(28 days)
Each Langston dual lumen catheter is indicated for delivery of contrast medium in angiographic studies and for simultaneous pressure measurement from two sites. This type of pressurement is useful in determining transvalvular, intravascular and intraventricular pressure gradients.
The Langston dual lumen catheters have two lumens, both with distal sideholes, to allow simultaneous pressure measurements from two sites. The high-pressure inner lumen, which extends the entire length of the catheter, can be used for pressurement and rapid delivery of contrast medium. The outer lumen ends proximal to the distal end of the catheter and is used for pressure measurement only. A side port fitted with an extension tube and a stopcock assembly is used for fluid flow and pressure measurement within the outer lumen. The Langston dual lumen catheter will accommodate a standard ≤ 0.038" diameter guidewire and is supplied with a single use pigtail straightener. The Langston dual lumen catheter is sterilized with ethylene oxide.
This document describes the FDA's 510(k) clearance for the Langston dual lumen catheter (K221470). It's a medical device submission, not a study proving the device meets acceptance criteria for an AI or diagnostic algorithm. Therefore, the questions related to AI/algorithm performance, ground truth, expert consensus, and comparative effectiveness studies are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the physical device based on the provided text.
Here's the breakdown of what can be found and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test) | Reported Device Performance |
|---|---|
| Bench Testing: | |
| Aspiration | Met specified acceptance criteria |
| Liquid Leak | Met specified acceptance criteria |
| Hub to Shaft Tensile | Met specified acceptance criteria |
| Static Burst | Met specified acceptance criteria |
| Flow Rate | Met specified acceptance criteria |
| Biocompatibility: | Complies with ISO 10993-1, leveraging previous testing |
Study that proves the device meets the acceptance criteria:
The study was a series of bench tests and biocompatibility evaluation to demonstrate substantial equivalence to a predicate device, focusing on a design modification to the strain relief to hub bond.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the document for any of the bench tests.
- Data Provenance: The tests were performed internally by Vascular Solutions LLC ("Performance Data" section). The country of origin and retrospective/prospective nature of data collection for these specific tests are not detailed, but they are generally considered prospective bench tests performed for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This document concerns a physical medical device (catheter) and its design validation via bench testing and biocompatibility, not an AI or diagnostic algorithm requiring expert "ground truth" for interpretative accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. As above, this is about physical device performance, not diagnostic interpretations requiring adjudication.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For Bench Testing: The "ground truth" was defined by the specified acceptance criteria for each individual physical performance test (e.g., a minimum tensile strength, a maximum leak rate). These criteria are objective measurements, not subjective expert interpretations or biological outcomes.
- For Biocompatibility: Compliance with ISO 10993-1 is the standard used, which involves a series of tests to assess biological safety.
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. There is no "training set."
In summary, this document is a regulatory clearance for a physical medical device. The "acceptance criteria" and "performance data" provided relate to the manufacturing and physical characteristics of the catheter, not to the diagnostic accuracy of an algorithm or the improvement of human readers with AI assistance.
§ 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).