(206 days)
The Concentric Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
The Concentric Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. A radiopaque marker is included on the distal end for angiographic visualization. A compliant balloon is mounted on the distal end to provide temporary vascular occlusion during angiographic procedures. A bifurcated luer hub on the proximal end allows attachments for flushing, inflation and aspiration. Balloon Guide Catheter dimensions and maximum recommended balloon inflation volume are indicated on product label. If indicated on product label, a dilator is provided.
The provided document describes a 510(k) submission for the Concentric Balloon Guide Catheter, focusing on its substantial equivalence to a predicate device and a minor modification to its indications for use. As such, the document does NOT contain information about a study proving device performance against acceptance criteria in the context of AI/ML or diagnostic accuracy, but rather verification testing for the physical device.
Therefore, many of the requested fields cannot be populated from the provided text.
Here's the information that can be extracted or deduced from the document regarding the device's acceptance criteria and the verification testing performed:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Test Performed) | Reported Device Performance |
|---|---|
| Tensile Testing | Meets predetermined specifications (remains applicable from predicate device) |
| Leak Testing | Meets predetermined specifications (remains applicable from predicate device) |
| Dimensional Testing | Meets predetermined specifications (remains applicable from predicate device) |
| Torque Testing | Meets predetermined specifications (remains applicable from predicate device) |
| Kink Resistance | Meets predetermined specifications (remains applicable from predicate device) |
| Simulated Use | Meets predetermined specifications (remains applicable from predicate device) |
| Biocompatibility Testing | Meets predetermined specifications (remains applicable from predicate device). |
| Additionally, for new colorant: |
- Hemolysis, Direct Contact Method: Successfully performed
- Hemolysis, Extract Method: Successfully performed
- Cytotoxicity - ISO MEM Elution: Successfully performed |
| Balloon Fatigue | Meets predetermined specifications (remains applicable from predicate device) |
| Inflation/Deflation Testing | Meets predetermined specifications (remains applicable from predicate device) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document does not specify sample sizes for these verification tests.
- The data provenance is not specified beyond being part of a 510(k) submission to the FDA (USA). The tests are verification tests for a physical device, not a study involving human data.
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. This is not a study involving diagnostic accuracy or human interpretation. The "ground truth" for the physical device tests would be established by engineering specifications and objective measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept is relevant for studies involving human interpretation and consensus establishment, not for objective physical device testing.
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
- No. This is a 510(k) submission for a physical medical device (catheter) and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML algorithm or software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the physical tests, the "ground truth" is based on predetermined engineering specifications and objective measurements for mechanical and biological properties (e.g., tensile strength, leak rates, dimensional tolerances, biocompatibility standards).
8. The sample size for the training set
- Not applicable. This is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. This is not a machine learning model.
§ 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).