(68 days)
The Switch-It catheter is intended to be used in conjunction with guide catheters to facilitate placement and exchange of guidewires in the discrete coronary and peripheral vasculature.
The Switch-It catheter (Switch-It) is an addition to the VSI guide extension catheter product family. Switch-It is a rapid-exchange catheter intended for use with a standard 6F guide catheter to place and exchange standard length 0.014" guidewires. The working length of Switch-It is 145 cm, consisting of a 117 cm proximal stainless steel push wire attached to a 28 cm microcatheter-type shaft. The push wire and shaft are joined by a short funnel section that directs a proximally inserted guidewire into the shaft. The inner diameter of the shaft is sized to accommodate an 0.014" guidewire. The distal 20 cm of the shaft has a hydrophilic coating and a platinum-iridium marker band located 2 mm or less from the distal tip, which is visible using standard fluoroscopic methods. The push wire has two positioning marks located at 95 cm (single mark) and 105 cm (double mark) from the distal tip, respectively.
The provided text describes the Switch-It™ Catheter and its 510(k) premarket notification. It outlines the device description, intended use, and substantial equivalence to predicate devices, supported by verification testing.
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for the performance tests. Instead, it describes the types of tests performed and concludes that the "Results of the verification testing did not raise new safety or performance questions." This implies that the device met whatever internal acceptance criteria were set for these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Simulated Anatomy/Concomitant Device Use | |
| (No new safety/performance issues when used with standard 6F guide catheter and 0.014" guidewires) | Results did not raise new safety or performance questions. |
| Kink Resistance | |
| (Device maintains integrity and functionality) | Results did not raise new safety or performance questions. |
| Tensile Strength | |
| (Device withstands appropriate tensile forces) | Results did not raise new safety or performance questions. |
| Torque Response | |
| (Device maintains steerability/response to torque) | Results did not raise new safety or performance questions. |
| Dimensional Verification | |
| (Device dimensions meet specifications) | Results did not raise new safety or performance questions. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes (number of devices or tests) for the verification testing. It also does not mention the data provenance (e.g., country of origin, retrospective or prospective) for these engineering tests. Given the nature of these tests (simulated anatomy, kink, tensile, torque, dimensional), they are typically conducted in a laboratory setting.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable. The study described is a series of engineering verification tests (simulated anatomy, kink, tensile, torque, dimensional verification) for a medical device. These types of tests do not typically involve human experts establishing "ground truth" in the way clinical studies or diagnostic AI algorithms do. The "ground truth" for these tests would be the established engineering standards and specifications.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated above.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document describes engineering verification tests, not a clinical study involving human readers or AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device described is a physical medical catheter, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the verification tests would be defined by engineering specifications and established test methods for catheter performance. For example, kink resistance would be judged against a defined kinking force threshold, tensile strength against a breaking point, and dimensional verification against manufacturing tolerances. These are objective measures rather than expert consensus, pathology, or outcomes data typically associated with diagnostic studies.
8. The Sample Size for the Training Set
Not applicable. The device is a physical catheter, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this device does not involve a training set.
§ 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).