(174 days)
The Valet™ Micro Catheter is indicated for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The Valet™ Micro Catheter is also indicated to infuse and deliver saline and contrast agents. The Valet™ Micro Catheter is not intended for use in the neurovasculature.
The Valet™ Micro Catheter is a support catheter comprised of a catheter shaft and hub. It is available in lengths 100, 123, 135, and 150 cm. The outer diameter is available in 2 sizes and is tapered from 2.3F to 1.8F and 4.0F to 3.5F. The device offers 45° and 60° angled tips as well as a straight tip.
The provided document describes the safety and effectiveness summary for the Volcano Valet™ Micro Catheter, which is a Class II device. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and biocompatibility testing. No clinical study or AI/Machine Learning component is mentioned.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Performance Testing | |
| Dimensional Verification | Confirmed against known standards, product specifications, or predicate device. |
| Leak Testing | Successfully completed. |
| Leak Testing of Air into the Hub During Aspiration | Successfully completed. |
| Catheter Bond Strength | Confirmed against known standards, product specifications, or predicate device. |
| Flexibility and Kink Test | Confirmed against known standards, product specifications, or predicate device. |
| Torque Strength Test | Confirmed against known standards, product specifications, or predicate device. |
| Radiopacity | Confirmed against known standards, product specifications, or predicate device. |
| Coating Adhesion | Confirmed against known standards, product specifications, or predicate device. |
| Coating Integrity | Confirmed against known standards, product specifications, or predicate device. |
| Particulate Evaluation | Confirmed against known standards, product specifications, or predicate device. |
| Catheter Body Burst Pressure | Confirmed against known standards, product specifications, or predicate device. |
| Contrast Media Flow Rate | Confirmed against known standards, product specifications, or predicate device. |
| Biocompatibility Testing | |
| Cytotoxicity | Successfully completed. |
| Sensitization | Successfully completed. |
| Intracutaneous (irritation) | Successfully completed. |
| Systemic Toxicity | Successfully completed. |
| ASTM Hemolysis | Successfully completed. |
| In Vitro Hemolysis | Successfully completed. |
| C3a Complement Activation | Successfully completed. |
| SC5-b Complement Activation | Successfully completed. |
| Pyrogens | Successfully completed. |
| Hemocompatibility | Successfully completed. |
| In vivo Thromboresistence | Successfully completed. |
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 any of the non-clinical or biocompatibility tests. The provenance of the data is also not specified, but it is implied to be internal testing conducted by Volcano Corporation, given the context of a 510(k) submission. These are non-clinical studies (bench and lab testing), not human or imaging 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 submission is for a medical device (catheter) and relies on non-clinical performance and biocompatibility testing. There is no mention of an "expert" panel establishing "ground truth" as would be the case for an AI/ML diagnostic device interpreting medical images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As there is no human interpretation or diagnostic decision involved in the described testing, no adjudication method is relevant.
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. A multi-reader multi-case study was not done. This device is a catheter, and the submission focuses on its physical and biological performance, not on AI-assisted human reading.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. There is no algorithm or AI component to this device. The testing described is for the physical and biological characteristics of the catheter itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" would be defined by known engineering standards, product specifications, or direct comparison to the predicate device's measured performance. For biocompatibility, the "ground truth" is established by validated biological test methods and their predetermined acceptance criteria (e.g., cell viability in cytotoxicity tests).
8. The sample size for the training set
Not applicable. There is no training set mentioned or implied as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set.
§ 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).