(315 days)
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.
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
The provided document is a 510(k) summary for the Kangzhan Infrared Thermometer (Model K9), seeking substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed product, rather than providing a standalone clinical study to establish novel performance criteria. Therefore, much of the requested information regarding detailed acceptance criteria and specific study designs to prove novel performance is not fully present or applicable in the context of a 510(k) submission. However, I can extract the information provided regarding the device's accuracy and the tests performed to establish substantial equivalence.
Here's an attempt to answer your questions based on the provided text, recognizing the limitations of a 510(k) summary:
1. A table of acceptance criteria and the reported device performance
The document references ISO 80601-2-56 and ASTM E1965 for accuracy standards. These standards typically define the acceptance criteria for the accuracy of clinical thermometers. The performance reported directly compares to these standards.
| Acceptance Criteria (from ISO 80601-2-56 and ASTM E1965) | Reported Device Performance (Infrared Thermometer Model K9) |
|---|---|
| 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°C - 42.9°C (107.8°F - 109.2°F) | ≤±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°C - 42.9°C (107.8°F - 109.2°F) |
| Measurement range | 32.0°C ~42.9°C (89.6°F - 109.2°F) |
| Non-contact use for forehead temperature measurement | Non-contact use, measurement site: Forehead |
| Resolution of display | 0.1°C / 0.1°F |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Clinical testing is conducted per ISO 80601-2-56 Second edition 2017-03... Sections 201.102 Clinical Accuracy Validation." However, it does not specify the sample size used for the test set or the data provenance (country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. For clinical thermometer accuracy, "ground truth" typically involves core body temperature measurements using highly accurate reference methods, often requiring clinical expertise in the measurement procedure rather than interpretive expertise.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable as the device is an Infrared Thermometer, not an AI-assisted diagnostic tool that involves "human readers." No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, a standalone performance evaluation was conducted for the device's accuracy against recognized standards (ISO 80601-2-56 and ASTM E1965). The reported "Reported Device Performance" in question 1 reflects this standalone performance. The device itself is an algorithm-driven electronic thermometer.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For clinical thermometers, the "ground truth" for accuracy validation typically involves
measurements obtained from a highly accurate reference thermometer placed at a core body temperature site (e.g., rectal, oral, or arterial catheter measurements in a clinical setting). The document does not explicitly state the specific ground truth method used, but it implicitly refers to the standards (ISO 80601-2-56) that dictate these methods for "Clinical Accuracy Validation."
8. The sample size for the training set
This is not applicable. The device is a traditional electronic thermometer, not an AI/machine learning device that typically requires a "training set."
9. How the ground truth for the training set was established
This is not applicable, as there is no "training set" for this type of 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
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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, nanshandistrict, 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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| 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 ofComparison | Subject device | Predicate device | SimilarorDifferent |
|---|---|---|---|
| 510(k) Number | K203497 | K191668 | / |
| Indication foruse | The Infrared Thermometer, Model K9is a non-contact infrared thermometerintended for the intermittentmeasurement and monitoring of humanbody temperature from forehead forclinical and home use environments. Itcan be used for anybody, e.g. forinfant, children and adults (Excludingneonates). The device does not requiresterilization and can be reused. | This device is a non-sterile, reusable,contact Infrared ForeheadThermometer (Model IR- FT)intended for intermittentdetermination of human bodytemperature through a touch on thecenter of the forehead as themeasurement site on people of allages. The Infrared ForeheadThermometer (Model IR- FT) can beused inclinical and homeenvironments. | Same |
| Thermometertype | Infrared forehead | Infrared forehead | Same |
| Components | The product is mainlycomposed of a temperature sensor, ahousing, a circuit board and a batterycompartment. | The product is mainlycomposed of a temperature sensor, ahousing, a circuit board and a batterycompartment. | Same |
| TemperatureMeasurementTechnology | The thermoneter uses a thermopilesensor with integrated thermistor forthe target reading, a thermistormounted in the head of thethermometer for ambienttemperature readings, and aninfrared proximity sensor fordetection of contact use andcompensation of the temperaturereading. | The thermometer uses a thermopilesensor with integrated thermistor forthe target reading, a thermistormounted in the head of thethermometer for ambient temperaturereadings, and an infrared proximitysensor fordetection of contact use andcompensation of the temperaturereading. | Same |
| KeyTemperatureSensor | High-end Thermopile DetectorTU05 manufactured by TEConnectivity inc | Thermopile SensorOTP-336 manufactured by Orientalsystem technology inc. | Same |
| Powerrequirements | DC 3V(2 AAA batteries) | D.C. 3 V (2 AAA dry batteries) | Same |
| Materials | Patient contacting materials includeABS+PC (Top cover, battery cover,chamber, button power,front cover)and PC(lens) | Patient contacting materials includePC (Top cover, battery cover,chamber, button power) andABS+TPU (front cover). | Similar(note 1#) |
| Temperaturerange | 32.0°C ~42.9°C (89.6°F -109.2°F) | 32.0°C~43.0°C (89.6°F -109.4°F) | Similar(note 2#) |
| Accuracy forbodytemperaturemeasurement | ≤±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) and42.1-42.9°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) and42.1-43°C (107.8°F -109.4°F) | ||
| Contact/noncontact use | Non contact use | None contact use | Same |
| Measurementsite | Forehead | Forehead | Same |
| Measurementdistance | Within 3 cm | Within 3 cm | Same |
| operatingmode | adjusted mode | adjusted mode | Same |
| referencebody site | oral | oral | Same |
| Resolution ofdisplay | 0.1°C / 0.1°F | 0.1°C / 0.1°F | Same |
| Signal outputAnd display | LED, Buzzer | LCD, Buzzer | Similar(note 3#) |
| Biocompatibility | ISO 10993-1 | ISO 10993-1 | Same |
| Voluntarystandards forClinicalElectronicThermometers | ISO 80601-2-56ASTM E1965 | ISO 80601-2-56ASTM E1965 | Same |
| MedicalElectrical Safetyand 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.
§ 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.