(31 days)
The Selector Angiographic Catheter is intended to deliver contrast medium during angiography as well as to provide a conduit for various diagnostic and therapeutic procedures. Selector Angiographic Catheters are intended for single-patient use only.
The Selector Angiographic Catheter consists of a radiopaque shaft with an attached molded female luer lock hub. The shaft of the catheter includes a flexible section and an optional soft distal tip. The Selector Angiographic catheter may vary with respect to length, diameter, curve style, and the number of side holes present. Selector Angiographic Catheters can be introduced into the selected blood vessel by either cutdown or percutaneous entry techniques.
Here's a breakdown of the acceptance criteria and study information for the Selector Angiographic Catheter based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Tensile Strength | Required criteria | Device meets criteria |
| Dynamic Pressure | Required criteria | Device meets criteria |
| Flow Rate | Required criteria | Device meets criteria |
| Diameters | Required criteria | Device meets criteria |
| Radiopacity | Required criteria | Device meets criteria |
| Biocompatibility | Required criteria | Device meets criteria |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample sizes used for the non-clinical performance testing. It also does not specify the country of origin for the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
This information is not applicable. The device is a physical medical device (catheter), and its performance is evaluated through physical and material property testing, not through expert review of data like an AI algorithm would be.
4. Adjudication Method for the Test Set:
This information is not applicable, as the evaluation involves non-clinical performance testing of a physical device, not subjective expert assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. This type of study is typically conducted for AI/software devices to assess the impact of AI assistance on human readers' performance. This document describes a physical medical device.
6. Standalone Performance Study:
Yes, a standalone performance study was done in the sense that the device's physical and material properties were tested independently against pre-defined performance criteria. The description "non-clinical performance testing to provide data supporting the safety and effectiveness of the device" indicates a standalone evaluation of the device itself.
7. Type of Ground Truth Used:
The "ground truth" for this device's performance is based on engineering specifications and established performance criteria for medical devices that ensure safety and effectiveness. This includes measurements of tensile strength, dynamic pressure, flow rate, diameters, radiopacity, and biocompatibility, as determined by laboratory testing.
8. Sample Size for the Training Set:
This information is not applicable. The device 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:
This information is not applicable, as there is no training set for a physical medical device.
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).