(240 days)
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.
The probes are indicated for use by qualified medical personnel only.
Prescription use only.
Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification.
Sensatronic Reusable Temperature Probes are constructed with the following features:
- . Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization
- . Two internal conductors for connection to the thermistor
- . Internal Kevlar fibers for strength and pull resistance
- Biocompatible outer jacket of thermoplastic rubber (TPR)
- . The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below)
- The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm
- 트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the Sensatronic Reusable Temperature Probes:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Accuracy (Temperature Measurement) | ± 0.1 °C (25 °C – 45 °C) [This is the predicate's accuracy in the physiological range, implying the new device meets this for substantial equivalence.] | ± 0.1 °C (25 °C – 45 °C) |
| Measurement Range | 0°C to 50°C | 0°C to 50°C |
| Electrical Safety | Compliance with IEC 60601-1 | The probes met acceptance criteria for compliance to IEC 60601-1. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | The probes met acceptance criteria for compliance to IEC 60601-1-2. |
| Usability | Compliance with IEC 60601-1-6 and IEC 62366 for professional use | Usability evaluation per IEC 60601-1-6 and IEC 62366 for professional use was conducted, and the probes met acceptance criteria. |
| Clinical Thermometer Specific Regs. | Compliance with ISO 80601-2-56 (including accuracy) | The probes met acceptance criteria for compliance to ISO 80601-2-56. |
| Environmental Storage | Compliance with IEC 60068-2-78 and IEC 60068-2-1 | Environmental storage testing was performed per IEC 60068-2-78 and IEC 60068-2-1, and the probes met acceptance criteria. |
| Risk Management | Compliance with ISO 14971 (acceptability of residual risks) | The probes met risk management criteria for acceptability of residual risks. |
| Biocompatibility | Compliance with ISO-10993-1, ISO-10993-5 (Cytotoxicity), and ISO-10993-10 (Irritation, Sensitization) | The probe materials met the acceptance criteria for biocompatibility based on cytotoxicity, irritation, and sensitization tests. |
| Cleaning/Disinfection Efficacy | Compliance with ISO 15583-5, AAMI TIR30, FDA Guidance for Reprocessing Medical Devices in Health Care Settings (bioburden removal, disinfection efficacy) | The probes met acceptance criteria for cleaning and disinfection. |
| Steam Sterilization Efficacy | Compliance with ISO 17665-1 and ISO 11737-2 | The probes met the acceptance criteria for steam sterilization. |
| Reuse Life Durability (Manual Cleaning) | Up to 300 cycles (performance maintained after testing) | The probes met acceptance criteria for durability and performance after testing up to 300 cycles for manual cleaning/disinfection. |
| Reuse Life Durability (Machine Wash) | Up to 300 cycles (performance maintained after testing) | The probes met acceptance criteria for durability and performance after testing up to 300 cycles for machine washing/disinfection. |
| Reuse Life Durability (Steam Sterilization) | Up to 100 cycles at 132°C/4 minutes (performance maintained after testing) | The probes met acceptance criteria for durability and performance after testing up to 100 cycles for steam sterilization. |
Study Information
-
Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for the test set in terms of individual devices tested for each criterion. The studies are referred to as "laboratory tested."
- Data Provenance: The studies were "laboratory tested," implying a controlled environment. The country of origin of the data is not explicitly stated, but the manufacturer is Sensatronic GmbH, located in Germany, suggesting the testing likely occurred there or at a contract lab. The studies were non-clinical.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a temperature probe, and its performance is evaluated against physical standards (e.g., NIST-traceable temperature references) and established engineering/medical device standards, not against human expert interpretation of data. Therefore, "ground truth" here refers to objective measurements and standard compliance.
-
Adjudication method for the test set:
- Not applicable. Performance is determined by objective measurement against established standards and criteria, not by expert adjudication.
-
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 a medical device for temperature measurement, not an AI or imaging diagnostic software. Therefore, an MRMC study is not relevant.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing performed was primarily "standalone" in the sense that the device's technical performance (accuracy, electrical safety, EMC, durability, sterilization efficacy, biocompatibility, etc.) was evaluated objectively against predefined standards, without direct human-in-the-loop performance in a clinical diagnostic sense. Its function is to provide a measurement, which is then used by human medical personnel. However, the term "standalone" is usually used in the context of AI algorithms, which isn't the case here.
-
The type of ground truth used:
- The ground truth consists of established engineering and medical device standards, physical measurement references, and predefined performance criteria. For instance, temperature accuracy is measured against traceable reference thermometers, and safety/EMC against the limits specified in the relevant IEC standards. Biocompatibility results are compared against the limits defined in ISO 10993.
-
The sample size for the training set:
- Not applicable. This device is a hardware product (temperature probe), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The design and manufacturing processes are likely iterative, but this is not a "training set" in the sense of data used to train an algorithm.
-
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.
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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services logo. On the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 11, 2021
Sensatronic GmbH % Stephen Gorski President Imagenix, Inc. S65 W35739 Piper Road Eagle, Wisconsin 53119
Re: K203643
Trade/Device Name: Sensatronic Reusable Temperature Probes Regulation Number: 21 CFR 880.2910 Regulation Name: Clinical electronic thermometer Regulatory Class: Class II Product Code: FLL Dated: July 9, 2021 Received: July 12, 2021
Dear Stephen Gorski:
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
{1}------------------------------------------------
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 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,
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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Indications for Use
510(k) Number (if known)
Device Name Sensatronic Reusable Temperature Probes
Indications for Use (Describe)
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.
The probes are indicated for use by qualified medical personnel only.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary in accordance with 21 CFR 807.92
| (a) | (1) | Submitted by: | Sensatronic GmbHAm Ring 9D-23970 WismarGermanyTel.: +49 3841 2252 440Fax: +49 3841 2252 442j.schwarz(at)sensatronic.com | |
|---|---|---|---|---|
| Contact Person: | Mr. Jens Schwarz | |||
| Position/Title: | General Manager | |||
| Date of Preparation: | July 9, 2021 | |||
| (2) | Trade Name: | Sensatronic Reusable Temperature Probes | ||
| Common/Classification Name: | Thermometer, Electronic, Clinical | |||
| Product Code(s): | 21 CFR §880.2910; FLL | |||
| Class: | Class II | |||
| (3) | Predicate Device(s): | Substantial Equivalence to: | ||
| K Number | Model | Manufacturer | ||
| K050837 | Reusable Temperature Probes (M1024254 SkinTemperature probe, reusable; M1024247, GPTemperature Probe, Adult, reusable; M1024251GP Temperature Probe, Pediatric, reusable) | GE Healthcare |
Reason for Submission: New Device(s)
(4) Description of Device:
Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification.
Sensatronic Reusable Temperature Probes are constructed with the following features:
- . Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization
- . Two internal conductors for connection to the thermistor
- . Internal Kevlar fibers for strength and pull resistance
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- Biocompatible outer jacket of thermoplastic rubber (TPR)
- . The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below)
- The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm
- 트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems. The following configurations are offered:
| TemperatureProbe Types | Model | Suffix(Connector) | Compatibility Series | Cable length | Diameter ofCable/(Tip) |
|---|---|---|---|---|---|
| GeneralPurpose | AR-275 | -PA | GE Healthcare (YSI¼ in. phono plug) | 275 cm | 4.0 mm(4.5 mm tip) |
| Rectal/EsophagealProbe, Large | AR-275AR-200AR-300AR-500 | -PRA-S2-S1-S1 | Schiller | 200 cm300 cm500 cm | |
| GeneralPurpose | PR-275 | -PA | GE Healthcare (YSI¼ in. phono plug) | 275 cm | 3.2 mm(3.7mm tip) |
| Rectal/EsophagealProbe, Medium | PR-275PR-200PR-300PR-500 | -PRA-S2-S1-S1 | Schiller | 200 cm300 cm500 cm | |
| GeneralPurposeRectal/Esophageal Probe,Small * | NR-275NR-275 | -PA-PRA | GE Healthcare (YSI¼ in. phono plug) | 275 cm | 3.2/2.3 mm(2.7mm tip) |
| SkinTemperatureProbe, Large | SAR-275SAR-275SAR-200SAR-300SAR-500 | -PA-PRA-S2-S1-S1 | GE Healthcare (YSI¼ in. phono plug) | 275 cm200 cm300 cm500 cm | 4.0 mm(16mm disk) |
| SkinTemperatureProbe, Medium | SPR-275SPR-275SPR-300SPR-500 | -PA-PRA-S1-S1 | GE Healthcare (YSI¼ in. phono plug)Schiller | 275 cm300 cm500 cm | 3.0 mm(10mm disk) |
| SkinTemperatureProbe, Small * | SNR-275SNR-275SNR-300 | -PA-PRA-S1 | GE Healthcare (YSI¼ in. phono plug)Schiller | 275 cm300 cm | 3.2/2.3 mm(6mm disk) |
- NOTE: The distal 50cm of the probe cable is stepped to the smaller diameter 2.3mm cable
Probe Connector Suffix Guide:
| Connector Suffix | Connector/Contact Description |
|---|---|
| -PA | 6.35 mm phono plug, 2 conductor, straight |
| -PRA | 6.35 mm phono plug, 2 conductor, right angle |
| -S1 | Siemens monitor, 5 pin, straight |
| -S2 | Siemens monitor, 8 pin, straight |
Table 1: Probe Configurations offered
(5) Intended use:
The intended use for the Sensatronic Reusable Temperature Probes is the same as the predicate Temperature Probes: monitoring of temperature.
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Indications for Use:
Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.
The probes are indicated for use by qualified medical personnel only.
Prescription use only.
(6) Technological Characteristics:
The Sensatronic Reusable Temperature Probes utilize the same technological principles as the predicate devices to measure temperature: both incorporate thermistor temperature sensors in the probes which utilize the YSI 400 resistance specification, and are offered in both rectal/esophageal and skin-applied models. Refer to the following comparison table:
Comparison of Technological Features to Predicate Devices:
| Product/Feature | SensatronicReusable TemperatureProbes | GE Healthcare ReusableTemperature Probes | Remark | |
|---|---|---|---|---|
| Manufacturer | Sensatronic GmbH | GE Healthcare | ||
| Model Number(s) | AR-275-PA; AR-275-PRA; AR-200-S2; AR-300-S1; AR-500-S1;PR-275-PA; PR-275-PRA; PR-200-S2; PR-300-S1; PR-500-S1;NR-275-PA; NR-275-PRA;SAR-275-PA; SAR-275-PRA; SAR-200-S2; SAR-300-S1; SAR-500-S1;SPR-275-PA; SPR-275-PRA; SPR-300-S1; SPR-500-S1;SNR-275-PA; SNR-275-PRA; SNR-300-S1 | M1024254 (Skin probe)M1024247 (GP Probe)M1024251 (GP Probe)GP is general purposeesophageal/rectal | Product range for bothdevices includes bothgeneral purpose and Skinprobes | |
| 510(k) Number | K203643 | K050837 | ||
| Application/Intended use: | Measurement andmonitoring of patienttemperature | Measurement andmonitoring of patienttemperature | Same | |
| Product/Feature | SensatronicReusable TemperatureProbes | GE Healthcare ReusableTemperature Probes | Remark | |
| Application Site(s) | Rectal/esophageal; Skin | Rectal/esophageal; Skin | Same application sites | |
| Reusable | ✓ YES | ✓ YES | Same | |
| Steam Sterilization | ✓ YES | ✓ YES | Same | |
| Operating principle(s) | Single thermistor sensor,with NTC (negativetemperature coefficient)specification meeting YSI400 series compatibility | Single thermistor sensor,with NTC (negativetemperature coefficient)specification meeting YSI400 series compatibility | Same thermistorcharacteristics, both meetYSI 400 seriescompatibility | |
| Accuracy | ± 0.1 °C (25 °C – 45 °C) | ± 0.1°C (0°C to 50°C) | Equivalent in thephysiological range | |
| Measurement Range | 0°C to 50°C | 0°C to 50°C | Same | |
| Probe Construction – Rectal/Esophageal | ||||
| Cable and Tip Material | BiocompatibleThermoplastic Elastomer | Biocompatible Plastic(type not specified) | Equivalent Function | |
| Tip Profile | Cylindrical, with formedrounded tip | Cylindrical, with formedrounded tip | Same | |
| Esophageal/Rectal ProbeTip dimensions | Type A: 4.5 mm;Type P: 3.7 mm;Type N: 2.7 mm | 4mm;3mm; | Sensatronic tip has 3available diameters, GEhas 2; minor differencesin dimensions | |
| Probe Construction – Skin | ||||
| Tip (Disk) Material | Stainless steel,Biocompatible Plastic | Stainless steel, Plastic(type not specified) | Equivalent function | |
| Tip (Disk) dimensions | Type A: 16 mm;Type P: 10 mm;Type N: 6 mm | 10 mm; | Sensatronic disk offers 3available diameters, GEoffers 1 | |
| Cable and Connector | ||||
| Cable overall length | 2.75 meters standardlength; 2, 3, and 5 metersin specific models | 3 meters (all models) | Equivalent functionality,some difference in length | |
| Connector(s) | Straight Phone Plug;Right Angle Phono Plug;Manufacture specifiedtypes (incl. Schiller); YSI400 series function | Straight Phone Plug); YSI400 series function | Equivalent electricalfunction; GE Healthcareoffers straight Phono plugstyle; Sensatronic Probesare offered in additionalconnector styles; all haveYSI 400 series function | |
| Cleaning, Disinfection, and Sterilization Methods | ||||
| Product/Feature | SensatronicReusable TemperatureProbes | GE Healthcare ReusableTemperature Probes | Remark | |
| Cleaning & DisinfectionMethod(s) | Manual wipe withcleaning agents ormachine washing;immersion in disinfectant | Manual wipe withcleaning agents ormachine wash;immersion in disinfectant | Equivalent function: bothsupport manual cleaning,machine wash anddisinfectant immersion | |
| Sterilization Method(s) | Steam autoclave at132°C/4 minutes(max 100 cycles) | 1) Plasma (Sterrad);2) Steam autoclave for 20minutes at 121°C/250°F(max 100 cycles), or3) Steam autoclave 18minutes at 134°C/273°F(max 30 cycles) | Equivalent function:Sensatronic specifiescurrent industry practicesfor autoclave temperatureof 132°C with 100 cyclesdurability; predicate lists30 cycles durability;Sensatronic does notspecify plasma (Sterrad)method | |
| Physical and Environmental Specifications | ||||
| Operating Conditions | 0°C...+50°C10...100 % r. h | 0°C - +50°C | Equivalent OperatingRange |
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Page 5 of 6
As summarized above, the Sensatronic Reusable Temperature Probes utilize equivalent technological characteristics and specifications as the listed predicate devices.
(b) (1) Non-Clinical Tests Submitted:
Sensatronic Reusable Temperature Probes were laboratory tested to current applicable standards for medical device electrical safety and electromagnetic compatibility as well as particular standards for clinical thermometers. The following standards were utilized in compliance testing:
- Electrical safety testing per IEC 60601-1 ●
- Electromagnetic compatibility testing per IEC 60601-1-2
- Usability evaluation per IEC 60601-1-6 and IEC 62366 for professional use ●
- Particular requirements for clinical thermometers per ISO 80601-2-56 ● including accuracy.
- Environmental storage testing per IEC 60068-2-78 and IEC 60068-2-1 ●
- . Cable pull testing per ANSI/AAMI/ EC53 (used as reference standard only)
The probes met acceptance criteria for compliance to the standards.
The probes were evaluated to the requirements of the following guidance:
- Guidance on the Content of Premarket Notification [510(k)] Submissions for . Clinical Electronic Thermometers, March 1993
The probes met the requirements of quidance.
Risk management, risk and hazard analysis of the probes was performed to the following standard:
- . Application of risk management to medical devices per ISO 14971
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The probes met risk management criteria for acceptability of residual risks.
Probe patient contact materials were evaluated for biocompatibility. The tests were performed to the following standards and included the listed tests:
- Biocompatibility testing per ISO-10993-1. ISO-10993-5 and ISO-10993-10 .
- . Cytotoxicity test
- . Irritation testing
- Sensitization testing
The probe materials met the acceptance criteria for biocompatibility.
The probes were evaluated for the efficacy of the specified manual and machine reprocessing methods and cleaning and disinfection agents for:
- Efficacy of cleaning/bioburden removal per methods of ISO 15583-5, AAMI . TIR30, FDA Guidance for Reprocessing Medical Devices in Health Care Settings
- Efficacy of disinfection methods (bioburden) ●
The probes met acceptance criteria for cleaning and disinfection.
The probes were evaluated for the efficacy of steam sterilization:
- . Efficacy of steam sterilization (gravity, forced vacuum) per methods of ISO 17665-1 and ISO 11737-2.
The probes met the acceptance criteria for steam sterilization.
The probes were evaluated for reuse life durability for per the reprocessing methods specified in device labeling:
- . Manual cleaning/disinfection: up to 300 cycles
- Machine washing/disinfection: ● up to 300 cycles
- . Steam sterilization: up to 100 cycles
The probes met acceptance criteria for durability and performance after testing.
In summary, the probes met acceptance criteria for conformance to the applicable standards, performance accuracy, biocompatibility, cleaning and disinfection, steam sterilization, and durability. Residual risks met criteria for acceptability for the intended use.
(2) Clinical Tests Submitted:
(none)
(3) Conclusions from Tests:
As described in (b)(1) and (b)(2) above, the Sensatronic Reusable Temperature Probes are equivalent to the predicate temperature probes as supported by compliance, laboratory, and biocompatibility testing.
The results of all tests demonstrate that the Sensatronic Reusable Temperature Probes meet specified requirements for device compatibility and substantial equivalence to the referenced 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.