(170 days)
Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.
The provided document is an FDA 510(k) Premarket Notification for an Infrared Forehead Thermometer, model: HS-9802D. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving de novo safety and effectiveness through extensive clinical trials for new technologies.
Therefore, the information requested in your prompt related to AI/ML device performance, expert adjudication, MRMC studies, and detailed ground truth establishment for training sets (which would be typical for an AI/ML device) is not present in this document because this is a traditional medical device submission for a thermometer, not an AI/ML diagnostic tool.
The "acceptance criteria" for this device are its ability to accurately measure temperature within specified tolerances, which is demonstrated through non-clinical performance testing and clinical accuracy testing as per established standards for thermometers.
Here's a breakdown of the information that is available in the document, framed as close as possible to your prompt, along with explanations for the missing information:
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
The document refers to the acceptance criteria as compliance with recognized consensus standards. The performance of the device is assessed against these standards.
| Criterion Type | Standard/Requirement | Acceptance Criteria (from standard) | Reported Device Performance/Compliance |
|---|---|---|---|
| Clinical Accuracy (Performance) | ASTM E1965-98 (2016), ISO 80601-2-56:2017+A1:2018 | ASTM E1965-98 (2016) criteria (typically, these standards specify maximum permissible errors for temperature measurements):- For the operating range of the device, the clinical accuracy should be within specified limits (e.g., ±0.2 °C or ±0.3 °C for certain temperature ranges, or specific deviations from reference oral temperature). Specific values are in the standard, not explicitly detailed here for criteria, but the "Measuring accuracy" in the comparison table gives inferred criteria for this device's claimed accuracy. | Measuring Accuracy (as per 6. Summary of technological characteristics):±0.3°C (0.5°F): 34.0 to 42.0 °C (93.2 to 107.6 °F).Study Conclusion: "The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016)." |
| Material Biocompatibility | ISO 10993-5, ISO 10993-10 | ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and skin sensitization) compliance. | "The proposed device has been validated for cytotoxicity per ISO 10993- 5 and Irritation as well as Sensitization per ISO 10993-10." |
| Electrical Safety | ANSI AAMI ES60601-1 | Compliance with the general requirements for basic safety and essential performance of medical electrical equipment. | "Meets ANSI AAMI ES60601-1" |
| Electromagnetic Compatibility | IEC 60601-1-2 | Compliance with requirements for electromagnetic disturbances. | "Meets IEC 60601-1-2" |
| Software (if applicable) | IEC 62304, FDA Guidance for Software (2005) | Compliance with medical device software life cycle processes and FDA guidance for software in medical devices. | "IEC 62304 are complied.""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." |
| General Requirements | IEC 60601-1-11 | Compliance with general requirements for basic safety and essential performance, specifically for home healthcare environment. | "The subject device complies the standard IEC 60601-1-11." |
| Packaging/Transport | ISTA 2A | Not explicitly stated, but compliance implies the device can withstand typical transport conditions. | "The operating condition of subject device has passed the tests... ISTA 2A." |
Study Proving Device Meets Acceptance Criteria
2. Sample size used for the test set and the data provenance:
- Sample Size: "The clinical accuracy testing evaluated 105 of subjects."
- Data Provenance: Not explicitly stated regarding country of origin. The test is described as "clinical accuracy testing" and is presumably prospective as it involves "subjects" undergoing measurement. It's safe to assume this was a prospective study conducted for the purpose of this submission.
- Retrospective/Prospective: Implied prospective as it "evaluated 105 subjects."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable in the traditional sense for a thermometer. Ground truth for temperature measurement is established by a reference thermometer (or method) that is itself calibrated and adheres to metrological standards. The document states:
- "Summary of reference equipment: Digital Thermometer, Model KFT-03, Manufacturer Kangfu Medical Equipment Factory, K Number K182652."
- This Digital Thermometer serves as the ground truth. It is a legally marketed device likely calibrated to national/international temperature standards.
- There were no "experts" establishing qualitative ground truth through image review or similar tasks as would be seen for an AI/ML diagnostic device.
4. Adjudication method for the test set:
- None. Adjudication is not relevant for direct temperature measurement, where the ground truth is a quantitative reading from a reference device.
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. This is not an AI/ML diagnostic device and does not involve human readers interpreting AI output. It is a standalone measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The device is an "Infrared Forehead Thermometer." Its performance is inherently "standalone" in that it takes a measurement directly. There's no separate "algorithm" being evaluated beyond the device's internal measurement and calculation process as a whole. The clinical accuracy study assesses the device's output against a reference standard without human interpretative input.
7. The type of ground truth used:
- Reference Device Measurement: The "ground truth" for body temperature was established by simultaneously measuring the subjects' temperatures using a "Digital Thermometer, Model KFT-03," which is a legally marketed and presumably well-calibrated device. This is analogous to using a gold-standard measurement tool.
8. The sample size for the training set:
- Not Applicable. This is a traditional medical device (thermometer), not an AI/ML model that requires a "training set." The device's internal algorithms are based on physics and calibration, not machine learning from a large dataset.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set (as in AI/ML), there is no ground truth established for one. The device is designed, manufactured, and calibrated according to established engineering principles for infrared thermometry. Calibration occurs at the factory using known temperature references.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
September 19, 2022
Jiaxing Shangjia Intelligence Technology Co., Ltd. % You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K213038
Trade/Device Name: Infrared Forehead Thermometer, model: HS-9802D Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL
Dear You Yijie:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated March 10, 2022. Specifically, FDA is updating this SE Letter typo in the trade name as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Payal Patel, OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices, 240-402-6029, payal.patel(@fda.hhs.gov.
Sincerely,
Danil WalloscheR
David Wolloscheck, Ph.D. For Payal Patel Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 10, 2022
Jiaxing Shangjia Intelligence Technology Co., Ltd. You Yijie Manager Oimmig Medical Consulting Service Co., Ltd. RM.1711. Building K. NO.101 Science Ave International Creative Valley Guangzhou, Guangdong 510663 China
Re: K213038
Trade/Device Name: Infrared Forehead Thermometer, model: HS-98020 Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: January 31, 2022 Received: January 31, 2022
Dear You Yijie:
We have reviewed vour 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
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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 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 medical devices and radiation-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,
FDA
Gang Peng for Payal Patel 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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Section 4: Indications for Use Statement (Form FDA 3881)
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Infrared Forehead Thermometer, model: HS-9802D
Indications for Use (Describe)
Infrared Forehead Thermometer, model: HS-9802D is intended for the intermittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
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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Section 5: 510(k) Summary
1. Submitter's Information
Establishment Registration Information
Name: Jiaxing Shangjia Intelligence Technology Co., Ltd. Address: Room 102 and Room 202, Building No.9, Jiaxing Intelligence & Innovation Park, No.36, South Changsheng Road, Jiaxing, Zhejiang, China
Contact Person of applicant
Name: Lou Yongwei Address: Room 102 and Room 202, Building No.9, Jiaxing Intelligence & Innovation Park, No.36, South Changsheng Road, Jiaxing, Zhejiang, China TEL: +86 0573 89978800 Email: 100831552@qq.com
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: Sep. 8, 2021
2. Device Information
| Device Common Name: | Clinical electronic thermometer |
|---|---|
| Trade Name: | Infrared ForeheadThermometer |
| Model: | HS-9802D |
| Regulation name: | Clinical electronic thermometer |
| Review Panel: | General Hospital |
| Product Code: | FLL |
| Regulation Class: | II |
| Regulation Number: | 880.2910 |
3. Predicate Device Information
| 510(k) submitter/holder: | Microlife Intellectual Property GmbH, Switzerland. |
|---|---|
| 510(K) Number: | K191829 |
| Trade Name: | Microlife Non-Contact Infrared Forehead Thermometer. |
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Model: FR1DG1 (NC200) Clinical electronic thermometer Classification name: Review panel: General Hospital Product code: FLL Regulation Class: Regulation Number: 880.2910
4. Device description
Infrared Forehead Thermometer, model: HS-9802D is a hand-held, battery powered, infrared thermometer that measures human body temperature from forehead. The reference body site is oral. The device measures temperature from center of the forehead.
Principle of operation:
Infrared Forehead Thermometer, model: HS-9802D is an electronic thermometer uses IR sensor (thermopile) to detect infrared radiation emitting from forehead, after then, the IR sensor outputs electrical signal which is fed to circuit for amplification and then being inputted to MCU, the MCU captures the temperature measured from center of forehead. The measured temperature will finally appear on LCD display.
5. Indications for Use
Infrared Forehead Thermometer, model: HS-9802D is intended for the internittent measurement and monitoring of human body temperature. The device is indicated for use by people of all ages in the home.
Summary of technological characteristics of device compared to 6. the predicate device
| SEComparisons | Subject device(Infrared Forehead Thermometer,model: HS-9802D) | Primary predicate device(K191829, Microlife Non-Contact InfraredForehead Thermometer, Model: FR1DG1(NC200)) | Discussion ofdifference |
|---|---|---|---|
| Classification | 21CFR 880.2910 | 21CFR 880.2910 | Same |
| Product Code | FLL | FLL | Same |
| FDA Class | II | II | Same |
| Intended Use | Infrared Forehead Thermometer, model:HS9802D is intended for the intermittentmeasurement and monitoring of human bodytemperature. The device is indicated for useby people of all ages in the home. | The Microlife Non-Contact InfraredForehead Thermometer, Model FR1DG1(NC200) is intended for the intermittentmeasurement and monitoring of humanbody temperature. The device isindicated for use by people of all ages inthe home. | Same |
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| Principle ofoperation | Measure temperature by reading infrared radiation emitting from the forehead when | Measure temperature by reading infrared radiation emitting from the forehead when | Same |
|---|---|---|---|
| the |
| thermometer is placed within fewcentimeters of forehead. | the thermometer is placed within fewcentimeters of forehead. | ||
|---|---|---|---|
| targetpopulation | people of all ages | people of all ages | Same |
| Measurementsite | forehead | forehead | Same |
| Material ofPatient contactcomponents | Probe: ABSCap: PSLiquid crystal display (LCD): GlassON/Scan button: ABSBattery Cover (shell has same material):ABSMemory button: Silica gel | Housing and battery cover material:ABS707Patient-Contact Button material: PMMA | Different(Discussion isindicated in D1) |
| Biocompabilitytesting | Meets ISO 10993- 5ISO 10993-10 | Meets ISO 10993- 5ISO 10993-10 | Same |
| Environment | home | home | Same |
| Design | Handheld | Handheld | Same |
| Measurementmethod | Infrared radiation detection | Infrared radiation detection | Same |
| Display Type | LCD | LCD | Same |
| MeasurementMode | Forehead mode | Forehead mode | Same |
| Reference site | Oral | Oral | Same |
| Key | Two buttons (ON/Scan button, Memorybutton) | Two buttons (M-button, START I/Obutton) | Same |
| Scale selection | °C/°F | °C/°F | Same |
| Display unit | °C/°F | °C/°F | Same |
| Hightemperaturewarning | Yes | Yes | Same |
| Low batteryindicator | Yes | Yes | Same |
| Sensor Type | Thermopile | Thermopile | Same |
| PerformanceTesting | Meets ASTM E1965-98 and ISO 80601-2-56 | Meets ASTM E1965-98 and ISO 80601-2-56 | Same |
| Electrical Safety | ANSI AAMI ES60601-1 | ANSI AAMI ES60601-1 | Same |
| EMC Meets | IEC 60601-1-2 | IEC 60601-1-2 | Same |
| MeasuringRange | 34.0 to 42.0 °C (93.2 to 107.6 °F). | 32.0-43.0 °C (89.6-109.4 °F) | Different(Discussion isindicated in D2) |
| Displayresolution | 0.1°F (0.1ć) | 0.1°F (0.1ć) | Same |
| Measuringaccuracy | ±0.3°C (0.5°F): 34.0 to 42.0 °C (93.2 to107.6 °F). | ±0.2 °C: 35.0 ~ 42.0 °C±0.3 °C: 34.0 ~ 34.9 °C, 42.1 ~ 43.0 °C | Different(Discussion isindicated in D3) |
| MeasuringDistance | < 2.5cm | < 5cm | Different(Discussion isindicated in D4) |
| Measurementdata memories | 6 sets memories | 30 sets memories | Different(Discussion isindicated in D5) |
| Backlight | Yes | Yes | Same |
| Auto-off time | 15 seconds | Approx. 1min second after lastmeasurement has been taken | Different(Discussion isindicated in D6) |
| Beeper indication | Yes | Yes | Same |
| OperationCondition | 5-40ć;20%-95%R.H., noncondensing | Ambient Temperature: 15°C | Different(Discussion isindicated in D7) |
| Storage andtransportationcondition | -20 - 50ć;10%-95%R.H., noncondensing, 70-106kPa | -25 ~ 55 °C (-13°F ~131°F) 15-95% relative maximum humidity | Different(Discussion isindicated in D8) |
| Physicaldimension | 134x76.5x38 mm | 156.7 x 43 x 47 mm | Different(Discussionisindicated in D9) |
| High temperaturealarm | Yes | Yes | Same |
| Power source | 3 V d.c. (2X AAA batteries) | 3.0V DC with 2 AAA batteries | Same |
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The discussion of differences exist between the subject and predicate device is listed in following:
D1: 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.
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- D2&D3: 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.
- D4: The Measuring Distance range of proposed device is in the range of the predicate device. The difference will not affect the safety and effectiveness.
- D5: The different memory number will not affect the safety and effectiveness.
- D6: The different Auto-off time will not affect the safety and effectiveness.
- D7: The operating condition of subject device has passed the safety test and comply with the requirement of ASTM E1965-98, 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.
- D8: The operating condition of subject device has passed the tests of ASTM E1965-98 and ISTA 2A, so the difference between the operating conditions of subject device and predicate device will not affect the safety and effectiveness.
- D9: The different dimension will not affect the safety and effectiveness.
Discussion of Non-Clinical Tests Performed for Safety and 7.
effectiveness 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 and IEC 62304 are complied, and see below table for details:
| Standards | Standards Name |
|---|---|
| ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012 | Medical Electrical Equipment - Part 1: General RequirementsFor Basic Safety And Essential Performance |
| IEC 60601-1-2: 2014 | Medical Electrical Equipment -- Part 1-2: GeneralRequirementsFor Basic Safety And Essential Performance -- CollateralStandard: Electromagnetic Disturbances -- Requirements AndTests |
| IEC 60601-1-11: 2015 | Medical Electrical Equipment - Part 1-2: General RequirementsFor Basic Safety And Essential Performance - CollateralStandard: Electromagnetic Disturbances - Requirements AndTests |
| ISO 80601-2-56:2017+A1:2018 | Medical Electrical Equipment - Part 2-56: ParticularRequirements For Basic Safety And Essential Performance OfClinical Thermometers For Body Temperature Measurement. |
| ASTM E1965-98:2016 | Standard Specification For Infrared Thermometers ForIntermittent Determination Of Patient Temperature |
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| IEC 62304:2006+A1:2015 | Medical device software - Software life cycle processes |
|---|---|
| ISO 10993-5:2009 | Biological evaluation of medical devices - Part 5: Tests for invitro cytotoxicity |
| ISO 10993-10:2010 | Biological evaluation of medical devices - Part 10: Tests forirritation and skin sensitization |
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 196598 (2016).
The clinical accuracy testing evaluated 105 of subjects, division of all subjects into (1) infantsnewborn up to one year, (2) children- greater than one to five years; and (3) adults-greater than five years ol. The test data showed the clinical accuracy of the subject device complied with the requirements of ASTM E1965-98 (2016).
Summary of reference equipment:
| Name | Digital Thermometer | Microlife Non-Contact InfraredForehead Thermometer |
|---|---|---|
| Model | KFT-03 | FR1DG1 (NC200) |
| Manufacturer | Kangfu Medical EquipmentFactory | Microlife Intellectual PropertyGmbH, Switzerland |
| Measuring Method | Contact | Non-Contact InfraredForehead |
| K Number | K182652 | K191829 |
9. Conclusions
Based on performance testing, comparison and analysis, the subject device Infrared Forehead Thermometer, model HS-9802D is substantially equivalent to the predicate device.
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§ 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.