(31 days)
The Sherlock 3CG™ Tip Confirmation System (TCS) is indicated for guidance and positioning of Peripherally Inserted Central Catheters (PICCs). The Sherlock 3CG™ TCS provides real-time PICC tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the patient's ECG signal, the Sherlock 3CG™ TCS is indicated for use as an alternative method to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients. 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 catheter insertion, the use of an additional method is required to confirm PICC tip location.
The Sherlock 3CGTM TCS is indicated for guidance and positioning of PICCs during insertion and placement. The Sherlock 3CGTM TCS provides real-time catheter tip location information by using passive magnet tracking and the patient's cardiac electrical activity (ECG). The Sherlock 3CGTM TCS displays the location of the PICC tip using a magnetic stylet and magnetic sensors. The Sherlock 3CGTM TCS also displays ECG waveforms received from the patient's skin (baseline ECG) and from the tip of the catheter (intravascular ECG) on the graphical user interface.
The Sherlock 3CG Tip Confirmation System (TCS) is indicated for guiding and positioning Peripherally Inserted Central Catheters (PICCs) by using passive magnet tracking and the patient's cardiac electrical activity (ECG). When relying on the ECG signal, it provides an alternative to chest X-ray and fluoroscopy for PICC tip placement confirmation in adult patients.
Here's an analysis of the acceptance criteria and study information provided:
1. Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list specific numerical acceptance criteria (e.g., a specific accuracy percentage for tip placement). Instead, it states that the device "met all pre-determined acceptance criteria" and "demonstrated substantial equivalence as compared to the predicate device." The overall conclusion from the testing is that the subject device "is as safe, as effective, and performs as well as or better than the predicate device."
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated) | Reported Device Performance |
|---|---|
| Device met predetermined performance specifications. | Met all pre-determined acceptance criteria. |
| Demonstrate substantial equivalence to predicate device. | Demonstrated substantial equivalence as compared to the predicate device. |
| As safe as predicate device. | Performs as well as or better than the predicate device. |
| As effective as predicate device. | Performs as well as or better than the predicate device. |
| As well as or better than predicate device in performance. | Performs as well as or better than the predicate device. |
2. Sample Size and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It refers to "verification and validation activities" and "in-house protocols" for determining the appropriate methods for evaluating performance.
3. Number of Experts and Qualifications for Ground Truth
The document does not specify the number of experts used or their qualifications to establish the ground truth for the test set.
4. Adjudication Method
The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The provided text does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The focus is on the device itself and its equivalence to a predicate device, rather than comparing human reader performance with and without AI assistance.
6. Standalone Performance Study
The information suggests that a standalone performance evaluation of the algorithm and device without a human-in-the-loop was conducted. The "verification and validation activities" and the statement that the device "met all pre-determined acceptance criteria" imply testing of the device's functionality and accuracy on its own. The primary claim is about the device's ability to locate the PICC tip, rather than its enhancement of human interpretation.
7. Type of Ground Truth Used
The type of ground truth used is not explicitly stated in the provided text. However, given the device's function of confirming PICC tip location as an alternative to chest X-ray and fluoroscopy, it is highly probable that the ground truth for tip location was established using imaging methods like X-ray or fluoroscopy, which are considered the conventional and definitive methods for confirming PICC tip placement at the time of the submission. It could also potentially involve direct visualization or measurement during a medical procedure.
8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set. The submission focuses on verification and validation testing for market clearance, not on the development or training of an AI model in detail.
9. How Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as it does not detail the development or training phases of the device.
§ 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.”