(14 days)
The VascuTraK™ II PTA Dilatation Catheter is intended for dilatation of stenoses in the peripheral arteries including the iliac, femoral, popliteal, ilio-femoral, infrapopliteal and renal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae.
The VascuTraK™ II Catheter is a sterile single use device that consists of a flexible shaft with a single through lumen terminating in a semi-compliant balloon. The catheter has a 24 cm lumen proximal to the balloon that accepts a 0.014" guidewire and an 18 mm lumen distal to the balloon that accepts a 0.014" guidewire. The distal balloon is inflated via a central lumen terminated in a luer fitting at the proximal end. The balloon is available in various diameters and lengths,
The provided text is a 510(k) summary for the VascuTraK™ II PTA Dilatation Catheter. It describes a medical device, its intended use, and the comparison to a predicate device. However, it does not include a study that proves the device meets specific acceptance criteria in the manner requested by the prompt (e.g., performance metrics like sensitivity, specificity, accuracy, or human reader improvement for an AI/CAD system).
This document is a regulatory submission for a physical medical device (a catheter), not a software or AI-based diagnostic device. Therefore, many of the requested categories like "multi reader multi case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "number of experts used to establish ground truth," "adjudication method," "sample size for training set," and "how ground truth for training set was established" are not applicable to this type of device.
The "acceptance criteria" and "device performance" in this context refer to engineering and biocompatibility testing for the catheter itself.
Here's an attempt to extract and reframe the information based on the provided text, acknowledging the limitations for a physical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria & Test | Reported Device Performance |
|---|---|
| Material Biocompatibility (ISO 10993-1 requirements) | Previously demonstrated for patient contact materials. No new materials used. |
| Sterilization Assurance Level (SAL) | Conforms to SAL of 10⁻⁶. (Prior sterilization testing is valid as modification doesn't affect sterilization.) |
| Balloon Performance | Results for modified device were consistent with those of the original device. |
| Tip Tensile Testing | Results for modified device were consistent with those of the original device. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in a quantifiable manner for the specific tests mentioned. The text states "Testing of the modified catheter was performed," but does not detail the sample sizes for balloon performance or tip tensile testing. Data provenance is not applicable in the context of clinical data for AI/CAD, as this is a physical device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. "Ground truth" in this context would refer to established engineering standards and material science, not expert interpretation of diagnostic images or patient outcomes.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used for resolving disagreements among human readers in diagnostic studies.
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/CAD device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/CAD device.
7. The Type of Ground Truth Used
For biocompatibility, the ground truth is established by ISO 10993-1 standards.
For sterilization, the ground truth is established by regulatory requirements for Sterility Assurance Level (SAL).
For balloon and tip performance, the ground truth is established by engineering specifications and performance data of the original (predicate) device.
8. The Sample Size for the Training Set
Not applicable. This refers to a training set for an algorithm, which is not relevant for this physical device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This refers to ground truth for an algorithm's training data.
Summary of the Study that Proves the Device Meets Acceptance Criteria (as described in the document):
The document details a Special 510(k) Device Modification for the VascuTraK™ II PTA Dilatation Catheter, which is a modification of the previously cleared VascuTraK™ PTA Dilatation Catheter (cleared under K063657).
The primary modification is to the distal tip configuration, changing from a short lumen tip to permit the use of an external guidewire for easier catheter exchange.
The study that proves the device meets acceptance criteria consists of:
- Reliance on prior demonstrations:
- Biocompatibility of patient contact materials was previously demonstrated in accordance with ISO 10993-1, and no new materials were used in the modification.
- The modification does not affect the ability to sterilize the device, so prior sterilization testing establishing a Sterility Assurance Level (SAL) of 10⁻⁶ is considered valid.
- Specific testing of the modified catheter:
- Balloon performance testing was conducted.
- Tip tensile testing was conducted.
- The "results for the modified device were consistent with those of the original device," indicating that the modification did not negatively impact these critical performance characteristics and that the device still met the established performance benchmarks set by its predicate.
The document concludes that there are "no new safety or effectiveness issues related to this device" based on these tests and comparisons. This type of submission relies heavily on the equivalence to a legally marketed predicate device, especially when the changes are minor and do not introduce new technology or materials.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).