(28 days)
The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring Catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressure measurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring catheter is intended for use as a pressure measurement catheter and for delivery of contrast media during angiographic studies. The DLP catheter consists of the Merit Medical Softouch Diagnostic Intravascular Catheter (K943739) as the inner lumen and an extruded outer lumen designed by Vascular Solutions. The inner lumen and hub assembly are purchased from Merit Medical in a non-sterile state. The Merit Softouch catheter and outer lumen are joined together using an adapter junction placed near the proximal end of the Merit Softouch catheter. The adapter junction incorporates a side port fitted with a stopcock/tube assembly for fluid flow and pressure measurement within the outer tube. The distal end of the outer tube is perforated with side holes to allow pressure measurement simultaneously with the sideholes at the tip of the catheter. The dual lumen catheter is deployed through standard guide catheters and will accommodate standard 0.038'' diameter guidewires.
The provided text describes a 510(k) submission for the Langston™ Dual Lumen Pressure Monitoring Catheter. This device is an Intravascular Diagnostic Catheter and is an unclassified device. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing a study that assesses its performance against specific acceptance criteria in a clinical setting.
Therefore, much of the requested information cannot be extracted directly from this document because it outlines a regulatory submission process for a medical device rather than for an AI/machine learning device that would undergo rigorous performance evaluation against established reference standards.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific "acceptance criteria" for device performance (e.g., accuracy, sensitivity, specificity) and corresponding reported performance are provided in the document. The submission focuses on demonstrating substantial equivalence to predicate devices based on design verification and biocompatibility.
2. Sample Size Used for the Test Set and Data Provenance:
No test set for evaluating the device's performance (in the context of AI/ML) is mentioned. The document refers to "design verification" non-clinical testing.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable. The document does not describe a study involving expert-established ground truth for device performance evaluation.
4. Adjudication Method:
Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or reported.
6. Standalone Performance:
No standalone (algorithm-only) performance is reported, as this is a physical medical device, not an AI algorithm.
7. Type of Ground Truth Used:
Not applicable in the context of an AI/ML device. For a physical medical device, "ground truth" would refer to its physical and functional characteristics verified through engineering and biocompatibility testing. The text states: "Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter along with biocompatibility assessments."
8. Sample Size for the Training Set:
Not applicable; no AI/ML model was trained.
9. How the Ground Truth for the Training Set Was Established:
Not applicable; no AI/ML model was trained.
Summary of Information from the Provided Text:
The document describes a 510(k) premarket notification for a medical device, not an AI/ML product. The regulatory pathway for this device relies on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing (design verification and biocompatibility) rather than clinical performance studies against specific acceptance criteria.
Key points from the document regarding the device's qualification:
- Non-Clinical Testing: "Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Dual Lumen Pressure Monitoring Catheter for its intended use."
- Clinical Testing: "No clinical evaluations of this product have been conducted." (This explicitly states the absence of human clinical trials).
- Predicate Devices: The device is deemed substantially equivalent to:
- Langston Dual Lumen Pigtail Catheters
- Cordis Dual Lumen Pressure Monitoring Catheter
- Merit Medical Softouch Diagnostic Intravascular Catheter
- Conclusion: "The testing performed confirms that the Langston Dual Lumen Pressure Monitoring Catheter will perform as intended." This statement refers to the non-clinical design verification and biocompatibility testing.
§ 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).