(207 days)
Not Found
No.
The document mentions "Not Found" for "Mentions AI, DNN, or ML" and "Mentions image processing." The device description and intended use focus on basic infrared temperature detection and display, with no indication of advanced data processing or learning capabilities.
No
The device is intended for measuring body temperature, which is a diagnostic function, not a therapeutic one. It does not treat or cure any condition.
Yes
The device is intended for "measuring human body temperature", which is a diagnostic function because it provides information about a person's health status (e.g., presence of fever). The "Indications for Use" section explicitly states this purpose.
No
The device is described as a "handheld, battery-powered device" that measures temperature by receiving infrared energy and displays results on an "LED or LCD display." While it can transfer results to an app via Bluetooth, its core function and primary output are hardware-based, fulfilling its intended use without relying solely on software for its medical purpose.
No.
The device measures physical parameters (body temperature) and does not involve in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
For T30:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment.
For TE-82:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment.
For TE-102 and TE-79:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.
Product codes (comma separated list FDA assigned to the subject device)
FLL
Device Description
The Infrared Thermometer is a non-sterile, reusable device. Infrared thermometer are handheld, battery-powered devices designed to measure body temperature by receiving infrared energy radiation from the ears or forehead. When measuring forehead temperature, it is non-contact. The device can be used by consumers in homecare environment. There are four models. T30, which can measure body temperature by receiving infrared energy from the forehead or ear canal. TE-82 measure body temperature by receiving infrared radiation from the ears; TE-79 and TE-102 can measure body temperature by receiving infrared energy radiation from the forehead.
The thermometer has the result of measurement through the forehead temperature mode or ear temperature mode directly displayed on the LED or LCD display.
The results of measurements can also be transferred to the APP via Bluetooth for recording and display
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
forehead and auditory canal (ear)
Indicated Patient Age Range
People of all ages (including adults / children / infants)
Intended User / Care Setting
consumers in homecare environment
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Test Summary - Summary of Accuracy repeatability verification: The testing is conducted pre ISO 80601-2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. This performance test consists of a minimum of 150 subjects, divided into four groups: 0 up to 3 months, 3 months up to 1 year, older than 1year and younger than 5 years, and older than 5 years... The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ISO 80601-2-56.
Non-clinical data: Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment - Part 1: 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.
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- ISO80601-2-56 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature Measurement
- Software Verification and Validation Testing
- Biocompatibility Test
- Cybersecurity
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
FDA 510(k) Clearance Letter - K243082
Page 1
April 25, 2025
Guangzhou Daxin Health Technology Co., Ltd
℅ Cassie Lee
Official Correspondent
Share Info (Guangzhou) Medical Consultant Ltd.
No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road,
Huangpu District
Guangzhou, Guangdong 510700
China
Re: K243082
Trade/Device Name: Infrared Thermometer
Regulation Number: 21 CFR 880.2910
Regulation Name: Clinical Electronic Thermometer
Regulatory Class: Class II
Product Code: FLL
Dated: March 19, 2025
Received: March 24, 2025
Dear Cassie Lee:
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 (the 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 available 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.
Page 2
K243082 - Cassie Lee Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K243082 - Cassie Lee Page 3
assistance/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
For David Wolloscheck
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known): K243082
Device Name: Infrared Thermometer
Indications for Use (Describe)
For T30:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment.
For TE-82:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment.
For TE-102 and TE-79:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary for K243082
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 801.92.
Prepared on: 4/25/2025
1. Submitter's Information
Sponsor Name: Guangzhou Daxin Health Technology Co., Ltd
Address: Room 810, No.1, Yichuang Street, Huangpu District, Guangzhou (China-Singapore Guangzhou Knowledge City) Guangdong
Post Code: 510700
Contact name: LuPeng Guo
Tel: +86 17324378052
E-mail: guolp@daxinhealth.com
Manufacturer Address: Room 601, Building 3, No. 9, Jinshagang Road 1, Dalang Town, Dongguan City Guangdong
D-U-N-S Number: 722481840
Application Correspondent:
Contact Person: Ms. Cassie Lee
Share Info (Guangzhou) Medical Consultant Ltd.
Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China
Tel: +86 20 8266 2446
Email: 382198657@qq.com
2. Subject Device Information:
Subject Device Information
Type of 510(k): Traditional
Device Name: Infrared Thermometer
Models: T30, TE-82, TE-79, TE-102
Classification Name: Clinical electronic thermometer.
Review Panel: General Hospital
Product Code: FLL
Regulation Number: 880.2910
Regulatory Class: II
3. Predicate Device Information
Predicate Device (K213011)
Sponsor: Bioland Technology Ltd
Trade Name: Infrared Thermometer
Model: E201
Page 6
Device Classification Name: Thermometer, Electronic, Clinical
Common Name: Clinical electronic thermometer
Review Panel: General Hospital
Product Code: FLL
Regulation Number: 880.2910
Regulation Class: II
4. Device Description
The Infrared Thermometer is a non-sterile, reusable device. Infrared thermometer are handheld, battery-powered devices designed to measure body temperature by receiving infrared energy radiation from the ears or forehead. When measuring forehead temperature, it is non-contact. The device can be used by consumers in homecare environment. There are four models. T30, which can measure body temperature by receiving infrared energy from the forehead or ear canal. TE-82 measure body temperature by receiving infrared radiation from the ears; TE-79 and TE-102 can measure body temperature by receiving infrared energy radiation from the forehead.
The thermometer has the result of measurement through the forehead temperature mode or ear temperature mode directly displayed on the LED or LCD display.
The results of measurements can also be transferred to the APP via Bluetooth for recording and display
5. Intended Use / Indications for Use
For T30:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment.
For TE-82:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment.
For TE-102 and TE-79:
The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment.
6. Comparison to predicate devices
Compare with the predicate devices, the subject device is very similar in design principle, intended use, indications for use, functions, material and the applicable standards. The differences between the subject device and predicate devices do not raise new questions of safety or effectiveness.
Page 7
| Elements of Comparison | Subject Device (K243082) | Predicate Device (K213011) | Verdict |
|---|---|---|---|
| Company | Guangzhou Daxin Health Technology Co., Ltd | Bioland Technology Ltd | — |
| Trade Name | Infrared Thermometer | Infrared Thermometer | — |
| Classification Name | Clinical electronic thermometer. | Clinical Electronic Thermometer | Same |
| 510(k) Number | K243082 | K213011 | — |
| Product Code | FLL | FLL | Same |
| Thermometer Type | Infrared Forehead or Ear Canal Thermometer | Infrared Forehead or Ear Canal Thermometer | Same |
Page 8
| Elements of Comparison | Subject Device (K243082) | Predicate Device (K213011) | Verdict |
|---|---|---|---|
| Intended Use / Indications for Use | For T30: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1-3cm. The device can be used by consumers in homecare environment. For TE-82: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the auditory canal. The device can be used by consumers in homecare environment. For TE-102 and TE-79: The Infrared Thermometer is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead. When measuring forehead temperature, it is non-contact and the distance of measurement is 3-5cm. The device can be used by consumers in homecare environment. | The Infrared Thermometer(model: E201) is a non-sterile, reusable, handheld device. It is intended for measuring human body temperature for people of all ages by detecting infrared heat from the forehead and auditory canal. When measuring forehead temperature, it is non-contact and the distance of measurement is 1~5cm. The device can be used by consumers in homecare environment. | Similar Note 2 |
Page 9
| Elements of Comparison | Subject Device (K243082) | Predicate Device (K213011) | Verdict |
|---|---|---|---|
| Contact type | Non-contact/ Contact | Contact/Non-contact | Same |
| Rx/OTC | OTC | OTC | Same |
| Display resolution | 0.1 °C /°F | 0.1 °C /°F | Same |
| Sensor type | Thermopile | Thermopile | Same |
| Response time | 1 s | 1 s | Same |
| Operating Environment Condition | Temperature: 50°F | 15~40 °C, RH≤85% (non-condense) | Same |
| Storage Environment Condition | Temperature: -4°F | -20~55°C, RH≤93% (non-condense) | Same |
| Intended patient | All kinds of patients (including adults / children / infants) | All kinds of patients (including adults / children / infants) | Same |
| Display | LCD/ LED Display | LCD Display | Different Note 5 |
| Reference body site | Axillary | Axillary | Same |
| Measurement method | Infrared radiation detection | Infrared radiation detection | Same |
| Measurement mode | Forehead mode Ear mode | Forehead mode Auditory canal mode | Same |
| Measuring range | 32.0°C | 32.0°C | Same |
| C/F switchable | Yes | Yes | Same |
| Measuring accuracy | ±0.4℉，96.8 | ±0.3℃(32.0℃~34.9℃) ±0.2℃(35.0℃~42.0℃) ±0.3℃(42.1℃~43.0℃) | Different Note 1 |
| Measurement distance | For forehead: T30: 1cm | Forehead mode:1-5 cm | Different Note 2 |
Page 10
| Elements of Comparison | Subject Device (K243082) | Predicate Device (K213011) | Verdict |
|---|---|---|---|
| Memory | 32 sets or 24 sets | 32 sets | Different Note 3 |
| Power source | 2xAAA (1.5V), DC 3.0V | 2xAAA (1.5V), DC 3.0V | Same |
| Signal transmission | BLE5.0 | N/A | Different Note 4 |
| Patient contact materials | ABS and PC | ABS | Different Note 6 |
| Electric Safety and EMC | IEC 60601-1: 2020 IEC 60601-1-11 IEC 60601-1-2:2020 | IEC 60601-1: 2005/A1; 2012 IEC 60601-1-2: 2014 | Same |
| Performance | ISO 80601-2-56 | ISO 80601-2-56 | Same |
Note 1:
The measurement range of subject device is different from the predicate device. The performance testing shows that the subject device complies with the performance standard ISO 80601-2-56. Therefore, this difference does not affect the performance and accuracy.
Note 2:
The measurement distance is different. But the Primary Predicate Device range covers the range of the subject device. So, the different does not raise different questions of safety and effectiveness.
Note 3:
The purpose of memory function is intended to store and view the previous measurement data. The function has been verified during software verification. The difference does not raise any issues on the device safety and effectiveness.
Note 4:
The Bluetooth version of subject device is different from the reference device. Compared with Bluetooth 4.0, Bluetooth 5.0 has improved in terms of transmission speed, coverage, energy consumption, multi-device connection, transmission distance and compatibility. The subject device complies with the performance standard FCC CFR Title 47 Part 15 Subpart c § 15.247. Therefore, this difference does not affect the performance and accuracy.
Note 5:
The subject device and predicate device display different screens. However, the subject device conforms to the requirements of IEC60601-1 standard, the display screen may be different, but it can still display information correctly, so this difference will not affect the performance and safety of the product.
Note 6:
Although the materials are slightly different, the materials of the subject device meet the requirements of the FDA's guidance document Use of International Standard Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1:
Page 11
Evaluation and testing within a risk management process". Therefore, this difference does not affect the biocompatibility safety of the product.
Final Conclusion:
The subject device is substantially equivalent to the predicate device K213011.
7. Test Summary
7.1 non-clinical data
Non-clinical tests were performed on the subject device in order to validate the design and to assure conformance with the following voluntary design standards in connection with medical device electrical safety, and electromagnetic compatibility:
- IEC 60601-1 2020-08 Edition 3.2 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - Note: This standard is recognized with relevant US national differences applied, see references #1 and #2 in the Relevant FDA Guidance and/or Supportive Publication section below.
- IEC 60601-1-11 Edition 2.1 2020-07 Medical Electrical Equipment - Part 1: 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.
- IEC 60601-1-2 Edition 4.1 2020-09 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
- ISO80601-2-56 Medical electrical equipment Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature Measurement
- 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, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator. - Biocompatibility Test
The subject device is biocompatible for its intended use. They are complied with the FDA's guidance document Use of International Standard Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". - Cybersecurity
Cybersecurity software documentation was created for subject Infrared Thermometer device according to FDA guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices "issued on October 18.2018.
Page 12
7.2 Summary of Accuracy repeatability verification
The testing is conducted pre ISO 80601-2-56 Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
This performance test consists of a minimum of 150 subjects, divided into four groups: 0 up to 3 months, 3 months up to 1 year, older than 1year and younger than 5 years, and older than 5 years... The test result demonstrated the clinical performance of the subject device complied with the requirement of standard ISO 80601-2-56.
9. Final Conclusion
The subject device has met all established acceptance criteria for performance testing and design verification testing. Results of performance and biocompatibility testing conducted demonstrate that the subject device supports a substantial equivalence determination to the predicate device K213011.