(273 days)
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.
The Infrared Body Thermometers measure temperature by pressing the On/Scan button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
The device can measure temperature with three modes, forehead scan mode and ear mode.
Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.
The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.
The provided text describes the acceptance criteria and the study conducted for the Infrared Body Thermometer, Model: HTD8222US.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Standard Reference) | Reported Device Performance (HTD8222US) |
|---|---|
| Measuring Accuracy (ASTM E1965-98) | ±0.2°C (0.4°F) within 35 |
| ±0.3°C (0.5°F) for 34.0°C ~ 34.9°C and 42.1°C ~ 43.0°C | |
| Clinical Accuracy (Forehead Mode) (Calculated per ASTM E:1965-98) | Clinical bias: 0.14°C/0.15°C/0.15°C with Uncertainty: ±0.14/ ±0.15/ ±0.14 for group I/II/II. Clinical repeatability: 0.12 °C |
| Clinical Accuracy (Forehead Scan Mode) (Calculated per ASTM E:1965-98) | Clinical bias: 0.16°C/0.15°C/0.14°C with Uncertainty: ±0.10/ ±0.09/ ±0.09 for group I/II/II. Clinical repeatability: 0.12 °C |
| Clinical Accuracy (Ear Mode) (Calculated per ASTM E:1965-98) | Clinical bias: 0.12 °C/0.10/0/10 with Uncertainty: ±0.12 °C/ ±0.14 °C/ ±0.14 °C for group I/II/II. Clinical repeatability: 0.12 °C |
| Biocompatibility (ISO 10993-5, ISO 10993-10) | Meets ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization) |
| Electrical Safety (ANSI AAMI ES60601-1) | Complied |
| EMC (IEC 60601-1-2) | Complied |
| Performance (ISO 80601-2-56) | Complied |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: 140 subjects.
- Data Provenance: The document does not explicitly state the country of origin. It indicates that the clinical investigation report and data analysis followed the requirements of ASTM E1965-98 (2016). It also mentions that the submitter is based in DongGuan City, Guangdong, China. Given this information, it is highly probable the study was conducted retrospectively in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
The document does not provide details on the number of experts or their specific qualifications (e.g., radiologist with X years of experience) used to establish the ground truth for the clinical accuracy testing. It only states that the "clinical investigation report and data analysis followed the requirements of the ASTM E 1965-98 (2016)."
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for establishing ground truth for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The study focuses on the standalone performance of the infrared thermometer and its comparison to standards, not on human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The document describes the clinical accuracy testing of the device itself (Infrared Body Thermometer, Model: HTD8222US) in various modes (forehead, forehead scan, ear) against the requirements of ASTM E1965-98 (2016). This evaluates the algorithm's performance in taking temperature measurements.
7. The Type of Ground Truth Used:
The ground truth for the clinical accuracy testing was established based on the requirements of ASTM E1965-98 (2016), which is a standard specification for infrared thermometers for intermittent determination of patient temperature. This implies a comparison to a reference temperature measurement method, likely a highly accurate clinical thermometer, to determine the bias and repeatability of the device.
8. The Sample Size for the Training Set:
The document does not specify a separate "training set" or its sample size. The description of clinical accuracy testing refers to a "test set" of 140 subjects. For medical devices like thermometers, it is common for the "training" (calibration and development) to be conducted internally by the manufacturer, and the regulatory filing focuses on the validation (test) phase.
9. How the Ground Truth for the Training Set was Established:
As no specific training set is mentioned, the method for establishing ground truth for a training set is not detailed in the provided information. However, the overall development and calibration of such a device would likely follow internal standards and involve rigorous testing against known temperature sources and potentially clinical reference thermometers to ensure accuracy and precision.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
December 9, 2020
HeiTaiDa Technology Co., Ltd. % You Yijie Manager Qimmiq Medical Consulting Service Co., Ltd RM. 1711, Building K. NO. 101 Science Ave International Creative Vallev Guangzhou, 510663 Cn
Re: K200781
Trade/Device Name: Infrared Body Thermometer, Model: HTD8222US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: November 9, 2020 Received: November 9, 2020
Dear You Yijie:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
CAPT Alan Stevens Director (acting) 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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Indications for Use
510(k) Number (if known) K200781
Device Name Infrared Body Thermometer, Model: HTD8222US
Indications for Use (Describe)
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
| 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
1. Submitter's Information
Establishment Reqistration Information
Name: HeTaiDa Technology Co., Ltd Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China. 523820
Contact Person of applicant
Name: Tom Chen Address: 4F, BaiShiDa High-Tech Park, XiangDong Industrial Area, DaLingShan Town, DongGuan City, Guangdong, China TEL: +86 769-82658050 FAX: +86 769-82658050 Email: tomchen@hetaida.com.cn
Contact Person of the Submission:
Name: Yijie You Address: RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone, Guangzhou China TEL: +86 020-8224 5821 FAX: +86 020-8224 5821 Email: Jet.you@qimmig-med.com
Date prepared: December 8, 2020
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Device Common Name: | Clinical electronic thermometer |
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8222US |
| Regulation name: | thermometer, electronic, clinical |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
| 510(K) number: | K200781 |
3. Predicate Device Information
Predicate Device #1:
510(k) submitter/holder: KAZ USA, Inc., A Helen of Troy Company 510(K) Number: K163516 Model: Braun No Touch + Forehead NTF3000 Thermometer
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Trade name: Infrared Thermometer Review Panel: General Hospital Product Code: FLL Requlation Class: II Requlation Number: 880.2910
Predicate Device #2:
510(k) submitter/holder: Exergen Corporation 510(K) Number: K011291 TemporalScannerThermometer Trade name: Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 880.2910
Predicate Device #3:
510(k) submitter/holder: KAZ USA, Inc (a Subsidiary of Helen of Troy, Inc) K152748 510(K) Number: Trade name: Braun Thermoscan® PRO 6000 Ear Thermometer Review Panel: General Hospital Product Code: FLL Regulation Class: II Regulation Number: 880.2910
4. Device description
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The Infrared Body Thermometer uses a thermopile sensor with integrated thermistor for the target reading, a thermistor mounted in the head of the thermometer for ambient temperature readings, a parabolic mirror to help focus the infrared energy emitted from the forehead or tympanic membrane and the adjacent surfaces for detection of non-contact use and contact use and compensation of the temperature reading.
The Infrared Body Thermometers measure temperature by pressing the On/Scan button to start the measurement of target's infrared radiation. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display. The total operation takes a few seconds.
The device can measure temperature with three modes, forehead scan mode and ear mode.
Both forehead mode and forehead scan mode modes are non-contact with human body and measure forehead temperature. The forehead mode measures temperature from middle of the forehead, forehead scan mode measures temperature by scan the forehead from left to right or from right to left with position light spot following within approximately 3~10 seconds, then the maximum temperature will display on the screen.
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The ear mode of Infrared Body Thermometer measure temperature by reading infrared radiation emitting from the eardrum tissue. After removing the probe covering cap, the small cone-shape end of the thermometer is inserted into the ear canal, where the eardrum (tympanic membrane) and surrounding tissues emit IR radiation.
Principle of operation:
Infrared Body Thermometer, model: HTD8222US, is a hand-held, battery powered, infrared thermometer that measures human body temperature through the opening of the auditory canal or on forehead, by measuring the infrared energy emitted in the area around the user's forehead or tympanic membrane and adjacent surfaces when placed within 1~5 centimeter of the subject's forehead or insert into auditory canal. The electrical signal read out from the detector is fed to the circuit for amplification and calculation. The final measured temperature will be appeared on a LCD display.
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5. Indications for Use
The Infrared Body Thermometer, Model: HTD822US, is an electronic clinical thermometer using an infrared sensor for the intermittent determination of body temperature from the forehead and auditory canal in people of all ages for home setting use.
6. Comparison of technological characteristics with the predicate devices (K163516, K011291 and K152748)
| SEComparisons | Subject deviceK200781(Infrared BodyThermometer,model:HTD8222US) | Predicate device #1(K163516, InfraredThermometer, Model:Braun No Touch +Forehead NTF3000Thermometer)(compared withForehead mode ofHTD8222US) | Predicate device #2(K011291,TemporalScannerThermometer)(compared withForehead scan modeof HTD8222US) | Predicate device #3(K152748, BraunThermoscan® PRO6000 EarThermometer)(compared with earmode ofHTD8222US) | Discussion ofdifference |
|---|---|---|---|---|---|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| ProductCode | FLL | FLL | FLL | FLL | Same |
| FDA Class | II | II | II | II | Same |
| Indicationsfor Use | The Infrared BodyThermometer, Model:HTD8222US, is anelectronic clinicalthermometer using aninfrared sensor for theintermittentdetermination of bodytemperature from theforehead and auditorycanal in people of allages for home settinguse. | The Braun No Touch +Forehead NTF3000Thermometer is anon-sterile, reusableclinical thermometerintended for theIntermittent determinationof human bodytemperature in a touchand no touch mode on thecenter of the forehead asthe measurement site onpeople of all ages. | The TemporalScannerThermometer is aninfrared thermometerintended for theintermittentmeasurement of humanbody temperature ofpeople of all ages. | A non-sterile,re-useable clinicalthermometer intendedfor the intermittentdetermination of thehuman's bodytemperature forpeople of all ages | Same |
| Principle ofoperation | Measure temperatureby reading infrared | Measure temperature byreading infrared radiation | Measure temperatureby reading infrared | Measure temperatureby reading infrared | Same |
| radiation emitting from the forehead tissue or tympanic membrane and adjacent surfaces when the thermometer is placed within few centimeters of forehead or inserted into auditory canal. | emitting from the forehead tissue when the thermometer is placed within few centimeters of forehead. | radiation emitting from the forehead tissue when the thermometer is placed within few centimeters of forehead. | radiation emitting from tympanic membrane and adjacent surfaces when the thermometer is inserted into auditory canal. | ||
| targetpopulation | people of all ages | people of all ages | people of all ages | people of all ages | Same |
| Measurementsite 1 | Forehead | forehead | forehead | NA | SamePredicate 3 has no forehead mode, the subject device is compared with predicated devices 1 and 2 for this technical item, and shows same with predicated devices 1 and 2. Since modes work not at the same time, The difference will not affect the determination of substantial equivalence |
| Measurementsite 2 | ear | NA | NA | ear | SamePredicate 1 and 2 has no ear mode, the proposed device is compared with predicated device 3 for this technical item, and shows same with predicated device 3. Since modes work not at the same time, the difference will not affect the determination of substantial equivalence |
| Type of thermometer | intermittent | intermittent | intermittent | intermittent | SameAll three predicate devicedeclare they areintended for intermittentmeasurement of humanbody temperature whichis indicated in theintended use/ Indicationsfor Use of 510(K)summary. |
| Material ofPatientcontactcomponents | ABS | NA, not contact withPatient body | ABS | Common Materials-including an impactresistant casing.Biocompatible metalsand resins. | SimilarThe proposed device hasbeen validated forcytotoxicity perISO 10993- 5 andIrritation as well asSensitization per ISO10993-10. The differencewill not affect thedetermination of substantialequivalence |
| Biocompability | Nature of body contactcategory: SurfaceContact class: A (<24 h)User and patientcontacting materialButton:ABS757 (green)LCD screen: PMMA(transparent)Shell: ABS757 (white)Meets ISO 10993-5 andISO 10993-10 | Nature of body contactcategory: SurfaceContact class: A (<24 h)User contacting materialhousing / handleand power button: ABStemperature buttonand nose/foreheadtouch bumper: TPRMeets ISO 10993 | Nature of body contactcategory: SurfaceContact class: A (<24 h)User and patientcontacting materialABSNot public | Nature of body contactcategory: SurfaceContact class: A (<24 h)User and patientcontacting materialCommon Materials-including an impactresistant casing.Biocompatible metalsand resins.Meets ISO 10993-5 andISO 10993-10 | SimilarSince the proposed devicehas been Validated forcytotoxicity perISO 10993- 5 andIrritation as well asSensitization per ISO10993-10, The differencewill not affect thedetermination of substantialequivalence |
| Environment | home | home | home | home | Same |
| Design | Handheld | Handheld | Handheld | Handheld | Same |
| Measurementmethod | Infrared radiationdetection | Infrared radiationdetection | Infrared radiationdetection | Infrared radiationdetection | Same |
| Display Type | LCD | LCD | LCD | LCD | Same |
| Measurementmode | Forehead mode/Forehead scan mode/ear mode | No touch way | Forehead scan | ear mode | Same |
| Key | One button(ON/Scanbutton) | Two buttons(Powerbutton, Temperaturebutton) | One button(SCAN Button) | Four buttons(Measure buttonC/F buttonMemory buttonTimer button) | SimilarThe different button numberwill not affect thedetermination of substantialequivalence |
| Scaleselection | °C/°F | °C/°F | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | °C/°F | °C/°F | Same |
| Hightemperaturewarning | Yes | Yes | Yes | No | SimilarThe existed difference willnot affect the determinationof substantial equivalence |
| Low batteryindicator | Yes | Yes | Yes | Yes | Same |
| Usercontactingmaterial | Button:ABS757 (green)LCD screen: PMMA(transparent)Shell: ABS757 (white) | housing / handleand power button: ABStemperature buttonand nose/foreheadtouch bumper: TPR | ABS | Common Materials-including an impactresistant casing.Biocompatiblemetals and resins. | SimilarSince the proposed device hasbeen Validated forcytotoxicity perISO 10993- 5 andIrritation as well asSensitization per ISO10993-10, The difference willnot affect the determination ofsubstantial equivalence |
| Sensor Type | Thermopile | Thermopile | Thermopile | Thermopile | Same |
| Performance | Meets ASTM E1965 | Meets ASTM E1965-98 | Meets ASTM E1965-98 | Meets ASTME1965-98 | Same |
| ElectricalSafety | ANSI AAMIES60601-1 | ANSI AAMIES60601-1 | ANSI AAMIES60601-1 | ANSI AAMIES60601-1 | Same |
| EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| MeasuringRange(forehead mode) | 34.0°C ~ 43.0°C | 34.4°C ~ 42.2°C | NA | NA | SimilarThe proposed device meetsASTM E1965-98, ISO |
| 80601-2-56 and thedifference does not affect thedetermination of substantialequivalence. | |||||
| SimilarThe proposed device meetsASTM E1965-98, ISO80601-2-56 and thedifference does not affect thedetermination of substantial equivalence. | |||||
| MeasuringRange(forehead scanmode) | $34.0°C ~ 43.0°C$ | NA | $15.5$ to $42°C$ | NA | |
| MeasuringRange(ear mode) | $34.0°C ~ 43.0°C$ | NA | NA | $20.0$ to $42.2°C$(68 to 108°F) | SimilarThe proposed device meetsASTM E1965-98, ISO80601-2-56 and thedifference does not affect thedetermination of substantial equivalence. |
| Displayresolution | $0.1°F (0.1°C)$ | $0.1°F (0.1°C)$ | $0.1°F (0.1°C)$ | $0.1°F (0.1°C)$ | Same |
| Measuringaccuracy | $±0.2°C (0.4°F)$ within$35 | $±0.2°C (0.4°F)$ within$35 | $±0.2°C (0.4°F)$ within$35 | $±0.2°C (0.4°F)$ within$35 | Same |
| Measuretime | ≤2S for Foreheadmode;3~10s for Foreheadscan mode;≤5s for ear mode. | ≤2S | Seconds | 2~3 Seconds | SimilarThe Measure time will notaffect the determination ofsubstantial equivalence |
| ColorIndication | Green: ≥ $35.8°C$ -$37.4 °C$( $96.2°-99.4°F$ )Yellow: ≥ $37.5°C$ -$38.5°C$ ( $99.5°F$ -$101.3°F$ ) | Green: > $35.7°-37.4 °C$(> $96.3°$ - $99.4 °F$ )Yellow: > $37.4°$ -$38.5 °C$(> $99.4°$ - $101.3 °F$ ) | NA | NA | SimilarThe ColorIndication will not affect thedetermination of substantialequivalence |
| Orange: ≥ 38.6 -43.0°C (101.4 -109.4°F) | Red: > 38.5° - 42.2 °C(> 101.3° - 108.0 °F) | ||||
| MeasuringDistance | 1 CM -5CM | 1 CM -5CM | 0 CM | 0 CM | Similar |
| Powersource | DC3.0V X1(CR2032) | Two (2) AA batteries | 9 volt Alkaline | Two AA AlkalineBatteries | Similar |
| Expectedbattery life | More than 1000measurements | at least 1000measurements | Approximately 7,500readings | 1000 measurements | Similar |
| Clinicalaccuracy(forehead mode) | Clinical bias:0.14°C/0.15°C/0.15°Cwith Uncertainty:$\pm$ 0.14/ $\pm$ 0.15/ $\pm$ 0.14for group I/II/IIClinical repeatability: | Not public | NA | NA | Different |
| 0.12 °C(Calculated per ASTME:1965-98) | of proposed device aresufficiently small andacceptable which will notaffect the determination ofsubstantial equivalenceeven though any differenceexisted. | ||||
| Clinicalaccuracy(forehead scanmode) | Clinical bias:0.16°C/0.15°C/0.14°Cwith Uncertainty:±0.10/ ±0.09/ ±0.09for group I/II/IIClinical repeatability:0.12 °C(Calculated per ASTME:1965-98) | NA | Meets ASTM E1965-98and EN60601-1standards for electronicand radiationthermometers to theextent applicable tothermometers whichmeasure the surface ofthe skin over thetemporal artery. | NA | SimilarThe clinical biases,uncertainties andRepeatability of ear modeof proposed device aresufficiently small andacceptable and meet therequirement of ASTME1965-98. Therefore, thedifference existed will notaffect the determination ofsubstantial equivalence. |
| Clinicalaccuracy(ear mode) | Clinical bias:0.12 °C/0.10/0/10with Uncertainty: ±0.12 °C/ ± 0.14 °C/ ±0.14 °Cfor group I/II/IIClinical repeatability:0.12 °C(Calculated per ASTME:1965-98) | NA | NA | Clinical bias: 0.09 °CLimits of agreement:0.58 °CClinical repeatability:0.19 °C(Calculated per ASTME:1965-98)(less than thestandard < 0.3 °C(0.57 °F) | SimilarThese clinical biases,uncertainties andRepeatability of ear modeof proposed device aresufficiently small andacceptable. The differenceexisted will not affect thedetermination of substantialequivalence. |
| Dimensions ofthe auditoryprobe | Short radius: 3.6mmLength radius: 7mmHigh: 23.31mm | NA | NA | Not public | DifferentSince the performance andsafety of ear mode of theproposed device arevalidated, the differenceexisted will not affect thedetermination of substantial |
| Operating condition | 10°C | 15 | 15.5 | 10 | SimilarThe operating condition ofsubject device has passedthe safety test, and theInstructions for Use providesthe operating condition, sothe difference between theoperating conditions ofsubject device andpredicate device will notaffect the determination ofsubstantial equivalence. |
| Storageconditions | Temp.:-20-55°C | Temperature range:-25 °C to 60 °C; | Temperature range:-20 °C to 50 °C; | Temperature range:-25 °C to 55 °C; | |
| Relative Humidity: ≤95% | Humidity range: 15- 95% | Humidity range: ≤ 95% | Humidity range: 15-95% | ||
| Atmosphericpressure:70-106Kpa | Atmospheric pressurerange: 700-1060hPA; | Atmospheric pressurerange: Not public | Atmospheric pressurerange: Not public | SimilarThe storage condition ofsubject device has passedthe safety test, and theInstructions for Use providesthe storage condition, so thedifference between theoperating conditions ofsubject device and predicatedevice will not affect thedetermination of substantialequivalence. |
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7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
The recognized consensus standards for safety of medical electrical equipment: ANSI AAMI ES60601-1. IEC 60601-1-11 for safety, IEC 60601-1-2 for electromagnetic compatibility, ASTM E 1965-98 and ISO 80601-2-56 for performance, ISO 10993-5 and ISO 10993-10 for Biocompability are complied, and see below table for details.
| Standards | Standards Name |
|---|---|
| ANSI AAMIES60601-1:2005/(R)2012and A1:2012 | Medical Electrical Equipment - Part 1: GeneralRequirements For Basic Safety And EssentialPerformance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance -- Collateral Standard: ElectromagneticDisturbances -- Requirements And Tests |
| ISO 80601-2-56: 2017 | Medical Electrical Equipment - Part 2-56: ParticularRequirements For Basic Safety And EssentialPerformance Of Clinical Thermometers For BodyTemperature Measurement. |
| ASTM E1965-98:2016 | Standard Specification For Infrared Thermometers ForIntermittent Determination Of Patient Temperature |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: GeneralRequirements For Basic Safety And EssentialPerformance - Collateral Standard: ElectromagneticDisturbances - Requirements And Tests |
| ISO 10993-5:2009 | Biological Evaluation Of Medical Devices - Part 5: TestsFor In Vitro Cytotoxicity |
| ISO 10993-10:2010 | Biological Evaluation Of Medical Devices - Part 10: TestsFor Irritation And Skin Sensitization |
Guidance Documents included:
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FDA Guidance On The Content of Premarket Notification 510(k) Submissions for Clinical Electronic Thermometers.
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Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
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General Principles of Software Validation: Final Guidance for Industry and FDA Staff, January 2002.
8. Clinical Accuracy Testing:
The clinical investigation report and data analysis followed the requirements of the ASTM E
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1965-98 (2016).
The clinical tests evaluated 140 of subjects. Each mode was evaluated in 0 up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups. The clinical performance test protocol and data analysis is conducted as the requirement of ASTM E1965-98 (2016). The test report showed the clinical performance of the subject device complied with the requirement of ASTM E1965-98 (2016).
9. Conclusions
Infrared Body Thermometer, model HTD8222US, has the same intended use and similar characteristics with the predicate device. Based on performance testing and compliance with standards demonstrate that the subject device Infrared Body Thermometer, model HTD8222US performs comparably to the predicate device that is currently marketed for the same intended use.
§ 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.