(82 days)
The Ursa™ angiographic catheter is intended for use in the delivery of radiopaque contrast media to selected sites in the coronary and peripheral vasculature. The device is for single use only. This device is not intended for use in the neurovasculature.
The Ursa™ angiographic catheters are sterile, single use, disposable devices designed to deliver radiopaque contrast media to selected sites in the vascular system. It is available in 39different curve shapes and three sizes of 4, 5 and 6F. This Special 510(k) adds sixteen (16) new shapes to the current commercially available selection of catheters. Each device consists of a catheter with luer connector: strain relief, catheter shaft, catheter soft extension and soft distal tip. The distal end of the catheter is formed into a variety of shapes required to access a variety of vascular anatomies. All versions of the catheters are designed to accept a maximum guidewire diameter of 0.038" and have a strain relief at the hub to shaft junction. Sideholes may be incorporated into the shaft to facilitate injection of radiopaque contrast media.
Here's an analysis of the provided text regarding the Ursa™ Angiographic Catheter:
The provided document describes a Special 510(k) submission for the Ursa™ Angiographic Catheter to add 16 new shapes. It focuses on demonstrating substantial equivalence to a predicate device (Ursa™ Angiographic Catheter K090427), rather than proving the device meets new acceptance criteria through a comprehensive clinical study or standalone algorithm performance.
Therefore, many of the requested sections below, particularly those related to AI/algorithm performance, multi-reader studies, and detailed ground truth establishment, are not applicable to this type of device submission.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (New Shapes) |
|---|---|
| Same Intended Use | Meets criteria |
| Similar Method of Operation and Design | Meets criteria |
| Identical Materials | Meets criteria |
| Same Basic Catheter Design | Meets criteria |
| Same Manufacturing Methods | Meets criteria |
| Same Packaging and Sterilization Method | Meets criteria |
| Performance Testing (Dimensional and Functional) | Conducted according to protocols |
Explanation: The "acceptance criteria" for a Special 510(k) for adding shapes to an existing device are primarily centered around demonstrating that the new shapes do not introduce new questions of safety or effectiveness and maintain the same characteristics and performance as the predicate device. The performance data focuses on verifying these aspects rather than establishing novel performance metrics.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated as a separate "test set" for a clinical study. Performance testing was conducted on the "sixteen (16) new shapes," which implies each new shape served as a "sample" for dimensional and functional tests.
- Data Provenance: Not applicable in the context of human data. The testing involves engineering and mechanical assessments of the physical devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This device submission does not involve clinical data or expert interpretation of images for ground truth. The "ground truth" for verifying the new shapes would be based on engineering specifications and physical measurements.
4. Adjudication Method for the Test Set:
- Not applicable. No expert adjudication process similar to clinical or imaging studies is described or expected for this type of submission.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is a medical device for delivering contrast media, not an AI or imaging analysis tool. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth: For the "performance testing," the ground truth would be against the established engineering specifications for the predicate device and relevant international standards for angiographic catheters (e.g., dimensions, material properties, burst pressure, flow rates, etc.).
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/machine learning device.
Summary of Study (Performance Testing for Special 510(k)):
The study described is not a clinical trial or an AI performance study. It is a series of engineering and benchtop performance tests conducted on the 16 new shapes of the Ursa™ Angiographic Catheter. The purpose of these tests was to demonstrate that these new shapes maintain substantial equivalence to the previously cleared predicate device.
The study did not involve human subjects, image interpretation by experts, or AI algorithms. Instead, it focused on:
- Dimensional verification: Ensuring the new shapes meet specified measurements.
- Functional testing: Verifying properties such as material integrity, burst pressure, flow rates, and other mechanical aspects critical to the catheter's safe and effective operation within its intended use.
The "study" served to confirm that the changes (introduction of new shapes) do not alter the fundamental safety or effectiveness profile of the device, thereby supporting its substantial equivalence claim to the predicate.
§ 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).