(112 days)
The Vascular Solutions Langston™ Dual Lumen Pressure Monitoring Catheter is indicated for delivery of contrast media 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 Catherer (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 catherer. 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 multiple holes to allow pressure measurement simultaneously with the inner catheter. The dual lumen catheter is deployed through standard introducers and will accommodate standard 0.038'' diameter guidewires.
The provided document, K050168, is a 510(k) Summary of Safety and Effectiveness for the Langston™ Dual Lumen Pressure Monitoring Catheter. This document is a premarket notification for a medical device and, as such, does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the manner typically seen for performance evaluations of AI/software devices.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing. It explicitly states that "No clinical evaluations of this product have been conducted." Therefore, the information requested regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies is not applicable to this submission, as such studies were not performed for this 510(k) clearance.
Here's a breakdown of the provided information in the context of your request:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, accuracy, or similar quantitative measures for an AI/software device. The implicit acceptance criterion for a 510(k) is "substantial equivalence" to predicate devices, supported by non-clinical testing.
- Reported Device Performance: Instead of performance metrics, the document reports the outcome of non-clinical testing.
- "Testing conducted included assessments of the design verification of the Dual Lumen Pressure Monitoring Catheter and biocompatibility assessments."
- "The results of this battery of tests confirmed the suitability of the Dual Lumen Pressure Monitoring Catheter for its intended use."
- This confirms the device met its design specifications and biocompatibility requirements but doesn't provide specific quantitative performance data in the context of your request.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No clinical or performance test set data is reported. The "testing" refers to bench testing and biocompatibility assessments, not data from a test set of cases.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth establishment by experts for a test set was performed or reported.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No clinical test set and thus no adjudication method for ground truth.
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:
- Not Applicable. This is a hardware device submission, not an AI/software device. No MRMC study was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a hardware device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable. No ground truth was established for "performance" as it relates to clinical outcomes or interpretation in the way an AI/software device would be evaluated. The "ground truth" equivalent here would be the engineering specifications and established safety standards met through bench testing.
8. The sample size for the training set:
- Not Applicable. This is not an AI/software device; there is no training set.
9. How the ground truth for the training set was established:
- Not Applicable. No training set was used.
In summary: The K050168 document is a traditional medical device 510(k) submission, not for an AI/software device. Its clearance is based on non-clinical testing demonstrating substantial equivalence to pre-existing predicate devices, not on the type of clinical performance studies and ground truth establishment typically required for AI-powered diagnostics.
§ 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).