(234 days)
General Purpose Temperature probes Dräger disposable general purpose temperature probes are intended for patient core body temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are inserted into the oesophagus or the rectum. Skin Temperature probes Dräger disposable skin temperature probes are intended for patient skin temperature measurement in combination with Dräger and Siemens patient monitoring systems. The probes are affixed on the patient's skin with an adhesive cover.
Temperature probes are used during patient temperature measurement and consist of a plug connected to a patient monitor and a thermistor on the patient end. The thermistor consists of a resistor which is sensitive to temperature changes. The portfolio includes General Purpose Temperature probes to be inserted into the oesophagus or the rectum and Skin Temperature Probes. The devices are intended for single patient use and can be used with Dräger and Siemens patient monitors.
Here's an analysis of the provided 510(k) summary, aiming to describe the acceptance criteria and the study proving the device meets them, based on the input text:
Acceptance Criteria and Device Performance for Dräger Temperature Probes (K121999)
Based on the provided 510(k) summary (K121999) for Dräger Temperature Probes, the document outlines verification and validation measures, but it does not explicitly state specific numerical acceptance criteria or detail the quantitative results of a study demonstrating these criteria have been met for accuracy. Instead, it relies on demonstrating substantial equivalence to predicate devices and adherence to general performance and safety tests.
The document indicates that the device's performance is within an acceptable range for clinicians, implying that the acceptance criteria for these tests were met, but the specific metrics are not provided.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (as implied) | Reported Device Performance (as implied) |
|---|---|---|
| Accuracy | Equivalent to predicate devices (implicit) | Performance given within the range the device can be used by clinicians. The function and principle of operation, as well as the characteristic of the used NTC (YS1400), are equal to predicates. |
| Biocompatibility | Use of biocompatible materials | Devices are made from biocompatible materials. |
| Electrical Safety | Meets relevant standards (implicit) | Verified. |
| Mechanical Integrity | Withstands bending, connection cycles, pull-off forces | Verified (bending, connection cycles, pull-off forces). |
| Environmental | Withstands shock & vibration, storage, transport | Verified (Shock & Vibration, Storage and Transport). |
| Labeling | Meets regulatory requirements | Verified (Labelling review). |
| Resistance to Fluids/Disinfectants | Withstands fluids and disinfectants (implicit) | Verified (Resistance to fluids and disinfectants). |
| Shelf Life | Meets specified shelf life (implicit) | Verified (Shelf Life). |
| Compatibility | Compatible with Dräger and Siemens patient monitors | Compatible to devices. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not specify the sample size used for the test set or the country of origin of the data. It mentions "Verification & validation measures include but are not limited to the following key tests," implying these tests were conducted, but offers no details about the testing methodology, sample sizes, or data provenance (retrospective or prospective) for each specific test.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Experts
The document does not mention the use of experts to establish ground truth for a test set. This type of device (temperature probes) typically relies on metrological standards and comparisons to reference instruments rather than expert opinion for ground truth.
4. Adjudication Method for the Test Set
As there's no mention of expert ground truth establishment, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not performed or is not mentioned in the provided document. This type of study is relevant for diagnostic imaging interpretation devices, not for basic medical instruments like temperature probes.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The device is a physical temperature probe, not an algorithm, so a "standalone (algorithm only without human-in-the-loop performance)" study is not applicable and therefore not mentioned. The probes' performance is evaluated standalone in terms of their physical and electrical properties when connected to a monitor.
7. Type of Ground Truth Used
The ground truth for the verification and validation tests would typically be established by metrological reference standards for temperature measurement, and possibly by laboratory testing against known environmental conditions, for tests like accuracy, electrical safety, mechanical tests, and environmental resistance. For biocompatibility, the ground truth is established by adherence to recognized biocompatibility standards (e.g., ISO 10993). The document confirms that for accuracy, the "function and principle of operation as well as the characteristic of the used NTC (YS1400) are equal" to predicate devices, implying that their inherent accuracy characteristics are comparable using established physical principles.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of this device. Temperature probes are not AI/ML devices that require training sets. Their performance is based on physical design and manufacturing.
9. How the Ground Truth for the Training Set Was Established
As there is no training set, this question is not applicable.
§ 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.