(267 days)
The digital thermometer intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
The digital thermometer is an electronic thermometer using a thermistor to measure human body temperature for people of all ages. The digital thermometer are designed to be non-sterile, reusable clinical thermometers intended for the determination of human body temperature by contact the sensing probe with patient's axillary and oral. The measurement duration is less than 1 minute. The device has a storage function in which the last measured value is automatically stored after measurement is successfully completed. This device is designed for people of all ages to use at home. There is BF applied part. No special protection against the use in the environment of ignitable gases.
The provided text is a 510(k) summary for a digital thermometer (Models T103, T104). It describes the device, its intended use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.
Here's an analysis to extract the requested information, specifically focusing on 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 compliance with several international and industry standards, including specific performance requirements related to temperature measurement accuracy. The acceptance criteria are implicit in these standards, and the reported performance is that the device "Pass[es]" the tests and "complies with the applicable requirements."
| Acceptance Criteria (Standard Reference & Description) | Reported Device Performance |
|---|---|
| ISO 80601-2-56: 2017 & ASTM E1112-00 (2008) - Performance Testing (Laboratory & Clinical Accuracy) - Displayed temperature range - Laboratory accuracy - Ambient conditions for operation and storage - Identification, marking, and documents - Clinical accuracy and repeatability for axillary and oral measurements | Pass "The T103 and T104 digital thermometer complies applicable requirements of ISO 80601-2-56 and ASTM E1112 including displayed temperature range, laboratory accuracy, ambient conditions for operation and storage, identification, marking and documents." "The subject complies with the applicable requirements set forth in the referenced performance standards." "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." |
| IEC 60601-1: 2005/A1: 2012 - Electrical Safety Testing - General requirements, protection against electrical hazards, mechanical hazards, excessive temperatures, hazardous situations, fault conditions, and constructions. | Pass "The subject complies with the applicable requirements set forth in the referenced electric safety standard." "The digital thermometer complies with to applicable IEC 60601-1 requirements..." |
| IEC 60601-1-2: 2014 - EMC Testing - Radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, power frequency magnetic field immunity test. | Pass "The subject complies with the applicable requirements set forth in the referenced EMC standard." "The digital thermometer complicable IEC 60601-1-2 requirements..." |
| IEC 60601-1-11: 2015 - Electrical Safety for Medical Devices in Home Healthcare Environment | Pass "The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-11:2015." "For lay person, the IEC 60601-1-11 was performed and the thermometer is accordance with applicable requirements." |
| IEC 60601-1-6 Edition 3.1 2013-10 - Usability | Pass "The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-6:2010+A1:2013." "Usability testing was completed in accordance with IEC 60601-1-6 and the digital thermometer is complied with the applicable requirements of standard." |
| ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2010 - Biocompatibility Testing - Cytotoxicity, Sensitization, and Irritation for patient-contacting materials (cap and outer shell). | Pass "The subject complies with the applicable requirements set forth in the referenced biological evaluation standards." "Biocompatibility of patient-contacting materials (cap and outer shell) was performed according to ISO 10993-1/5/10..." |
| Software Verification and Validation (according to "Guidance for the content for premarket submissions for software contained in medical devices") | "Software verification and validation report in accordance with 'Guidance for the content for premarket submissions for software contained in medical devices'." (Implicitly "Pass" as part of the overall acceptance for substantial equivalence.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: For clinical accuracy and repeatability testing, the study involved 150 subjects, divided into three age groups of 50 subjects each: infants (0-1 year), children (1-5 years), and adults (>5 years).
- Data Provenance: The document does not explicitly state the country of origin for the clinical data or whether it was retrospective or prospective. However, given the manufacturer is based in China and the nature of a 510(k) submission, it is likely that the testing (including clinical) was conducted in a controlled, prospective manner to meet regulatory requirements, potentially in China or a region where the standards are applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not specify the number or qualifications of experts used to establish the ground truth for the clinical accuracy and repeatability testing. It simply states that "The methods and criteria of clinical accuracy and repeatability testing had been clinically assessed to meet the requirements of clinical accuracy per the referenced standards." For a digital thermometer, the ground truth for temperature measurement is typically established by highly accurate reference thermometers or alternative validated methods under controlled clinical conditions, rather than expert consensus in the way image-based diagnoses might be.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method for the test set. Given the nature of a digital thermometer measuring a physiological parameter (body temperature), adjudication by multiple readers is not typically applicable in the same way it would be for interpreting medical images. The "ground truth" for temperature measurement would be derived from a highly accurate reference method.
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, an MRMC comparative effectiveness study was not done. This study is for a digital thermometer, which is a direct measurement device, not an AI-powered diagnostic tool that assists human readers. Therefore, the concept of human readers improving with or without AI assistance is not relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for this digital thermometer is its standalone performance in measuring body temperature. This means its accuracy and repeatability are assessed directly against established standards (ISO 80601-2-56 and ASTM E1112) without human interpretation affecting the device's reading. The user simply reads the displayed temperature.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the clinical accuracy and repeatability testing for the digital thermometer would be highly accurate reference temperature measurements obtained through methods specified by the referenced standards (ISO 80601-2-56 and ASTM E1112). These standards outline precise methods for temperature measurement validation, often using known stable temperature baths or highly calibrated reference thermometers. It's not based on expert consensus, pathology, or outcomes data in the way a diagnostic imaging AI would be.
8. The sample size for the training set
This document does not specify a training set sample size. Digital thermometers are hardware devices that perform a direct physical measurement using a thermistor and convert it to a digital display. They are not typically "trained" in the same way a machine learning algorithm would be. Their performance is inherent in their design, calibration, and manufacturing consistently across units.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of an AI/machine learning algorithm for this device. The device's performance is driven by its engineering and adherence to established physical principles and manufacturing tolerances, validated against standards using the test set described.
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March 31, 2021
Bioland Technology Ltd. Yiging Feng R.A No. A6B7 (Block G) ShangRong Industrial Zone No. 5 Baolong R Shenzhen, Guangdong 518116 China
Re: K201879
Trade/Device Name: Digital Thermometer Model T103, T104 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: February 26, 2021 Received: March 1, 2021
Dear Yiqing Feng:
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 (OS) 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,
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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K201879
Device Name Digital Thermometer, T103 and T104
Indications for Use (Describe)
The digital thermometer intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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K201879 510(k) Summary
A. Date of Summary Preparation: March 16, 2021
B. Applicant Information
Name: Bioland Technology Ltd.
Address: No. A6B7 (Block G) Shangrong Industrial Zone, No.5 Baolong Road, Baolong Community Longgang District, 518116 Shenzhen, Guangdong PEOPLE'S REPUBLIC OF CHINA
Tel: +86-755-36900999
Fax: +86-755-33296299
Contact person: Yiqing Feng
E-mail: requlator-a@bioland.com.cn
C. Subject Device Information
Trade name: Digital Thermometer Model: T103, T104 Classification name: Thermometer, Electronic, Clinical Product Code: FLL Regulation number: 21 CFR 880.2910 Device class: II
D. Predicate Device Information
Device name: Digital Thermometer 510(k) number: K190990 Manufacturer: Xiamen Ants Bro Technology Co., Ltd.
E. Intended use / Indication for Use
The digital thermometers are intended for the measurement and monitoring of human body temperature by users for home use. It can be used for axillary measurement and oral measurement.
F. Device Description
The digital thermometer is an electronic thermometer using a thermistor to measure human body temperature for people of all ages.
The digital thermometer are designed to be non-sterile, reusable clinical thermometers intended for the determination of human body temperature by contact the sensing probe with patient's axillary and oral. The measurement duration is less than 1 minute. The device has a storage function in which the last measured value is automatically stored after measurement is successfully completed.
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This device is designed for people of all ages to use at home. There is BF applied part. No special protection against the use in the environment of ignitable gases.
| Item | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | Bioland Technology Ltd | JOYTECH HEALTHCARE CO., LTD | N/A |
| Model | T103, T104 | TM-3002 | N/A |
| Classification | II | II | SE |
| Product code | FLL | FLL | SE |
| Classification name | Thermometer, electronic, clinical | Thermometer, electronic, clinical | SE |
| Regulation No. | 880.2910 | 880.2910 | SE |
| 510(K) number | K201879 | K190990 | N/A |
| Thermometer type | Digital thermometer | Digital thermometer | SE |
| Intended Use/Indication for use | The digital thermometer intended for themeasurement and monitoring of humanbody temperature by users for home use.It can be used for axillary measurementand oral measurement | Digital thermometer intended for themeasurement and monitoring of humanbody temperature by users for homeuse. It can be used for axillarymeasurement and oral measurement | SE |
| Sensor | Thermistor | Thermistor | SE |
| Signal Processingand display | Using the resistance change of thermalresistor to detect body temperature anddisplayed through the LCD. | Using the resistance change ofthermal resistor to detect bodytemperature and displayed throughthe LCD. | SE |
| Power requirement | 1.5V button battery | 1.5V button battery | SE |
| Measurement Site | Axillary and oral | Axillary and oral | SE |
| Measurement range | $32.0 °C | $32 °C~43.0 °C$ | SimilarNote 1 |
| Display resolution | $0.1 °C/0.1 °F$ | $0.1 °C$ | SimilarNote 1 |
| Measuring accuracy | $ ±0.1 °C (37.0 °C ~39.0 °C) ±0.2 °C (35.0 °C ~ 36.9 °C or 39.1 °C ~ 42.0 °C) ±0.3 °C (under 35.0 °C or over 42.0 °C) ±0.2 °F (98.0 °F ~ 102.0 °F) ±0.3 °F (95.0 °F ~ 97.9 °F or 102.1 °F ~ 107.6 °F) ±0.5 °F (under 95.0 °F or over 107.6 °F) $ | $ ±0.1°C, 37.0°C ~ 39.0°C ±0.2°C, 35.0°C ~36.9°C, 39.1 °C ~42.0 °C ±0.3 °C, 32.0°C ~34.9°C, 42.1 °C ~43.0 °C $ | SimilarNote 1 |
| Measurementspeed | Within 1 min | 45s | SimilarNote 2 |
| Power ON/OFF | Switch the thermometer ON and OFF bypress the power button, or automaticshutdown within 10 minutes | Switch the thermometer ON and OFFby shaking it or switch thethermometer ON and OFF by press | SimilarNote 3 |
| Item | Subject Device | Predicate Device | Remark |
| the power button. | |||
| Operating | 5°C | 5°C | |
| EnvironmentCondition | 15~95%RH (non-condensing) ,70-106kPa | 15%~95%RH700hPa ~ 1060hPa | SE |
| There s buzzing noise occur when thedevice turning on and when the | There s buzzing noise occur when thedevice turning on and when the | ||
| Voice function | device turning on and when themeasurement is completed. | device turning on and when themeasurement is completed. | SE |
| measurement is completed. | measurement is completed. | ||
| Patient contactingMaterials | Enclosure and key: ABS PlasticProbe: Stainless steel | Enclosure and key: ABS PlasticProbe: Stainless steel | SE |
| Probe cover use? | NO | NO | SE |
| Service life | 3 years | 3 years | SE |
| Ingress protectionrating | IP22 | IP22 | SE |
| Reprocessing | Cleaning | Cleaning | SE |
| IEC 60601-1 | IEC 60601-1 | ||
| Biocompatibility | ISO 80601-2-56 | ISO 80601-2-56 | |
| IEC 60601-1-2 | IEC 60601-1-2 | ||
| IEC 60601-1-11 | IEC 60601-1-11 | SE | |
| ASTM E1112 | ASTM E1112 | ||
| ISO 10993-1 | ISO 10993-1 | ||
| ISO 10993-5 | ISO 10993-5 | ||
| ISO 10993-10 | ISO 10993-10 | SE | |
G. Substantial Equivalence Table
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Note 1: Compared to the predicate device, the "Measurement range", "Display resolution" and "Measuring accuracy" of the subject device only added the requirement of the Fahrenheit scale. The accuracy requirement of the Celsius scale is the subject device measurement accuracy is in compliance with ISO 80601-2-56 and ASTM E1112 requirements. The differences of display resolution and measuring accuracy will not raise any safety or effectiveness issue.
Note 2: After placing the thermometer on the measurement site, the measured result can only be displayed when the temperature is stable. Generally, the measurement time is not fixed at a certain value, so the measurement speed of the subject device is within 1 minute. The difference of measurement speed will not raise any safety or effectiveness issue.
Note 3: Compared to the predicate device, the subject device can't be turned ON and OFF by shaking it, but it can automatically shut down within 10 minutes. This difference is a functional difference before and after measurement, which has no influence on the accuracy of measurement. The difference in Power ON/OFF will not raise any safety or effectiveness issue.
Based on the comparison chart above, we believe that the T103 and T104 digital thermometer is
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substantially equivalent to its predicate device cited above and do not raise any new safety and/or effectiveness issues.
H. Predicate Device Comparison
The subject device and the predicate device have the same intender user, target population, Measurement Site, Components, Sensor and the similar technical parameter; they both use thermistor resistance detection method to detect human body temperature. The subject device and predicate device conform to the same standards. Thus, the subject device is substantially equivalent to the predicate devices.
| Testing name | Referenced standard | Summary result | Verdict | |
|---|---|---|---|---|
| Electric safety testing | IEC 60601-1: 2005/A1: 2012 Medical electrical equipment Part 1: General requirements for basic safety and essential performanceFDA Recognition number: 19-4 | The subject complies with the applicable requirements set forth in the referenced electric safety standard. | Pass | |
| EMC testing | IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and testsFDA Recognition number: 19-8 | The subject complies with the applicable requirements set forth in the referenced EMC | Pass | |
| Electric safety for medical device used in the home healthcare environment | IEC 60601-1-11:2015 Medical electrical equipment – General requirements for basic safety and essential performance - Part 1-11: Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.FDA Recognition number: 5-89 | The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-11:2015 | Pass | |
| Usability | IEC 60601-1-6 Edition 3.1 2013-10 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: UsabilityFDA Recognition number: 5-89 | The subject complies with the applicable requirements set forth in the referenced IEC 60601-1-6:2010+A1:2013 | Pass | |
| Performance testing | ISO 80601-2-56 Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential | The subject complies with the applicable requirements set forth in the referenced performance | Pass | |
| performance of clinical thermometers forbody temperature measurement.FDA Recognition number: 6-403ASTM E1112-00 (2008) StandardSpecification for Electronic Thermometerfor Intermittent Determination of PatientTemperature | standards. | |||
| Biocompatibilitytesting | ISO 10993-1:2018 Biological evaluation ofmedical devices -- Part 1: Evaluation andtesting within a risk management processFDA Recognition number: 2-258ISO 10993-5: 2009 Biological evaluation ofmedical devices -- Part 5: Tests for In VitrocytotoxicityFDA Recognition number: 2-245ISO 10993-10: 2010 Biological evaluationof medical devices -- Part 10: Tests forirritation and delayed-type hypersensitivityFDA Recognition number: 2-174 | The subject complies with theapplicable requirements set forthin the referenced biologicalevaluation standards. | Pass |
Non-clinical Test l.
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All necessary testing was conducted on the T103 and T104 digital thermometer to support a determination of substantial equivalence to the predicate devices.
The nonclinical, bench testing included:
- Performance testing according to ISO 80601-2-56 and ASTM E1112 applicable 1. requirements;
-
- Electromagnetic compatibility testing;
- Evaluation of relevant electrical safety, electromagnetic compatibility and electrostatic 3. discharge requirements per IEC 60601-1 and IEC 60601-1-2.
- Performance testing is performed in accordance with ISO 80601-2-56 and ASTM E1112.The T103 and T104 digital thermometer complies applicable requirements of ISO 80601-2-56 and ASTM E1112 including displayed temperature range, laboratory accuracy, ambient conditions for operation and storage, identification, marking and documents.
- Electrical safety testing is performed in accordance with IEC 60601-1. The digital thermometer complies with to applicable IEC 60601-1 requirements including general requirements, protection against electrical hazards, protection against mechanical hazards, protection against excessive temperatures, hazardous situations and fault conditions, and constructions.
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- Electromagnetic Compatibility testing is performed in accordance with IEC 60601-1-2. The digital thermometer complicable IEC 60601-1-2 requirements including radiated emission test, electrostatic discharge immunity test, radiated RF electromagnetic field immunity test, and power frequency magnetic field immunity test.
- For lay person, the IEC 60601-1-11 was performed and the thermometer is accordance with applicable requirements
In addition to the above bench testing, the T103/T104 digital thermometer also underwent the following testing:
- E T103 and T104 digital thermometer via axillary and oral to get temperature value within 1 min. Biocompatibility of patient-contacting materials (cap and outer shell) was performed according to ISO 10993-1/5/10, the patient contacting materials of the outer shell and stainless-steel cap have been tested in accordance with ISO 10993-1 for Cytotoxicity, Sensitization, and Irritation.
- Software verification and validation report in accordance with "Guidance for the content for premarket submissions for software contained in medical devices"
- Usability testing was completed in accordance with IEC 60601-1-6 and the digital thermometer is complied with the applicable requirements of standard.
Non-clinical performance reports were provided to document verification and validation activities which are intended to demonstrate substantial equivalence of the subject device with the noted changes, to the predicate device.
The collective results of the nonclinical testing demonstrate that the materials chosen, the manufacturing processes, and design of the T103 and T104 digital thermometer meet the established specifications necessary for consistent performance during its intended use. In addition, the testing also demonstrates that the T103 and T104 digital thermometer does not raise different questions of safety or effectiveness when compared to the predicate devices.
The results demonstrate that the devices perform as intended and are substantially equivalent to the performance of the predicate in accordance with applicable standards.
J. Clinical Test
| Name of clinicaltesting | Referenced standard | Summary of testing | Patient population(age groups, numberof subjects) | Verdict |
|---|---|---|---|---|
| Clinicalaccuracy andrepeatabilitytesting | ISO 80601-2-56: 2017 Medicalelectrical equipment-Part 2-56:Particular requirements for basicsafety and essential performance | The methods andcriteria of clinicalaccuracy andrepeatability testing | 50 subjects in eachage group, infants(0-1 year), children(1-5 years) and adults | Pass |
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| of clinical thermometers for bodytemperature measurementFDA Recognition number: 6-403 | had been clinicallyassessed to meetthe requirements ofclinical accuracy perthe referencedstandards. | (>5 years) (Total 150 subjects) |
|---|---|---|
| ----------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------- | --------------------------------- |
K. Conclusion
Non-clinical and clinical performance was conducted on the subject device and all tests met specified criteria. Base on the information provided in this submission, the subject device, T103 and T104 digital thermometers are substantially equivalent to the 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.