(105 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the device description and performance studies do not indicate the use of AI/ML. The "ADJUSTED MODE" calculation is described as a conversion, not a learned algorithm.
No
The device is an infrared thermometer intended to measure human body temperature. It is a diagnostic tool, not a therapeutic one as it does not treat or cure any condition.
Yes
Explanation: The device is an infrared thermometer intended to detect human body temperature. Measuring body temperature is a diagnostic process used to identify fever, which is a symptom of various medical conditions.
No
The device description explicitly states it is a "hand-held device powered by batteries" and uses an "infrared sensor," indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "detect human body temperature of all ages" by measuring infrared radiation from the forehead. This is a direct measurement of a physiological parameter (temperature) from the body itself.
- Device Description: The device description confirms it's a hand-held infrared thermometer measuring body temperature.
- Lack of In Vitro Testing: IVD devices are designed to perform tests on samples taken from the human body (like blood, urine, tissue). This device does not require any such samples. It directly interacts with the body's surface.
- Performance Studies: The performance studies focus on the accuracy of temperature measurement, compliance with standards for medical electrical equipment, and software validation. These are typical for a medical device that interacts with the body, but not specifically for IVD performance metrics like sensitivity, specificity, etc., which relate to analyzing biological samples.
In summary, this device is a medical device used for measuring a physiological parameter in vivo (on the living body), not an IVD which performs tests in vitro (outside the living body) on biological samples.
N/A
Intended Use / Indications for Use
The HeTaiDa electronic thermometers HTD8818A, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8816C, HTD8816C, HTD8808C are intended for use in home and clinical environment.
Product codes
FLL
Device Description
The HeTaiDa infrared body thermometer, Models HTD8818A, HTD8816C, HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient's forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.
This submission is to notify that a legally marketed device (predicate) are modified by extending output range of body mode to 34°C 43°C ,operating mode to 15°C40°C, deleting offset parameter settings, shelf-life change from 3 years to 5 years.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Infrared sensor technology
Anatomical Site
Forehead
Indicated Patient Age Range
all ages
Intended User / Care Setting
Home and clinical 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)
Bench Tests:
- General requirements for basic safety and essential performance:
- Standard: IEC 60601-1:2005 (Third Edition) + CORP. 1:2006 + CORP. 2:2007
- Results: Pass
- 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:
- Standard: IEC 60601-1-11: 2015
- Results: Pass
- General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic compatibility:
- Standard: IEC 60601-1-2:2014
- Results: Pass
- Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement:
- Standard: ISO 80601-2-56:2017
- Results: Pass
- Medical device software - Software life-cycle processes:
- Standard: IEC 62304: 2006+A1:2015
- Results: Pass
Device Change Verification/Validation:
- Parameters Information on labeling change:
- Verification/Validation Method: Labeling and User manual checked according to IEC 60601-1 clause 7.9 Accompany documents, IEC60601-1-11 clause 7.4 instructions for use, IEC60601-1-2 for EMC declaration, ISO 80601-2-56:2017 clause 201.7.9 Accompany document.
- Summary of Results: All the changes have been added on labeling.
- Operating environment change:
- Verification/Validation Method: 1. Environmental operating conditions-continuous operating conditions test done by SGS laboratory according to IEC 60601-1-11:2015. 2. Clinical accuracy test based on the change done, compliant with ASTM E1965-98.
- Summary of Results: 1. The accuracy of laboratory under operating environment were with ±0.3°C. 2. The clinical bias is equal to 0.05°C/0.07°C/-0.04°C with uncertainty of ±0.20/±0.19/±0.18 respectively for group I (Infants), group II (children) and group III (adults). The "Repeatability" is: 0.13. It's considered reasonably small and not to pose a problem for diagnostic purposes.
- Storage environment change for HTD8818A:
- Verification/Validation Method: Environmental transportation and storage test done by SGS laboratory according to IEC 60601-1-11:2015.
- Summary of Results: After storage with lowest condition and highest condition of transportation and storage, basic safety and essential performance met the requirements of devices.
- Measurement Range change:
- Verification/Validation Method: 1. Laboratory accuracy test for lower limit and upper limit of measurement range under five different environments combined upper and lower limits of environmental temperature and humidity done, compliant with ISO 800601-2-56:2017. 2. Clinical accuracy test based on the change done, compliant with ASTM E1965-98.
- Summary of Results: 1. The accuracy of laboratory under operating environment were with ±0.3°C. 2. The clinical bias is equal to 0.05°C/0.07°C/-0.04°C with uncertainty of ±0.20/±0.19/±0.18 respectively for group I (Infants), group II (children) and group III (adults). The "Repeatability" is: 0.13. It's considered reasonably small and not to pose a problem for diagnostic purposes.
- Temperature range for Accuracy change:
- Verification/Validation Method: Laboratory accuracy test for lower limit and upper limit of measurement range under five different environments combined upper and lower limits of environmental temperature and humidity done, compliant with ISO 800601-2-56:2017.
- Summary of Results: The accuracy of laboratory under operating environment were with ±0.3°C.
- Feature: Memory change:
- Verification/Validation Method: According to procedure of IEC62304:2015, software was verified and validated from risk analysis, flowchart of procedure, unit testing, integrated testing and system testing.
- Summary of Results: The devices perform right functions, and don't introduce any bug.
- Feature: parameter setting change:
- Verification/Validation Method: According to procedure of IEC62304:2015, software was verified and validated from risk analysis, flowchart of procedure, unit testing, integrated testing and system testing.
- Summary of Results: The devices perform right functions, and don't introduce any bug.
- Shelf life change:
- Verification/Validation Method: Using accelerated aging test to verify the shelf life.
- Summary of Results: The test from July 3rd, 2017 to October 20th, 2017, totally 107 days and 22 cycles, Total test time is 2112 hours, the accelerated aging test time is 1056 hours under 75°C, 93%RH condition, the life is 5 years after calculation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
-
Accuracy:
- 34.0°C~34.9°C: ±0.3°C / 93.2°F -94.8°F: ±0.5°F
- 35.0°C~42.0°C: ±0.2°C / 95.0°F -107.6°F: ±0.4°F
- 42.1°C~43.0°C: ±0.3°C / 107.8°F -109.4°F: ±0.5°F
-
Clinical Bias:
- 0.05°C (Infants), 0.07°C (children), -0.04°C (adults)
- Uncertainty: ±0.20 (Infants), ±0.19 (children), ±0.18 (adults)
-
Repeatability: 0.13
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Next to the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are placed side-by-side.
May 4, 2021
HeTaiDa Technology Co., Ltd. Karen Ren Official Correspondent 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town DongGuan City, Guangdong 523820 China
Re: K203332
Trade/Device Name: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL
Dear Karen Ren:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 25, 2021. Specifically, FDA is updating this SE Letter due to a typo in the applicant name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, (240) 402-6029, payal.patel@fda.hhs.gov.
Sincerely,
James M. Simpson Jr -
S7
for Payal Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
HeiTaiDa Technology Co., Ltd. Karen Ren Official Correspondent 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area DaLingShan Town DongGuan City, Guangdong 523820 China
Re: K203332
Trade/Device Name: Non-contact Infrared Body Thermometer, Model HTD8808C, HTD8818A, HTD8816C Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 22, 2021 Received: January 26, 2021
Dear Karen Ren:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
2
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-devices/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 (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,
Pror
Paval Patel Acting Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Non-Contact Infrared Body Thermometer HTD8818A, HTD8816C, and HTD8808C
Indications for Use (Describe)
The HeTailDa electronic thermometers HTD8818A, HTD8808C are infrared thermometers which use infrared sensor to detect human body temperature of all ages. It is intended to be used on one's forehead to detect body temperature. The HTD8816C, HTD8816C, HTD8808C are intended for use in home and clinical environment.
| 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
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
1. Submitter's Information 1.1 Contact person of Applicant
| Name: | HeTaiDa Technology Co., Ltd |
|---|---|
| Address: | 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, |
| DaLingShan Town, DongGuan City, Guangdong, China. | |
| Phone No: | +86 769-82658050 |
| Fax No: | +86 769-82658050 |
| Contact | |
| Person: | Tom Chen |
| tomchen@hetaida.com.cn |
1.2 Contact person of the submission
| Name: | HeTaiDa Technology Co., Ltd |
|---|---|
| Address: | 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, |
| DaLingShan Town, DongGuan City, Guangdong, China. | |
| Phone No: | +86 769-82658050 |
| Fax No: | +86 769-82658050 |
| Contact | |
| Person: | Karen Ren |
| Hetaida10@hetaida.com.cn | |
| Date Summary | |
| Prepared: | July 31th, 2020 |
2. Device information
| Type of 510(k) submission: | Special |
|---|---|
| Device Common Name: | Clinical electronic thermometer |
| Name: | Non-contact Infrared Body Thermometer |
| Model | HTD8808C, HTD8818A, HTD8816C |
| 510(k) number | K203332 |
| Classification name: | thermometer, electronic, clinical |
| Product Code: | FLL |
| Regulation Class: | II |
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| Regulation | 880.2910 |
|---|---|
| Number: |
3. Predicate Device(s)
| Manufacturer | Predicate Device | 510(k) number |
|---|---|---|
| Hetaida Technology | ||
| Co., Ltd. | Non-contact infrared Body | |
| thermometer | K171888 |
4. Device Description
The HeTaiDa infrared body thermometer, Models HTD8818A,HTD8816C,HTD8808C are hand-held device powered by batteries and designed to measure human body temperature without contacting patient's forehead. The thermometer can switch modes between "Body Mode" and "Surface Mode". The "Surface Mode" is DIRECT MODE and the "Body Mode" is ADJUSTED MODE. Forehead temperature of the ADJUSTED MODE is calculated by converting the measured temperature of the DIRECT MODE to an axillary equivalent temperature without contacting the patients' forehead.
This submission is to notify that a legally marketed device (predicate) are modified by extending output range of body mode to 34°C 43°C ,operating mode to 15°C40°C, deleting offset parameter settings, shelf-life change from 3 years to 5 years.
5. Indication for Use.
No changes to the indication for use are proposed by this submission. The indication for Use are as follows:
The HeTaiDa electronic thermometers HTD8818A, HTD8816C, HTD8808C are infrared thermometers which use Infrared sensor to detect human body temperature of patients of all ages, It is intended to be used on one's forehead to detect body temperature. The HTD8818A, HTD8816C, HTD8808C are intended for use in home and clinical environment.
6. Comparison of Technological Characteristics
The modified HeTaiDa HTD8818A, HTD8816C and HTD8808C thermometers expand the measurement range of body mode from 34°C -42.9°C to 34°C -43.0°C, operating temperature from 15°C35°C to 15°C40°C, deleting offset parameter settings compared with unmodified HTD8818A, HTD8816C and HTD8808C thermometers. No changes have been made to the device's indications for use, intended use, algorithm or fundamental scientific technology as a result of the modification that has prompted this submission.
| Element of
| Comparison | Subject device(s) | Predicate device(s) | Comparison |
|---|---|---|---|
| Type of | |||
| Thermometer | Non-Contact Infrared body | ||
| thermometer | Non-Contact Infrared body | ||
| thermometer | Identical | ||
| Model | HTD8818A, HTD8816C, | ||
| HTD8808C | HTD8818A, HTD8816C, | ||
| HTD8808C | / | ||
| 510(K) | K203332 | K171888 | / |
| Principles of | |||
| operation | Based on Infrared Sensor | ||
| technology. The IR sensor can | |||
| output different signal when | |||
| measuring different object | |||
| temperature or in different ambient | |||
| temperature, and the ASIC can turn | |||
| the signal from IR Sensor to a | |||
| digital value and | |||
| display it on the LCD. | Based on Infrared Sensor | ||
| technology. The IR sensor | |||
| can output different signal | |||
| when measuring different | |||
| object temperature or in | |||
| different ambient | |||
| temperature, and the ASIC | |||
| can turn the signal from IR | |||
| Sensor to a digital value | |||
| and display it on the LCD. | Identical | ||
| Indication for | |||
| Use | The HeTaiDa electronic | ||
| thermometers HTD8818A, | |||
| HTD8816C, HTD8808C are infrared | |||
| thermometers which use Infrared | |||
| sensor to detect human body | |||
| temperature of patients of all ages, | |||
| It is intended to be used on one's | |||
| forehead to detect body | |||
| temperature. The HTD8818A, | |||
| HTD8816C, HTD8808C are | |||
| intended for use in home and | |||
| clinical environment. | The HeTaiDa electronic | ||
| thermometers HTD8818A, | |||
| HTD8816C, HTD8808C are | |||
| infrared thermometers which | |||
| use Infrared sensor to detect | |||
| human body temperature of | |||
| patients of all ages, It is | |||
| intended to be used on one's | |||
| forehead to detect body | |||
| temperature. The | |||
| HTD8818A, HTD8816C, | |||
| HTD8808C are intended for | |||
| use in home and clinical | |||
| environment. | Identical | ||
| labeling | Instructions for use, package, | ||
| and label | Instructions for use, package, | ||
| and label | Identical | ||
| components | Power / temperature measurement | ||
| button, Mode button, Memory button, | |||
| Set button, sensor, microcontroller, | |||
| & LCD | Power / temperature | ||
| measurement button, Mode | |||
| button, Memory button, Set | |||
| button, sensor, | |||
| microcontroller, & LCD | Identical | ||
| Sensor | The thermometer uses an infrared | ||
| thermopile sensor with integrated | |||
| thermistor mounted in the head of | |||
| the thermometer for the target | |||
| reading and ambient | |||
| temperature reading | The thermometer uses an | ||
| infrared thermopile sensor | |||
| with integrated thermistor | |||
| mounted in the head of the | |||
| thermometer for the target | |||
| reading and ambient | |||
| temperature reading | Identical | ||
| Power Supply | Two (2), AAA batteries | Two (2), AAA batteries | Identical |
| Materials | User contacting materials include | ||
| ABS (device housing / handle, power / | |||
| temperature button, memory | |||
| button, mode button). | |||
| Patient contact materials: None as | |||
| non-contact with patient | User contacting materials | ||
| include ABS (device housing | |||
| / handle, power / temperature | |||
| button, memory button, mode | |||
| button). | |||
| Patient contact materials: None | |||
| as non-contact with patient | Identical | ||
| Biocompatibili | |||
| ty | 1. Type of contact: direct contact for | ||
| users, non-contact for patients. |
- Nature of body contact category:
Surface Contact class: A (