(61 days)
The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.
The ATS Patient Interface Unit is intended to display continuous temperature measurements (C°) from the ATS Thermal Imaging Probe.
The Securus Aurora Thermographic System (ATS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on the Patient Interface Unit.
Aurora Thermographic System (ATS) consists of two components:
- A. ATS Thermal Imaging Probe
- B. ATS Patient Interface Unit
The ATS Thermal Imaging Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. In addition, the ATS Thermal Imaging Probe incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).
The ATS Thermal Imaging Probe and ATS Patient Interface Unit is a medical device intended for continuous esophageal temperature monitoring and displaying these temperature measurements. The product is a modification of the previously cleared InfraRed Thermographic System (IRTS). The modifications include combining two connectors into one handle, modifying the distal tip to include BaSO4 filler, changing the housing and circuit boards of the patient interface unit, and modifying the software.
Here's an analysis of the acceptance criteria and study proving the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Device Modification / Test Aspect | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| ATS Thermal Imaging Probe Modifications | ||
| Accuracy (Thermocouple) | Accuracy ± 0.3° C across the rated output range. | All samples tested met the accuracy acceptance criteria of ± 0.3° C. |
| Response Time (Thermocouple) | Response time same as predicate, < 2.5 seconds average. | Test results met the acceptance criteria < 2.5 seconds average. |
| IR Temperature Accuracy | IR Temperature Accuracy equivalent to predicate across rated output range ± 2°C. | All samples tested met the acceptance criteria ± 2°C across rated output range. |
| Mechanical Connections Strength (Tensile Test) | All connections and joints must withstand 3.37 lbs. | All connections and joints exceed 3.37 lbs tensile strength. |
| Biocompatibility | Test results must provide assurance of biocompatibility when tested in accordance with ISO 10993-1:2009. | All test results provide assurance of biocompatibility in accordance with ISO 10993-1:2009. |
| ATS Patient Interface Unit Modifications – Housing & Circuit Boards | ||
| EMC Compatibility | Must comply with recognized consensus standard for Electromagnetic compatibility (IEC 60601-1-2 Edition 4.0: 2014-02). | Compliance confirmed. Testing performed at certified test facility. |
| Electrical Safety | Must comply with recognized consensus standard for electrical safety (IEC 60601-1:2005 + A1:2012(E)). | Compliance confirmed. Testing performed at certified test facility. |
| Overall Performance (Circuit Boards) | The ATS Patient interface unit must meet all performance criteria and must support all software functions. | All accuracy testing meets criteria (see sections above). Software validation testing meets all acceptance criteria (see below). |
| ATS Patient Interface Unit Modifications - Software | ||
| Software Performance | Software must perform 100% of functional requirements in accordance with the requirements specifications. | Software validation confirms compliance with all requirements specifications. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes for "all samples tested" or the number of units tested for each criterion. It mentions "All samples tested" for thermocouple accuracy, IR accuracy, and mechanical connections.
Data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. However, based on the context of a 510(k) submission, the testing would typically be prospective and conducted in a controlled lab environment as part of the device development and validation process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable and not provided. The testing described is performance testing against established engineering and medical device standards (e.g., ISO 80601-2-56), not a diagnostic study relying on expert interpretation of results to establish ground truth. The "ground truth" for these tests comes from objective measurements and calibrated reference standards.
4. Adjudication Method for the Test Set
Not applicable. The tests are for objective device performance measurements against predefined technical specifications and standards, not for subjective interpretation requiring an adjudication 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. The device is a continuous esophageal temperature monitoring system, not an AI-assisted diagnostic imaging device that involves human readers interpreting data.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the testing described is primarily focused on the standalone performance of the device's hardware and software against objective technical standards. The thermocouple and infrared sensors' accuracy, response time, and the software's functional requirements are evaluated directly, independent of a human operator's interpretation, to ensure the device performs as intended.
7. The Type of Ground Truth Used
The ground truth used for these performance tests is based on objective measurements against established and calibrated reference standards as defined by recognized consensus standards, specifically ISO 80601-2-56 for clinical thermometers and relevant electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2). For example:
- Accuracy: Measurements against a known, precise temperature in a controlled bath.
- Response Time: Time taken to reach a stable reading after a known temperature differential, again in a controlled environment.
- Mechanical Strength: Application of a precisely measured force (3.37 lbs) and observation of joint integrity.
- Biocompatibility: Results from standardized biological tests as per ISO 10993-1:2009.
- Software Functionality: Verification against predefined software requirement specifications.
8. The Sample Size for the Training Set
Not applicable. This device is a medical instrument for direct measurement, not an AI/machine learning algorithm that requires a training set. The software mentioned in the document refers to control software for the device's operation, not a learning algorithm that processes data for diagnostic purposes.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set was used.
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March 21, 2018
Securus Medical Group, Inc. William J. Gorman Director of Quality and Regulatory Affairs 100 Cummings Center, Suite 215F Beverly, Massachusetts 01915
Re: K180148
Trade/Device Name: ATS Thermal Imaging Probe, ATS Patient Interface Unit Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical Electronic Thermometer Regulatory Class: Class II Product Code: FLL Dated: February 20, 2018 Received: February 21, 2018
Dear Mr. William J. Gorman:
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. 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.
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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 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Tina Kiang
s
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180148
Device Name
ATS Thermal Imaging Probe, ATS Patient Interface Unit
Indications for Use (Describe)
The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.
The ATS Patient Interface Unit is intended to display continuous temperature measurements (C°) from the ATS Thermal Imaging Probe.
| 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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In accordance with 21 CFR 807.87(h) and 21 CFR 807.92, the 510(k) Summary for the Aurora Thermographic System (ATS) made up of the ATS Thermal Imaging Probe and the ATS Patient Interface Unit is provided below.
1) Submitter
Securus Medical Group, Inc. 100 Cummings Center Suite 215F Beverly, MA 01915
978-317-0836 Phone: Contact: William J. Gorman Date Prepared: March 15, 2018
2) Device
| Trade name: | ATS Thermal Imaging ProbeATS Patient Interface Unit |
|---|---|
| ------------- | --------------------------------------------------------- |
Clinical Electronic Thermometer Common name:
Classification Number/ Classification name/Product code:
Clinical Electronic Thermometers are Class II devices under 21 CFR § 880.2910 and are classified by the General Hospital Panel. Product code - FLL.
3) Predicate Device
InfraRed Thermographic System (IRTS), (K152402).
Reference Device: None
4) Device Description
The Securus Aurora Thermographic System (ATS) is an esophageal temperature probe and monitoring system intended for continuous temperature monitoring of the patient's esophagus. The Probe includes a thermocouple sensor for temperature monitoring and a thermographic sensor for thermal imaging. Data from both sensors are displayed on the Patient Interface Unit.
Aurora Thermographic System (ATS) consists of two components:
- A. ATS Thermal Imaging Probe
- B. ATS Patient Interface Unit
The ATS Thermal Imaging Probe provides esophageal temperature monitoring through the use of a standard thermocouple mounted in a flexible 9 French catheter. This design is standard for esophageal temperature probes commonly used in the industry. In addition, the ATS Thermal Imaging Probe incorporates a thermographic sensor and fiber optic assembly to passively collect the infrared radiation that is self-emanating from the surrounding esophageal tissue surface. The ATS Patient Interface Unit displays temperature measurements (°C) from the ATS Thermal
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Imaging Probe. The ATS Patient Interface Unit has a Digital Video (DVI) port for streaming thermal image data to an auxiliary monitor (not offered with the system).
5) Indications for Use
The ATS Thermal Imaging Probe is intended for continuous esophageal temperature monitoring.
The ATS Patient Interface Unit is intended to display continuous esophageal temperature measurements (°C) from the ATS Thermal Imaging Probe.
6) Comparison of Technological Characteristics
The proposed Aurora Thermographic System (ATS) is a modification of the Securus Infrared Thermographic System (IRTS). Both systems include a 9 French Clinical Thermometer designed to provide continuous direct mode esophageal temperature monitoring through the use of a standard T-type thermocouple. In addition, both systems incorporate the identical infrared thermographic technology for quantifying surface temperature changes in the esophagus. Infrared accuracy and resolution are unchanged. The indications for use, intended use, temperature measurement technology and route of administration remain identical for the two systems.
The modifications involve hardware integration, software and packaging of the ATS Patient Interface Unit and ATS Thermal Imaging Probe.
| Technological Characteristics Comparison Table | |||
|---|---|---|---|
| ATS Thermal Imaging ProbeATS Patient Interface Unit | IRTS System (K152402) | Discussion | |
| Modified Device | Predicate Device | ||
| Intended Use | Continuous temperature monitoring ofthe patient's esophagus. | Continuous temperature monitoring ofthe patient's esophagus. | Identical |
| Indications for Use | The ATS Thermal Imaging Probeis intended for continuous esophagealtemperature monitoring.The ATS Patient Interface Unitis intended to display continuoustemperature measurements (C°) fromthe ATS Thermal Imaging Probe. | The IRTS Probeis intended for continuous esophagealtemperature monitoring.The IRTS Patient Monitoring Unit(PMU) with Patient Interface Unit(PIU)is intended to display continuoustemperature measurements (C°) fromthe IRTS Thermal Imaging Probe. | Identical |
| System Components | Temperature Probe 9 FrenchPatient Interface Unit (PIU) | Temperature Probe 9 FrenchPatient Interface Unit (PIU)Patient Monitoring Unit (PMU) | Similar |
| Probe Sterility | Provided non-sterile | Provided non-sterile | Identical |
| Route of Insertion | Oral or Nasal | Oral or Nasal | Identical |
| Probe Material(patient contact) | Polyethylene and Polyethylenecopolymer with BaSO4 | Polyethylene and platinum | Similar |
| Technological Characteristics Comparison Table | |||
| ATS Thermal Imaging ProbeATS Patient Interface Unit | IRTS System (K152402) | Discussion | |
| Modified Device | Predicate Device | ||
| Probe Size | 9 French catheter | 9 French catheter | Identical |
| Probe Length | 108 cm length | 150 cm length | Similar |
| TemperaturePrecision andResolution | 0.1° C | 0.1° C | Identical |
| Temperature Sensor | Type-T thermocouple | Type-T thermocouple | Identical |
| ThermocoupleSensor SignalProcessing andDisplay | Temperature is a function ofthermocouple voltageTemperature displayed in 0.1° Cincrements | Temperature is a function ofthermocouple voltageTemperature displayed in 0.1° Cincrements | Identical |
| ThermocoupleSensor Range | 25° - 45° C | 25° - 45° C | Identical |
| ThermocoupleSensor Accuracy | ± 0.3° Ctested in accordance with ISO 80601-2-56 | ± 0.3° Ctested in accordance with ISO 80601-2-56 | Identical |
| Transient ResponseTime ofTemperature Sensor | Both heating transient response timeand cooling transient response time areless than 2.5 seconds: time for probeplunged from reference bath to a waterbath with a 2° C differential.Tested in accordance with ISO 80601-2-56 | Both heating transient response timeand cooling transient response time areless than 2.5 seconds: time for probeplunged from reference bath to a waterbath with a 2° C differential.Tested in accordance with ISO 80601-2-56 | Identical |
| Infrared DetectorTechnology | Stirling cooled MCT | Stirling cooled MCT | Identical |
| Infrared SignalProcessing andDisplay | Relative display of color graphicalimage representing infrared radiationemitted from the body. | Relative display of color graphicalimage representing infrared radiationemitted from the body. | Identical |
| InfraredTemperature Range | Rated Output Range: -10°C to +70°CExtended Output Range -20°C to -10°CSpectral response 8-14µm | Rated Output Range: 35° to 60°CNo extended output range offeredSpectral response 8-11µm | Similar |
| InfraredTemperatureAccuracy | ± 2°C in the Rated Output Range | ± 2°C in the Rated Output Range | Identical |
| Technological Characteristics Comparison Table | |||
| ATS Thermal Imaging ProbeATS Patient Interface UnitModified Device | IRTS System (K152402)Predicate Device | Discussion | |
| InfraredTemperatureResolution | 0.1°C | 0.1° C | Identical |
| Infrared ImageField of View | 360° | 360° | Identical |
| Thermal Image Size | 128 x 60 array | 128 x 60 array | Identical |
| Power Supply | 100-240 Vac AC integrated powersupply 24 VDC | 100-240 Vac AC adaptor power supply24 VDC | Identical |
| Electrical SafetyandElectromagneticCompatibility | Fully complies with IEC60601-1:2005 +A1:2012IEC 60601-1-2:2014 | Fully complies with IEC60601-1:2005 +A1:2012IEC 60601-1-2:2007 | Identical |
| Data Output | Data provided to a monitor for display. | Data provided to a monitor for display. | Identical |
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The subject Aurora Thermographic System (ATS) is identical to the predicate device in the following areas:
- Identical Indications for Use and Intended Use ●
- Identical temperature monitoring technology
- Identical catheter diameter and route of administration ●
- Identical accuracy, resolution and response time ●
The primary differences between the proposed Aurora Thermographic System (ATS) and its predicate are the integration of two electronic devices into a single unit package and the related ATS Thermal Imaging Probe changes.
The predicate system includes 3 components.
- IRTS Thermal Imaging Probe
- IRTS Patient Monitoring Unit ●
- IRTS Patient Interface Unit ●
The modified Aurora Thermographic System (ATS) includes 2 components.
- ATS Thermal Imaging Probe ●
- ATS Patient Interface Unit ●
The ATS Thermal Imaging Probe incorporates a modification of the connection to the ATS Patient Interface Unit. The predicate IRTS Thermal Imaging Probe has two separate connectors, one for the thermocouple and one for the infrared measurement. The modified ATS Thermal Imaging Probe integrates the same thermocouple connector with the infrared connector to form a single connection. The ATS Thermal Imaging Probe length has been shortened from 150 cm to 108 cm.
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The infrared temperature range reported to the user has been modified from 35° - 60°C to -20°C -70°C. The infrared detector is unchanged and collects the same infrared energy as the predicate. The modified ATS Patient Interface Unit software allows more infrared data to be displayed.
The impact of each modification has been evaluated using the Securus Risk Management and Design Control systems. Each modification was considered for its impact. All verification testing (non-clinical, performance, and software validation) has been repeated to provide assurance that the modifications did not affect system performance.
Both systems have been validated using FDA recognized consensus standard ISO 80601-2-56:2017, Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement.
Thus, the differences between the systems do not raise new questions for the subject device.
7) Non Clinical Testing & Performance Data
A risk analysis was performed to identify risks associated with the device modifications. Verification and validation testing has been performed to demonstrate that identified risks have been mitigated. This testing demonstrates that the modified ATS Thermal Imaging Probe and the ATS Patient Interface Unit is substantially equivalent to the predicate.
| Device Modification | Associated Risk | Verification / ValidationMethod | AcceptanceCriteria | Results |
|---|---|---|---|---|
| ATS Thermal Imaging Probe Modifications | ||||
| Two connectors combinedinto one handle. | Electrical connections notadequate -Accuracy thermocouple | Testing in accordance with ISO80601-2-56 second Edition 2017-03: Medical electrical equipment -Part 2-56. | Accuracy $\pm$ 0.3° Cacross the rated outputrange. | All samples tested metthe accuracyacceptance criteria $\pm$0.3° C . |
| Two connectors combinedinto one handle. | Electrical connections notadequate -Response timethermocouple | Testing in accordance with ISO80601-2-56 second Edition 2017-03: Medical electrical equipment -Part 2-56. | Response time same aspredicate, < 2.5seconds average | Test results met theacceptance criteria <2.5 seconds average. |
| Two connectors combinedinto one handle. | Optical connections notadequate.Performance compromised- IR Accuracy | IR Temperature Accuracy testsand IR characterization testingover the rated temperature range. | IR TemperatureAccuracy equivalent topredicate across ratedoutput range $\pm$ 2°C. | All samples tested metthe acceptance criteria$\pm$ 2°C across ratedoutput range. |
| Two connectors combinedinto one handle. | Mechanical connections notadequate - modifiedconnections break | Tensile test all joints. | All connections andjoints must withstand3.37 lbs | All connections andjoints exceed 3.37 lbstensile strength. |
| Distal tip modified toinclude BaSO4 filler. | Biocompatibilitycompromised bymodification. | Testing based on ISO 10993-1:2009 Biological evaluation ofmedical devices - Part 1:Evaluation and testing within arisk management process, thefollowing tests are recommended:• Cytotoxicity• Sensitization• Irritation/IntracutaneousReactivity | Test results mustprovide assurance ofbiocompatibility whentested in accordancewith ISO 10993-1:2009. | All test results provideassurance ofbiocompatibility inaccordance with ISO10993-1:2009. |
| ATS Patient Interface Unit Modifications – Housing & Circuit Boards | ||||
| Housing (packaging)modified to new formfactor to accommodate | Modifications compromiseEMC compatibility | Testing in accordance withIEC 60601-1-2 Edition 4.0: 2014-02 Medical electrical equipment - | Must comply withrecognized consensusstandard for | Testing performed atcertified test facility. |
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| Device Modification | Associated Risk | Verification / ValidationMethod | AcceptanceCriteria | Results |
|---|---|---|---|---|
| touch screen and singleprobe connection. | Part 1-2: General requirements forbasic safety and essentialperformance - Collateral standard:Electromagnetic disturbances -Requirements and tests (4thEdition). | Electromagneticcompatibility | Compliance confirmed. | |
| Housing (packaging)modified to new formfactor to accommodatetouch screen and singleprobe connection. | Modifications compromiseelectrical safety | Testing in accordance with IEC60601-1:2005 + A1:2012(E),Medical electrical equipment -Part 1: General requirements forbasic safety and essentialperformance. | Must comply withrecognized consensusstandard for electricalsafety. | Testing performed atcertified test facility.Compliance confirmed. |
| Circuit boards modified toaccommodate modifiedhousing, single probeconnection and touchscreen. | Modifications compromiseperformance | All accuracy testing repeated (seesections above).Software validation testing coversall system functional requirements(see software below). | The ATS Patientinterface unit mustmeet all performancecriteria and mustsupport all softwarefunctions. | All accuracy testingmeets criteria (seesections above).Software validationtesting meets allacceptance criteria (seebelow) |
| ATS Patient Interface Unit Modifications - Software | ||||
| Software modifiedaccommodate modifiedcircuit boards, single probeconnection and touchscreen. | Software performancecompromised bymodification. | The software has been developedand validated in accordance withmedical device standards includingANSI/AAMI/IEC 62304:2006Medical device software -Software life cycle processes.Complete software validationtesting performed including 100%functional testing. | Software must perform100% of functionalrequirements inaccordance with therequirementsspecifications. | Software validationconfirms compliancewith all requirementsspecifications. |
8) Conclusions
A risk analysis was performed to identify risks associated with the device modifications. Verification and validation testing has been performed to demonstrate that the identified risks have been mitigated. This testing demonstrates that the modified ATS Thermal Imaging Probe and ATS Patient Interface Unit is substantially equivalent to the predicate.
§ 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.