(52 days)
Catheter stylets provide internal reinforcement to aid in catheter placement. When used with the Sherlock 3CG® Tip Confirmation System (TCS), the Sherlock 3CG® TPS Stylet also provides the placer rapid feedback on catheter tip location and orientation through the use of passive magnets and cardiac electrical signal detection.
The Sherlock 3CG® TPS Stylet has been developed to aid in the placement of Bard Access Systems' catheters using current placement techniques. The stylets are designed to give the catheters added support and stiffness while traversing the patient's venous system. Also, should the clinician choose to do so, the stylets have been designed to be used in conjunction with Sherlock 3CG® Tip Confirmation System to allow for rapid feedback of catheter tip placement.
The provided text is a 510(k) summary for the Sherlock 3CG® Tip Positioning System (TPS) Stylet. It describes the device, its intended use, and the performance testing conducted to demonstrate its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance tests for the device, specifically focusing on "Ship Testing" and "Tip Tracking Testing."
| Test Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Ship Testing | - Visual inspection and Integrity testing of header bag. |
- Visual inspection of components.
- Visual inspection of trays. | "The verification method for ship testing was executed in accordance with ISO 11607-1:2006... All testing passed the predetermined acceptance criteria." |
| Tip Tracking Testing | - Normal: $\overline{x} + k * s \le 1 \text{ cm or } 10^\circ$ - Non-Normal: $Ppk \ge k/3$ | "The Tip Tracking testing was executed per internal test methods and protocols. All testing passed the predetermined acceptance criteria." |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for either the "Ship Testing" or "Tip Tracking Testing." It also does not provide details on the data provenance (e.g., country of origin, retrospective or prospective). It simply states that "internal test methods and protocols" were used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
The document does not mention the use of experts or any process for establishing ground truth for the test set in the context of human-centric evaluation. The tests described are primarily device performance (engineering) verification tests.
4. Adjudication Method for the Test Set:
Not applicable, as the tests described are engineering verification tests, not clinical studies requiring human adjudication of results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
No, an MRMC comparative effectiveness study was not mentioned or implied. The focus of this 510(k) submission is on demonstrating substantial equivalence through technical and performance testing of the device itself, not on evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The device described, the Sherlock 3CG® Tip Positioning System (TPS) Stylet, is a physical medical device (a stylet with integrated technology for tip confirmation). It is not an "algorithm" in the sense of an AI/ML software. Therefore, the concept of "standalone performance" for an algorithm doesn't directly apply in the typical AI/ML context. The "Tip Tracking Testing" would be considered the standalone performance of the device's ability to track the tip.
7. The Type of Ground Truth Used:
For "Tip Tracking Testing," the ground truth would likely be established by a precisely measured, known physical position and orientation of the stylet tip. This is a technical (engineering) ground truth, not a clinical ground truth like pathology or outcome data. For "Ship Testing," the ground truth is simply meeting the defined visual and integrity criteria.
8. The Sample Size for the Training Set:
Not applicable, as this is a physical medical device and not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is a physical medical device and not an AI/ML algorithm requiring a training set.
Summary of Study Proof:
The document indicates that the Sherlock 3CG® TPS Stylet underwent verification testing to demonstrate its performance and substantial equivalence to a predicate device. The key tests reported are:
- Ship Testing: Evaluated the packaging integrity and component visual quality after simulated shipping. This was done in accordance with ISO 11607-1:2006.
- Tip Tracking Testing: Assessed the device's ability to accurately track the tip's location and orientation. This was conducted using internal test methods and protocols.
For both types of tests, the document explicitly states that "All testing passed the predetermined acceptance criteria." This statement is the proof that the device meets its established acceptance criteria. However, detailed data (e.g., specific values for mean, standard deviation, Ppk, or raw pass/fail rates beyond "all testing passed") and the sample sizes used for these tests are not provided in this summary. The ground truth for these tests is based on engineering measurements and established physical standards rather than clinical expert consensus or patient outcomes.
§ 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.”