(56 days)
The Radiant Medical Endocatheter Temperature Probe is indicated for use with the SetPoint/Reprieve Endovascular Temperature Management System to measure core body temperature.
The Endocatheter Temperature Probe consists of a sheath containing two thermistors on separate and independent circuits. This Probe is intended for placement into the inferior vena cava through the guidewire lumen of the catheter. The outer sheath is Pebax and has a soft, straight Pebax tip. The Endocatheter Probe is heparin-coated for hemocompatibility. The intended use is to measure a patient's core body temperature via venous blood temperature. The Endocatheter Probe is for single use only. It is provided sterile and packaged in a Tyvek/polyethylene pouch. Sterilization is by gamma irradiation.
Here's an analysis of the provided text regarding the Endocatheter Temperature Probe, structured to address your specific questions about acceptance criteria and the supporting study:
The provided document does not contain a detailed study report with specific acceptance criteria or performance metrics typical of clinical trials for efficacy. Instead, it describes a 510(k) premarket notification which focuses on demonstrating substantial equivalence to a predicate device, rather than proving novel clinical effectiveness or setting new performance benchmarks.
Therefore, many of your specific questions cannot be fully answered from this document. However, I will extract what is available and indicate when information is not present.
Acceptance Criteria and Study Details for the Endocatheter Temperature Probe (K042388):
The submission primarily relies on demonstrating that the device is substantially equivalent to a legally marketed predicate device (Radiant Medical Endovascular Temperature Probe, K024327). This means the "acceptance criteria" are largely centered on meeting existing standards and showing comparable functionality and safety to the predicate, rather than achieving specific quantitative performance targets against a clinical gold standard.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) summary, specific numerical acceptance criteria for performance (e.g., accuracy +/- X degrees with Y% confidence) and corresponding reported device performance values are not explicitly stated in this document in a tabular format. The "acceptance criteria" are implied by the performance tests conducted and the comparison to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functionality | Successful completion of performance verification tests in accordance with BS EN ISO 10555. |
| Biocompatibility | Successful completion of biocompatibility tests in accordance with ISO 10993. |
| Safety and Effectiveness | Performs with safety and effectiveness equivalent to the predicate device (Radiant Medical Endovascular Temperature Probe, K024327). |
| Core Body Temperature Measurement | Measures patient's core body temperature via venous blood temperature. |
| Probe Design/Materials | Sheath: Pebax; Tip: soft, straight Pebax; Heparin-coated. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for the Test Set: Not specified. The document mentions "performance verification tests" but does not detail the number of units tested or if any human subject testing was part of this verification.
- Data Provenance: The tests were conducted internally by Radiant Medical, Inc. The document does not specify country of origin for any human data (if collected) or indicate if the study was retrospective or prospective. It implies bench testing and potentially in vitro or animal studies for biocompatibility.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable/Not specified. This type of information (expert review for ground truth) is typically relevant for diagnostic imaging devices or devices where subjective expert assessment is critical. For a temperature probe, "ground truth" would likely be established against a highly accurate reference thermometer in a controlled environment, not via expert consensus.
4. Adjudication Method for the Test Set
Not applicable/Not specified. Adjudication methods (like 2+1 or 3+1) are used to resolve discrepancies in expert interpretations, which is not relevant for a device like a temperature probe that measures a biophysical parameter.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
No, a MRMC comparative effectiveness study was not done. This type of study is typically for diagnostic devices where human readers interpret medical images or data. The Endocatheter Temperature Probe is a measurement device.
6. Standalone Performance Study (Algorithm only without human-in-the-loop)
Yes, in essence, standalone performance testing was done. The "Performance Test" section states: "The Endocatheter Temperature Probe has been tested for functionality in accordance with BS EN ISO 10555 and for biocompatibility in accordance to ISO 10993." These are standards for catheter functionality and biocompatibility, implying the device's technical performance was assessed on its own. Specific numerical results are not provided in this summary.
7. Type of Ground Truth Used
The type of ground truth used would have been against reference standards for temperature measurement (e.g., highly accurate laboratory thermometers) for functionality testing, and standard laboratory methods for assessing material biocompatibility. It would not typically involve "expert consensus," "pathology," or "outcomes data" in the traditional sense for a device like this during premarket submission.
8. Sample Size for the Training Set
Not applicable. This device is a largely electromechanical temperature probe, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data science. The device's design and manufacturing processes are validated, not "trained."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set.
Summary Takeaway:
This document is a 510(k) summary for a temperature probe. The primary goal of a 510(k) is to demonstrate substantial equivalence to a predicate device, focusing on safety and effectiveness without requiring new clinical trials to prove efficacy. Therefore, the details requested about clinical study designs, expert reviews, and AI-related metrics are largely absent, as they are not typically part of a 510(k) submission for this class of device. The "studies" mentioned are performance verification tests against established national/international standards (BS EN ISO 10555, ISO 10993).
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).