(70 days)
The Vascular Solutions Langston™ Dual Lumen Pigtail 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 Pigtail 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 pigtail catheter and outer lumen are joined together using a adapter junction placed near the proximal end of the pigtail 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 pigtail. The dual lumen pigtail catheter is deployed through standard 8Fr guide catheters and will accommodate standard 0.038" diameter guidewires.
Acceptance criteria and the study proving the device meets them:
This submission is for a K041909 Dual Lumen Pigtail Catheter.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: For delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites (to determine transvalvular, intravascular, and intraventricular pressure gradients). | The "Summary of Non-Clinical Testing" states: "Testing conducted included assessments of the design verification of the Dual Lumen Pigtail Catheter along with biocompatibility assessments. The results of this battery of tests confirmed the suitability of the Dual Lumen Pigtail Catheter for its intended use." |
| Safety: Device is safe for its intended use. | Biocompatibility assessments were conducted as part of the non-clinical testing. (Specific safety metrics or thresholds are not provided in the document.) |
| Performance: Device performs as intended. | Non-clinical testing included "design verification" which confirmed "the suitability of the Dual Lumen Pigtail Catheter for its intended use." |
| Substantial Equivalence: Similar in intended use and function to predicate devices (Cordis Dual Lumen Pressure Monitoring Catheter (K914141), USCI Cardiovascular Catheter (K943739), and Merit Medical Softouch Diagnostic Intravascular Catheter (K810412)). | The submission concludes, "The Dual Lumen Pigtail Catheter is substantially equivalent to the Cordis Dual Lumen Pressure Monitoring Catheter, the USCI Cardiovascular Catheter and the Merit Medical Softouch Diagnostic Intravascular Catheter." |
2. Sample size used for the test set and the data provenance:
- Sample size for the test set: Not applicable for clinical data. The document explicitly states, "No clinical evaluations of this product have been conducted." For non-clinical testing, specific sample sizes for design verification or biocompatibility testing are not provided in this summary.
- Data provenance: Not applicable for clinical data. For non-clinical data, the provenance is internal testing performed by Vascular Solutions, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as no clinical evaluations were conducted that would require experts to establish ground truth from patient data. Non-clinical testing would have relied on design specifications and engineering standards.
4. Adjudication method for the test set:
- Not applicable, as no clinical evaluations were conducted that would require adjudication of patient data.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intravascular diagnostic catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical medical instrument, not a software algorithm.
7. The type of ground truth used:
- For the non-clinical testing, the "ground truth" would be established by engineering specifications, material standards, and performance benchmarks relevant to physical medical devices (e.g., pressure measurement accuracy based on calibrated instruments, material compatibility based on established biocompatibility standards).
- No clinical ground truth (e.g., expert consensus, pathology, outcomes data) was used, as no clinical studies were performed.
8. The sample size for the training set:
- Not applicable, as this is a physical medical device and not an AI/machine learning model 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 and not an AI/machine learning model whose training set would require ground truth establishment.
§ 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).