(24 days)
For use in those patients with cardiovascular defects wherein accurate measurement . I of the defect is important to select the appropriately sized occluder device.
The NuMED, Inc. PTS X™ Sizing Balloon catheter is a coaxial catheter for use in those patients with cardiovascular defects wherein accurate measurement of the defect is important to select the appropriately sized occluder device. The outer body is made of polymeric tubing, and the inner tubing is comprised of a multi layer extrusion of polyamide (Vestamid PA12) that surrounds a braid of 304 LV Stainless Steel. The catheter features a proximal end bifurcate with two distinct luminal passages. The inflation lumen terminates into a distally mounted balloon. This balloon is of the non-compliant variety and will have a typical single wall thickness of 0.0004". This balloon is designed to insert through the smallest possible introduction sleeve. The through lumen terminates at the tip of the catheter and will accept the passage of the appropriate guidewire. This lumen has radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. Additionally, there are two radiopaque platinum marker bands spaced at 10mm (as measured from leading edge to leading edge). These bands are located at the balloon center and are used as a distance reference. The catheter is white in color and the balloon material is clear. The catheter balloon diameter is stamped onto the Y sleeve and the balloon extension is labeled with balloon diameter x balloon length x introducer size x shaft size x usable length x guidewire size and the catheter lot number. The catheter is packaged in a polyethylene loop and is double packed in two heat sealed Tyvek pouches.
The provided text is a clearance letter from the FDA for the NuMED PTS X Sizing Balloon Catheter, not a study report. Therefore, it does not contain information about acceptance criteria, device performance, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document primarily states that the device is substantially equivalent to a legally marketed predicate device (NuMED PTS Catheter) based on its intended use and material similarity. It outlines the regulatory classification and general requirements for the device.
Here's a breakdown of why the requested information cannot be extracted from the provided text:
- No clinical study or performance data: The letter focuses on the regulatory clearance process and substantial equivalence, not on a detailed study proving performance against specific acceptance criteria.
- No mention of acceptance criteria: Specific metrics for device performance (e.g., accuracy of measurement, safety rates) that would constitute "acceptance criteria" are not listed.
- No device performance metrics: The document describes the device and its intended use but does not provide quantitative or qualitative data on how well it performs its function.
- No sample size for test set: No clinical or laboratory test results are detailed with sample sizes.
- No data provenance: Information on the origin of data (if any), such as geographical location or retrospective/prospective nature, is absent.
- No expert involvement: There is no mention of experts establishing ground truth or their qualifications.
- No adjudication method: This would be relevant to evaluating expert consensus, which isn't discussed.
- No MRMC study: The document does not describe any study involving human readers or AI assistance.
- No standalone algorithm performance: This device is a physical catheter, not an algorithm, so standalone algorithm performance is not applicable.
- No type of ground truth used: Since no performance study is described, there's no mention of ground truth.
- No sample size for training set/ground truth for training set: These concepts are typically relevant to AI/machine learning models, which this device is not. The "training" for this device would be its design and manufacturing processes, not data training.
In summary, the provided document is a regulatory clearance letter, not a study report. It does not contain the information required to populate the table or answer the specific questions about acceptance criteria, study details, and device performance.
§ 870.4450 Vascular clamp.
(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).