(305 days)
The BridgePoint Medical Stingray™ Orienting Balloon Catheter is indicated for directing, steering, controlling, and supporting a guidewire in order to access discrete regions of the coronary and peripheral vasculature.
The Stingray Orienting Balloon Catheter is a single use, over the wire, disposable percutaneous catheter consisting of a distal inflatable element, that when inflated with radiopaque contrast media provides visibility and intra-arterial stability. The catheter also includes a proximal shaft that provides flexibility and push and includes a guidewire lumen. The distal inflatable element consists of two small caliber inflatable Pebax® balloons positioned adjacent to a Pebax® and PTFE guide wire lumen. When inflated, these small caliber balloons along with the guidewire lumen define a planar geometry where the width of the construction (2.5 mm) is approximately 2.5 times its height. Within the inflatable element, the distal portion of the catheter includes two oppositely facing lateral ports that communicate with the central guide wire lumen. These ports allow the operator to direct a guidewire from the wire lumen outward at an angle (approximately 45°) to the catheter shaft. The Stingray Orienting Balloon Catheter has radiographic marks that allow the physician to determine the orientation of the catheter with respect to the vasculature. The distal portion of the Stingray Orienting Balloon Catheter is hydrophilic coated to enhance lubricity.
This document is a 510(k) summary for the BridgePoint Medical Stingray™ Orienting Balloon Catheter. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a formal study with acceptance criteria, sample sizes, and detailed ground truth methodology as might be seen for a novel device requiring a PMA or a more extensive clinical trial.
Based on the provided text, there is no specific efficacy or performance study detailed with quantitative acceptance criteria, reported device performance, sample sizes, expert ground truth, or MRMC studies typically found for AI/imaging device submissions. The submission relies on comparison to predicate devices to establish substantial equivalence.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
There is no such table in the provided text. The submission focuses on substantial equivalence to predicate devices based on intended use, method of operation, and technical aspects. Performance evaluation is mentioned in summary but not detailed with specific metrics or acceptance criteria.
2. Sample Sizes Used for the Test Set and Data Provenance:
Not applicable. This submission does not describe a performance study with a test set of data as it's typically understood for AI or diagnostic devices. The evaluation is based on comparison of design and function to predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No ground truth establishment by experts is described for a performance study.
4. Adjudication Method for the Test Set:
Not applicable. No performance study with adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No. This type of study is not mentioned or described.
6. If a Standalone (Algorithm Only) Performance Study Was Done:
No. This device is a physical medical catheter, not a software algorithm. Therefore, "standalone" performance in the context of AI/software is not applicable. The device's performance would be assessed through bench testing and, potentially, animal or limited human trials to assess safety and function (e.g., steerability, patency), but these details are not provided here in the 510(k) summary.
7. The Type of Ground Truth Used:
Not applicable. No formal ground truth establishment for a performance study is described here. The "truth" for this 510(k) is the established safety and effectiveness of the predicate devices.
8. The Sample Size for the Training Set:
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the information provided in the document:
The 510(k) summary for the BridgePoint Medical Stingray™ Orienting Balloon Catheter establishes substantial equivalence to existing predicate devices (LuMend Percutaneous Catheter K011562, Venture Wire Control Catheter Model WCC K061843, and Kerberos Occluding Guide Catheter and Accessories K041151). The basis for this equivalence is:
- Intended Use: All devices are designed to access discrete regions of the coronary and peripheral vasculature. The Stingray is indicated for directing, steering, controlling, and supporting a guidewire.
- Method of Operation: The Stingray uses non-therapeutic inflatable balloon elements at the distal tip for stability, visual orientation, and guidewire placement, similar to the Kerberos device.
- Technical Aspects: The device description highlights features like a distal inflatable element, radiopaque contrast media for visibility, intra-arterial stability, a proximal shaft for flexibility and push, a guidewire lumen, and lateral ports to direct a guidewire at an angle. It also mentions radiographic marks for orientation and a hydrophilic coating.
The "study" in this context is the comparison to predicate devices to demonstrate that the new device does not raise new questions of safety or effectiveness. The FDA's letter confirms that they have reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device implicitly meets the safety and performance standards established by those predicates, as determined by the FDA's regulatory review process, rather than through a direct comparative performance study against specific acceptance criteria outlined in this summary.
§ 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).