(349 days)
The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.
Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature. The forehead mode measures temperature from center of the forehead. Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.
The provided document is a 510(k) Summary for the HeTaiDa Technology Co., Ltd. Infrared Body Thermometer, Model: HTD8823US. It outlines the device's characteristics and its substantial equivalence to predicate devices, supported by non-clinical and clinical testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document references two primary performance standards for the Infrared Body Thermometer: ASTM E1965-98 (2016) and ISO 80601-2-56: 2017. While it states that the device "Meets" these standards, specific quantitative acceptance criteria from these standards and the device's reported performance against each of those specific numerical criteria (e.g., maximum permissible error at different temperature ranges) are not explicitly itemized in a table within the provided text.
However, the "Summary of technological characteristics of device compared to the predicate devices" (Pages 5-7) includes some key performance characteristics that imply acceptance criteria and performance, mostly by stating "Same" or "Similar" to predicates which are presumed to meet equivalent criteria.
Here's a curated table based on the available information, inferring acceptance criteria from the predicates and performance against those:
| Acceptance Criteria (Inferred from Standards/Predicates) | Reported Device Performance (HTD8823US) |
|---|---|
| Measuring Range for Forehead mode: | 34.0°C ~ 43.0°C (93.2°F ~109.4°F) |
| Predicate KAZ USA (K163516): 34.4°C ~42.2°C (93.9°F to 108.0°F) | (Similar, difference discussed in D6 and validated by ASTM E1965-98, ISO 80601-2-56) |
| Measuring Range for Forehead scan mode: | 34.0°C ~ 43.0°C (93.2°F ~109.4°F) |
| Predicate Exergen (K011291): 15.5°C to 42°C (60°F to 107.6°F) | (Similar, difference discussed in D7 and validated by ASTM E1965-98, ISO 80601-2-56) |
| Display Resolution: | 0.1°F (0.1°C) |
| Predicate KAZ USA (K163516): 0.1°F (0.1°C) | Same |
| Predicate Exergen (K011291): 0.1°F (0.1°C) | Same |
| Measuring Accuracy: | ±0.2°C (0.4°F) within 35°C ~ 42°C (95°F~107.6°F); ±0.3°C (0.5°F) for other range |
| Predicate KAZ USA (K163516): ±0.2°C (0.4°F) within 35°C ~42°C; ±0.3°C (0.5°F) for other range | Same |
| Predicate Exergen (K011291): ±0.2°C (0.4°F) within 35~42°C; ±0.3°C (0.5°F) for other range | Same |
| Measure time (Forehead mode): | ≤2S |
| Predicate KAZ USA (K163516): ≤2S | Same |
| Measure time (Forehead scan mode): | 3~10s |
| Predicate Exergen (K011291): Seconds | (Similar, difference discussed in D8 and validated by ASTM E1965-98, ISO 80601-2-56) |
| Measuring Distance for forehead mode: | 1 CM -5CM |
| Predicate KAZ USA (K163516): 1 CM -5CM | Same |
| Measuring Distance for forehead scan mode: | 0 cm |
| Predicate Exergen (K011291): 0 cm | Same |
| Biocompatibility: | Meets ISO 10993-5, ISO 10993-10 |
| Electrical Safety: | Complies with ANSI AAMI ES60601-1 |
| EMC: | Complies with IEC 60601-1-2 |
| Software Verification & Validation: | Complies with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" |
2. Sample size used for the test set and the data provenance
- Sample size for the test set: 140 subjects.
- Data provenance: The document does not explicitly state the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, but clinical accuracy studies for new devices are typically prospective. The text mentions "Each model was evaluated in 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups," indicating a structured, likely prospective clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. For a clinical thermometer, the "ground truth" for temperature measurement is typically established by using a highly accurate reference thermometer (e.g., laboratory-grade thermometer or a rectal/oral thermometer considered the gold standard in a clinical setting by trained medical professionals). The document only states "The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016)," which is a standard for infrared thermometers. It doesn't detail the personnel involved in supervised measurements.
4. Adjudication method for the test set
This information is not provided in the document. Adjudication methods like 2+1 or 3+1 are typical for subjective interpretations (e.g., radiology reads). For quantitative measurements like temperature, the ground truth is usually established by direct measurement with a reference standard, not typically through expert adjudication of images or subjective findings.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done, nor would it be relevant for this type of device. This device is an infrared thermometer, not an AI-assisted diagnostic tool that involves human "readers" or interpretation of complex cases. Therefore, there's no mention of AI assistance or its effect size on human performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a standalone algorithm, in the sense that it automatically measures and displays temperature without requiring human interpretation of an output from an underlying AI (beyond reading the numerical display). The "clinical accuracy testing" evaluates the device's performance in this standalone capacity.
7. The type of ground truth used
The ground truth for the clinical accuracy testing was established by comparing the device's measurements against a reference standard of body temperature measurement, as specified by ASTM E1965-98 (2016). While not explicitly stated, this usually involves a core body temperature measurement method (e.g., rectal, oral, or an equivalent highly accurate reference thermometry system) performed by trained personnel.
8. The sample size for the training set
This information is not applicable and therefore not provided. Infrared thermometers like the HTD8823US are hardware-based measurement devices that employ fixed algorithms and calibrations, not machine learning or AI models that require "training sets" in the conventional sense. Any "training" would refer to internal calibration and validation data used during the device design and manufacturing process, which is distinct from a machine learning training set.
9. How the ground truth for the training set was established
As inferred above, this information is not applicable as the device does not utilize a machine learning model that requires an external "training set" with established ground truth. The device is calibrated and validated against physical temperature standards and clinical performance requirements.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".
January 5, 2021
HeTaiDa Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Development Zone Guangzhou, 510663 China
Re: K200159
Trade/Device Name: Infrared Body Thermometer, Model: HTD8823US Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: December 7, 2020 Received: December 7, 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 Acting 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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Indications for Use
510(k) Number (if known) K200159
Device Name Infrared Body Thermometer, Model: HTD8823US
Indications for Use (Describe)
The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead 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 K200159
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@qimmiq-med.com
Date prepared: Dec. 16, 2020
2. Device Information
| Device Common Name: | Clinical electronic thermometer |
|---|---|
| Trade Name: | Infrared Body Thermometer |
| Model: | HTD8823US |
| Regulation name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
3. Predicate Device Information
Primary predicate device:
510(k) submitter/holder: KAZ USA, Inc., A Helen of Troy Company 510(K) Number: K163516 Model: Braun No Touch + Forehead NTF3000 Thermometer Trade name: Infrared Thermometer Review Panel: General Hospital Product Code: FLL
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Requlation Class: . Requlation Number: 880.2910
Secondary predicate device:
510(k) submitter/holder: Exergen Corporation 510(K) Number: K011291 Trade name: TemporalScanner Thermometer, SensorTouch Review Panel: General Hospital Product Code: FLL Regulation Class: -Regulation Number: 880.2910
4. Device description
Infrared (IR) Body Thermometer, model: HTD8823US, is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral.
The device can measure temperature with two modes, forehead mode and forehead scan mode, and both modes measure forehead temperature.
The forehead mode measures temperature from center of the forehead.
Forehead scan mode measures temperature by gently positioning the probe flush (flat) on the center of the forehead, midway between the eyebrow and the hairline, press and hold the On/Scan button. Lightly slide the thermometer across the forehead keeping the sensor flat and in contact with the skin until reaching the right hairline, release the On/Scan button and remove the thermometer from the forehead, then the temperature will display on the screen, the whole process takes 3~10 seconds.
Principle of operation:
Infrared Body Thermometer, model: HTD8823US, is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead. The IR sensor outputs electrical signal which is fed to circuit for amplification and then inputted to the microcontroller unit (MCU). For forehead mode, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display. For forehead scan mode, the MCU captures the highest temperature during scanning sampling process and calculation, finally the measured temperature will appear on LCD display.
5. Indications for Use
The Infrared Body Thermometer, Model: HTD8823US, is an electronic clinical thermometer using an infrared sensor to detect body temperature from the forehead in people of all ages for home setting use.
6. Summary of technological characteristics of device compared to the predicate devices (K163516 and K011291)
| SEComparisons | Subject device | Primary predicate device | Secondary predicatedevice | Discussionof difference |
|---|---|---|---|---|
| K200159(Infrared Body | (K163516, InfraredThermometer, Model: Braun | (K011291, |
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| Thermometer,model: HTD8823US) | No Touch + ForeheadNTF3000 Thermometer)(compared with Foreheadmode of HTD8823US) | TemporalScannerThermometer,SensorTouch)(compared with Foreheadscan mode ofHTD8823US) | ||
|---|---|---|---|---|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product Code | FLL | FLL | FLL | Same |
| FDA Class | II | II | II | Same |
| Intended Use | The Infrared BodyThermometer, Model:HTD8823US, is anelectronic clinicalthermometer using aninfrared sensor to detectbody temperature from theforehead in people of allages for home setting use. | The Braun No Touch +Forehead NTF3000Thermometer is a non-sterile,reusable clinical thermometerintended for the intermittentdetermination of human bodytemperature in a touch and notouch mode on the center ofthe forehead as themeasurement site on peopleof all ages. | The TemporalScannerThermometer is aninfrared thermometerintended for theintermittentmeasurement of humanbody temperature ofpeople of all ages | Similar(Discussion isindicated inD1) |
| Principle ofoperation | Forehead mode: Measuretemperature by readinginfrared radiation emittingfrom the forehead whenthe thermometer is placedwithin few centimeters offorehead. | Measure temperature byreading infrared radiationemitting from the foreheadwhen the thermometer isplaced within few centimetersof forehead. | NA | Same |
| Forehead scan mode:Measure temperature byreading infrared radiationemitting from the foreheadwhen the thermometer isplaced on the forehead. | NA | Measure temperature byreading infrared radiationemitting from theforehead when thethermometer is placedon the forehead. | Same | |
| targetpopulation | people of all ages | people of all ages | people of all ages | Same |
| Measurementsite | forehead | forehead | forehead | Same |
| Material ofPatientcontactcomponents | ABS (device housing/ handleand power button);PMMA(LCD screen) | ABS (device housing/ handle andpower button); TPR (temperaturebutton and nose / forehead touchbumper). | ABS | Similar(Discussion isindicated inD2) |
| Biocompabilitytesting | Meets ISO 10993- 5ISO 10993-10 | Meets ISO 10993 andFDA Bluebook memoG95-1 | Not public | Similar(Discussion isindicated inD3) |
| Environment | home | home | home | Same |
| Design | Handheld | Handheld | Handheld | Same |
| Measurementmethod | Infrared radiationdetection | Infrared radiation detection | Infrared radiationdetection | Same |
| Display Type | LCD | LCD | LCD | Same |
| Measurement | Forehead mode | Forehead mode | NA | Same |
| Mode | Forehead scan mode | NA | Forehead scan mode | Same |
| Key | One button(ON/Scan | Two button(Power button, | One button(SCAN | Similar(Discussion isindicated inD4) |
| button) | Temperature button) | Button) | indicated inD4) | |
| Scaleselection | °C/°F | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | °C/°F | Same |
| Hightemperaturewarning | Yes | Yes | Yes | Same |
| Low batteryindicator | Yes | Yes | Yes | Same |
| Case Material | ABS | ABS | ABS | Same |
| Sensor Type | Thermopile | Thermopile | Thermopile | Same |
| PerformanceTesting | Meets ASTM E1965-98and ISO 80601-2-56 | Meets ASTM E1965-98 andISO 80601-2-56 | Meets ASTM E1965-98 | Similar(Discussion isindicated in D5) |
| ElectricalSafety | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | Same |
| EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| MeasuringRange forForeheadmode | 34.0°C ~ 43.0°C(93.2°F ~109.4°F) | 34.4°C ~42.2°C(93.9°F to 108.0°F) | NA | Similar(Discussion isindicated in D6) |
| MeasuringRange forForeheadscan mode | 34.0°C ~ 43.0°C(93.2°F ~109.4°F) | NA | Forehead scan:15.5°C to 42°C(60°F to 107.6°F) | Similar(Discussion isindicated inD7) |
| Displayresolution | 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) within35°C ~ 42°C(95°F~107.6°F);±0.3°C (0.5°F) for otherrange | ±0.2°C (0.4°F) within 35°C~42°C (95°F ~107.6°F);±0.3°C (0.5°F) for otherrange | ±0.2°C (0.4°F) within35~42°C (95°F ~107.6°F);±0.3°C (0.5°F) for otherrange | Same |
| Measure time | ≤2S for Forehead mode;3~10s for Forehead scanmode; | ≤2S | Seconds | Similar(Discussion isindicated in D8) |
| ColorIndication | Green: ≥ 35.8°C -37.4 °C (96.4°F -99.3°F)Yellow: ≥ 37.5°C- 38.5°C(99.5°F -101.3°F)Orange: ≥ 38.6°C - 43.0°C(≥101.5°F -109.4°F) | Green: > 35.7 °C -37.4 °C(> 96.3°F - 99.3 °F)Yellow: > 37.4 °C - 38.5 °C(> 99.4°F - 101.3 °F)Red: > 38.5 °C - 42.2 °C(> 101.3°F - 108.0 °F) | NA | Similar(Discussion isindicated in D9) |
| MeasuringDistance forforeheadmode | 1 CM -5CM | 1 CM -5CM | NA | Same |
| MeasuringDistance forforehead scanmode | 0 cm | NA | 0 cm | Same |
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| Power source | 3 V d.c. (2X AAA batteries) | Two (2) AA batteries | 9 volt Alkaline | Similar(Discussion isindicated inD10) |
|---|---|---|---|---|
| Operating condition | Temperature: 5°C ~40°C(41°F ~104°F)Humidity: ≤ 95%(nocondensing) | Temperature: 15°C ~40°C(59°F ~104°F)Humidity: Not public | Temperature:15.5°C~40°C (60°F ~104°F)Humidity: ≤ 95%(nocondensing) | Different(Discussion isindicated inD11) |
The discussion of differences exist between the subject and predicate devices is listed in followina:
- D1: There is only difference in description, all three devices are infrared electronic clinical thermometer used to measure body temperature of all ages from forehead.
- D2: The proposed device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10. The difference will not affect the safety and effectiveness.
- D3: The proposed device has been validated for the lasted version of ISO 10993-5: 2009 and ISO 10993-10:2010. the difference will not affect the safety and effectiveness.
- D4: The different button number will not affect the safety and effectiveness.
- D5: The proposed device conducted performance testing in accordance with ASTM E1965-98. ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D6: The proposed device conducted performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D7: The proposed device conducted performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D8: The Measure time of proposed device was validated through performance testing in accordance with ASTM E1965-98, ISO 80601-2-56 to demonstrate the difference does not affect the safety and effectiveness.
- D9: The Color Indication of proposed device in upper temperature range ≥ 38.6℃ 43.0℃ is orange and the predicate is red in upper temperature range > 38.6℃ - 42.2℃, it's only different in visual effect of color, this difference does not affect the safety and effectiveness.
- D10: The proposed device was electromagnetic compatility and electrical safety in accordance with IEC 60601-1-2 and ANSI AAMI ES60601-1. The difference does not affect the safety and effectiveness.
- D11: The operating condition of subject device has passed the safety test, and the subject device complies the standard IEC 60601-1-11, so the difference between the operating conditions of subject device and predicate device will not affect the safety and effectiveness.
7. Discussion of Non-Clinical Tests Performed for Safety and effectiveness are as follows:
The recognized consensus standards for safety of medical 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 and IEC 62304 are complied, and see below table for details.
| Standards | Standards Name |
|---|---|
| ANSI AAMIES60601-1:2005/(R)2012 andA1:2012 | Medical Electrical Equipment - Part 1: General Requirements ForBasic Safety And Essential Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: General Requirements ForBasic Safety And Essential Performance -- Collateral Standard:Electromagnetic Disturbances -- Requirements And Tests |
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| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General Requirements ForBasic Safety And Essential Performance - Collateral Standard:Electromagnetic Disturbances - Requirements And Tests |
|---|---|
| ISO 80601-2-56: 2017 | Medical Electrical Equipment - Part 2-56: Particular RequirementsFor Basic Safety And Essential Performance Of ClinicalThermometers For Body Temperature Measurement. |
| ASTM E1965-98:2016 | Standard Specification For Infrared Thermometers For IntermittentDetermination Of Patient Temperature |
| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
Software verification and validation was performed for the subject device in accordance with Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - Guidance for Industry and FDA Staff, May 2005.
8. Discussion of Clinical Accuracy Testing Performed:
The clinical accuracy test report and data analysis followed the requirements of the ASTM E 1965-98 (2016).
The clinical accuracy testing evaluated 140 of subjects. Each model was evaluated in 0 up to 3 months, 3 months up to one year, older than 1 year and younger than 5 years, and older than 5 years age groups. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016).
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Infrared Body Thermometer, model HTD8823US is substantially equivalent to the predicate devices.
§ 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.