and a lens. This indicates it is a physical device with embedded software, not a software-only medical device.
Based on the provided information, 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 K9, measures human body temperature by detecting infrared energy radiated from the forehead. This is a direct measurement of a physiological parameter on the body, not a test performed on a sample taken from the body.
- Intended Use: The intended use clearly states "intermittent measurement and monitoring of human body temperature from forehead". This aligns with the function of a thermometer, not an in vitro diagnostic test.
Therefore, the Infrared Thermometer, Model K9, is a medical device, but it falls under the category of a clinical thermometer rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Infrared Thermometer, Model K9 is a non-contact infrared thermometer intended for the intermittent measurement and monitoring of human body temperature from forehead for clinical and home use environments. It can be used for anybody, e.g. for infant, children and adults (Excluding neonates). The device does not require sterilization and can be reused.
Product codes
FLL
Device Description
The Infrared Thermometer, Model K9 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 device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance.
The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm.
The Infrared Thermometer, Model K9, 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) LED and Backlight
- f) Alkaline batteries; size AAA, 2 x 1.5 V
- g) Lens
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead
Indicated Patient Age Range
infant, children and adults (Excluding neonates)
Intended User / Care Setting
clinical and home use environments
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)
Performance data includes "Non-Clinical Data" and "Clinical Data".
Non-Clinical Data:
- Biocompatibility testing: conducted in accordance with ISO 10993-1, including Cytotoxicity, Skin Sensitization, and Skin Irritation.
- Electrical safety and electromagnetic compatibility (EMC): complies with IEC 60601-1: 2012 and IEC 60601-1-2: 2014.
- Bench Testing: complies with IEC 60601-1-11: 2015 and ISO 80601-2-56 Second edition 2017-03 [Including: Amendment 1 (2018)].
- Software Verification and Validation Testing: documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software considered "Moderate" level of concern.
- Usability Testing: conducted according to FDA Guidance 1757. Applying Human Factors and Usability Engineering to Optimize Medical Device Design.
Clinical data:
- Clinical testing is conducted per ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. Sections 201.102 Clinical Accuracy Validation.
Summary:
Based on the non-clinical and clinical performance as documented in the development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Accuracy for body temperature measurement:
- ≤±0.2°C (0.4°F), for the range 35°C -42°C (95°F -107.6°F);
- ≤±0.3°C (0.5°F),for the range 32°C -34.9°C (89.6°F -94.8°F) and 42.1-42.9°C (107.8°F -109.2°F)
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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October 8, 2021
Kangzhan Communication Electronics Co., Ltd. Su Baotong General Manager No. 1008, songbai road, yangguang community, xili street, Nanshan District Shenzhen, 518055 China
Re: K203497
Trade/Device Name: Infrared Thermometer (Model K9) Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: August 30, 2021 Received: September 8, 2021
Dear Su Baotong:
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 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203497
Device Name Infrared Thermometer (Model K9)
Indications for Use (Describe)
The Infrared Thermometer, Model K9 is a non-contact intended for the intermittent measurement and monitoring of human body temperature from forehead for clinical and home use environments. It can be used for anybody, e.g. for infant, children and adults (Excluding neonates). The device does not require sterilization and can be reused.
| 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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K203497 - 510(K) SUMMARY
This summary of 510(K) safety and effective information is being submitted in accordance with the requirement SMDA and 21 CFR 807.92.
1. Submitter of 510(K):
| Date of Prepared: | October 8, 2021 |
|---|---|
| Submitter's Name: | Kangzhan Communication Electronics Co., Ltd. |
| Address: | 4th floor, building F, qihang kechuang industrial park, |
| No. 1008, songbai road, yangguang community, xili street, nanshan | |
| district, shenzhen City,China | |
| Contact person: | Mr. Su Baotong |
| TEL: | 0755-88377262/ |
| 13602582167 | |
| FAX: | / |
| Email: | kzs168@126.com |
2. Proposed Device and code:
| Device Trade Name: | Infrared Thermometer (Model K9) | |
|---|---|---|
| Common Name: | Clinical Electronic Thermometer | |
| Product Code: | FLL | |
| Regulation Name: | Clinical electronic thermometer | |
| Regulation number | 21 CFR 880.2910 | |
| Device Class | 2 |
3. Predicate Device:
| 510(K) | Trade or Proprietary or Model Name | Manufacturer |
|---|---|---|
| -------- | ------------------------------------ | -------------- |
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Image /page/4/Picture/0 description: The image shows the logo for KANGZHAN. The logo is a blue and orange geometric shape, with the word "KANGZHAN" written in blue below it. The geometric shape is a square with a triangle cut out of the top, with the top triangle being orange and the bottom square being blue.
| K191668 | Infrared Forehead Thermometer (Model IR-FT) | Comper Chuangxiang
(Beijing) technology Co.,
Ltd. |
| --------- | --------------------------------------------- | --------------------------------------------------------- |
|---|
4. Description of Proposed Device:
The Infrared Thermometer. Model K9 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 device uses CapSense Technology to detect distance this technology is used to assist measurement. The concept of proximity sensor detects human electrical proximity level to transform to distance.
The distance control feature is added to the user interface to identify the measurement distances are in the correct parameter. In other words, the device will enter into measurement mode after the correct measurement distance is detected. This device can take a measurement automatically when the device detects the distance is appropriate within 5 cm.
The Infrared Thermometer, Model K9, 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) LED and Backlight
- f) Alkaline batteries; size AAA, 2 x 1.5 V
- g) Lens
5. Indications for Use
The Infrared Thermometer, Model K9 is a non-contact infrared thermometer intended for the intermittent measurement and monitoring of human body temperature from forehead for clinical and home use environments. It can be used for anybody, e.g. for infant, children and adults (Excluding neonates). The device does not require sterilization and can be reused.
Technical and Performance 6.
The following table compares the device to the predicate device with basic technological characteristics.
Both subject and predicate devices use infrared technology to measure and monitor the body temperature by the site of Forehead.
Infrared Thermometer K9 has been compared to the Infrared Forehead Thermometer Infrared Forehead Thermometer Models: IR-FT (K191668) as a predicate device for substantial equivalence. A table comparing the two devices is provided as follows:
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| Elements of
Comparison | Subject device | Predicate device | Similar
or
Different |
|----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| 510(k) Number | K203497 | K191668 | / |
| Indication for
use | The Infrared Thermometer, Model K9
is a non-contact infrared thermometer
intended for the intermittent
measurement and monitoring of human
body temperature from forehead for
clinical and home use environments. It
can be used for anybody, e.g. for
infant, children and adults (Excluding
neonates). The device does not require
sterilization and can be reused. | This device is a non-sterile, reusable,
contact Infrared Forehead
Thermometer (Model IR- FT)
intended for intermittent
determination of human body
temperature through a touch on the
center of the forehead as the
measurement site on people of all
ages. The Infrared Forehead
Thermometer (Model IR- FT) can be
used inclinical and home
environments. | Same |
| Thermometer
type | Infrared forehead | Infrared forehead | Same |
| Components | The product is mainly
composed of a temperature sensor, a
housing, a circuit board and a battery
compartment. | The product is mainly
composed of a temperature sensor, a
housing, a circuit board and a battery
compartment. | Same |
| Temperature
Measurement
Technology | The thermoneter uses a thermopile
sensor with integrated thermistor for
the target reading, a thermistor
mounted in the head of the
thermometer for ambient
temperature readings, and an
infrared proximity sensor for
detection of contact use and
compensation of the temperature
reading. | The thermometer uses a thermopile
sensor with integrated thermistor for
the target reading, a thermistor
mounted in the head of the
thermometer for ambient temperature
readings, and an infrared proximity
sensor for
detection of contact use and
compensation of the temperature
reading. | Same |
| Key
Temperature
Sensor | High-end Thermopile Detector
TU05 manufactured by TE
Connectivity inc | Thermopile Sensor
OTP-336 manufactured by Oriental
system technology inc. | Same |
| Power
requirements | DC 3V(2 AAA batteries) | D.C. 3 V (2 AAA dry batteries) | Same |
| Materials | Patient contacting materials include
ABS+PC (Top cover, battery cover,
chamber, button power,front cover)
and PC(lens) | Patient contacting materials include
PC (Top cover, battery cover,
chamber, button power) and
ABS+TPU (front cover). | Similar
(note 1#) |
| Temperature
range | 32.0°C 42.9°C (89.6°F -109.2°F) | 32.0°C43.0°C (89.6°F -109.4°F) | Similar
(note 2#) |
| Accuracy for
body
temperature
measurement | ≤±0.2°C (0.4°F), for the range 35°C
-42°C (95°F -107.6°F); | ≤±0.2°C (0.4°F), for the range 35°C -
42°C (95°F -107.6°F); | Same |
| | ≤±0.3°C (0.5°F),for the range 32°C -
34.9°C (89.6°F -94.8°F) and
42.1-42.9°C (107.8°F -109.2°F) | ≤±0.3°C (0.5°F),for the range 32°C -
34.9°C (89.6°F -94.8°F) and
42.1-43°C (107.8°F -109.4°F) | |
| Contact/non
contact use | Non contact use | None contact use | Same |
| Measurement
site | Forehead | Forehead | Same |
| Measurement
distance | Within 3 cm | Within 3 cm | Same |
| operating
mode | adjusted mode | adjusted mode | Same |
| reference
body site | oral | oral | Same |
| Resolution of
display | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| Signal output
And display | LED, Buzzer | LCD, Buzzer | Similar
(note 3#) |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Voluntary
standards for
Clinical
Electronic
Thermometers | ISO 80601-2-56
ASTM E1965 | ISO 80601-2-56
ASTM E1965 | Same |
| Medical
Electrical Safety
and EMC | IEC 60601-1, IEC 60601-
1-2 | IEC 60601-1, IEC 60601-
1-2 | Same |
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Discussion:
From the comparison table1 and table2, the subject devices and predicate devices have the similar Intended use & Indications for Use, same measurement place, Scale selection, Display screen, Auto power-off while no operation & Conformance standard. There are slightly differences between the devices and predicate devices as follows,through the verification and validation process, it has been shown that the differences do not raise new questions of safety and effectiveness.
Note 1#: Materials:
The subject device and predicate device have both performed biocompatibility tests according to the ISO 10993- 1, both devices meet the requirements of ISO 10993-1. Therefore it is substantially equivalent on biocompatibility risk.
Note 2#: Temperature range
The measurement range of the subject device meets the requirements of ISO 80601-2-56 and ASTM E1965-98.
Note 3#: Signal output and display Meets the requirement of IEC 60601-1
Conclusion:
The subject device Infrared Thermometer (Model K9) has all features of the predicate device. The differences between them do not affect the safety and effectiveness. Thus, the subject device is substantially equivalent to the predicate device.
7. Performance Testing:
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Performance data includes "Non-Clinical Data" and "Clinical Data", brief description of which are shown as below.
7.1 Non-Clinical Data:
The following performance data were provided in support of the substantial equivalence determination.
7.2 Biocompatibility testing
The biocompatibility evaluation for the Non-Contact Infrared Forehead Thermometer were conducted in accordance with the International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA. The worst case of the whole system is considered tissue contacting for duration of less than 24 hours. And the testing included the following tests:
- Cytotoxicity
- Skin Sensitization
- Skin Irritation
7.3 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety and EMC testing were conducted on the Non-Contact Infrared Forehead Thermometer, consisting of all the modules and accessories in the system. The system complies with the IEC 60601-1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performance for safety and the IEC 60601-1-2: 2014 Medical electrical equipment -Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests standard for EMC.
7.4 Bench Testing
Bench testing was conducted on the Non-Contact Infrared Forehead Thermometer, consisting of all the accessories in the system. The system complies with the IEC 60601-1-11: 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 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)].
7.5 Software Verification and Validation Testing
Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern.
7.6 Usability Testing
Usability testing according to following FDA Guidance 1757. Applying Human Factors and
Usability Engineering to Optimize Medical Device Design, was conducted.
7.7 Clinical data:
Clinical testing is conducted per ISO 80601-2-56 Second edition 2017-03 Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. [Including: Amendment 1 (2018)]. Sections 201.102 Clinical Accuracy Validation
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7.7 Summary
Based on the non-clinical and clinical performance as documented in the development, the subject devices were found to have a safety and effectiveness profile that is similar to the predicate device.
8. Conclusions:
The proposed device has the same intended use and similar technological characteristics as the predicate device. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. Based on the conducted performance and safety testing, the Infrared Thermometer (Model: K9) is substantially equivalent (SE) to the Infrared Forehead Thermometer (Model IR-FT) cleared under K191668.