(202 days)
The PM2+ System and SmartPICC Stylet is indicated for guidance and positioning of commercially available central venous catheters. The Stylet provides stiffness for use in placement of the catheter, intravascular capability for ECG detection and recording for catheter guiding and positioning, and intravascular ionic dilution for supplemental catheter navigation. The SmartPICC Stylet, when used with the PM2+ System, provides real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information. When relying on the patient's ECG signal, the PM2+ System and SmartPICC Stylet is indicated for use as an alternative method to fluoroscopy or chest x-ray for central venous catheter tip placement confirmation in adult patients. The SmartPICC Stylet is indicated for use with PICC lines having a minimum lumen diameter of 0.021".
Limiting but not contraindicated situations for this technique are in patients where alterations of cardiac rhythm change the presentation of the P-wave as in atrial fibrillation, atrial flutter, severe tachycardia and pacemaker driven rhythm. In such patients, who are easily identifiable prior to central venous catheter insertion the use of an additional method is required to confirm catheter tip location.
The PM2+ System and SmartPICC Stylet is a device used by clinicians for bedside navigation and tip location confirmation of central venous catheters including PICCs. The PM2+ System and SmartPICC Stylet provide real-time catheter tip location information by using intravascular ECG (ivECG). The SmartPICC Stylet provides intravascular ECG for catheter tip location confirmation as well as an optional, ionic dilution navigation feature. The SmartPICC Stylet is used only during PICC installation, and removed once the PICC tip position is confirmed to be at the target location. The SmartPICC Stylet is electrically connected to the PM2+ system which processes, displays, and stores the ECG waveforms as well as the ionic dilution data. The PM2+ System is also compatible with the commercially available ECGuide Connector.
The provided FDA 510(k) clearance letter for the PM2+ System and SmartPICC Stylet does not include acceptance criteria or a detailed study that proves the device meets specific acceptance criteria related to its primary function (catheter tip placement confirmation using ECG).
The document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance metrics derived from a clinical trial.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The clearance letter states that "Performance testing performed on the PM2+ System and SmartPICC Stylet verified that device performance requirements including tensile strength, insertion force, corrosion resistance, catheter compatibility, leak testing, infusion rate testing, ionic dilution performance testing, algorithm verification, electrical hardware verification, sterile barrier packaging testing, biocompatibility, electrical safety, EMC, software verification and validation, design validation and human factors validation. All tests were successfully completed." However, the specific acceptance criteria (e.g., "tensile strength must be >X Newtons") and the measured performance values for these non-clinical tests are not disclosed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided for demonstrating the core performance of the device (catheter tip placement confirmation). The document explicitly states: "No human clinical data was provided to support substantial equivalence." This implies that there was no clinical test set for this specific submission to demonstrate the accuracy of the ECG-based tip localization. The performance testing mentioned in point 1 refers to non-clinical (engineering and benchtop) tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. As "No human clinical data was provided," there was no clinical ground truth established for a test set in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. As "No human clinical data was provided," there was no clinical test set 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
This information is not provided. The device is a "Tip Location System" and "Stylet," which assists in the placement of central venous catheters. It's not described as an AI system that improves human readers of medical images. The primary use case is direct guidance during placement, not interpretation of images post-placement. The clearance relies on substantial equivalence to predicate devices, where the ECG-based tip confirmation method is already established.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation of the algorithm's accuracy in determining catheter tip location is not explicitly detailed with specific metrics. While "algorithm verification" is listed as a completed test, the specific methodology, dataset, and performance criteria for this verification are not disclosed. The device description explicitly states it provides "real-time catheter tip location information by using the patient's physiological (cardiac electrical activity and blood flow) information," which implies it has an embedded algorithm, but its standalone performance against a ground truth is not specified in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests (tensile strength, etc.), the ground truth would be established by objective physical measurements. However, for the crucial function of accurate catheter tip placement confirmation using ECG, the document does not specify the type of ground truth used for algorithm verification, nor does it provide a clinical study where a ground truth (e.g., fluoroscopy, chest X-ray interpreted by experts, or MRI) would be established for comparison. The clearance implies that the underlying technology (ivECG for tip location) is already validated from the predicate devices.
8. The sample size for the training set
This information is not provided. Given "No human clinical data was provided" for the current submission, and the reliance on substantial equivalence, details about a training set for a new algorithm performance claim are absent. If the "algorithm verification" refers to the core ECG-based localization, the training would have been part of the predicate device development.
9. How the ground truth for the training set was established
This information is not provided. (See explanation for point 8).
In summary, the FDA 510(k) clearance for the PM2+ System and SmartPICC Stylet does not contain the detailed acceptance criteria and study data you requested for its primary function (ECG-based catheter tip localization). The clearance is based on demonstrating substantial equivalence to existing legally marketed predicate devices (K200037 Piccolo Medical SmartPICC System and K240486 PM2 System and ECGuide Connector) which already use similar technology, and on successful completion of various non-clinical engineering and benchtop performance tests. The document explicitly states that "No human clinical data was provided to support substantial equivalence" for this specific submission.
§ 880.5970 Percutaneous, implanted, long-term intravascular catheter.
(a)
Identification. A percutaneous, implanted, long-term intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings, such as luer hubs, and accessories that facilitate the placement of the device. The device allows for repeated access to the vascular system for long-term use of 30 days or more, and it is intended for administration of fluids, medications, and nutrients; the sampling of blood; and monitoring blood pressure and temperature. The device may be constructed of metal, rubber, plastic, composite materials, or any combination of these materials and may be of single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters.”