(105 days)
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.
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.
The provided text describes the acceptance criteria and the studies conducted to prove that the "Non-contact Infrared Body Thermometer" (Models HTD8808C, HTD8818A, HTD8816C) meets these criteria.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Labeling | All applicable items for the devices shall meet the requirements (IEC 60601-1 clause 7.9, IEC60601-1-11 clause 7.4, IEC60601-1-2 for EMC declaration, ISO 80601-2-56:2017 clause 201.7.9). | All the changes have been added on labeling. |
| Operating Environment Change | Laboratory Accuracy: Device complies with its specifications and all requirements of the standard when operated in normal use within Temperature. Clinical Accuracy: The bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer. The repeatability for the test article is less than or equal to ± 0.3°C. | Laboratory Accuracy: The accuracy of the laboratory under operating environment was within ±0.3°C. Clinical Accuracy: 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 | Device allowed to return and stabilize at operation conditions of normal use, and provides basic safety and essential performance. | 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 | Laboratory Accuracy: Laboratory accuracy for lower limit and upper limit of measurement range under five different environments shall be within ±0.3°C. Clinical Accuracy: The bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer. The repeatability for the test article is less than or equal to ± 0.3°C. | Laboratory Accuracy: The accuracy of the laboratory under operating environment was within ±0.3°C. Clinical Accuracy: 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 | Laboratory accuracy for lower limit and upper limit of measurement range under five different environments shall be within ±0.3°C. | The accuracy of the laboratory under operating environment was within ±0.3°C. |
| Feature: Memory Change | The device shall perform right functions, and don't introduce any bug. | The devices perform right functions, and don't introduce any bug. |
| Feature: Parameter Setting Change | The device shall perform right functions, and don't introduce any bug. | The devices perform right functions, and don't introduce any bug. |
| Shelf Life Change | All the functions and performance shall meet the requirements after each cycle in the expected shelf-life. | 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. |
2. Sample size used for the test set and the data provenance
The document refers to a clinical accuracy test (referenced as "Appendix 11" and compliant with ASTM E1965-98) for evaluating operating environment and measurement range changes.
-
Sample Size: The document indicates that clinical bias was calculated for three groups:
- Group I (Infants)
- Group II (Children)
- Group III (Adults)
However, the specific number of subjects within each group or the total sample size for the clinical test is not explicitly stated in the provided text.
-
Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document provides very limited information regarding the clinical study, particularly concerning the establishment of ground truth. It states that "the bias of the test thermometer is non-inferior to the bias of the predicate thermometer when compared to the reference thermometer." This implies a comparison to a "reference thermometer," which would typically be a highly accurate, calibrated device used to establish true body temperature.
- Number of Experts: Not mentioned.
- Qualifications of Experts: Not mentioned.
4. Adjudication method for the test set
The document does not describe any adjudication method (like 2+1 or 3+1). The evaluation of clinical accuracy seems to be based on direct comparison to a "reference thermometer" and statistical analysis of bias and repeatability.
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 device is a non-contact infrared body thermometer, not an AI-assisted diagnostic tool involving "human readers" or "cases" in the typical sense of medical imaging or clinical decision support systems. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers is not applicable to this device and was not performed.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
The device itself is a standalone thermometer. The "standalone" performance is assessed by various bench tests (IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, ISO 80601-2-56) and a clinical accuracy test comparing its readings directly to a reference thermometer. These tests evaluate the device's accuracy and functionality without human intervention outside of operating the device for measurement.
7. The type of ground truth used
The ground truth for the clinical accuracy tests appears to be established by comparison to a "reference thermometer." This indicates a highly accurate, calibrated device used to obtain the true body temperature against which the performance of the non-contact infrared thermometer is measured.
8. The sample size for the training set
The document primarily focuses on substantiation of modifications and performance testing, not on the development of the core algorithm. It does not provide information on a "training set" in the context of machine learning, as this is an infrared thermometer and not a learning-based algorithm. The device's "algorithm" likely refers to its internal logic for converting infrared readings to a displayed temperature, which would be developed through engineering and calibration, not a machine learning training set.
9. How the ground truth for the training set was established
As there is no mention of a traditional "training set" for a machine learning algorithm, this question is not directly applicable. The device's calibration and accuracy are established through laboratory and clinical testing against reference standards and methods, as detailed under points 1, 2, and 7.
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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
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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 |
| ContactPerson: | 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 |
| ContactPerson: | Karen Ren |
| Hetaida10@hetaida.com.cn | |
| Date SummaryPrepared: | 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 TechnologyCo., Ltd. | Non-contact infrared Bodythermometer | 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 ofComparison | Subject device(s) | Predicate device(s) | Comparison |
|---|---|---|---|
| Type ofThermometer | Non-Contact Infrared bodythermometer | Non-Contact Infrared bodythermometer | Identical |
| Model | HTD8818A, HTD8816C,HTD8808C | HTD8818A, HTD8816C,HTD8808C | / |
| 510(K) | K203332 | K171888 | / |
| Principles ofoperation | Based on Infrared Sensortechnology. The IR sensor canoutput different signal whenmeasuring different objecttemperature or in different ambienttemperature, and the ASIC can turnthe signal from IR Sensor to adigital value anddisplay it on the LCD. | Based on Infrared Sensortechnology. The IR sensorcan output different signalwhen measuring differentobject temperature or indifferent ambienttemperature, and the ASICcan turn the signal from IRSensor to a digital valueand display it on the LCD. | Identical |
| Indication forUse | The HeTaiDa electronicthermometers HTD8818A,HTD8816C, HTD8808C are infraredthermometers which use Infraredsensor to detect human bodytemperature of patients of all ages,It is intended to be used on one'sforehead to detect bodytemperature. The HTD8818A,HTD8816C, HTD8808C areintended for use in home andclinical environment. | The HeTaiDa electronicthermometers HTD8818A,HTD8816C, HTD8808C areinfrared thermometers whichuse Infrared sensor to detecthuman body temperature ofpatients of all ages, It isintended to be used on one'sforehead to detect bodytemperature. TheHTD8818A, HTD8816C,HTD8808C are intended foruse in home and clinicalenvironment. | Identical |
| labeling | Instructions for use, package,and label | Instructions for use, package,and label | Identical |
| components | Power / temperature measurementbutton, Mode button, Memory button,Set button, sensor, microcontroller,& LCD | Power / temperaturemeasurement button, Modebutton, Memory button, Setbutton, sensor,microcontroller, & LCD | Identical |
| Sensor | The thermometer uses an infraredthermopile sensor with integratedthermistor mounted in the head ofthe thermometer for the targetreading and ambienttemperature reading | The thermometer uses aninfrared thermopile sensorwith integrated thermistormounted in the head of thethermometer for the targetreading and ambienttemperature reading | Identical |
| Power Supply | Two (2), AAA batteries | Two (2), AAA batteries | Identical |
| Materials | User contacting materials includeABS (device housing / handle, power /temperature button, memorybutton, mode button).Patient contact materials: None asnon-contact with patient | User contacting materialsinclude ABS (device housing/ handle, power / temperaturebutton, memory button, modebutton).Patient contact materials: Noneas non-contact with patient | Identical |
| Biocompatibility | 1. Type of contact: direct contact forusers, non-contact for patients.2. Nature of body contact category:Surface Contact class: A (<24 h)3. Meets ISO 10993-5 and ISO10993-10 | 1. Type of contact: directcontact for users, non-contactfor patients.2. Nature of body contactcategory: Surface Contactclass: A (<24 h)3. Meets ISO 10993-5 andISO 10993-10 | Identical |
| Operatingenvironment | Temperature: 15°C ~ 40°CR.H.: ≤85%for HTD8808C,HTD8816C,≤95% for HTD8818A700-1060 hPA | Temperature: 15°C ~ 35°CR.H.: ≤85% 700-1060 hPA | SimilarThe operatingtemperatureenvironment of thesubject anddevices have passISO80601-2-56andIEC60601-1-11test, meet theseperformancestandards. and thedifference does notaffect thedetermination ofsubstantialequivalence. |
| Storageenvironment | -20°C -55°C / -4 °F - 131°F,≤93% R.H. for HTD8808C,HTD8816C,-25°C -55°C / -13 °F - 131°F,≤95% R.H. for HTD8818A700-1060 hPA | -20°C -55°C / -4 °F - 131°F,≤93% R.H.; 700-1060 hPA(0.7-1.06 atm) | SimilarThe storagecondition of subjectdevice has passedthe safety test, andthe Instructions forUse provides thestorage condition,so the differencebetween theoperating conditionsof subject deviceand predicatedevice will not affectthe determination ofsubstantialequivalence. |
| Displayresolution | 0.1°F /0.1 °C | 0.1 °F /0.1 °C | Identical |
| MeasurementRange | 34℃~43.0℃ | 34°C~42.9°C | Technologicalcharacteristicsare similar |
| Accuracy | $34.0℃ | $34.0℃~34.9℃:±0.3℃/ 93.2°F -94.8°F:±0.5°F;35.0℃~42.0℃ : ±0.2℃ /95.0°F -107.6°F:±0.4°F;42.1 ℃~42.9℃ :±0.3 ℃ /107.8°F-109.2°F: ±0.5°F;$ | Technological characteristics are similar |
| Response time | ≤2 seconds | ≤2 seconds | Identical |
| Feature | Memory capacity:50 readings for HTD8808C,HTD8816C, 10 readings forHTD8818AParameter setting:F1-UnitF2-Fever alert settingF3-Sound on/off setting forHTD8808C and HTD8816C,Unit setting/Prompt Sound on/offsetting for HTD8818A | Memory capacity :50 readingsParameter setting:F1-UnitF2-Fever alert settingF3-Sound on/offsettingF4- Overall temperature offset | Similar, the difference does not affect thedetermination of substantialequivalence.Similar, the difference does not affect thedetermination of substantialequivalence. |
| Fundamental technology | Infrared technology that converts auser's forehead temperature usingthe infrared energy emitted in thearea around the user's forehead toa reference site equivalenttemperature. | Infrared technology thatconverts a user's foreheadtemperature using theinfrared energy emitted inthe area around the user'sforehead to a reference siteequivalent temperature. | Identical |
| Performance | MeetsISO 80601-2-56:2017 | MeetsISO 80601-2-56:2009 | SubstantiallyEquivalent |
| ElectricalSafety | Meets ANSI / AAMI / IEC60601-1:2012 | Meets ANSI / AAMI / IEC60601-1:2012 | SubstantiallyEquivalent |
| EMC | Meets IEC 60601-1-2:2014 | Meets IEC 60601-1-2:2014 | SubstantiallyEquivalent |
| Shelf life | 5 years | 3 years | SubstantiallyEquivalent |
Substantial Equivalence Comparison Table
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7. Substantial Equivalence – Non-Clinical Evidence
The modifications to the device have been designed and assessed under design control processes compliant with FDA 21 CFR 820. Non-clinical testing has been performed todemonstrate that the safety and efficacy of the device remains substantially equivalent to its predicate.
| Model | Bench Tests | Standards | Results | Report File No. | |
|---|---|---|---|---|---|
| HTD8818AHTD8808CHTD8816C | General requirementsfor basic safety andessential performance | IEC 60601-1:2005 (ThirdEdition) +CORP. 1:2006+ CORP.2:2007 | Pass | GZME180100000901 | |
| General requirementsfor basic safety andessential performance– Collateral Standard:Requirements formedical electricalequipment andmedical electricalsystems used in thehome healthcareenvironment | IEC 60601-1-11: 2015 | Pass | GZME180100000902 | ||
| General requirementsfor basic safety andessential performance– Collateral Standard:Electromagneticcompatibility | IEC 60601-1-2:2014 | Pass | GZME180100001001 | ||
| Particularrequirements for basicsafety and essentialperformance of clinicalthermometers for bodytemperaturemeasurement | ISO 80601-2-56:2017 | Pass | GZME180100000903 | ||
| Medical devicesoftware - Softwarelife-cycle processes | IEC 62304:2006+A1:2015 | Pass | ZHTF-CE-01-006 |
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| Device Change | Risks | Verification/ValidationMethod(s) | AcceptanceCriteria | Summary ofResults |
|---|---|---|---|---|
| ParametersInformation onlabeling change | The parametersinformation on labelingdoesn't update on time,that would make usererror operation | Labeling and User manualare checked according toIEC 60601-1 clause 7.9Accompany documents,IEC60601-1-11 clause 7.4instructions for use,IEC60601-1-2 for EMCdeclaration, ISO 80601-2-56:2017 clause 201.7.9Accompany document.Please refer to Appendix 6and Appendix 7 | All applicableitems for thedevices shall meetthe requirements. | All the changeshave been addedon labeling |
| Operatingenvironmentchange | Inaccuracy reading todelay in patient treatmentin extended environment | 1.Environmental operatingconditions-continuousoperating conditions testwas done by SGSlaboratory according to IEC60601-1-11:2015Please refer to Appendix 62. Clinical accuracy testbased on the changewas done, which iscompliance with ASTME1965-98Please refer to Appendix 11 | 1. Device complywith itsspecifications and allrequirementsofstandard whenoperated innormal use withinTemperature.2. The bias of thetest thermometer isnon-inferior to thebias of the predicatethermometerwhencomparedtothereferencethermometer.Therepeatability for thetest article is lessthan or equal to ±0.3°C. | 1. The accuracy oflaboratory underoperatingenvironment werewith ±0.3°C2. The clinical biasis equal to0.05°C/0.07°C/-0.04°C withuncertainty of±0.20/±0.19/±0.18respectively forgroup I (Infants),group II (children)and group III(adults). The"Repeatability" is:0.13. It'sconsideredreasonably smalland not to pose aproblem fordiagnosticpurposes. |
| Storageenvironmentchange forHTD8818A | -Inaccuracy reading todelay in patient treatmentafter storage-Damage to device,device couldn't work. | Environmentaltransportationand storage test was doneby SGS laboratoryaccordingto IEC 60601-1-11:2015Please refer to Appendix 6 | Device allowed toreturn andstabilize atoperationconditions ofnormal use, andprovides basicsafety andessentialperformance | After storage withlowest conditionand highestcondition oftransportation andstorage, basicsafety andessentialperformance metthe requirementsof devices. |
| MeasurementRange change | -Inaccuracy reading todelay in patient treatmentin extended range, butvery low risk as very34-42.9°C to 34-43.0°C, and very lowpossibility to havehigh temperature forhuman | 1. Laboratory accuracy testforlower limit and upper limit ofmeasurement range underfivedifferentenvironments combinedupper and lower limits ofenvironmentaltemperature and humiditywere done, which iscompliance with ISO800601-2-56:2017Please refer to Appendix82. Clinical accuracy testbased on the changewas done, which iscompliance with ASTME1965-98Please refer to Appendix11 | 1. Laboratoryaccuracy for lowerlimit and upperlimit ofmeasurementrange under fivedifferentenvironmentsshall be within±0.3°C2. The bias of the testthermometer is non-inferior to the bias ofthe predicatethermometer whencompared to thereferencethermometer. Therepeatability for thetest article is less thanor equal to ± 0.3°C. | 1. The accuracy oflaboratory underoperatingenvironment werewith ±0.3°C2. The clinical biasis equal to 0.05°C/0.07°C/-0.04°Cwith uncertainty of±0.20/±0.19/±0.18respectively forgroup I (Infants),group II (children)and group III(adults). The"Repeatability" is:0.13. It'sconsideredreasonably smalland not to pose aproblem fordiagnosticpurposes. |
| Temperature rangefor Accuracychange | -Inaccuracy reading todelay in patient treatmentin extended range, | Laboratory accuracy test forlower limit and upper limit ofmeasurement range underfive different environmentscombined upper and lowerlimits of environmentaltemperature and humiditywere done, which iscompliance with ISO800601-2-56:2017Please refer to Appendix 8 | Laboratoryaccuracy for lowerlimit and upperlimit ofmeasurementrange under fivedifferentenvironmentsshall be within±0.3°C | The accuracy oflaboratory underoperatingenvironment werewith ±0.3°C |
| Feature: Memorychange | Decreasing memory sizedoesn't impact the safetyand effectiveness ofmedical device, so norisk | According to procedure ofIEC62304:2015, softwarewas verified and validatedfrom risk analysis, flowchartof procedure, unit testing,integrated testing andsystem testing.Please refer to Appendix 9software verification report | The device shallperform rightfunctions, anddon't introduceany bug. | The devicesperform rightfunctions, anddon't introduceany bug. |
| Feature: parameter setting change | ||||
| The function isn't relatedwith basic performance,deleting the functiondoesn't impact the safetyand effectiveness ofmedical device, so norisk | According to procedure ofIEC62304:2015, softwarewas verified and validatedfrom risk analysis, flowchartof procedure, unit testing,integrated testing andsystem testing.Please refer to Appendix 9software verification report | The device shallperform rightfunctions, anddon't introduceany bug. | The devicesperform rightfunctions, anddon't introduceany bug. | |
| Shelf life change | -The device damage orcouldn't work in theprolonged shelf life | Using accelerated aging testto verify the shelf life:1.Placed samples in thechamber with75°C and93%RH condition for48Hours, then take themout,placed them in the normalworking condition for 24hours for check, that calledacycle2.Start the second cycleonce the first cycle isfinished3. Repeated this cycle untilthe device some of itsfunction fails work orreachesthe former expected lifetime.Then test is over.Please refer to Appendix 10Shelf life validation report | All the functionsand performanceshall meet therequirements aftereach cycle in theexpected shelf-life. | The test from July3rd, 2017 toOctober 20th,2017, totally 107days and 22cycles, Total testtime is 2112hours, theaccelerated agingtest time is 1056hours under 75°C,93%RH condition,the life is 5 yearsafter calculation. |
Design control activities summary Table
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8. Substantial Equivalence - Clinical Evidence
The design of the submitted device specifications is substantially the same as the predicate, with minor difference in the measurement range, operating temperature and humidity range, and storage temperature and humidity range. Clinical evidence was not necessary to demonstrate substantial equivalence.
9. Conclusion
The HeTaiDa non-contact infrared body thermometers HTD8818A, HTD8816C and HTD8808C with changes described have similar intended use, principle of operation, and similar technological characteristics as the predicate device identified. The risk analysis and performance testing contained in this submission demonstrates the minor differences in technological characteristics between the subject device and the predicate do not raise different questions of safety and effectiveness. And we have verified that the mitigations based on risk analysis. Thus, in accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part807 and based on the information provided in this premarket notification, HeTaiDa Technology Co., Ltd. concludes that the Infrared Forehead Thermometers HTD8818A, HTD8816C, HTD8808C with changes described in this premarked notification are substantially equivalent to predicate device.
§ 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.