(62 days)
The speX LP Support Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.
The speX LP Support Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or coronary vasculature. The device consists of a support catheter body with a luer end. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.
Based on the provided text, the acceptance criteria and study information for the speX LP Support Catheter are as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Simulated Use Testing | All specified criteria for safety and performance. | "The speX LP Support Catheter met all specified criteria and did not raise new safety or performance questions." |
| Design Testing | Performance equal to legally marketed predicate devices. | "The design testing performed for the speX LP Support Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "Simulated Use Testing" and "design testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
The document does not provide information about experts, their number, or their qualifications for establishing ground truth. The testing appears to be nonclinical, focusing on device performance rather than clinical diagnostic accuracy.
4. Adjudication Method for the Test Set
The document does not mention any adjudication method, as the testing described is nonclinical.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was mentioned. The device is a support catheter, not an AI or diagnostic tool that would typically involve human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable as the device is a medical catheter, not an algorithm or AI system.
7. Type of Ground Truth Used
The "ground truth" for this device appears to be defined by engineering and performance specifications related to its function as a support catheter, as opposed to a diagnostic ground truth like pathology or outcome data. The stated goal was to meet "specified criteria" and have "performance equal to the legally marketed predicate devices."
8. Sample Size for the Training Set
Not applicable, as this is a physical medical device, not an AI 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.
§ 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).